| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Phase I, Single Center, Open-label, Dose Escalation Study of Recombinant Human Granulocyte Colony-stimulating Factor Fc Fusion Protein (F-627) in Breast Cancer Patient Receiving Adjuvant Chemotherapy [NCT02527746] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Reduce Intensity Conditioning (RIC) Allogenic Hematopoietic Stem Cell Transplantation (Allo HSCT) for Patients With Relapsed Multiple Myeloma: A Pilot Study [NCT04205240] | Phase 2 | 1 participants (Actual) | Interventional | 2020-12-22 | Terminated(stopped due to Poor accrual) |
| A Phase I Study of FT576 as Monotherapy and in Combination With Daratumumab in Subjects With Relapsed/Refractory Multiple Myeloma [NCT05182073] | Phase 1 | 168 participants (Anticipated) | Interventional | 2021-11-24 | Recruiting |
| Phase Ib/II Trial to Evaluate Safety and Efficacy of Oral Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease. [NCT03225417] | Phase 1/Phase 2 | 142 participants (Anticipated) | Interventional | 2017-05-16 | Active, not recruiting |
| S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's [NCT01925131] | Phase 1 | 50 participants (Actual) | Interventional | 2014-06-13 | Completed |
| Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD) [NCT01088724] | Phase 4 | 4 participants (Actual) | Interventional | 2002-02-28 | Completed |
| A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus [NCT00076752] | Phase 2 | 9 participants (Actual) | Interventional | 2004-01-30 | Completed |
| Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma [NCT00075582] | Phase 3 | 390 participants (Actual) | Interventional | 2004-09-04 | Completed |
| Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial [NCT00088530] | Phase 3 | 140 participants (Actual) | Interventional | 2004-07-31 | Completed |
| Pilot Trial of Hyper-CVAD and Methotrexate/ARA C Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma [NCT00041132] | Phase 2 | 56 participants (Actual) | Interventional | 2002-09-30 | Completed |
| A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma [NCT03943472] | Early Phase 1 | 10 participants (Anticipated) | Interventional | 2019-07-08 | Recruiting |
| A Phase II/III Prospective, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed/ Refractory B-Acute Lymphoblastic Leukaemia [NCT03937544] | Phase 2/Phase 3 | 10 participants (Anticipated) | Interventional | 2019-03-19 | Recruiting |
| Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria [NCT01222052] | Phase 3 | 4,150 participants (Actual) | Interventional | 2002-01-31 | Active, not recruiting |
| A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer [NCT05681728] | Phase 2 | 26 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
| Role of Alpha-Lipoic Acid Against Chemotherapy Induced Toxicities in Breast Cancer Patients [NCT03908528] | | 64 participants (Actual) | Interventional | 2019-03-01 | Completed |
| Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma [NCT01149902] | Phase 1 | 10 participants (Anticipated) | Interventional | 2010-07-31 | Recruiting |
| Allogeneic HSCT Without Preparative Chemotherapy or With Low-Intensity Preparative Chemotherapy Using Sirolimus and Sirolimus-Generated Donor Th2 Cells for Therapy of Refractory Leukemia, Lymphoma, Myeloma, or Myelodysplastic Syndrome [NCT00074490] | Phase 2 | 442 participants (Actual) | Interventional | 2004-01-01 | Terminated(stopped due to Premature closure due to inability to accrue to ARM IVD, cohorts 1 and 2) |
| A Phase II Study of the Bruton's Tyrosine Kinase Inhibitor, Zanubrutinib, in Combination With Lenalidomide Plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT05200312] | Phase 2 | 36 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
| Combined Phase I-Phase II Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma [NCT03448978] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2018-02-26 | Completed |
| A Phase II Study of R-CHOP and Ibritumomab Tiuxetan (Zevalin) for Elderly Patients With Previously Untreated Diffuse Large B-Cell Lymphoma [NCT00058422] | Phase 2 | 65 participants (Actual) | Interventional | 2003-02-10 | Completed |
| Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma [NCT00038142] | Phase 2 | 46 participants (Actual) | Interventional | 1997-11-30 | Terminated(stopped due to Low Accrual) |
| Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer [NCT01090128] | Phase 1 | 27 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to Drug Manufacturer withdrew support for studies not in metastatic breast cancer) |
| A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer [NCT01199432] | Phase 4 | 501 participants (Anticipated) | Interventional | 2010-10-31 | Completed |
| HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen [NCT03850366] | Phase 2 | 15 participants (Anticipated) | Interventional | 2016-03-08 | Recruiting |
| A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells [NCT01779050] | Phase 2 | 7 participants (Actual) | Interventional | 2013-12-19 | Terminated(stopped due to Loss of study funding) |
| Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy [NCT00303719] | Phase 2 | 342 participants (Actual) | Interventional | 2002-03-26 | Terminated(stopped due to IRB Study Closure) |
| A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease [NCT00302003] | Phase 3 | 287 participants (Actual) | Interventional | 2006-02-28 | Completed |
| Open-label Multi-center Randomized Non-inferiority Study to Compare Efficacy and Safety of Pegylated Liposomal Doxorubicin Versus Doxorubicin for Newly Diagnosed Peripheral T-cell Lymphoma [NCT03952572] | Phase 3 | 244 participants (Anticipated) | Interventional | 2019-05-10 | Recruiting |
| Fludarabine-based Conditioning for Allogeneic Marrow Transplantation From HLA-compatible Unrelated Donors in Severe Aplastic Anemia (BMT CTN #0301) [NCT00326417] | Phase 1/Phase 2 | 97 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease [NCT00265889] | Phase 2 | 42 participants (Actual) | Interventional | 2002-02-28 | Completed |
| Phase II Study of Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Hematopoietic Malignancies Including Those That Are Challenging to Engraft [NCT03187756] | Phase 2 | 6 participants (Actual) | Interventional | 2017-06-02 | Terminated(stopped due to Procedure has become standard of care - protocol is no longer necessary) |
| Thalidomide-Dexamethasone Incorporated Into Double Autologous Stem-Cell Transplantation for Patients Less Than 65 Years of Age With Newly Diagnosed Multiple Myeloma [NCT01341262] | Phase 2 | 378 participants (Actual) | Interventional | 2002-03-31 | Completed |
| Epigenetically-Modified Autologous Tumor Cell Vaccs and ISCOMATRIX(TM) Adjuvant With Metronomic Oral Cyclophosphamide and Celecoxib in Pts Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleur [NCT01341496] | Phase 1 | 41 participants (Actual) | Interventional | 2011-04-18 | Terminated |
| A Phase 1b, Multicenter, Open-label Trial of Oncolytic MG1 Expressing MAGE-A3 (MG1-MAGEA3) With Adenovirus Vaccine Expressing MAGE-A3 (Ad-MAGEA3), in Combination With Immune Modulating Therapy in Patients With Metastatic Melanoma or Previously Treated Cut [NCT03773744] | Phase 1 | 0 participants (Actual) | Interventional | 2020-02-15 | Withdrawn(stopped due to insufficient suitable drug supply) |
| Study Of Reduced Dose Craniospinal Radiotherapy (1800 cGy) And Chemotherapy In Children With Newly-Diagnosed Standard-Risk Posterior Fossa Primitive Neuro-ectodermal Tumor (PNET/Medulloblastoma) [NCT00031590] | Phase 2 | 30 participants (Actual) | Interventional | 2001-04-30 | Terminated(stopped due to The study was terminated prematurely due to slow accrual.) |
| A Randomized, Phase III Study Comparing TAC (Docetaxel, Doxorubicin, Cyclophosphamide) With TCX ( Docetaxel, Cyclophosphamide, Capecitabine) as Adjuvant Treatment for Node-Positive Her2-Negative Breast Cancer [NCT01354522] | Phase 3 | 400 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting |
| A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma [NCT01352338] | Phase 1/Phase 2 | 82 participants (Actual) | Interventional | 2011-08-31 | Completed |
| "A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone (ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol" [NCT00002766] | Phase 3 | 170 participants (Actual) | Interventional | 1996-03-31 | Completed |
| A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma [NCT00027846] | Phase 2 | 378 participants (Actual) | Interventional | 2003-08-31 | Completed |
| Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study [NCT00026208] | Phase 2 | 76 participants (Actual) | Interventional | 2001-06-30 | Completed |
| A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Prev [NCT06047080] | Phase 3 | 1,130 participants (Anticipated) | Interventional | 2023-09-18 | Recruiting |
| A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies [NCT05694364] | Phase 1 | 88 participants (Anticipated) | Interventional | 2023-01-25 | Recruiting |
| A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma [NCT05347485] | Phase 2 | 86 participants (Actual) | Interventional | 2022-05-13 | Active, not recruiting |
| A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis [NCT05250973] | Phase 2 | 150 participants (Anticipated) | Interventional | 2022-03-01 | Recruiting |
| Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors [NCT05075993] | Phase 1 | 352 participants (Anticipated) | Interventional | 2021-11-12 | Recruiting |
| A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) [NCT04923893] | Phase 3 | 650 participants (Anticipated) | Interventional | 2021-08-19 | Recruiting |
| A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies [NCT04904588] | Phase 2 | 300 participants (Anticipated) | Interventional | 2021-09-30 | Recruiting |
| Selinexor in Combination With Chemotherapy to Treat Relapsed/Refractory Multiple Myeloma Patients [NCT04877275] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-05-21 | Recruiting |
| A Phase II Study of High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) [NCT03945591] | Phase 2 | 23 participants (Actual) | Interventional | 2019-06-20 | Active, not recruiting |
| Multi-center Phase I/II Study of NY-ESO-1 T Cell Receptor Gene Transferred T Lymphocytes in Patients With Synovial Sarcoma [NCT03250325] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2017-09-20 | Completed |
| Registry of IgA Nephropathy in Chinese Children [NCT03015974] | | 1,200 participants (Anticipated) | Observational [Patient Registry] | 2016-01-31 | Recruiting |
| A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL) [NCT02048813] | Phase 3 | 529 participants (Actual) | Interventional | 2014-02-20 | Active, not recruiting |
| Phase II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4 for Patients With Metastatic Melanoma [NCT02027935] | Phase 2 | 16 participants (Actual) | Interventional | 2015-01-22 | Active, not recruiting |
| Efficacy of First Line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for Patients With Waldenström's Macroglobulinemia [NCT01788020] | Phase 3 | 202 participants (Actual) | Interventional | 2013-11-30 | Active, not recruiting |
| A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With [NCT01275677] | Phase 3 | 3,270 participants (Actual) | Interventional | 2011-01-06 | Active, not recruiting |
| Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II [NCT00233987] | Phase 2 | 98 participants (Actual) | Interventional | 2005-10-31 | Completed |
| Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II [NCT00070018] | Phase 2 | 46 participants (Actual) | Interventional | 2004-02-29 | Completed |
| A Feasibility Study of Vorinostat (SAHA) Combined With Isotretinoin and Chemotherapy in Infants With Embryonal Tumors of the Central Nervous System [NCT00867178] | Phase 1 | 33 participants (Actual) | Interventional | 2009-02-25 | Completed |
| Prospective Non-randomized Multicenter Study to Assess the Efficacy Response Duration and Toxicity of RFC as First-line Treatment and R as Maintenance Treatment, in Patients Diagnosed of Follicular Non Hodgkin Lymphoma [NCT01124526] | Phase 4 | 75 participants (Actual) | Interventional | 2004-09-30 | Completed |
| Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer [NCT01227408] | Phase 2 | 0 participants (Actual) | Interventional | 2009-02-28 | Withdrawn(stopped due to Sponsor withdrew due to funding issues) |
| Efficacy and Safety of Tocilizumab and Tofacitinib in the Treatment of Patients With Vascular Behçet's Syndrome [NCT05845723] | Phase 2 | 81 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
| Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases [NCT05805605] | Phase 2 | 56 participants (Anticipated) | Interventional | 2023-05-01 | Recruiting |
| A Multicenter, Open-label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors [NCT05678205] | Phase 1/Phase 2 | 133 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
| A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Chidamide Combined With CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisone ) in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma [NCT03853044] | Phase 2 | 23 participants (Anticipated) | Interventional | 2018-12-29 | Active, not recruiting |
| Phase II Study of Reduced-Intensity Allogeneic Stem Cell Transplant for High-Risk Chronic Lymphocytic Leukemia (CLL) [NCT01027000] | Phase 2 | 68 participants (Actual) | Interventional | 2010-02-28 | Completed |
| Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors [NCT00379340] | Phase 3 | 395 participants (Actual) | Interventional | 2007-02-26 | Active, not recruiting |
| Randomized Comparison of Cyclophosphamide Versus Fludarabine in Addition to Anti-thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Adult Acquired Aplastic Anemia [NCT01145976] | Phase 3 | 98 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt [NCT05195086] | | 122 participants (Actual) | Observational | 2018-07-01 | Completed |
| CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study [NCT04375631] | Phase 1 | 120 participants (Anticipated) | Interventional | 2020-12-03 | Recruiting |
| A Phase IB/II Study of Durvalumab (MEDI4736) Combined With Dose-dense EC in a Neoadjuvant Setting for Patients With Locally Advanced Luminal B HER2(-) or Triple Negative Breast Cancers. [NCT03356860] | Phase 1/Phase 2 | 57 participants (Actual) | Interventional | 2017-04-13 | Active, not recruiting |
| Molecular Triaging of Newly Diagnosed Breast Cancer for Preoperative Therapies [NCT01159236] | | 0 participants (Actual) | Interventional | 2010-09-30 | Withdrawn(stopped due to Recent developments lead to re-evaluation of study.) |
| Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial [NCT05834582] | Phase 2 | 60 participants (Anticipated) | Interventional | 2023-04-08 | Recruiting |
| Phase I/II Trial of Allograft Engineered MSC-IFNα Combined With or Without Immunochemotherapy for Locally Advanced/Metastatic Solid Tumors [NCT05699811] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2023-02-23 | Recruiting |
| Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients [NCT04348006] | Phase 4 | 0 participants (Actual) | Interventional | 2020-03-01 | Withdrawn(stopped due to No patients were enrolled in the study) |
| High-dose Cyclophosphamide for the Treatment of ROHHAD (Rapid Onset Obesity, Hypoventilation, Hypothalamic Dysfunction, and Autonomic Dysregulation) Syndrome [NCT02441491] | | 12 participants (Anticipated) | Interventional | 2015-03-31 | Active, not recruiting |
| COBALT: Evaluation of CAR19 T-cells as an Optimal Bridge to Allogeneic Transplantation [NCT02431988] | Phase 1 | 10 participants (Actual) | Interventional | 2016-06-30 | Completed |
| Prospective, Multi-center Phase I/II Trial of Lenalidomide and Dose-Adjusted EPOCH-R in MYC-Associated B-Cell Lymphomas [NCT02213913] | Phase 1/Phase 2 | 46 participants (Anticipated) | Interventional | 2014-07-29 | Active, not recruiting |
| Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy With Metronomic/Oral Chemotherapy (Cytophosphan Combined With Low-dose Methotrexate)and COX-2 Inhibition (Celecoxib) [NCT01175772] | Phase 2 | 6 participants (Actual) | Interventional | 2010-08-31 | Terminated(stopped due to Due to change in the national policy of medications) |
| Dose-reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study (RICMAC) [NCT01203228] | Phase 3 | 129 participants (Actual) | Interventional | 2004-05-31 | Terminated |
| Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.) [NCT01301040] | Phase 2 | 2 participants (Actual) | Interventional | 2011-03-31 | Terminated(stopped due to Slow recruitment) |
| Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial [NCT03818334] | Phase 2/Phase 3 | 50 participants (Anticipated) | Interventional | 2018-11-06 | Recruiting |
| Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502) [NCT02918292] | Phase 2 | 32 participants (Actual) | Interventional | 2017-07-03 | Completed |
| Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen [NCT02722668] | Phase 2 | 16 participants (Actual) | Interventional | 2017-05-15 | Active, not recruiting |
| A Randomized Study Evaluating the Safety and Effects of the Combination of Palbociclib With Epirubicin and Cyclophosphamide Followed by Paclitaxel as Neoadjuvant Therapy in Triple Negative Breast Cancer [NCT03756090] | | 100 participants (Anticipated) | Interventional | 2018-12-01 | Not yet recruiting |
| First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study [NCT05280626] | Phase 2 | 100 participants (Anticipated) | Interventional | 2022-03-25 | Not yet recruiting |
| Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer. Phase I Feasibility Study of Hifu-Induced Hyperthermia, LTLD and Cyclophosphamide for Metastatic Breast Cancer [NCT03749850] | Phase 1 | 12 participants (Anticipated) | Interventional | 2021-03-31 | Recruiting |
| Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum [NCT02054104] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2014-09-03 | Terminated(stopped due to Vaccine production halted in 2015, thus study is terminated.) |
| A Phase I/II Study of Metronomic Cyclophosphamide and Oncolytic Poxvirus JX-594 in Patients With Advanced Hormone-receptor Positive and Triple Negative Breast Cancer and Advanced Soft Tissue Sarcoma (METROmaJX) [NCT02630368] | Phase 1/Phase 2 | 197 participants (Anticipated) | Interventional | 2015-09-18 | Recruiting |
| Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer [NCT00068601] | Phase 3 | 257 participants (Actual) | Interventional | 2003-10-31 | Completed |
| Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma. A Phase II Study (Allo-MM-PostCy-Study) [NCT03700450] | Phase 2 | 37 participants (Actual) | Interventional | 2018-03-16 | Active, not recruiting |
| Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors [NCT00054327] | Phase 2 | 34 participants (Actual) | Interventional | 2000-11-30 | Completed |
| Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER) [NCT02953340] | Phase 3 | 237 participants (Actual) | Interventional | 2017-05-10 | Completed |
| Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) [NCT03518112] | Phase 2 | 6 participants (Actual) | Interventional | 2018-04-18 | Terminated(stopped due to Due to Competing Studies) |
| A Phase II Study of R-CHOP With Intensive CNS Prophylaxis and Scrotal Irradiation in Patients With Primary Testicular Diffuse Large B-cell Lymphoma [NCT00945724] | Phase 2 | 54 participants (Actual) | Interventional | 2009-04-30 | Active, not recruiting |
| Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab ( [NCT00021255] | Phase 3 | 3,222 participants (Actual) | Interventional | 2001-04-30 | Completed |
| A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After PD1 Blockade [NCT03003676] | Phase 1 | 21 participants (Actual) | Interventional | 2016-12-31 | Completed |
| Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances [NCT05110742] | Phase 1/Phase 2 | 48 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
| ATTAMAGE-A1.: Phase I/II Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity MAGE-A1-Specific T-Cell Receptor (TCR) Combined With Atezolizumab in Patients With Metastatic MAGE-A1 Expressing Cancer [NCT04639245] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2021-07-19 | Terminated(stopped due to Terminated due to slow accrual.) |
| Reduced Intensity Related Donor Peripheral Blood Derived Hematopoietic Progenitor Cell Transplantation for Patients With Severe Sickle Cell Disease [NCT04362293] | Phase 2 | 40 participants (Anticipated) | Interventional | 2020-04-30 | Suspended(stopped due to We are holding enrollment, due to some recent SAEs.) |
| Anti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell Transplantation [NCT03622788] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2019-08-08 | Recruiting |
| Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors [NCT00006734] | Phase 3 | 587 participants (Actual) | Interventional | 2001-05-31 | Completed |
| A Phase 2 Study of GVAX Colon Vaccine (With Cyclophosphamide) and Pembrolizumab in Patients With Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer [NCT02981524] | Phase 2 | 17 participants (Actual) | Interventional | 2017-05-26 | Completed |
| Cyclophosphamide Versus Placebo in Scleroderma Lung Study [NCT00004563] | Phase 3 | 158 participants (Actual) | Interventional | 1999-08-31 | Completed |
| Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous IL-21 Modulated CD8+ Antigen-Specific T Cells For Patients With Metastatic Melanoma [NCT01106235] | Phase 1 | 12 participants (Anticipated) | Interventional | 2010-04-30 | Terminated |
| Reduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic Anemia [NCT01129323] | | 0 participants (Actual) | Interventional | 2009-11-30 | Withdrawn(stopped due to This study did not accrue any subjects and due to this will be closed.) |
| Safety and Tolerability of Bevacizumab Plus Paclitaxel vs. Bevacizumab Plus Metronomic Cyclophosphamide and Capecitabine as First-Line Therapy in Patients With HER2-Negative Metastatic or Locally Recurrent Breast Cancer - A Multicenter, Randomized Phase I [NCT01131195] | Phase 3 | 139 participants (Actual) | Interventional | 2010-07-19 | Completed |
| Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture [NCT03925233] | | 300 participants (Anticipated) | Observational | 2019-01-02 | Enrolling by invitation |
| Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer [NCT01329627] | Phase 2 | 12 participants (Actual) | Interventional | 2010-08-31 | Terminated(stopped due to Toxicity) |
| Multicenter Study of Pomalidomide, Cyclophosphamide, and Dexamethasone in Relapsed Refractory Myeloma: Safety Profile in Mexican Population [NCT03601624] | Phase 2 | 18 participants (Anticipated) | Interventional | 2018-09-01 | Recruiting |
| "Maximizing Outcome of Multiple Sclerosis Transplantation: MOST Trial" [NCT03342638] | Phase 3 | 66 participants (Actual) | Interventional | 2017-11-08 | Terminated(stopped due to PI Sabbatical) |
| A Phase II, Randomised Study of CHOP-R in Combination With Acalabrutinib Compared to CHOP-R in Patients With Newly Diagnosed Richter's Syndrome and a Platform for Initial Investigations Into Activity of Novel Treatments in Relapsed/Refractory and Newly Di [NCT03899337] | Phase 2 | 105 participants (Anticipated) | Interventional | 2019-07-23 | Recruiting |
| A Phase-1 Trial of Adoptive Transfer of Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Combined With Vaccine Boost and Bevacizumab for Recurrent Ovarian Fallopian Tube or Primary Peritoneal Cancer Previously Vaccinated With Autologous Tumor Vacci [NCT01312376] | Phase 1 | 18 participants (Actual) | Interventional | 2011-03-31 | Terminated |
| Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy w/ Adenoviral & Yeast-based Vaccines to Induce T-cell Responses in Subjects w/ Advanced, Unresectable & Untransplantable HCC [NCT03563170] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-05-25 | Withdrawn(stopped due to Enrollment not initiated) |
| Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone [NCT01288131] | Phase 3 | 8 participants (Actual) | Interventional | 2009-01-31 | Terminated(stopped due to We observed >90 % efficacy in cyclophosphamide and Prednisolone group for treatment of anti-i-HuEpo associated PRCA) |
| A Randomized Phase II, Open Label, Study of Daratumumab, Weekly Low-Dose Oral Dexamethasone and Cyclophosphamide With or Without Pomalidomide in Patients With Relapsed and Refractory Multiple Myeloma [NCT03215524] | Phase 2 | 120 participants (Actual) | Interventional | 2017-10-25 | Completed |
| A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL [NCT01287741] | Phase 3 | 1,418 participants (Actual) | Interventional | 2011-07-26 | Terminated(stopped due to The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.) |
| High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma [NCT01177371] | Phase 2 | 13 participants (Actual) | Interventional | 1988-03-31 | Completed |
| A Multicentre Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL) [NCT04914741] | Phase 1/Phase 2 | 80 participants (Actual) | Interventional | 2021-06-29 | Active, not recruiting |
| Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With PSMA Peptide Target Module (TMpPSMA) for the Treatment of Patients With Progressive Dis [NCT04633148] | Phase 1 | 51 participants (Anticipated) | Interventional | 2020-11-23 | Recruiting |
| A Phase 1, Open-label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (KarMMa-4) [NCT04196491] | Phase 1 | 13 participants (Actual) | Interventional | 2020-05-27 | Completed |
| Related and Unrelated Donor Hematopoietic Stem Cell Transplant for DOCK8 Deficiency [NCT01176006] | Phase 2 | 90 participants (Anticipated) | Interventional | 2010-10-05 | Recruiting |
| An Investigational Randomized Study on Epirubicin Plus Cyclophospamide (EC) or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil (CMF) Versus Nab-paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Ri [NCT01204437] | Phase 2/Phase 3 | 400 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Randomized Study of Efficacy & Safety of Lapatinib & Epirubicin & Cyclophosphamide (EC90) Followed by Paclitaxel & Lapatinib Compared With EC90 Followed by Paclitaxel & Trastuzumab, as Neoadjuvant Therapy in Patients With Previously Untreated ErbB2-overex [NCT01205217] | Phase 2 | 0 participants (Actual) | Interventional | 2010-12-31 | Withdrawn(stopped due to Data presented at SABCS 2010 showing that dual blockade is superior to monotherapy) |
| Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma [NCT00005780] | Phase 2 | 26 participants (Actual) | Interventional | 2000-06-01 | Completed |
| A Randomised Phase II Trial of Cyclophosphamide and Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma (RRMM) Patients Who Have Relapsed After Treatment With Thalidomide, Lenalidomide and Bortezomib. [NCT02461888] | Phase 2 | 112 participants (Actual) | Interventional | 2015-12-31 | Active, not recruiting |
| Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study [NCT05959720] | | 180 participants (Anticipated) | Observational [Patient Registry] | 2023-09-05 | Recruiting |
| Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer [NCT03006302] | Phase 2 | 40 participants (Actual) | Interventional | 2018-01-31 | Active, not recruiting |
| Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy [NCT01871766] | Phase 2 | 98 participants (Actual) | Interventional | 2013-12-04 | Active, not recruiting |
| A MULTICENTER, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS [NCT01346787] | Phase 2 | 58 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Pilot Open-label Trial of Nivolumab Combined With Chemotherapy in Refractory Myelodysplastic Syndromes. [NCT03259516] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2017-05-25 | Terminated(stopped due to Slow recruitment rate) |
| Genetically Engineered T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor for Treatment of Patients With B Cell Malignancies [NCT02456350] | Phase 1 | 36 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| Phase II Multicentric, Randomized Trial, Exploring Intensified Rituximab Prephase Monotherapy Before Standard Fludarabine-Cyclophosphamide-Rituximab Regimen in Previously Untreated Symptomatic B-cell Chronic Lymphocytic Leukemia [NCT01370772] | Phase 2 | 140 participants (Actual) | Interventional | 2011-05-31 | Completed |
| Effect of Cyclophosphamide Versus Mycophenolate Mofetil in Induction Therapy of Lupus Nephritis in Nepalese Population [NCT03200002] | Phase 2 | 49 participants (Actual) | Interventional | 2014-01-01 | Completed |
| A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma [NCT04484506] | Phase 2 | 150 participants (Anticipated) | Interventional | 2011-10-20 | Recruiting |
| NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy [NCT03197584] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
| Efficacy of Consolidative Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Limited-stage Follicular Lymphoma: Wuhan University Cancer Center -NHL01 Trial [NCT02449252] | Phase 3 | 120 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
| Phase I Study to Evaluate the Safety and Effectiveness of Anti-CD33 CAR NK Cell Therapy in Relapsed/Refractory Acute Myeloid Leukemia [NCT05008575] | Phase 1 | 27 participants (Anticipated) | Interventional | 2021-12-23 | Recruiting |
| Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia [NCT01358253] | Phase 4 | 100 participants (Actual) | Interventional | 2010-12-31 | Completed |
| NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy [NCT03175666] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
| Single Center Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) Combined With Programmed Cell Death-1（PD-1） Inhibitor in the Treatment of Chinese Patients With Advanced Refractory Solid Tumors [NCT03171220] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2017-06-01 | Recruiting |
| NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With Programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Inhibitors [NCT03169738] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-02-28 | Withdrawn(stopped due to Trial not initiated) |
| NANT Merkel Cell Carcinoma (MCC) Vaccine: Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After Anti-programmed Death-ligand 1 (PD-L1) Therapy [NCT03167164] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
| Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma [NCT04440436] | Phase 1/Phase 2 | 52 participants (Anticipated) | Interventional | 2020-06-04 | Recruiting |
| A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib [NCT04546620] | Phase 2 | 453 participants (Anticipated) | Interventional | 2021-10-19 | Recruiting |
| [NCT01569204] | Phase 2 | 100 participants (Anticipated) | Interventional | 2012-10-31 | Completed |
| Phase I Dose-Escalation Study of BCMA/CS1 Bispecific Chimeric Antigen Receptor (CAR)-T Cells for Relapsed/Refractory Multiple Myeloma [NCT05950113] | Phase 1 | 30 participants (Anticipated) | Interventional | 2024-03-28 | Not yet recruiting |
| A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR [NCT05714345] | Phase 2 | 70 participants (Anticipated) | Interventional | 2023-03-31 | Recruiting |
| A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations [NCT05624554] | Phase 3 | 300 participants (Anticipated) | Interventional | 2023-03-16 | Recruiting |
| A Single-arm, Multi-center, Phase Ib/II Study of Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients (Xplore Trial) [NCT05577364] | Phase 1/Phase 2 | 54 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
| A Phase Ib Study to Evaluate Safety and Persistence of ex Vivo Expanded Universal Donor NK Cells in Combination With IL-2 and TGFbeta Receptor I Inhibitor Vactosertib in Patients With Locally Advanced/Metastatic Colorectal Cancer and Relapsed/Refractory H [NCT05400122] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-09-09 | Suspended(stopped due to Insufficient staff) |
| Surgery for Mesothelioma After Radiation Therapy Using Exquisite Systemic Therapy [NCT05380713] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-05-03 | Recruiting |
| A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma [NCT04880434] | Phase 2 | 90 participants (Anticipated) | Interventional | 2021-04-27 | Active, not recruiting |
| TCRαβ+ T-cell/CD19+ B-cell Depleted Hematopoietic Grafts and a Reduced Intensity Preparative Conditioning Regimen Containing JSP191 (Briquilimab) to Achieve Engraftment and Blood Reconstitution in Patients With Fanconi Anemia [NCT04784052] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2021-12-07 | Recruiting |
| A Phase 1 Clinical Trial of Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma [NCT04545762] | Phase 1 | 36 participants (Anticipated) | Interventional | 2020-09-11 | Recruiting |
| Evaluating Clinical and Immunological Effects of Rituximab With Cyclophosphamide Compared to Rituximab Alone in AAV Patients [NCT03942887] | Phase 3 | 100 participants (Anticipated) | Interventional | 2019-05-03 | Recruiting |
| A Phase II Study of Ibrutinib Plus Rituximab With Hyper-CVAD Consolidation in Newly Diagnosed Young Patients With Mantle Cell Lymphoma: A Window Period for Bioimmunotherapy Before Chemotherapy [NCT02427620] | Phase 2 | 131 participants (Anticipated) | Interventional | 2015-06-03 | Active, not recruiting |
| Vorinostat With Gemcitabine/Clofarabine/Busulfan for Allogeneic Transplantation for Aggressive Lymphomas [NCT04220008] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
| Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors [NCT04526509] | Phase 1 | 11 participants (Actual) | Interventional | 2020-12-21 | Active, not recruiting |
| A Phase Ib Safety lead-in, Followed by Phase II Trial of ADG106 in Combination With Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Stage I-III HER2 Negative Breast Cancer [NCT05275777] | Phase 1/Phase 2 | 66 participants (Anticipated) | Interventional | 2022-05-19 | Recruiting |
| Comparison of Gemcitabine, Oxaliplatin and Pegaspargase and Etoposide, Vincristine, Doxorubicin, Cyclophosphamide and Prednisone as First-line Chemotherapy in Patients With NK/T-cell Lymphoma：a Prospective Randomized Phase III Study [NCT02359162] | Phase 3 | 50 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to The study is out of date) |
| A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723) [NCT03085914] | Phase 1/Phase 2 | 70 participants (Actual) | Interventional | 2017-05-02 | Completed |
| Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients [NCT02336386] | Phase 3 | 100 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
| Phase 2 Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas [NCT00069238] | Phase 2 | 31 participants (Actual) | Interventional | 2003-09-19 | Completed |
| Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxe [NCT05207514] | Phase 3 | 320 participants (Anticipated) | Interventional | 2022-02-01 | Not yet recruiting |
| A MULTICENTER, OPEN LABEL, RANDOMIZED PHASE III STUDY OF POMALIDOMIDE-DEXAMETHASONE vs POMALIDOMIDE-CYCLOPHOSPHAMIDE-DEXAMETHASONE IN MULTIPLE MYELOMA (MM) PATIENTS WHO EXPERIENCE BIOCHEMICAL OR CLINICAL RELAPSE DURING LENALIDOMIDE MAINTENANCE TREATMENT [NCT03440411] | Phase 3 | 9 participants (Actual) | Interventional | 2016-02-18 | Terminated(stopped due to Low enrollment) |
| Daratumumab Plus Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) in Previously Untreated and Relapsed Subjects With Multiple Myeloma [NCT02951819] | Phase 2 | 101 participants (Actual) | Interventional | 2016-11-09 | Completed |
| NANT N2013-02 A Phase I Study of Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma [NCT02298348] | Phase 1 | 18 participants (Anticipated) | Interventional | 2015-04-30 | Active, not recruiting |
| N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan for Patients With Relapsed or Refractory Neuroblastoma [NCT02030964] | Phase 1 | 30 participants (Anticipated) | Interventional | 2013-12-31 | Active, not recruiting |
| Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma [NCT03706547] | Phase 1 | 20 participants (Anticipated) | Interventional | 2018-10-30 | Not yet recruiting |
| Anti-Angiogenic Therapy After Autologous Stem Cell Rescue (ASCR) for Pediatric Solid Tumors [NCT01661400] | Phase 1 | 14 participants (Actual) | Interventional | 2012-10-26 | Active, not recruiting |
| A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects [NCT03629873] | Phase 2 | 69 participants (Anticipated) | Interventional | 2018-02-01 | Active, not recruiting |
| A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors [NCT04319757] | Phase 1 | 36 participants (Anticipated) | Interventional | 2020-05-19 | Recruiting |
| Open-Label Phase 1b/2a Clinical Trial to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells (GSK3377794) in Combination With Anti-Cancer Agents Including Pembrolizumab in HLA-A2+ Participants [NCT03697824] | Phase 2 | 0 participants (Actual) | Interventional | 2019-02-25 | Withdrawn(stopped due to Internal decision, study will be replaced with a larger monotherapy trial) |
| Autologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease [NCT04224558] | Phase 1/Phase 2 | 15 participants (Anticipated) | Interventional | 2020-12-15 | Recruiting |
| A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer [NCT05420467] | Phase 4 | 2,413 participants (Anticipated) | Interventional | 2022-07-10 | Recruiting |
| A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes [NCT02224872] | Phase 2 | 18 participants (Actual) | Interventional | 2014-08-31 | Completed |
| A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) as Front-Line Therapy for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT03023046] | Phase 2 | 54 participants (Actual) | Interventional | 2017-02-23 | Completed |
| Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial [NCT03617432] | Phase 2 | 114 participants (Anticipated) | Interventional | 2018-08-28 | Recruiting |
| A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects With Relapsed/Refractory Multiple Myeloma [NCT03318861] | Phase 1 | 17 participants (Actual) | Interventional | 2017-10-20 | Terminated(stopped due to The study was terminated due to lack of efficacy) |
| RAPID Feasibility Study: A Pilot Study for the Rapid Infusion of Dinutuximab [NCT05421897] | Phase 4 | 11 participants (Anticipated) | Interventional | 2022-10-24 | Recruiting |
| A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (BMT CTN #0901) [NCT01339910] | Phase 3 | 272 participants (Actual) | Interventional | 2011-06-30 | Terminated(stopped due to Accrual terminated as recommended by the data and safety monitoring board.) |
| A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women With Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects With Peritoneal Mesothelioma With Recurrence After Prior Chemotherapy [NCT03608618] | Phase 1 | 14 participants (Actual) | Interventional | 2018-08-27 | Terminated(stopped due to Sponsor shift in focus) |
| Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer. [NCT01378533] | Phase 3 | 100 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting |
| Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial). [NCT02978495] | Phase 2 | 154 participants (Actual) | Interventional | 2017-05-17 | Completed |
| Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in HER2-negative Operable Breast [NCT01314833] | Phase 3 | 1,570 participants (Actual) | Interventional | 2010-06-01 | Completed |
| Phase I Study To Evaluate The Use Of Autologous T- Antigen-Presenting Cells (T-APC) To Enhance The Persistence Of Adoptively Transferred CD8+ Antigen-Specific T Cells (CTL) Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma [NCT01339663] | Phase 1 | 12 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Purine-Alkylator Combination In Follicular Lymphoma Immuno-Chemotherapy for Older Patients: a Phase III Comparison of First-line R-CVP Versus R-FC [NCT01303887] | Phase 3 | 680 participants (Anticipated) | Interventional | 2009-10-31 | Recruiting |
| Multi-center, Phase II Study to Assess the Safety and Efficacy of Haploidentical Bone Marrow Transplantation Using Reduced Intensity Conditioning(RIC)Regimen and Post-transplant Cyclophosphamide,in Patients With Poor Prognosis Lymphomas [NCT02049580] | Phase 2 | 47 participants (Anticipated) | Interventional | 2013-07-31 | Recruiting |
| A Phase 1b Clinical Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, as a Chemoprotection Agent in Patients With TP53-Mutated, HER2 Negative Breast Cancer Receiving Neoadjuvant or Adjuvant Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (T [NCT05622058] | Phase 1 | 6 participants (Actual) | Interventional | 2023-01-09 | Terminated(stopped due to The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.) |
| A Pilot Study of Myeloablative Allogeneic or Haploidentical Stem Cell Transplantation With High Dose PT-Cy in Relapsed/Refractory AML [NCT02057770] | Phase 1 | 25 participants (Actual) | Interventional | 2014-02-28 | Terminated(stopped due to Low accrual rate) |
| NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With CTLA4 Blockade [NCT02070406] | Phase 1 | 4 participants (Actual) | Interventional | 2014-07-17 | Terminated(stopped due to low accrual) |
| Phase I Neo-Adjuvant Nivolumab + IRX-2 Followed by Surgery for Resectable Oral Cavity Cancer or HPV-Associated Oropharynx Cancer [NCT03575234] | Phase 1 | 0 participants (Actual) | Interventional | 2020-07-01 | Withdrawn(stopped due to funding and drug were withdrawn) |
| Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma. [NCT02086942] | Phase 2 | 94 participants (Anticipated) | Interventional | 2013-08-31 | Recruiting |
| A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors [NCT04596033] | Phase 1 | 49 participants (Actual) | Interventional | 2020-11-11 | Terminated(stopped due to Business reasons) |
| Multi-center, Investigator Initiated Phase 1 Study of MAGE-A4 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors [NCT02096614] | Phase 1 | 18 participants (Actual) | Interventional | 2014-04-30 | Completed |
| A Phase I Study Evaluating Allogeneic Memory T Cells Engineered to Express Chimeric Antigen Receptors Specific for CD19 for the Treatment of Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19-Positive Leukemia [NCT04881240] | Phase 1 | 60 participants (Anticipated) | Interventional | 2023-12-31 | Recruiting |
| Phase 1 Study of the Administration of T Lymphocytes Expressing the Kappa Chimeric Antigen Receptor (CAR) and CD28 Endodomain for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. [NCT04223765] | Phase 1 | 20 participants (Anticipated) | Interventional | 2020-11-12 | Recruiting |
| A Phase II Study of Neovii Anti-human T-lymphocyte Immunoglobulin (ATLG, Grafalon®) With Post Transplant Escalated Doses of Post-transplant-Cyclophosphamide to Prevent Acute and Chronic GVHD Post Allogeneic Stem Cell Transplantation [NCT03357159] | Phase 2 | 30 participants (Anticipated) | Interventional | 2018-09-06 | Recruiting |
| Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs. RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma [NCT01856192] | Phase 2 | 349 participants (Actual) | Interventional | 2013-08-27 | Active, not recruiting |
| A Phase I Trial Using In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies [NCT01430390] | Phase 1 | 19 participants (Actual) | Interventional | 2011-09-30 | Active, not recruiting |
| A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma [NCT01145209] | Phase 2 | 32 participants (Actual) | Interventional | 2010-07-01 | Completed |
| Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Severe Congenital Anemias Including Sickle Cell Disease and Beta-Thalassemia [NCT00977691] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2009-12-14 | Active, not recruiting |
| Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00137111] | Phase 3 | 501 participants (Actual) | Interventional | 2000-07-08 | Completed |
| Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma [NCT00133991] | Phase 2 | 23 participants (Actual) | Interventional | 2005-07-31 | Completed |
| A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors [NCT03733587] | Phase 1 | 24 participants (Actual) | Interventional | 2018-10-17 | Completed |
| An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia [NCT03564704] | Phase 2/Phase 3 | 80 participants (Anticipated) | Interventional | 2016-02-14 | Recruiting |
| QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic Cancer [NCT03563144] | Phase 2 | 0 participants (Actual) | Interventional | 2018-08-31 | Withdrawn(stopped due to Trial not initiated) |
| Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients [NCT00392327] | Phase 3 | 379 participants (Actual) | Interventional | 2007-03-26 | Active, not recruiting |
| A Study to Determine the Feasibility of Treating Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Using Autologous NY-ESO-1 Specific CD8+ T Cells With Cyclophosphamide Pre-conditioning But Without the Use of IL-2 [NCT02059850] | Phase 1 | 0 participants (Actual) | Interventional | 2014-07-31 | Withdrawn |
| Shortened-duration Tacrolimus Following Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide [NCT01342289] | Phase 1 | 127 participants (Actual) | Interventional | 2011-08-31 | Completed |
| CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplant for Malignant Disease [NCT02061800] | Phase 1/Phase 2 | 15 participants (Anticipated) | Interventional | 2013-06-03 | Recruiting |
| A Phase I/II Study of Carfilzomib in Combination With R-CHOP (CR-CHOP) for Patients With Diffuse Large B-cell Lymphoma [NCT02073097] | Phase 1/Phase 2 | 48 participants (Actual) | Interventional | 2015-01-28 | Active, not recruiting |
| RACIN, A Phase I Study of the Combination of Nivolumab Associated With Low-dose Radiation, Aspirin/ Celecoxib, and Either Ipilimumab or Low-dose Cyclophosphamide, Followed by Nivolumab Maintenance, in Patients With Advanced, TIL-negative Solid Tumors [NCT03728179] | Phase 1 | 50 participants (Anticipated) | Interventional | 2019-01-16 | Active, not recruiting |
| Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer [NCT02115152] | Phase 2 | 100 participants (Anticipated) | Interventional | 2014-06-30 | Not yet recruiting |
| An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma [NCT03553238] | Phase 2/Phase 3 | 70 participants (Anticipated) | Interventional | 2016-02-14 | Recruiting |
| A Phase II Evaluation of Pembrolizumab in Combination With IV Bevacizumab and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer [NCT02853318] | Phase 2 | 40 participants (Actual) | Interventional | 2016-09-01 | Completed |
| A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse [NCT04546399] | Phase 2 | 550 participants (Anticipated) | Interventional | 2020-12-04 | Suspended(stopped due to Other - FDA Partial Clinical Hold) |
| Allogeneic Stem Cell Transplantation for Patients With Hematological Malignancies Using Multiple Unrelated Cord Blood Units [NCT00547196] | | 10 participants (Actual) | Interventional | 2005-08-16 | Active, not recruiting |
| A Randomized Phase II Study to Compare ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation [NCT03602898] | Phase 2 | 0 participants (Actual) | Interventional | 2021-06-01 | Withdrawn(stopped due to Insufficient funding) |
| A Multiple Center Study on NOXA Expression-guided Randomized Chidamide Bridging Intervention in CAR-T Treated NHL Patients [NCT05370547] | Phase 1/Phase 2 | 120 participants (Anticipated) | Interventional | 2022-05-25 | Recruiting |
| Clinical Research of Gene Therapy for Refractory B-Cell Non-Hodgkin Lymphoma Using Autologous T Cells Expressing a Chimeric Antigen Receptor Specific to the CD19 Antigen [NCT02134262] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2014-05-31 | Recruiting |
| Donor-Derived Very-Rapid Manufactured CD19-Specific T Cells for Lymphoid Malignancies After Allogeneic Hematopoietic Stem-Cell Transplantation [NCT03579888] | Phase 1 | 4 participants (Actual) | Interventional | 2020-06-26 | Terminated(stopped due to Study halted prematurely) |
| A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy With Cyclophosphamide, Procarbazine, Prednisone, Etoposide and Mitoxantrone (BrEPEM) for Older Patients With Untreated Hodgkin Lymphoma (HL) [NCT03576378] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2018-08-08 | Active, not recruiting |
| A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide [NCT03575520] | Phase 2 | 63 participants (Actual) | Interventional | 2016-06-07 | Completed |
| A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone [NCT00033293] | Phase 3 | 53 participants (Actual) | Interventional | 2004-03-15 | Completed |
| A Pilot Phase I Trial of IL-21 Expanded, Off the Shelf, Third-Party Natural Killer (NK) Cells in Combination With Mogamulizumab in Patients With Cutaneous T-Cell Lymphomas or Adult T-Cell Leukemia/Lymphomas [NCT04848064] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-05-06 | Recruiting |
| A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies [NCT04162756] | | 0 participants | Expanded Access | | Approved for marketing |
| A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma [NCT01343043] | Phase 1 | 50 participants (Actual) | Interventional | 2012-09-27 | Completed |
| A Phase I/II Clinical Trial of NK Cells Administration to Prevent Disease Relapse for Patient With High-Risk Myeloid Malignancies Undergoing Haploidentical Stem-Cell Transplantation [NCT01904136] | Phase 1/Phase 2 | 90 participants (Anticipated) | Interventional | 2014-04-22 | Completed |
| A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Po [NCT01966471] | Phase 3 | 1,846 participants (Actual) | Interventional | 2014-01-31 | Completed |
| Open-label, Randomized, Comparative Phase 2 Study of Combination Immunotherapy Plus Standard-of-care Chemotherapy Versus Standard-of-care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer [NCT04390399] | Phase 2 | 328 participants (Anticipated) | Interventional | 2020-07-21 | Recruiting |
| An Indian Multicentric Open Label Prospective Phase IV Study to Evaluate Safety and Efficacy of Trastuzumab in Her2 Positive, Node Positive or High Risk Node Negative Breast Cancer as Part of a Treatment Regimen Consisting of Doxorubicin, Cyclophosphamide [NCT02419742] | Phase 4 | 110 participants (Actual) | Interventional | 2015-08-18 | Completed |
| Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T Cells Carrying Reverse Chimeric Antigen Receptors (Allo RevCAR01 T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With S [NCT05949125] | Phase 1 | 37 participants (Anticipated) | Interventional | 2023-08-31 | Not yet recruiting |
| Phase 1/2 Trial of Ixazomib in Combination With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis [NCT01864018] | Phase 1/Phase 2 | 87 participants (Actual) | Interventional | 2013-08-20 | Active, not recruiting |
| Phase II Trial of Paclitaxel Combined With Trastuzumab and Pertuzumab as Pre-Operative Therapy for Inflammatory Breast Cancer [NCT01796197] | Phase 2 | 23 participants (Actual) | Interventional | 2013-08-31 | Active, not recruiting |
| Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life [NCT00911183] | Phase 2 | 67 participants (Actual) | Interventional | 2008-12-02 | Completed |
| Observational Study of Low Dose FCR in the Treatment of Elderly/Comorbid Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma: The Q-lite Project [NCT02156726] | | 200 participants (Anticipated) | Observational | 2011-03-31 | Active, not recruiting |
| Pilot Study Evaluating An Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX) and Low Dose Cyclophosphamide Integrated With Fractionated Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX Chemotherapy in Patients With Resected Adenoca [NCT01595321] | | 19 participants (Actual) | Interventional | 2012-10-29 | Active, not recruiting |
| Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source [NCT02167958] | Phase 1 | 28 participants (Actual) | Interventional | 2015-02-11 | Completed |
| Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer [NCT00976131] | Phase 1 | 7 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis [NCT04380831] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2022-02-24 | Recruiting |
| A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma [NCT01074060] | Phase 1 | 18 participants (Actual) | Interventional | 2010-04-30 | Completed |
| A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL) [NCT01148446] | Phase 3 | 226 participants (Actual) | Interventional | 2003-01-31 | Completed |
| A Multicenter, Randomized, Double-blind, Prospective Study to Evaluate the Efficacy and Safety of Vincristine, Dactinomycin/Cyclophosphamide Combination Therapy Combined With Liposomal Doxorubicin/Doxorubicin/Pharmorubicin/Pirarubicin in 0.5-14 Year Old C [NCT03892330] | Phase 4 | 120 participants (Anticipated) | Interventional | 2019-06-01 | Not yet recruiting |
| Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors (CARE) [NCT04715191] | Phase 1 | 24 participants (Anticipated) | Interventional | 2024-01-03 | Not yet recruiting |
| Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer With Homologous Recombination Repair Deficiency [NCT03876886] | Phase 3 | 200 participants (Anticipated) | Interventional | 2019-02-22 | Recruiting |
| A Phase I Clinical Trial of Human CD19/BCMA Bispecific CAR-T Cell Therapy for Subjects With Relapsed and Refractory POMES Syndrome. [NCT03879382] | Phase 1 | 10 participants (Anticipated) | Interventional | 2019-02-27 | Active, not recruiting |
| A Phase II Study Of Pegylated Liposomal Doxorubicin (Doxil) In Combination With Rituxan, Cyclophosphamide, Vincristine and Prednisone (DR-COP) In Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas [NCT00184002] | Phase 2 | 68 participants (Actual) | Interventional | 2003-01-10 | Completed |
| A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation [NCT01283776] | Phase 2 | 11 participants (Actual) | Interventional | 2011-03-31 | Completed |
| A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eli [NCT02513186] | Phase 1 | 90 participants (Actual) | Interventional | 2015-09-30 | Active, not recruiting |
| A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer [NCT00149214] | Phase 2 | 257 participants (Actual) | Interventional | 2005-09-30 | Completed |
| Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus [NCT02444728] | Phase 3 | 50 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to Because of insufficient enrollement) |
| First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia [NCT04638790] | Phase 3 | 300 participants (Anticipated) | Interventional | 2020-02-01 | Recruiting |
| A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell L [NCT04799275] | Phase 2/Phase 3 | 422 participants (Anticipated) | Interventional | 2021-05-20 | Recruiting |
| Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia [NCT05665114] | Phase 1 | 18 participants (Anticipated) | Interventional | 2022-12-24 | Recruiting |
| HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies [NCT00145626] | Phase 2 | 40 participants (Actual) | Interventional | 2004-05-31 | Completed |
| Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune®) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Ha [NCT03790072] | Phase 1 | 10 participants (Actual) | Interventional | 2018-11-27 | Completed |
| A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma [NCT02043587] | Phase 2 | 31 participants (Actual) | Interventional | 2014-01-31 | Terminated(stopped due to Original investigator for the trial has left) |
| Phase II Study of High-Dose Topotecan, Cyclophosphamide and Melphalan for the Treatment of Multiple Myeloma [NCT01039025] | Phase 2 | 60 participants (Actual) | Interventional | 2002-02-18 | Completed |
| Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source [NCT01028716] | Phase 2 | 46 participants (Actual) | Interventional | 2010-05-19 | Terminated(stopped due to The study experienced lower accrual rates after the onset of COVID. Upon review of the collected data it was deemed that an adequate amount of subjects has been enrolled to date to assess study aims.) |
| A Phase I Feasibility Trial of Cyclophosphamide, Alvocidib (Flavopiridol) and Rituximab (CAR) in Patients With High Risk B-cell CLL/SLL [NCT01076556] | Phase 1 | 9 participants (Actual) | Interventional | 2010-04-30 | Terminated |
| Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma [NCT00134082] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer [NCT00121134] | | 164 participants (Actual) | Interventional | 2005-06-30 | Completed |
| Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer [NCT00119262] | Phase 2 | 226 participants (Actual) | Interventional | 2005-10-31 | Completed |
| Phase 1 and 2 Study of Combination Treatment of Bortezomib, Fludarabine and Cyclophosphamide in Patients With Recurrent Mantle Cell Lymphoma [NCT01322776] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
| Hematopoietic Stem Cell Transplantation for Malignant Infantile Osteopetrosis [NCT01087398] | Phase 2/Phase 3 | 10 participants (Anticipated) | Interventional | 2009-09-30 | Recruiting |
| Phase II Study of Metastatic Cancer That Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-p53 T Cell Receptor (TCR)-Gene Engineered Lymphocytes [NCT00393029] | Phase 2 | 12 participants (Actual) | Interventional | 2006-10-31 | Completed |
| Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease [NCT00388349] | Phase 2 | 146 participants (Actual) | Interventional | 2001-09-30 | Completed |
| "First Line Treatment in HIV-related Large Cell Non Hodgkin Lymphoma at High Risk, Including Early Consolidation With High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation" [NCT01045889] | Phase 2 | 27 participants (Actual) | Interventional | 2007-01-31 | Completed |
| Randomized Trial of Unmanipulated Versus Expanded Cord Blood [NCT00067002] | Phase 2 | 110 participants (Actual) | Interventional | 2003-04-30 | Completed |
| A Randomized Trial of Sirolimus-Based Graft Versus Host Disease Prophylaxis After Hematopoietic Stem Cell Transplantation in Relapsed Acute Lymphoblastic Leukemia [NCT00382109] | Phase 3 | 146 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months) [NCT00096135] | | 168 participants (Actual) | Interventional | 2004-11-30 | Completed |
| Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg [NCT05780554] | | 42 participants (Anticipated) | Interventional | 2023-03-10 | Enrolling by invitation |
| A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC) [NCT05447702] | Phase 2 | 35 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
| A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Clinical Activity of Durvalumab in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) or With Lenalidomide Plus R-CHOP (R2-CHOP) in Subjects With [NCT03003520] | Phase 2 | 46 participants (Actual) | Interventional | 2017-02-28 | Completed |
| Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer [NCT02768701] | Phase 2 | 40 participants (Actual) | Interventional | 2016-10-18 | Completed |
| A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma [NCT05934097] | Phase 1 | 0 participants (Actual) | Interventional | 2022-12-31 | Withdrawn(stopped due to This study was withdrawn (Sponsor decision).) |
| Total Body Irradiation/ Fludarabine/ Busulfan/ Cyclophosphamide (TFBC) Combined With Umbilical Cord Blood Transplantation (UCBT) in the Treatment of High-risk Malignant Hematological Diseases [NCT05929092] | | 40 participants (Anticipated) | Interventional | 2023-06-01 | Recruiting |
| Autologous TRAC Locus-inserted CD19-targeting Synthetic T-cell Receptor Antigen Receptor T (STAR-T) Cells for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma [NCT05631912] | Phase 1/Phase 2 | 38 participants (Anticipated) | Interventional | 2023-06-30 | Recruiting |
| Dose-dense Epirubicin Hydrochloride With Cyclophosphamide Followed by Nanoparticlealbumin-bound Paclitaxel With PD-1 Regimen in Neoadjuvant Therapy for Patients With Triple-negative Breast Cancer [NCT04418154] | Phase 2 | 70 participants (Actual) | Interventional | 2020-06-09 | Active, not recruiting |
| A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia [NCT03991884] | Phase 1 | 24 participants (Actual) | Interventional | 2019-09-24 | Completed |
| 'ADVANCE' (A Pilot Trial) ADjuVANt Chemotherapy in the Elderly: Developing and Evaluating Lower-Toxicity Chemotherapy Options for Older Patients With Breast Cancer [NCT03858322] | Phase 1 | 41 participants (Anticipated) | Interventional | 2019-03-21 | Active, not recruiting |
| A 2 Step Approach to Matched Related Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies-5+5 Dosing [NCT03712878] | Phase 2 | 10 participants (Actual) | Interventional | 2018-09-19 | Active, not recruiting |
| A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma [NCT03391466] | Phase 3 | 359 participants (Actual) | Interventional | 2018-01-25 | Active, not recruiting |
| A Phase 3 Multicenter, Randomized, Prospective, Open-label Trial of Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab Plus Venetoclax (RVe) Versus Obinutuzumab (GA101) Plus Venetoclax (GVe) Versus Obinutuzumab Plus Ibrutinib Plus Venetoclax (GIVe) in [NCT02950051] | Phase 3 | 926 participants (Actual) | Interventional | 2016-12-13 | Active, not recruiting |
| A Phase I/II Clinical Trial of Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin [NCT02414269] | Phase 1/Phase 2 | 113 participants (Actual) | Interventional | 2015-05-31 | Active, not recruiting |
| A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial [NCT02244125] | Phase 2 | 100 participants (Actual) | Interventional | 2014-04-14 | Completed |
| Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC) [NCT01140373] | Phase 1 | 13 participants (Actual) | Interventional | 2010-06-30 | Active, not recruiting |
| Transplantation of Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation or Cyclophosphamide/Fludarabine/Thiotepa/Total Body Irradiation Myeloablative Preparative Regimen [NCT00719888] | Phase 2 | 135 participants (Actual) | Interventional | 2005-11-18 | Active, not recruiting |
| Randomized Phase II Study of Docetaxel, Adriamycin, and Cytoxan (TAC) Versus Adriamycin/Cytoxan, Followed by Abraxane/Carboplatin (ACAC) +/- Trastuzumab as Neoadjuvant Therapy for Patients With Stage II-III Breast Cancer [NCT00295893] | Phase 2 | 121 participants (Actual) | Interventional | 2005-09-27 | Active, not recruiting |
| A Phase II Trial Involving Patients With Recurrent PCNSL Treated With Carboplatin/BBBD, by Adding Rituxan (Rituximab), An Anti CD-20 Antibody, To The Treatment Regimen [NCT00074165] | Phase 2 | 17 participants (Actual) | Interventional | 2003-01-31 | Terminated(stopped due to Lack of accrual) |
| High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer [NCT00003927] | Phase 1 | 15 participants (Actual) | Interventional | 1999-05-18 | Completed |
| A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia [NCT00003910] | Phase 2 | 59 participants (Actual) | Interventional | 1999-09-15 | Terminated |
| A Phase 1b/2 Trial of the IRX-2 Regimen and Pembrolizumab in Patients With Advanced Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma [NCT03918499] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2019-04-19 | Completed |
| Optimizing Neoadjuvant Systemic Treatment for HER2 Positive Breast Cancer - the TRAIN-2 Study [NCT01996267] | Phase 3 | 437 participants (Actual) | Interventional | 2013-12-31 | Active, not recruiting |
| Biomarker Discovery Randomized Phase IIb Trial With Carboplatin-cyclophosphamide Versus Paclitaxel With or Without Atezolizumab as First-line Treatment in Advanced Triple Negative Breast Cancer [NCT01898117] | Phase 2 | 304 participants (Actual) | Interventional | 2013-07-31 | Active, not recruiting |
| A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed By DD Paclitaxel (DD AC→P); DD AC Followed By [NCT00093795] | Phase 3 | 4,894 participants (Actual) | Interventional | 2004-10-31 | Completed |
| Cyclophosphamide Versus Mycophenolate Mofetil for Children With Steroid-dependent Idiopathic Nephrotic Syndrome : a Multicenter Randomized Controlled Trial [NCT01092962] | Phase 3 | 70 participants (Actual) | Interventional | 2010-09-30 | Completed |
| A Phase III Randomized Trial With NEOadjuvant Chemotherapy (TAC) With or Without ZOledronic Acid for Patients With HER2- Negative Large Resectable or Locally Advanced Breast Cancer(NEO-ZOTAC) [NCT01099436] | Phase 3 | 250 participants (Actual) | Interventional | 2010-04-30 | Completed |
| A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma [NCT00376961] | Phase 2 | 68 participants (Actual) | Interventional | 2006-08-31 | Completed |
| Sequential High-Dose Melphalan and Busulfan/Cyclophosphamide Followed by Peripheral Blood Progenitor Cell Rescue, Interferon/Thalidomide and Pamidronate for Patients With Multiple Myeloma [NCT00004088] | Phase 2 | 77 participants (Actual) | Interventional | 1999-04-13 | Completed |
| A Three-Arm Randomized Trial to Compare Adjuvant Adriamycin and Cyclophosphamide Followed by Taxotere (AC-T); Adriamycin and Taxotere (AT); and Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients With Positive Axillary Lymph Nodes [NCT00003782] | Phase 3 | 5,351 participants (Actual) | Interventional | 1999-03-31 | Completed |
| Phase 2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Recurrent Survivin-Expressing Diffuse Large B-Cell Lymphoma (DLBCL) [NCT02323230] | Phase 2 | 4 participants (Actual) | Interventional | 2015-01-31 | Terminated(stopped due to new study) |
| Phase III Trial Assessing the Interest of a Maintenance Chemotherapy Combining Docetaxel (Taxotere) 5-FU After Induction Treatment by Aintensive Chemotherapy for Inflammatory Breast Cancers [NCT02324088] | Phase 3 | 174 participants (Actual) | Interventional | 2000-10-31 | Completed |
| Chidamide Plus Post-transplantation Cyclophosphamide and Cyclosporine to Prevent Graft-versus-host Disease After Myeloablative Conditioning, Matched Peripheral-blood Stem-cell Transplantation [NCT03336632] | Phase 2 | 50 participants (Anticipated) | Interventional | 2019-01-01 | Not yet recruiting |
| Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer. [NCT03332576] | Phase 1 | 37 participants (Actual) | Interventional | 2013-08-23 | Completed |
| Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer. [NCT05243524] | Phase 2 | 16 participants (Actual) | Interventional | 2022-08-05 | Terminated(stopped due to Closure of IMV operations) |
| Clinical Study to Assess Efficacy and Safety of MDA-TIL (Autologous Expanded Tumor Infiltrating Lymphocytes) Across Multiple Tumor Types [NCT03610490] | Phase 2 | 27 participants (Actual) | Interventional | 2018-08-17 | Active, not recruiting |
| Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study [NCT02223208] | Phase 1/Phase 2 | 89 participants (Actual) | Interventional | 2014-09-30 | Active, not recruiting |
| A Phase I/II Clinical Trial of Lenalidomide in Combination With Oral Cyclophosphamide in Patients With Previously Treated Hormone Refractory Prostate Cancer [NCT01093183] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2010-03-04 | Terminated(stopped due to study sponsors withdrew support for the study drug.) |
| A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) [NCT03321890] | Phase 2 | 102 participants (Anticipated) | Interventional | 2017-03-07 | Recruiting |
| A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Hematologic Malignancies [NCT04282174] | Phase 2 | 0 participants (Actual) | Interventional | 2022-09-30 | Withdrawn(stopped due to Study was split into two new studies before the first participant was enrolled.) |
| Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer [NCT02183805] | Phase 2 | 6 participants (Actual) | Interventional | 2014-06-17 | Terminated(stopped due to Difficulty accruing subjects the study accrual was closed) |
| A Phase I Study to Examine the Toxicity of Allogeneneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewings [NCT02472392] | Phase 1 | 10 participants (Anticipated) | Interventional | 2013-04-30 | Completed |
| A Phase I Study of Adoptive Immunotherapy for Advanced B-Cell Maturation Antigen (BCMA)+ Multiple Myeloma With Autologous CD4+ and CD8+ T Cells Engineered to Express a BCMA-Specific Chimeric Antigen Receptor [NCT03338972] | Phase 1 | 28 participants (Actual) | Interventional | 2017-11-29 | Completed |
| Novel BCMA-targeted CAR-T Cell Therapy for Multiple Myeloma [NCT04706936] | Phase 1 | 25 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
| A Phase 1/2 Study of Ixazomib as a Replacement for Bortezomib or Carfilzomib for Multiple Myeloma (MM) Patients Recently Relapsed or Refractory to Their Last Combination Regimen Containing Either Bortezomib or Carfilzomib [NCT02206425] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2014-09-30 | Completed |
| A PHASE II, MULTI-CENTER, OPEN LABEL STUDY OF CYCLOPHOSPHAMIDE IN MULTIPLE MYELOMA PATIENTS WITH BIOCHEMICAL PROGRESSION DURING LENALIDOMIDE-DEXAMETHASONE TREATMENT FOR RELAPSED/REFRACTORY MULTIPLE MYELOMA [NCT02206503] | Phase 2 | 13 participants (Actual) | Interventional | 2013-03-31 | Completed |
| A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma [NCT05351346] | Phase 3 | 1,100 participants (Anticipated) | Interventional | 2022-06-01 | Recruiting |
| Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) Early Breast Cancer: a Double Blind, Multi-center, Randomized Phase III Trial [NCT06144944] | Phase 3 | 160 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
| A Phase I Safety and Feasibility Study of Cellular Immunotherapy for Extensive Stage Small Cell Neuroendocrine Prostate Cancer Using Autologous T Cells Lentivirally Transduced to Express L1CAM-Specific Chimeric Antigen Receptor [NCT06094842] | Phase 1 | 20 participants (Anticipated) | Interventional | 2024-03-01 | Not yet recruiting |
| Phase I/II Study Using Prophylactic Donor Lymphocyte Infusion Early Post-Transplant After Allogeneic Hematopoietic Cell Transplantation Using Post-Transplantation Cyclophosphamide for High-Risk Hematologic Malignancies [NCT05327023] | Phase 1/Phase 2 | 430 participants (Anticipated) | Interventional | 2022-05-23 | Recruiting |
| Phase 1 Trial for Patients With Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells [NCT05088356] | Phase 1 | 40 participants (Anticipated) | Interventional | 2021-09-07 | Recruiting |
| Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies [NCT04088864] | Phase 1 | 52 participants (Anticipated) | Interventional | 2020-01-10 | Suspended(stopped due to Business decision) |
| PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS [NCT03709680] | Phase 2 | 184 participants (Anticipated) | Interventional | 2019-05-24 | Recruiting |
| Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years [NCT01096368] | Phase 3 | 479 participants (Actual) | Interventional | 2010-05-07 | Active, not recruiting |
| Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer [NCT00861705] | Phase 2 | 454 participants (Actual) | Interventional | 2009-05-15 | Active, not recruiting |
| Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948] | Phase 2 | 97 participants (Actual) | Interventional | 2009-09-01 | Active, not recruiting |
| Phase II Study of MK-3475 in Conjunction With Lymphodepletion, TIL, and High or Low Dose IL-2 in Patients With Metastatic Melanoma [NCT02500576] | Phase 2 | 18 participants (Actual) | Interventional | 2015-08-07 | Completed |
| A Prospective, Multicenter, Open-label Comparison of Pre-surgical Myocet/ Cyclophosphamide (MC) q3w Followed by Either MC or Paclitaxel - Depending on Early Response Assessment by Ultrasound or by Toxicity for Elderly Non Frail Primary Breast Cancer Patie [NCT02214381] | Phase 3 | 80 participants (Anticipated) | Interventional | 2014-07-31 | Active, not recruiting |
| Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer [NCT01779206] | Phase 2/Phase 3 | 4,936 participants (Anticipated) | Interventional | 2012-05-31 | Active, not recruiting |
| Bortezomib in Combination With Continuous Low-dose Oral Cyclophosphamide and Dexamethason Followed by Maintenance in Primary Refractory or Relapsed Bortezomib naïve Multiple Myeloma Patients. A Prospective Phase II Study. [NCT02467010] | Phase 2 | 73 participants (Actual) | Interventional | 2008-09-30 | Completed |
| A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma [NCT01265901] | Phase 3 | 339 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia [NCT00924170] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2008-10-31 | Completed |
| A Phase 1/2 Open-Label Multicenter Study of Avadomide (CC-122) in Combination With R-CHOP-21 for Previously Untreated Poor Risk (IPI>=3) Diffuse Large B-Cell Lymphoma [NCT03283202] | Phase 1 | 35 participants (Actual) | Interventional | 2017-10-04 | Completed |
| A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors [NCT02737475] | Phase 1/Phase 2 | 166 participants (Actual) | Interventional | 2016-06-17 | Completed |
| Phase I Study of Malignancies That Express NY-ESO-1 With T Cell Receptor-transduced T Cells Targeting NY-ESO-1 [NCT02457650] | Phase 1 | 36 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| A Randomised, Open-label Phase II Study to Determine the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in Women With Triple-negative Breast Cancer [NCT05498896] | Phase 2 | 146 participants (Actual) | Interventional | 2018-12-19 | Active, not recruiting |
| Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation [NCT03229616] | Phase 2/Phase 3 | 122 participants (Anticipated) | Interventional | 2017-07-05 | Recruiting |
| Pilot Study of Autologous Anti-CD19 4-1BB CAR T Cells With Cell-intrinsic PD1 Inhibition in Relapsed or Refractory B-cell Lymphoma [NCT03208556] | Phase 1 | 20 participants (Anticipated) | Interventional | 2017-06-21 | Recruiting |
| Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma [NCT00151281] | Phase 2 | 25 participants (Actual) | Interventional | 2004-11-30 | Completed |
| Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT02445404] | Phase 2 | 134 participants (Anticipated) | Interventional | 2015-09-23 | Recruiting |
| 3RD GENERATION GD2 SPECIFIC CHIMERIC ANTIGEN RECEPTOR AND INDUCIBLE CASPASE 9 SAFETY SWITCH TRANSDUCED AUTOLOGOUS NATURAL KILLER T-CELLS TO TREAT CHILDREN WITH NEUROBLASTOMA (GINAKIT) [NCT02439788] | Phase 1 | 0 participants (Actual) | Interventional | 2017-08-31 | Withdrawn(stopped due to Based on newly available preclinical data we changed the CAR construct to a more effective version and will now study that product on a different protocol.) |
| Phase II Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R in Untreated De Novo Diffuse Large B-Cell Lymphomas [NCT03188198] | Phase 2 | 60 participants (Anticipated) | Interventional | 2016-06-01 | Recruiting |
| Evaluation of the Immunological Effects of a Combined Treatment With Radiation and Cyclophosphamide in Metastasized Breast Cancer Patients [NCT02441270] | Early Phase 1 | 0 participants (Actual) | Interventional | 2015-04-30 | Withdrawn(stopped due to Study was never started.) |
| An Open-Label, Multinational, Multicenter, Phase IIIB Study to Assess Safety of Rituximab Following Subcutaneous Administration in Patients With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A [NCT02406092] | Phase 3 | 122 participants (Actual) | Interventional | 2015-10-13 | Completed |
| A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer [NCT02950259] | Phase 1 | 16 participants (Actual) | Interventional | 2017-02-09 | Active, not recruiting |
| NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL [NCT03169790] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
| A Phase I Trial of B-cell Maturation Antigen (BCMA) Targeted EGFRt/BCMA-41BBz Chimeric Antigen Receptor (CAR) Modified T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma (MM) [NCT03070327] | Phase 1 | 20 participants (Actual) | Interventional | 2017-02-27 | Active, not recruiting |
| Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies [NCT01652092] | | 30 participants (Anticipated) | Interventional | 2012-09-04 | Recruiting |
| A Phase 1/2 Study of Cytokine-Induced Memory-Like NK Cells in Patients With AML or MDS [NCT01898793] | Phase 1/Phase 2 | 89 participants (Actual) | Interventional | 2014-08-11 | Terminated(stopped due to Insufficient funding/staff) |
| CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid [NCT03492255] | | 49 participants (Actual) | Interventional | 2018-04-12 | Terminated(stopped due to Significative difference between percentage of renal response (primary outcome) between the two study arms.) |
| Single-Arm, Open Label, Interventional Phase II Clinical Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy [NCT03674411] | Phase 2 | 22 participants (Actual) | Interventional | 2019-01-02 | Active, not recruiting |
| A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma [NCT05155215] | Phase 1/Phase 2 | 68 participants (Anticipated) | Interventional | 2021-12-31 | Not yet recruiting |
| The Safety,Tolerance and Efficacy of Neoantigen Targeting T Cells Suspension for Intravenous Infusion(Neo-T) to Advanced Solid Tumor [NCT05798546] | Phase 1 | 21 participants (Anticipated) | Interventional | 2022-09-28 | Recruiting |
| Prospective, Single-center, Single-arm, Open-label Study of Obinutuzumab, Zanubrutinib and Lenalidomide Sequential CD19/CD22 CAR-T in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma [NCT05797948] | | 20 participants (Anticipated) | Interventional | 2022-07-01 | Enrolling by invitation |
| Phase I/II Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma [NCT05703854] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2023-03-29 | Recruiting |
| Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients With Newly Diagnosed High-Risk Neuroblastoma [NCT01798004] | Phase 1 | 150 participants (Actual) | Interventional | 2013-04-08 | Active, not recruiting |
| A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG [NCT01256398] | Phase 2 | 66 participants (Actual) | Interventional | 2010-12-14 | Completed |
| A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma [NCT01175356] | Phase 1 | 99 participants (Actual) | Interventional | 2010-10-04 | Active, not recruiting |
| Phase IV/II Trial With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab in Patients With Metastatic Breast Cancer With Overexpression of Human Epidermal Growth Factor Receptor 2 (HER2)/Neu [NCT00258960] | Phase 2 | 49 participants (Actual) | Interventional | 2006-02-15 | Completed |
| Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes [NCT00121992] | Phase 3 | 1,060 participants (Actual) | Interventional | 1999-07-31 | Completed |
| Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer [NCT00070564] | Phase 3 | 3,294 participants (Actual) | Interventional | 2003-11-30 | Active, not recruiting |
| Multi-center, Investigator Initiated Phase 1 Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors [NCT02366546] | Phase 1 | 9 participants (Actual) | Interventional | 2015-03-31 | Active, not recruiting |
| Improved Post-Transplant Cyclophosphamide Regimens for Unmanipulated Haploidentical Transplant in Pediatric Patients With Refractory Acute Myeloid Leukemia [NCT03654703] | Phase 2 | 100 participants (Anticipated) | Interventional | 2015-03-01 | Enrolling by invitation |
| A Pilot Study of EBV-TCR-T(YT-E001) in NPC Patients [NCT03648697] | Phase 2 | 20 participants (Anticipated) | Interventional | 2018-10-10 | Recruiting |
| A Phase Ib Study With a Safety lead-in Cohort and Expansion Phase, of the Safety, Tolerability, Biological Effect, and Efficacy of Allogenic Natural Killer Cells in Combination With Trastuzumab and Pertuzumab in Adult Patients With Refractory Metastatic H [NCT05385705] | Phase 1 | 20 participants (Anticipated) | Interventional | 2022-05-11 | Recruiting |
| CD19+ Chimeric Antigen Receptor T Cells for Patients With Advanced Lymphoid Malignancies [NCT02529813] | Phase 1 | 26 participants (Actual) | Interventional | 2015-12-16 | Completed |
| A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients With MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen [NCT02481310] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2015-10-28 | Active, not recruiting |
| A Pilot Study of Reduced Intensity HLA-Haploidentical Hematopoietic Cell Transplantation With Post-Transplant Cyclophosphamide in Patients With Advanced Myelofibrosis [NCT03426969] | Early Phase 1 | 3 participants (Actual) | Interventional | 2018-01-31 | Completed |
| QUILT-3.091 NANT Chordoma Vaccine: A Randomized Phase 1b/2 Trial of the NANT Chordoma Vaccine vs. Radiation in Subjects With Unresectable Chordoma. [NCT03647423] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-08-31 | Withdrawn(stopped due to Trial not initiated) |
| A Phase 1, Open-label, Multicenter Trial of Oral Azacitidine (CC-486) Plus R-CHOP in Subjects With High Risk (IPI 3 or More) Previously Untreated Diffuse Large B-cell Lymphoma or Grade 3B Follicular Lymphoma. [NCT02343536] | Phase 1 | 59 participants (Actual) | Interventional | 2015-04-29 | Completed |
| A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome [NCT02328950] | | 50 participants (Anticipated) | Observational | 2014-12-31 | Recruiting |
| QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After P [NCT03387111] | Phase 1/Phase 2 | 65 participants (Anticipated) | Interventional | 2018-01-13 | Active, not recruiting |
| An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alon [NCT02855359] | Phase 2 | 24 participants (Actual) | Interventional | 2016-08-31 | Terminated(stopped due to Sponsor decision based on portfolio prioritization) |
| Safety and Efficacy Evaluation of IM19 CAR-T Cells on Refractory or Relapsed B-ALL Patients [NCT03142646] | Phase 1/Phase 2 | 60 participants (Anticipated) | Interventional | 2016-08-30 | Recruiting |
| Phase 1b/2a Trial of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) From an HLA-partially Matched Related or Unrelated Donor After TCRαβ+ T-cell/CD19+ B-cell Depletion for Patients Who Will Receive a Kidney Transplant (KT) From the Same HSCT/KT [NCT05508009] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2023-01-10 | Recruiting |
| A Phase I/Ib Study of Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide and/or Bendamustine [NCT02996773] | Phase 1 | 50 participants (Actual) | Interventional | 2016-11-29 | Active, not recruiting |
| An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma [NCT01370694] | Phase 1 | 7 participants (Actual) | Interventional | 2011-08-19 | Terminated(stopped due to The study was terminated for business reasons.) |
| Randomized Study Comparing i.v. Busulfan (Busilvex®) Plus Fludarabine (BuFlu) Versus Busilvex® Plus Cyclophosphamide (BuCy2) as Conditioning Regimens Prior AlloHSCT in Patients (Age >= 40 and =<65 Years) With AML in Complete Remission. [NCT01191957] | Phase 3 | 252 participants (Actual) | Interventional | 2008-01-31 | Completed |
| A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease [NCT00157196] | Phase 2 | 22 participants (Actual) | Interventional | 2005-04-30 | Completed |
| Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances [NCT05092451] | Phase 1/Phase 2 | 94 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
| Evolutionary Inspired Therapy for Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma [NCT04388839] | Phase 2 | 28 participants (Anticipated) | Interventional | 2020-09-27 | Recruiting |
| A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor [NCT04145349] | Phase 1/Phase 2 | 34 participants (Anticipated) | Interventional | 2020-01-22 | Active, not recruiting |
| Co-stimulation With Ipilimumab to Enhance Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Patients With Metastatic Melanoma [NCT01701674] | | 13 participants (Actual) | Interventional | 2012-10-09 | Active, not recruiting |
| A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy [NCT04437160] | Phase 2 | 286 participants (Anticipated) | Interventional | 2020-02-01 | Recruiting |
| Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia [NCT05519384] | Early Phase 1 | 12 participants (Anticipated) | Interventional | 2022-09-14 | Recruiting |
| A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene [NCT01088789] | Phase 2 | 71 participants (Actual) | Interventional | 2010-04-20 | Active, not recruiting |
| A Phase III,Randomized, Multi-center, Open Label Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in BRCA1/2 Wide-type Stage III and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC) [NCT04520074] | Phase 3 | 590 participants (Anticipated) | Interventional | 2021-10-08 | Recruiting |
| Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Solid Tumor [NCT03658785] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2018-12-10 | Not yet recruiting |
| The Usage of Neuropsychological Tests and Multi-mode Magnetic Resonance Imaging in Patients With Autoimmune Encephalitis for Cognitive Neural Mechanism [NCT03530462] | | 22 participants (Actual) | Observational | 2017-04-07 | Completed |
| Dose Escalation of VP-16 With Cyclophosphamide and Total Body Irradiation as Preparative Regimen for Autologous Transplantation for High-Grade Lymphoma and Acute Lymphoblastic Leukemia [NCT00004898] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 1999-10-31 | Completed |
| A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide)+Bevacizumab vs. (Placebo Injection/Placebo Pill) +Bevacizumab in the Treatment of Recurrent/Progressive, Bevacizumab naïve Glioblastoma Multiforme and Glioasarcoma [NCT01903330] | Phase 2 | 84 participants (Anticipated) | Interventional | 2014-03-31 | Active, not recruiting |
| Peripheral Stem Cell Transplantation Protocol for Patients With Previously Treated Advanced Breast Cancer - A Phase II Pilot Study [NCT00004172] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| Adjuvant Chemotherapy of Breast Cancer: Sequential Chemotherapy vs. Standard Therapy. Prospective Randomised Comparison of 4 x Epirubicin and Cyclophosphamide (EC) --> 4 x Docetaxel (Doc) vs. 6 x CMF / CEF in Patients With 1 to 3 Positive Lymph Nodes [NCT02115204] | Phase 3 | 2,011 participants (Actual) | Interventional | 2000-06-30 | Completed |
| Open-label, Randomized, Multicenter, International, Parallel Exploratory Phase II Study, Comparing 3 FEC-3 Docetaxel Chemotherapy to Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk [NCT02400567] | Phase 2 | 125 participants (Actual) | Interventional | 2015-01-31 | Completed |
| A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients [NCT01210768] | Phase 2 | 254 participants (Anticipated) | Interventional | 2010-06-30 | Active, not recruiting |
| A Randomized Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto) [NCT02125344] | Phase 3 | 961 participants (Actual) | Interventional | 2014-12-31 | Completed |
| A Phase 2 Clinical Trial to Evaluate the Efficacy of Zanubrutinib Followed Zanubrutinib Plus FCR (Fludarabine Cyclophosphamide and Rituximab) / BR(Bendamustine and Rituximab) in Newly Diagnosed Symptomatic CLL/SLL (STOP Trial) [NCT05287984] | Phase 2 | 63 participants (Anticipated) | Interventional | 2022-03-22 | Not yet recruiting |
| A Phase I Study of Oral Metronomic Dosing of Oral Cyclophosphamide With Dexamethasone for Metastatic Castration Resistant Prostate Cancer [NCT05479578] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-06-29 | Recruiting |
| A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR20A in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) o [NCT04030195] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2020-03-24 | Completed |
| High-dose Post-transplantation Cyclophosphamide as Graft Versus-host Disease Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation [NCT02294552] | Phase 2 | 200 participants (Actual) | Interventional | 2014-10-31 | Completed |
| A Single Center, Open Label, Single Arm Exploratory Clinical Study of CD19-Directed Allogeneic Chimeric Antigen Receptor CART-cell Immunotherapy Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia [NCT04173988] | Early Phase 1 | 6 participants (Anticipated) | Interventional | 2020-01-09 | Recruiting |
| A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer. [NCT03515798] | Phase 2 | 81 participants (Anticipated) | Interventional | 2018-07-24 | Recruiting |
| A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (DA-EPCH-PR) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas [NCT04231877] | Phase 1 | 50 participants (Anticipated) | Interventional | 2020-10-27 | Recruiting |
| Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells as Immunotherapy for Patients With Pediatric Solid Tumors [NCT02932956] | Phase 1 | 10 participants (Actual) | Interventional | 2018-12-17 | Active, not recruiting |
| A Phase I/IIa Study of TGFß Blockade in TCR-Engineered T-Cell Cancer Immunotherapy in Patients With Advanced Malignancies [NCT02650986] | Phase 1/Phase 2 | 15 participants (Actual) | Interventional | 2017-07-14 | Active, not recruiting |
| Ph1 Cyclophosphamide & Alemtuzumab in CD52+ R/R Double-Hit, Diffuse Lg B-cell or High Gr B-cell Lymphomas, NOS With MYC & BCL2 Over-expression, MYC-Positive Transformed Follicular Lymphoma, & CD52+ Mature T-cell Lymphoproliferative Disorder [NCT03132584] | Phase 1 | 3 participants (Actual) | Interventional | 2017-07-30 | Terminated(stopped due to slow accrual) |
| A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor [NCT02639650] | Phase 3 | 214 participants (Anticipated) | Interventional | 2016-03-01 | Recruiting |
| Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer [NCT03497702] | Phase 2 | 114 participants (Anticipated) | Interventional | 2017-05-08 | Recruiting |
| Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS) [NCT00354835] | Phase 3 | 481 participants (Actual) | Interventional | 2006-12-26 | Completed |
| The Safety and Efficacy of Double-target CART-19 and 20 Cells in Relapse and Refractory Patients With CD19+/CD20+ Non-Hodgkin's Lymphoma (NHL) [NCT06160362] | | 20 participants (Anticipated) | Interventional | 2023-10-31 | Recruiting |
| Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC [NCT05645380] | Phase 2 | 139 participants (Anticipated) | Interventional | 2022-12-05 | Recruiting |
| A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma [NCT05621668] | Phase 1 | 40 participants (Anticipated) | Interventional | 2023-09-08 | Recruiting |
| A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11) [NCT05113251] | Phase 3 | 900 participants (Anticipated) | Interventional | 2021-10-25 | Recruiting |
| A Phase II Study to Determine the Response Kinetics, Safety, and Efficacy of Brentuximab Vedotin and Nivolumab Alone and Then Combined With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone for Patients With Untreated Primary Mediastinal Large B-Ce [NCT04745949] | Phase 2 | 40 participants (Anticipated) | Interventional | 2021-05-10 | Recruiting |
| A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis [NCT03201965] | Phase 3 | 416 participants (Actual) | Interventional | 2017-10-05 | Active, not recruiting |
| A Phase 1b Study of Neratinib, Pertuzumab, and Trastuzumab With Taxol (3HT) in Metastatic and Locally Advanced Breast Cancer, and Phase II Study of 3HT Followed by AC in HER2 + Primary IBC, and Neratinib With Taxol (NT) Followed by AC in HR+ /HER2- Primar [NCT03101748] | Phase 1/Phase 2 | 43 participants (Actual) | Interventional | 2018-01-29 | Active, not recruiting |
| A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults [NCT02003222] | Phase 3 | 488 participants (Actual) | Interventional | 2014-05-19 | Active, not recruiting |
| Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors [NCT02161692] | Phase 2 | 0 participants | Interventional | 1996-12-31 | Completed |
| A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma [NCT00101010] | Phase 2 | 80 participants (Actual) | Interventional | 2005-09-30 | Completed |
| A Multi-center, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Mizoribine in Comparison With Cyclophosphamide in the Treatment of Lupus Nephritis [NCT02256150] | Phase 3 | 250 participants (Actual) | Interventional | 2014-11-30 | Completed |
| A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement [NCT04432714] | Phase 1/Phase 2 | 81 participants (Anticipated) | Interventional | 2020-06-09 | Recruiting |
| A Study to Infuse ROR1-Specific Autologous T Cells for Patients With Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) [NCT02194374] | Phase 1 | 0 participants (Actual) | Interventional | 2015-01-31 | Withdrawn(stopped due to Study closed with no enrollment due to unavailability of reagent.) |
| Phase I Study of the Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma [NCT02650648] | Phase 1 | 85 participants (Actual) | Interventional | 2016-01-31 | Active, not recruiting |
| A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer. [NCT02225652] | Phase 2 | 11 participants (Actual) | Interventional | 2010-09-30 | Completed |
| Glypican 3-specific Chimeric Antigen Receptor Expressing T Cells as Immunotherapy for Patients With Hepatocellular Carcinoma [NCT02905188] | Phase 1 | 9 participants (Actual) | Interventional | 2019-03-28 | Completed |
| Aflac LL1602 ENCERT: A Phase 1 Trial Using Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Relapsed T Cell Lymphoblastic Leukemia/Lymphoma [NCT03328104] | Phase 1 | 8 participants (Actual) | Interventional | 2018-07-24 | Completed |
| A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia [NCT02723994] | Phase 2 | 171 participants (Actual) | Interventional | 2016-09-30 | Active, not recruiting |
| Phase I-II Study of Escalating Doses of Large Field Image-Guided Intensity Modulated Radiation Therapy (IMRT) Using Helical Tomotherapy in Combination With Etoposide (VP16) and Cytoxan as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) [NCT00576979] | Phase 1/Phase 2 | 51 participants (Actual) | Interventional | 2008-03-04 | Active, not recruiting |
| Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT00390793] | Phase 2 | 107 participants (Actual) | Interventional | 2006-09-28 | Active, not recruiting |
| Phase I Study of MLN 9708 in Addition to Chemotherapy for the Treatment of Acute Lymphoblastic Leukemia in Older Adults [NCT02228772] | Phase 1 | 19 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients [NCT04945954] | | 15 participants (Anticipated) | Interventional | 2021-06-30 | Not yet recruiting |
| Outcomes of Patients After Allogenic Hematopoietic Cell Transplantation With Decitabine-containing Conditioning Regimen and Acetylcysteine Treatment [NCT04945096] | Phase 3 | 100 participants (Anticipated) | Interventional | 2021-07-01 | Not yet recruiting |
| Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-BL-M-04 and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise [NCT03479918] | Phase 3 | 80 participants (Anticipated) | Interventional | 2018-03-15 | Recruiting |
| Multi-Institutional Prospective Pilot Study of Lupron to Enhance Lymphocyte Immune Reconstitution Following Allogeneic Bone Marrow Transplantation in Post-Pubertal Children and Adults With Molecular Imaging Evaluation [NCT01338987] | Phase 2 | 76 participants (Actual) | Interventional | 2011-04-19 | Completed |
| Phase I Clinical Trial of Human AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) [NCT04732845] | Phase 1 | 36 participants (Anticipated) | Interventional | 2021-04-26 | Recruiting |
| Phase I Clinical Trial of AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non Hodgkin Lymphoma [NCT03434769] | Phase 1 | 31 participants (Actual) | Interventional | 2018-07-09 | Active, not recruiting |
| A Phase II Study of Metronomic Chemotherapy in Elderly Non-fit Patients (>65 Years) With Aggressive B-Cell Lymphomas [NCT03161054] | Phase 2 | 21 participants (Actual) | Interventional | 2017-09-12 | Completed |
| A Phase 3 Open-label, Controlled, Randomised, Multi-centre Trial Comparing Imlifidase and Standard-of-care With Standard-of-care Alone in the Treatment of Severe Anti-GBM Antibody Disease (Goodpasture Disease) [NCT05679401] | Phase 3 | 50 participants (Anticipated) | Interventional | 2022-12-22 | Recruiting |
| PNOC018 A Phase 1 Clinical Trial of Autologous T Cells Expressing a TCR Specific for H3.3K27M With Inhibition of Endogenous TCR (KIND T Cells) in HLA-A*0201-positive Participants With Newly Diagnosed H3.3K27M-positive Diffuse Midline Gliomas [NCT05478837] | Phase 1 | 12 participants (Anticipated) | Interventional | 2023-07-20 | Recruiting |
| Adcetris (Brentuximab Vedotin), Substituting Vincristine in the OEPA/COPDac Regimen [Treatment Group 3 (TG3) of Euro-Net C1] With Involved Node Radiation Therapy for High Risk Pediatric Hodgkin Lymphoma (HL) [NCT01920932] | Phase 2 | 77 participants (Actual) | Interventional | 2013-08-12 | Active, not recruiting |
| A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients [NCT01106898] | Phase 2 | 112 participants (Actual) | Interventional | 2010-03-24 | Completed |
| A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma. [NCT00601003] | Phase 2 | 112 participants (Actual) | Interventional | 2008-01-14 | Completed |
| Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA) [NCT06066424] | Phase 1 | 54 participants (Anticipated) | Interventional | 2023-10-24 | Recruiting |
| Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY) [NCT06042569] | Phase 2 | 174 participants (Anticipated) | Interventional | 2023-12-28 | Recruiting |
| Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): A Randomised Phase II Trial of Investigator Choice Standard Therapy Versus Sequential Novel Therapy Experimental Arms [NCT05848765] | Phase 2 | 284 participants (Anticipated) | Interventional | 2023-09-04 | Recruiting |
| PD-1 Silent PSMA/PSCA Targeted CAR-T for the Treatment of Prostate Cancer [NCT05732948] | Phase 1 | 12 participants (Anticipated) | Interventional | 2018-08-02 | Recruiting |
| A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly- [NCT04824092] | Phase 3 | 899 participants (Actual) | Interventional | 2021-05-11 | Active, not recruiting |
| International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 [NCT03643276] | Phase 3 | 5,000 participants (Anticipated) | Interventional | 2018-07-15 | Recruiting |
| Phase I Trial of Ruxolitinib in Combination With a Pediatric Based-regimen for Adolescents and Young Adults (AYAs) With Ph-like Acute Lymphoblastic Leukemia (ALL) [NCT03571321] | Phase 1 | 15 participants (Anticipated) | Interventional | 2019-05-28 | Recruiting |
| A Randomized Phase 2 Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL) [NCT01979536] | Phase 2 | 137 participants (Actual) | Interventional | 2013-11-13 | Active, not recruiting |
| Phase II Study of Combination of Hyper-CVAD and Ponatinib in Patients With Philadelphia (PH) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT01424982] | Phase 2 | 88 participants (Actual) | Interventional | 2011-10-05 | Active, not recruiting |
| A Randomized Trial for Adults With Newly Diagnosed Acute Lymphoblastic Leukemia [NCT01085617] | Phase 3 | 1,033 participants (Actual) | Interventional | 2010-12-31 | Active, not recruiting |
| A Multicentre, Open-Label, Exploratory Phase Ib Clinical Study to Assess Safety and Efficacy of an EGFR Tyrosine Kinase Inhibitor in Combination With EGF Pathway Targeting Immunisation (EGF-PTI) in Treatment-Naïve Patients With EGFR Mutant NSCLC. The EPIC [NCT03623750] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2018-07-06 | Completed |
| Decitabine-primed Tandem Targeting CD19 and CD20 Chimeric Antigen Receptor T Cells Treatment in Relapsed and/or Refractory Non-Hodgkin's Lymphoma Patients [NCT04697940] | Phase 1/Phase 2 | 33 participants (Anticipated) | Interventional | 2020-12-15 | Recruiting |
| A Phase II Trial of Weekly Bortezomib and Dexamethasone With Oral Metronomic Cyclophosphamide in Elderly Patients With Plasma Cell Myeloma [NCT02082405] | Phase 2 | 0 participants (Actual) | Interventional | 2015-04-30 | Withdrawn(stopped due to Funding unavailable) |
| The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train. [NCT05816694] | Phase 2 | 50 participants (Anticipated) | Interventional | 2023-04-30 | Not yet recruiting |
| A Phase 1/2 Single-center Study Evaluating the Safety and Efficacy of TRAC and Power3 Genes Knock-out Allogeneic CD19-targeting CAR-T Cell (ATHENA) Therapy in Adults With Refractory/Relapsed B-cell Non-Hodgkin Lymphoma [NCT06014073] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2023-09-06 | Recruiting |
| A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation [NCT04024761] | Phase 1 | 50 participants (Anticipated) | Interventional | 2019-08-31 | Active, not recruiting |
| A Pilot Study of a Personalized Neoantigen Cancer Vaccine With and Without Low-Dose Cyclophosphamide or Pembrolizumab in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated Chronic Lymphocytic Leukemia. [NCT03219450] | Phase 1 | 15 participants (Anticipated) | Interventional | 2021-08-18 | Recruiting |
| An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC [NCT03554109] | Phase 2 | 0 participants (Actual) | Interventional | 2018-09-30 | Withdrawn(stopped due to Trial not initiated) |
| Indoleamine-2,3-dioxygenase (IDO) Inhibition With INCB024360 and Intraperitoneal Delivery of Allogeneic Natural Killer Cells for Women With Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer [NCT02118285] | Phase 1 | 2 participants (Actual) | Interventional | 2014-07-28 | Completed |
| Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma With High-Dose Cyclophosphamide, Total Body Irradiation and Involved-Field Radiation Therapy [NCT00004908] | Phase 2 | 0 participants | Interventional | 1999-11-30 | Completed |
| Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia [NCT00004896] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation [NCT00004230] | Phase 3 | 35 participants (Actual) | Interventional | 1999-10-31 | Completed |
| Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) [NCT04067102] | | 0 participants (Actual) | Interventional | 2019-05-10 | Withdrawn(stopped due to No patients recruited) |
| Assessment of Rituximab Therapeutic Response Versus Conventional Treatment in the Management of Refractory Nephrotic Syndrome [NCT05553496] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2022-09-25 | Not yet recruiting |
| A Phase II, Multicenter, Open Label Study of Treatment Intensification With ACVD and Brentuximab-Vedotin in Advanced-stage Hodgkin Lymphoma Patients With a Positive Interim PET Scan After 2 ABVD Cycles [NCT03527628] | Phase 2 | 220 participants (Anticipated) | Interventional | 2018-01-01 | Recruiting |
| Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer - a Two Step Study With a Retrospective Analyses Followed by a Translational Phase II Study [NCT04350021] | | 40 participants (Anticipated) | Observational | 2019-03-01 | Recruiting |
| NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With Pancreatic Cancer Who Have [NCT03387098] | Phase 1/Phase 2 | 173 participants (Anticipated) | Interventional | 2018-01-02 | Active, not recruiting |
| A Phase I/II, Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men With Advanced Metastatic Castration-resistant Prostate Cancer. [NCT03514836] | Phase 1/Phase 2 | 5 participants (Actual) | Interventional | 2018-05-23 | Terminated(stopped due to insufficient accrual) |
| The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients: A Multicentric, Open-label, Non-randomized Concurrent Control, Non-inferiority Trial [NCT03123770] | Phase 4 | 384 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
| A Pilot Phase II Study for Children With Infantile Fibrosarcoma [NCT00072280] | Phase 2 | 7 participants (Actual) | Interventional | 2004-11-30 | Terminated(stopped due to Due to poor accrual) |
| Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane. [NCT01208818] | Phase 3 | 284 participants (Anticipated) | Interventional | 2011-06-30 | Completed |
| Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) Who Are Eligible for Autologous Stem Cell Transplantation: Multicenter Phase 2 Study [NCT01114048] | Phase 2 | 78 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer [NCT01329640] | Phase 2 | 9 participants (Actual) | Interventional | 2010-09-30 | Terminated |
| A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer [NCT01238770] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Intra-osseous Co-transplant of Cord Blood and Mesenchymal Stromal Cells: A Feasibility Study [NCT02181478] | Early Phase 1 | 6 participants (Actual) | Interventional | 2015-07-22 | Completed |
| Phase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease) [NCT02228512] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2014-08-15 | Withdrawn |
| A Novel TBI Free Conditioning Protocol for Haploidentical Hematopoeitic Stem Cell Transplant in Acquired Aplastic Anemia [NCT03955601] | Phase 2 | 30 participants (Anticipated) | Interventional | 2018-07-12 | Recruiting |
| A Pilot Study of EPOCH-F/R Induction Chemotherapy and Reduced-Intensity, HLA-Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation, With Cyclosporine & Methotrexate GVHD Prophylaxis for Refractory or Relapsed Hematologic Malignancies [NCT00051311] | Phase 2 | 62 participants (Actual) | Interventional | 2003-01-03 | Completed |
| S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study) [NCT00064337] | Phase 2 | 104 participants (Actual) | Interventional | 2004-01-31 | Completed |
| Pilot Study of Allogeneic/Syngeneic Blood Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas [NCT00043979] | Phase 2 | 60 participants (Actual) | Interventional | 2002-09-19 | Completed |
| A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG [NCT00039377] | Phase 2 | 58 participants (Actual) | Interventional | 2002-04-30 | Completed |
| ARTemis - Avastin Randomized Trial With Neo-Adjuvant Chemotherapy for Patients With Early Breast Cancer [NCT01093235] | Phase 3 | 800 participants (Anticipated) | Interventional | 2009-04-30 | Recruiting |
| High-Dose Chemo-Radiotherapy for Patients With Primary Refractory and Relapsed Hodgkin's Disease [NCT00003631] | Phase 2 | 118 participants (Actual) | Interventional | 1998-08-31 | Completed |
| Metronomic Poly-chemotherapy for Metastatic Colorectal Cancer at Progression Following Established Treatments: Clinical and Laboratory Research [NCT02280694] | Phase 2 | 45 participants (Actual) | Interventional | 2015-01-31 | Completed |
| HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte Globulin [NCT01105273] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2009-07-31 | Completed |
| An Open-Label Phase I/II Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer [NCT05981014] | Phase 1/Phase 2 | 196 participants (Anticipated) | Interventional | 2023-08-01 | Recruiting |
| An Open-Label Phase I/II Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer [NCT05981001] | Phase 1/Phase 2 | 170 participants (Anticipated) | Interventional | 2023-08-01 | Recruiting |
| Allogeneic Hematopoietic Cell Transplantation With Cyclophosphamide, Fludarabine, and Antithymocyte Globulin in Lower Risk Myelodysplastic Syndrome Phase 2 Extension Study [NCT06098326] | Phase 2 | 30 participants (Anticipated) | Interventional | 2018-03-06 | Active, not recruiting |
| Efficacy and Safety of Allogeneic Hematopoietic Cell Transplantation Using Post-transplantation Cyclophosphamide for Graft-versus-host Disease Prophylaxis in Higher-risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, and Secondary AML Patients [NCT06098313] | Phase 2 | 113 participants (Anticipated) | Interventional | 2020-07-01 | Active, not recruiting |
| Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies. [NCT06092047] | Early Phase 1 | 10 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| BRE-08: A Phase II Study of an All-Oral Adjuvant Chemotherapy Regimen of Cyclophosphamide, Methotrexate, and Capecitabine (CMC) for Early-Stage Breast Cancer [NCT06085742] | Phase 2 | 25 participants (Anticipated) | Interventional | 2023-10-31 | Recruiting |
| A Dose-escalation Clinical Study of QH103 Cell Injection (CD19 CAR-γδT Cell Injection) in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). [NCT06056752] | Phase 1 | 10 participants (Anticipated) | Interventional | 2023-09-27 | Recruiting |
| A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-naïve Patients With MCD Subtype DLBCL [NCT05234684] | Phase 3 | 150 participants (Anticipated) | Interventional | 2022-11-02 | Recruiting |
| Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia [NCT02303821] | Phase 1 | 130 participants (Anticipated) | Interventional | 2015-02-16 | Recruiting |
| A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy) [NCT02112916] | Phase 3 | 847 participants (Actual) | Interventional | 2014-10-04 | Active, not recruiting |
| "A Novel Pediatric-Inspired Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia" [NCT01920737] | Phase 2 | 39 participants (Actual) | Interventional | 2013-08-31 | Active, not recruiting |
| A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination With Rituximab-CHOP in Patients With Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL) [NCT00972478] | Phase 1/Phase 2 | 83 participants (Actual) | Interventional | 2010-11-15 | Active, not recruiting |
| Investigator Initiated Pilot Study of Microarray Directed Therapy for Diffuse Large B-cell Lymphoma Using Genasense With CHOP-R [NCT00736450] | Early Phase 1 | 37 participants (Actual) | Interventional | 2008-07-23 | Terminated(stopped due to Manufacturer is no longer making the drug.) |
| Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation With a Conditioning Regimen of Targeted Busulfan, Cyclophosphamide, and Thymoglobulin [NCT00611351] | Phase 2 | 5 participants (Actual) | Interventional | 2005-06-07 | Completed |
| B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR) [NCT04897321] | Phase 1 | 32 participants (Anticipated) | Interventional | 2022-07-06 | Recruiting |
| A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) [NCT04663347] | Phase 1/Phase 2 | 662 participants (Anticipated) | Interventional | 2020-11-03 | Recruiting |
| Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T Cells (GD2CART) for Diffuse Intrinsic Pontine Gliomas (DIPG) and Spinal Diffuse Midline Glioma (DMG) [NCT04196413] | Phase 1 | 54 participants (Anticipated) | Interventional | 2020-06-04 | Recruiting |
| A Phase I Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2, a Genetically Engineered HSV-1 Virus, and Immunomodulation With Cyclophosphamide [NCT03152318] | Phase 1 | 62 participants (Anticipated) | Interventional | 2017-07-18 | Recruiting |
| Treatment Plan for Hematologic Malignancies Using Intravenous Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide to Examine Results, Success and Side Effects of Treatment With Chemotherapy Only, as a Preparative The [NCT01339988] | Phase 4 | 10 participants (Anticipated) | Interventional | 2011-06-30 | Not yet recruiting |
| A Prospective， Randomized， Open-label， Multicentric，phaseIII Clinical Trial Compared With PC and CEF100 Followed by Docetaxel as Adjuvant Chemotherapy Regimen for Chinese Primary Triple Negative Breast Cancer Patients [NCT01216111] | Phase 3 | 647 participants (Actual) | Interventional | 2011-01-01 | Completed |
| Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer [NCT01120171] | Phase 2 | 64 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to Due to poor accrual) |
| Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) With Pembrolizumab, in Subjects Who Have Failed Cisplatin-Based Chemotherapy With Locally Advanced (Unresectable) or Metastatic Transitional Cell Cancer (TCC) of the Urothelium [NCT03935347] | Phase 2 | 0 participants (Actual) | Interventional | 2019-06-20 | Withdrawn(stopped due to no accrual) |
| A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With R/R MM Who Received Three or More Lines of Therapy [NCT05998928] | Phase 2 | 10 participants (Anticipated) | Interventional | 2023-07-27 | Recruiting |
| A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER) [NCT04637763] | Phase 1 | 72 participants (Anticipated) | Interventional | 2021-05-26 | Recruiting |
| St. Jude ELIOT: Phase 1 Evaluation of LY2606368, a Molecularly-Targeted CHK1/2 Inhibitor Therapy, in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tu [NCT04023669] | Phase 1 | 21 participants (Actual) | Interventional | 2019-08-08 | Active, not recruiting |
| A Phase II Study of Split-Dose R-CHOP in Older Adults With Diffuse Large B-cell Lymphoma [NCT03943901] | Phase 2 | 26 participants (Anticipated) | Interventional | 2021-02-17 | Recruiting |
| Phase I and Dose-Expansion Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas [NCT03220022] | Phase 1 | 54 participants (Anticipated) | Interventional | 2018-03-16 | Recruiting |
| A Randomized Phase II Trial Comparing a Calcineurin Inhibitor-free Graft-versus-host Disease Prophylaxis Regimen With Post-transplantation Cyclophosphamide and Abatacept to Standard of Care [NCT03680092] | Phase 2 | 43 participants (Actual) | Interventional | 2019-11-26 | Active, not recruiting |
| "A Single-Center, Open-Label Study to Evaluate the Safety and Efficacy of Nipent, Cytoxan, and Rituxan (PCR) in the Treatment of Previously Untreated and Treated, Stage III or IV, Low-Grade B-Cell Non-Hodgkin's Lymphoma or Bulky Lymphoma" [NCT00496873] | Phase 2 | 100 participants (Actual) | Interventional | 2005-06-30 | Completed |
| A Prospective, Controlled Study of Double Filtration Plasmapheresis (DFPP) in Patients With Antineutrophil Cytoplasmic Autoantibody Associated Glomerulonephritis (AAGN) [NCT02294344] | | 14 participants (Actual) | Interventional | 2014-06-30 | Terminated(stopped due to The recruitment of subject is very difficult.) |
| Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma [NCT06140966] | Phase 2 | 54 participants (Anticipated) | Interventional | 2023-10-20 | Recruiting |
| A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies [NCT05665062] | Phase 1 | 36 participants (Anticipated) | Interventional | 2022-06-24 | Recruiting |
| A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic [NCT05457556] | Phase 3 | 435 participants (Anticipated) | Interventional | 2023-03-15 | Recruiting |
| A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features [NCT05382338] | Phase 3 | 225 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting |
| A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma [NCT05304585] | Phase 3 | 205 participants (Anticipated) | Interventional | 2022-08-04 | Recruiting |
| A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance i [NCT04994132] | Phase 3 | 118 participants (Anticipated) | Interventional | 2021-09-14 | Recruiting |
| Itacitinib to Prevent Graft Versus Host Disease [NCT04859946] | Phase 1 | 30 participants (Anticipated) | Interventional | 2022-01-11 | Recruiting |
| Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT) [NCT04322318] | Phase 2 | 221 participants (Anticipated) | Interventional | 2020-10-19 | Recruiting |
| Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP 2577) With and Without Topotecan and Cyclophosphamide in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas [NCT03600649] | Phase 1 | 50 participants (Anticipated) | Interventional | 2018-06-04 | Active, not recruiting |
| International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147] | Phase 3 | 475 participants (Anticipated) | Interventional | 2017-08-08 | Recruiting |
| A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL) [NCT02981628] | Phase 2 | 80 participants (Anticipated) | Interventional | 2017-06-19 | Active, not recruiting |
| Partially HLA-Mismatched Related Donor Hematopoietic Stem Cell Transplantation Using Killer Immunoglobulin Receptor and Human Leukocyte Antigen Based Donor Selection [NCT02880293] | | 44 participants (Actual) | Interventional | 2016-08-23 | Completed |
| A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients [NCT02724579] | Phase 2 | 45 participants (Anticipated) | Interventional | 2017-11-17 | Recruiting |
| Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) [NCT02101853] | Phase 3 | 669 participants (Actual) | Interventional | 2014-12-17 | Active, not recruiting |
| A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy With Rituximab in HIV-Related B-Cell Non-Hodgkin's Lymphoma [NCT01193842] | Phase 1/Phase 2 | 107 participants (Actual) | Interventional | 2010-10-06 | Completed |
| A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer [NCT00433511] | Phase 3 | 4,994 participants (Actual) | Interventional | 2007-11-02 | Active, not recruiting |
| Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma [NCT00408005] | Phase 3 | 1,895 participants (Actual) | Interventional | 2007-01-22 | Active, not recruiting |
| HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma [NCT01356680] | Phase 3 | 1,100 participants (Actual) | Interventional | 2012-01-13 | Completed |
| Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer, A Collaborative Trial [NCT01229605] | Phase 2 | 0 participants (Actual) | Interventional | 2010-10-31 | Withdrawn(stopped due to Study was not a good fit for the patient population seen at this hospital.) |
| Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression [NCT00275054] | Phase 3 | 825 participants (Actual) | Interventional | 2005-10-31 | Completed |
| An Assessment of the Safety and Feasibility of Administering T-Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-Cell Lymphoma [NCT00924326] | Phase 1/Phase 2 | 43 participants (Actual) | Interventional | 2009-02-17 | Completed |
| A Phase II Study for the Treatment of Non-metastatic Nodular Desmoplastic Medulloblastoma in Children Less Than 4 Years of Age [NCT02017964] | Phase 2 | 26 participants (Actual) | Interventional | 2013-12-24 | Completed |
| A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer [NCT03556358] | Phase 3 | 809 participants (Actual) | Interventional | 2018-06-28 | Completed |
| Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide [NCT01374620] | Phase 1 | 28 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T Cells (ACTolog® IMA101) Alone or in Combination With Atezolizumab in Patients With Relapsed and/or Refractory Solid Cancers [NCT02876510] | Phase 1 | 38 participants (Actual) | Interventional | 2017-06-30 | Completed |
| ABCDE: A Phase II Randomized Study of Adjuvant Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer [NCT00925652] | Phase 2 | 55 participants (Actual) | Interventional | 2010-09-30 | Terminated(stopped due to The study was terminated early due to slow accrual.) |
| Clinical Study of Redirected Autologous T Cells With a BCMA-targeted Chimeric Antigen Receptor in Patients With Refractory or Relapsed Multiple Myeloma [NCT03716856] | Phase 1 | 11 participants (Actual) | Interventional | 2018-03-23 | Active, not recruiting |
| Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes [NCT03894007] | Phase 2 | 6 participants (Actual) | Interventional | 2019-05-23 | Terminated(stopped due to Security and effect data from another ongoing study.) |
| High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) [NCT00075725] | Phase 3 | 3,154 participants (Actual) | Interventional | 2003-12-29 | Completed |
| Permeability Factor in Focal Segmental Glomerulosclerosis [NCT00007475] | Phase 1/Phase 2 | 15 participants (Actual) | Interventional | 2000-12-31 | Completed |
| A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease [NCT00025259] | Phase 3 | 1,734 participants (Actual) | Interventional | 2002-09-30 | Completed |
| Clinical Study on the Efficacy and Safety of Tofatib and Cyclophosphamide in the Treatment of Active IgG4 Related Diseases [NCT05625581] | | 40 participants (Anticipated) | Observational | 2022-11-10 | Recruiting |
| Phase II Randomized Study of Doxorubicin and Cyclophosphamide With or Without Intermittent Sunitinib in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor [NCT01176799] | Phase 2 | 73 participants (Anticipated) | Interventional | 2010-08-31 | Recruiting |
| SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant) [NCT00004031] | Phase 3 | 397 participants (Actual) | Interventional | 1997-07-31 | Completed |
| A Phase II Study of Fludarabine Induction With Sequential High Dose Cyclophosphamide and Rituximab as Consolidation Therapy for Previously Untreated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia [NCT00003659] | Phase 2 | 39 participants (Actual) | Interventional | 1998-09-30 | Completed |
| Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis [NCT02529839] | | 20 participants (Anticipated) | Interventional | 2015-10-31 | Not yet recruiting |
| A Phase II Randomized, Non-inferiority Study Comparing the Efficacy and Safety of Dalpiciclib Combined With AI With Neoadjuvant Chemotherapy in ER+ HER2- Postmenopausal Breast Cancer Patients [NCT06107673] | Phase 2 | 144 participants (Anticipated) | Interventional | 2023-09-30 | Recruiting |
| Evaluation of MEpolizumab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study [NCT05030155] | Phase 3 | 100 participants (Anticipated) | Interventional | 2022-05-30 | Recruiting |
| Phase I/Ib Study of Parsaclisib (INCB50465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (PaR-CHOP) Immunochemotherapy for Patients With Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma [NCT04323956] | Phase 1 | 50 participants (Actual) | Interventional | 2020-06-15 | Active, not recruiting |
| Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy and Ponatinib Followed by Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT03147612] | Phase 2 | 21 participants (Actual) | Interventional | 2018-02-08 | Active, not recruiting |
| A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL) [NCT03126916] | Phase 3 | 724 participants (Anticipated) | Interventional | 2018-05-14 | Active, not recruiting |
| A Trial to Evaluate the Immunogenicity and Safety of a Melanoma Helper Peptide Vaccine Plus Novel Adjuvant Combinations (MEL63) [NCT02425306] | Phase 1/Phase 2 | 48 participants (Actual) | Interventional | 2015-05-12 | Terminated(stopped due to Slow accrual to part 2 of the study. Accrual to part 1 is complete.) |
| Umbilical Cord Blood Transplant for Congenital Pediatric Disorders [NCT00950846] | | 40 participants (Actual) | Interventional | 2009-09-30 | Completed |
| A Pilot Trial of the Combination of Vemurafenib With Adoptive Cell Therapy in Patients With Metastatic Melanoma [NCT01585415] | Phase 1 | 12 participants (Actual) | Interventional | 2012-04-09 | Terminated |
| A Cancer Research UK Phase I Trial of Adoptive Transfer of Autologous Tumor Antigen-Specific T Cells With Preconditioning Chemotherapy and Intravenous IL2 in Patients With Advanced CEA Positive Tumors [NCT01212887] | Phase 1 | 14 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to due to safety concerns and lack of efficacy) |
| Safety and Efficacy of Anti-CD7 CAR-Engineered T Cells for Relapsed/Refractory T Lymphoid Malignancies: a Single-center, Open-label, Non-randomized, Single-arm Clinical Study [NCT04823091] | Phase 1 | 24 participants (Anticipated) | Interventional | 2021-04-15 | Recruiting |
| Phase I Study of Adoptive T-Cell Therapy With HER-2/Neu (HER-2)-Specific Memory CD8+ T Lymphocytes Obtained Following In Vivo Priming With a Peptide Vaccine in Patients With Advanced Stage HER-2-Positive Breast Cancer [NCT01219907] | Phase 1 | 0 participants (Actual) | Interventional | 2012-06-30 | Withdrawn |
| Clinical Study on the Safety and Efficacy of QN-023a Targeting CD33 in Acute Myeloid Leukemia [NCT05665075] | Phase 1 | 19 participants (Anticipated) | Interventional | 2022-12-24 | Recruiting |
| Tacrolimus Versus Cyclophosphamide as Treatment for Diffuse Proliferative or Membranous Lupus Nephritis: Prospective Cohort Study [NCT01207297] | Phase 1 | 40 participants (Actual) | Interventional | 2003-03-31 | Completed |
| The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer [NCT03814447] | Early Phase 1 | 10 participants (Anticipated) | Interventional | 2019-08-16 | Recruiting |
| Phase Ib Study of Monoclonal Antibody to OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer After Systemic Therapy [NCT01303705] | Phase 1 | 13 participants (Actual) | Interventional | 2010-10-14 | Completed |
| A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive [NCT01304797] | Phase 1 | 75 participants (Anticipated) | Interventional | 2011-03-31 | Active, not recruiting |
| Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma [NCT03794167] | Phase 2 | 75 participants (Actual) | Interventional | 2012-06-01 | Completed |
| Multicenter Registry of Pediatric Lupus Nephritis in China [NCT03791827] | | 1,200 participants (Anticipated) | Observational | 2018-12-01 | Recruiting |
| A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma [NCT01309789] | Phase 1 | 39 participants (Actual) | Interventional | 2011-02-28 | Completed |
| JAK Inhibitor Prior to Allogeneic Stem Cell Transplant for Patients With Primary and Secondary Myelofibrosis: A Prospective Study [NCT02251821] | Phase 2 | 99 participants (Actual) | Interventional | 2014-10-20 | Active, not recruiting |
| Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib as Adjuvant Therapy for Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas [NCT01143545] | Phase 1 | 10 participants (Actual) | Interventional | 2010-12-07 | Terminated(stopped due to Closed accrual due to unpromising results and the opening of study 14C0053 targeting the same population.) |
| "A Phase I Study Evaluating the Feasibility and Safety of Infusion of Re-Stimulated Autologous Tumor-Infiltrating Lymphocytes (TILs) Followed by Low-Dose Interleukin-2 Therapy in Patients With Platinum Resistant High Grade Serous Ovarian, Fallopian Tube, [NCT01883297] | Phase 1 | 3 participants (Actual) | Interventional | 2015-01-31 | Active, not recruiting |
| Safety and Effectiveness of MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer [NCT03916679] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2019-04-20 | Recruiting |
| A Phase III, Randomized, Two-armed, Triple Blinded, Parallel, Active Controlled Non-Inferiority Clinical Trial of AryoTrust (AryoGen Trastuzumab) Efficacy and Safety in Comparison to Herceptin (Genentech) in HER2-Positive Breast Cancer [NCT03425656] | Phase 3 | 108 participants (Actual) | Interventional | 2016-07-09 | Completed |
| A Phase 2 Study of Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS [NCT04893915] | Phase 2 | 0 participants (Actual) | Interventional | 2022-06-30 | Withdrawn(stopped due to No funding support) |
| Phase 1 Trial of Autologous T Cells Engineered to Express NY-ESO-1 TCR and CRISPR Gene Edited to Eliminate Endogenous TCR and PD-1 (NYCE T Cells) [NCT03399448] | Phase 1 | 3 participants (Actual) | Interventional | 2018-09-05 | Terminated(stopped due to Sponsor has terminated trial to pursue other targets.) |
| PI3Kδ Inhibitor Parsaclisib in Combination With Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in Participants With Previously Untreated Peripheral T-cell Lymphoma [NCT05238064] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2022-03-31 | Not yet recruiting |
| Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A [NCT01858922] | Phase 2 | 40 participants (Actual) | Interventional | 2012-12-19 | Active, not recruiting |
| Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia [NCT02162420] | | 50 participants (Anticipated) | Interventional | 2015-01-10 | Recruiting |
| Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL) [NCT01251107] | Phase 3 | 331 participants (Actual) | Interventional | 2000-03-31 | Completed |
| Phase II Study Testing Prophylaxis Feasibility of Graft Versus Host Disease With Only High Dose Cyclophosphamide Post-transplantation for Patients Eligible to a Reduced-intensity Conditioning Regiment Prior to Allogenic Transplantation With a Compatible F [NCT03263767] | Phase 2 | 47 participants (Actual) | Interventional | 2018-01-15 | Terminated(stopped due to Security criteria (MTD)) |
| SBG 2000-1. Individually Dose-adjusted FEC Compared to Standard FEC as Adjuvant Chemotherapy for Node Positive or High-risk Node Negative Breast Cancer. A Randomized Study by the Scandinavian Breast Group [NCT03888677] | Phase 3 | 1,535 participants (Actual) | Interventional | 2001-02-28 | Completed |
| Phase I Study of Valproic Acid Expanded Cord Blood Stem Cells as an Allogeneic Donor Source for Adults With Hematological Malignancies [NCT03885947] | Phase 1 | 7 participants (Actual) | Interventional | 2019-02-21 | Completed |
| Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment [NCT01156883] | | 76 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Optimization of the T Regulatory Cell and T Effector Cell Doses in Recipients of Double UCB Transplantation for Treatment of Hematological Malignancies [NCT01163201] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2014-01-31 | Withdrawn(stopped due to Replaced by a new study) |
| Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation [NCT03385096] | Phase 2/Phase 3 | 122 participants (Anticipated) | Interventional | 2018-01-02 | Recruiting |
| Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma: a UNICANCER/GERICO Multicenter Program [NCT04757337] | Phase 3 | 214 participants (Anticipated) | Interventional | 2021-06-18 | Recruiting |
| A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation (HSCT) in Patients With Relapsed Lymphoma [NCT02652468] | | 11 participants (Actual) | Interventional | 2016-03-10 | Completed |
| Prospective Randomized Controlled Study on the Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer [NCT03373708] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2017-12-20 | Not yet recruiting |
| Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Primary Central Nervous System Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation [NCT03733327] | Phase 2/Phase 3 | 20 participants (Anticipated) | Interventional | 2018-11-30 | Recruiting |
| Clinical Research of Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Children With Stage 4/M Neuroblastoma: A Prospective, Single-arm, Phase II, Multi-center Trial [NCT05303727] | Phase 2 | 64 participants (Anticipated) | Interventional | 2022-08-31 | Not yet recruiting |
| A Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell Transplantation [NCT01194791] | Phase 2 | 30 participants (Anticipated) | Interventional | 2010-10-31 | Completed |
| The CONFRONT Phase I - II Trial: ACtivatiON oF Immune RespONse in paTients With R-M Head and Neck Cancer. Multimodality Immunotherapy With Avelumab, Short Course Radiotherapy and Cyclophosphamide in Head and Neck Cancer. [NCT03844763] | Phase 1/Phase 2 | 71 participants (Anticipated) | Interventional | 2019-01-07 | Recruiting |
| A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer [NCT05420454] | Phase 4 | 1,576 participants (Anticipated) | Interventional | 2022-07-10 | Recruiting |
| A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies [NCT05705570] | Phase 1 | 30 participants (Anticipated) | Interventional | 2023-03-01 | Not yet recruiting |
| A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer [NCT01206881] | Phase 2 | 45 participants (Anticipated) | Interventional | 2009-03-31 | Completed |
| Addition of Gemcitabine to the Standard Reduced Busulfan and Cyclophosphamide (BUCY2) Pre Allogeneic Hematopoietic Stem Cell Transplantation Conditioning for Acute Lymphoblastic Leukemia [NCT03339700] | Phase 2 | 15 participants (Anticipated) | Interventional | 2018-09-15 | Recruiting |
| A Single Arm, Multi-center, Phase II Clinical Trial of Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma and CD79A/CD79B Genetic Abnormality [NCT04668365] | Phase 2 | 59 participants (Anticipated) | Interventional | 2020-12-25 | Recruiting |
| A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma [NCT04433156] | Phase 2 | 60 participants (Anticipated) | Interventional | 2020-04-22 | Recruiting |
| NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adaptive T-cell Therapy (Adenovirus, Yeast, Fusion Protein Vaccine) in Subjects With Pancreatic Cancer Who [NCT03329248] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2017-11-06 | Active, not recruiting |
| A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer [NCT03799913] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2019-04-10 | Recruiting |
| A Phase I and Feasibility Study of Everolimus (RAD001) Plus R-CHOP for New Untreated Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01334502] | Phase 1 | 26 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Phase I Trial of Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia [NCT03318016] | Phase 1 | 5 participants (Actual) | Interventional | 2017-12-15 | Completed |
| A Phase I Trial for the Evaluation of the In Vivo Persistence of Adoptively-transferred Tumor-Infiltrating Lymphocytes Cultured With a Pharmacologic Inhibitor of AKT in Patients With Metastatic Melanoma [NCT02489266] | Phase 1 | 0 participants (Actual) | Interventional | 2015-06-24 | Withdrawn |
| Adjuvant Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleura, or Mediastinum [NCT01313429] | Phase 1 | 19 participants (Actual) | Interventional | 2011-03-04 | Terminated(stopped due to Per stopping rule if 12 patients underwent immune response analysis after 6 vaccinations and none developed a response, the protocol would stop accrual.) |
| A Phase II, Multicenter, Prospective, Non-randomised, Open-label, Clinical Trial to Evaluate Effectiveness and Safety of BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation [NCT03315520] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-01-22 | Recruiting |
| Multi-center, Open-label, Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy With MG4101 Plus Rituximab in Patient With Relapsed/Refractory Non-Hodgkin's Lymphoma of B-cell Origin [NCT03778619] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2018-11-28 | Active, not recruiting |
| T Cell Therapy for Patients With Metastatic Ovarian Cancer [NCT02482090] | Phase 1 | 6 participants (Actual) | Interventional | 2015-07-31 | Completed |
| Efficiency of Baracetinib to Induce Remission of Active Lupus Nephritis [NCT05432531] | Phase 3 | 60 participants (Anticipated) | Interventional | 2022-06-01 | Active, not recruiting |
| Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease : Multicentric Randomized Phase III Trial [NCT03770663] | Phase 3 | 76 participants (Anticipated) | Interventional | 2021-02-05 | Recruiting |
| Bevacizumab and Trastuzumab With Paclitaxel on Women With Her2+ Breast Cancer Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast C [NCT01321775] | Phase 2 | 44 participants (Anticipated) | Interventional | 2009-08-31 | Recruiting |
| A Randomized, Open-label, Single-center Study Comparing Cyclophosphamide at a Dose of 25 mg/kg/Day and Cyclophosphamide at a Dose of 50 mg/kg/Day in Graft Versus Host Disease Prophylaxis [NCT05158608] | Phase 3 | 100 participants (Anticipated) | Interventional | 2022-01-01 | Not yet recruiting |
| GD2-CAR PERSIST: Production and Engineering of GD2-Targeted, Receptor Modified T Cells (GD2CART) for Osteosarcoma or Neuroblastoma to Increase Systemic Tumor Exposure [NCT04539366] | Phase 1 | 67 participants (Anticipated) | Interventional | 2022-01-25 | Suspended(stopped due to Interim Monitoring) |
| Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma [NCT03107988] | Phase 1 | 65 participants (Actual) | Interventional | 2017-09-05 | Active, not recruiting |
| Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma [NCT02605421] | Phase 2 | 12 participants (Anticipated) | Interventional | 2016-06-30 | Recruiting |
| Open-Label Pilot Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells Alone or in Combination With Pembrolizumab in HLA-A2+ Subjects With NY-ESO-1 and/or LAGE-1a Positive Relapsed and R [NCT03168438] | Phase 1 | 6 participants (Actual) | Interventional | 2017-08-18 | Terminated(stopped due to The study was terminated following an internal review of the company's research and development portfolio) |
| A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic Malignancies [NCT01100944] | Phase 1/Phase 2 | 26 participants (Actual) | Interventional | 2010-03-04 | Terminated(stopped due to Principal investigator left the National Institutes of Health (NIH).) |
| Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia [NCT00882323] | Phase 2 | 33 participants (Anticipated) | Interventional | 2008-11-30 | Recruiting |
| Phase II Randomized Trial of ABT-888 in Combination With Metronomic Oral Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal, Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, or Triple-Negative Breast Cancer [NCT01306032] | Phase 2 | 124 participants (Actual) | Interventional | 2011-01-12 | Completed |
| A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma, Double Expressor Lymphoma and High-Gr [NCT04479267] | Phase 2 | 49 participants (Anticipated) | Interventional | 2020-08-21 | Recruiting |
| A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma [NCT02890602] | Phase 2 | 53 participants (Actual) | Interventional | 2012-09-01 | Completed |
| Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas [NCT01030900] | Phase 2 | 50 participants (Actual) | Interventional | 2009-10-22 | Completed |
| A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma [NCT01026220] | Phase 3 | 166 participants (Actual) | Interventional | 2009-12-07 | Completed |
| A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas [NCT00006721] | Phase 3 | 571 participants (Actual) | Interventional | 2001-03-31 | Active, not recruiting |
| Phase I/II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Tumor Infiltrating Lymphocytes Genetically Engineered to Express IL-12 [NCT01236573] | Phase 1/Phase 2 | 34 participants (Actual) | Interventional | 2010-10-31 | Terminated(stopped due to Unexpected toxicities, likely due to TIL/IL-12 & low % of durable responses.) |
| Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-VEGFR2 Gene Engineered CD8+ Lymphocytes [NCT01218867] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2010-11-10 | Terminated(stopped due to No objective responses were observed.) |
| Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER2+Breast Cancer: a Multicenter, Randomized, Open-label, Parallel-Group Controlled Trial [NCT04290793] | Phase 2/Phase 3 | 280 participants (Anticipated) | Interventional | 2020-03-01 | Not yet recruiting |
| A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children With Recurrent and or Refractory Solid Tumors [NCT00628732] | Phase 2 | 36 participants (Anticipated) | Interventional | 2005-01-31 | Completed |
| Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic Anemia [NCT01193283] | Phase 1/Phase 2 | 22 participants (Actual) | Interventional | 2010-08-31 | Completed |
| A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma [NCT00770224] | Phase 2 | 87 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders [NCT00636909] | Phase 2 | 25 participants (Actual) | Interventional | 1999-07-31 | Completed |
| CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors [NCT01014767] | Phase 3 | 27 participants (Actual) | Interventional | 2009-11-30 | Terminated(stopped due to PI departure from coordinating institution) |
| Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study [NCT02871869] | Phase 2/Phase 3 | 316 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
| Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics [NCT00719173] | Phase 1 | 19 participants (Actual) | Interventional | 2005-08-31 | Completed |
| A Phase II Randomized Multicenter Open Label Prospective Study of Neoadjuvant Chemotherapy Docetaxel With or Without MEK Inhibitor SELUMETINIB in Patients With Early and Locally Advanced Triple Negative Breast Cancer [NCT02685657] | Phase 2 | 164 participants (Anticipated) | Interventional | 2016-09-30 | Not yet recruiting |
| Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma [NCT00577993] | Phase 3 | 210 participants (Actual) | Interventional | 1998-03-16 | Completed |
| Phase II, Open, Not Randomized Clinical Trial, to Evaluate the Sequential Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in her2 Negative Breast Cancer Patients [NCT00721747] | Phase 2 | 83 participants (Anticipated) | Interventional | 2008-01-31 | Active, not recruiting |
| T Cells co- Expressing a Second Generation Glypican 3-specific Chimeric Antigen Receptor With Cytokines Interleukin-21 and 15 as Immunotherapy for Patients With Liver Cancer [NCT04093648] | Phase 1 | 0 participants (Actual) | Interventional | 2020-01-31 | Withdrawn(stopped due to The key elements of this study were incorporated into another study.) |
| Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design (GeparX) [NCT02682693] | Phase 2 | 780 participants (Actual) | Interventional | 2017-02-13 | Completed |
| Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation [NCT00740467] | Phase 2 | 50 participants (Anticipated) | Interventional | 2008-01-31 | Recruiting |
| Comparison of Intravenous Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Proliferative Lupus Nephritis [NCT02645565] | Phase 4 | 75 participants (Actual) | Interventional | 2015-12-31 | Completed |
| Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma [NCT05077527] | Phase 1 | 20 participants (Anticipated) | Interventional | 2024-01-15 | Not yet recruiting |
| Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic/Dendritic Cell N [NCT03017820] | Phase 1 | 120 participants (Anticipated) | Interventional | 2017-04-04 | Recruiting |
| A Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies [NCT02566304] | Phase 2 | 35 participants (Anticipated) | Interventional | 2015-11-13 | Active, not recruiting |
| Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors [NCT01946529] | Phase 2 | 24 participants (Actual) | Interventional | 2013-12-27 | Active, not recruiting |
| Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreated Mantle Cell Lymphoma [NCT00878254] | Phase 2 | 25 participants (Actual) | Interventional | 2009-03-25 | Active, not recruiting |
| A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer [NCT00146562] | Phase 2 | 135 participants (Actual) | Interventional | 2003-07-31 | Completed |
| EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial [NCT02858804] | Phase 4 | 55 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
| Phase II Study of Bortezomib in Combination With Cyclophosphamide and Rituximab for Relapsed/Refractory Mantle Cell Lymphoma [NCT00958256] | Phase 2 | 22 participants (Actual) | Interventional | 2009-08-31 | Completed |
| A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation [NCT00691015] | Phase 2 | 48 participants (Actual) | Interventional | 2008-05-31 | Completed |
| A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC) [NCT00950300] | Phase 3 | 596 participants (Actual) | Interventional | 2009-10-16 | Completed |
| Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals (BMT CTN #0903) [NCT01410344] | Phase 2 | 20 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Randomized Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Greater Than 10 (≥ 11) and Less Than 25 (≤ 24) [NCT00941330] | Phase 2 | 31 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Myeloma X Relapse (Intensive): A Phase III Study to Determine the Role of a Second Autologous Stem Cell Transplant as Consolidation Therapy in Patients With Relapsed Multiple Myeloma Following Prior High-dose Chemotherapy and Autologous Stem Cell Rescue. [NCT00747877] | Phase 3 | 460 participants (Anticipated) | Interventional | 2008-04-30 | Recruiting |
| Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis [NCT00753103] | Phase 2 | 37 participants (Actual) | Interventional | 2003-01-31 | Completed |
| A Phase II Study Incorporating Bone Marrow Microenvironment (ME) - Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DTPACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance [NCT00572169] | Phase 3 | 177 participants (Actual) | Interventional | 2006-11-30 | Active, not recruiting |
| A Study of Outcomes and Toxicity of Busulfex as Part of a High Dose Chemotherapy Preparative Regimen in Autologous Hematopoietic Stem Cell Transplantation for Patients With Plasma Cell Myeloma [NCT00941720] | Phase 2 | 71 participants (Actual) | Interventional | 2009-06-11 | Completed |
| Phase I Study of Carfilzomib-based Chemotherapy Mobilization for Autologous Stem Cell Transplantation in Multiple Myeloma [NCT03909412] | Phase 1 | 18 participants (Anticipated) | Interventional | 2019-10-08 | Recruiting |
| Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma [NCT00669877] | Phase 2 | 56 participants (Actual) | Interventional | 2002-08-31 | Completed |
| Neoadjuvant Weekly Nab-paclitaxel (Abraxane®) Plus Carboplatin Followed By Doxorubicin Plus Cyclophosphamide With Bevacizumab Added Concurrently To Chemotherapy For Palpable And Operable Triple Negative Invasive Breast Cancer [NCT00777673] | Phase 2 | 60 participants (Anticipated) | Interventional | 2008-10-31 | Active, not recruiting |
| Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Haematological Diseases Using a Reduced Intensity Conditioning Regimen [NCT00959231] | Phase 2 | 60 participants (Anticipated) | Interventional | 2009-01-31 | Recruiting |
| Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients [NCT00129376] | Phase 2 | 63 participants (Actual) | Interventional | 2003-02-28 | Completed |
| Study Comparing Paclitaxel Plus Carboplatin Versus Anthracyclines Followed by Docetaxel as Adjuvant Chemotherapy for Triple Negative Breast Cancer [NCT04031703] | Phase 3 | 647 participants (Actual) | Interventional | 2011-01-01 | Completed |
| Delayed Tolerance Through Mixed Chimerism [NCT05900401] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2023-10-01 | Recruiting |
| A Phase II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) After Neoadjuvant Chemotherapy in Women With HER2/Neu (0-2+), Hormone Receptor (HR) Negative Stage II-III Breast Cancers [NCT01147016] | Phase 2 | 8 participants (Actual) | Interventional | 2010-07-31 | Terminated(stopped due to Primary co-investigator leaving the institution & funding transfer.) |
| A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Castration Resistant Prostate Cancer [NCT02867345] | | 0 participants (Actual) | Observational | 2016-11-30 | Withdrawn(stopped due to no funding or finacial support) |
| A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Muscle-invasive Bladder Cancer [NCT02863913] | Phase 1 | 0 participants (Actual) | Interventional | 2016-09-30 | Withdrawn(stopped due to No funding) |
| A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus [NCT00626197] | Phase 3 | 381 participants (Actual) | Interventional | 2008-02-15 | Terminated(stopped due to Study was terminated due to an imbalance of serious and opportunistic infections in the ocrelizumab treated patients versus the placebo arm.) |
| Nivolumab and Oral Cyclophosphamide for Relapsed/Refractory Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndrome (MDS) [NCT03417154] | Phase 2 | 12 participants (Actual) | Interventional | 2018-08-13 | Completed |
| A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity [NCT03032783] | Phase 2 | 63 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
| Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors [NCT02838342] | Phase 2 | 28 participants (Actual) | Interventional | 2015-05-19 | Completed |
| A Safety and Efficacy Study of Autologous Chimeric Antigen Receptor Engineered T Cells Redirected to EGFRvIII in Patients With Recurrent Glioblastoma Multiforme [NCT02844062] | Phase 1 | 20 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
| The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Rand [NCT05018520] | Phase 3 | 800 participants (Anticipated) | Interventional | 2021-09-17 | Recruiting |
| An Open-Label, Randomized, Pharmacokinetic Study of vinCRIStine Sulfate LIPOSOME Injection Ready-to-Use (VSLI-RTU) Formulation (1-Vial) and Marqibo® Formulation (3-Vials) in Patients With Hematological Malignancies [NCT04243434] | Phase 1 | 56 participants (Anticipated) | Interventional | 2020-08-15 | Not yet recruiting |
| Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias [NCT00852709] | Phase 1 | 35 participants (Anticipated) | Interventional | 2007-09-01 | Terminated(stopped due to Lack of accrual) |
| Pilot Study of Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer [NCT00615901] | | 38 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Reduced Intensity Conditioning Regimen for Low- and Intermediate-risk Myelodysplastic Syndrome Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation [NCT03412266] | Phase 2 | 50 participants (Anticipated) | Interventional | 2018-02-01 | Recruiting |
| Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors [NCT02784054] | Phase 2 | 25 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting |
| AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB - LR and PNET 5 MB - WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR), OR TP53 MUTATION, AND REGISTRY FOR MB OCCU [NCT02066220] | Phase 2/Phase 3 | 360 participants (Anticipated) | Interventional | 2014-06-30 | Active, not recruiting |
| Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving CAR T Cell Therapy With Yescarta/AxicabtageNeciloleucel (ODIN) [NCT05950802] | Phase 1 | 40 participants (Anticipated) | Interventional | 2023-07-14 | Recruiting |
| Phase I/II Clinical Trial of HER2 Targeted HypoSti.CAR-T Cells in Treating Patients With HER2 Positive Local Advanced or Metastatic Solid Tumors [NCT05681650] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2023-10-11 | Recruiting |
| A Phase 1/2a, Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors [NCT05672459] | Phase 1/Phase 2 | 117 participants (Anticipated) | Interventional | 2023-06-21 | Recruiting |
| Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma. A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi. [NCT05058404] | Phase 3 | 602 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
| Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL [NCT04529772] | Phase 3 | 600 participants (Anticipated) | Interventional | 2020-10-08 | Recruiting |
| A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractor [NCT04416984] | Phase 1/Phase 2 | 160 participants (Anticipated) | Interventional | 2020-05-21 | Recruiting |
| A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) [NCT04301076] | Phase 1 | 30 participants (Anticipated) | Interventional | 2021-08-31 | Recruiting |
| Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis [NCT04022239] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2020-03-13 | Recruiting |
| Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis [NCT03520647] | Phase 2 | 56 participants (Anticipated) | Interventional | 2019-02-19 | Recruiting |
| A Multi-Stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma [NCT02436707] | Phase 2 | 320 participants (Anticipated) | Interventional | 2015-10-27 | Recruiting |
| Safety and Feasibility of Stem Cell Gene Transfer Following R-EPOCH for Non-Hodgkin Lymphoma in AIDS Patients Using Peripheral Blood Stem/Progenitor Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs [NCT02337985] | Phase 1 | 10 participants (Anticipated) | Interventional | 2015-11-20 | Active, not recruiting |
| Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult P [NCT02153580] | Phase 1 | 37 participants (Actual) | Interventional | 2014-09-24 | Active, not recruiting |
| A Multi-Centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone, and Rituximab (BCVP-R) for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First- [NCT00428142] | Phase 2 | 95 participants (Actual) | Interventional | 2007-05-01 | Completed |
| A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage [NCT04440267] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-06-20 | Not yet recruiting |
| Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02 [NCT00258427] | Phase 2 | 14 participants (Actual) | Interventional | 2002-03-26 | Completed |
| To Evaluate the Efficacy and Safety of Toripalimab Combined With Chemotherapy (Epirubicin + Cyclophosphamide → Nab-paclitaxel + Carboplatin) in the Neoadjuvant Treatment of Triple-negative Breast Cancer After High-intensity Focused Ultrasound (HIFU) Induc [NCT05491694] | Phase 2 | 20 participants (Anticipated) | Interventional | 2022-09-01 | Not yet recruiting |
| Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells to Augment Single or Double Myeloablative Cord Blood Transplantation in Patients With Hematologic Malignancies [NCT01175785] | Phase 2 | 15 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Multi-center Clinical Study of Immunosuppressants, Cyclophosphamide, And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia [NCT02838992] | Phase 4 | 130 participants (Anticipated) | Interventional | 2017-02-28 | Not yet recruiting |
| Plinabulin vs. Pegfilgrastim in Reducing the Duration of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) [NCT04227990] | Phase 2 | 115 participants (Actual) | Interventional | 2017-11-27 | Completed |
| Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing Human Thyroglobulin to Patients With Thyroglobulin Expressing Thyroid Cancer [NCT02390739] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2015-03-02 | Withdrawn |
| A Pilot Study of AMP-224, a PD-1 Inhibitor, in Combination With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer [NCT02298946] | Phase 1 | 17 participants (Actual) | Interventional | 2014-11-21 | Completed |
| Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma [NCT00004231] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma Who Have Had Prior Radiation Therapy [NCT00004171] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer [NCT03907852] | Phase 1/Phase 2 | 175 participants (Anticipated) | Interventional | 2019-04-15 | Recruiting |
| A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity [NCT02609386] | Phase 2 | 105 participants (Actual) | Interventional | 2015-12-31 | Completed |
| NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy [NCT03136406] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2017-08-14 | Active, not recruiting |
| A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer [NCT05114720] | Phase 3 | 520 participants (Anticipated) | Interventional | 2021-11-11 | Recruiting |
| An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer [NCT00656669] | | 23 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Pilot Study of Adoptive Cell Transfer for the Treatment of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes [NCT02774291] | Early Phase 1 | 3 participants (Actual) | Interventional | 2017-04-20 | Terminated(stopped due to Due to lack of accrual the study was formally terminated on 01-JUL-2020. Primary Completion and Study Completion Dates have been revised based accordingly based on respective definitions) |
| Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors [NCT03302403] | | 18 participants (Actual) | Interventional | 2017-12-29 | Active, not recruiting |
| A Phase 1, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia [NCT06128044] | Phase 1 | 70 participants (Anticipated) | Interventional | 2023-12-05 | Not yet recruiting |
| Phase II Pilot Study of Brentuximab Vedotin, Rituximab and Dose Attenuated CHP in Elderly Patients With DLBCL [NCT02734771] | Phase 2 | 24 participants (Anticipated) | Interventional | 2016-06-30 | Active, not recruiting |
| A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies [NCT05579769] | Phase 2 | 32 participants (Anticipated) | Interventional | 2022-11-04 | Recruiting |
| A Prospective, Multisite, Randomized, Open-label Phase III Clinical Trial (CLOVER Study)Comparing 4 Cycles With 6 Cycles of TC (Docetaxel+Cyclophosphamide) Adjuvant Chemotherapy for 1-3 Lymph Node Positive ER+/HER2- Early Breast Cancer [NCT03926091] | Phase 3 | 2,172 participants (Anticipated) | Interventional | 2019-04-01 | Recruiting |
| A Phase II Trial of Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma [NCT01864109] | Phase 2 | 83 participants (Actual) | Interventional | 2013-05-31 | Active, not recruiting |
| Randomized Double Blind Double Dummy Control Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid [NCT03295383] | Phase 3 | 130 participants (Anticipated) | Interventional | 2019-07-11 | Recruiting |
| Multi-center Randomized Study to Compare Efficacy and Safety of Decitabine Plus CHOP (D-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT03553537] | Phase 3 | 100 participants (Anticipated) | Interventional | 2018-06-30 | Not yet recruiting |
| An Assessor-Blinded, Randomised Controlled Trial of Acupuncture to Prevent Chemobrain in Breast Cancer Patients [NCT02457039] | | 93 participants (Actual) | Interventional | 2015-10-31 | Completed |
| QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer [NCT03574649] | Phase 2 | 0 participants (Actual) | Interventional | 2018-09-30 | Withdrawn(stopped due to Trial not initiated) |
| CORALLEEN: A Phase 2 Clinical Trial of Multi-agent Chemotherapy or Letrozole Plus Ribociclib (LEE011) as Neoadjuvant Treatment for Postmenopausal Patients With Luminal B/HER2-negative Breast Cancer. [NCT03248427] | Phase 2 | 106 participants (Actual) | Interventional | 2017-07-13 | Completed |
| A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer After Definitive Chemoradiation [NCT00828009] | Phase 2 | 70 participants (Actual) | Interventional | 2011-01-17 | Completed |
| A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy [NCT00109837] | Phase 2 | 79 participants (Actual) | Interventional | 2005-04-30 | Completed |
| Phase 1 Study of Cabozantinib in Combination With Topotecan-Cyclophosphamide for Patients With Relapsed Ewing Sarcoma or Osteosarcoma [NCT04661852] | Phase 1 | 12 participants (Actual) | Interventional | 2020-12-23 | Completed |
| Atezolizumab, Pertuzumab and Trastuzumab With Chemotherapy as Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer (APTneo) [NCT03595592] | Phase 3 | 650 participants (Anticipated) | Interventional | 2018-09-07 | Active, not recruiting |
| Post-transplant Cyclophosphamide for HLA-haploidentical Transplantation in Wiskott-Aldrich Syndrome [NCT03198195] | | 5 participants (Actual) | Observational [Patient Registry] | 2015-03-10 | Enrolling by invitation |
| QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy [NCT03197571] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
| Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma: a Pilot Feasibility Study Using a Novel Protocol [NCT02447055] | Early Phase 1 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn |
| Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence: A Multi-Institutional Study [NCT02446431] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting |
| Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS). Part A: an Open Label Phase-II Study With Six Intravenous Cyclophosphamide Infusions Four Weeks Apart, and Follow-up for 12 Months [NCT02444091] | Phase 2 | 40 participants (Actual) | Interventional | 2015-03-31 | Completed |
| A Phase 1b Study to Evaluate Safety and Clinical Activity of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Triple Negative Breast Cancer (TNBC) - (KEYNOTE 173) [NCT02622074] | Phase 1 | 60 participants (Actual) | Interventional | 2016-01-27 | Completed |
| Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in [NCT06099366] | Phase 2 | 116 participants (Anticipated) | Interventional | 2024-01-15 | Not yet recruiting |
| Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL: a Single-arm, Multicenter, Open, Phase II Study [NCT06093841] | Phase 2 | 46 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
| Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study [NCT05929768] | Phase 3 | 2,400 participants (Anticipated) | Interventional | 2023-09-15 | Recruiting |
| Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) [NCT05008224] | Phase 2 | 146 participants (Actual) | Interventional | 2021-10-07 | Active, not recruiting |
| A Maintenance Protocol of Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors [NCT04469530] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-09-16 | Recruiting |
| Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma [NCT02617485] | Phase 3 | 143 participants (Actual) | Interventional | 2015-12-31 | Completed |
| T Regulatory Cell for Suppression of Acute Graft-vs-Host-Disease in Recipients of a Non-Myeloablative Umbilical Cord Blood Transplantation for Treatment of Hematological Malignancies [NCT02118311] | Phase 2 | 0 participants (Actual) | Interventional | 2016-06-30 | Withdrawn(stopped due to Changing study design. Will replace with a different protocol.) |
| A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma [NCT06172296] | Phase 3 | 478 participants (Anticipated) | Interventional | 2024-02-14 | Not yet recruiting |
| A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1) [NCT06091254] | Phase 3 | 478 participants (Anticipated) | Interventional | 2023-12-12 | Recruiting |
| Tumor Infiltrating Lymphocytes in Pediatric Malignant Solid Tumors: A Prospective Biobanking Study and Phase I Clinical Trial [NCT06047977] | Phase 1 | 30 participants (Anticipated) | Interventional | 2024-02-01 | Not yet recruiting |
| A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma [NCT06026319] | Phase 1 | 24 participants (Anticipated) | Interventional | 2023-10-26 | Recruiting |
| A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic CD20-conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies [NCT05653271] | Phase 1 | 42 participants (Anticipated) | Interventional | 2023-01-21 | Recruiting |
| A Phase 2 Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids In Subjects With Relapsed Or Refractory Large B-Cell Lymphoma In The Outpatient Setting [NCT05459571] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-08-09 | Recruiting |
| Graft vs Host Disease Prophylaxis in Unrelated Donor Transplantation: a Randomized Clinical Trial Comparing PTCY vs ATG (GRAPPA) [NCT05153226] | Phase 3 | 540 participants (Anticipated) | Interventional | 2022-03-02 | Recruiting |
| N9: Pilot Study of Novel Shortened Induction Chemotherapy for High-Risk Neuroblastoma [NCT04947501] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2021-06-22 | Recruiting |
| A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression [NCT04569032] | Phase 2 | 80 participants (Anticipated) | Interventional | 2020-11-12 | Recruiting |
| A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal [NCT04109066] | Phase 3 | 521 participants (Actual) | Interventional | 2019-11-20 | Active, not recruiting |
| Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？ [NCT03550781] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2018-06-01 | Not yet recruiting |
| A Non-inferior, Randomized Controlled Phase III Clinical Study Comparing the Efficacy of TCbHPand ECHP-THP in Neoadjuvant Treatment of Operable HER2-positive Breast Cancer [NCT05474690] | Phase 3 | 456 participants (Anticipated) | Interventional | 2022-05-11 | Recruiting |
| Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL) [NCT00103285] | Phase 3 | 5,377 participants (Actual) | Interventional | 2005-04-11 | Completed |
| A Phase 1b Study of JCAR014, Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor, in Combination With Durvalumab (MEDI4736) for Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma [NCT02706405] | Phase 1 | 30 participants (Actual) | Interventional | 2016-11-15 | Terminated(stopped due to Terminated due to slow accrual.) |
| A Cancer Research UK Phase I Trial of Anti-GD2 Chimeric Antigen Receptor (CAR) Transduced T-cells (1RG-CART) in Patients With Relapsed or Refractory Neuroblastoma [NCT02761915] | Phase 1 | 17 participants (Actual) | Interventional | 2016-02-29 | Completed |
| A Pilot Open-Label Clinical Trial Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs Specific for NY-ESO-1 in Subjects With Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC) [NCT02588612] | Phase 1 | 10 participants (Actual) | Interventional | 2016-02-01 | Completed |
| A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Proge [NCT00109031] | Phase 3 | 47 participants (Actual) | Interventional | 2005-01-31 | Completed |
| Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT [NCT06108739] | Phase 3 | 196 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
| Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer. [NCT06072612] | Phase 3 | 404 participants (Anticipated) | Interventional | 2023-10-20 | Recruiting |
| A Phase I Trial of Anti-CD19 and Anti-CD20 Bicistronic Chimeric Antigen Receptor T- Cells for Treating B-cell Malignancies [NCT05797233] | Phase 1 | 58 participants (Anticipated) | Interventional | 2023-08-28 | Recruiting |
| A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial) [NCT05722418] | Phase 1 | 50 participants (Anticipated) | Interventional | 2023-02-06 | Recruiting |
| A Phase 1 Single Arm, Open Label Study to Evaluate the Safety of UF-KURE19 Cells in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas [NCT05400109] | Phase 1 | 10 participants (Anticipated) | Interventional | 2023-04-26 | Recruiting |
| A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma [NCT04696731] | Phase 1 | 120 participants (Anticipated) | Interventional | 2021-02-24 | Recruiting |
| A Phase II Study of Nivolumab in Combination With DA-REPOCH Followed by Short Course Nivolumab Consolidation in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma [NCT03749018] | Phase 2 | 30 participants (Anticipated) | Interventional | 2019-01-02 | Active, not recruiting |
| Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major [NCT03171831] | Phase 4 | 30 participants (Anticipated) | Interventional | 2017-04-01 | Recruiting |
| [NCT02412423] | Phase 4 | 30 participants (Actual) | Interventional | 2015-03-31 | Completed |
| Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma [NCT00126191] | Phase 2 | 10 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to closed due to slow accrual) |
| A Phase II Study of Pomalidomide, Daily Low Dose Oral Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma [NCT02176213] | Phase 2 | 35 participants (Actual) | Interventional | 2014-06-30 | Completed |
| Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients [NCT06009627] | Phase 2/Phase 3 | 119 participants (Anticipated) | Interventional | 2023-04-11 | Recruiting |
| A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric Antigen Receptor in Children and Young Adults With GD2+ Solid Tumors [NCT02107963] | Phase 1 | 15 participants (Actual) | Interventional | 2014-02-28 | Completed |
| Phase 3 Open-label, Multicentre, Randomised Trial to Establish Safety & Efficacy of an EGF Cancer Vaccine in Inoperable, Stage IV Biomarker Positive,Wild Type EGF-R NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care [NCT02187367] | Phase 3 | 106 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to Sponsor decision based on slow recruitment and new emerging drug combinations) |
| Cyclophosphamide Added to Standard Immunosuppressive Therapy With Eltrombopag as Front-line Therapy in Patients With Severe Aplastic Anemia [NCT05975996] | Phase 2 | 43 participants (Anticipated) | Interventional | 2023-07-10 | Recruiting |
| A Phase 1 Study Combining Venetoclax With a Pediatric-Inspired Regimen for Newly Diagnosed Adults With B Cell Ph-Like Acute Lymphoblastic Leukemia [NCT05157971] | Phase 1 | 6 participants (Anticipated) | Interventional | 2022-03-17 | Recruiting |
| Phase I Study of Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL): ALL-6 Protocol [NCT00940524] | Phase 1 | 7 participants (Actual) | Interventional | 2009-07-31 | Completed |
| ER/HER2/Ki67 Breast Cancer Subtypes as Predictive Factors for Response to Adjuvant Dose-dense Therapy, and Basal Subtypes of Double-negative Breast Cancer as Prognostic Factors in Intergroup Trial C9741 [NCT00897026] | | 1,195 participants (Actual) | Observational | 2008-07-31 | Completed |
| A Phase II Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Patients With Monoclonal Gammopathy of Renal Significance (MGRS) [NCT06083922] | Phase 2 | 53 participants (Anticipated) | Interventional | 2023-10-16 | Recruiting |
| CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research [NCT05999994] | Phase 2 | 105 participants (Anticipated) | Interventional | 2020-01-22 | Recruiting |
| Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC) [NCT05681780] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2022-12-23 | Recruiting |
| A Phase I Study to Evaluate PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer [NCT03873805] | Phase 1 | 14 participants (Actual) | Interventional | 2019-08-20 | Active, not recruiting |
| Haploidentical Allogeneic Peripheral Blood Transplantation: Clinical Trial and Laboratory Correlates Examining Checkpoint Immune Regulators' Expression [NCT03480360] | Phase 3 | 20 participants (Anticipated) | Interventional | 2018-03-28 | Active, not recruiting |
| Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma [NCT01783535] | Phase 2 | 174 participants (Anticipated) | Interventional | 2013-06-19 | Active, not recruiting |
| Multicenter Uveitis Steroid Treatment (MUST) Trial [NCT00132691] | Phase 4 | 255 participants (Actual) | Interventional | 2005-09-30 | Completed |
| RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer [NCT05256745] | Phase 1/Phase 2 | 48 participants (Anticipated) | Interventional | 2023-06-06 | Recruiting |
| A Phase I/II Open-Label Study of ECT-001-Expanded Cord Blood Transplantation in Pediatric and Young Adult (<21year) Patients With High-Risk and Very High-Risk Myeloid Malignancies [NCT04990323] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
| A Multicenter, Open Label, Randomized Phase II Study Comparing Daratumumab Combined With Bortezomib-Cyclophosphamide-dexamethasone (Dara-VCd) Versus the Association of Bortezomib-Thalidomide-dexamethasone (VTd) as Pre Transplant Induction and Post Transpl [NCT03896737] | Phase 2 | 401 participants (Actual) | Interventional | 2019-04-16 | Active, not recruiting |
| A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma [NCT03161379] | Phase 2 | 30 participants (Anticipated) | Interventional | 2018-02-02 | Active, not recruiting |
| A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine [NCT02994927] | Phase 3 | 331 participants (Actual) | Interventional | 2017-03-15 | Completed |
| A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma [NCT00004197] | Phase 2 | 0 participants | Interventional | 1999-06-25 | Completed |
| Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients [NCT00129389] | Phase 3 | 1,925 participants (Actual) | Interventional | 2003-09-19 | Completed |
| A Phase I Clinical Trial of T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma [NCT03958656] | Phase 1 | 13 participants (Actual) | Interventional | 2019-06-13 | Completed |
| Phase I/II Trial of Systemic Administration of Edmonston Strain of Measles Virus, Genetically Engineered to Express NIS, With or Without Cyclophosphamide, in Patients With Recurrent or Refractory Multiple Myeloma [NCT00450814] | Phase 1/Phase 2 | 48 participants (Actual) | Interventional | 2006-11-30 | Completed |
| A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT02538926] | Phase 2 | 0 participants (Actual) | Interventional | 2018-07-01 | Withdrawn(stopped due to Drugs unavailable) |
| Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers [NCT06119685] | Phase 1/Phase 2 | 128 participants (Anticipated) | Interventional | 2023-10-25 | Recruiting |
| Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma [NCT06045247] | Phase 2 | 40 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
| A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma [NCT06043323] | Phase 2 | 20 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
| A Pilot Study to Evaluate the Safety and Feasibility of Induction of Mixed Chimerism in Severe Aplastic Anemia Patients With COH-MC-17: A Non-Myeloablative/ Reduced-Intensity, Conditioning Regimen and CD4+ T-Cell-Depleted Haploidentical Hematopoietic Tran [NCT05757310] | Phase 1 | 6 participants (Anticipated) | Interventional | 2024-04-01 | Recruiting |
| "A Pilot Window-3 Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma" [NCT05495464] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2022-11-18 | Recruiting |
| Phase I/II Study Using Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists [NCT05463133] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2022-07-08 | Recruiting |
| Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies [NCT04959175] | Phase 1/Phase 2 | 320 participants (Anticipated) | Interventional | 2021-09-23 | Recruiting |
| Phase II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Peripheral T Cell Lymphoma [NCT04083495] | Phase 2 | 20 participants (Anticipated) | Interventional | 2019-09-17 | Recruiting |
| A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Tr [NCT03970096] | Phase 2 | 120 participants (Anticipated) | Interventional | 2019-11-19 | Recruiting |
| Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-A [NCT03666000] | Phase 1/Phase 2 | 120 participants (Anticipated) | Interventional | 2019-03-11 | Recruiting |
| A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma [NCT03624036] | Phase 1 | 16 participants (Actual) | Interventional | 2018-11-15 | Terminated(stopped due to Development program terminated) |
| A Phase I Clinical Trial of T Cells Expressing a Novel Fully-human Anti-BCMA CAR for Treating Multiple Myeloma [NCT03602612] | Phase 1 | 35 participants (Actual) | Interventional | 2018-09-14 | Active, not recruiting |
| Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Solid Tumors of Pediatric Origin in Children and Young Adults [NCT03420963] | Phase 1 | 38 participants (Anticipated) | Interventional | 2018-08-31 | Recruiting |
| Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT02877303] | Phase 2 | 80 participants (Anticipated) | Interventional | 2016-11-01 | Recruiting |
| A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70-Expressing Cancers [NCT02830724] | Phase 1/Phase 2 | 124 participants (Anticipated) | Interventional | 2017-04-06 | Recruiting |
| A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3) [NCT02614066] | Phase 1/Phase 2 | 125 participants (Actual) | Interventional | 2016-03-07 | Completed |
| A Reduced Intensity Conditioning Regimen With CD3-Depleted Hematopoietic Stem Cells to Improve Survival for Patients With Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation [NCT00566696] | Phase 2 | 73 participants (Actual) | Interventional | 2007-12-14 | Completed |
| High-Dose Cyclophosphamide in Treating Patients With Acute Graft-Versus-Host Disease That Did Not Respond to Steroid Therapy [NCT00492921] | Phase 2 | 12 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Study to Infuse Haploidentical Natural Killer Cells in Patients With Relapsed or Refractory Neuroblastoma [NCT00698009] | Phase 2 | 1 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to Slow accrual.) |
| A Phase I/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of HY004 in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL) [NCT06009107] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2023-10-18 | Not yet recruiting |
| A Multicentric, Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion (SDI) in Patients With Previously Untreated Advanced Follicular Lymphoma [NCT03817853] | Phase 4 | 114 participants (Actual) | Interventional | 2019-02-26 | Completed |
| Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00549848] | Phase 3 | 600 participants (Actual) | Interventional | 2007-10-29 | Completed |
| Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma [NCT00958854] | Phase 2 | 37 participants (Anticipated) | Interventional | 2006-01-31 | Recruiting |
| Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents [NCT00749723] | Phase 2/Phase 3 | 174 participants (Actual) | Interventional | 2006-02-01 | Completed |
| Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI) [NCT00104299] | Phase 2/Phase 3 | 197 participants (Actual) | Interventional | 2005-01-31 | Completed |
| "A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients" [NCT00432172] | Phase 2 | 189 participants (Actual) | Interventional | 2007-04-24 | Completed |
| A Phase 1b, Open-Label, Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With R-CHOP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8) [NCT04974996] | Phase 1 | 0 participants (Actual) | Interventional | 2022-02-01 | Withdrawn(stopped due to Decision to not proceed with study.) |
| A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis [NCT00981708] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2008-02-29 | Completed |
| A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3 [NCT05492682] | Phase 1 | 15 participants (Anticipated) | Interventional | 2023-02-02 | Recruiting |
| A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL) [NCT00098839] | Phase 1/Phase 2 | 134 participants (Actual) | Interventional | 2005-02-28 | Completed |
| Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial. [NCT00751517] | Phase 2 | 0 participants | Interventional | | Active, not recruiting |
| Phase II Study of Dose-Dense Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/NEU-Overexpressed/Amplified Breast Cancer: Feasibility [NCT00482391] | Phase 2 | 95 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Multicentre, Non-Randomised, Open-Label Phase II Study to Evaluate the Efficacy and Safety of Induction Treatment With Rituximab, Fludarabine, Cyclophosphamide, Followed by Rituximab Maintenance Therapy (R-Fc-Rm) in the First Line Treatment of Chronic Lym [NCT00545714] | Phase 2 | 86 participants (Actual) | Interventional | 2007-11-21 | Completed |
| A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk) [NCT00974792] | Phase 2 | 150 participants (Anticipated) | Interventional | 2006-01-31 | Recruiting |
| Phase II Study of Pentostatin With Cyclophosphamide and Rituximab for Previously Untreated Patients With Chronic Lymphocytic Leukemia [NCT00541034] | Phase 2 | 49 participants (Actual) | Interventional | 2005-05-31 | Completed |
| Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma [NCT00540644] | Phase 2 | 70 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Multi-center, Open Label, Randomized Trial Comparing Single Versus Double Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients With High Risk Leukemia and Myelodysplasia (BMT CTN #0501) [NCT00412360] | Phase 3 | 224 participants (Actual) | Interventional | 2006-12-31 | Completed |
| Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer [NCT00779129] | Phase 2 | 70 participants (Actual) | Interventional | 2003-03-31 | Completed |
| T-Cell or Natural Killer (NK) Cell Adback in Patients With Lymphoid Malignancies Receiving Allogeneic Stem Cell Transplantation With Campath-IH Containing Conditioning Regimens [NCT00536978] | Phase 2 | 22 participants (Actual) | Interventional | 2007-09-30 | Completed |
| A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811] | Phase 2 | 97 participants (Actual) | Interventional | 2004-06-30 | Completed |
| Randomized Comparison of Cyclophosphamide Versus Cyclophosphamide Plus Fludarabine In Addition To Anti-Thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Bone Marrow Failure Syndrome [NCT00774527] | Phase 3 | 82 participants (Actual) | Interventional | 2003-03-31 | Completed |
| Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT) [NCT00066469] | Phase 2 | 55 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Preoperative Therapy With Epirubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab and Postoperative Therapy With Trastuzumab in Patients With HER-2 Over Expressed Breast Cancer [NCT00795899] | Phase 2 | 230 participants (Actual) | Interventional | 2002-01-31 | Completed |
| First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG. [NCT00801281] | Phase 3 | 250 participants (Actual) | Interventional | 2007-02-28 | Completed |
| Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma [NCT00651755] | | 23 participants (Actual) | Interventional | 2008-03-31 | Completed |
| A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL) [NCT00061945] | Phase 1/Phase 2 | 302 participants (Actual) | Interventional | 2003-06-30 | Completed |
| Phase Ib Study To Assess The Feasibility And Safety Of Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes In Advanced Solid Tumors [NCT03992326] | Phase 1 | 6 participants (Actual) | Interventional | 2019-09-01 | Terminated(stopped due to Internal competitive study that is open) |
| CD34+Stem Cell Selection for Patients Receiving Partially Matched Family or Matched Unrelated Adult Donor Allogeneic Stem Cell Transplantations for Malignant and Non-Malignant Disease [NCT01049854] | Phase 2 | 20 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (MACLO/IVAM) in Patients With Previously Untreated Mantle Cell Lymphoma [NCT00450801] | Phase 2 | 22 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer [NCT00820547] | Phase 2 | 100 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer [NCT00994968] | Phase 2 | 49 participants (Anticipated) | Interventional | 2009-07-31 | Recruiting |
| [A Prospective, Randomized Trial to Assess the Added Value of Concomitant Modulated Electro-hyperthermia in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy - an Investigator Initiated Study] [NCT05889390] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting |
| Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells [NCT05389514] | | 0 participants | Expanded Access | | Available |
| Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only [NCT01265849] | Phase 3 | 928 participants (Actual) | Interventional | 2010-12-31 | Completed |
| "Low-dose Cytotoxics as Anti-angiogenesis Treatment Following Adjuvant Induction Chemotherapy for Patients With ER-negative and PgR-negative Breast Cancer" [NCT00022516] | Phase 3 | 1,086 participants (Actual) | Interventional | 2000-11-30 | Completed |
| Phase II Study of Pembrolizumab In Combination With R-CHOP for Patients With Untreated, High-Risk, Non-Germinal Center-Derived DLBCL [NCT03995147] | Phase 2 | 51 participants (Anticipated) | Interventional | 2019-08-29 | Recruiting |
| Active Immunization of Sibling Stem Cell Transplant Donors Against Purified Myeloma Protein of the Stem Cell Recipient With Multiple Myeloma in the Setting of Non-Myeloablative, HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation [NCT00006184] | Phase 2 | 20 participants (Actual) | Interventional | 2001-02-08 | Completed |
| A Pilot Trial of Sequential Primary (Neoadjuvant) Combination Chemotherapy With Docetaxel/Capecitabine (TX) and Doxorubicin/Cyclophosphamide (AC) in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression [NCT00005908] | Phase 2 | 30 participants (Actual) | Interventional | 2000-06-30 | Completed |
| Chemotherapy Plus Lapatinib or Trastuzumab or Both in Her2+ Primary Breast Cancer. A Randomized Phase IIb Study With Biomarker Evaluation. [NCT00429299] | Phase 2 | 121 participants (Actual) | Interventional | 2006-08-31 | Completed |
| Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma [NCT00004228] | Phase 3 | 393 participants (Actual) | Interventional | 2000-06-30 | Completed |
| A Multi-Center Phase 2 Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam, Alemtuzumab) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia [NCT00230282] | Phase 2 | 25 participants (Actual) | Interventional | 2004-07-31 | Completed |
| Primary Systemic Therapy Using Sequential Docetaxel/Cyclophosphamide/Bevacizumab Followed by Doxorubicin in Operable/Locally Advanced Breast Cancer [NCT00203502] | Phase 2 | 40 participants (Actual) | Interventional | 2005-09-30 | Completed |
| A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma [NCT00073918] | Phase 2 | 111 participants (Actual) | Interventional | 1999-02-28 | Completed |
| Vaccination to Enhance the Anti-Tumor Activity of GD2 Chimeric Antigen Receptor-Expressing, VZV-Specific T Cells in Subjects With Advanced Sarcomas and Neuroblastoma (VEGAS) [NCT01953900] | Phase 1 | 26 participants (Anticipated) | Interventional | 2014-04-30 | Active, not recruiting |
| Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression [NCT01036087] | Phase 2 | 47 participants (Actual) | Interventional | 2010-11-30 | Completed |
| A Multi-center, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Mizoribine in Comparison With Cyclophosphamide in the Treatment of Refractory Nephrotic Syndrome [NCT02257697] | Phase 3 | 239 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma [NCT03528421] | Phase 1 | 30 participants (Anticipated) | Interventional | 2018-05-22 | Recruiting |
| A Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide for Children and Young Adults With Refractory Crohn's Disease. [NCT02225795] | | 0 participants (Actual) | Interventional | 2014-08-31 | Withdrawn(stopped due to recruitment difficulty) |
| Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma [NCT02767674] | Phase 3 | 258 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting |
| Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial [NCT00901069] | Phase 1 | 12 participants (Actual) | Interventional | 2009-05-31 | Completed |
| Phase I Study of Infusion of Umbilical Cord Blood (UCB) Derived CD25+CD4+ T-Regulatory (Treg) Cells After Nonmyeloablative Cord Blood Transplantation [NCT00602693] | Phase 1 | 41 participants (Actual) | Interventional | 2007-07-23 | Completed |
| Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children [NCT00897871] | | 60 participants (Anticipated) | Observational | 2007-02-28 | Recruiting |
| Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm [NCT00908869] | Phase 1 | 30 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Randomized Phase III Trial Evaluating the Role of Autologous Stem Cell Transplantation in Previously Untreated Patients With Stage B and C Chronic Lymphocytic Leukemia [NCT00931645] | Phase 3 | 241 participants (Actual) | Interventional | 2001-04-30 | Completed |
| QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies [NCT05379647] | Phase 1 | 24 participants (Anticipated) | Interventional | 2021-11-04 | Recruiting |
| Shanghai General Hospital, Shanghai, Jiao Tong University School of Medicine [NCT05379569] | Phase 4 | 142 participants (Anticipated) | Interventional | 2022-05-15 | Recruiting |
| A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of HRYZ-T101 TCR-T Cell for HPV18 Positive Advanced Solid Tumor [NCT05787535] | Phase 1 | 17 participants (Anticipated) | Interventional | 2023-03-21 | Recruiting |
| Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study [NCT00933517] | Phase 2 | 62 participants (Actual) | Interventional | 2009-09-30 | Completed |
| A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients [NCT03493854] | Phase 3 | 500 participants (Actual) | Interventional | 2018-06-14 | Completed |
| A Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab [NCT03384277] | Phase 4 | 66 participants (Actual) | Interventional | 2017-12-29 | Completed |
| Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer [NCT06058377] | Phase 3 | 3,680 participants (Anticipated) | Interventional | 2023-11-27 | Recruiting |
| A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation [NCT00049517] | Phase 3 | 657 participants (Actual) | Interventional | 2002-12-19 | Completed |
| Allogeneic Transplantation Using Mini-Conditioning for Treatment of Stage IV Breast Cancer [NCT00006261] | Phase 2 | 0 participants (Actual) | Interventional | 2000-05-31 | Withdrawn |
| Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer [NCT00003519] | Phase 3 | 2,778 participants (Anticipated) | Interventional | 1998-08-20 | Completed |
| A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis [NCT00564889] | Phase 2 | 35 participants (Actual) | Interventional | 2007-12-31 | Completed |
| Allogeneic Hematopoietic Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors [NCT03615105] | Phase 2 | 9 participants (Actual) | Interventional | 2018-07-25 | Active, not recruiting |
| A Phase II Randomized Trial Evaluating Neoadjuvant Dose-Dense Doxorubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab/Pertuzumab (AC THP) and Docetaxel/Carboplatin/Trastuzumab/Pertuzumab (TCHP) For Early Her2Neu Positive Breast Cancer [NCT03329378] | Phase 2 | 7 participants (Actual) | Interventional | 2019-01-24 | Terminated(stopped due to Data Safety Monitoring Board is in agreement with the study findings so far and the stopping rule has been met, which suspends the study treatment arms in March 2021.) |
| A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma [NCT00101101] | Phase 2 | 43 participants (Actual) | Interventional | 2004-07-31 | Completed |
| A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer [NCT02785250] | Phase 1/Phase 2 | 85 participants (Anticipated) | Interventional | 2016-04-30 | Active, not recruiting |
| Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy [NCT02782754] | Phase 2 | 40 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
| Phase II Study of Metastatic Melanoma Using a Chemoradiation Lymphodepleting Conditioning Regimen Followed by Infusion of Anti-Mart-1 and Anti-gp100 TCR-Gene Engineered Lymphocytes and Peptide Vaccines [NCT00923195] | Phase 2 | 4 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis During the Induction of Remission Period-EUROLUPUS vs. RITUXILUP Regimen: A Randomized Study [NCT05207358] | Phase 4 | 30 participants (Anticipated) | Interventional | 2022-03-02 | Recruiting |
| Phase I/II Study of Metastatic Cancer That Expresses Her-2 Using Lymphodepleting Conditioning Followed by Infusion of Anti-Her-2 Gene Engineered Lymphocytes [NCT00924287] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to This study was terminated after the first patient treated on study died as a result of the treatment.) |
| Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis [NCT02756546] | Phase 1/Phase 2 | 100 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Pilot Study of Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in High-Risk Breast Cancer: Feasibility [NCT00617370] | | 38 participants (Actual) | Interventional | 2004-11-30 | Completed |
| A Randomized Phase II Pilot Study to Evaluate Safety and Efficacy of the Addition of Vismodegib to Standard Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients [NCT02694224] | Phase 2 | 40 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
| Phase IB Study Investigating the Tolerability, Immunomodulatory Impacts and, Therapeutic Correlates of the Novel Toll-like Receptor 8 Agonist Motolimod (MOTO) Plus Cyclophosphamide (CTX) Treatment of Advanced Solid Tumors [NCT02650635] | Phase 1 | 4 participants (Actual) | Interventional | 2016-02-05 | Terminated(stopped due to permanently closed per sponsor's request) |
| Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease. The ANTARES Study [NCT04166565] | Phase 2 | 41 participants (Actual) | Interventional | 2019-10-31 | Active, not recruiting |
| A Pilot Preoperative Trial of Ganetespib With Paclitaxel for Triple-Negative Breast Cancer [NCT02637375] | | 0 participants (Actual) | Interventional | 2016-05-31 | Withdrawn(stopped due to Study never opened (terminated as study drug no longer available)) |
| A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis [NCT02693210] | Phase 2 | 161 participants (Actual) | Interventional | 2001-02-28 | Completed |
| A Myeloablative Conditioning Regimen Consisting of Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients With Hematological Malignancy. [NCT00597519] | Phase 2 | 28 participants (Actual) | Interventional | 2006-03-31 | Completed |
| Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Fibrolamellar or Non-fibrolamellar Hepatocellular Carcinoma (HCC) Including Fibrolamellar HCC [NCT02702960] | Phase 2 | 0 participants (Actual) | Interventional | 2016-03-31 | Withdrawn(stopped due to This study was withdrawn due to lack of necessary resources from the liver transplant surgical group.) |
| A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2 [NCT00615602] | Phase 3 | 489 participants (Actual) | Interventional | 2004-10-31 | Completed |
| A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma [NCT03704298] | Phase 1 | 15 participants (Actual) | Interventional | 2018-11-20 | Terminated(stopped due to Development program terminated) |
| AflacST1502: A Phase II Study of Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors [NCT02574728] | Phase 2 | 60 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
| Multicenter, Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-mNHL-BFM-90 and (Auto-SCT)in Patients With DLBCL [NCT02842931] | Phase 3 | 300 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
| A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and Consolidated by Autologous Stem Cell Transplant, in Yo [NCT00646854] | Phase 3 | 136 participants (Actual) | Interventional | 2008-06-30 | Completed |
| "Phase II, Multicenter, Trial, Exploring Chemo-free Treatment (GA101+Ibrutinib) and MRD-driven Strategy in Previously Untreated Symptomatic B-chronic Lymphocytic Leukemia Medically Fit A Study From the Goelams/GCFLLC/MW Intergroup" [NCT02666898] | Phase 2 | 135 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC) [NCT06096038] | Phase 1/Phase 2 | 33 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| Single Center Pilot Study to Investigate the Efficacy of Adding Itacitinib to Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning Matched Donor Hematopoietic Cell Transplantation With Peripheral B [NCT05364762] | Phase 2 | 50 participants (Anticipated) | Interventional | 2022-11-23 | Recruiting |
| Allogeneic Hematopoietic Cell Transplantation Using Post-transplantation Cyclophosphamide in Myelodysplastic Syndrome Patients [NCT02969980] | Phase 2 | 30 participants (Actual) | Interventional | 2016-11-30 | Completed |
| A Pilot Study to Evaluate the Safety and Feasibility of Cellular Immunotherapy Using Genetically Modified Autologous CD20-Specific T Cells For Patients With Relapsed or Refractory Mantle Cell and Indolent B Cell Lymphomas [NCT00621452] | Phase 1 | 12 participants (Anticipated) | Interventional | 2007-08-31 | Completed |
| Open-label, Phase I, Multi-center Study to Determine in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients the Recommended Dose of CYAD-02 After a Non-myeloablative Preconditioning Chemotherapy Followed by a Potential Consolid [NCT04167696] | Phase 1 | 27 participants (Anticipated) | Interventional | 2019-11-25 | Recruiting |
| Pilot Study (Phase II) of Pomalidomide, Oral Dexamethasone and Very Low-dose Cyclophosphamide in Patients With Refractory Multiple Myeloma Who Have Received Lenalidomide and Bortezomib [NCT04243109] | Phase 2 | 6 participants (Actual) | Interventional | 2017-02-23 | Terminated(stopped due to Low recruitment rate. Lack of interest of the sponsor.) |
| "A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)" [NCT00681993] | | 35 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies and Solid Tumors [NCT00640796] | Phase 1 | 22 participants (Actual) | Interventional | 2008-09-30 | Completed |
| European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents [NCT02684708] | Phase 3 | 2,200 participants (Anticipated) | Interventional | 2015-10-01 | Active, not recruiting |
| CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday [NCT00683319] | | 50 participants (Anticipated) | Observational | 2008-04-30 | Active, not recruiting |
| Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (CP) in Patients With Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II Study From the French Sarcoma Group. [NCT02805725] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2015-12-31 | Completed |
| Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study [NCT04009525] | Phase 4 | 800 participants (Anticipated) | Interventional | 2019-06-01 | Recruiting |
| A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT00873093] | Phase 2 | 148 participants (Actual) | Interventional | 2009-03-31 | Completed |
| PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial [NCT02624973] | Phase 2 | 200 participants (Actual) | Interventional | 2016-04-15 | Active, not recruiting |
| A Phase 1, Multicenter, Open-Label, Dose Escalating Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (RHIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid [NCT02781467] | Phase 1 | 10 participants (Actual) | Interventional | 2016-07-11 | Terminated(stopped due to Business Decision) |
| A Phase Ib Feasibility Study of Personalized Kinase Inhibitor Therapy Combined With Induction in Acute Leukemias Who Exhibit In Vitro Kinase Inhibitor Sensitivity [NCT02779283] | Phase 1 | 7 participants (Actual) | Interventional | 2016-01-13 | Completed |
| Pilot Study of Haploidentical Natural Killer Cell Infusions for Poor Prognosis Non-AML Hematologic Malignancies [NCT00697671] | Phase 1 | 48 participants (Actual) | Interventional | 2007-03-31 | Completed |
| A Prospective Phase II Trial of Modified MRC UKALL Ⅻ/ECOG E2993 Regimen in the Treatment of Low Risk Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia for Young Adults [NCT02660762] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
| Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma [NCT00978913] | Phase 1 | 31 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer [NCT00542191] | Phase 2 | 30 participants (Actual) | Interventional | 2007-07-31 | Terminated(stopped due to Enrollment Completed) |
| Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma [NCT00581776] | Phase 2 | 30 participants (Actual) | Interventional | 2005-05-31 | Completed |
| Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+) [NCT00668616] | Phase 3 | 1,034 participants (Actual) | Interventional | 2000-03-31 | Completed |
| Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients [NCT00129922] | Phase 3 | 1,289 participants (Actual) | Interventional | 1999-11-30 | Completed |
| Clinical Study of Natural Killer Cell Infusion in Patients With Acute Myeloid Leukemia [NCT04221971] | Phase 1 | 10 participants (Anticipated) | Interventional | 2020-10-31 | Not yet recruiting |
| Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma [NCT00683670] | Phase 1 | 17 participants (Actual) | Interventional | 2008-08-31 | Completed |
| An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma [NCT00825149] | Phase 1 | 137 participants (Actual) | Interventional | 2009-02-28 | Completed |
| Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in Patients With R/R B-Cell Acute Lymphoblastic Leukemia [NCT05225831] | Early Phase 1 | 100 participants (Anticipated) | Interventional | 2021-08-15 | Recruiting |
| DFCI ALL Adult Consortium Protocol: Adult ALL Trial [NCT01005758] | Phase 2 | 180 participants (Anticipated) | Interventional | 2009-01-31 | Not yet recruiting |
| Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide [NCT00999986] | Phase 3 | 104 participants (Actual) | Interventional | 2007-01-31 | Completed |
| A Phase I/II Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1. [NCT05881525] | Phase 1 | 18 participants (Anticipated) | Interventional | 2023-06-01 | Recruiting |
| Phase I/II Study to Test the Immunogenicity, Feasibility, and Safety of Autologous PEP-DC Vaccine vs. Autologous OC-DC Vaccine Followed by PEP-DC Vaccine, in Combination With Low-dose Cyclophosphamide, in Patients With Advanced HGSOC [NCT05714306] | Phase 1/Phase 2 | 16 participants (Anticipated) | Interventional | 2023-06-30 | Not yet recruiting |
| Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics [NCT06013423] | Phase 2 | 54 participants (Anticipated) | Interventional | 2024-02-06 | Not yet recruiting |
| An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors [NCT06013111] | Phase 1 | 9 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
| A Pilot Clinical Trial of Autologous EphA-2-Targeting Chimeric Antigen Receptor Dendritic Cell Vaccine Loaded With KRAS Mutant Peptide in Combination With Anti-PD-1 Antibody/Anti-CTLA4 Antibody for Local Advanced/Metastatic Solid Tumors. [NCT05631899] | Phase 1 | 10 participants (Anticipated) | Interventional | 2023-04-03 | Recruiting |
| A Pilot Clinical Trial of Autologous EphA-2-Targeting Chimeric Antigen Receptor Dendritic Cell Vaccine Loaded With TP53 Mutant Peptide Plus ICIs for Local Advanced/Metastatic Solid Tumors or Relapsed/Refractory Lymphomas. [NCT05631886] | Phase 1 | 10 participants (Anticipated) | Interventional | 2023-07-04 | Recruiting |
| A Single Arm Phase II Study of High-Dose Weekly Carfilzomib Plus Cyclophosphamide and Dexamethasone in the Treatment of Relapsed Multiple Myeloma After 1-3 Prior Therapies [NCT02597062] | Phase 2 | 76 participants (Actual) | Interventional | 2016-07-05 | Completed |
| A Platform Study of Combination Immunotherapy for the Neoadjuvant and Adjuvant Treatment of Patients With Surgically Resectable Adenocarcinoma of the Pancreas [NCT02451982] | Phase 2 | 76 participants (Anticipated) | Interventional | 2016-03-28 | Recruiting |
| Phase Ib Study to Test the Feasibility and Safety of a Personalized Vaccine in Combination With Low-dose Cyclophosphamide in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) [NCT05195619] | Phase 1 | 16 participants (Anticipated) | Interventional | 2021-12-10 | Recruiting |
| Safety and Anti-HIV Activity of Autologous CD4+ and CD8+ T Cells Transduced With a Lentiviral Vector Encoding Bi-specific Anti-gp120 CAR Molecules (LVgp120duoCAR-T) in Anti-retroviral Drug-treated HIV-1 Infection [NCT04648046] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
| Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts [NCT04542824] | Phase 1/Phase 2 | 102 participants (Anticipated) | Interventional | 2020-08-20 | Active, not recruiting |
| European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors [NCT02813135] | Phase 1/Phase 2 | 460 participants (Anticipated) | Interventional | 2016-08-03 | Recruiting |
| Phase II Study of Total Marrow and Lymphoid Irradiation (TMLI) Given in Combination With Cyclophosphamide and Etoposide as Conditioning for Allogeneic (HSCT) in Patients With High-Risk Acute Lymphocytic or Myelogenous Leukemia [NCT02094794] | Phase 2 | 87 participants (Anticipated) | Interventional | 2014-05-12 | Recruiting |
| A Phase II Trial of Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma (BMS #CA225-331/Lilly Trial Alias I4E-US-X007) [NCT01025089] | Phase 2 | 18 participants (Anticipated) | Interventional | 2009-12-31 | Active, not recruiting |
| Pentostatin, Cyclophosphamide Plus Rituximab (PCR) for the Therapy of Poor-Prognosis Chronic Graft-Versus-Host Disease [NCT01001780] | Phase 2 | 0 participants (Actual) | Interventional | 2009-08-31 | Withdrawn(stopped due to Study stopped early due to poor accrual.) |
| A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL) [NCT05888493] | Phase 3 | 108 participants (Anticipated) | Interventional | 2023-10-02 | Recruiting |
| A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410] | Phase 3 | 1,875 participants (Anticipated) | Interventional | 2023-05-11 | Recruiting |
| ANGIO-A: Safety and Tolerability of Oral Cyclophosphamide and Sorafenib With Intravenous Bevacizumab With the Addition of Atezolizumab in Pediatric Solid Tumor Patients [NCT05468359] | Phase 1/Phase 2 | 64 participants (Anticipated) | Interventional | 2022-11-07 | Recruiting |
| Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma [NCT05283720] | Phase 2 | 394 participants (Anticipated) | Interventional | 2022-06-14 | Recruiting |
| A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma [NCT04989803] | Phase 1 | 114 participants (Anticipated) | Interventional | 2021-10-27 | Recruiting |
| A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors [NCT04931342] | Phase 2 | 550 participants (Anticipated) | Interventional | 2021-10-07 | Recruiting |
| Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin in Metastatic Colorectal Cancer Carcinoma An Open-label Phase II [NCT04534218] | Phase 2 | 49 participants (Actual) | Interventional | 2020-10-16 | Completed |
| A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625] | Phase 3 | 6,720 participants (Anticipated) | Interventional | 2019-07-03 | Recruiting |
| A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer [NCT01358877] | Phase 3 | 4,804 participants (Actual) | Interventional | 2011-11-08 | Active, not recruiting |
| Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma [NCT00670358] | Phase 1/Phase 2 | 138 participants (Actual) | Interventional | 2008-08-25 | Active, not recruiting |
| A Proof of Concept Study of TBio-4101 (an Autologous Selected and Expanded Tumor Infiltrating Lymphocyte [TIL] Therapy) Using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients W [NCT05628883] | Phase 1 | 25 participants (Anticipated) | Interventional | 2022-11-22 | Recruiting |
| A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis [NCT05197842] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2022-02-22 | Recruiting |
| Pilot Study to Assess the Feasibility, Safety and Efficacy of Adoptive Transfer of Autologous Tumor-Infiltrating Lymphocytes Enriched for Tumor Antigen Specificity (NeoTIL) in Advanced Solid Tumors [NCT04643574] | Phase 1 | 42 participants (Anticipated) | Interventional | 2021-03-09 | Active, not recruiting |
| A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma [NCT04626791] | Phase 2 | 45 participants (Anticipated) | Interventional | 2021-08-03 | Recruiting |
| A Phase II Study of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) Alternating With Pralatrexate (P) as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin Lymphoma [NCT01336933] | Phase 2 | 34 participants (Actual) | Interventional | 2011-07-06 | Completed |
| Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma [NCT00352027] | Phase 2 | 81 participants (Actual) | Interventional | 2006-07-20 | Completed |
| A Phase 1 Study of R-CHOP Plus SYK Inhibitor TAK-659 for the Front-Line Treatment of High-Risk Diffuse Large B Cell Lymphoma (DLBCL) [NCT03742258] | Phase 1 | 12 participants (Actual) | Interventional | 2019-03-13 | Active, not recruiting |
| Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells [NCT00354172] | Phase 2 | 16 participants (Actual) | Interventional | 2006-02-28 | Terminated(stopped due to Competing study was started.) |
| A Phase I Study of B-Cell Maturation Antigen (BCMA)-Specific Chimeric Antigen Receptor T Cells in Combination With JSMD194, a Small Molecule Inhibitor of Gamma Secretase, in Patients With Relapsed or Persistent Multiple Myeloma [NCT03502577] | Phase 1 | 18 participants (Anticipated) | Interventional | 2018-05-23 | Suspended(stopped due to Waiting on confirmation of additional funding) |
| A Phase II Trial of Cyclophosphamide, Bortezomib and Dexamethasone (CYBOR-D) in Patients With Newly Diagnosed Active Multiple Myeloma [NCT00609167] | Phase 2 | 63 participants (Actual) | Interventional | 2006-12-31 | Completed |
| Rasburicase to Prevent Graft -Versus-Host Disease [NCT00513474] | Phase 1 | 46 participants (Actual) | Interventional | 2008-01-31 | Completed |
| An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Antitumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With RCHOP Chemotherapy and Rituximab (MabThera®) Maintenance in Patients With First-line Advanced Follicular [NCT00896519] | Phase 2 | 30 participants (Anticipated) | Interventional | 2009-03-31 | Not yet recruiting |
| Phase II Study to Evaluate the Safety and Efficacy of the Treatment With Pentostatin, Cyclophosphamide and Rituximab Followed by Rituximab Maintenance in Previously Untreated and Relapsed Patients With Immunocytoma/Morbus Waldenström, B-CLL and Other Indo [NCT00927797] | Phase 2 | 185 participants (Anticipated) | Interventional | 2005-02-28 | Active, not recruiting |
| Phase III Comparison of Adjuvant Chemoendocrine Therapy With CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients With Involved Axillary Lymph Nodes and Positive Receptors [NCT00929591] | Phase 3 | 1,558 participants (Actual) | Interventional | 1989-05-31 | Completed |
| Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer [NCT00934739] | Phase 2/Phase 3 | 150 participants (Actual) | Interventional | 2007-06-30 | Terminated |
| T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma. [NCT00937625] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2009-06-30 | Completed |
| Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients [NCT01009970] | Phase 2 | 50 participants (Anticipated) | Interventional | 2010-05-31 | Recruiting |
| NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy [NCT03563157] | Phase 1/Phase 2 | 332 participants (Anticipated) | Interventional | 2018-05-25 | Active, not recruiting |
| An Open-label, Randomized, Comparative Pilot Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer [NCT00394251] | Phase 2 | 197 participants (Actual) | Interventional | 2006-08-01 | Completed |
| Phase II Study of Neoadjuvant Treatment With NOV-002 in Combination With Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients With Stages IIB-IIIC Breast Cancer [NCT00499122] | Phase 2 | 41 participants (Actual) | Interventional | 2007-06-04 | Completed |
| Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma [NCT00499616] | Phase 3 | 464 participants (Actual) | Interventional | 2007-10-08 | Completed |
| Phase I - II Study of Doxil® In Combination With Daily Oral Cyclophosphamide and Herceptin for Patients With HER-2/Neu Positive Disease In Patients With Metastatic Breast Cancer [NCT00331552] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2006-02-28 | Completed |
| An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL [NCT00410163] | Phase 2 | 61 participants (Actual) | Interventional | 2007-01-31 | Completed |
| An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL). [NCT00494780] | Phase 2 | 59 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Phase 1/2 Study of AMG 531 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Patients With Aggressive Non-Hodgkin's Lymphoma Receiving R-HyperCVAD Alternating With R-Ara-C/MTX [NCT00299182] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2006-03-31 | Completed |
| Clofarabine Based Remission Induction Followed by Haploidentical Stem Cell Transplantation in Children With Refractory Hematological Malignancies [NCT01025778] | Phase 2 | 7 participants (Actual) | Interventional | 2009-12-31 | Completed |
| A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With [NCT00312208] | Phase 3 | 3,299 participants (Actual) | Interventional | 2001-11-30 | Completed |
| Phase II Clinical Trial of Patients With High-Grade Glioma Treated With Intra-Arterial Carboplatin-Based Chemotherapy, Randomized to Treatment With or Without Delayed Intravenous Sodium Thiosulfate as a Potential Chemoprotectant Against Severe Thrombocyto [NCT00075387] | Phase 2 | 48 participants (Actual) | Interventional | 2003-03-07 | Active, not recruiting |
| A Phase I-II Study of Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Previously Treated Patients With Chronic Lymphocytic Leukemia and Other Low Grade B-Cell Neoplasms [NCT00546377] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2005-07-31 | Completed |
| Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study) [NCT01046487] | Phase 1 | 26 participants (Actual) | Interventional | 2009-01-31 | Completed |
| An Open, Randomized Clinical Phase I/II Trial to Investigate Maximum Tolerated Dose, Efficacy, and Safety of Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined [NCT01019174] | Phase 1/Phase 2 | 40 participants (Actual) | Interventional | 2009-11-30 | Completed |
| A Prospective, Randomized, Active Controlled, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis. [NCT00377637] | Phase 3 | 370 participants (Actual) | Interventional | 2005-07-31 | Completed |
| Rheumatoid Arthritis: Tolerance Induction by Mixed Chimerism [NCT00282412] | Phase 1 | 4 participants (Actual) | Interventional | 2002-09-30 | Terminated(stopped due to No participant enrolled for three years. No plan to continue study.) |
| Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Selected Non-Malignant Diseases [NCT01019876] | Phase 2/Phase 3 | 50 participants (Anticipated) | Interventional | 2002-06-30 | Recruiting |
| Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00481832] | Phase 2 | 50 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Accrual Factor) |
| Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myelogenous Leukemia in Remission Using HLA-Matched Sibling Donors, HLA-Matched Unrelated Donors, or HLA-Mismatched Familial Donors - A Phase 2 Study [NCT01020734] | Phase 2 | 263 participants (Actual) | Interventional | 2011-05-31 | Completed |
| CD-34 Selection for Ex-vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning [NCT00368355] | Phase 2 | 46 participants (Actual) | Interventional | 2000-04-30 | Completed |
| Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas [NCT00991211] | Phase 3 | 549 participants (Actual) | Interventional | 2004-01-31 | Completed |
| A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia, Inborn Errors in Metabolism, or Inherited Hematologic Stem Cell Disorders [NCT00003336] | Phase 2 | 6 participants (Actual) | Interventional | 1998-01-31 | Completed |
| Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL [NCT00121199] | Phase 2 | 73 participants (Actual) | Interventional | 2005-06-30 | Completed |
| Phase II Trial of Combined Immunochemotherapy With Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab (FMC-Alemtuzumab) in Patients With Previously Treated or Untreated T-Prolymphocytic Leukemia [NCT01186640] | Phase 2 | 16 participants (Actual) | Interventional | 2010-06-30 | Completed |
| A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine [NCT03600909] | Phase 2 | 3 participants (Actual) | Interventional | 2018-05-15 | Terminated(stopped due to Accrual has been slow) |
| A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amy [NCT04512235] | Phase 3 | 267 participants (Actual) | Interventional | 2020-11-12 | Active, not recruiting |
| Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX [NCT04216524] | Phase 2 | 40 participants (Anticipated) | Interventional | 2020-05-29 | Recruiting |
| A Single-arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma [NCT04214626] | Phase 2 | 60 participants (Actual) | Interventional | 2020-01-02 | Active, not recruiting |
| A Phase I Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma [NCT00915408] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer [NCT03412877] | Phase 2 | 270 participants (Anticipated) | Interventional | 2018-09-06 | Recruiting |
| Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma [NCT01865110] | Phase 3 | 623 participants (Actual) | Interventional | 2013-11-30 | Active, not recruiting |
| A Phase II Clinical Trial of Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Patients With Metastatic Melanoma [NCT01659151] | Phase 2 | 17 participants (Actual) | Interventional | 2012-08-03 | Active, not recruiting |
| Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma [NCT00577096] | | 120 participants (Actual) | Interventional | 2001-10-31 | Completed |
| International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy [NCT00690560] | Phase 2 | 30 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer [NCT00820690] | | 80 participants (Actual) | Observational | 2008-07-31 | Active, not recruiting |
| A Two-Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Advanced Cutaneous T Cell Lymphoma [NCT02548468] | Phase 1 | 0 participants (Actual) | Interventional | 2015-11-20 | Withdrawn(stopped due to Slow accrual) |
| A Randomized, Double-Blind, Controlled, Phase II Multicenter Trial of CTLA4Ig (Abatacept) Plus Cyclophosphamide vs Cyclophosphamide Alone in the Treatment of Lupus Nephritis [NCT00774852] | Phase 2 | 137 participants (Actual) | Interventional | 2008-11-30 | Completed |
| Open Label Randomized Clinical Trial of Standard Neoadjuvant Chemotherapy (Paclitaxel Followed by FEC) Versus the Combination of Paclitaxel and RAD001 Followed by FEC in Women With Triple Receptor-Negative Breast Cancer (CRAD001C24101) [NCT00499603] | Phase 2 | 62 participants (Actual) | Interventional | 2007-07-31 | Active, not recruiting |
| Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer [NCT00689156] | Phase 3 | 2,015 participants (Actual) | Interventional | 2008-06-30 | Completed |
| A Randomized Phase II Study to Investigate the Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Containing Chemotherapy in Triple Negative Breast Cancer (GeparNuevo) [NCT02685059] | Phase 2 | 174 participants (Actual) | Interventional | 2016-06-30 | Completed |
| Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) [NCT00772668] | | 3 participants (Actual) | Interventional | 2009-09-25 | Terminated(stopped due to Funding) |
| Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC) OTT 15-04 [NCT02688803] | Phase 4 | 2 participants (Actual) | Interventional | 2016-08-31 | Completed |
| A Phase 1/2 Dose Escalation Study With Expansion Cohorts to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies [NCT02963831] | Phase 1/Phase 2 | 67 participants (Actual) | Interventional | 2017-09-07 | Completed |
| A Phase II, Prospective, Multi-center Study of Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS [NCT04181489] | Phase 2 | 55 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
| Multicenter Phase II Single Arm Open-label Study on the Feasibility, Safety and Efficacy of Combination of CHOP-21 Supplemented With Obinutuzumab and Ibrutinib in Untreated Young High Risk Diffuse Large B-cell Lymphoma (DLBCL) Patients. [NCT02670317] | Phase 2 | 1 participants (Actual) | Interventional | 2016-09-30 | Terminated(stopped due to GA101-CHOP not advantage from rituximab-CHOP) |
| IIT2022-03-Paquette-GeriBMT: A Phase I Study of De-Escalation of Post-Transplant Cyclophosphamide Dosing in Patients Aged >/= 70 Years Undergoing Conditioning With Fludarabine and Total Body Irradiation 800 cGy [NCT05849207] | Phase 1 | 26 participants (Anticipated) | Interventional | 2023-10-24 | Recruiting |
| A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer [NCT00652691] | Phase 1 | 48 participants (Anticipated) | Interventional | 1998-08-31 | Completed |
| Efficacy and Safety Study of TA(E)C-GP Versus A(E)C-T for the High Risk Triple-negative Breast Cancer Patients Predicted by the Messenger RNA (mRNA)-Long Non-coding RNA (lncRNA) Signature and Validation of the Signature's Efficacy [NCT02641847] | Phase 2/Phase 3 | 503 participants (Anticipated) | Interventional | 2015-07-31 | Recruiting |
| Phase I/II Open-Label Monocentric Clinical Trial for Induction of Tolerance With CD34-Enriched Autologous Hematopoietic Stem Cell Transplantation After High-Dose Chemotherapy With Cyclophosphamide and Rabbit-Antithymocyte Globulin for Refractory Autoimmun [NCT00742300] | Phase 1/Phase 2 | 0 participants | Interventional | 1998-01-31 | Active, not recruiting |
| A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer [NCT00656123] | Phase 1 | 9 participants (Actual) | Interventional | 2008-03-31 | Completed |
| T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma [NCT04160195] | Phase 1 | 2 participants (Actual) | Interventional | 2019-12-20 | Terminated(stopped due to The original principal investigator left the National Institutes of Health (NCI) and the decision was made to close the study to enrollment.) |
| A Single-center, Randomized, Open-label, Phase III Study Comparing PD-1 Combined With Anthracycline/Taxane-based Adjuvant Chemotherapy and Antivascular Therapy Versus Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer [NCT05862064] | Phase 3 | 606 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
| Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease [NCT04154735] | Phase 2 | 0 participants (Actual) | Interventional | 2019-11-30 | Withdrawn(stopped due to Discontinued by Investigator) |
| A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer Defined as Primary Tumor That is Her2-neu and Low [NCT02593227] | Phase 2 | 80 participants (Actual) | Interventional | 2016-04-30 | Completed |
| A Pilot Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using Total Body Irradiation, Cyclophosphamide and Fludarabine [NCT00595127] | | 21 participants (Actual) | Interventional | 2001-06-30 | Completed |
| Randomized Trial of GVHD Prophylasxis With Post-transplantation Cyclophocphomide (PTCy) or Thymoglobulin in Unrelated SCT Recepients With Chronic Myeloproliferative Neoplasms and Myelodisplatic Syndrome [NCT02627573] | Phase 2 | 32 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to Poor recruitment) |
| Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma [NCT00808899] | Phase 2 | 4 participants (Actual) | Interventional | 2008-12-31 | Terminated(stopped due to Voluntarily closed and terminated by the PI due to lack of feasibility) |
| Chemo Sensitization Before Hematopoietic Stem Cell Transplantation With a CXCR4 Antagonist in Patients With Acute Leukemia in Complete Remission: Pilot Study [NCT02605460] | Phase 2 | 20 participants (Anticipated) | Interventional | 2014-02-28 | Recruiting |
| Treatment of Severe (Types II and III) Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation [NCT00705120] | Phase 1 | 9 participants (Actual) | Interventional | 1995-11-30 | Completed |
| A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-mismatched Bone Marrow for Patients With Hematologic Malignancies [NCT00796562] | Phase 2 | 107 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Renal Allograft Tolerance Through Mixed Chimerism [NCT00801632] | Phase 2 | 5 participants (Actual) | Interventional | 2008-12-31 | Completed |
| A Phase I Clinical Trial Combining Nivolumab and Tumor Infiltrating Lymphocytes (TIL) for Patients With Advanced Non-Small Cell Lung Cancer [NCT03215810] | Phase 1 | 20 participants (Actual) | Interventional | 2017-10-11 | Completed |
| An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma [NCT02559154] | Phase 4 | 80 participants (Actual) | Interventional | 2010-07-31 | Active, not recruiting |
| A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging [NCT00822120] | Phase 2 | 371 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Randomized Comparison of Once-daily Intravenous Busulfan Plus Cyclophosphamide Versus Fludarabine as a Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation in Leukemia and Myelodysplastic Syndrome [NCT00774280] | Phase 3 | 130 participants (Actual) | Interventional | 2002-05-31 | Completed |
| Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy [NCT04138979] | | 80 participants (Anticipated) | Observational | 2019-09-12 | Recruiting |
| Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer [NCT02613026] | Phase 3 | 104 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Bendamustine and Rituximab (BR) in Patients With Previously Untreated Chronic Lymphocytic Leukaemia [NCT00769522] | Phase 3 | 564 participants (Actual) | Interventional | 2008-10-02 | Completed |
| An Open Label, Multicenter Phase 1-2 Study to Investigate the Effectiveness, Safety and Immunogenicity of a Monotherapy With Intradermal IMA910 Plus GM-CSF Following Pre-treatment With Low-dose Cyclophosphamide in Advanced Colorectal Carcinoma Patients Wh [NCT00785122] | Phase 1/Phase 2 | 92 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Prospective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis Patients [NCT04101578] | | 2,000 participants (Anticipated) | Observational | 2017-02-08 | Recruiting |
| Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation [NCT05755854] | Phase 1 | 10 participants (Anticipated) | Interventional | 2023-05-03 | Recruiting |
| PANTHER. A Randomized Phase 3 Study Comparing Biweekly and Tailored Epirubicin + Cyclophosphamide Followed by Biweekly Tailored Docetaxel (dtEC→dtT) Versus Three Weekly Epirubicin + Cyclophosphamide + 5-fluorouracil Followed by Docetaxel (FEC→T) in Lymph [NCT00798070] | Phase 3 | 2,017 participants (Actual) | Interventional | 2007-02-28 | Active, not recruiting |
| A Phase II Study of Neoadjuvant Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With Inflammatory Breast Cancer Whose Tumors Overexpress ErbB2 (Her2/Neu) [NCT00756470] | Phase 2 | 15 participants (Actual) | Interventional | 2008-10-31 | Terminated(stopped due to Slow accrual.) |
| Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer [NCT00789581] | Phase 3 | 614 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Randomized Phase III Study on Bortezomib and Low-Dose Dexamethasone With or Without Continuous Low-Dose Oral Cyclophosphamide for Primary Refractory or Relapsed Multiple Myeloma [NCT00813150] | Phase 3 | 96 participants (Actual) | Interventional | 2009-01-31 | Completed |
| A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Hematologic Malignancies [NCT01760655] | Phase 2 | 62 participants (Actual) | Interventional | 2012-12-24 | Completed |
| A Phase III Multicenter, Open-label Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma [NCT00719472] | Phase 3 | 451 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP [NCT00450385] | Phase 2 | 57 participants (Actual) | Interventional | 2007-04-24 | Terminated(stopped due to Investigator Decision due to insufficient accrual.) |
| A Phase I/II of Vorinostat Plus CHOP in Untreated T-cell Non-Hodgkin's Lymphoma [NCT00787527] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2008-11-30 | Completed |
| Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic Anemia [NCT00737685] | Phase 2 | 30 participants (Anticipated) | Interventional | 2006-01-31 | Active, not recruiting |
| Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma [NCT00577629] | Phase 2 | 39 participants (Actual) | Interventional | 2005-06-18 | Completed |
| Phase I-II Non-Randomized Study of Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Indolent Non Hodgkin Lymphoma [NCT00807196] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2008-09-30 | Recruiting |
| [NCT02583828] | | 200 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
| Safety and Efficacy Study of Mitoxantrone Hydrochloride Liposome Injection Plus Cyclophosphamide,Vincristine and Prednison (CNOP)in Diffuse Large B Cell Lymphoma [NCT02595242] | Phase 1 | 0 participants (Actual) | Interventional | 2015-06-30 | Withdrawn |
| A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation [NCT00482053] | Phase 2 | 3 participants (Actual) | Interventional | 2006-10-31 | Terminated(stopped due to Low accrual) |
| Fludarabine, Cyclophosphamide, and Multiple Dose Rituximab as Frontline Therapy in Chronic Lymphocytic Leukemia (CLL) [NCT00794820] | Phase 2 | 66 participants (Actual) | Interventional | 2003-12-31 | Completed |
| A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer [NCT00455533] | Phase 2 | 384 participants (Actual) | Interventional | 2007-10-31 | Completed |
| NK Cells Infusion as Consolidation Treatment of Acute Myeloid Leukemia in Children and Adolescents [NCT02763475] | Phase 2 | 7 participants (Actual) | Interventional | 2016-05-31 | Completed |
| A Randomized, Double-Blind, International Multi-Centre, Phase III Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy Versus Placebo in Combination With C [NCT04301739] | Phase 3 | 522 participants (Anticipated) | Interventional | 2020-04-17 | Not yet recruiting |
| A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma. [NCT00715208] | Phase 2 | 55 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Sirolimus and Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation [NCT01220297] | Phase 2 | 3 participants (Actual) | Interventional | 2006-08-31 | Terminated(stopped due to Low accrual) |
| Three-arm Clinical Trial for Patients With Hematologic Malignancies and Mismatched Donors - Haploidentical, 1 Antigen Mismatch Related or Unrelated, and Matched Unrelated Donor (MUD)- Using a T-cell Replete Allograft and High-dose Post-transplant Cyclopho [NCT01010217] | Phase 2 | 176 participants (Actual) | Interventional | 2009-11-05 | Completed |
| A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cell for HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers [NCT05122221] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-07-17 | Recruiting |
| A Randomized Trial of the I-BFM-SG for the Management of Childhood Non-B Acute Lymphoblastic Leukemia [NCT00764907] | Phase 3 | 4,000 participants (Anticipated) | Interventional | 2002-11-30 | Recruiting |
| Post Transplant Cyclophosphamide for Unrelated and Related Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies [NCT01349101] | Phase 2 | 80 participants (Actual) | Interventional | 2011-02-10 | Completed |
| Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma [NCT00641095] | Phase 2/Phase 3 | 370 participants (Actual) | Interventional | 2006-12-07 | Completed |
| To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study [NCT05656079] | | 204 participants (Anticipated) | Interventional | 2021-07-01 | Recruiting |
| A Phase II Study of VcR-CVAD With Rituximab Maintenance for Untreated Mantle Cell Lymphoma [NCT00433537] | Phase 2 | 77 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Anti-CD7 Universal CAR-T Cells for CD7+ T/NK Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial [NCT04264078] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
| An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients [NCT00931918] | Phase 2 | 206 participants (Actual) | Interventional | 2009-10-31 | Completed |
| The Efficiency and Safety of N-acetylcysteine for Prevention of Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation [NCT05907486] | Phase 3 | 260 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
| Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission [NCT00002514] | Phase 3 | 1,929 participants (Actual) | Interventional | 1993-05-07 | Completed |
| High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients Without Complete Pathological Response to Neoadjuvant Chemotherapy [NCT02670109] | Phase 2 | 20 participants (Anticipated) | Interventional | 2018-02-01 | Recruiting |
| Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL) [NCT00968253] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2009-11-30 | Completed |
| A Randomized, Multicenter, Open Phase III Study Comparing a Dose-Intensified 8 Week Schedule of Adriamycin and Docetaxel (ADOC) With a Sequential 24 Week Schedule of Adriamycin/Cyclophosphamide Followed by Docetaxel (AC-DOC) Regimen as Preoperative Therap [NCT00793377] | Phase 3 | 913 participants (Actual) | Interventional | | Completed |
| A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease (BMT CTN 1301; Progress II) [NCT02345850] | Phase 3 | 346 participants (Actual) | Interventional | 2015-08-31 | Completed |
| A Randomised Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide Compared to Doxorubicin and Cyclophosphamide in Operable Node Negative Breast Cancer With Normal Topoisomerase IIα Expression [NCT00801411] | Phase 2 | 318 participants (Anticipated) | Interventional | 2008-10-31 | Recruiting |
| A Phase 1/1B Dose-Escalation Study to Determine the Safety and Tolerability of SCH 717454 Administered in Combination With Chemotherapy in Pediatric Subjects With Advanced Solid Tumors (Protocol No. 05883) [NCT00960063] | Phase 1 | 4 participants (Actual) | Interventional | 2009-11-11 | Terminated(stopped due to Study was terminated for business reasons.) |
| Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis [NCT00424489] | Phase 1 | 9 participants (Actual) | Interventional | 2002-02-28 | Terminated(stopped due to No participants enrolled for more than two years. No plan to continue study.) |
| PEPI: Protracted Etoposide in a Phase II Upfront Window for Induction Therapy for High Risk Neuroblastoma [NCT00578864] | Phase 2 | 13 participants (Actual) | Interventional | 2007-03-31 | Completed |
| A Phase II Trial of Transplants From HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies and Other Lethal H [NCT01119066] | Phase 2 | 422 participants (Actual) | Interventional | 2010-05-03 | Completed |
| A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma [NCT00554788] | Phase 3 | 60 participants (Actual) | Interventional | 2008-02-04 | Active, not recruiting |
| Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve. [NCT00712452] | | 19 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to problems of insuffisant recruitment) |
| Phase II Trial of the Addition of PEG-Asparaginase to the Hyper-CVAD Regimen in Adult Newly-Diagnosed Acute Lymphoblastic Leukemia [NCT01005914] | Phase 2 | 11 participants (Actual) | Interventional | 2009-06-30 | Terminated(stopped due to Increased rate of bacterial infections) |
| Pilot Study of Allogeneic Stem Cell Transplantation From Unrelated Donors for Patients With Severe Homozygous Beta 0/+ Thalassemia or Severe Variants of Beta 0/+ Thalassemia [NCT00578292] | | 10 participants (Actual) | Interventional | 2004-02-29 | Terminated(stopped due to Stem cell transplant was determined SOC for this disease (study is not relevant)) |
| Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II) [NCT00883129] | Phase 2 | 142 participants (Actual) | Interventional | 2009-09-30 | Completed |
| A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies [NCT05589896] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
| A Phase I/II Clinical Trail of TC-E202 Targeting HPV16 E6 for Relapsed/Refractory to Standard Treatment or Metastatic Cervical Carcinoma [NCT05357027] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2022-08-10 | Recruiting |
| Smart Stop: A Phase II Trial of Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Prior to and With Standard Chemotherapy for Patients With Newly Diagnosed DLBCL [NCT04978584] | Phase 2 | 60 participants (Anticipated) | Interventional | 2022-03-03 | Recruiting |
| Study of FT538 in Combination With Daratumumab in Acute Myeloid Leukemia [NCT04714372] | Phase 1 | 11 participants (Actual) | Interventional | 2021-11-03 | Active, not recruiting |
| Phase Ib of Cyclophosphamide, Pomalidomide, Dexamethasone and Daratumumab (CPD-DARA) in Patients With Relapsed/Refractory Multiple Myeloma. (The CPD-DARA Study) [NCT04667663] | Phase 1 | 20 participants (Anticipated) | Interventional | 2021-12-08 | Active, not recruiting |
| High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease [NCT02629120] | Phase 1/Phase 2 | 44 participants (Actual) | Interventional | 2015-12-17 | Active, not recruiting |
| Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma [NCT02306161] | Phase 3 | 312 participants (Actual) | Interventional | 2014-12-12 | Active, not recruiting |
| Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma [NCT02176967] | Phase 3 | 621 participants (Anticipated) | Interventional | 2014-08-08 | Active, not recruiting |
| A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen [NCT02133196] | Phase 2 | 85 participants (Anticipated) | Interventional | 2014-10-23 | Recruiting |
| A Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic Sclerosis [NCT01413100] | Phase 2 | 21 participants (Actual) | Interventional | 2011-09-15 | Active, not recruiting |
| A Randomised Phase II Feasibility Study Investigating the Biological Effects of the Addition of Zoledronic Acid to Neoadjuvant Combination Chemotherapy on Invasive Breast Cancer [NCT00525759] | Phase 2 | 40 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity [NCT00092222] | Phase 2 | 75 participants (Actual) | Interventional | 2004-10-28 | Active, not recruiting |
| A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients [NCT00433420] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 2003-04-30 | Active, not recruiting |
| Protocol for the Study and Treatment of Patients With Intraocular Retinoblastoma [NCT00186888] | Phase 3 | 107 participants (Actual) | Interventional | 2005-04-07 | Active, not recruiting |
| Administration of Her2 Chimeric Antigen Receptor Expressing T Cells for Subjects With Advanced Sarcoma (HEROS) [NCT00902044] | Phase 1 | 36 participants (Anticipated) | Interventional | 2010-02-11 | Active, not recruiting |
| Autologous Bone Marrow Transplant for Children With AML in First Complete Remission: Use of Marker Genes to Investigate the Biology of Marrow Reconstitution and the Mechanism of Relapse [NCT00667927] | Phase 1 | 17 participants (Actual) | Interventional | 1991-03-31 | Completed |
| Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma [NCT00413959] | Phase 2 | 12 participants (Actual) | Interventional | 2006-08-31 | Terminated |
| A Safety Study of Autologous T Cells Engineered to Target CD19 and CRISPR Gene Edited to Eliminate Endogenous HPK1 (XYF19 CAR-T Cells) for Relapsed or Refractory Haematopoietic Malignancies. [NCT04037566] | Phase 1 | 40 participants (Anticipated) | Interventional | 2019-08-31 | Recruiting |
| A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma [NCT04061772] | Phase 2 | 54 participants (Anticipated) | Interventional | 2019-08-12 | Recruiting |
| A Feasibility Study of Combination Therapy With Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for HER-2/Neu-Overexpressing Metastatic Breast Cancer. [NCT00399529] | Phase 2 | 22 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies [NCT02793544] | Phase 2 | 80 participants (Actual) | Interventional | 2016-12-31 | Completed |
| Tailored-dose Sorafenib Plus Metronomic Cyclophosphamide in Advanced Neuroendocrine Tumors (NET): a Phase II Clinical Trial Based on Individual Pharmacodynamic Assessment [NCT00605566] | Phase 2 | 22 participants (Actual) | Interventional | 2008-01-31 | Completed |
| A Randomized Phase II Trial to Assess the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous R [NCT02789332] | Phase 2 | 107 participants (Actual) | Interventional | 2016-09-30 | Completed |
| Dose-dense Doxorubicin/Cyclophosphamide With Intermittent Low-dose Sunitinib as Neoadjuvant or First-line Palliative Treatment of Newly Diagnosed HER2 Negative Breast Cancer Patients With Measurable Primary Breast Tumor [NCT02790580] | Phase 2 | 98 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting |
| A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma [NCT01144403] | Phase 2 | 8 participants (Actual) | Interventional | 2010-06-30 | Terminated |
| Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer [NCT02897050] | Phase 2 | 170 participants (Anticipated) | Interventional | 2016-09-30 | Suspended |
| A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer [NCT00887536] | Phase 3 | 1,613 participants (Actual) | Interventional | 2009-05-31 | Completed |
| NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With Nivolumab PD-1 Blockade [NCT02775292] | Phase 1 | 1 participants (Actual) | Interventional | 2017-01-03 | Completed |
| A Prospective, Belgian Multi-center, Single-arm, Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer [NCT04224922] | Phase 2 | 63 participants (Actual) | Interventional | 2015-05-31 | Completed |
| "Precision Study on Cocktail Therapy to Improve the Efficacy of Hepatitis B-related Hepatocellular Carcinoma" [NCT04317248] | Phase 2 | 600 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
| European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified [NCT00025623] | Phase 2 | 0 participants | Interventional | 1999-07-31 | Completed |
| A Phase I/II Study of Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation [NCT02750254] | Phase 1 | 5 participants (Actual) | Interventional | 2016-06-27 | Terminated(stopped due to Toxicity. Only enrolled patients in phase I portion of trial.) |
| Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer [NCT01049425] | Phase 3 | 3,198 participants (Actual) | Interventional | 2009-02-05 | Completed |
| Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies [NCT00857389] | Phase 2 | 60 participants (Actual) | Interventional | 2009-03-02 | Completed |
| A Phase IIb, Randomized, Multicenter, Noncomparative Pilot Study of the Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab ± Trastuzumab for the Adjuvant Treatment of Patients With Node-Positive & High-Risk Node-Negative Bre [NCT00365365] | Phase 2 | 214 participants (Actual) | Interventional | 2006-08-31 | Completed |
| T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study. [NCT00937300] | Phase 1 | 0 participants (Actual) | Interventional | 2009-06-30 | Withdrawn(stopped due to The patients eligible for this trial do not exist anymore due to change in procedures.) |
| An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis [NCT00607581] | Phase 2 | 21 participants (Actual) | Interventional | 2008-02-29 | Completed |
| AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA [NCT01055496] | Phase 1 | 103 participants (Actual) | Interventional | 2010-03-31 | Completed |
| A Phase I/II Trial of Escalating Dose of Yttrium-90-labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Etoposide and Cyclophosphamide Followed by AHSCT for Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma [NCT00562978] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2000-05-16 | Completed |
| A Phase I/Ib Study of Alisertib Plus R-EPOCH for Treatment of Myc-Positive Aggressive B-Cell Lymphomas [NCT02700022] | Phase 1 | 1 participants (Actual) | Interventional | 2016-10-31 | Terminated(stopped due to Lack of funding) |
| Phase I Study of Pegylated Liposomal Doxorubicin Combined With Cyclophosphamide and Vincristine in Treatment Progress, Relapse, and Refractory Solid Tumors in Children [NCT04213612] | Phase 1 | 21 participants (Anticipated) | Interventional | 2019-12-30 | Not yet recruiting |
| A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma [NCT02879669] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2016-06-30 | Active, not recruiting |
| A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy [NCT02879513] | Phase 3 | 290 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
| A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patien [NCT00688740] | Phase 3 | 1,491 participants (Actual) | Interventional | 1997-06-30 | Completed |
| Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation [NCT02671708] | Phase 2/Phase 3 | 153 participants (Actual) | Interventional | 2016-01-31 | Completed |
| Efficacy and Safety of Baricitinib in Systemic Sclerosis: a Phase IV, Double-blinded, Controlled Study. [NCT05300932] | Phase 4 | 60 participants (Anticipated) | Interventional | 2022-03-08 | Recruiting |
| Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure [NCT00854139] | Phase 1 | 10 participants (Actual) | Interventional | 2001-08-31 | Completed |
| A Phase II Trial of Reduced Intensity Conditioning and Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplantation for High-risk Solid Tumors [NCT01804634] | Phase 2 | 60 participants (Anticipated) | Interventional | 2013-03-27 | Recruiting |
| A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma and ATRT [NCT01356290] | Phase 2 | 100 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting |
| A Pilot Study of Chemotherapy Intensification by Adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents With an Interval Compression Schedule in Newly Diagnosed Patients With Localized Ewing Sarcoma Family of Tumors [NCT00618813] | | 35 participants (Actual) | Interventional | 2008-03-31 | Completed |
| Phase I Trial of Tandem Chemotherapy Cycles as Consolidation Therapy for High-Risk Epithelial Ovarian and Primary Peritoneal Cancer Utilizing Intraperitoneal Paclitaxel/IV Cyclophosphamide Followed by IV Topotecan/Intraperitoneal Cisplatin/IV Melphalan Us [NCT00550784] | Phase 1 | 8 participants (Actual) | Interventional | 2001-01-31 | Completed |
| An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Children With Relapsed and Refractory Acute Lymphoblastic Leukemia [NCT04626765] | Early Phase 1 | 50 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
| A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation [NCT04626726] | Early Phase 1 | 50 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
| CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH] [NCT00562068] | Phase 1 | 30 participants (Anticipated) | Interventional | 2007-05-31 | Recruiting |
| A Phase 2 Trial of Cryosurgical Freezing and Multiplex Immunochemotherapy in Patients With Metastatic Solid Cancer [NCT04713371] | Phase 2 | 32 participants (Anticipated) | Interventional | 2021-05-19 | Recruiting |
| A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in [NCT02032277] | Phase 3 | 634 participants (Actual) | Interventional | 2014-04-02 | Completed |
| T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer [NCT04611126] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2021-04-22 | Recruiting |
| A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia [NCT00868413] | Phase 1 | 32 participants (Actual) | Interventional | 2009-11-30 | Completed |
| A Pilot Induction Regimen Incorporating Chimeric 14.18 Antibody (ch14.18, Dinutuximab) (NSC# 764038) and Sargramostim (GM-CSF) for the Treatment of Newly Diagnosed High-Risk Neuroblastoma [NCT03786783] | Phase 2 | 42 participants (Actual) | Interventional | 2019-01-14 | Active, not recruiting |
| Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors [NCT00872625] | Phase 1 | 26 participants (Actual) | Interventional | 2007-04-30 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Study of Intravenously Administered ALE.F02 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Renal Sparing in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis With Rapidly Progressive Glom [NCT06047171] | Phase 2 | 60 participants (Anticipated) | Interventional | 2023-09-07 | Recruiting |
| A Protocol for the Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease [NCT06023641] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
| Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma [NCT05201248] | Phase 1 | 49 participants (Actual) | Interventional | 2022-03-10 | Active, not recruiting |
| A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity [NCT04339777] | Phase 2 | 66 participants (Anticipated) | Interventional | 2020-09-22 | Recruiting |
| Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab [NCT00667329] | Phase 1 | 14 participants (Actual) | Interventional | 1999-07-09 | Completed |
| Phase I/II Trial of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation [NCT05895201] | Phase 1/Phase 2 | 72 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
| A Phase I Study to Evaluate the Safety of Escalating Doses of Lymphodepleting Conditioning Chemotherapy Prior to CD19 Chimeric Antigen Receptor T Cells in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma [NCT05052528] | Phase 1 | 36 participants (Anticipated) | Interventional | 2021-09-17 | Recruiting |
| Phase I Study of Escalating Doses of Carfilzomib With Hyper-CVAD in Patients With Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma [NCT02293109] | Phase 1 | 10 participants (Actual) | Interventional | 2015-12-17 | Completed |
| The Treatment of Hematologic Malignancies With Single or Double Umbilical Cord Blood Unit Transplantation Followed by Graft-versus-Host Prophylaxis With Tacrolimus and Mycophenolate Mofetil [NCT00608517] | | 6 participants (Actual) | Interventional | 2005-09-30 | Terminated(stopped due to slow accrual) |
| A Safety and Bioactivity Study of Combination Therapy With Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-Secreting Breast Tumor Vaccine for the Treatment of Patients With High Risk/ Metastatic HER-2/Neu- Overexpressing Breast Cancer With No Evid [NCT00847171] | Phase 2 | 20 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Phase 1/2 Study of VELCADE® (Bortezomib), Dexamethasone, and Revlimid® (Lenalidomide) Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma [NCT00507442] | Phase 1/Phase 2 | 158 participants (Actual) | Interventional | 2007-08-31 | Completed |
| A Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies [NCT00890955] | Phase 1 | 36 participants (Actual) | Interventional | 2009-03-31 | Completed |
| A Phase II Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma [NCT00513604] | Phase 2 | 158 participants (Actual) | Interventional | 2007-06-30 | Completed |
| The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis [NCT01015456] | Phase 3 | 59 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to Data Safety Monitoring Board concerning of the participants' safety) |
| Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma [NCT01005537] | | 0 participants | Expanded Access | 2009-06-30 | No longer available |
| Phase 1/2 Study of Metastatic Renal Cancer Using T-Cells Transduced With a T-Cell Receptor Which Recognizes TRAIL Bound to the DR4 Receptor [NCT00923390] | Phase 1 | 5 participants (Actual) | Interventional | 2009-03-02 | Terminated |
| Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia [NCT00671658] | Phase 2 | 220 participants (Actual) | Interventional | 2002-11-30 | Completed |
| Phase II Randomized Trial of Early Versus Late Vaccination in Patients With High Risk CLL [NCT00343447] | Phase 2 | 0 participants (Actual) | Interventional | 2006-08-31 | Withdrawn |
| A Randomized Phase II Study of Dose-Adjusted EPOCH-R and R-VACOP-B in Primary Mediastinal (Thymic) Large B-Cell Lymphoma [NCT00983944] | Phase 2 | 0 participants (Actual) | Interventional | 2009-09-30 | Withdrawn(stopped due to Inadequate Accrual) |
| A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab [NCT00625898] | Phase 3 | 3,509 participants (Actual) | Interventional | 2008-04-30 | Terminated |
| Adoptive Transfer of Haploidentical NK Cells in Combination With Epratuzumab for the Treatment of Relapsed Acute Lymphoblastic Leukemia [NCT00941928] | Phase 2 | 2 participants (Actual) | Interventional | 2009-07-31 | Terminated(stopped due to Slow accrual) |
| Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies [NCT01093586] | Phase 2 | 14 participants (Actual) | Interventional | 2007-09-30 | Completed |
| A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL) [NCT00671034] | Phase 3 | 166 participants (Actual) | Interventional | 2008-07-21 | Completed |
| Pilot Study of RNA-Redirected Autologous T Cells Engineered to Contain Anti-CD123 Linked to TCR and 4-1BB Signaling Domains in Patients With Refractory or Relapsed Acute Myeloid Leukemia [NCT02623582] | Early Phase 1 | 7 participants (Actual) | Interventional | 2015-12-31 | Terminated(stopped due to This study was terminated due to lack of funding.) |
| A Randomized, Double-blind, Controlled Phase III Study of Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Combination With Hormonal Treatment Versus Hormonal Treatment Alone for First-line Therapy of Post-menopausal Women With Estrogen Receptor (ER)-Posi [NCT00925548] | Phase 3 | 16 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to See termination reason in the below Purpose statement) |
| Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for Patients With GATA2 Mutations [NCT00923364] | Phase 2 | 19 participants (Actual) | Interventional | 2009-05-07 | Completed |
| A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive Breast C [NCT02605915] | Phase 1 | 98 participants (Anticipated) | Interventional | 2015-12-31 | Completed |
| A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A)and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) as Neoadju [NCT00856492] | Phase 2 | 215 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Pilot Study of Sequential Angiogenic Blockade for the Treatment of Recurrent Mullerian Malignancies [NCT00856180] | Phase 2 | 20 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients [NCT00899847] | Phase 2 | 9 participants (Actual) | Interventional | 2009-05-31 | Completed |
| Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma [NCT00567567] | Phase 3 | 665 participants (Actual) | Interventional | 2007-11-05 | Completed |
| A Randomized, Phase II Study Comparing DA (Paclitaxel, Pirarubicin) With DAC ( Paclitaxel, Pirarubicin，Cyclophosphamide) as Postoperative Adjuvant Treatment for Early-stage Breast Cancer [NCT02838225] | Phase 2 | 300 participants (Actual) | Interventional | 2009-01-31 | Completed |
| A Phase II Clinical Trial of Four Cycles of Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Given Concurrently With Pazopanib as Neoadjuvant Therapy Followed by Postoperative Pazopanib for Women With Locally Advanced Breast Cancer [NCT00849472] | Phase 2 | 101 participants (Actual) | Interventional | 2009-07-31 | Completed |
| A Phase 2 Study of Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone (LR-CD) for Untreated Low Grade Non-Hodgkin Lymphoma Requiring Therapy [NCT00784927] | Phase 2 | 36 participants (Actual) | Interventional | 2008-11-30 | Completed |
| Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer [NCT00795678] | | 10 participants (Actual) | Observational | 2008-09-30 | Completed |
| Pilot Study of Unrelated Cord Blood Transplantation in Patients With Poor Risk Haematological Malignancies [NCT00916045] | Phase 2 | 40 participants (Anticipated) | Interventional | 2009-09-30 | Terminated(stopped due to Recruitment issues) |
| Clinical Study on Induction of Remission Using Bortezomib (Vel), Cyclophosphamide (C), and Dexamethasone (D) in Patients Until 60 Years of Age With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy: (VelCD; Deutsche Studiengruppe Multipl [NCT00833560] | Phase 2 | 401 participants (Actual) | Interventional | 2006-03-31 | Completed |
| Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor (CAR) Targeting GPC3 for the Treatment of Recurrent or Refractory Lung Squamous Cell Carcinoma [NCT02876978] | Phase 1 | 20 participants (Anticipated) | Interventional | 2016-03-31 | Recruiting |
| A Phase I Clinical Trial of T-Cells Targeting CD19 and CD22 for Subjects With CD19-positive Acute Lymphoblastic Leukemia [NCT04303520] | Phase 1 | 20 participants (Anticipated) | Interventional | 2018-05-03 | Recruiting |
| A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM) [NCT00990496] | Phase 1 | 25 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to Accrual goals not met) |
| A Randomized, Multi-Center Phase III Trial Comparing Two Conditioning Regimens (CloFluBu and BuCyMel) in Children With Acute Myeloid Leukemia Undergoing Allogeneic Stem Cell Transplantation. [NCT05477589] | Phase 3 | 170 participants (Anticipated) | Interventional | 2022-06-07 | Recruiting |
| Efficacy and Safety of Velcade Plus Dexamethasone (VD), VD+Cyclophosphamide or VD Plus Lenalidomide in MMY Patients Who Are Refractory or Have Relapsed After Their Primary Therapy for MMY and Have Achieved Stable Disease After 4 Cycles of VD [NCT00908232] | Phase 2 | 163 participants (Actual) | Interventional | 2008-05-31 | Completed |
| A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large [NCT04920617] | Phase 2 | 102 participants (Anticipated) | Interventional | 2021-06-18 | Recruiting |
| Metronomic Oral Cyclosphosphamide as Third-line Systemic Treatment or Beyond in Patients With Inoperable Locoregionally Advanced Recurrent or Metastatic Nasopharyngeal Carcinoma [NCT02794077] | Phase 2 | 56 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Phase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis [NCT00939549] | Phase 2 | 0 participants (Actual) | Interventional | 2010-11-30 | Withdrawn(stopped due to Study revised to retrospective chart review) |
| A Phase II Pilot Multicenter Study of Denileukin Diftitox Alone and in Combination With ICE (ICED) Chemotherapy in Children, Adolescents and Young Adults (CAYA) With Relapsed or Refractory Anaplastic Large Cell Lymphoma [NCT00801918] | Phase 2 | 0 participants (Actual) | Interventional | 2008-12-31 | Withdrawn(stopped due to Lack of funding) |
| An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgk [NCT00562965] | Phase 3 | 29 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to See termination reason in detailed description.) |
| Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion Before Tumor-Infiltrating Lymphocyte Therapy With Lifileucel in Metastatic Melanoma [NCT06151847] | Phase 2 | 12 participants (Anticipated) | Interventional | 2024-01-27 | Recruiting |
| A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide [NCT00759824] | Phase 2 | 64 participants (Actual) | Interventional | 2008-09-30 | Completed |
| A Phase III Randomized Trial Comparing Unrelated Donor Bone Marrow Transplantation With Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) [NCT05600426] | Phase 3 | 234 participants (Anticipated) | Interventional | 2023-01-25 | Recruiting |
| A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD) [NCT05040568] | Phase 1 | 15 participants (Anticipated) | Interventional | 2022-02-28 | Recruiting |
| Bortezomib, Cyclophosphamide and Dexamethasone (BCD) in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD) : a Prospective, Single-center, Single-arm, Phase-II Pilot Trial [NCT03982771] | Phase 2 | 30 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
| An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic L [NCT03384654] | Phase 2 | 47 participants (Actual) | Interventional | 2018-05-14 | Completed |
| Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT04098653] | Phase 2/Phase 3 | 196 participants (Anticipated) | Interventional | 2019-09-30 | Recruiting |
| A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463] | Phase 3 | 600 participants (Actual) | Interventional | 2015-03-19 | Active, not recruiting |
| Busulfan, Cyclophosphamide, Imatinib Mesylate and Autologous Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia [NCT01003054] | Phase 2 | 24 participants (Actual) | Interventional | 2005-03-31 | Completed |
| Reduced Intensity Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) Supplemented With Donor Natural Killer (NK) Cell Infusions in Patients With High Risk Myeloid Malignancies Who Are Unsuitable for Fully Myeloablative Transplantation [NCT00303667] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2005-01-31 | Completed |
| Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Glucocorticoids Plus Cytoxan [NCT05667883] | | 50 participants (Anticipated) | Observational | 2023-06-30 | Not yet recruiting |
| SJCAR19: A Phase I/II Study Evaluating SJCAR19 (CD19-Specific CAR Engineered Autologous T-Cells) in Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19+ Acute Lymphoblastic Leukemia [NCT03573700] | Phase 1/Phase 2 | 26 participants (Actual) | Interventional | 2018-07-24 | Active, not recruiting |
| A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP [NCT02889523] | Phase 1/Phase 2 | 214 participants (Actual) | Interventional | 2016-10-31 | Active, not recruiting |
| A Randomized Three-arm Neoadjuvant and Adjuvant Feasibility and Toxicity Study of a GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine Administered Either Alone or in Combination With Either a Single Intravenous Dose or Daily Metronomic Oral Doses of C [NCT00727441] | Phase 2 | 87 participants (Actual) | Interventional | 2008-07-02 | Completed |
| A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia [NCT00602459] | Phase 2 | 418 participants (Actual) | Interventional | 2008-01-15 | Completed |
| Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93) [NCT00199069] | Phase 4 | 720 participants | Interventional | 1993-04-30 | Completed |
| Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109] | Phase 2/Phase 3 | 63 participants (Actual) | Interventional | 2008-07-14 | Completed |
| A Randomized, Open-Label, Multicenter Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly [NCT00722137] | Phase 3 | 487 participants (Actual) | Interventional | 2008-05-01 | Completed |
| A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With Mabthera (Rituximab) Versus No Treatment, After Induction Treatment With Rituximab, Cladribine and Cyclophosphamide (RCC) on Progression-Free Survival in Previously Untreate [NCT00718549] | Phase 3 | 128 participants (Actual) | Interventional | 2009-07-21 | Completed |
| Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer [NCT01067989] | Phase 2 | 22 participants (Actual) | Interventional | 2010-03-31 | Terminated(stopped due to No satisfactory acrual) |
| A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination W [NCT04884035] | Phase 1 | 174 participants (Anticipated) | Interventional | 2021-09-15 | Recruiting |
| Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI. [NCT01848132] | Phase 2 | 121 participants (Actual) | Interventional | 2013-10-03 | Completed |
| A Phase 1 Study to Evaluate TAG72-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced Epithelial Ovarian Cancer [NCT05225363] | Phase 1 | 33 participants (Anticipated) | Interventional | 2022-05-05 | Recruiting |
| Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma [NCT00003042] | Phase 2 | 41 participants (Actual) | Interventional | 1997-05-30 | Active, not recruiting |
| An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia [NCT01873807] | Phase 4 | 100 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
| Letrozole Plus Oral Cyclophosphamide Plus/Minus Sorafenib as Primary Systemic Treatment in Post-menopausal, Estrogen Receptor Positive, Breast Cancer Patients [NCT00954135] | Phase 2 | 190 participants (Anticipated) | Interventional | 2007-09-30 | Active, not recruiting |
| Phase III Trail of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction [NCT01917578] | Phase 3 | 4 participants (Anticipated) | Interventional | 2008-08-31 | Recruiting |
| Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With Transcatheter Arterial Chemoembolization (TACE) to Treat Advanced Hepatocellular Carcinoma (HCC): Phase II Clinical Trial [NCT04011033] | Phase 2/Phase 3 | 144 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
| Autologous Chimeric Antigen Receptor Engineered T Cell Immunotherapy for Desensitization in Patients Awaiting Kidney Transplantation [NCT06056102] | Phase 1 | 20 participants (Anticipated) | Interventional | 2024-01-05 | Not yet recruiting |
| A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577) [NCT05266196] | Phase 1/Phase 2 | 10 participants (Anticipated) | Interventional | 2022-01-15 | Enrolling by invitation |
| Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer [NCT00538031] | Phase 2 | 52 participants (Actual) | Interventional | 2003-12-22 | Completed |
| p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial [NCT00844506] | Phase 2 | 19 participants (Anticipated) | Interventional | 2008-10-31 | Completed |
| A Neoadjuvant Study of Chemotherapy Versus Endocrine Therapy in Postmenopausal Patients With Primary Breast Cancer [NCT00963729] | Phase 3 | 756 participants (Anticipated) | Interventional | 2008-09-30 | Completed |
| Phase I / II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma [NCT02025881] | Phase 1/Phase 2 | 29 participants (Actual) | Interventional | 2013-09-14 | Active, not recruiting |
| Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia [NCT02042690] | Phase 3 | 131 participants (Actual) | Interventional | 2014-07-31 | Completed |
| UARK 2006-15: A Phase III Randomized Study of Tandem Transplants With or Without Bortezomib (Velcade) and Thalidomide (Thalomid) to Evaluate Its Effect on Response Rate and Durability of Response in Multiple Myeloma Patients [NCT00574080] | Phase 3 | 20 participants (Actual) | Interventional | 2006-07-31 | Terminated(stopped due to low accrual) |
| Phase II Multicenter, Open-label, Single Arm Clinical Study of Pomalidomide and dexamethasonE in RelapSed Myeloma Plus rEsponse Adapted Cyclophosphamide as a Tailored InnoVativE Strategy [NCT02046915] | Phase 2 | 60 participants (Actual) | Interventional | 2014-04-30 | Completed |
| [NCT00005892] | | 0 participants | Interventional | 2000-03-31 | Completed |
| Phase II Study of Radiolabeled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-Identical Related Peripheral Blood Stem Cell Transplantation [NCT00005940] | Phase 2 | 18 participants (Actual) | Interventional | 1999-10-31 | Completed |
| Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL) [NCT00005964] | Phase 2 | 59 participants (Actual) | Interventional | 2000-05-31 | Completed |
| Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer [NCT00005970] | Phase 3 | 3,436 participants (Actual) | Interventional | 2000-05-19 | Completed |
| Primed Peripheral Blood Stem Cell Autologous Transplantation for Lymphoma and Hodgkin's Disease [NCT00005985] | Phase 2 | 213 participants (Actual) | Interventional | 2000-08-31 | Completed |
| A Phase I Open-Label, Safety Study of Haploidentical Bone Marrow Transplantation (BMT) After Ex Vivo Treatment of Bone Marrow With Anti-B7.1 and Anti-B7.2 Antibodies [NCT00005988] | Phase 1 | 5 participants (Actual) | Interventional | 2000-02-29 | Completed |
| Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors: A Phase I Trial of Pre-Transplant Cyclophosphamide [NCT00006042] | Phase 1 | 0 participants | Interventional | 1999-12-31 | Completed |
| [NCT00006054] | | 0 participants | Interventional | 2000-03-31 | Terminated |
| Autotransplantation and Her 2 Neu Antibody Immunotherapy in Advanced Breast Cancer [NCT00006123] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2000-07-31 | Withdrawn(stopped due to Never started) |
| Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study [NCT00006126] | Phase 1 | 0 participants (Actual) | Interventional | 1999-09-30 | Withdrawn(stopped due to Unable to accrue subjects.) |
| Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells [NCT00006252] | Phase 2 | 47 participants (Actual) | Interventional | 2001-02-28 | Completed |
| Autologous Transplantation for Chronic Myelogenous Leukemia Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming [NCT00005986] | Phase 2 | 0 participants | Interventional | 2000-08-31 | Terminated(stopped due to Principal investigator left the university.) |
| Autologous Transplantation for Non-Hodgkin's Lymphoma and Hodgkin's Disease Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Mobilization Using Hematopoietic Cytokines Plus Chemotherapy [NCT00005998] | Phase 2 | 0 participants (Actual) | Interventional | 2000-01-31 | Withdrawn(stopped due to Withdrawn because study never enrolled patients) |
| A Phase II Multicentre Trial of Gemcitabine, CVP, and Rituximab (R-GCVP) for the Treatment of Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma, Considered Unsuitable for R-CHOP Chemotherapy [NCT00971763] | Phase 2 | 62 participants (Actual) | Interventional | 2006-03-31 | Completed |
| [NCT00006055] | | 10 participants | Interventional | 2000-03-31 | Active, not recruiting |
| Purine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic Anemia [NCT00006379] | Phase 2 | 58 participants (Actual) | Interventional | 2000-06-30 | Completed |
| Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis [NCT00007995] | Phase 2 | 75 participants (Anticipated) | Interventional | 1999-07-31 | Completed |
| A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer [NCT00008034] | Phase 1 | 15 participants (Actual) | Interventional | 2000-02-29 | Completed |
| T-cell Depletion In Unrelated Donor Marrow Transplantation [NCT00006451] | Phase 3 | 0 participants (Actual) | Interventional | 1996-04-30 | Withdrawn(stopped due to Terminated (due to no accrual)) |
| TREATMENT OF CHILDREN AND YOUNG ADULTS WITH RECURRENT/REFRACTORY SOLID TUMORS WITH HIGH DOSE ETOPOSIDE AND CARBOPLATIN PLUS ESCALATING DOSE CYCLOPHOSPHAMIDE, FOLLOWED BY HEMATOPOIETIC RESCUE USING AUTOLOGOUS CD34+ SELECTED BLOOD STEM CELLS: A PILOT STUDY [NCT00007813] | Phase 1 | 21 participants (Actual) | Interventional | 1997-05-31 | Completed |
| CAMP 013:- Tandem Thiotepa Regimen For Selected Malignant Gliomas:1) Primary Or Recurrent Glioblastoma Multiforme (GBM); and 2) Recurrent Anaplastic Astrocytomas (AA), Oligodendrogliomas (O), Oligoastrocytomas (OA), Ependymomas And Primitive Neuroectoderm [NCT00008008] | Phase 2 | 40 participants (Anticipated) | Interventional | 1997-09-30 | Completed |
| High-Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support And One Of Two Regimens Aimed At Modifying Immune Reconstitution In Women With High Risk Stage 2 And Stage 3 Breast Cancer [NCT00008203] | Phase 3 | 0 participants | Interventional | 1996-05-31 | Completed |
| "Nutritional Ergogenic Aids: The Effects of Carbohydrate-Protein Supplementation During Endurance Exercise" [NCT00972387] | | 12 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y) [NCT00863460] | Phase 2 | 140 participants (Actual) | Interventional | 2008-10-03 | Active, not recruiting |
| A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide [NCT00389506] | | 0 participants (Actual) | Interventional | 2006-09-30 | Withdrawn |
| A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment (EAE116) [NCT05147493] | Phase 2 | 51 participants (Anticipated) | Interventional | 2022-04-30 | Not yet recruiting |
| Differential Gene Regulation During Neoadjuvant Therapy Trial of Epirubicin/Cyclophosphamide (EC) vs Docetaxel/Capecitabine (DX) Regimens in Patients With Large ER-positive and ER-negative Breast Cancers: A Randomized Phase II Trial. [NCT01869192] | Phase 2 | 72 participants (Actual) | Interventional | 2003-03-05 | Completed |
| A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients With Refractory Multiple Myeloma [NCT00005834] | Phase 3 | 19 participants (Actual) | Interventional | 2000-04-30 | Terminated(stopped due to poor accrual) |
| Allogeneic Bone Marrow Transplantation for Marrow Failure States [NCT00005852] | Phase 2 | 0 participants | Interventional | 1996-06-30 | Terminated(stopped due to low accrual) |
| [NCT00010387] | Phase 2 | 32 participants | Interventional | 1999-03-31 | Completed |
| Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy [NCT00001212] | Phase 2 | 45 participants | Interventional | 1986-11-30 | Completed |
| Escalating Dose Intravenous Methotrexate Without Leucovorin Rescue Versus Oral Methotrexate and Single Versus Double Delayed Intensification for Children With Standard Risk Acute Lymphoblastic Leukemia [NCT00005945] | Phase 3 | 3,054 participants (Actual) | Interventional | 2000-06-30 | Completed |
| A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer [NCT00005960] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Active, not recruiting |
| Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming [NCT00005984] | Phase 2 | 22 participants (Actual) | Interventional | 2000-08-31 | Terminated(stopped due to Study terminated as principal investigator [PI] left the university.) |
| Autologous Transplantation for Multiple Myeloma: A Research Study of Multiple Myeloma Using Chemotherapy Plus Growth Factor Primed Peripheral Blood Stem Cells Followed by Autologous Transplantation and Post-Transplant Immunotherapy [NCT00005987] | Phase 2 | 87 participants (Actual) | Interventional | 2000-08-31 | Terminated(stopped due to Withdrawn because treatment guidelines changed) |
| [NCT00014755] | Phase 1 | 35 participants | Interventional | 1997-12-31 | Completed |
| A 2X2X2 Factorial Randomized Phase III Trial Of Multimodality Therapy Comparing 4 Cycles Of Doxorubicin And Cyclophosphamide With Or Without Dexrazoxane (AC+/-Z) Followed By 12 Weeks Of Weekly Paclitaxel With Or Without Trastuzumab (T+/-H) Followed By Loc [NCT00016276] | Phase 3 | 396 participants (Actual) | Interventional | 2001-05-31 | Terminated(stopped due to Administratively complete.) |
| First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane [NCT00017095] | Phase 3 | 1,856 participants (Actual) | Interventional | 2001-03-31 | Completed |
| A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma [NCT00017290] | Phase 3 | 0 participants | Interventional | 2000-11-30 | Active, not recruiting |
| [NCT00017641] | Phase 1 | 10 participants | Interventional | 2001-04-30 | Active, not recruiting |
| A Phase II Study of the Clinical and Immunological Effects of NY-ESO-1 ISCOM® Vaccine in Patients With Measurable Stage III and IV Malignant Melanoma [NCT00518206] | Phase 2 | 46 participants (Actual) | Interventional | 2003-11-28 | Completed |
| The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC) [NCT00152178] | Phase 3 | 680 participants (Anticipated) | Interventional | 1996-07-31 | Completed |
| Pilot Study of the Pre-Conditioning Effects of Anti-Macrophage Therapy Using PD 0360324 in Recurrent Platinum-Resistant Epithelial Ovarian Cancer [NCT02948101] | Phase 2 | 0 participants (Actual) | Interventional | 2018-12-31 | Withdrawn(stopped due to PI's request) |
| Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma [NCT02951728] | Phase 1/Phase 2 | 58 participants (Anticipated) | Interventional | 2016-10-31 | Active, not recruiting |
| Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults [NCT00797810] | Phase 4 | 25 participants (Anticipated) | Interventional | 2006-12-31 | Recruiting |
| A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer [NCT00146588] | | 55 participants (Actual) | Interventional | 2002-04-30 | Completed |
| "A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early Triple Negative Breast Cancer" [NCT04335669] | Phase 3 | 920 participants (Anticipated) | Interventional | 2019-12-20 | Recruiting |
| Umbilical Cord Blood Transplantation From Unrelated Donors [NCT03016806] | Phase 1 | 30 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
| A Pilot Study of Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide (AC) With GMCSF Followed by Weekly Carboplatin/Paclitaxel With Plus or Minus Trastuzumab (TC ± H) in the Treatment of Breast Cancer [NCT00256243] | Phase 2 | 48 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma [NCT00278161] | Phase 2 | 94 participants (Actual) | Interventional | 2005-01-31 | Completed |
| A Safety and Efficacy Study of Autologous Chimeric Switch Receptor Engineered T Cells Redirected to PD-L1 in Patients With Recurrent Glioblastoma Multiforme [NCT02937844] | Phase 1 | 20 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
| Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders [NCT00533923] | Phase 2 | 25 participants (Anticipated) | Interventional | 2002-12-31 | Completed |
| Phase I Study of Vaccination With CpG 7909 and Montanide ISA 720 With or Without Cyclophosphamide in Combination Either With NY-ESO-1-derived Peptides or the NY-ESO-1 Protein in Patients With NY-ESO-1-expressing Tumors [NCT00819806] | Phase 1 | 21 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen [NCT00719849] | Phase 2 | 13 participants (Actual) | Interventional | 2005-11-30 | Terminated(stopped due to A new protocol was developed to replace this protocol in 2008, with removal of ATG and extension of MMF duration.) |
| High Dose Sequential Therapy for Poor Risk Recurrent or Refractory Hodgkin's Disease [NCT00544570] | | 30 participants (Anticipated) | Interventional | 1998-04-30 | Completed |
| Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy Plus Trastuzumab With Lapatinib in Patients With Resected HER2 + Breast Cancer [NCT00436566] | Phase 2 | 122 participants (Actual) | Interventional | 2007-03-16 | Completed |
| S0833, Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients With Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged ≤ 65 Years [NCT01055301] | Phase 2 | 0 participants (Actual) | Interventional | 2011-07-31 | Withdrawn(stopped due to lack of accrual) |
| Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old [NCT01026116] | Phase 3 | 521 participants (Actual) | Interventional | 2009-12-31 | Completed |
| An Open-label, Randomized, Phase 2 Study of R-CHOP Plus Enzastaurin Versus R-CHOP in the First-Line Treatment of Patients With Intermediate and High-Risk Diffuse Large B-Cell Lymphoma [NCT00451178] | Phase 2 | 101 participants (Actual) | Interventional | 2007-05-31 | Completed |
| A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer [NCT00446030] | Phase 2 | 127 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Hematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic Anemia [NCT00455312] | Phase 2/Phase 3 | 36 participants (Actual) | Interventional | 2007-08-31 | Completed |
| Adjuvant Treatment of Biologically Aggressive Breast Cancer (N-,N+1,3): Controlled Clinical Study [NCT01031030] | Phase 3 | 800 participants (Anticipated) | Interventional | 1997-11-30 | Active, not recruiting |
| High Dose Immune Suppression With Hematopoietic Stem Cell Support in Refractory Vasculitis, Necrotizing Vasculitis, Neurovascular Behcet's Disease, and Sjogren's Syndrome [NCT00278512] | Phase 1 | 7 participants (Actual) | Interventional | 2003-08-31 | Terminated(stopped due to No participant enrolled over five years. No plan to continue the study.) |
| A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease. [NCT00409188] | Phase 3 | 1,513 participants (Actual) | Interventional | 2007-01-31 | Completed |
| A Randomized, Open-label Study to Compare the Effect of CellCept Plus Corticosteroids, and Cyclophosphamide Plus Corticosteroids Followed by Azathioprine, on Remission Rate in Patients With Lupus Nephritis [NCT00425438] | Phase 3 | 52 participants (Actual) | Interventional | 2007-03-31 | Terminated(stopped due to Study was terminated early for administrative reasons.) |
| Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia [NCT00274846] | Phase 2 | 21 participants (Actual) | Interventional | 2005-03-31 | Completed |
| A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Wit [NCT00408408] | Phase 3 | 1,206 participants (Actual) | Interventional | 2006-11-30 | Active, not recruiting |
| A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias. [NCT00315705] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2006-03-31 | Completed |
| The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children [NCT02532777] | Phase 2 | 100 participants (Anticipated) | Interventional | 2015-08-31 | Recruiting |
| A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma [NCT00290433] | Phase 2 | 55 participants (Actual) | Interventional | 2003-09-30 | Completed |
| A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies [NCT00429416] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2004-03-31 | Completed |
| Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients [NCT00429182] | Phase 2 | 32 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Adaptive Randomization of Fludarabine-Melphalan Versus Fludarabine-Cyclophosphamide Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor for Metastatic Renal Cell Carcinoma [NCT00429026] | Phase 2 | 40 participants (Actual) | Interventional | 2004-01-31 | Terminated(stopped due to Slow accrual, study terminated.) |
| A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma [NCT00301821] | Phase 2 | 107 participants (Actual) | Interventional | 2006-01-31 | Completed |
| A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib [NCT01324596] | Phase 3 | 1,132 participants (Actual) | Interventional | 2011-04-30 | Completed |
| A Randomized Multicenter Trial of Neoadjuvant Taxotere (T) and Adriamycin/Cytoxan (Ac): A Validation [NCT00206518] | Phase 2 | 167 participants (Actual) | Interventional | 2004-09-30 | Completed |
| Phase II Neoadjuvant Chemotherapy Trial in Clinical Stage II/III Her2Neu Positive Breast Cancer With Sequential AC -> Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 (Lapatinib) Followed by 1 Year Adjuvant Trastuzumab [NCT00404066] | Phase 2 | 21 participants (Actual) | Interventional | 2006-10-31 | Completed |
| Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis [NCT01047072] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn |
| Peripheral Blood Stem Cell Allotransplantation for Hematological Malignancies Using a Positive Stem Cell Selection Technique for T Cell Depletion, Followed by Delayed T Cell Add-Back [NCT00378534] | Phase 2 | 116 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy [NCT00278109] | Phase 1/Phase 2 | 27 participants (Actual) | Interventional | 2004-07-31 | Completed |
| Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia [NCT00187096] | | 49 participants (Actual) | Interventional | 2005-09-30 | Completed |
| Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma [NCT00185614] | Phase 2 | 63 participants (Actual) | Interventional | 2000-08-31 | Completed |
| Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma [NCT00354744] | Phase 3 | 109 participants (Actual) | Interventional | 2006-07-31 | Completed |
| A Multicenter Phase II Study Incorporating DOXIL® and Rituximab Into the Magrath Regimen for HIV-Negative and HIV-Positive Patients With Newly Diagnosed Burkitt's and Burkitt-like Lymphoma [NCT00392990] | Phase 2 | 25 participants (Actual) | Interventional | 2007-02-06 | Completed |
| A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia [NCT00136084] | Phase 3 | 238 participants (Actual) | Interventional | 2002-08-31 | Completed |
| A Phase 1 Dose Escalation Study of Seneca Valley Virus (NTX-010), A Replication-Competent Picornavirus, in Relapsed/Refractory Pediatric Patients With Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features [NCT01048892] | Phase 1 | 22 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Treatment of High Risk Renal Tumors: A Groupwide Phase II Study [NCT00335556] | Phase 2 | 291 participants (Actual) | Interventional | 2006-06-30 | Completed |
| A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy [NCT06154252] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2023-11-17 | Recruiting |
| Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure [NCT06142396] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
| A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab W [NCT06112379] | Phase 3 | 1,728 participants (Anticipated) | Interventional | 2023-11-14 | Recruiting |
| Phase II Investigation of Pembrolizumab in Combination With Bevacizumab and Oral Cyclophosphamide in Patients With High Grade Ovarian Cancer and Surgically Documented Minimal Residual Disease After Frontline Therapy [NCT06083844] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-12-12 | Recruiting |
| A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma [NCT06079164] | Phase 1 | 39 participants (Anticipated) | Interventional | 2023-11-09 | Recruiting |
| Phase 1 Study of Copanlisib With Dose-adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas [NCT04933617] | Phase 1 | 8 participants (Actual) | Interventional | 2022-03-24 | Completed |
| A Phase 1 Open-label, Multicenter Study Evaluating the Safety of KITE-222, an Autologous Anti-CLL-1 CAR T-cell Therapy, in Subjects With Relapsed/Refractory Acute Myeloid Leukemia [NCT04789408] | Phase 1 | 40 participants (Anticipated) | Interventional | 2021-07-19 | Recruiting |
| A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study [NCT04745832] | Phase 3 | 82 participants (Actual) | Interventional | 2021-08-13 | Terminated(stopped due to Discontinuation of zandelisib program) |
| Timed Sequential Busulfan and Post Transplant Cyclophosphamide for Allogeneic Transplantation [NCT02861417] | Phase 2 | 204 participants (Actual) | Interventional | 2016-08-05 | Active, not recruiting |
| A Phase I/II Trial of CHOEP Chemotherapy Plus Lenalidomide as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT02561273] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2015-09-28 | Completed |
| First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents [NCT01088750] | Phase 4 | 225 participants (Actual) | Interventional | 2009-11-01 | Completed |
| Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment [NCT01060410] | | 222 participants (Actual) | Observational | 2010-05-31 | Completed |
| A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-cell Chronic Lymphocytic Leukemia [NCT00254163] | Phase 3 | 184 participants (Actual) | Interventional | 2003-12-31 | Completed |
| Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy, Total Body Irradiation and Reconstitution With CD34+ Cells [NCT00096382] | Phase 2 | 34 participants (Actual) | Interventional | 2004-09-30 | Completed |
| A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cance [NCT00513695] | Phase 2 | 68 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Anti-Angiogenic Chemotherapy: A Phase II Trial of the Oral 5-Drug Regimen (Thalidomide, Celecoxib, Fenofibrate, Etoposide and Cyclophosphamide) in Patients With Relapsed or Progressive Cancer [NCT00357500] | Phase 2 | 101 participants (Actual) | Interventional | 2005-01-31 | Completed |
| Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies [NCT00381680] | Phase 3 | 275 participants (Actual) | Interventional | 2007-03-31 | Completed |
| "Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for Mantle Cell Lymphoma" [NCT00490529] | Phase 2 | 59 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Phase 2 Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus [NCT00483119] | Phase 2 | 9 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to Study was terminated due to the death of the PI.) |
| A Multicenter Phase IIb Randomised, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer [NCT00157209] | Phase 2 | 171 participants (Actual) | Interventional | 2000-08-31 | Completed |
| A Phase II Study of the Novel Proteasome Inhibitor Bortezomib in Combination With Rituximab, Cyclophosphamide and Prednisone in Patients With Relapsed/Refractory Indolent B-Cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) [NCT00295932] | Phase 1/Phase 2 | 79 participants (Actual) | Interventional | 2005-12-13 | Completed |
| Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen [NCT00309842] | Phase 2 | 213 participants (Actual) | Interventional | 2005-07-28 | Completed |
| Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT). [NCT01070862] | Phase 3 | 0 participants | Interventional | 2003-05-31 | Completed |
| Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients [NCT00270894] | Phase 2 | 30 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation [NCT00293384] | | 40 participants (Actual) | Interventional | 2004-10-31 | Completed |
| Phase II Trial of Adjuvant TC (Docetaxel/Cyclophosphamide) Plus Trastuzumab in HER2-Positive Early Stage Breast Cancer Patients [NCT00493649] | Phase 2 | 493 participants (Actual) | Interventional | 2007-06-30 | Completed |
| A Phase II Randomized Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old o [NCT00290498] | Phase 2 | 67 participants (Actual) | Interventional | 2005-08-01 | Completed |
| A Clinical Trial Of Adjuvant Therapy Comparing Six Cycles Of 5-Fluorouracil, Epirubicin And Cyclophosphamide (FEC) To Four Cycles Of Adriamycin And Cyclophosphamide (AC) In Patients With Node-Negative Breast Cancer [NCT00087178] | Phase 3 | 2,722 participants (Actual) | Interventional | 2004-05-31 | Completed |
| Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia [NCT00448019] | Phase 2 | 64 participants (Actual) | Interventional | 2007-02-28 | Completed |
| High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Transplantation in Patients With Refractory Idiopathic Inflammatory Myopathy Diseases: A Phase I Trial [NCT00278564] | Phase 1 | 7 participants (Actual) | Interventional | 2005-09-30 | Terminated(stopped due to high relapse rate) |
| An Open, Multi-center, Randomized Trial Comparing Haploidentical HSCTs From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies [NCT04547049] | Phase 3 | 160 participants (Anticipated) | Interventional | 2020-09-01 | Recruiting |
| Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer [NCT00193115] | Phase 2 | 32 participants | Interventional | 2004-03-31 | Completed |
| Efficacy & Safety of Bevacizumab as Neoadjuvant Treatment in Patients With Locally Advanced Inflammatory Breast Cancer, a Pilot Study. [NCT01880385] | Phase 1 | 30 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
| Phase II Study Evaluating The Infusion Of Autologous Tumor-Infiltrating Lymphocytes (TILs) And Low-Dose Interleukin-2 (IL-2) Therapy Following A Preparative Regimen Of Non-Myeloablative Lymphodepletion Using Cyclophosphamide And Fludarabine In Patients Wi [NCT01883323] | Phase 2 | 12 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Phase II Comparative Study of Myocet Plus Cyclophosphamide in First Line Treatment of HER2 Negative Metastatic Breast Patients [NCT01885013] | Phase 2 | 126 participants (Actual) | Interventional | 2010-09-30 | Completed |
| A Randomized Multicenter Trial of Neoadjuvant Taxotere and Adriamycin/Cytoxan(AC): A Biologic Correlative Study [NCT00206466] | Phase 2 | 70 participants (Actual) | Interventional | 2002-04-30 | Completed |
| A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY) [NCT01907529] | Phase 2/Phase 3 | 300 participants (Anticipated) | Interventional | 2019-08-31 | Enrolling by invitation |
| Randomized Phase II Trial of Cyclophosphamide With Allogeneic Non-Small Cell Lung Cancer (NSCLC) DRibble Vaccine Alone or With Granulocyte-Macrophage Colony-Stimulating Factor or Imiquimod for Adjuvant Treatment of Definitively-Treated Stage IIIA or IIIB [NCT01909752] | Phase 2 | 12 participants (Actual) | Interventional | 2013-07-31 | Completed |
| [NCT01910844] | Phase 2 | 3 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to Because of difficulties in recruting) |
| [NCT01910870] | Phase 2 | 4 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to Because of difficulties in recruiting) |
| A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer [NCT01918124] | Phase 2 | 80 participants (Anticipated) | Interventional | 2008-01-31 | Completed |
| A Prospective Phase II Randomized, Blinded Study to Demonstrate the Effectiveness of Jobelyn for the Treatment of Breast Cancer Patients. [NCT01936064] | Phase 1/Phase 2 | 60 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
| TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies [NCT03849651] | Phase 2 | 140 participants (Anticipated) | Interventional | 2019-01-31 | Recruiting |
| A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patie [NCT00203372] | Phase 2 | 6 participants (Actual) | Interventional | 2005-05-31 | Completed |
| A Phase I/II Study of the SV-BR-1-GM Regimen in Metastatic or Locally Recurrent Breast Cancer Patients in Combination With Retifanlimab [NCT03328026] | Phase 1/Phase 2 | 36 participants (Anticipated) | Interventional | 2018-03-16 | Enrolling by invitation |
| Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD) [NCT03219359] | Phase 2 | 50 participants (Anticipated) | Interventional | 2017-07-12 | Recruiting |
| A Phase II Study of Ibrutinib in Combination With Fludarabine, Cyclophosphamide, and Rituximab (iFCR) in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia [NCT02251548] | Phase 2 | 85 participants (Actual) | Interventional | 2014-10-31 | Active, not recruiting |
| Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Adults and Children With Relapsed or Refractory Acute Leukemias [NCT00293410] | Phase 1 | 70 participants (Anticipated) | Interventional | 2005-11-30 | Completed |
| Allogeneic Bone Marrow Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies Using a Preparative Regimen of Busulfan, Cyclophosphamide, and Fludarabine [NCT00208923] | Phase 2 | 55 participants (Anticipated) | Interventional | 1998-07-31 | Completed |
| German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2) [NCT00199004] | Phase 4 | 60 participants (Anticipated) | Interventional | 2004-04-30 | Completed |
| Phase I/II Study of Bortezomib (VELCADE) Plus Rituximab-HyperCVAD Alternating With Bortezomib Plus Rituximab-High Dose Methotrexate/Cytarabine in Patients With Untreated Aggressive Mantle Cell Lymphoma [NCT00477412] | Phase 1/Phase 2 | 107 participants (Actual) | Interventional | 2007-04-03 | Completed |
| Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation [NCT00209222] | Phase 3 | 360 participants (Anticipated) | Interventional | 2004-07-31 | Recruiting |
| Pilot Study of Local Tumor Irradiation With Autologous T-Cell Infusion for Metastatic Renal Cell Carcinoma [NCT01943188] | Phase 1 | 2 participants (Actual) | Interventional | 2014-05-31 | Terminated |
| Phase I Study of Cellular Adoptive Immunotherapy Using Autologous CD4+ NY-ESO-1-Specific T Cells and Anti-CTLA4 For Patients With NY-ESO-1-Expressing Tumors [NCT02210104] | Phase 1 | 0 participants (Actual) | Interventional | 2016-12-31 | Withdrawn(stopped due to Issues with tetramer staining) |
| Phase I Dose Escalation Study of N-Acetylcysteine Administered in Conjunction With Carboplatin, Cyclophosphamide, and Etoposide Phosphate BBBD, in Children With Malignant Brain Tumors [NCT00238173] | Phase 1 | 2 participants (Actual) | Interventional | 2004-12-31 | Terminated(stopped due to OHSU IRB closed study to further enrollment 2/17/2006) |
| Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning [NCT00238368] | Phase 2 | 59 participants (Actual) | Interventional | 2004-02-29 | Completed |
| Rituximab, Methotrexate, Procarbazine, Vincristine, Lenalidomide (RL-MPV) Followed by BBC (BCNU, Busulfan, Cyclophosphamide) High-dose Chemotherapy With Auto-HCT and Maintenance Therapy With Nivolumab in Newly Diagnosed Primary CNS Lymphoma [NCT05425654] | Phase 2 | 30 participants (Anticipated) | Interventional | 2021-05-17 | Recruiting |
| Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma [NCT01947062] | Phase 3 | 60 participants (Anticipated) | Interventional | 2013-10-31 | Not yet recruiting |
| Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia [NCT01949129] | Phase 2/Phase 3 | 1,000 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting |
| A Randomized, Controlled Mutiple-center Clinical Research on the Treatment With Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma [NCT01949818] | Phase 4 | 120 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting |
| A Multicenter Clinical Study on the Safety and Efficacy of CAR-T in the Treatment of Relapsed / Refractory Non Hodgkin's Lymphoma [NCT04666168] | | 200 participants (Anticipated) | Interventional | 2020-10-22 | Recruiting |
| Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Plasma Cell Tumors [NCT04665076] | | 60 participants (Anticipated) | Interventional | 2020-10-22 | Recruiting |
| A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Who Had Complete Remission as Assessed by PET-CT After Immune-chemotherapy [NCT05874778] | Phase 2 | 108 participants (Anticipated) | Interventional | 2023-05-15 | Not yet recruiting |
| Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer [NCT05872412] | Phase 2 | 82 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
| A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study [NCT00241254] | Phase 3 | 138 participants (Actual) | Interventional | 2005-12-31 | Completed |
| Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia [NCT00245115] | Phase 1 | 7 participants (Actual) | Interventional | 2005-10-31 | Terminated(stopped due to Expiration of study supply) |
| European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) [NCT01955187] | Phase 3 | 86 participants (Actual) | Interventional | 2014-01-31 | Completed |
| Personalized Monitoring of Intravenous Busulfan Dosing for Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation. [NCT01959477] | Early Phase 1 | 33 participants (Actual) | Interventional | 2014-03-31 | Completed |
| Phase II Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma [NCT05996185] | Phase 2 | 36 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
| A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE) [NCT05869955] | Phase 1 | 43 participants (Anticipated) | Interventional | 2023-09-13 | Recruiting |
| An Open-Label, Multinational, Multicenter, Phase IIIb Study With Subcutaneous Administration of Trastuzumab in Patients With HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction [NCT01964391] | Phase 3 | 174 participants (Actual) | Interventional | 2014-02-21 | Completed |
| A Pilot Study of SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) as Maintenance Therapy [NCT01966289] | Phase 1 | 18 participants (Actual) | Interventional | 2014-04-14 | Completed |
| Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes [NCT01967823] | Phase 2 | 11 participants (Actual) | Interventional | 2013-10-24 | Completed |
| Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer [NCT01969032] | Phase 2 | 41 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Phase IIA Basket Study of Pixatimod (PG545) in Combination With Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and Pixatimod (PG545) in Combination With Nivolumab and Low-dose Cyclophosphamide in MSS Metastatic Colorectal Carcinoma (m [NCT05061017] | Phase 2 | 14 participants (Actual) | Interventional | 2021-10-28 | Active, not recruiting |
| "A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE M [NCT01971658] | Phase 3 | 358 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults [NCT04530565] | Phase 3 | 348 participants (Anticipated) | Interventional | 2021-01-25 | Recruiting |
| An Open-Label, Phase I/II Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT04517435] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 2021-04-28 | Active, not recruiting |
| A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS [NCT01974518] | Phase 3 | 20 participants (Anticipated) | Interventional | 2013-11-30 | Active, not recruiting |
| Clinical Study to Assess Efficacy and Safety of LN-145/LN-145-S1 (Autologous Centrally Manufactured Tumor Infiltrating Lymphocytes) Across Multiple Tumor Types [NCT03449108] | Phase 2 | 30 participants (Actual) | Interventional | 2018-04-27 | Active, not recruiting |
| HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or [NCT02875314] | Phase 4 | 250 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
| Personalized NK Cell Therapy in CBT [NCT02727803] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-05-19 | Recruiting |
| A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-supported Sequential Administration of FE75C Followed by Docetaxel Versus Docetaxel/Cyclophosphamide Doublet as Adjuvant Chemotherapy in Women With HER-2 Negative, Axillary Lymph Node Positive [NCT01985724] | Phase 3 | 650 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Phase II, Open-label Non-randomized Trial to Investigate the Efficacy of Bevacizumab in Combination With Dose Dense Sequential Chemotherapy in the Neo-adjuvant Setting for HER2 Negative Breast Cancer Patients [NCT01985841] | Phase 2 | 34 participants (Actual) | Interventional | 2011-10-31 | Terminated(stopped due to Due to poor accrual) |
| HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers [NCT02379520] | Phase 1 | 32 participants (Anticipated) | Interventional | 2015-09-30 | Active, not recruiting |
| A Combined Phase I/II Feasibility-and-Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy [NCT02229084] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2015-01-14 | Completed |
| A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer [NCT01750073] | Phase 2 | 92 participants (Actual) | Interventional | 2012-12-07 | Active, not recruiting |
| A Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial（BTD-CHINA-TRIAL） [NCT04612582] | Phase 4 | 70 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
| Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia [NCT01995331] | Phase 4 | 30 participants (Anticipated) | Interventional | 2012-03-31 | Active, not recruiting |
| Pharmacogenetic Risk Factors of Doxorubicin-Cyclophosphamide Chemotherapy Related Toxicities in Breast Cancer Patients [NCT04581967] | | 100 participants (Anticipated) | Observational | 2020-10-15 | Recruiting |
| Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer：A Prospective, Randomized Trial [NCT02005783] | Phase 2 | 50 participants (Anticipated) | Interventional | 2013-10-31 | Completed |
| A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study [NCT00225173] | Phase 2 | 45 participants (Anticipated) | Interventional | 2001-10-31 | Terminated |
| Stratified Therapy on Pediatric AAGN Based on Risk Assessment-A Prospective, Multicenter, Open, Tendentious Matched Control Clinical Study [NCT05969522] | Phase 4 | 200 participants (Anticipated) | Interventional | 2023-01-01 | Recruiting |
| Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma [NCT05422066] | Phase 2 | 50 participants (Anticipated) | Interventional | 2022-07-26 | Recruiting |
| A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer [NCT05020860] | Phase 2 | 185 participants (Anticipated) | Interventional | 2023-04-18 | Recruiting |
| A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC) [NCT03036488] | Phase 3 | 1,174 participants (Actual) | Interventional | 2017-03-07 | Active, not recruiting |
| The VICTORY Study: A Phase I Study of Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation [NCT05005299] | Phase 1 | 18 participants (Anticipated) | Interventional | 2022-06-08 | Recruiting |
| A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-Specific Chimeric Antigen Receptor-Positive T Cells in Patients With Metastatic Mesothelin-Expressing Breast Cancer [NCT02792114] | Phase 1 | 186 participants (Actual) | Interventional | 2016-06-30 | Active, not recruiting |
| An Open-Label, Multicenter, Phase Ib Trial of GA101 (RO5072759) in Combination With Chemotherapy in Patients With Previously Untreated Chronic Lymphocytic Leukemia [NCT01300247] | Phase 1 | 41 participants (Actual) | Interventional | 2011-05-31 | Completed |
| Cyclophosphamide in the Treatment of Panniculitis Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes [NCT03936829] | | 10 participants (Anticipated) | Interventional | 2019-04-28 | Recruiting |
| Sequential Myeloablative Autologous Stem Cell Transplantation Followed by Allogeneic Non-Myeloablative Stem Cell Transplantation for Patients With Poor Risk Lymphomas [NCT01181271] | Phase 2 | 42 participants (Actual) | Interventional | 2010-08-31 | Completed |
| MT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell Infusions [NCT02582775] | Phase 2 | 17 participants (Actual) | Interventional | 2016-03-31 | Completed |
| An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening [NCT05777369] | | 30 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
| An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untre [NCT01292603] | Phase 1 | 240 participants (Actual) | Interventional | 2011-04-18 | Completed |
| Combined Phase I/II Clinical Study of EMD531444(L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Stage III Unresectable Non-small Cell Lung Cancer Following Primary Chemoradiotherapy [NCT00960115] | Phase 1/Phase 2 | 178 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Phase II, Randomised, Multicentre Study With Two Treatment Arms (R-COMP Versus R-CHOP) in Newly Diagnosed Elderly Patients (≥60 Years) With Non-localised Diffuse Large B-cell Lymphoma (DLBCL)/Follicular Lymphoma Grade IIIb. [NCT02012088] | Phase 2 | 91 participants (Actual) | Interventional | 2013-10-11 | Active, not recruiting |
| Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescents [NCT02014506] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
| A Reduced Intensity Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies. [NCT00739141] | Phase 2 | 86 participants (Actual) | Interventional | 2008-08-12 | Completed |
| A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer [NCT00047099] | Phase 3 | 446 participants (Anticipated) | Interventional | 2001-08-31 | Completed |
| Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial [NCT04264039] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2020-04-01 | Not yet recruiting |
| Phase Ⅱ Study of G-CSF, Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Multiple Myeloma [NCT02027220] | Phase 2 | 60 participants (Anticipated) | Interventional | 2013-12-31 | Recruiting |
| [NCT00005898] | Phase 1/Phase 2 | 30 participants | Interventional | 2000-02-29 | Completed |
| A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation [NCT00005946] | Phase 1 | 0 participants | Interventional | 2000-10-31 | Completed |
| Rituximab, Cyclophosphamide, and Corticosteroids at Low Cumulative Doses to Induce Remission in Primary Membranous Nephropathy [NCT05679336] | | 40 participants (Anticipated) | Interventional | 2018-05-01 | Recruiting |
| Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemoth [NCT00006258] | Phase 2 | 0 participants | Interventional | 1997-11-30 | Completed |
| Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma [NCT00005824] | Phase 2 | 0 participants | Interventional | 2000-11-30 | Completed |
| Transplantation of HLA Haploidentical Marrow Cells After Ex Vivo Exposure to Recipient Alloantigen in Presence of CTLA4-Ig - A Phase II Study of Tolerance Induction in Donor T Cells by Blockade of the CD80/CD86:CD28 Costimulatory Signal [NCT00005854] | Phase 2 | 0 participants | Interventional | 1999-12-31 | Completed |
| A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-I [NCT00005866] | Phase 3 | 240 participants (Anticipated) | Interventional | 2000-02-29 | Completed |
| [NCT00005893] | | 0 participants | Interventional | 2000-06-30 | Completed |
| Pilot Study on Allogeneic Stem Cell Transplantation Following Conditioning With Fludarabine and an Alkylating Agent in Patients With High-Risk Chronic Lymphocytic Leukemia [NCT00281983] | Phase 1/Phase 2 | 100 participants (Actual) | Interventional | 2000-06-30 | Completed |
| Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma [NCT00005959] | Phase 2 | 0 participants | Interventional | 1999-12-31 | Active, not recruiting |
| A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All [NCT00005977] | Phase 3 | 83 participants (Actual) | Interventional | 2000-09-30 | Completed |
| Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-cell Non-Hodgkin's Lymphoma [NCT00006669] | Phase 2 | 0 participants (Actual) | Interventional | 1999-09-30 | Withdrawn |
| High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia [NCT00008190] | Phase 2 | 0 participants | Interventional | 1999-03-31 | Completed |
| A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma [NCT06153251] | Phase 1 | 130 participants (Anticipated) | Interventional | 2024-01-08 | Not yet recruiting |
| An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of CRG-022, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell The [NCT05972720] | Phase 2 | 123 participants (Anticipated) | Interventional | 2023-08-01 | Recruiting |
| A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination With Allogeneic Natural Killer Cells (AB-101) in Subjects With Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma [NCT05883449] | Phase 2 | 154 participants (Anticipated) | Interventional | 2023-10-10 | Recruiting |
| A Clinical Study to Evaluate the Safety and Effectiveness of CD19-CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory B Cell Lymphoma [NCT04715217] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2021-01-04 | Recruiting |
| A Clinical Study to Evaluate the Safety and Effectiveness of CD19-BCMA CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Multiple Myeloma [NCT04714827] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2021-01-22 | Recruiting |
| A Phase II Study Using the Administration of Autologous T-Cells Engineered Using the Sleeping Beauty Transposon/Transposase System to Express T-Cell Receptors Reactive Against Mutated Neoantigens in Patients With Metastatic Cancer [NCT04102436] | Phase 2 | 210 participants (Anticipated) | Interventional | 2024-01-03 | Not yet recruiting |
| Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma [NCT03269669] | Phase 2 | 95 participants (Anticipated) | Interventional | 2018-01-23 | Recruiting |
| A Phase II Trial of Combination of Oral Lenalidomide and Low-dose Cyclophosphamide for Patients With Antibiotics-unresponsive Extranodal Marginal Zone B-cell Lymphoma [NCT04604028] | Phase 2 | 21 participants (Anticipated) | Interventional | 2020-11-10 | Not yet recruiting |
| An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Multiple Myeloma (MM) [NCT04626752] | Early Phase 1 | 50 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
| A Pilot Study of Safety and Feasibility of Stem Cell Therapy for Aids Lymphoma Using Stem Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs [NCT00569985] | Phase 1 | 5 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Multicentre Study to Determine the Cardiotoxicity of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone) Compared to R-COMP (Rituximab, Cyclophosphamide, Liposomal Doxorubicin, Vincristin and Prednisolone) in Patients With Diffu [NCT00575406] | Phase 2 | 94 participants (Actual) | Interventional | 2007-12-31 | Completed |
| A Phase III Trials Program Exploring the Integration of Bevacizumab, Everolimus (RAD001), and Lapatinib Into Current Neoadjuvant Chemotherapy Regimes for Primary Breast Cancer [NCT00567554] | Phase 3 | 2,600 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Efficacy and Safety of Dose-dense Epirubicin and Cyclophosphamide Plus Paclitaxel as Neoadjuvant Chemotherapy for HER2-negative Early Breast Cancer：a Multicenter Randomized Controlled Trial [NCT04576143] | Phase 2/Phase 3 | 260 participants (Anticipated) | Interventional | 2020-09-20 | Recruiting |
| A Phase 1 Trial of Escalating Doses of Karenitecin Plus Cyclophosphamide Administered Intravenously Daily for 5 Consecutive Days in Pediatric Patients With Refractory or Recurrent Solid Tumors [NCT00586560] | Phase 1 | 15 participants (Actual) | Interventional | 2007-02-28 | Completed |
| A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma [NCT00193479] | Phase 2 | 51 participants (Actual) | Interventional | 2003-04-30 | Completed |
| Randomized Phase-III Trial Comparing Fludarabine and Cyclophosphamide Plus Rituximab (FCR) to FC and MabCampath (FCCam) for Previously Untreated Fit Patients With Chronic Lymphocytic Leukemia (CLL) [NCT00564512] | Phase 3 | 178 participants (Actual) | Interventional | 2007-11-30 | Completed |
| A Phase 1/2 Dose-Escalating Study of ALIMTA and Cyclophosphamide Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer [NCT00190671] | Phase 1/Phase 2 | 103 participants (Actual) | Interventional | 2005-06-30 | Completed |
| Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma [NCT01132807] | Phase 2 | 164 participants (Actual) | Interventional | 2010-05-31 | Completed |
| Randomised Phase II Trial of Neoadjuvant Weekly Paclitaxel Plus Carboplatin Compared to Weekly Paclitaxel Alone Followed in Both Arms by Doxorubicin and Cyclophosphamide for Operable or Locally Advanced Basal-like Subtype Breast Cancer Correlating BRCA-1 [NCT00589238] | Phase 2 | 16 participants (Actual) | Interventional | 2008-01-31 | Terminated |
| Phase II Study of an All-Oral Combination of Capecitabine (X) and Cyclophosphamide (C) in Patients With Anthracycline- and Taxane-Pretreated Metastatic Breast Cancer [NCT00589901] | Phase 2 | 60 participants (Anticipated) | Interventional | 2006-08-31 | Recruiting |
| CINJALL: Treatment for Children With Acute Lymphocytic Leukemia [NCT00176462] | Phase 2 | 60 participants (Actual) | Interventional | 2001-02-28 | Completed |
| Allogeneic Hematopoietic Cell Transplantation to Correct the Biochemical Defect and Create Tolerance to Donor Tissue in Subjects With Epidermolysis Bullosa [NCT00478244] | | 7 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to Competing studies) |
| Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive [NCT00556127] | Phase 2 | 94 participants (Actual) | Interventional | 2002-06-30 | Completed |
| Allogeneic Bone Marrow Transplantation for the Treatment of Genetic Disorders of Erythropoiesis [NCT00578435] | Phase 2 | 25 participants (Anticipated) | Interventional | 1994-01-31 | Completed |
| Evaluation of Efficacy and Safety of Glucocorticosteroid Combined With Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of Patients With Lupus Nephritis. [NCT01646736] | Phase 2/Phase 3 | 130 participants (Anticipated) | Interventional | 2012-07-31 | Recruiting |
| A Single-arm Multi-center Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia [NCT01681563] | Phase 2 | 47 participants (Actual) | Interventional | 2011-09-30 | Completed |
| A Phase I/II Trial to Assess the Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Recurrent Advanced/Metastatic Endometrial Cancer Patients [NCT02755844] | Phase 1/Phase 2 | 35 participants (Actual) | Interventional | 2016-09-23 | Completed |
| Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NYESO1 and LAGE1a, and Co-expressing CD8α (GSK3901961) in Participants With NYESO1 and/or LAGE1a Positive Previously Treated Advance [NCT06048705] | Phase 1 | 7 participants (Actual) | Interventional | 2021-03-09 | Terminated(stopped due to The study was terminated due to a change in GSK's R&D priorities.) |
| A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors [NCT05395052] | Phase 1 | 5 participants (Actual) | Interventional | 2022-05-31 | Terminated(stopped due to This study was terminated by the Sponsor.) |
| Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas [NCT05389423] | Phase 1 | 20 participants (Anticipated) | Interventional | 2023-06-27 | Recruiting |
| Pharmacologic Pretransplant Immunosuppression (PTIS) + Reduced Toxicity Conditioning (RTC) Allogeneic Stem Cell Transplantation in Inherited Hematologic Disorders [NCT05293509] | Phase 2 | 0 participants (Actual) | Interventional | 2022-03-02 | Withdrawn(stopped due to 0 accrual) |
| A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors [NCT05069935] | Phase 1 | 16 participants (Actual) | Interventional | 2021-10-15 | Terminated(stopped due to This study was terminated by the Sponsor.) |
| Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia [NCT04825496] | Phase 1 | 18 participants (Anticipated) | Interventional | 2021-04-09 | Recruiting |
| A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma [NCT04614636] | Phase 1 | 42 participants (Actual) | Interventional | 2020-10-17 | Terminated(stopped due to This study was terminated by the Sponsor.) |
| A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors [NCT04551885] | Phase 1 | 12 participants (Actual) | Interventional | 2020-09-07 | Terminated(stopped due to This study was terminated by the Sponsor.) |
| Pilot Study of Anakinra to Mitigate CAR-T Toxicity in Subjects With Relapsed or Refractory Large B-Cell Lymphoma [NCT04432506] | Phase 2 | 20 participants (Anticipated) | Interventional | 2020-07-27 | Active, not recruiting |
| A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma [NCT04171843] | Phase 1 | 48 participants (Actual) | Interventional | 2020-04-30 | Terminated(stopped due to Study was terminated due to lack of sufficient therapeutic effect) |
| A Phase II Study of Ibrutinib Plus Rituximab Followed by Venetoclax and Hyper-CVAD Consolidation in Newly Diagnosed Young Patients With Mantle Cell Lymphoma: Window II Protocol [NCT03710772] | Phase 2 | 50 participants (Anticipated) | Interventional | 2019-05-01 | Active, not recruiting |
| Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT03136146] | Phase 2 | 42 participants (Anticipated) | Interventional | 2017-08-09 | Recruiting |
| Siplizumab-based Conditioning for Hematopoietic Stem Cell Transplantation in Patients With Advanced Sickle Cell Disease (CD2 SCD) [NCT06078696] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2023-09-28 | Recruiting |
| A Phase II Trial of Pembrolizumab in Combination With Chimeric Antigen Receptor Therapy in Patients With Relapsed/Refractory Primary Mediastinal B-cell Lymphoma [NCT05934448] | Phase 2 | 35 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| A Phase II Comparative, Open-Label, Randomized, Multicenter, China-Only Study to Investigate the Pharmacokinetics, Efficacy and Safety of Subcutaneous Rituximab Versus Intravenous Rituximab Both in Combination With CHOP in Previously Untreated Patients Wi [NCT04660799] | Phase 2 | 50 participants (Actual) | Interventional | 2021-02-24 | Completed |
| Transplantation Using Reduced Intensity Approach for Patients With Sickle Cell Disease From Mismatched Family Donors of Bone Marrow [NCT02757885] | Phase 2 | 10 participants (Actual) | Interventional | 2019-07-10 | Completed |
| A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With Trastuzumab in Stage I-II HER2/Neu Positive Breast Cancer Patients [NCT02654119] | Phase 2 | 20 participants (Actual) | Interventional | 2015-12-11 | Active, not recruiting |
| A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype [NCT02443077] | Phase 3 | 302 participants (Anticipated) | Interventional | 2016-10-12 | Active, not recruiting |
| A Phase 1b/2 Study of IPI-145 in Combination With Fludarabine, Cyclophosphamide, and Rituximab (iFCR) in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia. [NCT02158091] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2014-06-27 | Active, not recruiting |
| Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) for the Treatment of Hematological Diseases [MT2015-32] [NCT02661035] | Phase 2 | 156 participants (Actual) | Interventional | 2017-03-09 | Completed |
| Phase II Study of the Dose Adjusted EPOCH Regimen in Combination With Ofatumumab/Rituximab as Therapy for Patients With Newly Diagnosed or Relapsed/Refractory Burkitt Leukemia or Relapsed/Refractory Acute Lymphoblastic Leukemia [NCT02199184] | Phase 2 | 6 participants (Actual) | Interventional | 2015-01-14 | Completed |
| A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis [NCT01659658] | Phase 3 | 177 participants (Actual) | Interventional | 2012-12-12 | Terminated(stopped due to Sponsor's decision) |
| A Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Short-Term Cultured Tumor-Infiltrating Lymphocytes Plus IL-2 Following Either a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen Alone or in Conjunction With [NCT01319565] | Phase 2 | 102 participants (Actual) | Interventional | 2011-03-24 | Active, not recruiting |
| Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy) [NCT01190930] | Phase 3 | 9,350 participants (Actual) | Interventional | 2010-08-09 | Active, not recruiting |
| A Multi-center, Prospective Study of Clinical Outcome and Immune Reconstruction in G-CSF/ATG and PT-Cy Based Haploidentical Transplantation [NCT05629260] | | 300 participants (Anticipated) | Observational | 2022-12-01 | Recruiting |
| BMT-06: Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Cyclophosphamide and Post-Transplant Cyclophosphamide Conditioning for Partially HLA Mismatched (Haploidentical) Allogeneic Transplantation in Patie [NCT04187105] | Phase 2 | 27 participants (Anticipated) | Interventional | 2020-01-27 | Recruiting |
| Phase I Clinical Trial Assessing the Combination of Chemokine Modulation With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer [NCT04081389] | Phase 1 | 9 participants (Actual) | Interventional | 2019-12-06 | Completed |
| Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults [NCT03779854] | Phase 2 | 68 participants (Anticipated) | Interventional | 2019-08-29 | Recruiting |
| Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) [NCT03630211] | Phase 2 | 8 participants (Anticipated) | Interventional | 2018-07-31 | Recruiting |
| A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cyclophosphamide) in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma [NCT03190265] | Phase 2 | 61 participants (Actual) | Interventional | 2017-12-14 | Completed |
| Phase I Study of Escalating Doses of Total Marrow and Lymphoid Irradiation (TMLI) During Conditioning for HLA-Haploidentical Hematopoietic Cell Transplantation With Post-Transplant Cyclophosphamide in Patients With Myelodysplasia or Acute Leukemia [NCT02446964] | Phase 1 | 24 participants (Anticipated) | Interventional | 2015-06-25 | Active, not recruiting |
| Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a CD123-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR for Patients With CD123+ Relapsed/Refractory Acute Myeloid Leukem [NCT02159495] | Phase 1 | 31 participants (Actual) | Interventional | 2015-12-15 | Active, not recruiting |
| Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD) [NCT00107198] | Phase 2 | 188 participants (Actual) | Interventional | 2006-01-02 | Active, not recruiting |
| A Phase 1 Study of Crizotinib in Combination With Conventional Chemotherapy for Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma [NCT01606878] | Phase 1 | 46 participants (Actual) | Interventional | 2013-04-29 | Completed |
| Allogeneic Bone Marrow Transplantation (Allo-BMT) From Human Leukocyte Antigen (HLA) - Identical Related and Unrelated Donors in Patients With Hematological Malignancies With High Risk of Relapse Using Cyclophosphamide (CY) and Mesenchymal Stromal Cells ( [NCT02270307] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
| Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab [NCT04135092] | | 0 participants | Expanded Access | | No longer available |
| A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope Folate Receptor Alpha Peptide Vaccine Used in Combination With Cyclophosphamide in Subjects Previously Treated for Breast or Ovarian Cancer [NCT01606241] | Phase 1 | 24 participants (Anticipated) | Interventional | 2012-07-24 | Completed |
| Phase II Randomized Study of Maintenance Treatment With Bevacizumab or Bevacizumab Plus Metronomic Chemotherapy After First-line Induction FOLFOXIRI Plus Bevacizumab for Metastatic Colorectal Cancer Patients [NCT02271464] | Phase 2 | 232 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer [NCT00107276] | Phase 2 | 112 participants (Actual) | Interventional | 2005-08-31 | Completed |
| A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 [NCT01332968] | Phase 3 | 1,401 participants (Actual) | Interventional | 2011-07-06 | Completed |
| Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma [NCT01321008] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2011-05-31 | Terminated(stopped due to Slow Accrual) |
| A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant [NCT01078441] | Phase 2 | 2 participants (Actual) | Interventional | 2010-09-30 | Terminated(stopped due to The study was closed early due to weak accrual on June 26, 2012.) |
| Pilot Study to Evaluate the Safety and Feasibility of Induction of Mixed Chimerism in Sickle Cell Disease Patients With COH-MC-17: a Non-Myeloablative, Conditioning Regimen and CD4+ T-cell-depleted Haploidentical Hematopoietic Transplant [NCT03249831] | Phase 1 | 3 participants (Actual) | Interventional | 2019-01-04 | Active, not recruiting |
| HLA Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease [NCT00578643] | Phase 2 | 15 participants (Actual) | Interventional | 2004-03-31 | Completed |
| Effects of Chemotherapy on Brain Structure and Function [NCT00755313] | | 81 participants (Actual) | Observational | 2007-05-31 | Completed |
| Tandem High-dose Chemotherapy and Autologous Stem Cell Rescue in Patients With High-risk Neuroblastoma [NCT00793845] | Phase 2 | 40 participants (Anticipated) | Interventional | 2008-08-31 | Completed |
| An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System [NCT04561557] | Early Phase 1 | 18 participants (Anticipated) | Interventional | 2020-09-22 | Recruiting |
| A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatmen [NCT00114530] | Phase 2/Phase 3 | 75 participants (Actual) | Interventional | 2005-06-30 | Completed |
| A Prospective Control Study of Comparing Intermediate-dose Cyclophosphamide(ID-CTX) and G-CSF Plus or Not Recombinant Human Thrombopoietin (rhTPO) for PBSC Mobilization in Patients With Multiple Myeloma [NCT02572596] | | 200 participants (Anticipated) | Interventional | 2013-01-01 | Recruiting |
| MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer [NCT00652899] | Phase 2 | 14 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to Withdrawn due to toxicity) |
| Phase I/II Trial to Determine the Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Ste [NCT05436418] | Phase 1/Phase 2 | 240 participants (Anticipated) | Interventional | 2022-11-18 | Recruiting |
| Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen [NCT04195633] | Phase 2 | 60 participants (Anticipated) | Interventional | 2021-01-25 | Recruiting |
| Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies [NCT02419495] | Phase 1 | 221 participants (Actual) | Interventional | 2015-06-26 | Active, not recruiting |
| An Multi-site, Open, Prospective Study to Assess the Efficacy and Safety of Multi-target Therapy in the Treatment of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis [NCT00876616] | | 362 participants (Actual) | Interventional | 2009-04-30 | Completed |
| "Phase Ib Study of Weekly Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA) in Transplant Eligible Patients With Newly Diagnosed Multiple Myeloma (MM): The CyBorD-DARA Study" [NCT02955810] | Phase 1 | 18 participants (Anticipated) | Interventional | 2016-11-30 | Active, not recruiting |
| Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study [NCT00976300] | Phase 2 | 40 participants (Actual) | Interventional | 2002-01-31 | Completed |
| Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 TCR-Gene Engineered Lymphocytes [NCT00670748] | Phase 2 | 45 participants (Actual) | Interventional | 2008-05-29 | Terminated(stopped due to A more highly selected protocol with ESO TCR opened for pts with melanoma) |
| Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients With Hematologic Malignancies [NCT03642626] | | 240 participants (Anticipated) | Observational | 2018-12-18 | Recruiting |
| A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients. [NCT00727415] | Phase 1/Phase 2 | 42 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Phase I Study of Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma [NCT00877110] | Phase 1 | 71 participants (Actual) | Interventional | 2009-04-02 | Completed |
| A Pilot Study of Adjuvant Doxorubicin and Cyclophosphamide Followed by Paclitaxel Plus Sorafenib in Women With Node Positive or High-Risk Early Stage Breast Cancer [NCT00544167] | | 45 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Association of Rituximab to Immunochemotherapy With CVP + Interferon in Newly Diagnosed Follicular Lymphoma Patients With Intermediate-high FLIPI Score. Phase II Study. [NCT00842114] | Phase 2 | 50 participants (Actual) | Interventional | 2006-02-28 | Completed |
| Melanoma Peptide-Loaded Dendritic Cell Vaccine in HLA-A*0201 Patients With Stage IV Melanoma: A Phase II Randomized Trial to Compare Vaccination With and Without Cyclophosphamide Treatment. [NCT00722098] | Phase 2 | 9 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to Early termination due to lesser accrual, and data analysis not done.) |
| Allogeneic Bone Marrow Transplantation From HLA Identical Related Donors for Patients With Hemoglobinopathies: Hemoglobin SS, Hemoglobin SC, or Hemoglobin SB0/+ Thalassemia [NCT00578344] | | 8 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to Terminated due to no new subject enrollment during the last 3 year period.) |
| Total Marrow Irradiation and Myeloablative Chemotherapy Followed By Double Umbilical Cord BloodTransplantation In Patients With Refractory Acute Leukemia [NCT00686556] | Phase 1 | 12 participants (Actual) | Interventional | 2012-08-31 | Completed |
| S0629, Observational Study of Asymptomatic Waldenstrom's Macroglobulinemia and Phase II Study of Tandem Autologous Transplant and Maintenance Treatment for Patients With Symptomatic Disease [NCT00723658] | Phase 2 | 0 participants (Actual) | Interventional | 2008-09-30 | Withdrawn(stopped due to lack of accrual) |
| A Phase II Study of Anti-CD3 x Anti-HER2/Neu Armed Activated T Cells for Patients With HER2/Neu (0, 1+ or 2+) Metastatic Breast Cancers. [NCT01022138] | Phase 2 | 43 participants (Actual) | Interventional | 2010-03-08 | Terminated |
| Randomised Phase II Study of Metronomic Chemotherapy Plus the Same Aromatase Inhibitor Compared to Metronomic Chemotherapy Alone in Women With Hormone Receptor Positive, Her-2 Non-Overexpressing Advanced Breast Cancer Whose Disease Has Progressed While Re [NCT00687648] | Phase 2 | 70 participants (Anticipated) | Interventional | 2008-05-31 | Recruiting |
| Phase II Clinical Trial to Assess the Efficacy of ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab in Patients Who Have Failed Prior Treatment With Radiation and Temozolomide [NCT05366062] | Phase 2 | 28 participants (Anticipated) | Interventional | 2022-07-01 | Not yet recruiting |
| A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer [NCT00912444] | Phase 3 | 102 participants (Actual) | Interventional | 2009-07-31 | Terminated(stopped due to TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.) |
| Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxor [NCT00726700] | Phase 2 | 109 participants (Actual) | Interventional | 2004-05-31 | Completed |
| Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients [NCT03012100] | Phase 2 | 280 participants (Actual) | Interventional | 2017-03-31 | Active, not recruiting |
| Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study [NCT00866307] | Phase 1 | 104 participants (Actual) | Interventional | 2009-02-23 | Completed |
| A Phase 2 Multicenter Study of First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia [NCT01004497] | Phase 2 | 51 participants (Actual) | Interventional | 2010-03-31 | Completed |
| A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and SLL [NCT01005979] | Phase 1 | 6 participants (Actual) | Interventional | 2010-07-31 | Terminated(stopped due to Slow Accrual) |
| Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2) [NCT00301925] | Phase 3 | 4,400 participants (Anticipated) | Interventional | 2005-12-16 | Active, not recruiting |
| AIEOP LLA 2000 Multicenter Study for the Diagnosis and Treatment of Childhood Acute Lymphoblastic Leukemia [NCT00613457] | Phase 3 | 2,039 participants (Actual) | Interventional | 2000-09-30 | Completed |
| [NCT00615173] | Phase 3 | 81 participants (Actual) | Interventional | 2006-07-31 | Completed |
| Phase I Study of Bevacizumab and Sorafenib Combined With Low Dose Cyclophosphamide in Patients With Refractory Solid Tumors and Leukemia [NCT00665990] | Phase 1 | 49 participants (Actual) | Interventional | 2007-11-30 | Completed |
| A Randomized Phase II Study of Bevacizumab (NSC 704865) Combined With Vincristine, Topotecan and Cyclophosphamide in Patients With First Recurrent Ewing Sarcoma [NCT00516295] | Phase 2 | 7 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52 [NCT00505921] | Phase 2 | 27 participants (Actual) | Interventional | 2003-03-31 | Terminated(stopped due to Slow Accrual.) |
| A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas [NCT00669812] | Phase 2 | 60 participants (Anticipated) | Interventional | 2008-02-29 | Recruiting |
| Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamid and Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ Acute Myelogenous Leukemia/Myelodysplastic Syndrome/Juvenile Myelomonocytic Leukemia [NCT00669890] | Phase 1 | 12 participants (Actual) | Interventional | 2004-05-31 | Terminated(stopped due to PI left institution) |
| A Phase 1, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis [NCT05938725] | Phase 1 | 12 participants (Anticipated) | Interventional | 2023-04-28 | Recruiting |
| A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT) [NCT05878184] | Phase 1 | 54 participants (Anticipated) | Interventional | 2023-05-02 | Recruiting |
| A Phase 1b Dose Escalation Study of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers in Adult Patients With Relapsed or Refractory CD19 B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocyti [NCT05702853] | Phase 1/Phase 2 | 27 participants (Anticipated) | Interventional | 2023-11-06 | Recruiting |
| A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell [NCT04980222] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-03-22 | Recruiting |
| Response-based Treatment of High-risk Neuroblastoma [NCT02771743] | Phase 2 | 54 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| Pilot Study of Feasibility and Safety of Personalized Autologous CD8+ T Cell Therapy Plus Anti-PD1 Antibody in Advanced Solid Malignancies [NCT02757391] | Phase 1 | 1 participants (Actual) | Interventional | 2019-08-09 | Terminated(stopped due to Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.) |
| A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma [NCT02753647] | Phase 2 | 49 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
| International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy [NCT02724163] | Phase 3 | 700 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
| A Randomized Phase II Trial of Bevacizumab (Avastin) and Temsirolimus (Torisel) in Combination With Intravenous Vinorelbine and Cyclophosphamide in Patients With Recurrent/Refractory Rhabdomyosarcoma [NCT01222715] | Phase 2 | 87 participants (Actual) | Interventional | 2010-10-31 | Completed |
| SHORT-HER: MULTICENTRIC RANDOMISED PHASE III TRIAL OF 2 DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENS PLUS 3 VS 12 MONTHS OF TRASTUZUMAB IN HER2 POSITIVE BREAST CANCER PATIENTS [NCT00629278] | Phase 3 | 2,500 participants (Anticipated) | Interventional | 2007-12-31 | Recruiting |
| A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of B7H3 or HBsAg Targeting CAR-T in Treating Advanced Hepatocellular Carcinoma [NCT05323201] | Phase 1/Phase 2 | 15 participants (Anticipated) | Interventional | 2022-02-10 | Recruiting |
| A Phase II Study of Intraventricular Methotrexate With Systemic Topotecan and Cyclophosphamide in Children With Recurrent or Progressive Malignant Brain Tumors [NCT02684071] | Phase 2 | 3 participants (Actual) | Interventional | 2016-02-29 | Terminated(stopped due to Lack of additional funding; patients (3) no longer receiving intervention.) |
| IL-1 Receptor Antagonist to Prevent Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome [NCT04205838] | Phase 2 | 36 participants (Anticipated) | Interventional | 2020-03-04 | Recruiting |
| A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib Combined With Chemotherapy for Patients With High Risk Diffuse Large B-Cell Lymphoma [NCT02636322] | Phase 2 | 60 participants (Actual) | Interventional | 2016-03-29 | Completed |
| Modified BFM-95 Regimen for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults:a Prospective Phase II Study [NCT02396043] | Phase 2 | 50 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting |
| Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia [NCT00003764] | Phase 3 | 280 participants (Anticipated) | Interventional | 2000-03-09 | Completed |
| A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer [NCT02664103] | Phase 2 | 2 participants (Actual) | Interventional | 2016-01-23 | Completed |
| An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in [NCT02846428] | Phase 2 | 182 participants (Actual) | Interventional | 2004-03-31 | Completed |
| A Pilot Study for Soft Tissue Sarcoma [NCT00662233] | Early Phase 1 | 28 participants (Actual) | Interventional | 1991-10-31 | Completed |
| A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Pa [NCT01200758] | Phase 3 | 410 participants (Actual) | Interventional | 2011-02-15 | Completed |
| Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort [NCT04745728] | Phase 3 | 200 participants (Anticipated) | Interventional | 2021-04-14 | Recruiting |
| International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Subprotocol D: Trametinib + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With [NCT05658640] | Phase 1/Phase 2 | 26 participants (Anticipated) | Interventional | 2023-04-01 | Not yet recruiting |
| A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26) [NCT00689845] | | 120 participants (Anticipated) | Interventional | 2007-06-30 | Recruiting |
| A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Metastatic Renal Cell Carcinoma [NCT02867332] | Phase 1 | 0 participants (Actual) | Interventional | 2016-11-30 | Withdrawn(stopped due to No funding) |
| A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens With Weekly Paclitaxel Plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide With Postoperative Trastuzumab in Women With Locall [NCT01008150] | Phase 2 | 141 participants (Actual) | Interventional | 2010-10-31 | Completed |
| A Phase I/II Study of Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 Chimeric Antigen Receptor T-Cells in Patients With Refractory CD19+ B-lineage Leukemia/Lymphoma [NCT02685670] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2016-02-29 | Recruiting |
| Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer [NCT04182568] | Phase 4 | 100 participants (Anticipated) | Interventional | 2019-08-21 | Recruiting |
| A Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's Disease [NCT02676622] | Phase 2 | 0 participants (Actual) | Interventional | 2013-04-30 | Withdrawn(stopped due to PI moved to a different institution.) |
| Phase II Study of Ibrutinib in Combination With Rituximab-CHOP in Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma 54179060LYM2003 (Nick Name: IVORY Study) [NCT02670616] | Phase 2 | 24 participants (Actual) | Interventional | 2016-05-01 | Completed |
| Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL) [NCT00816595] | Phase 2 | 68 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Randomized Phase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Patients With Metastatic Hormone Reseptor Positive Breast Cancer [NCT03409198] | Phase 2 | 82 participants (Actual) | Interventional | 2018-01-21 | Active, not recruiting |
| Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome [NCT01868269] | Phase 3 | 102 participants (Actual) | Interventional | 2013-04-18 | Active, not recruiting |
| Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT [NCT02876679] | Phase 2 | 94 participants (Actual) | Interventional | 2017-04-06 | Completed |
| A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab & CVP (IO-R-CVP) vs Gemcitabine Plus Rituximab & CVP (Gem-R-CVP) for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy [NCT01679119] | Phase 2 | 129 participants (Actual) | Interventional | 2013-10-31 | Completed |
| Phase II Study Evaluating the Toxicity and Efficacy of a Modified German Paediatric Hodgkin's Lymphoma Protocol (HD95) in Young Adults (Aged 18-30 Years) With Hodgkin's Lymphoma [NCT00666484] | Phase 2 | 47 participants (Actual) | Interventional | 2008-03-31 | Completed |
| Allogenic Immunotherapy Based on Natural Killer Cell Adoptive Transfer in Metastatic Gastrointestinal Carcinoma Treated With Cetuximab : a Phase I Trial [NCT02845999] | Phase 1 | 9 participants (Actual) | Interventional | 2009-11-30 | Completed |
| Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning [NCT00809341] | Phase 2 | 27 participants (Actual) | Interventional | 2009-01-31 | Terminated(stopped due to Low accrual) |
| Pilot Evaluation of Bevacizumab, in Combination With Docetaxel and Cyclophosphamide in the Adjuvant Treatment of Patients With HER 2 Negative Breast Cancer [NCT00911716] | | 106 participants (Actual) | Interventional | 2008-10-31 | Completed |
| An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHO [NCT00877006] | Phase 3 | 447 participants (Actual) | Interventional | 2009-04-30 | Completed |
| [NCT02627248] | Phase 4 | 200 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
| Efficacy and Safety of Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (oFCG) in the Treatment of Newly Diagnosed Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) [NCT05322733] | Phase 2 | 25 participants (Anticipated) | Interventional | 2022-04-15 | Recruiting |
| Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia [NCT05660473] | Phase 2 | 100 participants (Anticipated) | Interventional | 2022-10-31 | Recruiting |
| To Investigate the Safety and Preliminary Efficacy of EBV CAR-T Cells in the Treatment of Relapsed/Refractory EBV-positive Nasopharyngeal Carcinoma [NCT05654077] | Early Phase 1 | 24 participants (Anticipated) | Interventional | 2022-01-18 | Recruiting |
| Adjuvant Trastuzumab vs Observation in Locally Advanced Breast Cancer Treated With Neoadjuvant Trastuzumab [NCT00533936] | Phase 2 | 160 participants (Anticipated) | Interventional | 2006-09-30 | Recruiting |
| A Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Hodgkin's Lymphoma [NCT04665063] | | 20 participants (Anticipated) | Interventional | 2020-10-22 | Recruiting |
| An Open-label, Multi-center, Phase Ib Clinical Trial of Chidamide Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphoma Patients [NCT02809573] | Phase 1 | 30 participants (Actual) | Interventional | 2016-08-11 | Completed |
| Graft-versus-host Disease Prophylaxis With Post-transplantation Cyclophosphamide and Ruxolitinib in Patients With Myelofibrosis [NCT02806375] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2016-01-31 | Completed |
| An International, Multicentre, Randomised Controlled Trial. Treatment for Classical Hodgkin Lymphoma in Children and Adolescents Standard Treatment (Chemotherapy and RT) Compared With Experimental Treatment (Chemotherapy Without RT or Restricted to RT) [NCT02797717] | | 2,200 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
| Phase II Prospective Trial of Addition of Rituximab to Reduced Dose CHOP Chemotherapy in DLBC L Patients Aged 65 Years and Over [NCT02792491] | Phase 2 | 57 participants (Actual) | Interventional | 2012-08-31 | Active, not recruiting |
| A Phase 2, Single Arm, Multi Center Trial Evaluating the Efficacy of the COmbination of Sirolimus and cYclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and chOndrosarcoma [NCT02821507] | Phase 2 | 70 participants (Actual) | Interventional | 2014-06-30 | Completed |
| Randomized Comparison of a Preoperative, Dose-Intensified, Interval-Shortened, Sequential Chemotherapy With Epirubicin, Paclitaxel and CMF ± Darbepoetin Alfa Versus a Preoperative, Sequential Chemotherapy With Epirubicin and Cyclophosphamide Followed by P [NCT00544232] | Phase 3 | 720 participants (Actual) | Interventional | 2002-08-31 | Completed |
| [NCT00544505] | | 10 participants (Anticipated) | Interventional | 2007-09-30 | Active, not recruiting |
| A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma [NCT01992653] | Phase 1/Phase 2 | 85 participants (Actual) | Interventional | 2013-11-29 | Completed |
| A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Ritu [NCT01389427] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2011-11-30 | Completed |
| Reduced Intensity Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Sirolimus/Mycophenolate Mofetil/RGI-2001 Based GVHD Prevention: a Pilot Study [NCT04473911] | Phase 1 | 25 participants (Actual) | Interventional | 2020-08-14 | Active, not recruiting |
| A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients With High-Risk Squamous Cell Carcinoma of the Oral Cavity [NCT02873819] | Phase 2 | 80 participants (Actual) | Interventional | 2017-03-30 | Completed |
| A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM) [NCT01403285] | Phase 1 | 6 participants (Actual) | Interventional | 2011-08-31 | Terminated(stopped due to Due to poor accrual. This decision was taken without any safety reasons. Since beginning of the study (June 2011) only six patients were enrolled.) |
| Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer [NCT00434031] | Phase 2 | 0 participants (Actual) | Interventional | 2007-09-30 | Withdrawn(stopped due to lack of enrollment) |
| AX (Doxorubicin, Capecitabine) Versus AC (Doxorubicin, Cyclophosphamide) as Adjuvant Treatment for Node-Negative Breast Cancer [NCT01415336] | Phase 2/Phase 3 | 300 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| Phase I/II Study of MLN4924 Alone Followed by Dose-Adjusted EPOCH-Rituximab + MLN4924 With Gene Expression Profiling and Mutational Analysis in Relapsed/Refractory de Novo Diffuse Large B-Cell Lymphoma [NCT01415765] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2011-07-15 | Withdrawn |
| Phase 1-2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer [NCT01416038] | Phase 1 | 19 participants (Actual) | Interventional | 2011-12-31 | Completed |
| Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF [NCT00331097] | Phase 3 | 300 participants (Actual) | Interventional | 2003-07-31 | Completed |
| A Phase I Trial of Consolidation Therapy With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 in Patients With Chronic Lymphocytic Leukemia Following Upfront Chemotherapy With Pentostatin, Cyclophosphamide and Rituximab [NCT01416974] | Phase 1 | 13 participants (Actual) | Interventional | 2011-08-22 | Completed |
| Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status [NCT00333008] | Phase 2 | 27 participants | Interventional | 2006-05-31 | Recruiting |
| A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer [NCT00420563] | Phase 2 | 88 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression Profile-Based Test to Select Patients for Preoperative Taxane/Anthracycline Chemotherapy for Stage I-III Breast Cancer [NCT00336791] | Phase 3 | 273 participants (Actual) | Interventional | 2003-09-30 | Completed |
| Phase II Study of Shortened-duration Tacrolimus Following Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Malignancies That Are Challenging to Engraft [NCT02556931] | Phase 2 | 117 participants (Actual) | Interventional | 2015-12-31 | Completed |
| Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma [NCT01427114] | Phase 2 | 33 participants (Actual) | Interventional | 2011-07-01 | Completed |
| A Feasibility Study of Organ-Sparing Marrow-Targeted Irradiation (OSMI) to Condition Patients With High-Risk Hematologic Malignancies Prior to Allogeneic Hematopoietic Stem Cell Transplantation [NCT02122081] | Phase 1 | 33 participants (Actual) | Interventional | 2015-07-27 | Completed |
| Randomized Phase II/III Study of Individualized Neoadjuvant Chemotherapy in ' Triple Negative' Breast Tumors [NCT01057069] | Phase 2/Phase 3 | 310 participants (Actual) | Interventional | 2010-01-31 | Active, not recruiting |
| A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-NKT in the Treatment of Relapsed or Metastatic Advanced Renal Cell Carcinoma. [NCT06182735] | Phase 1 | 9 participants (Anticipated) | Interventional | 2023-07-17 | Recruiting |
| Ofatumumab (O) in Combination With Chemotherapy: Hyper-Fractionated Cyclophosphamide, Doxorubicin, Vincristine and Dexamethasone (O-HyperCVAD) Alternating With Ofatumumab High-Dose Cytarabine and Methotrexate (O-MA) for Patients With Newly Diagnosed Mantl [NCT01527149] | Phase 2 | 37 participants (Actual) | Interventional | 2011-12-06 | Active, not recruiting |
| A Randomized Multicenter Trial Comparing Weekly Docetaxel and CMF in the Adjuvant Treatment of Women With High-Risk Breast Cancer Who Are > 65 Years Old or Are Not Candidates for Anthracycline-Based Adjuvant Therapy [NCT00193011] | Phase 3 | 150 participants (Anticipated) | Interventional | 2002-03-31 | Completed |
| [NCT00006056] | | 40 participants | Interventional | 2000-03-31 | Active, not recruiting |
| Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas [NCT04074746] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2020-07-18 | Active, not recruiting |
| CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients [NCT00400075] | Phase 4 | 124 participants | Interventional | 1996-07-31 | Active, not recruiting |
| Treatment of Patients With Metastatic Melanoma by Lymphodepleting Conditioning Followed by Infusion of TCR-Gene Engineered Lymphocytes and Subsequent Fowlpox gp100 Vaccination [NCT00085462] | Phase 1 | 61 participants (Anticipated) | Interventional | 2004-05-31 | Completed |
| A Phase I Trial of Imatinib, Bevacizumab, & Metronomic Cyclophosphamide as Antiangiogenic Therapy in Refractory Metastatic Solid Tumors [NCT00390156] | Phase 1 | 35 participants (Actual) | Interventional | 2006-08-31 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis [NCT02222155] | Phase 2 | 42 participants (Actual) | Interventional | 2015-02-04 | Completed |
| A Phase I/II Clinical Trial of Nivolumab in Progressive/Relapsed Pediatric Solid Tumors [NCT02901145] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2016-11-30 | Not yet recruiting |
| Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma [NCT00169130] | Phase 2/Phase 3 | 300 participants | Interventional | 1999-10-31 | Completed |
| A Phase III Trial to Compare ETC vs, EC-TX and Ibandronate vs. Observation in Patients With Node-positive Primary Breast Cancer (GAIN) [NCT00196872] | Phase 3 | 3,000 participants (Anticipated) | Interventional | 2004-07-31 | Completed |
| A Prospective Phase I/IIa, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of oNKord®, an Off-the-shelf, ex Vivo-cultured Allogeneic NK Cell Preparation, in Subjects With Acute Myeloid Leukemia Who Are in Morphologic Complete Remission W [NCT04632316] | Phase 1/Phase 2 | 33 participants (Anticipated) | Interventional | 2020-12-08 | Recruiting |
| Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1) [NCT00199017] | Phase 4 | 75 participants (Anticipated) | Interventional | 2004-04-30 | Completed |
| An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected With a Test Measur [NCT03412643] | Phase 2 | 64 participants (Anticipated) | Interventional | 2018-05-14 | Recruiting |
| A Randomized Phase II Study of Bevacizumab in Combination With Docetaxel in Locally Advanced Breast Cancer [NCT00027885] | Phase 2 | 49 participants (Actual) | Interventional | 2001-11-30 | Completed |
| Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy for Postmenopausal Estrogen Receptor-positive Breast Cancer: a Prospective Randomized Controlled Double-blind Phase IV Trial [NCT04137640] | Phase 4 | 152 participants (Anticipated) | Interventional | 2021-07-19 | Not yet recruiting |
| Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma [NCT00712582] | Phase 2 | 96 participants (Actual) | Interventional | 2008-07-01 | Completed |
| Phase II Study of Dose-Adjusted EPOCH+/-Rituximab in Adults With Untreated Burkitt Lymphoma, c-MYC Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma [NCT01092182] | Phase 2 | 194 participants (Actual) | Interventional | 2010-03-25 | Completed |
| The Effect of Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab Combined With Pertuzumab: A Single-center Phase II Clinical Study [NCT04255056] | Phase 2 | 27 participants (Anticipated) | Interventional | 2020-02-01 | Not yet recruiting |
| Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Stud [NCT02807103] | Phase 3 | 107 participants (Actual) | Interventional | 2016-12-05 | Completed |
| Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas [NCT02784015] | Phase 2 | 41 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting |
| A Randomised Pilot Study of Neoadjuvant Everolimus Plus Letrozole Compared With FEC in Postmenopausal Patients With ER-positive, HER2-negative Breast Cancer [NCT02742051] | Phase 2 | 40 participants (Actual) | Interventional | 2016-06-30 | Completed |
| A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer [NCT05451849] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2022-06-21 | Active, not recruiting |
| Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial [NCT04664972] | Phase 2 | 212 participants (Actual) | Interventional | 2018-11-23 | Completed |
| A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese P [NCT04024462] | Phase 3 | 200 participants (Actual) | Interventional | 2020-02-05 | Active, not recruiting |
| Phase I Study of Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children With Relapsed and Refractory Solid Tumors and Leukemias [NCT02512926] | Phase 1 | 4 participants (Actual) | Interventional | 2016-02-16 | Active, not recruiting |
| A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma [NCT00743509] | Phase 2 | 49 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis [NCT04424602] | Phase 4 | 40 participants (Actual) | Interventional | 2021-04-05 | Completed |
| A Phase I/II Trial in Patients With Metastatic Gastrointestinal Epithelial Cancer Administering Tumor-Infiltrating Lymphocytes in Which the Gene Encoding CISH Was Inactivated Using the CRISPR/Cas9 System [NCT04426669] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2020-05-15 | Recruiting |
| Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas [NCT00554164] | Phase 3 | 1,073 participants (Actual) | Interventional | 2007-11-30 | Completed |
| The METROPHOLYS Study Metronomic Cyclophosphamide vs Doxorubicin in Elderly Patients With Advanced Soft Tissue Sarcomas Randomized, Controlled Open Label Clinical Trial [NCT04656262] | Phase 3 | 132 participants (Anticipated) | Interventional | 2018-09-10 | Recruiting |
| Associations Between Genetic Polymorphisms of Drug Transporter Genes and Toxicity of Doxorubicin and Cyclophosphamide Chemotherapy in Breast Cancer Patients [NCT04654195] | | 100 participants (Anticipated) | Observational | 2020-12-01 | Recruiting |
| Phase I Clinical Trial Evaluating Safety of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL) [NCT04653493] | Phase 1 | 22 participants (Anticipated) | Interventional | 2021-08-31 | Not yet recruiting |
| A Randomized Study of Lamivudine Prophylaxis or Treatment Against Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen [NCT00201318] | Phase 2 | 50 participants | Interventional | 2001-09-30 | Completed |
| Phase 1/2 Dose Escalation Study of CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies [NCT05442515] | Phase 1/Phase 2 | 116 participants (Anticipated) | Interventional | 2022-12-28 | Recruiting |
| Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer [NCT00201708] | Phase 2 | 56 participants (Actual) | Interventional | 2004-10-31 | Completed |
| High-Dose Chemotherapy With Tandem Peripheral Blood Stem Cell (PBSC) Rescue for the Treatment of High-Risk Pediatric Solid Tumors. [NCT00179816] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 1999-04-30 | Recruiting |
| Allogeneic Stem Cell Transplantation From HLA/MLC Genotype Identical Donors for Patients With High Risk Sickle Cell Disease [NCT00186810] | Phase 2 | 15 participants (Actual) | Interventional | 1992-12-31 | Completed |
| A Randomized Phase III Study of the Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia [NCT00186966] | Phase 3 | 394 participants (Actual) | Interventional | 2002-03-31 | Completed |
| Phase I/Ib Study of Adoptive Cellular Therapy Using Autologous IL-21-Primed CD8+ Tumor Antigen-Specific T Cells in Combination With Utomilumab (PF-05082566) in Patients With Platinum Resistant Ovarian Cancer [NCT03318900] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2018-07-16 | Completed |
| A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer [NCT01622361] | Phase 3 | 290 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
| Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease. (BMTCTN1507) [NCT03263559] | Phase 2 | 80 participants (Anticipated) | Interventional | 2017-10-03 | Active, not recruiting |
| Treatment for Newly Diagnosed Patients With Stage III/IV Non-Hodgkin Lymphoma-Study XIII (A Therapeutic Pilot Study) [NCT00187122] | | 42 participants (Actual) | Interventional | 1993-03-31 | Completed |
| Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors [NCT00578266] | Phase 1 | 8 participants (Actual) | Interventional | 2007-02-28 | Completed |
| Small Noncleaved Cell (SNCC), Non-Hodgkin Lymphoma (NHL), Large Cell NHL (B-Cell) and B-Cell Acute Lymphoblastic Leukemia (B-ALL) Study II [NCT00187161] | Phase 2 | 68 participants (Actual) | Interventional | 1994-11-30 | Completed |
| A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia [NCT00337246] | Phase 2 | 56 participants (Anticipated) | Interventional | 2005-07-31 | Completed |
| [NCT00339118] | Phase 4 | 0 participants | Interventional | | Not yet recruiting |
| Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy [NCT00510367] | Early Phase 1 | 61 participants (Actual) | Interventional | 2001-08-07 | Completed |
| Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response [NCT00425516] | Phase 2 | 264 participants (Actual) | Interventional | 2007-01-31 | Completed |
| A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma [NCT00513955] | Phase 2 | 50 participants (Actual) | Interventional | 2006-06-30 | Completed |
| [NCT00186797] | | 28 participants | Interventional | 2002-12-31 | Completed |
| Large Cell Lymphoma, Pilot Study III [NCT00187070] | | 8 participants (Actual) | Interventional | 1997-12-31 | Completed |
| [NCT00189644] | Phase 3 | 0 participants | Interventional | | Active, not recruiting |
| CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura) [NCT00190229] | | 200 participants (Actual) | Interventional | 2002-09-30 | Completed |
| Phase II Trial of Reduced Intensity Conditioning Hematopoietic Stem Cell Transplantation for Primary Immune Deficiencies, Immune Dysregulatory Syndromes, and Inherited Bone Marrow Failure Syndromes Using Post-Transplant Cyclophosphamide [NCT04232085] | Phase 2 | 27 participants (Anticipated) | Interventional | 2020-02-12 | Recruiting |
| T Cell Receptor Alpha/Beta T Cell Depleted (α/β TCD) Hematopoietic Cell Transplantation in Patients With Fanconi Anemia (FA) [NCT03579875] | Phase 2 | 48 participants (Anticipated) | Interventional | 2018-11-13 | Recruiting |
| A Phase 2 Study of Pomalidomide as a Replacement for Lenalidomide for Multiple Myeloma Patients Relapsed or Refractory to a Lenalidomide-Containing Combination Regimen [NCT02188368] | Phase 2 | 45 participants (Actual) | Interventional | 2014-07-07 | Terminated(stopped due to Lack of enrollment) |
| Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases [NCT01962636] | | 200 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
| Low Dose Chemotherapy (Metronomic Therapy) Versus Best Supportive Care in Progressive and/or Refractory Pediatric Malignancies: a Double Blind Placebo Controlled Randomized Study [NCT01858571] | Phase 3 | 108 participants (Actual) | Interventional | 2013-10-31 | Completed |
| Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children [NCT01861561] | Phase 4 | 43 participants (Actual) | Interventional | 2013-05-31 | Terminated(stopped due to The duration of the study is longer than 5 years and we can not recruit the participants to the target number.) |
| A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease [NCT01862926] | Phase 2/Phase 3 | 104 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Phase II Study of Short High-dose CHOP Chemotherapy for Aggressive Non-Hodgkin's Lymphoma [NCT00192764] | Phase 2 | 45 participants | Interventional | 1996-12-31 | Completed |
| LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia [NCT00526409] | Phase 4 | 40 participants (Anticipated) | Interventional | 2005-06-30 | Completed |
| A Two-Cohort Randomized Phase 2 Trial of the IRX-2 Regimen in Women With Squamous Cervical Intraepithelial Neoplasia 3 (CIN 3) or Vulvar Intraepithelial Neoplasia 3 (VIN 3) [NCT03267680] | Phase 2 | 11 participants (Actual) | Interventional | 2017-11-08 | Active, not recruiting |
| Rituximab For Prevention Of Acute Graft-Versus-Host Disease (GVHD) After Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (HCT) [NCT01044745] | Phase 2 | 20 participants (Actual) | Interventional | 2009-12-10 | Terminated(stopped due to Study was closed to accrual for safety related to the frequency of BK infections.) |
| [NCT02937662] | Phase 2 | 60 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
| Busulfan Plus Cyclophosphamide vs Total Body Irradiation Plus Cyclophosphamide Conditioning Regimen for Standard-risk Acute Lymphocytic Leukemia Undergoing HLA-matched Allogeneic Hematopoietic Stem Cell Transplantation [NCT02670252] | Phase 3 | 550 participants (Actual) | Interventional | 2016-01-31 | Completed |
| The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia. [NCT02924753] | Phase 1 | 20 participants (Anticipated) | Interventional | 2016-07-18 | Recruiting |
| A Phase 1 Open-Label Dose-Escalation Study of the Safety of Adoptively Transferred Autologous CD8+ T Lymphocytes Targeting HPV-16 E6/E7, HPV-18 E6/E7 and Survivin in Patients With Relapsed or Refractory HPV-related Oropharyngeal Cancers [NCT05582590] | Phase 1 | 36 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
| [NCT00538395] | | 100 participants (Anticipated) | Interventional | 2007-09-30 | Active, not recruiting |
| International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia [NCT00550992] | | 445 participants (Anticipated) | Interventional | 2006-01-31 | Recruiting |
| Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration [NCT05296317] | | 100 participants (Anticipated) | Interventional | 2022-09-02 | Recruiting |
| A Phase Ⅱ Study to Evaluate Efficacy and Safety of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) [NCT04676997] | Phase 2 | 20 participants (Anticipated) | Interventional | 2020-05-20 | Recruiting |
| A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies [NCT00782379] | Phase 2 | 20 participants (Actual) | Interventional | 2008-10-31 | Completed |
| "High Dose Interleukin-2 (IL-2) Therapy In Lymphodepleted Primed Patients With Metastatic Melanoma" [NCT00085423] | Phase 2 | 20 participants (Actual) | Interventional | 2004-02-29 | Completed |
| Carfilzomib and Dexamethasone in Combination With Cyclophosphamide vs. Carfilzomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma: a Phase II Randomized Controlled Trial [NCT03336073] | Phase 2 | 199 participants (Actual) | Interventional | 2017-12-18 | Active, not recruiting |
| Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors [NCT02013336] | Phase 1 | 30 participants (Anticipated) | Interventional | 2013-12-31 | Recruiting |
| Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients [NCT05580887] | | 35 participants (Anticipated) | Observational | 2022-05-12 | Recruiting |
| Prospective, Sequential Multiple Assignment, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia [NCT01976182] | Phase 2 | 166 participants (Anticipated) | Interventional | 2013-11-26 | Recruiting |
| A Phase I/II Study of Fludarabine, Cyclophosphamide, Rituximab, and Vorinostat Followed by Rituximab and Vorinostat Maintenance Therapy in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) [NCT00918723] | Phase 1/Phase 2 | 40 participants (Actual) | Interventional | 2009-06-30 | Completed |
| Clinical Study on the Safety and Efficacy of Anti-PSMA CAR NK Cells in Metastatic Castration-resistant Prostate Cancer (mCRPC) [NCT03692663] | Early Phase 1 | 9 participants (Anticipated) | Interventional | 2018-12-01 | Recruiting |
| Phase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain Amyloidosis [NCT01072773] | Phase 2 | 2 participants (Actual) | Interventional | 2010-03-31 | Completed |
| A Multi-center Randomized Phase II Study of Doxorubicin Liposome Versus Epirubicin Plus Cyclophosphamide Combined With Trastuzumab and Pertuzumab(HP), Followed by Taxon Plus HP as Neoadjuvant Therapy for HER2-positive Early Breast Cancer [NCT04172259] | Phase 2 | 156 participants (Anticipated) | Interventional | 2019-01-10 | Active, not recruiting |
| Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT03488225] | Phase 2 | 4 participants (Actual) | Interventional | 2018-03-28 | Terminated(stopped due to the study was closed early due to competing trials) |
| AUTOLOGOUS BONE MARROW TRANSPLANTATION USING C-MYB (LR-3001) ANTISENSE OLIGODEOXYNUCLEOTIDE TREATED BONE MARROW IN CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC OR ACCELERATED PHASE [NCT00002592] | Phase 2 | 40 participants (Anticipated) | Interventional | 1993-06-30 | Completed |
| PHASE II TRIAL OF CHEMOTHERAPY PLUS RADIOTHERAPY FOR MANAGEMENT OF PRIMARY CENTRAL NERVOUS SYSTEM NON-HODGKIN'S LYMPHOMA (PCNSL) [NCT00002676] | Phase 2 | 36 participants (Actual) | Interventional | 1995-07-31 | Completed |
| PHASE III MULTICENTRE TRIAL OF TREATMENT OF NEUROBLASTOMA IN CHILDREN AND ADOLESCENTS [NCT00002802] | Phase 3 | 500 participants (Anticipated) | Interventional | 1990-07-31 | Completed |
| Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia [NCT00002838] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 1995-12-31 | Completed |
| MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood [NCT00002898] | Phase 3 | 400 participants (Anticipated) | Interventional | 1995-01-31 | Completed |
| Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease [NCT00003114] | Phase 2 | 5 participants (Actual) | Interventional | 1997-07-31 | Completed |
| Phase I/II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation Followed by Allogeneic T-cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Melanoma [NCT00003552] | Phase 1/Phase 2 | 0 participants | Interventional | 1999-01-31 | Terminated |
| High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria [NCT00004464] | Phase 2 | 69 participants (Actual) | Interventional | 1996-02-29 | Completed |
| Cyclophosphamide Plus Transplantation of Partially HLA-mismatched (Haploidentical), CD8+ T Cell-depleted Peripheral Blood Cells for Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, Lymphoma, or Myeloproliferative Disorders [NCT00356928] | Phase 1 | 14 participants (Actual) | Interventional | 2006-10-31 | Terminated(stopped due to Poor accrual) |
| Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas: A Multi-Centre Phase I and II Study [NCT00363090] | Phase 1/Phase 2 | 84 participants (Anticipated) | Interventional | 2006-09-30 | Recruiting |
| Clarithromycin Plus CTd (Cyclophosphamide,Thalidomide and Dexamethasone)Regimen for Patients With Newly Diagnosed Multiple Myeloma:a Phase 3 , Multicenter,Randomized, Open-Label Trial. [NCT02248428] | Phase 3 | 130 participants (Anticipated) | Interventional | 2012-04-30 | Recruiting |
| A Phase I Study To Determine the Feasibility of Using Autologous NY-ESO-1 Specific CD8+ T Cells For the Treatment of Patients With Advanced Myxoid/ Round Cell Liposarcoma and Synovial Sarcoma. [NCT01477021] | Phase 1 | 6 participants (Actual) | Interventional | 2012-01-31 | Completed |
| A Phase I Clinical Trial Assessing the Safety and Feasibility of Administration of pNGVL4a-CRT/E7(Detox) DNA Vaccine Using the Intramuscular TriGridTM Delivery System in Combination With Cyclophosphamide in HPV-16 Associated Head and Neck Cancer Patients [NCT01493154] | Phase 1 | 2 participants (Actual) | Interventional | 2012-04-30 | Terminated(stopped due to Study Funding Terminated) |
| [NCT02273583] | Phase 2 | 738 participants (Anticipated) | Interventional | 2006-05-31 | Recruiting |
| Randomized Phase II/III Study of Intensified Alkylating Agent Chemotherapy With Peripheral Blood Progenitor Cell Support in the Preoperative Chemotherapy of Breast Tumors That Are Deficient for Homologous Recombination. [NCT00448266] | Phase 2/Phase 3 | 12 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Activation of a similar multicenter study for same population) |
| Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H [NCT00458250] | Phase 1 | 10 participants (Anticipated) | Interventional | 2006-09-30 | Completed |
| ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia [NCT00430118] | Phase 3 | 4,559 participants (Actual) | Interventional | 2000-07-31 | Completed |
| Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Stud [NCT00006461] | Phase 3 | 82 participants (Actual) | Interventional | 2000-10-31 | Completed |
| A Pilot Study of Bevacizumab With Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Dose Dense Nanoparticle Albumin Bound Paclitaxel for the Treatment of Early Stage Breast Cancer [NCT00436709] | | 75 participants (Anticipated) | Interventional | 2006-07-31 | Active, not recruiting |
| Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma [NCT00438984] | Phase 1 | 11 participants (Actual) | Interventional | 2006-12-31 | Completed |
| A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942) [NCT00592111] | Phase 2 | 21 participants (Actual) | Interventional | 1996-03-31 | Completed |
| MUK Nine b: OPTIMUM. A Phase II Study Evaluating Optimised Combination of Biological Therapy in Newly Diagnosed High Risk Multiple Myeloma and Plasma Cell Leukaemia. [NCT03188172] | Phase 2 | 95 participants (Anticipated) | Interventional | 2017-09-28 | Active, not recruiting |
| A Phase 1 Dose Escalation Study of Reolysin, a Replication Competent Reovirus, in Pediatric Patients With Relapsed or Refractory Solid Tumors [NCT01240538] | Phase 1 | 26 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Dendritic Cell-based Immunotherapy Combined With Low-dose Cyclophosphamide in Patients With Malignant Mesothelioma [NCT01241682] | Phase 1 | 10 participants (Actual) | Interventional | 2009-10-31 | Completed |
| A Randomized Phase III Trial of Neoadjuvant Therapy for Patients With Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered With Weekly Paclitaxel Following A [NCT00486668] | Phase 3 | 529 participants (Actual) | Interventional | 2007-07-31 | Active, not recruiting |
| Infusion of Allogeneic, 3rd Party CD19-specific T Cells for Patients With Refractory CD19+ B-Lineage Lymphoid Malignancies [NCT02274506] | Phase 1 | 0 participants (Actual) | Interventional | 2014-10-20 | Withdrawn(stopped due to PI's response to ePAAC, has withdrawn the protocol acknowledging the PI's action.) |
| PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia [NCT00494897] | Phase 4 | 374 participants (Actual) | Interventional | 1996-06-30 | Completed |
| Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naive Pa [NCT00712881] | Phase 2 | 126 participants (Actual) | Interventional | 2008-10-13 | Completed |
| Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer [NCT00499733] | Early Phase 1 | 19 participants (Actual) | Interventional | 2007-06-30 | Terminated(stopped due to The study was terminated per PI decision.) |
| Phase I/II Randomized Trial of Cord Blood-derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma [NCT06066359] | Phase 1/Phase 2 | 44 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
| A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation With JSP191-Based Conditioning in Participants With GATA2 Deficiency [NCT05907746] | Phase 2 | 32 participants (Anticipated) | Interventional | 2023-11-29 | Recruiting |
| A Phase Ib Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Patients With Untreated BCL-2 Immunohistochemistry (IHC) [NCT04790903] | Phase 1 | 50 participants (Anticipated) | Interventional | 2021-07-02 | Active, not recruiting |
| Treatment of Patients With Advanced Breast Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Breast Cancer Trial [NCT02965950] | Phase 2 | 190 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
| Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases [NCT04083183] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2020-06-16 | Recruiting |
| A Phase I Trial of Lymphodepletion Plus Adoptive Cell Therapy With High-Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma [NCT04052334] | Phase 1 | 10 participants (Actual) | Interventional | 2019-09-27 | Active, not recruiting |
| A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement [NCT02828358] | Phase 2 | 78 participants (Actual) | Interventional | 2017-04-01 | Active, not recruiting |
| Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation [NCT00055653] | Phase 2 | 0 participants | Interventional | 2003-01-31 | Completed |
| LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive [NCT00526305] | Phase 4 | 100 participants (Anticipated) | Interventional | 2000-01-31 | Completed |
| A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer [NCT00525642] | Phase 2/Phase 3 | 603 participants (Actual) | Interventional | 2003-06-30 | Active, not recruiting |
| Marched Pair Study of the Standard Chemotherapy 4doxorubicin Plus Cyclophosphamide(AC) 60 + 4 Docetaxel Protocol Versus 4 PLD C35+4 Docetaxel in Neoadjuvant Chemotherapy of Breast Cancer [NCT02953184] | Phase 2 | 160 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
| A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma [NCT00513188] | | 0 participants (Actual) | Interventional | 2007-02-28 | Withdrawn |
| Adjuvant Cytotoxic Chemotherapy In Older Women [NCT00516425] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 2007-01-31 | Recruiting |
| LAL-BR/2001: Study Treatment to Low Risk ALL [NCT00526175] | Phase 4 | 150 participants (Anticipated) | Interventional | 2001-06-30 | Completed |
| T Cell Therapy for Patients With Metastatic Renal Cell Carcinoma [NCT02926053] | Phase 1 | 6 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
| A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients With Newly Diagnosed AL Amyloid [NCT06022939] | Phase 3 | 338 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| A Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias [NCT04623944] | Phase 1 | 90 participants (Anticipated) | Interventional | 2020-09-21 | Recruiting |
| Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed MYC/BCL2 Double-Expressor DLBCL [NCT04231448] | Phase 3 | 423 participants (Actual) | Interventional | 2020-05-21 | Active, not recruiting |
| Phenotypic Personalized Medicine: Systematically Optimized Combination Therapy in Multiple Myeloma Using CURATE.AI [NCT03759093] | Phase 2/Phase 3 | 20 participants (Anticipated) | Interventional | 2023-09-10 | Recruiting |
| Nivolumab With Standard of Care Chemotherapy for the First Line Treatment of Peripheral T Cell Lymphoma [NCT03586999] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2018-11-07 | Active, not recruiting |
| A Pilot Study of a GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With a PD-1 Blockade Antibody (Pembrolizumab) and a Macrophage Targeting Agent (CSF1R Inhibitor) for the Treatment of Patients With Borderline Resectable Adenocarcinoma of the [NCT03153410] | Early Phase 1 | 12 participants (Anticipated) | Interventional | 2018-09-27 | Active, not recruiting |
| Modified BFM (Berlin-Frankfurt-Munster)Backbone Therapy for Chinese Children or Adolescents With Newly Diagnosed Lymphoblastic Lymphoma [NCT02845882] | Phase 3 | 150 participants (Anticipated) | Interventional | 2016-01-31 | Active, not recruiting |
| A Phase I Clinical Trial of Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors [NCT02498912] | Phase 1 | 18 participants (Actual) | Interventional | 2015-08-31 | Active, not recruiting |
| A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma [NCT02348216] | Phase 1/Phase 2 | 307 participants (Actual) | Interventional | 2015-04-21 | Completed |
| A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193] | Phase 3 | 218 participants (Actual) | Interventional | 2008-01-15 | Active, not recruiting |
| Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer [NCT02909751] | Phase 2 | 80 participants (Actual) | Interventional | 2016-09-14 | Completed |
| The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial [NCT02936375] | Phase 2 | 120 participants (Anticipated) | Interventional | 2017-09-07 | Recruiting |
| Autologous T Cells With a Chimeric Antigen Receptor in Patients With CD19-positive Malignant B Cell Leukemia and Lymphoma [NCT02933775] | Phase 1 | 45 participants (Anticipated) | Interventional | 2016-10-31 | Not yet recruiting |
| Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somat [NCT01283386] | Phase 4 | 26 participants (Actual) | Interventional | 2011-04-27 | Terminated |
| P-Gemoxd Regimen Followed by Radiotherapy Versus P-CHOP Regimen Followed by Radiotherapy in ENKTL With Early Stage: a Randomized, Multicenter, Open-label, Phase 2 Study [NCT02918747] | Phase 2 | 100 participants (Actual) | Interventional | 2016-09-30 | Active, not recruiting |
| Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe) [NCT04942730] | Phase 2 | 40 participants (Anticipated) | Interventional | 2021-01-21 | Recruiting |
| A Phase II Trial of HSCT for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine [NCT02143830] | Phase 2 | 70 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting |
| A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma [NCT01313884] | Phase 2 | 3 participants (Actual) | Interventional | 2011-05-31 | Terminated(stopped due to Study did not reach primary objective; study did not accrue enough patients.) |
| Graft-versus-host Disease Prophylaxis With Combination of Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies (PTBCy) [NCT04943757] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-01-21 | Recruiting |
| A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies [NCT02623439] | Phase 2 | 20 participants (Anticipated) | Interventional | 2012-07-31 | Suspended(stopped due to On hold for toxicitiy) |
| Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies [NCT02581007] | Phase 2 | 25 participants (Actual) | Interventional | 2015-10-26 | Completed |
| LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma [NCT04043494] | Phase 3 | 683 participants (Anticipated) | Interventional | 2019-08-23 | Recruiting |
| Phase I Trial of Oral Cyclophosphamide in Combination With Celecoxib in Patients With Advanced Malignancies [NCT00551889] | Phase 1 | 57 participants (Actual) | Interventional | 2001-09-30 | Completed |
| A Randomized Pilot Trial of Consolidation With an Adjuvant Ovarian Cancer Vaccine Oregovomab (Ovarex ®) With/Without Single-Dose Cyclophosphamide After a Complete Clinical Response to Second-Line Taxane/Platinum-Based Therapy to Determine Immune Response [NCT00551265] | | 0 participants (Actual) | Interventional | 2007-10-31 | Withdrawn |
| Ma-Spore ALL 2010 Study [NCT02894645] | Phase 4 | 500 participants (Anticipated) | Interventional | 2008-10-31 | Recruiting |
| A Phase 2 Trial of Cryosurgical Freezing and Intratumoral Combination Immunotherapy in Men With Metastatic Prostatic Adenocarcinoma [NCT04090775] | Phase 2 | 12 participants (Actual) | Interventional | 2019-06-28 | Completed |
| A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma [NCT02529852] | Phase 1/Phase 2 | 59 participants (Actual) | Interventional | 2015-11-04 | Completed |
| Study to Evaluate the Efficacy and Safety of Relmacabtagene Autoleucel (Relma-cel) as First-Line Therapy in Adult Participants With High-Risk Large B-Cell Lymphoma [NCT05590221] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-01-03 | Recruiting |
| A Multi-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 With Immunotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin. [NCT04673617] | Phase 1/Phase 2 | 108 participants (Anticipated) | Interventional | 2021-03-29 | Recruiting |
| Phase I/II Study De-intensifying Exposure of Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HLA-haploidentical Hematopoietic Cell Transplantation for Hematologic Malignancies [NCT03983850] | Phase 1/Phase 2 | 400 participants (Anticipated) | Interventional | 2019-07-09 | Recruiting |
| Engaging the Immune System to Improve the Efficacy of Neoadjuvant Chemo-endocrine Therapy for Premenopausal Luminal B Breast Cancer Patients [NCT04659551] | Phase 2 | 43 participants (Actual) | Interventional | 2017-10-05 | Completed |
| A Phase 2 Study to Investigate the Safety, Tolerability and Anti-tumor Activity of Golidocitinib in Combination With CHOP as the Front-line Treatment for Participants With Peripheral T-cell Lymphomas (PTCL) [NCT05963347] | Phase 2 | 45 participants (Anticipated) | Interventional | 2023-08-03 | Recruiting |
| Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3) [NCT00144807] | Phase 2 | 128 participants (Actual) | Interventional | 2003-12-31 | Completed |
| Phase 2 Study of Personalized r-ATG Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT (PRAISE-IR) [NCT04872595] | Phase 2 | 56 participants (Anticipated) | Interventional | 2021-04-30 | Recruiting |
| Clinical Trial Evaluating the Safety and Activity of Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer [NCT04146298] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2021-10-21 | Recruiting |
| A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients [NCT03745326] | Phase 1/Phase 2 | 70 participants (Anticipated) | Interventional | 2019-05-16 | Recruiting |
| A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients [NCT03190941] | Phase 1/Phase 2 | 110 participants (Anticipated) | Interventional | 2017-09-21 | Recruiting |
| Phase I/II Study of Autologous Tumor Cell Vaccination Using Metronomic Cyclophosphamide, 3-Dimensional Conformal Radiotherapy, Intra/Peri-Tumor Injection of Poly ICLC With Trans-Hepatic Arterial Embolization Followed by Poly ICLC Boosting in Patients With [NCT00553683] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2007-10-31 | Active, not recruiting |
| Study of GSK2302024A Antigen-Specific Cancer Immunotherapeutic Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer [NCT01220128] | Phase 2 | 66 participants (Actual) | Interventional | 2011-04-11 | Terminated(stopped due to Study termination due to negative Ph III of another study product from same technology platform.) |
| A Multicenter, Phase III, Randomized Study to Evaluate the Efficacy of Response-adapted Strategy to Define Maintenance After Standard Chemoimmunotherapy in Patients With Advanced-stage Follicular Lymphoma. [NCT02063685] | Phase 3 | 807 participants (Actual) | Interventional | 2012-07-31 | Completed |
| Phase I Study of Cellular Immunotherapy Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Children With Recurrent/Refractory Malignant Brai [NCT04510051] | Phase 1 | 18 participants (Anticipated) | Interventional | 2020-12-04 | Recruiting |
| A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubici [NCT03467373] | Phase 1 | 172 participants (Anticipated) | Interventional | 2018-03-13 | Active, not recruiting |
| Cord Blood Ex-Vivo MSC Expansion Plus Fucosylation to Enhance Homing and Engraftment [NCT03096782] | Phase 2 | 6 participants (Actual) | Interventional | 2017-10-13 | Completed |
| Reduced Intensity Conditioning (RIC) and Transplantation of HLA(Human Leukocyte Antigen)-Haploidentical Related Bone Marrow (Haplo-BM) For Patients With Hematologic Diseases [NCT02145039] | | 2 participants (Actual) | Interventional | 2014-10-31 | Terminated(stopped due to Replaced by another study.) |
| Pre-administration of Rabbit Antithymocyte Globulin to Optimize Donor T-Cell Engraftment Following Reduced Intensity Allogeneic Peripheral Blood Progenitor Cell Transplantation From Matched-Related Donors [NCT00787761] | Phase 2 | 24 participants (Actual) | Interventional | 2007-04-30 | Completed |
| A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia [NCT01677949] | Phase 2 | 0 participants (Actual) | Interventional | 2013-12-31 | Withdrawn(stopped due to Slow accrual) |
| Phase I/II Study of Adoptive T Cell Therapy Following In Vivo Priming With a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine in Patients With Advanced Stage HER2 Overexpressing Breast Cancer [NCT00791037] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study [NCT05287308] | | 500 participants (Anticipated) | Interventional | 2022-03-31 | Not yet recruiting |
| Reduced Intensity Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies [NCT00818961] | Phase 2 | 36 participants (Actual) | Interventional | 2005-05-31 | Terminated(stopped due to terminated early due to meeting end point with fewer patients than anticipated) |
| A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in Combination With Low Dose Cyclophosphamide and Pembrolizumab, in Subjects With Selected Advanced and Recurrent Solid Tumours. [NCT03836352] | Phase 2 | 184 participants (Anticipated) | Interventional | 2018-12-21 | Active, not recruiting |
| RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE) [NCT02643420] | Phase 3 | 406 participants (Actual) | Interventional | 2016-01-19 | Completed |
| A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC [NCT00981799] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2010-06-30 | Terminated(stopped due to Slow accrual rate) |
| Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak) for In-vivo Purging and Post-Transplant Therapy: A Multicenter Phase II Clinical Trial [NCT00632827] | Phase 2 | 21 participants (Actual) | Interventional | 2008-07-01 | Terminated(stopped due to Manufacturing shortage of both Diftitox and Doxil) |
| A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germi [NCT01040871] | Phase 2 | 164 participants (Actual) | Interventional | 2010-01-31 | Completed |
| A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma [NCT03093168] | Phase 1 | 10 participants (Anticipated) | Interventional | 2017-02-15 | Recruiting |
| A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL) [NCT05006664] | Phase 2 | 33 participants (Anticipated) | Interventional | 2021-10-31 | Not yet recruiting |
| A Phase 2 Study of Acalabrutinib in Combination With Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas [NCT05583149] | Phase 2 | 27 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting |
| Nonmyeloablative BMT With Post-transplant Cyclophosphamide, Rituximab and Optimized Donor Selection for B-cell Lymphomas [NCT00946023] | Phase 2 | 135 participants (Actual) | Interventional | 2009-07-31 | Terminated(stopped due to Funding was unavailable to complete the study as originally planned.) |
| A Multi-national, Double-blind, Placebo-controlled, Randomized, Phase III Clinical Trial of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Asian Subjects With Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) Who Have Demons [NCT01015443] | Phase 3 | 285 participants (Actual) | Interventional | 2009-12-31 | Terminated(stopped due to The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.) |
| LCI-BRE-MTN-NIR-001: A Phase I Study of Niraparib in Combination With Standard Chemotherapy in Metastatic Triple-Negative Breast Cancer [NCT04762901] | Phase 1 | 0 participants (Actual) | Interventional | 2021-04-01 | Withdrawn(stopped due to Funding was terminated.) |
| Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma [NCT01004991] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Phase I Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ NYESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 for Patients With Sarcoma [NCT03450122] | Phase 1 | 15 participants (Actual) | Interventional | 2018-09-13 | Completed |
| MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial [NCT00577122] | Phase 2 | 30 participants (Actual) | Interventional | 2007-07-31 | Completed |
| A Randomized Trial of Antithymocyte Globulin and Cyclosporine Versus Cyclophosphamide and Cyclosporine in the Treatment of Severe Aplastic Anemia [NCT00001626] | Phase 2 | 33 participants (Actual) | Interventional | 1997-06-02 | Completed |
| Phase II Study of Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, and Ifosfamide, Followed by Resection and Radiotherapy in Patients With Peripheral Primitive Neuroectodermal Tumors or Ewing's Sarcoma [NCT00002466] | Phase 2 | 0 participants | Interventional | 1990-05-31 | Completed |
| BUSULFAN AND CYCLOPHOSPHAMIDE FOR CYTOREDUCTION OF PATIENTS WITH ACUTE AND CHRONIC LEUKEMIAS AND MYELODYSPLASTIC SYNDROMES UNDERGOING ALLOGENEIC BONE MARROW TRANSPLANTATION WHO CANNOT BE TREATED WITH TOTAL BODY IRRADIATION [NCT00002502] | Phase 2 | 0 participants | Interventional | 1992-07-31 | Completed |
| The Treatment of Multiple Myeloma Utilizing VBMCP Chemotherapy Alternating With High-Dose Cyclophosphamide and Alpha2b-Interferon Versus VBMCP: A Phase III Study for Previously Untreated Multiple Myeloma [NCT00002556] | Phase 3 | 312 participants (Actual) | Interventional | 1994-07-31 | Completed |
| PROTOCOL FOR THE SCOTTISH PREMENOPAUSAL CHEMO-ENDOCRINE TRIAL [NCT00002580] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 1993-06-30 | Completed |
| A Pilot Study to Evaluate The Effects of Neoadjuvant AZD2171, a VEGF Receptor Tyrosine Kinase Inhibitor With Docetaxel, Doxorubicin, and Cyclophosphamide Chemotherapy in Previously Untreated Locally Advanced Breast Cancer [NCT00310089] | | 33 participants (Anticipated) | Interventional | 2006-01-31 | Completed |
| A PHASE II STUDY OF MITOXANTRONE AND HIGH-DOSE ARA-C FOLLOWED BY INTENSIVE CONSOLIDATION WITH CYCLOPHOSPHAMIDE AND ETOPOSIDE FOR MYELOID BLAST CRISIS OF CHRONIC MYELOGENOUS LEUKEMIA (CML) [NCT00002598] | Phase 2 | 30 participants (Anticipated) | Interventional | 1994-06-30 | Completed |
| National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study [NCT00002610] | Phase 3 | 203 participants (Actual) | Interventional | 1996-01-31 | Completed |
| A PILOT TRIAL OF INTERLEUKIN-2 WITH G-CSF AS PRIMING THERAPY FOR PERIPHERAL BLOOD STEM CELL HARVESTING IN PATIENTS WITH ADVANCED BREAST CANCER: STAMP V HIGH DOSE CHEMOTHERAPY, STEM CELL INFUSION AND POST-INFUSION G-CSF AND INTERLEUKIN-2 [NCT00002616] | Phase 1 | 36 participants (Anticipated) | Interventional | 1995-02-28 | Active, not recruiting |
| N7: EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA [NCT00002634] | Phase 2 | 45 participants (Anticipated) | Interventional | 1995-02-28 | Completed |
| ACUTE MYELOID LEUKAEMIA TRIAL 12 [NCT00002658] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 1994-01-31 | Active, not recruiting |
| A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4) [NCT00002700] | Phase 3 | 392 participants (Anticipated) | Interventional | 1995-08-31 | Completed |
| A Phase II Trial of T-Cell Depleted Marrow Grafts Combined With Infusions of G-CSF Stimulated, CD34 Ceprate Stem Cell Column Selected, E-Rosette Depleted Peripheral Blood Progenitor Cells Derived From HLA Haplotype Matched Related Donors for Patients With [NCT00002718] | Phase 2 | 31 participants (Actual) | Interventional | 1995-11-30 | Completed |
| A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin Plus Paclitaxel Plus Cyclophosphamide With High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women With 4-9 Involved Axillary Lymph [NCT00002772] | Phase 3 | 602 participants (Actual) | Interventional | 1996-07-31 | Terminated(stopped due to poor accrual) |
| Randomized Trial of High-dose Epirubicin and Cyclophosphamide x 3 Supported by Peripheral Blood Progenitor Cells Versus Anthracycline and Cyclophosphamide x 4 Followed by Cyclophosphamide, Methotrexate, and 5-fluorouracil x 3 as Adjuvant Treatment for Hig [NCT00002784] | Phase 3 | 344 participants (Actual) | Interventional | 1996-06-30 | Completed |
| PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO THE HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH BREAST CANCER [NCT00002628] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 1994-11-30 | Active, not recruiting |
| Bone Marrow Transplantation for Chronic Lymphocytic Leukemia [NCT00002844] | Phase 2 | 49 participants (Actual) | Interventional | 1991-03-05 | Completed |
| A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer [NCT00003012] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 1996-10-31 | Completed |
| Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma [NCT00003060] | Phase 1 | 6 participants (Anticipated) | Interventional | 1995-03-31 | Terminated(stopped due to lack of patient accrual) |
| Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients With Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma [NCT00003150] | Phase 3 | 630 participants (Anticipated) | Interventional | 1997-12-31 | Completed |
| Randomized Phase III Study in Low Grade Lymphoma Comparing Maintenance Anti-CD20 Antibody Versus Observation Following Induction Therapy [NCT00003204] | Phase 3 | 515 participants (Actual) | Interventional | 1998-03-31 | Completed |
| A Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors [NCT00003288] | Phase 1 | 12 participants (Actual) | Interventional | 1998-08-31 | Completed |
| Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse [NCT00003396] | Phase 2 | 42 participants (Anticipated) | Interventional | 1998-09-30 | Completed |
| Autologous Transplantation With and High Dose BCNU and Melphalan Followed by Consolidation With DCEP Plus Taxol/Cisplatin in Patients With Poor Prognosis Low Grade Non-Hodgkin's Lymphoma and Chronic Lymphocyte Leukemia, Who Have Received < or = 12 Months [NCT00003402] | Phase 2 | 35 participants (Anticipated) | Interventional | 1999-01-31 | Completed |
| Randomized Trial of Autologous GVHD for Refractory Lymphoma [NCT00003414] | Phase 3 | 50 participants (Anticipated) | Interventional | 1997-10-31 | Completed |
| Phase III Randomized Study of Cisplatin and Etoposide With or Without Epirubicin and Cyclophosphamide for Extensive Stage Small Cell Lung Cancer [NCT00003606] | Phase 3 | 216 participants (Anticipated) | Interventional | 1996-03-31 | Completed |
| Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer [NCT00003696] | Phase 3 | 250 participants (Anticipated) | Interventional | 1998-10-31 | Active, not recruiting |
| Treatment of High Risk Central Nervous System Embryonal Tumors With Conventional Radiotherapy and Intensive Consolidation Chemotherapy With Peripheral Blood Progenitor Cell (PBSC) Support [NCT00003846] | Phase 2 | 25 participants (Actual) | Interventional | 1999-07-31 | Completed |
| Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors [NCT00003852] | Phase 2 | 45 participants (Anticipated) | Interventional | 1998-03-31 | Terminated(stopped due to lack of patient inclusion) |
| Radiolabeled BC8 (Anti-CD45) Antibody Combined With Cyclophosphamide and Total Body Irradiation Followed by HLA-matched Related or Unrelated Stem Cell Transplantation as Treatment for Advanced Acute Lymphocytic Leukemia [NCT00003870] | Phase 2 | 40 participants (Anticipated) | Interventional | 1999-02-28 | Completed |
| Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies [NCT00003960] | Phase 2 | 36 participants (Anticipated) | Interventional | 1998-04-30 | Completed |
| A Phase III Study of High-Dose Chemotherapy Using Busulfan, Melphalan and Thiotepa Versus Cyclophosphamide,Thiotepa, Carboplatin Followed by Autologous Stem Cell Transplantation in Patients With High-Risk Primary Stage II or III (Non-Inflammatory) Breast [NCT00003972] | Phase 3 | 280 participants (Anticipated) | Interventional | 1998-07-31 | Completed |
| The Value of High Dose Versus Standard Dose ARA-C During Induction and of IL-2 After Intensive Consolidation/Autologous Stem Cell Transplantation in Patients (Age 15-60 Years) With Acute Myelogenous Leukemia. A Randomized Phase II Trial of the EORTC and t [NCT00004128] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 1999-09-30 | Active, not recruiting |
| A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma [NCT00004188] | Phase 3 | 495 participants (Actual) | Interventional | 2001-02-28 | Completed |
| Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide [NCT00004218] | Phase 3 | 0 participants | Interventional | 1999-10-31 | Completed |
| SIOP Study of Combined Modality Treatment in Childhood Ependymoma [NCT00004224] | Phase 2 | 65 participants (Anticipated) | Interventional | 1999-01-31 | Completed |
| Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors [NCT00005622] | Phase 2 | 72 participants (Actual) | Interventional | 1996-05-31 | Completed |
| Mechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association Studies [NCT01799460] | | 80 participants (Anticipated) | Observational | 2010-12-31 | Recruiting |
| Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status [NCT01271010] | Phase 4 | 89 participants (Actual) | Interventional | 2011-06-17 | Terminated |
| A Single-Arm Phase I/II Study Evaluating the Safety and Clinical Efficacy Of the 2-nd Generation CD19 Autologous CAR T Cells on the CliniMACS Prodigy Automated Manufacturing Platform in Treatment of Paediatric And Young Adult Patients With Relapsed/Refrac [NCT03467256] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2018-05-14 | Active, not recruiting |
| High-Dose Therapy and Autologous Stem Cell Transplantation During Remission in Poor-Risk Age-Adjusted International Prognostic Index High and High-Intermediate Risk Group Patients With Intermediate Grade and High-Grade Non-Hodgkin's Lymphoma Including Man [NCT00559104] | Phase 2 | 60 participants (Actual) | Interventional | 1998-10-31 | Completed |
| Haploidentical Stem Cell Transplant Using Post Transplant Cyclophosphamide for GvHD Prophylaxis: A Pilot Study [NCT02248597] | Phase 2 | 27 participants (Actual) | Interventional | 2015-02-25 | Completed |
| Phase 2 Study of Alisertib as a Single Agent in Recurrent or Progressive Central Nervous System (CNS) Atypical Teratoid Rhabdoid Tumors (AT/RT) and Extra-CNS Malignant Rhabdoid Tumors (MRT) and in Combination Therapy in Newly Diagnosed AT/RT [NCT02114229] | Phase 2 | 125 participants (Actual) | Interventional | 2014-05-14 | Active, not recruiting |
| Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor [NCT00085202] | Phase 3 | 416 participants (Actual) | Interventional | 2003-08-31 | Active, not recruiting |
| An Open-Label Phase II Study of the Safety and Efficacy of Doxorubicin and Cyclophosphamide in Combination With Bortezomib, Lenalidomide, and Dexamethasone for Treatment of Patients With Newly Diagnosed Multiple Myeloma [NCT01481194] | Phase 2 | 35 participants (Actual) | Interventional | 2011-11-30 | Completed |
| A Phase I Study of Infusion of HER-2/Neu Specific T Cells in Patients With Advanced Stage HER-2/Neu Expressing Cancers Who Have Received a HER-2/Neu Vaccine [NCT00228358] | Phase 1 | 8 participants (Actual) | Interventional | 2003-06-30 | Completed |
| Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors [NCT00066482] | | 19 participants (Actual) | Interventional | 2004-07-31 | Completed |
| Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma [NCT00245089] | Phase 2 | 41 participants (Anticipated) | Interventional | 2004-05-31 | Recruiting |
| Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies [NCT00246103] | Phase 1 | 82 participants (Actual) | Interventional | 2004-03-31 | Completed |
| A Pilot Study of Using Filgrastim-Primed Bone Marrow in Human Leukocyte Antigen (HLA) Matched Related Donor Allogenetic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies [NCT00253552] | | 4 participants (Actual) | Interventional | 2004-05-31 | Terminated(stopped due to Terminated at request of PI as study was outdated.) |
| A Comparative Study for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers [NCT00262210] | Phase 2 | 50 participants | Interventional | 1995-06-30 | Completed |
| Management of Children Aged Less Than 3 Years With Brain Tumors [NCT00281905] | Phase 2 | 50 participants (Anticipated) | Interventional | 1992-06-30 | Active, not recruiting |
| Protocol for Infants With Neuroblastoma Diagnosed Under the Age of One Year [NCT00287950] | | 120 participants (Anticipated) | Interventional | 1992-09-30 | Active, not recruiting |
| A Cyclophosphamide/Fludarabine/Total Body Irradiation Preparative Regimen for Patients With Hematological Malignancy Receiving Unrelated Donor Umbilical Cord Blood Transplantation [NCT00290641] | | 68 participants (Actual) | Interventional | 2001-04-30 | Completed |
| Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia [NCT00130195] | Phase 2 | 100 participants (Actual) | Interventional | 2002-09-30 | Completed |
| Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL) [NCT00201721] | Phase 2 | 28 participants (Actual) | Interventional | 2002-07-31 | Completed |
| Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis [NCT00307645] | Phase 3 | 160 participants | Interventional | 2003-05-31 | Terminated |
| A Phase Ib/2 Trial of Fludarabine/Melphalan/Total Body Irradiation With Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched-Related and Matched-Unrelated Allogeneic Hematopoietic Cell Transplantation [NCT03192397] | Phase 1/Phase 2 | 35 participants (Actual) | Interventional | 2017-08-09 | Active, not recruiting |
| UARK 98-018, A Randomized Phase II Trial of DCEP or DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse in Patients With Multiple Myeloma [NCT00083681] | Phase 2 | 180 participants | Interventional | 1998-06-30 | Completed |
| Pyrotinib as Neoadjuvant Agent for Non-objective Response Patients of HER2-positive Early Breast Cancer Treated by Trastuzumab, Pertuzumab, and Chemotherapy (PYHOPE-BC-104): a Randomized, Controlled, Phase Ⅱ Trial [NCT04717531] | Phase 2 | 60 participants (Anticipated) | Interventional | 2021-06-03 | Recruiting |
| A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas [NCT00323323] | Phase 1 | 24 participants (Actual) | Interventional | 2004-03-31 | Completed |
| Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Anti Cluster of Differentiation Antigen 19 (Anti-CD19) Chimeric Antigen Receptor T (CAR T) Cell Therapy With Kymriah/tIsagenlecleucel (LOKI) [NCT06003179] | Phase 1 | 40 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| A Phase I/IIa Multicenter Study Evaluating the Safety and Efficacy of CAR20(NAP)-T in Patients With Relapsed/Refractory B Cell Lymphoma (CARMA-01 Study) [NCT06002659] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| A Phase II Study of Reduced Dose Post Transplantation Cyclophosphamide as GvHD Prophylaxis in Adult Patients With Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation [NCT06001385] | Phase 2 | 170 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
| A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission. [NCT05990985] | | 20 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
| A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers [NCT05035407] | Phase 1 | 100 participants (Anticipated) | Interventional | 2022-03-08 | Recruiting |
| Haploidentical Donor Hematopoietic Cell Transplantation for Patients With Severe Aplastic Anemia [NCT04558736] | Phase 2 | 21 participants (Anticipated) | Interventional | 2021-01-21 | Active, not recruiting |
| Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With CD123 Target Module (TM123) for the Treatment of Patients With Hematologic and Lymphati [NCT04230265] | Phase 1 | 90 participants (Anticipated) | Interventional | 2020-01-28 | Recruiting |
| A Phase 1 Open-Label, Multi-Center Study of PSMA Targeted Genetically Modified Chimeric Antigen Receptor T Cells in Patients With Metastatic Castration Resistant Prostate Cancer [NCT04227275] | Phase 1 | 16 participants (Actual) | Interventional | 2019-11-22 | Terminated(stopped due to Based on the safety events and evidence of biologic activity without sustained clinical responses the Sponsor finds the risk/benefit analysis unfavorable for patients and has terminated the study.) |
| A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation [NCT04177004] | Phase 1 | 36 participants (Anticipated) | Interventional | 2021-04-30 | Recruiting |
| A Phase II Study of Nivolumab in Combination With Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma [NCT04119336] | Phase 2 | 2 participants (Actual) | Interventional | 2020-02-14 | Terminated(stopped due to Study closure initiated by industry funding sponsor for commercial reasons.) |
| Phase I/II Study of Dual CD19-CD22 Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced CD19+ CD22+ Lymphoid Malignancies [NCT04029038] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2019-05-15 | Withdrawn(stopped due to 0 participant accrual) |
| Phase 1 Study of Lentivirally Transduced T Cells Engineered to Contain Anti-CD123 Linked to TCRζ and 4-1BB Signaling Domains in Subjects With Refractory or Relapsed Acute Myeloid Leukemia [NCT03766126] | Phase 1 | 12 participants (Anticipated) | Interventional | 2018-12-06 | Active, not recruiting |
| A Pilot Study of Reduced Intensity HLA-Haploidentical Hematopoietic Cell Transplantation With Post-Transplant Cyclophosphamide in Patients With Advanced Myelofibrosis [NCT03118492] | Phase 1 | 16 participants (Anticipated) | Interventional | 2017-05-24 | Recruiting |
| Allogeneic Hematopoietic Stem Cell Transplant for Patients With Mutations in GATA2 or the MonoMAC Syndrome [NCT01861106] | Phase 2 | 144 participants (Anticipated) | Interventional | 2013-07-24 | Recruiting |
| UARK 2008-03 Phase II Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy (No Prior Transplant) [NCT00871013] | Phase 2 | 160 participants (Anticipated) | Interventional | 2009-03-31 | Active, not recruiting |
| Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia [NCT00039130] | Phase 2 | 105 participants (Actual) | Interventional | 2002-05-31 | Completed |
| A Study in Metastatic Melanoma Using a Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 TCR-Gene Engineered Lymphocytes and Subsequent Peptide Immunization [NCT00091104] | Phase 1 | 136 participants (Anticipated) | Interventional | 2004-07-31 | Completed |
| Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable and/or Locally Advanced Breast Cancer. The INTENS Study [NCT00314977] | Phase 3 | 200 participants (Anticipated) | Interventional | 2006-02-28 | Completed |
| Phase II Study in Metastatic Renal Cell Cancer Using Cultured, Tumor-Reactive Lymphocytes and Interleukin-2 [NCT00091611] | Phase 1 | 3 participants (Actual) | Interventional | 2004-09-30 | Terminated(stopped due to This study was terminated due to low accrual.) |
| A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy [NCT00317785] | Phase 2 | 50 participants (Anticipated) | Interventional | 2005-05-31 | Completed |
| The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells [NCT00084695] | Phase 2 | 25 participants (Anticipated) | Interventional | 2003-09-30 | Recruiting |
| Phase I Cinical Sudy of Lposomal Mitoxantrone Hydrochloride Combined With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Previously Untreated Peripheral T-cell Lymphoma [NCT05458180] | Phase 1 | 18 participants (Anticipated) | Interventional | 2022-07-07 | Not yet recruiting |
| Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide: A Phase I/IIA Study [NCT00094380] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2004-09-30 | Completed |
| A Phase I Study to Assess the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors [NCT05141474] | Early Phase 1 | 10 participants (Anticipated) | Interventional | 2021-10-28 | Recruiting |
| A Multicenter, Single Arm, Open Label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HRYZ-T101 Injection for HPV18 Positive Solid Tumor [NCT05952947] | Phase 1 | 32 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| Phase II, Randomized, Open-label, International, Multicenter Study to Compare Efficacy of Standard Chemotherapy vs. Letrozole Plus Abemaciclib as Neoadjuvant Therapy in HR-positive/HER2-negative High/Intermediate Risk Breast Cancer Patients [NCT04293393] | Phase 2 | 200 participants (Actual) | Interventional | 2020-10-02 | Active, not recruiting |
| A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Pati [NCT04285567] | Phase 3 | 166 participants (Actual) | Interventional | 2020-05-28 | Active, not recruiting |
| A Multicenter,Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH and R-CEOP90, With or Without Upfront Auto-HSCT，in Newly Diagnosed Young Patients With Intermediate/High-risk DLBCL [NCT03213977] | Phase 3 | 475 participants (Anticipated) | Interventional | 2017-02-01 | Recruiting |
| Phase I Study of Autologous Transgenic T-Cells Expressing High Affinity Mesothelin-Specific T-Cell Receptor (TCR) (FH-TCR Tᴍsʟɴ) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma [NCT04809766] | Phase 1 | 15 participants (Anticipated) | Interventional | 2021-12-14 | Recruiting |
| Hemophagocytic Lymphohistiocytosis [NCT00334672] | Phase 3 | 288 participants (Anticipated) | Interventional | 2006-03-31 | Active, not recruiting |
| UARK 2003-18, A Phase II Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant in Relapsed Multiple Myeloma [NCT00089453] | Phase 1 | 10 participants (Actual) | Interventional | 2003-09-30 | Completed |
| A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma [NCT00334867] | Phase 3 | 0 participants (Actual) | Interventional | 2005-12-31 | Withdrawn(stopped due to withdrawn) |
| A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer [NCT00089726] | Phase 2 | 100 participants | Interventional | 2003-03-31 | Completed |
| Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia [NCT00343369] | | 550 participants (Anticipated) | Interventional | 2003-01-31 | Recruiting |
| A Pilot Study to Evaluate the Co-infusion of Ex Vivo Expanded Umbilical Cord Blood Progenitors With an Unmanipulated Cord Blood Graft in Patients Undergoing Umbilical Cord Blood Transplantation for Hematologic Malignancies [NCT00343798] | Phase 1 | 23 participants (Actual) | Interventional | 2006-04-30 | Completed |
| Pilot Trial of Two Dose Levels of Thymoglobulin® as Part of a Myeloablative-Conditioning for a HLA Identical Matched Related Donor (MRD) Stem Cell Transplant With Cyclosporine (CsA) as Posttransplant Graft vs Host Disease (GvHD) Prophylaxis [NCT00093587] | | 0 participants | Interventional | 2004-08-31 | Active, not recruiting |
| A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody NSC # 742460]) in Combination With Intensive Multi-agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma [NCT01055314] | Phase 2 | 175 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Randomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated Vasculitides [NCT00430105] | Phase 2/Phase 3 | 160 participants | Interventional | 1998-02-28 | Completed |
| A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer [NCT00431080] | Phase 3 | 478 participants (Actual) | Interventional | 2004-08-31 | Completed |
| A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia. [NCT00131313] | Phase 4 | 180 participants | Interventional | 2003-01-31 | Recruiting |
| First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents [NCT00433459] | Phase 3 | 2,134 participants (Actual) | Interventional | 2007-01-31 | Completed |
| Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy [NCT00135954] | Phase 3 | 29 participants (Actual) | Interventional | 1997-07-31 | Completed |
| Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer [NCT00136539] | Phase 2 | 41 participants (Actual) | Interventional | 1999-03-31 | Completed |
| FAB LMB 96 -- Treatment of Mature B-CELL Lymphoma/Leukemia: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study [NCT00002757] | Phase 3 | 1,148 participants (Actual) | Interventional | 2001-06-30 | Completed |
| A Phase II Trial With VELCADE® (PS-341), Cytoxan (Cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD) in Previously Untreated Multiple Myeloma Patients [NCT00438841] | Phase 2 | 43 participants (Anticipated) | Interventional | 2006-08-31 | Active, not recruiting |
| Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma [NCT00110006] | | 0 participants (Actual) | Interventional | 2004-12-31 | Withdrawn(stopped due to No accrual) |
| Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders [NCT00053989] | Phase 2 | 41 participants (Actual) | Interventional | 2002-01-29 | Completed |
| A Phase III Randomized Study of Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer [NCT00352378] | Phase 3 | 209 participants (Actual) | Interventional | 2002-06-30 | Completed |
| "Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide (TPC) in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)" [NCT00445900] | Phase 2 | 22 participants (Anticipated) | Interventional | 2004-10-31 | Completed |
| Autologous Purged Hematopoietic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML) [NCT00446173] | Phase 2 | 0 participants (Actual) | Interventional | 2007-03-31 | Withdrawn(stopped due to Terminated due to low accrual.) |
| A Prospective, Open-label，Multicentre，Real-word Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy as Neoadjuvant Therapy for Women With HER2-positive and p95HER2-positive，PI3K Mutation，or PTEN Loss Breast Cancer [NCT03273595] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
| Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Treatment of Indolent Lymphoid Malignancies [NCT00473551] | Phase 1 | 4 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Terminated due to slow accrual.) |
| A Phase IB Study to Assess the Safety and Efficacy of Neoadjuvant Administration of Autologous Tumor Infiltrating Lymphocytes (LN144/Lifileucel) and Pembrolizumab for Treatment of Patients With Locally Advanced (Stage IIIB-D)/Metastatic (Stage IV) Melanom [NCT05176470] | Phase 1 | 15 participants (Anticipated) | Interventional | 2022-07-01 | Recruiting |
| Cord Blood Expansion on Mesenchymal Stem Cells [NCT00498316] | Phase 1 | 98 participants (Actual) | Interventional | 2007-07-03 | Completed |
| A Randomised Multicentric Phase III Study for the Treatment of Young Patients With High Risk (IPI 2-3) Diffuse Large B-Cell Lymphoma. Dose Dense Chemotherapy + Rituximab +/- Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous St [NCT00499018] | Phase 3 | 399 participants (Anticipated) | Interventional | 2006-01-31 | Active, not recruiting |
| Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Ope [NCT00424203] | Phase 2 | 40 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Phase II Clinical Trial of the Use of Post-Transplant Cyclophosphamide for Graft Versus Host Disease (GvHD) Prophylaxis Following Matched Unrelated Donor (MUD) and Mismatched Unrelated Donor (MMUD)Hematopoietic Stem Cell Transplant (HSCT) [NCT02065154] | Phase 2 | 39 participants (Actual) | Interventional | 2013-08-27 | Completed |
| Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults [NCT00131027] | Phase 3 | 240 participants (Anticipated) | Interventional | 2002-09-30 | Recruiting |
| A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel [NCT00131963] | | 94 participants (Actual) | Observational | 2003-10-31 | Completed |
| Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1. [NCT00140595] | Phase 3 | 380 participants (Anticipated) | Interventional | 2003-12-31 | Completed |
| A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma [NCT00141648] | | 70 participants (Actual) | Interventional | 2000-09-30 | Completed |
| A Phase II Study Evaluating the Efficacy and Safety of Bortezomib (Velcade™) Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT00136565] | Phase 2 | 60 participants (Actual) | Interventional | 2006-01-08 | Completed |
| A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers [NCT02858310] | Phase 1/Phase 2 | 180 participants (Anticipated) | Interventional | 2017-01-27 | Recruiting |
| Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer [NCT00140075] | Phase 3 | 606 participants (Actual) | Interventional | 2000-11-30 | Completed |
| Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies (UCAML) [NCT01247701] | | 16 participants (Actual) | Interventional | 2010-11-30 | Completed |
| A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) [NCT05578976] | Phase 3 | 900 participants (Anticipated) | Interventional | 2023-02-08 | Recruiting |
| A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma [NCT05371093] | Phase 3 | 230 participants (Anticipated) | Interventional | 2022-09-12 | Recruiting |
| Phase I/II First-in-Human Trial With CAR19 Regulatory T Cells (CAR19-tTreg) in Adults With Relapsed/Refractory CD19+ B Acute Lymphocytic Leukemia [NCT05114837] | Phase 1/Phase 2 | 31 participants (Anticipated) | Interventional | 2024-05-31 | Not yet recruiting |
| A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586] | Phase 3 | 244 participants (Anticipated) | Interventional | 2021-10-05 | Recruiting |
| Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas [NCT03984448] | Phase 2/Phase 3 | 363 participants (Anticipated) | Interventional | 2019-10-22 | Active, not recruiting |
| A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects With Relapsed/Refractory HPV16+ Cancers [NCT03912831] | Phase 1 | 8 participants (Actual) | Interventional | 2019-04-30 | Terminated(stopped due to Development program terminated) |
| First-Line Therapy With Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (iFCG) for Patients With Chronic Lymphocytic Leukemia (CLL) With Mutated IGHV Gene and Non-Del(17p) [NCT02629809] | Phase 2 | 81 participants (Actual) | Interventional | 2016-03-18 | Active, not recruiting |
| Administration Of TGF-beta Resistant Cytotoxic T-Lymphocytes to Patients With EBV-positive Nasopharyngeal Carcinoma (RESIST-NPC) [NCT02065362] | Phase 1 | 14 participants (Anticipated) | Interventional | 2015-02-28 | Active, not recruiting |
| A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer With TGF-Beta Resistant (DNRII) and NGFR Transduced T-Cells Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma [NCT01955460] | Phase 1 | 15 participants (Anticipated) | Interventional | 2014-10-15 | Recruiting |
| Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT01371630] | Phase 1/Phase 2 | 276 participants (Anticipated) | Interventional | 2011-08-26 | Recruiting |
| A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab [NCT01174121] | Phase 2 | 332 participants (Anticipated) | Interventional | 2010-08-26 | Recruiting |
| A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8) Versus CHOP Chemotherapy Alone for Newly Diagnosed, Previously Untreated, Aggressive Non-Hodgkin's Lymphoma [NCT00004112] | Phase 3 | 0 participants | Interventional | 1999-09-01 | Completed |
| Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial [NCT03676504] | Phase 1/Phase 2 | 68 participants (Anticipated) | Interventional | 2018-09-07 | Recruiting |
| A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic St [NCT00464646] | Phase 2 | 105 participants (Actual) | Interventional | 2007-05-31 | Completed |
| A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma [NCT00478218] | Phase 2 | 53 participants (Actual) | Interventional | 2006-07-31 | Completed |
| A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Hematopoietic Stem Cells From HLA-Compatible Related or Unrelated Donors in Patients With B Cell Lymphoid Malignancies [NCT00425802] | Phase 2 | 61 participants (Actual) | Interventional | 2006-11-28 | Completed |
| A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL) [NCT00439296] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2006-05-22 | Terminated(stopped due to The study was stopped due to poor accrual and lack of funding.) |
| A Phase II Study of Preoperative Dose-dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Paclitaxel (T) With Bevacizumab in ER+ and/or PR+, HER2-negative Operable Breast Cancer [NCT00546156] | Phase 2 | 104 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-gp100:154-162 TCR-Gene Engineered Lymphocytes [NCT00509496] | Phase 2 | 21 participants (Actual) | Interventional | 2007-06-30 | Terminated(stopped due to Low accrual) |
| A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors [NCT00555048] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2007-09-30 | Terminated(stopped due to Low accrual) |
| Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma [NCT00525876] | | 49 participants (Actual) | Interventional | 2005-01-31 | Completed |
| A Phase II Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-Host-Exhausting and Timely Dose-Reduced Mel-80-CFZ-TD-Pace Transplant(s) With Interspersed Mel-20-CFZ-TD-Pace With CFZ-RD and CFZ-D Ma [NCT02128230] | Phase 2 | 20 participants (Actual) | Interventional | 2014-06-10 | Terminated(stopped due to Low enrollment and Futility as determined by Amgen's Carfilzomib NASCR program.) |
| A Phase I Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of Chemotherapeutic Regiments in Surgical Patients With Infiltrating Ductal Carcinoma of Breast [NCT02897700] | Phase 1 | 300 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
| Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 F5 TCR-Gene Engineered Lymphocytes and ALVAC Virus Immunization [NCT00612222] | Phase 2 | 4 participants (Actual) | Interventional | 2008-01-31 | Terminated(stopped due to The study was terminated due to low accrual.) |
| Allogeneic Transplant for Hematological Malignancy [NCT00176930] | | 330 participants (Actual) | Interventional | 2001-10-31 | Terminated(stopped due to replaced by another study ; Trial re-written as MT2015-29) |
| Phase I/II Study of SU11248 (Sutent) in Combination With Metronomic Dosing of Cyclophosphamide and Methotrexate in Patients With Metastatic Breast Cancer [NCT00616122] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2006-03-01 | Terminated(stopped due to Risk to benefit ratio not acceptable) |
| A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T Cells in Adults With B Cell Malignancies [NCT04735471] | Phase 1 | 78 participants (Anticipated) | Interventional | 2021-03-04 | Recruiting |
| CD34 Selected Allogeneic Hematopoietic Cell Transplantation With Myeloablative Conditioning and CD8+ Memory T Cell Infusion For Patients With Myelodysplastic Syndrome, Acute Leukemia, and Chronic Myelogenous Leukemia [NCT04151706] | Phase 2 | 20 participants (Anticipated) | Interventional | 2020-02-27 | Suspended(stopped due to Interim analysis) |
| A Phase II Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing Solid Tumours. [NCT01285817] | Phase 2 | 79 participants (Actual) | Interventional | 2011-01-12 | Completed |
| A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma [NCT00678327] | Phase 3 | 1,202 participants (Actual) | Interventional | 2008-08-29 | Active, not recruiting |
| Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT03596892] | Phase 2/Phase 3 | 122 participants (Anticipated) | Interventional | 2018-07-31 | Recruiting |
| Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma [NCT02987244] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2016-03-31 | Recruiting |
| A Phase II Study of Umbilical Cord Blood Transplantation Following Myeloablative or Reduced-Intensity Conditioning [NCT00676806] | Phase 2 | 7 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to Slow accrual) |
| A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE), and Dexamethasone (R-CYBOR-D) in Relapsed Low Grade and Mantle Cell Lymphoma [NCT00711828] | Phase 2 | 21 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Prospective Identification of Significant Prognostic Factors in Patients Treated With Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia. [NCT00759798] | Phase 2 | 289 participants (Actual) | Interventional | 2008-08-13 | Completed |
| Trial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's Disease [NCT00787722] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 2009-10-10 | Completed |
| Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25 [NCT00832338] | Phase 2 | 23 participants (Actual) | Interventional | 2009-04-30 | Terminated(stopped due to Funding withdrawn) |
| A Multi-center, Phase 2, Single-Arm, Open-Label Exploratory Study of Individually- Optimized Conditioning Using Pharmacokinetics [PK]-Directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in [NCT00948090] | Phase 2 | 207 participants (Actual) | Interventional | 2010-01-31 | Completed |
| A Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine [NCT00987480] | Phase 2 | 45 participants (Actual) | Interventional | 2009-09-25 | Completed |
| Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients With High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia [NCT01008462] | Phase 2 | 16 participants (Actual) | Interventional | 2010-03-18 | Completed |
| Pomalidomide in Relapsed and Refractory Multiple Myeloma (RRMM) [NCT02406222] | Phase 2 | 124 participants (Actual) | Interventional | 2016-03-31 | Active, not recruiting |
| Allogeneic Hematopoietic Stem Cell Transplantation for Standard Risk Inherited Metabolic Disorders [NCT01043640] | Phase 2 | 46 participants (Actual) | Interventional | 2009-12-31 | Completed |
| A Phase I Trial of Dasatinib (PDGFR and SRC Inhibitor), Temsirolimus, and Cyclophosphamide in Patients With Advanced Solid Tumors [NCT02389309] | Phase 1 | 14 participants (Actual) | Interventional | 2015-10-05 | Active, not recruiting |
| Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma [NCT00501826] | Phase 2 | 160 participants (Anticipated) | Interventional | 2007-07-11 | Recruiting |
| A Randomised Phase II Study in Metastatic Melanoma to Evaluate the Efficacy of Adoptive Cellular Therapy With Tumour Infiltrating Lymphocytes (TIL) and Assessment of High Versus Low Dose Interleukin-2 [NCT01995344] | Phase 2 | 2 participants (Actual) | Interventional | 2014-03-01 | Terminated(stopped due to Withdrawal of funding) |
| Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30) [NCT01105650] | Phase 2 | 13 participants (Actual) | Interventional | 2010-07-31 | Completed |
| A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma or Lymphoma [NCT01146834] | Phase 3 | 47 participants (Actual) | Interventional | 2011-03-31 | Completed |
| A Phase II Clinical Trial of Sapacitabine, Cyclophosphamide, and Rituximab (SCR) for Relapsed Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) and Deletion 11q22-23 by FISH [NCT01253460] | Phase 2 | 18 participants (Actual) | Interventional | 2011-08-22 | Terminated(stopped due to Accrual not met) |
| Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia [NCT01363128] | Phase 2 | 72 participants (Actual) | Interventional | 2011-07-12 | Completed |
| Phase II Study in Patients With Metastatic Melanoma Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of MART-1 Reactive Peripheral Blood Lymphocytes (PBL) With or Without High Dose Aldesleukin [NCT01495572] | Phase 2 | 5 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to Due to slow accrual, the investigator decided to close the study.) |
| A Phase I Study of FT819 in Subjects With B-cell Malignancies [NCT04629729] | Phase 1 | 396 participants (Anticipated) | Interventional | 2021-07-26 | Recruiting |
| A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12) [NCT03761056] | Phase 2 | 42 participants (Actual) | Interventional | 2019-01-29 | Completed |
| Phase 2 Study of an Immune Therapy, DPX-Survivac With Low Dose Cyclophosphamide Administered With Pembrolizumab in Patients With Persistent or Recurrent/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) [NCT03349450] | Phase 2 | 25 participants (Actual) | Interventional | 2018-03-13 | Completed |
| Autologous Stem Cell Transplant In Patients With Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL) [NCT03125642] | Phase 2 | 150 participants (Anticipated) | Interventional | 2017-04-20 | Recruiting |
| Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation [NCT00653068] | Phase 3 | 70 participants (Actual) | Interventional | 2008-12-08 | Active, not recruiting |
| A Pilot Phase II Trial Of Irinotecan Plus Carboplatin, And Irinotecan Maintenance Therapy (High-Risk Patients Only), Integrated Into The Upfront Therapy Of Newly Diagnosed Patients With Intermediate - And High-Risk Rhabdomyosarcoma [NCT00077285] | Phase 2 | 65 participants (Anticipated) | Interventional | 2003-10-31 | Active, not recruiting |
| Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma [NCT00005867] | Phase 3 | 310 participants (Anticipated) | Interventional | 1998-01-31 | Completed |
| [NCT00005891] | | 0 participants | Interventional | 2000-03-31 | Completed |
| Herceptin and Paclitaxel in Locally Advanced Breast Cancer With Her-2 Overexpression [NCT00009997] | Phase 1 | 0 participants | Interventional | 1999-03-31 | Completed |
| A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma [NCT00017368] | Phase 2 | 42 participants (Actual) | Interventional | 2001-04-30 | Completed |
| Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR) [NCT00526318] | | 360 participants (Anticipated) | Interventional | 2007-01-31 | Recruiting |
| Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase. [NCT00184041] | Phase 2 | 47 participants (Actual) | Interventional | 2004-07-31 | Completed |
| Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study [NCT00544219] | | 156 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study [NCT00162656] | Phase 3 | 848 participants (Actual) | Interventional | 1996-05-31 | Completed |
| Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin [NCT02096588] | Phase 2 | 34 participants (Actual) | Interventional | 2014-05-20 | Active, not recruiting |
| Phase I/II Study of CD40 Ligand Expressing MSLN-CAR T Cell Treatment in MSLN Positive Advanced/Metastatic Solid Tumors [NCT05693844] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2023-01-20 | Recruiting |
| A Pilot Study of NY-ESO-1c259T Cells in Subjects With Advanced Myxoid/ Round Cell Liposarcoma [NCT02992743] | Phase 2 | 23 participants (Actual) | Interventional | 2016-12-06 | Completed |
| The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial [NCT02903524] | Phase 4 | 300 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
| A Phase 2 Study of CC220 (Iberdomide) Combined With Low-dose Cyclophosphamide and Dexamethasone in Relapsed/Refractory Multiple Myeloma (IberCd): ICON Study [NCT04392037] | Phase 2 | 60 participants (Actual) | Interventional | 2021-02-17 | Active, not recruiting |
| NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma [NCT00410631] | Phase 3 | 642 participants (Anticipated) | Interventional | 2004-10-31 | Recruiting |
| A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF: Cyclophosphamide+Methotrexate+Fluorouracil (Arm A) Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF (Arm B) Versus Sequential Intensified Epidoxorubicin Follo [NCT00174707] | Phase 3 | 998 participants (Actual) | Interventional | 1997-12-31 | Completed |
| Therapy for Children With Advanced Stage High Risk Neuroblastoma [NCT00186849] | Phase 2 | 30 participants (Actual) | Interventional | 1997-10-31 | Completed |
| Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00187005] | Phase 3 | 53 participants (Actual) | Interventional | 1998-07-31 | Terminated(stopped due to Toxicity) |
| A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01359592] | Phase 2 | 159 participants (Actual) | Interventional | 2011-09-30 | Active, not recruiting |
| Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394) [NCT00590785] | Phase 3 | 60 participants (Anticipated) | Interventional | 1996-08-13 | Completed |
| Primary Effusion Lymphoma: A Pilot Trial of Bevacizumab and Modified Dose-Adjusted Infusional CDE Chemotherapy Preceded by a Brief Pre-Phase Assessment of Targeted Oncolytic Virotherapy With Bortezomib, Zidovudine and Valganciclovir [NCT00217503] | Phase 2 | 15 participants (Anticipated) | Interventional | 2005-07-31 | Completed |
| A Phase I-II Study of the Combination of Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL) [NCT02420717] | Phase 2 | 11 participants (Actual) | Interventional | 2015-07-15 | Terminated(stopped due to Study was closed early due to low accrual and lack of response.) |
| Treatment of Acute Lymphoblastic Leukemia in Children [NCT00400946] | Phase 3 | 800 participants (Actual) | Interventional | 2005-04-30 | Completed |
| HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD [NCT02661503] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
| A Phase I Study of Zoledronic Acid (Zometa) With Cyclophosphamide in Children With Recurrent or Refractory Neuroblastoma and Cortical Bone Involvement (NANT 2004-01) [NCT00206388] | Phase 1 | 21 participants (Actual) | Interventional | 2005-04-30 | Completed |
| Adjuvant Therapy for High-Risk Localized Breast Cancer With Weekly Adriamycin +/- Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Taxol for 12 Weeks, Phase II [NCT00194753] | Phase 2 | 80 participants (Actual) | Interventional | 2001-12-31 | Completed |
| Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study [NCT00197912] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2004-09-30 | Completed |
| An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL) [NCT04626739] | Early Phase 1 | 100 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
| Efficacy and Safety of Cyclophosphamide in the Treatment of Refractory Proliferative Arachnoiditis in Central Nervous System Tuberculosis- A Randomized Double Blinded Placebo Controlled Trial [NCT04620772] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2021-01-01 | Not yet recruiting |
| A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants [NCT06097364] | Phase 3 | 733 participants (Anticipated) | Interventional | 2023-11-14 | Recruiting |
| A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptima [NCT06045806] | Phase 3 | 618 participants (Anticipated) | Interventional | 2023-10-16 | Recruiting |
| A Combined Phase i/II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG STERILE Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer [NCT02938442] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2019-01-25 | Completed |
| Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children [NCT04610125] | | 30 participants (Anticipated) | Interventional | 2020-06-23 | Recruiting |
| A Multicenter, Open Label Phase I/II Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma (MM) Patients [NCT02204241] | Phase 1/Phase 2 | 36 participants (Actual) | Interventional | 2014-06-30 | Completed |
| A Phase II, Multicenter, Single Arm Study to Determine the Efficacy and Safety of Low Dose Fludarabine and Cyclophosphamide Combined With Standard Dose Rituximab as Primary Therapy in Elderly Untreated Patients (>/=65 Years Old) With Chronic Lymphocytic L [NCT01263704] | Phase 2 | 42 participants (Actual) | Interventional | 2011-07-17 | Completed |
| A Phase 1 Study to Evaluate Intracerebroventricular (ICV) Administration of CD19-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Primary CNS Lymphoma [NCT05625594] | Phase 1 | 20 participants (Anticipated) | Interventional | 2023-06-29 | Recruiting |
| Low Intensity Allogeneic Hematopoietic Stem Cell Transplantation Therapy of Metastatic Renal Cell Carcinoma Using Early and Multiple Donor Lymphocyte Infusions Consisting of Sirolimus-Generated Donor Th2 Cells [NCT00923845] | Phase 2 | 25 participants (Actual) | Interventional | 2008-03-01 | Completed |
| A Phase 1/2 Trial (CheckCell-2) in Patients With Metastatic Non-small Cell Lung Cancer (NSCLC) Administering Tumor-Infiltrating Lymphocytes (TILs) in Which the Gene Encoding CISH Was Inactivated Using the CRISPR/Cas9 System [NCT05566223] | Phase 1/Phase 2 | 70 participants (Anticipated) | Interventional | 2023-02-28 | Not yet recruiting |
| ALL Adult Consortium Trial: Adult ALL Trial [NCT00476190] | Phase 2 | 112 participants (Anticipated) | Interventional | 2007-04-30 | Active, not recruiting |
| An Open Label, Repeat Dose, Randomized, Two Period Crossover Study to Investigate the Potential Pharmacokinetic Interactions Between Oral GW679769 and Intravenous Cyclophosphamide in Cancer Patients [NCT00334646] | Phase 1 | 25 participants (Actual) | Interventional | 2005-08-10 | Terminated(stopped due to compound terminated) |
| A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood [NCT00354419] | Phase 1 | 30 participants (Anticipated) | Interventional | 2006-02-28 | Terminated(stopped due to Low accrual) |
| Randomized Phase I/II Pilot Study of the Immunogenicity of Cyclophosphamide With Peptide Pulsed Mature Dendritic Cells for Patients With Previously Treated Ovarian Epithelial or Primary Peritoneal Carcinoma [NCT00478452] | Phase 1 | 14 participants (Actual) | Interventional | 2005-08-31 | Completed |
| A Phase I Study of ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer [NCT00496665] | Phase 1 | 25 participants (Actual) | Interventional | 2007-07-31 | Completed |
| A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies [NCT00477035] | Phase 1 | 22 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies (UCALL) [NCT01247688] | | 0 participants (Actual) | Interventional | 2010-11-30 | Withdrawn(stopped due to This study was withdrawn due to low accrual.) |
| A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu [NCT02276300] | Phase 1 | 2 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL [NCT01516567] | Phase 2 | 47 participants (Actual) | Interventional | 2012-04-01 | Active, not recruiting |
| Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial [NCT01516580] | Phase 3 | 482 participants (Actual) | Interventional | 2011-12-31 | Active, not recruiting |
| A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas [NCT03277729] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2017-12-05 | Recruiting |
| A Phase I/II Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor (TCR)-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers [NCT05296564] | Phase 1/Phase 2 | 3 participants (Anticipated) | Interventional | 2022-04-01 | Recruiting |
| Phase II Study of Evaluating the Efficacy of Total Marrow and Lymphoid Irradiation (TMLI) as the Conditioning Regimen for HLA-Haploidentical Hematopoietic Cell Transplantation in Patients With Myelodysplasia or Acute Leukemia [NCT04262843] | Phase 2 | 70 participants (Anticipated) | Interventional | 2020-02-07 | Recruiting |
| A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Ear [NCT03726879] | Phase 3 | 454 participants (Actual) | Interventional | 2019-01-11 | Completed |
| A Phase I/II Trial of IMA970A Plus CV8102 Following a Single Pre-vaccination Infusion of Cyclophosphamide in Patients With Very Early, Early and Intermediate Stage of Hepatocellular Carcinoma After Any Standard Treatments [NCT03203005] | Phase 1/Phase 2 | 22 participants (Actual) | Interventional | 2017-09-18 | Completed |
| Phase II Study Of Combination Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer [NCT02876302] | Phase 2 | 23 participants (Actual) | Interventional | 2017-04-26 | Active, not recruiting |
| A Phase 1 Safety Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia [NCT03126864] | Phase 1 | 11 participants (Actual) | Interventional | 2017-08-04 | Terminated(stopped due to Terminated per the PI's request.) |
| Phase 2 Trial of Ixazomib Combinations in Patients With Relapsed Multiple Myeloma [NCT01415882] | Phase 2 | 108 participants (Actual) | Interventional | 2012-01-31 | Active, not recruiting |
| Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility [NCT00591851] | Phase 2 | 70 participants (Actual) | Interventional | 2004-12-31 | Completed |
| A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. [NCT00336024] | Phase 3 | 91 participants (Actual) | Interventional | 2007-08-06 | Active, not recruiting |
| [NCT01526499] | Phase 2 | 60 participants (Anticipated) | Interventional | 2011-12-31 | Recruiting |
| "Protocol CCAM 05-02 Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma" [NCT01527422] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Pilot Study Assessing the Feasibility of a Surgery and Chemotherapy-Only Approach in the Upfront Therapy of Children With Wnt Positive Standard Risk Medulloblastoma [NCT02212574] | Early Phase 1 | 6 participants (Actual) | Interventional | 2017-04-04 | Terminated(stopped due to Participant relapses led to abrupt stop of study.) |
| Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer [NCT01530607] | Phase 3 | 416 participants (Actual) | Interventional | 2009-11-30 | Completed |
| A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Bortezomib-, Carfilzomib-, or IMID-Refractory Multiple Myeloma [NCT01537861] | Early Phase 1 | 7 participants (Actual) | Interventional | 2012-06-30 | Terminated(stopped due to Unexpected toxicity (2 early deaths)) |
| High-dose Cyclophosphamide for Severe Refractory Crohn Disease [NCT01836289] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2015-03-31 | Withdrawn(stopped due to Too difficult to recruit given new Crohn's medications approved) |
| A Phase II Study of Rituximab Intense Dosing With CHOP-21 (RID-CHOP) in Patients With Previously Untreated High or High-Intermediate Risk IPI (3-5) Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01539174] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to No Funding Source and Competing Trials) |
| A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis [NCT01539902] | Phase 2 | 25 participants (Anticipated) | Interventional | 2012-02-29 | Recruiting |
| Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide in Locally Advanced or Node Positive Primary Breast Cancer With Companion Pharmacokinetic and Pharmacogenomic Analyses [NCT01540110] | Phase 2 | 21 participants (Actual) | Interventional | 2010-08-11 | Completed |
| Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma [NCT00002474] | Phase 2 | 0 participants | Interventional | 1991-02-28 | Completed |
| CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY [NCT00002498] | Phase 2 | 0 participants | Interventional | 1992-07-31 | Active, not recruiting |
| EUROPEAN INTERGROUP COOPERATIVE EWING'S SARCOMA STUDY [EICESS 92] [NCT00002516] | Phase 3 | 0 participants | Interventional | 1992-07-31 | Active, not recruiting |
| A RANDOMIZED TRIAL OF UNMODIFIED VERSUS T-CELL DEPLETED ALLOGENEIC HLA-IDENTICAL BONE MARROW TRANSPLANTATION FOR THE TREATMENT OF ACUTE LEUKEMIAS [NCT00002534] | Phase 3 | 0 participants | Interventional | 1993-05-31 | Completed |
| A RANDOMIZED PROSPECTIVE TRIAL OF CHOP VERSUS MCOP IN ELDERLY PATIENTS WITH INTERMEDIATE AND HIGH GRADE NON-HODGKIN'S LYMPHOMA (AGED 65 YEARS AND OVER) [NCT00002576] | Phase 3 | 200 participants (Anticipated) | Interventional | 1992-11-30 | Completed |
| Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors [NCT00002594] | Phase 2 | 31 participants (Actual) | Interventional | 1994-09-30 | Completed |
| HIGH-DOSE MELPHALAN CHEMOTHERAPY AND TOTAL BODY RADIATION WITH PERIPHERAL BLOOD STEM-CELL RECONSTITUTION FOR PATIENTS WITH RELAPSING MULTIPLE MYELOMA [NCT00002630] | Phase 2 | 50 participants (Anticipated) | Interventional | 1993-06-30 | Completed |
| Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia [NCT00002744] | Phase 3 | 1,970 participants (Actual) | Interventional | 1996-05-31 | Completed |
| Induction Intensification in Infant ALL: A Children's Oncology Group Study [NCT00002756] | Phase 2 | 221 participants (Actual) | Interventional | 1996-06-30 | Completed |
| Randomised Comparisons, in Myeloma Patients of All Ages, of Thalidomide, Lenalidomide, Carfilzomib and Bortezomib Induction Combinations, and of Lenalidomide and Combination Lenalidomide Vorinostat as Maintenance (Myeloma XI) [NCT01554852] | Phase 3 | 4,420 participants (Actual) | Interventional | 2010-05-31 | Active, not recruiting |
| PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER [NCT00002858] | Phase 3 | 280 participants (Anticipated) | Interventional | 1993-03-31 | Active, not recruiting |
| A Double-blind, Multicenter, Parallel Study Comparing the Efficacy and Safety of Kytril Tablets With Placebo, in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-based or Carboplatin-based Chemotherapy [NCT00005024] | Phase 3 | 0 participants | Interventional | | Active, not recruiting |
| Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis [NCT00103792] | Phase 3 | 90 participants (Anticipated) | Interventional | 2004-12-31 | Recruiting |
| European Cooperative Study of Chemotherapy and Surgery Comparing Adjuvant Doxorubicin Followed by CMF vs. Adjuvant Doxorubicin/Paclitaxel Followed by CMF vs. Primary Doxorubicin/Paclitaxel Followed by CMF in Women With Operable Breast Cancer and T>2 cm [NCT00003013] | Phase 3 | 450 participants (Anticipated) | Interventional | 1996-10-31 | Completed |
| Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma [NCT00004039] | Phase 2 | 0 participants (Actual) | Interventional | 1998-06-30 | Withdrawn(stopped due to No patient accruals) |
| Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies [NCT00003163] | Phase 2 | 10 participants (Anticipated) | Interventional | 1997-09-30 | Active, not recruiting |
| The Unrelated Donor Marrow Transplantation Trial [NCT00003187] | Phase 2/Phase 3 | 19 participants (Actual) | Interventional | 1995-05-31 | Completed |
| Treatment of Newly Diagnosed Medulloblastoma and Supratentorial PNET in Patients At Least 3 Years With a Phase II Topotecan Window (High-Risk Patients Only), Risk-Adapted Radiation Therapy, and Dose-Intensive Chemotherapy With Peripheral Blood Stem Cell S [NCT00003211] | Phase 2 | 94 participants (Actual) | Interventional | 1996-10-31 | Completed |
| A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Th [NCT00007904] | Phase 2 | 16 participants (Actual) | Interventional | 2000-07-31 | Completed |
| CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor [NCT00007982] | Phase 2 | 30 participants (Anticipated) | Interventional | 1999-04-30 | Completed |
| A Randomized, Double-Blind, Phase 2 Study Evaluating the Safety of Same Day Versus Next Day Administration of Pegfilgrastim With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) in Women With Breast Cancer [NCT00115414] | Phase 2 | 0 participants | Interventional | | Completed |
| Transplantation of Unrelated Donor Hematopoietic Stem Cells for the Treatment of Hematological Malignancies [NCT00281879] | Phase 2 | 200 participants (Actual) | Interventional | 2006-02-28 | Terminated |
| Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma. [NCT02752815] | Phase 4 | 290 participants (Anticipated) | Interventional | 2016-06-14 | Active, not recruiting |
| PHASE II STUDY OF HIGH-DOSE CYCLOPHOSPHAMIDE PLUS RECOMBINANT HUMAN GRANULOCYTE-COLONY STIMULATING FACTOR (rhG-CSF) IN THE TREATMENT OF FOLLICULAR LOW-GRADE NON-HODGKIN'S LYMPHOMA [NCT00002501] | Phase 2 | 29 participants (Actual) | Interventional | 1992-10-31 | Completed |
| MULTICENTRE TRIAL OF INTENSIFIED THERAPY FOR ADULT ALL (O5/93) [NCT00002531] | Phase 2 | 0 participants | Interventional | 1993-01-31 | Active, not recruiting |
| Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation. [NCT00002657] | Phase 2 | 20 participants (Actual) | Interventional | 1995-05-31 | Completed |
| A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Ce [NCT05673785] | Phase 2 | 52 participants (Anticipated) | Interventional | 2023-02-10 | Recruiting |
| Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer [NCT00020176] | Phase 2 | 0 participants | Interventional | 2000-06-30 | Completed |
| [NCT00010413] | Phase 2 | 35 participants | Interventional | 1999-04-30 | Completed |
| A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia [NCT00022126] | Phase 2 | 6 participants (Actual) | Interventional | 2002-11-30 | Completed |
| Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma [NCT00022945] | Phase 2 | 0 participants | Interventional | | Completed |
| A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis [NCT00024193] | Phase 2 | 0 participants | Interventional | 1999-04-30 | Active, not recruiting |
| Clinical Correlative Studies In Primary Central Nervous System Germ Cell Tumors: The Third International CNS Germ Cell Tumor Study Group Protocol [NCT00025324] | Phase 2 | 0 participants | Interventional | 2000-12-31 | Active, not recruiting |
| A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Diseas [NCT00025363] | Phase 2 | 150 participants (Actual) | Interventional | 2001-11-30 | Completed |
| Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia (CML) Interferon-a Vs. Allogeneic Stem Cell Transplantation Vs. High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase [NCT00025402] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 1997-07-31 | Active, not recruiting |
| MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood [NCT00025441] | Phase 2 | 0 participants | Interventional | 1998-11-30 | Completed |
| A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic Malignancies [NCT02566395] | Phase 3 | 10 participants (Anticipated) | Interventional | 2014-12-31 | Completed |
| European Infant Neuroblastoma Study - Unresectable Tumors (MYCN Not Amplified) [NCT00025597] | Phase 2 | 0 participants | Interventional | 1999-07-31 | Completed |
| A Randomized Trial Of BEAM Plus PBSCT Versus Single Agent High-Dose Therapy Followed By BEAM Plus PBSCT In Patients With Relapsed Hodgkin's Disease [NCT00025636] | Phase 3 | 220 participants (Anticipated) | Interventional | 2001-07-31 | Active, not recruiting |
| Protocol for Related Donor Hematopoietic Stem Cell Transplantation (HSCT) for Treatment of Symptomatic Genetic Lymphohematological Diseases [NCT02512679] | Phase 2 | 20 participants (Actual) | Interventional | 2007-02-28 | Terminated(stopped due to Optimal dose obtained for engraftment and minimizing toxicity) |
| A Phase II Study Of Mobilization Chemotherapy With GMCSF And GCSF Followed By High Dose Therapy Combined With IL2 Activated Autologous Peripheral Blood Stem Cells Followed By Sequential IL2 Therapy As Treatment For Solid Tumors And Lymphoma [NCT00027937] | Phase 2 | 0 participants | Interventional | 2001-08-31 | Completed |
| A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas [NCT00012207] | Phase 1 | 12 participants (Anticipated) | Interventional | 2000-09-30 | Completed |
| Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma [NCT00028600] | Phase 2 | 60 participants (Actual) | Interventional | 2001-11-30 | Completed |
| A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma [NCT00028717] | Phase 3 | 400 participants (Anticipated) | Interventional | 2001-02-28 | Active, not recruiting |
| Sibling Donor Cord Blood Banking and Transplantation [NCT00029380] | Phase 2 | 30 participants (Anticipated) | Interventional | 1999-01-31 | Completed |
| Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma [NCT00032149] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2001-10-31 | Active, not recruiting |
| [NCT00000596] | Phase 2 | 0 participants | Interventional | 1978-06-30 | Completed |
| Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma [NCT00000689] | Phase 1 | 18 participants | Interventional | | Completed |
| A Randomized Phase II Study Of CMF Alone And In Combination With Anti c-erbB2 Antibody (Herceptin) In Women With c-erbB2 Positive Metastatic Breast Cancer [NCT00036868] | Phase 2 | 90 participants (Actual) | Interventional | 2002-02-28 | Active, not recruiting |
| A Randomized Pivotal Clinical Trial To Assess The Efficacy Of Pre-operative Focused Microwave Thermotherapy Treatment Combined With Pre-operative Chemotherapy For Cytoreduction Of Advanced Breast Cacer In Intact Breast [NCT00036985] | Phase 2 | 0 participants | Interventional | 2001-08-31 | Active, not recruiting |
| Effect of Cytoreductive Chemotherapy Combined With Highly Active Antiretroviral Therapy on Lymph Node HIV DNA in HIV-Infected Subjects [NCT00000899] | Phase 1 | 10 participants | Interventional | | Completed |
| Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide [NCT00396682] | Phase 3 | 12 participants (Anticipated) | Interventional | 2007-02-28 | Completed |
| The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia [NCT00016302] | | 100 participants (Actual) | Interventional | 2001-04-30 | Completed |
| [NCT00016458] | Phase 2 | 20 participants | Interventional | 2000-06-30 | Completed |
| Treatment of Mantle Cell Lymphomas at Advanced Stages: Prospective Randomized Comparison of Myeloablative Radiochemotherapy Followed by Blood Stem Cell Transplantation Versus Maintenance With Interferon Alpha in First Remission After Initial Cytoreductive [NCT00016887] | Phase 3 | 0 participants | Interventional | 2000-12-31 | Active, not recruiting |
| A Phase I Trial Of G3139 (BCL-2 Antisense, NSC# 683428, IND# 58842) Combined With Cytotoxic Chemotherapy In Relapsed Childhood Solid Tumors [NCT00039481] | Phase 1 | 15 participants (Actual) | Interventional | 2002-11-30 | Completed |
| Transplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation Study [NCT00040651] | Phase 1 | 15 participants | Interventional | 2002-07-31 | Terminated |
| A Clinicopathological Study In Burkitts's And Burkitt-Like Non-Hodgkin's Lymphoma [NCT00040690] | Phase 2 | 120 participants (Anticipated) | Interventional | 2008-11-30 | Completed |
| Pilot Study of Systemic and Intrathecal Chemotherapy Followed by Conformal Radiation for Infants With Brain Tumors [NCT00042367] | | 119 participants (Actual) | Interventional | 2000-04-04 | Completed |
| [NCT00017628] | Phase 1 | 20 participants | Interventional | 2001-04-30 | Completed |
| Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maint [NCT01532856] | Phase 3 | 64 participants (Actual) | Interventional | 2007-01-31 | Active, not recruiting |
| High-Dose Therapy and Autologous Blood Stem Cell Transplantation (ASCT) Followed by Post-Transplant Immunotherapy With Costimulated Autologous T-Cells in Conjunction With Pneumococcal Conjugate Vaccine Immunization for Patients With Multiple Myeloma [NCT00046852] | Phase 1/Phase 2 | 0 participants | Interventional | 2001-12-31 | Completed |
| Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas [NCT00047281] | Phase 2 | 0 participants | Interventional | 2004-03-31 | Completed |
| A Phase I-II Study of R115777 (ZARNESTRA) Plus Doxorubicin and Cyclophosphamide in Patients With Locally Advanced Breast Cancer and Metastatic Breast Cancer [NCT00049114] | Phase 2 | 62 participants (Actual) | Interventional | 2003-02-28 | Completed |
| A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia [NCT05576181] | Phase 1 | 19 participants (Anticipated) | Interventional | 2022-10-15 | Not yet recruiting |
| A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 (ThisCART19A) in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy [NCT05640713] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-12-01 | Not yet recruiting |
| A Pilot Study Of Sequential Vaccinations With Recombinant Vaccinia-CEA(6D)-TRICOM, And Recombinant Fowlpox-CEA(6D)-TRICOM (B7.1/ICIAM-1/LFA-3) With Sargramostim (GM-CSF), In Conjunction With Standard Adjuvant Chemotherapy In High Risk Breast Cancer Patien [NCT00052351] | Phase 2 | 0 participants | Interventional | 2002-09-30 | Completed |
| Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Year [NCT00052936] | Phase 3 | 1,506 participants (Actual) | Interventional | 2001-01-31 | Completed |
| National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma [NCT00053092] | Phase 2 | 82 participants (Anticipated) | Interventional | 2002-10-31 | Completed |
| Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery [NCT00053911] | Phase 3 | 0 participants | Interventional | 2002-11-30 | Terminated |
| Conditioning With Targeted Busulfan, Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell (PBSC) Transplantation for Myelodysplasia and Myeloproliferative Disorders [NCT00054340] | Phase 1/Phase 2 | 0 participants | Interventional | 2002-10-31 | Completed |
| Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer [NCT00056095] | Phase 2 | 57 participants (Actual) | Interventional | 2002-11-04 | Completed |
| Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Includ [NCT00060385] | Phase 2/Phase 3 | 3 participants (Actual) | Interventional | 2003-03-31 | Terminated(stopped due to low accrual) |
| Pilot Study for Therapy Optimising for Hodgkin's Lymphoma in Childhood and Adolescence; Optimising Therapy for Boys With Hodgkin's Lymphoma in Intermediate and Advanced Stages. Safety and Efficacy Study for Drug Combination VECOPA [NCT00398554] | Phase 2 | 16 participants (Actual) | Interventional | 2005-06-30 | Completed |
| A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy [NCT00062140] | Phase 1 | 0 participants | Interventional | 2003-04-30 | Completed |
| A Randomized Controlled, Phase III Trial in HER2-positive Lymph Node Positive Early Breast Cancer to Compare the Efficacy and Safety of Epriubin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Pertuzumab (EC-THP) Versus Docetaxel and Carb [NCT05883852] | Phase 3 | 1,406 participants (Anticipated) | Interventional | 2023-06-07 | Recruiting |
| A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies [NCT01384513] | Phase 2 | 40 participants (Actual) | Interventional | 2011-08-04 | Completed |
| Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study [NCT00070174] | Phase 2 | 350 participants (Actual) | Interventional | 2003-12-31 | Completed |
| Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma [NCT00070447] | Phase 2 | 0 participants | Interventional | 2003-11-30 | Completed |
| 2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia (CLL) - A Prospective Multicenter Phase II Trial [NCT00072007] | Phase 2 | 43 participants (Actual) | Interventional | 2002-06-30 | Completed |
| Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma [NCT00072319] | Phase 2 | 0 participants | Interventional | 2003-08-31 | Completed |
| Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma [NCT00073879] | | 0 participants | Interventional | 2003-04-30 | Completed |
| A Phase I Study of Decitabine (NSC# 127716, IND# 50733) in Combination With Doxorubicin and Cyclophosphamide in the Treatment of Relapsed or Refractory Solid Tumors [NCT00075634] | Phase 1 | 21 participants (Actual) | Interventional | 2003-12-31 | Completed |
| Idarubicin and Ara-C in Combination With Gemtuzumab-Ozogamicin (IAGO) for Young Untreated Patients, Without an HLA Identical Sibling, With High Risk MDS or AML Developing After a Preceding Period With MDS During 6 Months Duration: A Phase II Study [NCT00077116] | Phase 2 | 31 participants (Actual) | Interventional | 2003-11-30 | Completed |
| A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma [NCT00079105] | Phase 2 | 175 participants (Actual) | Interventional | 2004-01-31 | Completed |
| Treatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen [NCT00079144] | Phase 2 | 0 participants | Interventional | 2004-01-31 | Completed |
| Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma [NCT00079261] | Phase 2 | 25 participants (Actual) | Interventional | 2004-01-31 | Completed |
| Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotep [NCT00392886] | Phase 3 | 120 participants (Anticipated) | Interventional | 2004-03-31 | Active, not recruiting |
| A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OTI-010 in Subjects Who Receive HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies [NCT00081055] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn |
| Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer [NCT00083161] | Phase 2 | 8 participants (Actual) | Interventional | 2003-06-30 | Completed |
| Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma [NCT00135499] | Phase 3 | 138 participants (Actual) | Interventional | 2001-10-16 | Terminated(stopped due to Recruitment too low) |
| A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma [NCT00005613] | Phase 2 | 147 participants (Actual) | Interventional | 1996-03-31 | Completed |
| Phase II Trial Using Aldesleukin (IL-2) Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma [NCT00138229] | Phase 2 | 6 participants (Actual) | Interventional | 2005-07-31 | Terminated |
| Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma [NCT03092453] | Phase 1 | 12 participants (Anticipated) | Interventional | 2017-05-01 | Active, not recruiting |
| Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated CLL With Four or Six Cycles of Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide Followed by Lenalidomide Consolidation/ Maintenance [NCT01723839] | Phase 2 | 21 participants (Actual) | Interventional | 2012-02-22 | Completed |
| High-dose Alkylating Chemotherapy in Oligo-metastatic Breast Cancer Harboring Homologous Recombination Deficiency [NCT01646034] | Phase 3 | 74 participants (Actual) | Interventional | 2014-09-30 | Active, not recruiting |
| Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Non-Myeloablative But Lymphocyte Depleting Regimen [NCT00001832] | Phase 2 | 170 participants (Actual) | Interventional | 1999-08-31 | Completed |
| [NCT00010400] | | 35 participants | Interventional | 1997-04-30 | Completed |
| International Pleuropulmonary Blastoma (PPB) Treatment and Biology Registry Protocol [NCT01464606] | | 156 participants (Actual) | Interventional | 2009-12-22 | Active, not recruiting |
| Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer: A Phase II Prospective Randomized Trial [NCT00012311] | Phase 2 | 0 participants | Interventional | 2000-01-31 | Active, not recruiting |
| Hepatocellular Carcinoma Family of Tumours In Children / Adolescents and Young Adults [NCT00276705] | Phase 2 | 47 participants (Anticipated) | Interventional | 2005-06-30 | Active, not recruiting |
| Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors [NCT00014573] | Phase 2 | 0 participants | Interventional | 1998-08-31 | Completed |
| Treatment Protocol for T-Cell and B-Precursor Cell Lymphoblastic Lymphoma of the European Inter-group Co-operation on Childhood Non-Hodgkin-Lymphoma (EICNHL) [NCT00275106] | Phase 3 | 600 participants (Anticipated) | Interventional | 2004-09-30 | Terminated(stopped due to Withdrawn due to an excess of toxic deaths) |
| A Comparative Randomized Study of Standard Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory and Locally A [NCT00016406] | Phase 3 | 399 participants (Actual) | Interventional | 2001-05-31 | Completed |
| Low Dose Chlorambucil Maintenance Vs. No Treatment Following High-Dose Chlorambucil Induction In Patients With Advanced B-Chronic Lymphocytic Leukemia. A Randomized Phase III Study Of The EORTC LG (CLL-3) [NCT00017108] | Phase 3 | 0 participants | Interventional | 2001-03-31 | Active, not recruiting |
| Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma [NCT00017225] | Phase 2 | 0 participants | Interventional | 1997-05-31 | Completed |
| Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support [NCT00017381] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2001-04-30 | Completed |
| [NCT00017654] | | 3 participants | Interventional | 2001-04-30 | Active, not recruiting |
| PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA [NCT00018954] | Phase 2 | 0 participants | Interventional | 1992-10-31 | Completed |
| A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma [NCT00020943] | Phase 2 | 79 participants (Actual) | Interventional | 2001-06-30 | Completed |
| Combination of Chemotherapy With Taxol, Adriamycin, and Cytoxan (TAC), Multiple Infusions of Activated T Cells (ATC), Interleukin-2 (IL-2) and GM-CSF for High Risk Breast Cancer With and Without Her2/Neu Overexpression. (Phase I/II) [NCT00022230] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2000-01-31 | Withdrawn(stopped due to PI left Institution) |
| A Children's Oncology Group Pilot Study for the Treatment of Very High Risk Acute Lymphoblastic Leukemia in Children and Adolescents (Imatinib (STI571, GLEEVEC) NSC#716051) [NCT00022737] | Phase 3 | 220 participants (Actual) | Interventional | 2002-10-31 | Completed |
| Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia [NCT02971982] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
| Phase II Window Evaluation of the Farnesyl Transferase Inhibitor (R115777) Followed by 13-CIS Retinoic Acid, Cytosine Arabinoside and Fludarabine Plus Hematopoietic Stem Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia [NCT00025038] | Phase 2 | 100 participants (Actual) | Interventional | 2001-06-30 | Completed |
| Treatment Of Recurrent Central Nervous System Primitive Neuroectodermal Tumors (PNETs) In Children And Adolescents A Strategy Including The Use Of High Dose Thiotepa And High Dose Carboplatin [NCT00025077] | Phase 2 | 50 participants (Anticipated) | Interventional | 2000-01-31 | Completed |
| A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma [NCT05051891] | Phase 3 | 356 participants (Anticipated) | Interventional | 2021-12-22 | Recruiting |
| Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification [NCT00025428] | Phase 3 | 100 participants (Anticipated) | Interventional | 2000-12-31 | Completed |
| A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor [NCT00025545] | Phase 2 | 0 participants | Interventional | 1996-03-31 | Completed |
| Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study [NCT00027573] | Phase 2 | 36 participants (Actual) | Interventional | 2001-10-31 | Completed |
| Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients With B-Cell Non-Hodgkin's Lymphoma [NCT00028665] | Phase 2 | 37 participants (Actual) | Interventional | 2000-06-30 | Completed |
| Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning: a Phase II Randomized Study From the Belgian Hematology Society (BHS) [NCT03852407] | Phase 2 | 114 participants (Anticipated) | Interventional | 2019-02-04 | Recruiting |
| Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma [NCT00393107] | Phase 2 | 54 participants | Interventional | 2000-03-31 | Completed |
| Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL) [NCT00032019] | Phase 2 | 78 participants (Actual) | Interventional | 2002-02-28 | Completed |
| Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL) [NCT00276848] | Phase 3 | 375 participants (Actual) | Interventional | 1999-07-31 | Completed |
| Campath 1H (Alemtuzumab) Combined With High-Dose Therapy and Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia [NCT00276809] | Phase 2 | 30 participants (Anticipated) | Interventional | 2001-06-30 | Completed |
| Randomized Study of Radiotherapy in Patients With Stage 2B/3 (INSS) Neuroblastoma in Children Over 1 Year of Age [NCT00276731] | Phase 3 | 0 participants | Interventional | 1995-03-31 | Active, not recruiting |
| Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL [NCT00275015] | Phase 2 | 169 participants (Actual) | Interventional | 1998-01-31 | Completed |
| A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma [NCT05020444] | Phase 1 | 18 participants (Anticipated) | Interventional | 2021-10-05 | Recruiting |
| A Phase Ib, Open-Label, Multicohort Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Patients With Triple-Negative Breast Cancer [NCT04584112] | Phase 1 | 83 participants (Actual) | Interventional | 2020-09-28 | Completed |
| A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease (GVHD) [NCT04202835] | Phase 2 | 80 participants (Anticipated) | Interventional | 2020-10-13 | Recruiting |
| A Phase I Open Label Clinical Trial Evaluating the Safety and Efficacy of Adoptive Transfer of NY-ESO-1 TCR Engineered Autologous T Cells in Combination With Decitabine in Patients With Recurrent or Treatment Refractory Ovarian Cancer [NCT03017131] | Phase 1 | 9 participants (Actual) | Interventional | 2017-12-08 | Active, not recruiting |
| Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Ne [NCT00630032] | Phase 3 | 762 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Phase 1/2 Trial of TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Acute Lymphoblastic Leukemia (ALL) [NCT04323657] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2020-03-27 | Completed |
| Safety and Efficacy of Campath in Nonmyeloablative Transplantation [NCT00038844] | | 65 participants (Actual) | Interventional | 2001-06-30 | Completed |
| A Randomized Study of Two Methods of CNS Prophylaxis in Patients With Acute Lymphoblastic Leukemia [NCT00019409] | Phase 3 | 0 participants (Actual) | Interventional | 1999-10-31 | Withdrawn |
| Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life [NCT00039351] | Phase 2 | 32 participants (Actual) | Interventional | 2002-03-31 | Completed |
| 'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer [NCT00039546] | Phase 3 | 0 participants | Interventional | 2001-08-31 | Active, not recruiting |
| Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial [NCT00343785] | Phase 2 | 21 participants (Actual) | Interventional | 2006-02-28 | Completed |
| Intensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple Sclerosis [NCT00040482] | Phase 2 | 10 participants | Interventional | 1999-04-30 | Completed |
| N8: Dose-Intensive Chemotherapy Plus Biologics in the Treatment of Neuroblastoma [NCT00040872] | Phase 2 | 0 participants | Interventional | 2000-06-30 | Completed |
| Pentostatin, Cyclophosphamide And Rituximab (PCR) For B-Cell Chronic Lymphocytic Leukemia (CLL) And Small B-Cell Lymphocytic Lymphoma (SLL): Four Phase II Trials With Patient Stratification Based On Prior Therapy [NCT00049413] | Phase 2 | 0 participants | Interventional | 2002-06-30 | Completed |
| Intensive Induction Therapy for Children With Acute Lymphoblastic Leukemia (ALL) Who Experience a Bone Marrow Relapse [NCT00049569] | | 126 participants (Anticipated) | Interventional | 2003-01-31 | Completed |
| An Open Label Prospective Randomised Study Comparing The Use Of Vincristine, Adriamycin And Cyclophosphamide (VAC) Versus Epirubicin, Cisplatin And Continuous 5-Flourouracil (ECF) In Patients With Unknown Primary Carcinoma (UPC) [NCT00022178] | Phase 3 | 0 participants | Interventional | 1998-12-31 | Active, not recruiting |
| Safety and Efficacy of Sequential Treatment With a Combination of Rituximab, Fludarabine and Cyclophosphamide Followed by Zevalin (Rituximab and Y-Ibritumomab Tiuxetan) - A Phase I/II Study for Treatment of Patients With Relapsed Indolent and Transformed [NCT00397800] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2005-06-30 | Active, not recruiting |
| "Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of Less Advanced Myelodysplasi" [NCT00024050] | Phase 2 | 0 participants | Interventional | 2001-02-28 | Completed |
| A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castlem [NCT03864419] | Phase 1 | 40 participants (Anticipated) | Interventional | 2019-10-24 | Recruiting |
| Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma (NHL and HD) [NCT00024128] | Phase 2 | 0 participants (Actual) | Interventional | 2001-08-31 | Withdrawn(stopped due to Withdrawn prior to initiation.) |
| Randomized Study Of Fludarabine And Cyclophosphamide With Or Without Genasense (Bcl-2 Antisense Oligonucleotide) In Subjects With Relapsed Or Refractory Chronic Lymphocytic Leukemia [NCT00024440] | Phase 3 | 0 participants | Interventional | 2001-07-31 | Completed |
| Randomized Phase III Trial Of Rituximab (NSC #687451) And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma [NCT00052923] | Phase 3 | 427 participants (Anticipated) | Interventional | 2003-03-31 | Completed |
| Protocol For The Treatment Of Relapsed And Refractory Wilms Tumour And Clear Cell Sarcoma Of The Kidney (CCSK) [NCT00025103] | Phase 2 | 75 participants (Anticipated) | Interventional | 2001-05-31 | Active, not recruiting |
| European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN Not Amplified [NCT00025610] | Phase 2 | 0 participants | Interventional | 1999-07-31 | Completed |
| European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors [NCT00025649] | Phase 2 | 0 participants | Interventional | 1999-07-31 | Completed |
| Phase II Trial of T-Cell Depleted Hematopoietic Stem Cell Transplants (SBA-E-BM) From HLA Compatible Related or Unrelated Donors After a Myeloablative Preparative Regimen of Hyperfractionated TBI, Thiotepa and Cyclophosphamide (TBI/Thio/cy) for Treatment [NCT00028730] | Phase 2 | 25 participants (Actual) | Interventional | 2001-08-31 | Completed |
| A Randomized Phase III Study On The Effect Of Thalidomide Combined With Adriamycin, Dexamethasone (AD) And High Dose Melphalan In Patients With Multiple Myeloma [NCT00028886] | Phase 3 | 450 participants (Anticipated) | Interventional | 2001-03-31 | Active, not recruiting |
| A Randomized, Double Blind, Pacebo-Controlled Study to Assess The Feasibility, Toxicity And Efficacy (Phase I/II) Of A Chinese Herbal Therapy (CHT) For Symptom Management In Women Undergoing Chemotherapy For Stage I/II/III Breast Cancer [NCT00028964] | Phase 1/Phase 2 | 0 participants | Interventional | 2001-02-28 | Completed |
| High Risk Neuroblastoma Study 1 Of Siop-Europe [NCT00030719] | Phase 3 | 175 participants (Anticipated) | Interventional | 2001-12-31 | Recruiting |
| Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis [NCT00058578] | Phase 1 | 24 participants | Interventional | 1999-06-30 | Completed |
| Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors [NCT00060255] | Phase 2 | 451 participants (Actual) | Interventional | 1991-12-31 | Completed |
| A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer [NCT00033683] | Phase 2 | 0 participants | Interventional | 2001-02-28 | Active, not recruiting |
| A Phase I Study Of G3139 Antisense Oligonucleotide (Oblimersen) In Combination With CHOP And Rituximab In Untreated Advanced Stage Diffuse Large B Cell Lymphoma [NCT00070083] | Phase 1 | 0 participants | Interventional | 2003-07-31 | Completed |
| A Pilot Induction Regimen Incorporating Topotecan for Treatment of Newly Diagnosed High Risk Neuroblastoma [NCT00070200] | Phase 1 | 31 participants (Actual) | Interventional | 2004-03-31 | Completed |
| A Phase III Randomized Neoadjuvant Study of Sequential Epirubicin/Cyclophosphamide and Paclitaxel + - Gemcitabine in Poor Risk Early Breast Cancer [NCT00070278] | Phase 3 | 800 participants (Anticipated) | Interventional | 2005-01-31 | Active, not recruiting |
| Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia [NCT00066417] | Phase 2 | 51 participants (Anticipated) | Interventional | | Terminated(stopped due to Trial was withdrawn for drug availability issues.) |
| Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer [NCT00038402] | Phase 3 | 74 participants (Actual) | Interventional | 2001-04-30 | Completed |
| Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies [NCT00068523] | | 10 participants (Actual) | Interventional | 2003-06-30 | Completed |
| Allogeneic Bone Marrow Transplant From HLA Identical Related Donors for Patients With High Risk Hemoglobinopathies: Hemoglobin SS, Hemoglobin SC, Hemoglobin SB0/+ Thalassemia, or Homozygous B0/+ Thalassemia or Severe Variants of B0/+ Thalassemia [NCT00040469] | Phase 2 | 15 participants | Interventional | 2000-08-31 | Terminated(stopped due to accrual was slow and sporadic so the study was closed) |
| Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation [NCT00209209] | Phase 3 | 570 participants (Anticipated) | Interventional | 2004-01-14 | Active, not recruiting |
| A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And Chronic Lymphocytic Leukemia (CLL) [NCT00041288] | Phase 2 | 10 participants (Actual) | Interventional | 2001-10-31 | Terminated(stopped due to Poor accrual and difficulty with multicenter logistics) |
| Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma [NCT00041327] | Phase 2 | 19 participants (Actual) | Interventional | 2002-10-31 | Completed |
| A Single-arm Study Evaluating the Relative Dose Intensity of IV CMF Given on Day 1 and Day 8 With Pegfilgrastim Support in Subjects With Stage I-III Breast Cancer [NCT00124111] | Phase 2 | 0 participants | Interventional | | Completed |
| CHUSPAN SCS BP Treatment of Churg-Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients. [NCT00399399] | Phase 4 | 72 participants | Interventional | 1996-07-31 | Active, not recruiting |
| A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer [NCT00074139] | Phase 1 | 0 participants (Actual) | Interventional | 2003-09-30 | Withdrawn(stopped due to No patients were enrolled) |
| Combination Chemotherapy (Methotrexate, Cyclophosphamide, And Etoposide Phosphate) Delivered In Conjunction With Osmotic Blood-Brain Barrier Disruption (BBBD), With Intraventricular Cytarabine +/- Intra-Ocular Chemotherapy, In Patients With Primary Centra [NCT00074178] | Phase 2 | 22 participants (Actual) | Interventional | 2000-01-31 | Completed |
| Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia [NCT00131053] | Phase 2 | 120 participants (Anticipated) | Interventional | 2002-09-30 | Recruiting |
| Nephroblastoma (Wilms Tumour) Clinical Trial And Study [NCT00047138] | Phase 3 | 350 participants (Anticipated) | Interventional | 2001-01-31 | Recruiting |
| Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) With Advanced Stage Diffuse Large B-Cel [NCT00080847] | Phase 2 | 160 participants (Actual) | Interventional | 2004-03-31 | Terminated |
| T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies [NCT00080925] | Phase 1 | 20 participants (Anticipated) | Interventional | 2004-02-29 | Completed |
| Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies [NCT00176839] | Phase 2/Phase 3 | 11 participants (Actual) | Interventional | 2000-06-07 | Terminated(stopped due to Replaced by a different study) |
| Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG) [NCT00147901] | Phase 2 | 61 participants (Actual) | Interventional | 2005-01-31 | Completed |
| Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer [NCT00148681] | Phase 2 | 49 participants (Actual) | Interventional | 2001-05-31 | Completed |
| Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa [NCT00049439] | Phase 2 | 54 participants (Actual) | Interventional | 1998-03-31 | Completed |
| A Phase I/II Study of Immunologically Engineered rhG-CSF Mobilized Peripheral Blood Stem Cells (PBSC) for Allogeneic Transplant From HLA Identical, Related Donors for Treatment of Myeloid Malignancies [NCT00049634] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2002-01-31 | Completed |
| A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC) [NCT00152191] | Phase 3 | 1,300 participants (Anticipated) | Interventional | 1996-10-31 | Completed |
| Metronomic Chemotherapy With Bevacizumab for Advanced Breast Cancer [NCT00083031] | Phase 2 | 57 participants (Actual) | Interventional | 2003-07-31 | Completed |
| UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients [NCT00083538] | Phase 2 | 40 participants (Actual) | Interventional | 2001-02-28 | Completed |
| Randomised Trial Comparing Chemotherapy Mit CHOEP (Cyclophosphamid, Doxorubicin, Vincristin, Etoposid Und Prednison) In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Pr [NCT00053768] | Phase 3 | 392 participants (Actual) | Interventional | 2002-04-30 | Completed |
| Double Dose Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Stage Neuroblastoma and Sarcomas [NCT00165139] | Phase 2 | 20 participants (Actual) | Interventional | 1996-01-31 | Completed |
| Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer [NCT00165451] | Phase 2 | 20 participants (Actual) | Interventional | 2001-06-30 | Completed |
| Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia [NCT00054236] | Phase 1 | 55 participants (Actual) | Interventional | 2002-05-31 | Completed |
| Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of [NCT00054587] | Phase 3 | 3,010 participants (Actual) | Interventional | 2001-06-30 | Completed |
| Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL). [NCT00169156] | Phase 2 | 27 participants (Actual) | Interventional | 2005-12-31 | Completed |
| Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma [NCT00055640] | Phase 2 | 9 participants (Actual) | Interventional | 2002-10-31 | Completed |
| Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer [NCT00055679] | Phase 3 | 1,512 participants (Actual) | Interventional | 2002-08-31 | Completed |
| An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvan [NCT00174655] | Phase 3 | 2,887 participants (Actual) | Interventional | 1998-06-30 | Completed |
| Evaluation of Response Rate to Pre-Operative Docetaxel + Herceptin Study Part A and Docetaxel Study Part B in Locally Advanced Breast Cancer Patients, Stratified by HER2-Status Trial - PHASE II [(Herceptin Docetaxel Neoadjuvant) HEDON] [NCT00398489] | Phase 2 | 94 participants (Anticipated) | Interventional | 2006-10-31 | Active, not recruiting |
| Haploidentical Donor NK Cell Adoptive Therapy and Double T Cell Depleted Umbilical Cord Blood Transplantation With Post-Transplant IL-2 Immune Therapy For Refractory Acute Myeloid Leukemia [NCT00871689] | Phase 2 | 2 participants (Actual) | Interventional | 2009-01-31 | Terminated(stopped due to Due to graft failure.) |
| Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL) [NCT00057005] | Phase 1 | 6 participants (Actual) | Interventional | 2003-02-28 | Completed |
| Efficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical Trial [NCT05532111] | | 60 participants (Anticipated) | Interventional | 2022-09-01 | Not yet recruiting |
| Pomalidomide, Ixazomib, and Dexamethasone (PId) With or Without Intensification by Cyclophosphamide (PICd): A Phase II Study in Relapsed or Refractory Multiple Myeloma [NCT03731832] | Phase 2 | 82 participants (Anticipated) | Interventional | 2018-09-20 | Active, not recruiting |
| Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia [NCT00187057] | | 6 participants (Actual) | Interventional | 2002-09-30 | Completed |
| A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL). [NCT00195871] | Phase 2 | 155 participants (Actual) | Interventional | 2004-02-29 | Active, not recruiting |
| A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia ( [NCT00199186] | Phase 2 | 0 participants | Interventional | 2002-03-31 | Recruiting |
| Tumor Infiltrating Lymphocytes (TIL Cells) Transduced With An Interleukin-2 (SBIL-2) Gene Following The Administration Of A Nonmyeloablative But Lymphocyte Depleting Regimen in Metastatic Melanoma [NCT00062036] | Phase 1/Phase 2 | 33 participants (Anticipated) | Interventional | 2003-06-30 | Completed |
| A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor [NCT00095862] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2004-11-30 | Terminated |
| Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer [NCT00559845] | Phase 2 | 56 participants (Actual) | Interventional | 2008-02-29 | Completed |
| A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma [NCT00337987] | Phase 2 | 49 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma [NCT00345865] | Phase 2 | 473 participants (Actual) | Interventional | 2005-08-24 | Completed |
| HLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting Cyclophosphamide [NCT00358657] | Phase 2 | 14 participants (Actual) | Interventional | 2006-05-24 | Terminated(stopped due to Low accrual) |
| An Intergroup Phase II Clinical Trial for Adolescents and Young Adults With Untreated Acute Lymphoblastic Leukemia (ALL) [NCT00558519] | Phase 2 | 318 participants (Actual) | Interventional | 2008-03-12 | Active, not recruiting |
| A Phase II Study of Cell Transfer Therapy for Metastatic Melanoma Using 41BB Selected Tumor Infiltrating Lymphocytes Plus IL-2 Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen [NCT02111863] | Phase 2 | 6 participants (Actual) | Interventional | 2014-02-21 | Terminated(stopped due to Study terminated due to low accrual and change in research focus.) |
| Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL) [NCT00412243] | Phase 1/Phase 2 | 51 participants (Actual) | Interventional | 2006-03-31 | Completed |
| A Phase II Clinical Trial of Bevacizumab Beginning Concurrently With a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy Followed by Postoperative Bevacizumab Alone for Women With Locally [NCT00365417] | Phase 2 | 45 participants (Actual) | Interventional | 2006-08-31 | Completed |
| Allogeneic Natural Killer Cells in Patients With Advanced Metastatic Breast Cancer [NCT00376805] | Phase 2 | 6 participants (Actual) | Interventional | 2006-04-30 | Terminated(stopped due to Withdrawn due to toxicity) |
| Phase I/II Study of Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-Associated Large Cell Lymphoma [NCT02911142] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2017-07-03 | Active, not recruiting |
| Enhancing Immunotherapy by Targeting the EGFR Pathway in Inflammatory Breast Cancer: A Phase II Study of Panitumumab (PmAb) and Pembrolizumab (Pembro) in Combination With Neoadjuvant Chemotherapy (NAC) in Patients With Newly Diagnosed Triple Negative Infl [NCT05177796] | Phase 2 | 0 participants (Actual) | Interventional | 2022-03-11 | Withdrawn(stopped due to 0 participants recruited) |
| Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies [NCT03241940] | Phase 1 | 50 participants (Anticipated) | Interventional | 2017-10-20 | Recruiting |
| Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies [NCT03233854] | Phase 1 | 60 participants (Anticipated) | Interventional | 2017-09-01 | Recruiting |
| A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With B Cell Lymphoid Malignancies [NCT00387959] | Phase 2 | 17 participants (Actual) | Interventional | 2006-07-31 | Completed |
| A Phase II Study of Combination Oral CC-5013 Lenalidomide (Revlimid™), Oral Sunitinib (Sutent™) and Low Dose Oral Metronomic Cyclophosphamide for the Treatment of Stage IV Ocular Melanoma [NCT00482911] | Phase 2 | 12 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to Investigator left the institute.) |
| A Two Step Approach To Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies From HLA Partially-Matched Related Donors [NCT00429143] | Phase 1/Phase 2 | 27 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH [NCT04540380] | Phase 1 | 6 participants (Anticipated) | Interventional | 2021-09-01 | Recruiting |
| Comparing Post-Transplant Cyclophosphamide With Calcineurin Inhibitors as A GVHD Prophylaxis to Standard Care of Methotrexate and Calcineurin Inhibitors for Acute Leukemia Incorporating Patient Pharmacogenomics Profiling [NCT04314219] | Phase 3 | 264 participants (Anticipated) | Interventional | 2021-08-15 | Recruiting |
| Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen [NCT01873833] | Phase 2 | 10 participants (Actual) | Interventional | 2013-07-29 | Terminated(stopped due to Insufficient accrual) |
| A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched and HLA-Matched Bone Marrow for Patients With Sickle Cell Anemia and Other Hemoglobinopathies [NCT00489281] | Phase 2 | 43 participants (Actual) | Interventional | 2008-06-23 | Terminated(stopped due to Initiation of CMS BMT study for sickle-cell disease operating under NCT01166009 made further accrual to this study impossible.) |
| High Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma) [NCT00501995] | Phase 3 | 6 participants (Actual) | Interventional | 2001-02-28 | Completed |
| T-Regulatory Cell Kinetics Post Transplant For Patients Undergoing Matched Sibling Stem Cell Transplantation [NCT00578461] | | 26 participants (Actual) | Interventional | 2007-10-31 | Terminated |
| T-Regulatory Cell Kinetics for Patients Receiving Alemtuzamb and Undergoing Stem Cell Transplantation From HLA Mismatched-Related, or HLA Matched, or One Antigen Mismatched-Unrelated Donors [NCT00578539] | | 24 participants (Actual) | Interventional | 2007-10-31 | Terminated |
| A Phase II Trial of Preoperative Cisplatin and Bevacizumab in Estrogen Receptor (ER) Negative, Progesterone (PR) Negative, Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer [NCT00580333] | Phase 2 | 51 participants (Actual) | Interventional | 2007-09-30 | Completed |
| MT2007-12 Allogeneic Natural Killer Cells With Rituximab in Patients With CD20 Positive Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia. Strategies to Increase Sensitivity of CLL Tumor Cells to Natural Killer Cell-Immune-Mediated Cytolysis [NCT00625729] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2008-01-31 | Terminated(stopped due to No patients exhibited natural killer cell expansion (primary endpoint).) |
| Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform [NCT05916755] | | 100 participants (Anticipated) | Observational | 2023-01-13 | Recruiting |
| A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer [NCT05914753] | | 200 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
| A Study of Cyclophosphamide, Fludarabine, and Antithymocyte Globulin Followed by Matched Sibling Donor Hematopoietic Cell Transplantation in Patients With Fanconi Anemia [NCT00630253] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2000-02-17 | Completed |
| A Phase II Study of Combination Nilotinib and Hyper-CVAD in Patients Newly Diagnosed With Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia Blast-Phase Lymphoid Lineage [NCT01670084] | Phase 2 | 0 participants (Actual) | Interventional | 2012-12-31 | Withdrawn(stopped due to No Accrual) |
| Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With R-CHOP in a Cohort of Patients With DLBCL/tFL/ High Grade B-NHL [NCT03704714] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2018-11-20 | Suspended(stopped due to Protocol being amended for stats/accrual changes as per PI) |
| A Multi-Center Phase I/II Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) [NCT00667615] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Nonrandomized Ph II Study of Multimodality Therapy for Stg IIB, IIIA/B, or Stg IV Breast Cancer w/4 Cycles of Adriamycin and Cytoxan (AC),Followed by 12 Weeks of Paclitaxel w/ or w/o Herceptin Followed by Local Therapy Followed by Wkly Herceptin or no Add [NCT00006110] | Phase 2 | 82 participants (Actual) | Interventional | 1998-12-31 | Completed |
| Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors (SAA MUD) [NCT00578903] | Phase 2 | 22 participants (Actual) | Interventional | 2002-02-28 | Terminated |
| Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma [NCT03084380] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2017-06-01 | Not yet recruiting |
| DLCL002 Protocol for Young Patients With Newly Diagnosed High Risk Aggressive B-cell Lymphoma, a Multicenter Phase II Study [NCT03837873] | Phase 2 | 118 participants (Anticipated) | Interventional | 2019-01-21 | Recruiting |
| Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy [NCT04771871] | Phase 2 | 42 participants (Anticipated) | Interventional | 2021-11-29 | Recruiting |
| Asia-wide, Multicenter Open-label, Phase II Non-randomised Study Involving Children With Down Syndrome Under 21 Year-old With Newly Diagnosed, Treatment naïve Acute Lymphoblastic Leukemia [NCT03286634] | Phase 2 | 60 participants (Anticipated) | Interventional | 2017-04-18 | Recruiting |
| Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin in the Preoperative Setting: the BREAKFAST Trial [NCT04248998] | Phase 2 | 30 participants (Actual) | Interventional | 2020-05-05 | Active, not recruiting |
| Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma [NCT00637832] | Phase 2 | 1 participants (Actual) | Interventional | 2008-04-01 | Terminated(stopped due to no information) |
| Non-Myeloablative Chemotherapy Followed by HLA-Matched Related Allogeneic Stem Cell Transplantation for Hematologic Malignancies [NCT00741455] | | 18 participants (Actual) | Interventional | 2004-06-30 | Completed |
| Phase I/II Study of Metastatic Cancer That Expresses MAGE-A3/12 Using Lymphodepleting Conditioning Followed by Infusion of Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes [NCT01273181] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2010-12-31 | Terminated |
| An Open Label Phase I/II Study of the Safety and Efficacy of Cyclophosphamide, Bortezomib (VELCADE), Pegylated Liposomal Doxorubicin (DOXIL), and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma [NCT00750815] | Phase 1/Phase 2 | 58 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies. [NCT00800839] | Phase 2 | 56 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Phase II Study of CD62L+-Derived T Lymphocytes Transduced With a T Cell Receptor Recognizing the NY-ESO-1 Antigen and Aldesleukin Following Lymphodepletion in Patients With NY-ESO-1 Expressing Melanoma [NCT02062359] | Phase 2 | 2 participants (Actual) | Interventional | 2014-02-28 | Terminated(stopped due to Study was closed due to poor accrual.) |
| A Randomized Phase II Trial of R-HCVAD/MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant Vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients ≤ 65 Years of Age With [NCT01412879] | Phase 2 | 53 participants (Actual) | Interventional | 2011-11-30 | Completed |
| T Cell Therapy in Combination With Peginterferon for Patients With Metastatic Melanoma [NCT02379195] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Allogeneic Hematopoietic Stem Cell Transplantation For Severe Osteopetrosis [NCT00775931] | Phase 2/Phase 3 | 7 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Combination Pegylated Liposomal Doxorubicin, Bortezomib, Cyclophosphamide, and Dexamethasone for Multiple Myeloma (PLD-BCD) [NCT00849251] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to One of the study drugs is not available.) |
| A Phase I/IIa Open Label, Non-Randomized, Multicenter Study of CYNK-101 in Combination With Trastuzumab and Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Aenocarcinoma [NCT05207722] | Phase 1/Phase 2 | 52 participants (Anticipated) | Interventional | 2022-04-14 | Active, not recruiting |
| Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma [NCT00866749] | Phase 2 | 120 participants (Actual) | Interventional | 2006-09-12 | Completed |
| Phase II Study of Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER2-Negative Breast Cancer [NCT00866905] | Phase 2 | 168 participants (Actual) | Interventional | 2009-04-30 | Completed |
| A Randomized Phase II Study to Compare the Net Clinical Benefit of Cyclosporine and Sirolimus Combined With MMF or Post-Transplant Cyclophosphamide as GVHD Prophylaxis After HLA-Matched or HLA-Mismatched Unrelated G-CSF Mobilized Blood Cell Transplantatio [NCT03246906] | Phase 2 | 160 participants (Anticipated) | Interventional | 2017-09-11 | Recruiting |
| Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL) [NCT01839097] | Phase 1 | 23 participants (Actual) | Interventional | 2013-05-31 | Completed |
| T-Cell Depleted Double UCB With Post Transplant IL-2 for Refractory Myeloid Leukemia [NCT01464359] | Phase 2 | 3 participants (Actual) | Interventional | 2011-10-31 | Terminated(stopped due to Slow accrual) |
| Phase II Subcutaneous VELCADE and Oral Cyclophosphamide-based Induction + Sequential VELCADE and Revlimid Maintenance for Newly Diagnosed Multiple Myeloma in Non-transplant Candidates: An Entirely Non-intravenous Regimen [NCT01729338] | Phase 2 | 17 participants (Actual) | Interventional | 2012-12-19 | Terminated |
| A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy [NCT06019507] | Phase 2 | 12 participants (Anticipated) | Interventional | 2022-06-29 | Recruiting |
| A Phase II Trial of De-escalated PTCy and Ruxolitinib for GVHD Prophylaxis in Patients Undergoing Reduced Intensity Conditioning Allogeneic HCT [NCT05622318] | Phase 2 | 56 participants (Anticipated) | Interventional | 2023-08-29 | Recruiting |
| A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome [NCT05027945] | Phase 2 | 37 participants (Anticipated) | Interventional | 2023-02-23 | Recruiting |
| Open-label Phase I, Multi-center Study to Determine the Recommended Dose of CYAD-211 After a Non-myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients With Relapsed or Refractory Disease [NCT04613557] | Phase 1 | 18 participants (Actual) | Interventional | 2020-11-16 | Active, not recruiting |
| Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis [NCT04384692] | Phase 2 | 45 participants (Anticipated) | Interventional | 2020-12-18 | Recruiting |
| Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for Patients With Relapsing Remitting Multiple Sclerosis [NCT03477500] | Phase 3 | 100 participants (Anticipated) | Interventional | 2018-03-21 | Recruiting |
| A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL [NCT03150693] | Phase 3 | 310 participants (Anticipated) | Interventional | 2017-06-01 | Suspended(stopped due to Unacceptable Toxicity) |
| An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer [NCT03099356] | Phase 2 | 19 participants (Anticipated) | Interventional | 2017-04-27 | Recruiting |
| A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer With T -Cells Transduced With CXCR2 and NGFR Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma [NCT01740557] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2015-01-28 | Completed |
| A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma [NCT01231906] | Phase 3 | 642 participants (Actual) | Interventional | 2010-11-22 | Active, not recruiting |
| An Multicenter, Randomized, Controlled, Prospective Clinical Study of Mitoxantrone Liposome Combined With PTCy as Conditioning Regimen in Allo-HSCT in Acute Leukemia [NCT05739630] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2023-01-01 | Recruiting |
| Non-myeloablative Hematopoietic Stem Cell Transplantation for Stiff Person Syndrome (SPS) and Anti-GAD Antibody Variants: Progressive Encephalomyelitis With Rigidity and Myoclonus (PERM), and Adult Onset Autoimmune Anti-GAD Positive Cerebellar Ataxia [NCT02282514] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2014-10-31 | Terminated(stopped due to Could not predict who would respond, relapse or go into remission) |
| Haploidentical Transplant for Patients With Chronic Granulomatous Disease (CGD) Using Post-Transplant Cyclophosphamide [NCT02282904] | Phase 1/Phase 2 | 7 participants (Actual) | Interventional | 2014-10-23 | Terminated |
| Randomized Open Label Phase II Trial of Neoadjuvant Carboplatin Plus Docetaxel or Carboplatin Plus Paclitaxel Followed by Doxorubicin Plus Cyclophosphamide in Stage I-III Triple-negative Breast Cancer [NCT02413320] | Phase 2 | 101 participants (Actual) | Interventional | 2015-07-31 | Completed |
| Clinical Study of the Efficacy and Safety of XPO-1 Inhibitors in Combination With CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma [NCT05322330] | Phase 2 | 20 participants (Anticipated) | Interventional | 2022-02-10 | Recruiting |
| Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL) [NCT00596154] | Phase 2 | 33 participants (Actual) | Interventional | 2004-12-31 | Completed |
| Phase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical Transplantation [NCT02960646] | Phase 1 | 11 participants (Actual) | Interventional | 2017-01-18 | Completed |
| A Phase ll Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (RM-CHOP) for Previously Untreated Aggressive Diffuse Large B-cell Lymphoma [NCT02531308] | Phase 2 | 5 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to poor accrual) |
| a 3 Arm Randomized Study on Health-related Quality of Life of Elderly Patients With Advanced Soft Tissue Sarcoma Undergoing Doxorubicin Alone Every Three Weeks or Doxorubicin Weekly or Cyclophosphamide Plus Predniso(lo)ne Treatment [NCT04780464] | Phase 3 | 185 participants (Anticipated) | Interventional | 2022-04-11 | Recruiting |
| Phase Ib/II Study of the Combination of Low-Intensity Chemotherapy and Tagraxofusp in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT05032183] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2022-02-17 | Recruiting |
| A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer. [NCT00176605] | Phase 2 | 15 participants (Actual) | Interventional | 2005-05-31 | Completed |
| Risk-stratified Therapy for Primary and Secondary AML and MDS. A Randomized Study by AMLCG in Relation to Cytogenetically Defined Prognostic Factors (1) on the Role of High-dose AraC as Part of Double Induction, (2) on G-CSF Priming, and (3) on High-dose [NCT00266136] | Phase 3 | 3,500 participants (Actual) | Interventional | 1999-06-30 | Completed |
| The Effect of Metformin on Breast Cancer Patients [NCT04559308] | Phase 2 | 80 participants (Anticipated) | Interventional | 2019-06-01 | Recruiting |
| Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01 [NCT00235235] | | 80 participants (Actual) | Observational | 2005-09-30 | Terminated(stopped due to Funding terminated) |
| Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL [NCT04548700] | Phase 1 | 63 participants (Anticipated) | Interventional | 2020-12-24 | Recruiting |
| A Randomised Clinical Trial of Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in ANCA Associated Vasculitis. [NCT00414128] | Phase 2/Phase 3 | 140 participants (Actual) | Interventional | 2007-03-31 | Completed |
| A Phase II (Single Center) Study of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer [NCT02215876] | Phase 2 | 0 participants (Actual) | Interventional | 2014-09-30 | Withdrawn(stopped due to No patients recruited.) |
| Single Patient Protocol: A Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab [NCT04536922] | Phase 2 | 0 participants (Actual) | Interventional | 2021-01-27 | Withdrawn(stopped due to Subject no longer able to participate in this single pt study.) |
| Study of Carfilzomib in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma [NCT02217163] | Phase 2 | 30 participants (Actual) | Interventional | 2014-10-31 | Completed |
| Phase II Trial of Rituximab and Autologous Stem Cell Transplantation for Refractory B Cell Large Cell Lymphoma [NCT00242996] | Phase 2 | 44 participants (Anticipated) | Interventional | 2004-03-31 | Completed |
| Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL. [NCT00244127] | Phase 2 | 75 participants | Interventional | 2002-10-31 | Active, not recruiting |
| Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma [NCT00245141] | Phase 2 | 32 participants (Anticipated) | Interventional | 2004-05-31 | Recruiting |
| [NCT00284271] | Phase 2 | 65 participants (Actual) | Interventional | 2004-01-31 | Completed |
| UKCCSG Stage IIB/3 (INSS) Neuroblastoma Pilot Study [ENSG VI (Pilot 2B/3)] [NCT00416676] | Phase 3 | 30 participants (Anticipated) | Interventional | | Active, not recruiting |
| Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-day Intervals, Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Year [NCT00278421] | Phase 3 | 592 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Optimising Therapy for Boys With Hodgkin's Lymphoma and Quality Assurance of Therapy for Girls With Hodgkin's Lymphoma Until Start of a New Prospective Trial for Hodgkin's Lymphoma in Childhood and Adolescence [NCT00416832] | Phase 2 | 648 participants (Anticipated) | Interventional | 2002-11-30 | Completed |
| "Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer" [NCT01641406] | Phase 2 | 60 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
| Treatment of Advanced Chronic Lymphocytic Leukemia (CLL) Fludarabine, Mitoxantrone and Cyclophosphamide With or Without G-CSF [NCT00416910] | Phase 3 | 83 participants (Actual) | Interventional | 1999-07-31 | Terminated(stopped due to low recruitment) |
| Purine Analog-Based Conditioning for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic Anemia [NCT00427336] | | 9 participants (Actual) | Interventional | 2000-12-31 | Completed |
| Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL [NCT00281931] | Phase 2 | 21 participants (Anticipated) | Interventional | 1999-09-30 | Terminated |
| Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study [NCT00107380] | Phase 2 | 86 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Nonmyeloablative Bone Marrow Transplants in Hematologic Malignancies: Dose Finding Study for Post-Transplant Immunosuppression [NCT00255710] | Phase 1 | 60 participants (Anticipated) | Interventional | 2002-07-31 | Completed |
| Transplantation of Umbilical Cord Blood From Related and Unrelated Donors [NCT00290628] | | 43 participants (Actual) | Interventional | 1999-10-31 | Terminated(stopped due to Replaced with another study) |
| 2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC) [NCT00290667] | Phase 2 | 586 participants (Actual) | Interventional | 2004-02-29 | Completed |
| Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma [NCT00262886] | Phase 2 | 35 participants (Anticipated) | Interventional | 2001-08-31 | Completed |
| [NCT00265031] | Phase 3 | 0 participants | Interventional | 1999-01-31 | Completed |
| "Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx, Doxil) for Women (Age 66 Years or Older) With Endocrine Nonresponsive Breast Cancer Who Are Not Suitable for Being Offered a Standard Chemotherapy Regimen" [NCT00296010] | Phase 3 | 77 participants (Actual) | Interventional | 2005-08-31 | Terminated(stopped due to Accrual rate was too low) |
| Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Multiple Sclerosis [NCT00296205] | Phase 2 | 25 participants (Anticipated) | Interventional | 2003-10-31 | Withdrawn(stopped due to I am changing locations to Johns Hopkins Medical Center) |
| Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen [NCT00270881] | Phase 1/Phase 2 | 33 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants [NCT00307671] | Phase 4 | 108 participants (Actual) | Interventional | 2005-07-31 | Completed |
| QUILT-3.080: Phase 1B/2 Trial Of The NANT Pancreatic Cancer Vaccine As Treatment For Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-Of-Care Therapy [NCT03586869] | Phase 1/Phase 2 | 173 participants (Anticipated) | Interventional | 2018-07-28 | Active, not recruiting |
| Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia [NCT00278213] | Phase 2 | 17 participants (Anticipated) | Interventional | 2002-09-30 | Completed |
| Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-day Intervals or 14-d [NCT00278408] | Phase 3 | 700 participants (Actual) | Interventional | 2005-11-30 | Completed |
| European Infant Neuroblastoma Study Final Protocol [NCT00417053] | Phase 3 | 0 participants | Interventional | | Active, not recruiting |
| An Open Label Phase II Trial to Investigate the Cardiac Effects of Pegylated Liposomal Doxorubicine (Caelyx) in Elderly Breast Cancer Patients With New Imaging and Biochemical Techniques. [NCT00284336] | Phase 2 | 16 participants | Interventional | 2006-01-31 | Completed |
| Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab [NCT00285389] | Phase 2 | 39 participants (Actual) | Interventional | 2002-02-28 | Completed |
| A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer [NCT00288002] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2005-01-31 | Completed |
| A Phase Ib Open-Label Study Evaluating the Safety and Efficacy of NKTR-255 in Combination With CD19-Directed CAR-T Cell Therapy in Patients With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) [NCT05359211] | Phase 1 | 24 participants (Anticipated) | Interventional | 2022-12-08 | Recruiting |
| An Adaptive Randomized Neoadjuvant Two Arm Trial in Triple-negative Breast Cancer Comparing a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy (neoMono) [NCT04770272] | Phase 2 | 416 participants (Actual) | Interventional | 2021-03-01 | Active, not recruiting |
| Phase II Study of Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation [NCT04679012] | Phase 2 | 20 participants (Anticipated) | Interventional | 2021-09-24 | Recruiting |
| BRAVO: Newly-Diagnosed Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Recovery From Focal Radiotherapy Alone or Focal Radiotherapy and Dose-intensified Temozolomide (Phase I) [NCT03396575] | Phase 1 | 21 participants (Anticipated) | Interventional | 2018-07-17 | Active, not recruiting |
| A Prospective, Randomized, Multicenter, Open-label Comparison of Pre-surgical Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy Given for Twelve Weeks With a Quality of Life Assessment of Trastuzumab, Pertu [NCT03272477] | Phase 2 | 257 participants (Actual) | Interventional | 2017-10-05 | Active, not recruiting |
| 2015-12: A Phase II Study Exploring the Use of Early and Late Consolidation/Maintenance With Anti-CD38 (Protein) Monoclonal Antibody to Improve Progression Free Survival in Patients With Newly Diagnosed Multiple Myeloma [NCT03004287] | Phase 2 | 50 participants (Anticipated) | Interventional | 2017-07-01 | Active, not recruiting |
| A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4) [NCT02625480] | Phase 1/Phase 2 | 116 participants (Anticipated) | Interventional | 2016-02-01 | Recruiting |
| Multicenter Therapy Optimizing Study for Treatment of Children and Adolescents With Intracranial Medulloblastoma / PNET and Ependymoma [NCT00303810] | | 567 participants (Actual) | Interventional | 2001-01-31 | Completed |
| Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma [NCT00324831] | Phase 3 | 480 participants (Anticipated) | Interventional | | Suspended |
| Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia [NCT00295997] | | 35 participants (Anticipated) | Interventional | 2005-05-31 | Active, not recruiting |
| A Phase II Study Using a Peptide Vaccine With or Without Aldesleukin Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma [NCT00303836] | Phase 2 | 58 participants (Actual) | Interventional | 2005-11-30 | Terminated |
| Five-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intrav [NCT00336414] | Phase 3 | 0 participants (Actual) | Interventional | 2006-06-30 | Withdrawn(stopped due to the study is withdrawn due to low and unexpected enrollment rate) |
| A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients [NCT00309569] | Phase 3 | 429 participants (Actual) | Interventional | 1991-10-31 | Completed |
| CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT) [NCT00309881] | Phase 2 | 75 participants (Anticipated) | Interventional | 2003-04-30 | Completed |
| Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment [NCT00309920] | | 1,234 participants (Anticipated) | Interventional | 2004-01-31 | Recruiting |
| Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE] [NCT00311636] | Phase 3 | 280 participants (Anticipated) | Interventional | 2003-09-30 | Completed |
| Combined Modality Treatment for Patients With Stage IV Melanoma: Cyclophosphamide and a Dendritic Cell Vaccine Loaded With Killed Allogeneic Melanoma Cells [NCT00313235] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2006-03-31 | Completed |
| A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25) [NCT05537766] | Phase 2 | 90 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
| Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopa [NCT01503905] | | 600 participants (Anticipated) | Interventional | 2011-12-31 | Recruiting |
| Phase Ib Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors [NCT02869217] | Phase 1 | 22 participants (Anticipated) | Interventional | 2016-09-30 | Active, not recruiting |
| HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3 Depletion for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors After Conditioning of TBI, Fludarabine, Cyclophosphamide and Antithymocyte Glo [NCT01509300] | Phase 1/Phase 2 | 10 participants (Anticipated) | Interventional | 2012-01-31 | Recruiting |
| Natural Killer Cells in Allogeneic Cord Blood Transplantation [NCT01619761] | Phase 1 | 13 participants (Actual) | Interventional | 2013-05-03 | Active, not recruiting |
| Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma [NCT01622439] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma [NCT00003605] | Phase 2 | 0 participants (Actual) | Interventional | 1998-05-31 | Withdrawn(stopped due to no patient accrual) |
| Phase II Pilot Study of Cyclophosphamide Therapy for Refractory Antibody-Mediated Rejection in Kidney Transplantation [NCT01630538] | Phase 2 | 4 participants (Actual) | Interventional | 2013-06-30 | Terminated(stopped due to After March 2015, unable to enroll due to patients meeting exclusion criteria.) |
| A Randomized Trial Comparing CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy in Older Adults With Acute Myelogenous Leukemia in First Complete Remission [NCT01639456] | Phase 2 | 0 participants (Actual) | Interventional | 2013-10-31 | Withdrawn(stopped due to study was abandoned and a new study was written to replace this one) |
| A Phase Ib Trial of Zanubrutinib in Combination With R-CHOP (ZaR-CHOP) for Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT04850495] | Phase 1 | 24 participants (Anticipated) | Interventional | 2021-11-16 | Suspended(stopped due to Pending amendment) |
| Hematopoietic Stem Cell Transplantation Using Alternate Donor Umbilical Cord Blood Options [NCT01652014] | Phase 2 | 0 participants (Actual) | Interventional | 2014-01-31 | Withdrawn(stopped due to Funding unavailable) |
| Autologous CD19 Specific T-cell Infusion in Patients With B-cell Chronic Lymphocytic Leukemia (B-CLL) [NCT01653717] | Phase 1 | 30 participants (Anticipated) | Interventional | 2013-06-11 | Completed |
| Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognos [NCT01659099] | Phase 3 | 671 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to experimental treatment not Superior to standard - no need to continue the follow-up) |
| A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to ASCT in Patients With Transplant Eligible Newly Diagnosed Myeloma [NCT01660750] | Phase 1 | 29 participants (Actual) | Interventional | 2013-01-31 | Completed |
| A Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of Therapy [NCT01679041] | Phase 2 | 1 participants (Actual) | Interventional | 2012-11-30 | Terminated(stopped due to Insufficient accruals; PI leaving site) |
| A Phase 2, Randomized Study of VELCADE® (Bortezomib), Dexamethasone, and Thalidomide Versus VELCADE® (Bortezomib), Dexamethasone, Thalidomide, and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma Who Are Candidates for Autologous Tr [NCT00531453] | Phase 2 | 98 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Comparison the Safety and Efficacy of Epirubicin Plus Cyclophosphamide (EC)Versus Docetaxel Plus Cyclophosphamide (TC) in Lymph Node Negative, ER Positive, Her2 Negative Breast Cancer Patients as Adjuvant Chemotherapy [NCT02549677] | Phase 4 | 294 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Dose Escalation Study of CD19 Chimeric Antigen Receptor (CAR) T Cells With a CD34 Selection Marker in Adults With Recurrent or Refractory B Cell Malignancies [NCT04214886] | Phase 1 | 24 participants (Anticipated) | Interventional | 2019-12-31 | Active, not recruiting |
| Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 F5 TCR-Gene Engineered Lymphocytes [NCT00509288] | Phase 2 | 24 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Molecular Imaging for Response Assessment of Bevacizumab + Docetaxel as Neoadjuvant Chemotherapy in Primary Breast Cancer [NCT01690325] | Phase 2 | 21 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to Therapy of HER2+ patients according to protocol was no longer appropriate. Patient enrolment behind planned schedule and challenges of site performance) |
| Neo-/Adjuvant Phase III Trial to Compare Intense Dose-dense Chemotherapy to Tailored Dose-dense Chemotherapy in Patients With High-risk Early Breast Cancer (GAIN-2) [NCT01690702] | Phase 3 | 2,886 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Dose Escalation Study Phase I/II of Umbilical Cord Blood-Derived CAR-Engineered NK Cells in Conjunction With Lymphodepleting Chemotherapy in Patients With Relapsed/Refractory B-Lymphoid Malignancies [NCT03056339] | Phase 1/Phase 2 | 44 participants (Actual) | Interventional | 2017-06-21 | Completed |
| An Open-label Phase II Study of the Efficacy and Safety of the Combination of Fludarabine, Cyclophosphamide and Rituximab in Patients With Chronic Lymphocytic Leukaemia Who Are Newly Diagnosed, Have Relapsed or Are Resistant to First-Line Treatment [NCT00812669] | Phase 2 | 52 participants (Actual) | Interventional | 2008-08-18 | Completed |
| Defining the Molecular Profile of Breast Cancer in Uganda and Its Clinical Implications [NCT03518242] | Phase 1 | 100 participants (Actual) | Interventional | 2018-06-06 | Completed |
| Adaptive Phase II Randomized Non-comparative Trial of Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients: TONIC-trial [NCT02499367] | Phase 2 | 84 participants (Anticipated) | Interventional | 2015-08-31 | Active, not recruiting |
| Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen [NCT02199041] | Phase 2 | 24 participants (Actual) | Interventional | 2014-07-11 | Terminated(stopped due to The study was halted early due to slow accrual.) |
| A Phase I/II Study Evaluating the Safety and Efficacy of Adding a Single Prophylactic Donor Lymphocyte Infusion (DLI) of Natural Killer Cells Early After Nonmyeloablative, HLA-Haploidentical Hematopoietic Cell Transplantation - A Multi Center Trial [NCT00789776] | Phase 1/Phase 2 | 41 participants (Actual) | Interventional | 2008-10-13 | Completed |
| A Phase I-II Study of PTX-200 Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer [NCT01697293] | Phase 1/Phase 2 | 34 participants (Actual) | Interventional | 2012-01-31 | Terminated(stopped due to criteria for continuing enrollment in Phase 2 portion was not met) |
| Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation [NCT02161783] | | 50 participants (Anticipated) | Observational | 2014-10-06 | Recruiting |
| High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN) [NCT01704716] | Phase 3 | 3,300 participants (Anticipated) | Interventional | 2002-02-28 | Recruiting |
| A Phase I Study of Adoptive Transfer of Autologous Tumour Antigen-Specific T Cells With Pre-conditioning Chemotherapy and Intravenous IL2 in Patients With CD19 Positive Malignancy [NCT01493453] | Phase 1 | 17 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to Investigation into serious breach) |
| Phase II Clinical Study of Metronomic Oral Cyclophosphamide in Elderly and/or Pre-treated Patients With Advanced Sarcomas [NCT01716689] | Phase 2 | 24 participants (Actual) | Interventional | 2012-06-30 | Completed |
| A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma [NCT05294055] | Phase 2 | 120 participants (Anticipated) | Interventional | 2022-04-26 | Recruiting |
| "A Phase II Study With a Sequential Clofarabine-cyclophosphamide Combination Schedule as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) in Adult Patients" [NCT01462253] | Phase 2 | 35 participants (Actual) | Interventional | 2012-10-31 | Completed |
| CHEMO-T: Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (CHOP) Versus Gemcitabine, Cisplatin and Methyl Prednisolone (GEM-P) in the First Line Treatment Of T-cell Lymphoma,a Multicentre Randomised Phase II Study [NCT01719835] | Phase 2 | 87 participants (Actual) | Interventional | 2012-03-31 | Active, not recruiting |
| Phase Ib, Single-arm, Proof-of-principle Trial Investigating the Cytokine Profile and Specific T Cell Response in Peripheral Blood of Non-small Cell Lung Cancer (NSCLC) Subjects With Unresected Stage III Disease Treated With L-BLP25 [NCT01731587] | Phase 1 | 0 participants (Actual) | Interventional | 2001-01-31 | Withdrawn(stopped due to The objectives of this trial are no longer deemed appropriate for the clinical development of L-BLP25 therefore this trial is withdrawn) |
| An Open-label,Multicenter Randomised Study of CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for the New Diagnosed Young Patients With T Cell Non-hodgkin Lymphoma [NCT01746992] | Phase 4 | 200 participants (Anticipated) | Interventional | 2012-09-30 | Active, not recruiting |
| Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis [NCT01749111] | Phase 3 | 3 participants (Actual) | Interventional | 2012-12-31 | Terminated(stopped due to Lack of accrual) |
| "Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients" [NCT06176339] | Phase 2 | 70 participants (Anticipated) | Interventional | 2023-12-15 | Not yet recruiting |
| Treatment Protocol for Newky Diagnosed Adult Ph-Chromosome Positive (BCR::ABL1) Acute Lymphoblastic Leukemia (LALPh2022) [NCT06175702] | | 150 participants (Anticipated) | Observational | 2023-12-25 | Not yet recruiting |
| CARTIMMUNE: A Single-Center Study of Patients With Autoimmune Diseases Receiving an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (KYV 101) [NCT06152172] | Phase 1 | 24 participants (Anticipated) | Interventional | 2024-02-29 | Not yet recruiting |
| Phase I/II Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer [NCT05922930] | Phase 1/Phase 2 | 51 participants (Anticipated) | Interventional | 2023-10-11 | Recruiting |
| An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23) [NCT05605899] | Phase 3 | 300 participants (Anticipated) | Interventional | 2023-02-10 | Recruiting |
| A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (AS [NCT05257083] | Phase 3 | 750 participants (Anticipated) | Interventional | 2023-10-10 | Recruiting |
| Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer [NCT05106296] | Phase 1 | 37 participants (Anticipated) | Interventional | 2022-02-08 | Recruiting |
| Phase I Study of GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Hepatocellular Carcinoma (HCC) [NCT05003895] | Phase 1 | 38 participants (Anticipated) | Interventional | 2021-12-08 | Recruiting |
| Phase 2 Trial of Indoximod With Chemotherapy and Radiation for Children With Progressive Brain Tumors or Newly Diagnosed DIPG [NCT04049669] | Phase 2 | 140 participants (Anticipated) | Interventional | 2019-10-02 | Recruiting |
| Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC) [NCT03742986] | Phase 2 | 8 participants (Actual) | Interventional | 2019-05-02 | Completed |
| A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Di [NCT03274492] | Phase 3 | 1,000 participants (Actual) | Interventional | 2017-11-16 | Active, not recruiting |
| A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy [NCT01758120] | Phase 4 | 135 participants (Actual) | Interventional | 2012-12-31 | Active, not recruiting |
| Haploidentical Stem Cell Transplantation With Fixed Dose of T Cells After in Vitro T Cell Depletion Using CD3 Monoclonal Antibody for Children With Acquired Severe Aplastic Anemia [NCT01759732] | Phase 2 | 10 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting |
| Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies [NCT01760226] | Early Phase 1 | 4 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Phase I/II Study of TLR7 Agonist Imiquimod, Cyclophosphamide, and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases [NCT01421017] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2011-08-19 | Completed |
| Phase 2 Multicenter, Study to Assess the Efficacy and the Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab (FCO2) Chemoimmunotherapy in Young (≤65 Yrs) Patients With Chronic Lymphocytic Leukemia (CLL). [NCT01762202] | Phase 2 | 80 participants (Actual) | Interventional | 2013-11-05 | Completed |
| Cyclophosphamide-Busulfan Versus Busulfan-Cyclophosphamide as Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Leukemia: a Prospective Randomized Study to Assess Liver Toxicity [NCT01779882] | | 72 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Chronic Effect of Doxorubicin and Cyclophosphamide on Neurovascular Control and Blood Pressure in Women in Adjuvant Treatment for Breast Neoplasia [NCT04568161] | | 15 participants (Anticipated) | Interventional | 2020-08-03 | Recruiting |
| A Phase II Study Evaluating Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors for Prevention of GVHD [NCT02220985] | Phase 2 | 84 participants (Actual) | Interventional | 2015-02-03 | Active, not recruiting |
| UARK 2008-02, A Phase II Trial for High-risk Myeloma Evaluation Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-host-exhausting and Timely Dose-reduced MEL-80-VRD-PACE Tandem Transplants [NCT00869232] | Phase 2 | 90 participants (Actual) | Interventional | 2008-10-31 | Active, not recruiting |
| Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study) [NCT01808911] | Phase 3 | 164 participants (Anticipated) | Interventional | 2012-05-31 | Recruiting |
| A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of DA-EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis [NCT01818908] | Phase 2 | 50 participants (Anticipated) | Interventional | 2012-06-30 | Active, not recruiting |
| High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) [NCT04221035] | Phase 3 | 800 participants (Anticipated) | Interventional | 2019-11-05 | Recruiting |
| A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14) [NCT04002401] | Phase 2 | 27 participants (Actual) | Interventional | 2019-11-05 | Completed |
| A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP. [NCT01843868] | | 130 participants (Anticipated) | Interventional | 2013-05-31 | Not yet recruiting |
| Lymphodepleting Chemotherapy With Rituximab and Allogeneic Natural Killer Cells for Patients With Refractory Lymphoid Malignancies (MT2009-15) [NCT01181258] | Phase 2 | 16 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Phase I/II Study in WT1-Expressing Non-small Cell Lung Cancer and Mesothelioma, Comparing Cellular Adoptive Immunotherapy With Polyclonal Autologous Central Memory to Naïve CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T-Cell Receptor [NCT02408016] | Phase 1/Phase 2 | 11 participants (Actual) | Interventional | 2015-05-22 | Terminated(stopped due to Terminated due to loss of funding) |
| Allogenic CD19-targeting Chimeric Antigen Receptor γδT Cells Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma [NCT05554939] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2022-12-11 | Recruiting |
| A Phase 2 Study of Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide in Relapsed/Refractory Multiple Myeloma [NCT03184194] | Phase 2 | 62 participants (Actual) | Interventional | 2018-02-21 | Active, not recruiting |
| A Multicentre, Open-label, Randomised Trial of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Posit [NCT05159193] | Phase 3 | 372 participants (Anticipated) | Interventional | 2021-12-20 | Recruiting |
| A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma [NCT05800366] | Phase 2 | 40 participants (Anticipated) | Interventional | 2023-04-06 | Recruiting |
| Neoadjuvant Therapy and Biomarker Analysis of Stage II and III Breast Cancer With Docetaxel/Capecitabine and Celecoxib Followed by Doxorubicin/Cyclophosphamide and Celecoxib [NCT00665457] | Phase 2 | 3 participants (Actual) | Interventional | 2004-04-15 | Terminated(stopped due to study drug was removed from the market and low enrollment.) |
| Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation for Patients With Hematologic Malignancies [NCT01749293] | Phase 2 | 3 participants (Actual) | Interventional | 2012-08-30 | Terminated(stopped due to The protocol design is being reconfigured in order to open a new study.) |
| A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer [NCT01547741] | Phase 3 | 1,871 participants (Actual) | Interventional | 2012-04-30 | Active, not recruiting |
| A Two Step Approach to Haploidentical Hematopoietic Stem Cell Transplantation for Patients in Remission From HLA Partially-Matched Related Donors-Effect of Maternal Donors on Outcomes [NCT01871441] | Phase 2 | 4 participants (Actual) | Interventional | 2013-05-17 | Terminated(stopped due to Trial was closed due to poor accrual.) |
| G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With Secondary Acute Myeloid Leukemia Evolving From MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT05449899] | Phase 2/Phase 3 | 232 participants (Anticipated) | Interventional | 2022-07-31 | Recruiting |
| Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes [NCT00003270] | Phase 2 | 20 participants (Actual) | Interventional | 1997-09-04 | Completed |
| Bridging Study: A Phase 2 Study Investigating Clofarabine, Cyclophosphamide and Etoposide for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia and Minimal Residual Disease [NCT02349178] | Phase 2 | 6 participants (Actual) | Interventional | 2014-12-08 | Terminated(stopped due to Low accrual) |
| A Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched and HLA-Matched Bone Marrow for Patients With Sickle Cell Disease and Other Hemoglobinopathies [NCT01850108] | | 21 participants (Actual) | Interventional | 2013-05-31 | Active, not recruiting |
| Autologous Activated T-Cells Transduced With A 3rd Generation GD-2 Chimeric Antigen Receptor And iCaspase9 Safety Switch Administered To Patients With Relapsed Or Refractory Neuroblastoma (GRAIN) [NCT01822652] | Phase 1 | 11 participants (Actual) | Interventional | 2013-08-31 | Active, not recruiting |
| ALICE: A Randomized Placebo-controlled Phase II Study Evaluating Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer [NCT03164993] | Phase 2 | 68 participants (Actual) | Interventional | 2017-06-01 | Completed |
| A Phase II Randomized Study of Three Subcutaneous Bortezomib-based Consolidation Treatments for Patients Completing Induction Therapy and Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma [NCT01706666] | Phase 2 | 3 participants (Actual) | Interventional | 2012-12-07 | Completed |
| A Multicenter, Single-arm Prospective Phase II Study of Chidamide in Combination With Chemotherapy for Neoadjuvant Treatment of HR-positive/HER2-negative Breast Cancer [NCT05400993] | Phase 2 | 59 participants (Anticipated) | Interventional | 2022-05-23 | Recruiting |
| Pilot Study of Affinity-enhanced Anti-NY-ESO-1 TCR Engineered Autologous T Cells in NSCLC Patients [NCT03029273] | Phase 1 | 20 participants (Anticipated) | Interventional | 2017-03-21 | Recruiting |
| Safety and Efficiency of Anti-CD19/CD22 Tandem Fully Human Chimeric Antigen Receptor (CAR)-Transduced T-cell Therapy for Pediatric and Young Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia: a Single Centre, Non-randomised, Open [NCT04499573] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2020-07-27 | Active, not recruiting |
| Phase II Trial of Exemestane With Immunomodulatory Cyclophosphamide in ER and/or PR-positive and HER2/Neu Negative Metastatic Breast Cancer [NCT01963481] | Phase 2 | 23 participants (Actual) | Interventional | 2013-09-30 | Completed |
| A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma [NCT01700946] | Phase 2 | 80 participants (Actual) | Interventional | 2013-04-15 | Completed |
| Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncolo [NCT00553202] | Phase 2 | 158 participants (Actual) | Interventional | 2008-01-31 | Completed |
| A Phase I, Open-Label Study to Assess the Effect of Escalating Doses of Cyclophosphamide on the Engraftment of SB-728-T in Aviremic HIV-Infected Subjects on HAART [NCT01543152] | Phase 1/Phase 2 | 26 participants (Actual) | Interventional | 2011-12-31 | Completed |
| A Phase II Study of Lymphodepletion Followed by Autologous Tumor-Infiltrating Lymphocytes and High-Dose Aldesleukin for Human Papillomavirus-Associated Cancers [NCT01585428] | Phase 2 | 29 participants (Actual) | Interventional | 2012-04-13 | Completed |
| A Phase II Study of GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine in Combination With PD-1 Blockade Antibody (Pembrolizumab) and Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Locally Advanced Adenocarcinoma of the P [NCT02648282] | Phase 2 | 58 participants (Actual) | Interventional | 2016-07-18 | Completed |
| A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study) [NCT02379585] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2013-01-31 | Terminated(stopped due to PI Decision) |
| Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies [NCT01807611] | Phase 2 | 82 participants (Actual) | Interventional | 2013-05-16 | Completed |
| Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma [NCT00000801] | Phase 2 | 33 participants | Interventional | | Completed |
| A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Re [NCT03725059] | Phase 3 | 1,240 participants (Anticipated) | Interventional | 2018-12-27 | Active, not recruiting |
| Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies [NCT03448393] | Phase 1 | 140 participants (Anticipated) | Interventional | 2018-03-26 | Recruiting |
| Treatment of Wegener's Granulomatosis With Cyclophosphamide [NCT00001155] | Phase 2 | 200 participants | Interventional | 1976-02-29 | Completed |
| A Multicenter Phase 1, Open-Label Trial of Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies [NCT05270057] | Phase 1 | 33 participants (Anticipated) | Interventional | 2023-01-26 | Recruiting |
| A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors [NCT00001209] | Phase 1 | 120 participants | Interventional | 1986-10-31 | Completed |
| A Pilot Study of the Administration of Young Tumor Infiltrating Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen in Metastatic Melanoma [NCT01468818] | Phase 2 | 18 participants (Actual) | Interventional | 2011-09-30 | Terminated(stopped due to Study was closed prematurely due to slow and insufficient accrual.) |
| A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide [NCT00002475] | Phase 2 | 40 participants (Anticipated) | Interventional | 1991-04-30 | Completed |
| Phase II Study of High-Dose Cytarabine, Cisplatin, and Dexamethasone Followed By Cyclophosphamide, Etoposide, Total Body Irradiation, and Autologous Bone Marrow Rescue in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma [NCT00002481] | Phase 2 | 0 participants | Interventional | 1990-03-31 | Active, not recruiting |
| Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone. [NCT00002529] | Phase 3 | 452 participants (Actual) | Interventional | 1993-05-31 | Completed |
| TUMOR INFILTRATING LYMPHOCYTE THERAPY FOR ADVANCED MELANOMA USING IMMUNOMODULATION, A PHASE II STUDY [NCT00002535] | Phase 2 | 0 participants | Interventional | 1993-07-31 | Completed |
| ALLOGENEIC AND SYNGENEIC MARROW TRANSPLANTATION IN PATIENTS WITH ACUTE NON-LYMPHOCYTIC LEUKEMIA [NCT00002547] | Phase 2 | 280 participants (Actual) | Interventional | 1987-08-31 | Completed |
| TREATMENT OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES USING MARROW TRANSPLANTATION FROM UNRELATED DONORS MATCHED FOR HLA OR INCOMPATIBLE FOR ONE HLA LOCUS ANTIGEN [NCT00002553] | Phase 2 | 50 participants (Anticipated) | Interventional | 1990-08-31 | Completed |
| "RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY (ATT) VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5" [NCT00002565] | Phase 3 | 61 participants (Actual) | Interventional | 1994-05-25 | Completed |
| Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II [NCT00002571] | Phase 2 | 52 participants (Actual) | Interventional | 1994-06-30 | Completed |
| International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Sub-protocol B Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric P [NCT05751044] | Phase 1/Phase 2 | 26 participants (Anticipated) | Interventional | 2023-10-01 | Not yet recruiting |
| A Phase I Study of Bevacizumab With Bolus and Metronomic Cyclophosphamide and Zoledronic Acid in Children With Recurrent or Refractory Neuroblastoma [NCT00885326] | Phase 1 | 29 participants (Actual) | Interventional | 2009-12-31 | Completed |
| INTENSIVE THERAPY WITH GROWTH FACTOR SUPPORT FOR PATIENTS WITH EWING'S TUMOR METASTATIC AT DIAGNOSIS: A PEDIATRIC ONCOLOGY GROUP PHASE II STUDY [NCT00002643] | Phase 2 | 130 participants (Actual) | Interventional | 1995-04-30 | Completed |
| Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma [NCT00002649] | Phase 3 | 206 participants (Actual) | Interventional | 1995-05-31 | Completed |
| Sequential Adjuvant Chemotherapy With Doxorubicin, Taxol, and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes [NCT00002679] | Phase 2 | 89 participants (Actual) | Interventional | 1994-02-28 | Completed |
| LSA5 PROTOCOL FOR THE TREATMENT OF ADVANCED PEDIATRIC AND ADOLESCENT NON-HODGKIN'S LYMPHOMA (NHL) [NCT00002691] | Phase 2 | 0 participants | Interventional | 1995-08-31 | Completed |
| Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients [NCT03023358] | Phase 3 | 174 participants (Anticipated) | Interventional | 2017-02-28 | Not yet recruiting |
| T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant [NCT01621477] | Phase 2 | 34 participants (Actual) | Interventional | 2012-08-31 | Terminated(stopped due to Study was terminated in August 2016 due to replacement by a new study.) |
| A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma [NCT01435499] | Phase 1 | 21 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Phase I Clinical Trial of Anti-CD19/20/22 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, B-Prolymphocytic Leukemia) [NCT05418088] | Phase 1 | 36 participants (Anticipated) | Interventional | 2022-06-30 | Recruiting |
| Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT04922567] | Phase 2 | 289 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
| A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in High-Risk Previously Untreated Patients With CLL [NCT00525603] | Phase 2 | 60 participants (Actual) | Interventional | 2005-06-30 | Completed |
| Phase III, Open-label, Multicentre, Randomised Trial to Establish Safety and Efficacy of an EGF Cancer Vaccine in Inoperable, Late Stage (IIIb/IV) NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care. [NCT01444118] | Phase 3 | 0 participants | Interventional | 2011-11-30 | Terminated(stopped due to The early termination is not related to safety/toxicity but to initiate new Phase III with biomarker to enrich population & to further strengthen OS benefit) |
| A Phase I Study of ABT-888 in Combination With Metronomic Cyclophosphamide in Adults With Refractory Solid Tumors and Lymphomas [NCT01445522] | Phase 1 | 35 participants (Actual) | Interventional | 2008-12-03 | Completed |
| Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus Versus Conventional Therapy in Relapse of Granulomatosis With Polyangiitis (Wegener's Granulomatosis) SPARROW Study - SPAnidin in Rel [NCT01446211] | Phase 3 | 4 participants (Actual) | Interventional | 2011-11-30 | Terminated(stopped due to Change of design consideration) |
| A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis [NCT01451489] | | 70 participants (Actual) | Interventional | 2011-10-13 | Terminated(stopped due to The recruitment of subject is very difficult) |
| Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) [NCT05963217] | Phase 1 | 19 participants (Anticipated) | Interventional | 2023-07-26 | Recruiting |
| A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors [NCT05887726] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
| RAVEN: A Phase I/II Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax [NCT05192889] | Phase 1/Phase 2 | 90 participants (Anticipated) | Interventional | 2022-08-25 | Recruiting |
| Study of CD19/CD20 Bispecific Chimeric Antigen Receptor (CAR)-T Cells for the Treatment of Relapsed or Refractory B-Cell Lymphomas and Chronic Lymphocytic Leukemia (CD20 - Cluster of Differentiation Antigen 20) [NCT04007029] | Phase 1 | 24 participants (Anticipated) | Interventional | 2019-10-04 | Recruiting |
| A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer [NCT03498716] | Phase 3 | 2,203 participants (Actual) | Interventional | 2018-08-02 | Completed |
| An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma [NCT02265770] | Phase 2/Phase 3 | 536 participants (Anticipated) | Interventional | 2015-06-02 | Recruiting |
| A Phase I Dose Escalation Safety and Feasibility Study of WT1-Specific T Cells for the Treatment of Patients With Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Carcinomas [NCT00562640] | Phase 1 | 12 participants (Actual) | Interventional | 2007-10-16 | Completed |
| A Phase I Trial of Temsirolimus (CCI-779, Pfizer, Inc.) in Combination With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma [NCT01614197] | Phase 1 | 16 participants (Actual) | Interventional | 2015-07-03 | Completed |
| A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders [NCT00544115] | Phase 2 | 260 participants (Actual) | Interventional | 2001-10-16 | Active, not recruiting |
| A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma [NCT01468740] | Phase 2 | 130 participants (Anticipated) | Interventional | 2004-03-31 | Recruiting |
| A Randomized, Open-Label Comparative Study of Combination Therapy With Cyclophosphamide and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine With or Without Trastuzumab for the Treatment of Metastatic Breast Cancer That Does NOT Over-express HER-2/Neu [NCT00971737] | Phase 2 | 63 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N) [NCT05582499] | Phase 1/Phase 2 | 716 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting |
| A Phase Ib/II Study of Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies [NCT01554371] | Phase 1/Phase 2 | 44 participants (Actual) | Interventional | 2012-03-27 | Completed |
| A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy [NCT03018535] | Phase 3 | 76 participants (Actual) | Interventional | 2012-01-31 | Active, not recruiting |
| Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study) [NCT03802773] | | 10 participants (Anticipated) | Observational | 2019-03-14 | Recruiting |
| T-cell Therapy in Combination With Checkpoint Inhibitors for Patients With Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer [NCT03287674] | Phase 1/Phase 2 | 7 participants (Actual) | Interventional | 2017-10-09 | Completed |
| Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma [NCT01000285] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2010-09-30 | Completed |
| A Phase I/II Trial of Cyclophosphamide, Carfilzomib, Thalidomide and Dexamethasone (CYCLONE) in Patients With Newly Diagnosed Active Multiple Myeloma [NCT01057225] | Phase 1/Phase 2 | 64 participants (Actual) | Interventional | 2010-03-31 | Completed |
| T2007-002 A Phase II Study of Clofarabine With Etoposide and Cyclophosphamide in Relapsed/Refractory AML (IND 104,650) [NCT00939653] | Phase 2 | 6 participants (Actual) | Interventional | 2009-07-10 | Terminated(stopped due to Due to insufficient research institution participation and patient enrollment) |
| Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction [NCT03593902] | Phase 2/Phase 3 | 9 participants (Actual) | Interventional | 2018-05-17 | Terminated(stopped due to PI Sabbatical) |
| A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer [NCT03609047] | Phase 2 | 366 participants (Anticipated) | Interventional | 2019-06-14 | Active, not recruiting |
| A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety, Tolerability and Efficacy of Olaparib in Combination With Carboplatin: Part A: Dose Escalation of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breas [NCT02561832] | Phase 1 | 15 participants (Actual) | Interventional | 2015-11-06 | Terminated(stopped due to This decision was based upon strategic considerations impacting the clinical development of olaparib in this indication.) |
| Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial [NCT03149679] | Phase 2 | 12 participants (Actual) | Interventional | 2017-05-09 | Terminated(stopped due to The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.) |
| Transplantation Of Umbilical Cord Blood From Unrelated Donors In Patients With Haematological Diseases Using A Myeloablative Conditioning Regimen [NCT02310997] | Phase 2 | 11 participants (Actual) | Interventional | 2011-07-31 | Terminated(stopped due to Trial closed early due to poor recruitment) |
| Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia With Minimal Residual Disease [NCT05601830] | Phase 1 | 18 participants (Anticipated) | Interventional | 2022-10-28 | Recruiting |
| MT2008-15: Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Nonmyeloablative Preparative Regimen and Priming With Complement 3a Fragment (C3a) [NCT00963872] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2010-03-31 | Terminated(stopped due to Lack of efficacy after interim analysis) |
| A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer [NCT02234921] | Phase 1 | 3 participants (Actual) | Interventional | 2014-10-24 | Completed |
| A Pilot Study of Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic Anemia [NCT01187017] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2010-08-31 | Completed |
| International, Multi-centre Randomised Clinical Trial of Obinutuzumab Versus Corticosteroid and Cyclophosphamide in Primary Membranous Nephropathy (REMIT Trial). [NCT06120673] | Phase 3 | 224 participants (Anticipated) | Interventional | 2024-07-31 | Not yet recruiting |
| Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma [NCT00871481] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Phase Ⅱ Study to Evaluate the Efficacy and Safety of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy With Triple Negative Breast Cancer (TNBC) [NCT05088057] | Phase 2 | 30 participants (Anticipated) | Interventional | 2021-09-20 | Recruiting |
| A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL [NCT04423926] | Phase 1/Phase 2 | 91 participants (Anticipated) | Interventional | 2020-06-10 | Recruiting |
| Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Sickle Cell Anemia From HLA Matched or Partially-Matched Related Donors [NCT01350232] | | 2 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to Poor accrual) |
| A Phase II Study Incorporating Panobinostat, Bortezomib and Liposomal Vincristine Into Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma [NCT02518750] | Phase 2 | 3 participants (Actual) | Interventional | 2016-11-23 | Terminated(stopped due to Due to slow accrual) |
| A Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem Cells [NCT03333486] | Phase 2 | 31 participants (Actual) | Interventional | 2017-12-07 | Active, not recruiting |
| A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors [NCT00500890] | Phase 3 | 2 participants (Actual) | Interventional | 2005-09-02 | Terminated(stopped due to PI has left the institution) |
| Treatment of Stage IV Breast Cancer With Activated T Cells After Peripheral Blood Stem Cell Transplant (Pilot Phase II) [NCT00020722] | Phase 2 | 7 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to Lack of funding to continue study.) |
| A Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL Amyloidosis [NCT03252600] | Phase 2 | 53 participants (Anticipated) | Interventional | 2017-08-25 | Active, not recruiting |
| Phase 1 Trial of Umbilical Cord Blood Natural Killer Cells (CB-NK) Expressing Soluble IL-15 (sIL-15) and PD-L1 +/- Atezolizumab in Non-Small Cell Lung Cancer Patients Refractory to PD-1/PD-L1 Immune Checkpoint Inhibitors [NCT05334329] | Phase 1 | 21 participants (Anticipated) | Interventional | 2022-07-20 | Recruiting |
| A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients [NCT00001384] | Phase 2 | 35 participants | Interventional | 1994-05-31 | Completed |
| A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer [NCT00001426] | Phase 2 | 66 participants (Actual) | Interventional | 1995-02-03 | Completed |
| A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction, High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support, and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer [NCT00001498] | Phase 2 | 55 participants | Interventional | 1996-02-29 | Completed |
| A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma [NCT00000658] | Phase 3 | 250 participants | Interventional | | Completed |
| A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE [NCT00002482] | Phase 1/Phase 2 | 0 participants | Interventional | 1991-06-30 | Active, not recruiting |
| INTENSIFICATION WITH HIGH DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN FOR INTERMEDIATE OR HIGH GRADE LYMPHOMA PATIENTS WHO FAILED PRIMARY COMBINATION CHEMOTHERAPY [NCT00002488] | Phase 2 | 0 participants | Interventional | 1991-12-31 | Active, not recruiting |
| HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN [NCT00002494] | Phase 2 | 134 participants (Actual) | Interventional | 1992-05-31 | Completed |
| Pilot Study in AIDS-Related Lymphomas [NCT00002524] | Phase 2 | 46 participants (Actual) | Interventional | 1993-06-30 | Completed |
| Double-Blind Randomized Trial of Tamoxifen Versus Placebo in Patients With Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy [NCT00002542] | Phase 3 | 672 participants (Actual) | Interventional | 1993-07-20 | Completed |
| Standard Dose Versus Myeloablative Therapy for Previously Untreated Symptomatic Multiple Myeloma, A Phase III Intergroup Study [NCT00002548] | Phase 3 | 899 participants (Actual) | Interventional | 1994-01-31 | Completed |
| RADIOLABELED BC8 (ANTI-CD45) ANTIBODY COMBINED WITH BUSULFAN AND CYCLOPHOSPHAMIDE AS TREATMENT FOR ACUTE MYELOGENOUS LEUKEMIA IN FIRST OR SECOND REMISSION OR UNTREATED FIRST RELAPSE FOLLOWED BY HLA-IDENTICAL RELATED MARROW TRANSPLANTATION [NCT00002554] | Phase 2 | 30 participants (Anticipated) | Interventional | 1993-11-30 | Completed |
| INTERNATIONAL RANDOMIZED STUDY FOR THE SALVAGE TREATMENT OF GERM CELL TUMOURS [NCT00002566] | Phase 3 | 280 participants (Anticipated) | Interventional | 1994-02-28 | Completed |
| RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS [NCT00002596] | Phase 3 | 270 participants (Anticipated) | Interventional | 1994-09-30 | Completed |
| Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7) [NCT00199082] | Phase 4 | 650 participants (Anticipated) | Interventional | 2002-07-31 | Completed |
| HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA [NCT00002638] | Phase 2 | 30 participants (Anticipated) | Interventional | 1995-03-31 | Completed |
| Phase II Trial of Sequential High-Dose Alkylating Agents in Metastatic Breast Cancer [NCT00002680] | Phase 2 | 40 participants (Actual) | Interventional | 1994-02-28 | Completed |
| TREATMENT OF ISOLATED CNS RELAPSE OF ACUTE LYMPHOBLASTIC LEUKEMIA -- A PEDIATRIC ONCOLOGY GROUP-WIDE PHASE II STUDY [NCT00002704] | Phase 2 | 156 participants (Actual) | Interventional | 1996-01-31 | Completed |
| Phase I Pilot Study of Multiple Cycles of High Dose Chemotherapy With Peripheral Blood Stem Cell Infusions In Advanced Stage Neuroblastoma [NCT00002740] | Phase 1 | 30 participants (Anticipated) | Interventional | 1996-05-31 | Completed |
| A Pilot Study For The Treatment of Newly-Diagnosed Disseminated Anaplastic Large Cell Ki-1 Lymphoma and T-Large Cell Lymphoma [NCT00002590] | Phase 2 | 221 participants (Actual) | Interventional | 1994-07-31 | Completed |
| A PILOT STUDY OF TOTAL BODY IRRADIATION AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS TRANSPLANTATION WITH CD34 SELECTED PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA [NCT00002788] | Phase 1 | 15 participants (Anticipated) | Interventional | 1995-10-31 | Completed |
| Belantamab Mafodotin, Cyclophosphamide and Dexamethasone in Relapsed/Refractory Multiple Myeloma [NCT04896658] | Phase 1/Phase 2 | 64 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
| Randomized, Blinded Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and TNF-α Release [NCT01205503] | Phase 2 | 32 participants (Actual) | Interventional | 2010-09-30 | Completed |
| Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF [NCT00003490] | Phase 2 | 30 participants (Anticipated) | Interventional | 1998-10-31 | Completed |
| A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Ca [NCT00003088] | Phase 3 | 2,005 participants (Actual) | Interventional | 1997-09-30 | Completed |
| Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients [NCT00493870] | Phase 3 | 1,961 participants (Actual) | Interventional | 2007-05-29 | Completed |
| A Phase I/II Dose Escalation Trial of Carboplatin With Amifostine Pretreatment to Augment High Dose Cyclophosphamide With Autologous Peripheral Blood Stem Cell Support for the Treatment of Patients With Epithelial Ovarian Cancer [NCT00003136] | Phase 1/Phase 2 | 11 participants (Actual) | Interventional | 1996-12-31 | Completed |
| Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma [NCT00072566] | Phase 2 | 70 participants (Actual) | Interventional | 2003-12-31 | Completed |
| Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study [NCT00002812] | Phase 3 | 2,078 participants (Actual) | Interventional | 1996-09-30 | Completed |
| A Phase I-II Study of Pentostatin With Cyclophosphamide for Previously Treated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia [NCT00003658] | Phase 2 | 60 participants (Anticipated) | Interventional | 1998-09-30 | Completed |
| A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients [NCT00002836] | Phase 3 | 184 participants (Actual) | Interventional | 1995-09-26 | Completed |
| PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT [NCT00002854] | Phase 1 | 33 participants (Actual) | Interventional | 1994-12-31 | Completed |
| Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III) [NCT00003214] | Phase 3 | 300 participants (Anticipated) | Interventional | 1996-07-31 | Completed |
| Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradia [NCT00003700] | Phase 2 | 163 participants (Actual) | Interventional | 1999-01-31 | Completed |
| Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma [NCT00003958] | Phase 3 | 702 participants (Actual) | Interventional | 2002-09-30 | Completed |
| Treatment for Extrachoroidal or Metastatic Retinoblastoma [NCT00004006] | Phase 2 | 4 participants (Actual) | Interventional | 1997-11-30 | Completed |
| A Phase II Study of Thalidomide and Cyclophosphamide in Patients With Recurrent or Refractory Malignancies [NCT00003754] | Phase 2 | 0 participants | Interventional | 1998-09-30 | Completed |
| A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia [NCT00003340] | Phase 2 | 0 participants | Interventional | 1997-11-30 | Completed |
| Phase I Trial of High Dose Chemotherapy Using Amifostine for In-Vivo Protection of GM-CSF Primed Progenitor Cells [NCT00004036] | Phase 1 | 30 participants (Anticipated) | Interventional | 1997-11-30 | Active, not recruiting |
| A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas [NCT00003784] | Phase 2 | 102 participants (Actual) | Interventional | 1999-05-31 | Completed |
| A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC) [NCT00003352] | Phase 2 | 89 participants (Actual) | Interventional | 1998-06-30 | Completed |
| A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8) [NCT00003364] | Phase 3 | 398 participants (Anticipated) | Interventional | 1993-01-31 | Completed |
| A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery [NCT00014222] | Phase 3 | 2,104 participants (Actual) | Interventional | 2000-12-04 | Completed |
| Radiolabeled BC8 (Anti-CD45) Antibody Combined With Cyclophosphamide and Total Body Irradiation Followed by HLA-matched Related or Unrelated Stem Cell Transplantation as Treatment for Advanced Acute Myeloid Leukemia and Myelodysplastic Syndrome [NCT00003868] | Phase 2 | 40 participants (Anticipated) | Interventional | 1999-02-28 | Completed |
| A Phase II Pilot Study of Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support Without Conventional-Dose Induction Chemotherapy for Women With Metastatic Breast Cancer [NCT00004900] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study [NCT00004114] | Phase 1 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to Study never opened) |
| A Phase II Multi-Institution Study of Docetaxel and Doxorubicin as Induction Therapy Followed by Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support for Women With Metastatic Breast Cancer [NCT00004906] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Keratinocyte Growth Factor (rHuKGF) in Patients With Hematologic Malignancies Undergoing Total Body Irradiation (TBI) and High-Dose Chemotherapy With Autologous Peripheral Blood Pro [NCT00004132] | Phase 2 | 0 participants | Interventional | 2000-01-31 | Completed |
| A Single Dose-escalation and Dose-expansion Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Refractory or Relapsed B Cell Lymphoma. [NCT05776407] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 2023-05-31 | Not yet recruiting |
| Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia [NCT00199095] | Phase 4 | 40 participants | Interventional | 1997-02-28 | Completed |
| Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99) [NCT00199056] | Phase 4 | 225 participants | Interventional | 1999-10-31 | Completed |
| Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2) [NCT00198978] | Phase 4 | 377 participants (Actual) | Interventional | 2003-01-31 | Completed |
| High Dose Paclitaxel Added to Cyclophosphamide and Thiotepa Followed by Autologous Stem Cell Rescue: A Phase I Trial in Advanced Breast Cancer [NCT00004174] | Phase 1 | 30 participants (Actual) | Interventional | 1999-10-31 | Completed |
| Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study [NCT00005578] | Phase 3 | 219 participants (Actual) | Interventional | 1997-03-31 | Completed |
| ALinC 17: Protocol for Patients With Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia (ALL): A Phase III Study [NCT00005596] | Phase 3 | 1,076 participants (Actual) | Interventional | 2000-04-30 | Completed |
| A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation [NCT00005092] | Phase 1 | 7 participants (Actual) | Interventional | 1999-05-28 | Completed |
| Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia [NCT00004474] | Phase 3 | 224 participants | Interventional | 1998-09-30 | Completed |
| A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Human Leukocyte Antigen Partially-Matched Related Donor [NCT01341301] | Phase 2 | 25 participants (Actual) | Interventional | 2010-05-31 | Completed |
| Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma [NCT00258206] | Phase 2 | 21 participants (Actual) | Interventional | 2004-12-31 | Completed |
| A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants With Resected Melanoma [NCT00118274] | Phase 1/Phase 2 | 170 participants (Actual) | Interventional | 2005-03-31 | Completed |
| A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL [NCT04025593] | Phase 2 | 128 participants (Anticipated) | Interventional | 2019-07-17 | Recruiting |
| Use of Cyclophosphamide/Fludarabine to Promote in Vivo Expansion of Donor Lymphocyte Infusions (DLI) to Enhance Efficacy After Allogeneic Transplant [NCT00167180] | Phase 2 | 57 participants (Actual) | Interventional | 2004-01-31 | Terminated(stopped due to Accrual Goal Met) |
| A Phase II Study to Evaluate the Efficacy of Posttransplant Cyclophosphamide for Prevention of Chronic Graft-versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation [NCT01427881] | Phase 2 | 43 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathy Using a Preparative Regimen to Achieve Stable Mixed Chimerism [NCT00176852] | Phase 2/Phase 3 | 22 participants (Actual) | Interventional | 2002-06-30 | Completed |
| A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL) [NCT01082939] | Phase 2 | 80 participants (Actual) | Interventional | 2002-12-31 | Completed |
| Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia [NCT05099471] | Phase 2 | 80 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma [NCT04625907] | Phase 1/Phase 2 | 1,672 participants (Anticipated) | Interventional | 2020-09-17 | Recruiting |
| Randomised Phase II/III Study of Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia [NCT04061512] | Phase 2/Phase 3 | 148 participants (Anticipated) | Interventional | 2020-02-03 | Recruiting |
| A Randomised Phase IIb Trial of Bevacizumab Added to Temozolomide ± Irinotecan for Children With Refractory/Relapsed Neuroblastoma - BEACON-Neuroblastoma Trial [NCT02308527] | Phase 2 | 225 participants (Actual) | Interventional | 2013-07-31 | Active, not recruiting |
| Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma [NCT00602667] | Phase 2 | 293 participants (Actual) | Interventional | 2007-12-17 | Active, not recruiting |
| Reduced-intensity, Related-donor Allogeneic BMT With Fludarabine, Busulfan, and High-dose Posttransplantation Cyclophosphamide for Hematologic Malignancies [NCT01135329] | Phase 2 | 15 participants (Actual) | Interventional | 2010-08-31 | Terminated(stopped due to The stopping rule was met and hence the study was closed) |
| A Study to Evaluate the Efficacy of CellCept, Administered in a Sequential Treatment Scheme, in Delaying Progressive Renal Damage in Patients With Lupus Nephritis [NCT02081183] | Phase 3 | 16 participants (Actual) | Interventional | 2006-03-31 | Terminated |
| Monoinstitutional Phase II Trial Addressing Tolerability and Activity of RCHOP Chemoimmunotherapy Preceded by BBB Permeabilization by t-NGR Necrosis Factor in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma [NCT03536039] | Phase 2 | 28 participants (Actual) | Interventional | 2016-01-27 | Completed |
| A Phase 1b Clinical Trial of Anti-BCMA Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Multiple Myeloma [NCT05577000] | Phase 1 | 24 participants (Anticipated) | Interventional | 2021-10-18 | Recruiting |
| PLD Plus Cyclophosphamide Followed by Nab-paclitaxel (Nab-P) as Primary Chemotherapy Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer: A Single-arm Phase 2 Trial(Brecan Trial) [NCT05346107] | Phase 2 | 100 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
| University of Arkansas (UARK 2001-12), A Phase III Study of DTPACE Followed by Tandem Transplant With MEL 200 Versus MEL/DTPACE Hybrid and DTPACE Consolidation in Patients With Active Multiple Myeloma [NCT00083915] | Phase 3 | 97 participants (Actual) | Interventional | 2001-06-30 | Completed |
| A Phase II Study of EL625 in Patients in Persistent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma [NCT00636155] | Phase 2 | 20 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to funding) |
| Thalidomide, Cyclophosphamide and Dexamethasone for Adult Patients With Recurrent/Refractory Langerhans Cell Histiocytosis: A Single Arm, Single Center, Prospective Phase 2 Study [NCT04120519] | Phase 2 | 20 participants (Anticipated) | Interventional | 2019-10-10 | Recruiting |
| Phase II Study of Metastatic Melanoma Using a Nonmyeloablative Lymphodepleting Regimen Followed by Melanoma-Reactive T-Cells Sensitized in Vitro With Peptide-Pulsed Drosophila Cells [NCT01271907] | Phase 2 | 3 participants (Actual) | Interventional | 2011-04-15 | Terminated(stopped due to Study was terminated due to withdrawal of CRADA partner.) |
| A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednis [NCT01974440] | Phase 3 | 405 participants (Actual) | Interventional | 2014-01-31 | Completed |
| Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients [NCT00129935] | Phase 3 | 1,384 participants (Actual) | Interventional | 2004-02-29 | Completed |
| High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma [NCT03061656] | Phase 2 | 40 participants (Anticipated) | Interventional | 2009-01-01 | Active, not recruiting |
| Phase I/II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Gene Engineered Lymphocytes Cotransduced With Genes Encoding IL-12 and Anti-NY ESO-1 TCR [NCT01457131] | Phase 1 | 2 participants (Actual) | Interventional | 2011-10-06 | Terminated |
| Phase II Study of Lymphocytes Generated With Engineered Cells for Costimulation Enhancement in Patients With Metastatic Melanoma Following Lymphodepletion [NCT01369875] | Phase 2 | 2 participants (Actual) | Interventional | 2011-06-17 | Terminated(stopped due to Premature closure. Protocol did not meet its primary objective.) |
| A Phase II Study of Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma [NCT05909826] | Phase 2 | 49 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
| A Randomized, Open-label, Single-center, Phase III Trial Comparing Docetaxel Plus Carboplatin (TCb) Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel (EC-T) Regimen as Adjuvant Chemotherapy in Patients With LN≥4 Estrogen Receptor Positive and [NCT05901428] | Phase 3 | 1,736 participants (Anticipated) | Interventional | 2023-06-01 | Recruiting |
| CAR- PRISM (PRecision Intervention Smoldering Myeloma): A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in High-Risk Smoldering Myeloma [NCT05767359] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-04-19 | Recruiting |
| Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Patients With CD30+ Nonseminomatous Germ Cell Tumors (NSGCT) [NCT05634785] | Phase 2 | 18 participants (Anticipated) | Interventional | 2022-12-09 | Recruiting |
| A Phase 1 Study of Autologous Activated T-cells Targeting the B7-H3 Antigen in Subjects With Recurrent Epithelial Ovarian Cancer [NCT04670068] | Phase 1 | 21 participants (Anticipated) | Interventional | 2021-01-27 | Recruiting |
| Phase 1 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, as a Single Agent or With Irinotecan, Irinotecan Plus Temozolomide, or With Cyclophosphamide Plus Topotecan in Pediatric Patients With Refractory Malignancies. [NCT04239092] | Phase 1 | 68 participants (Anticipated) | Interventional | 2020-06-05 | Active, not recruiting |
| A Phase 2 Study of Pembrolizumab (MK-3475), DPX-Survivac Vaccine and Low Dose of Cyclophosphamide Combination in Patients With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer [NCT03029403] | Phase 2 | 47 participants (Actual) | Interventional | 2018-02-12 | Active, not recruiting |
| A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma [NCT01878617] | Phase 2 | 660 participants (Actual) | Interventional | 2013-06-23 | Active, not recruiting |
| Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms [NCT00217425] | Phase 2 | 46 participants (Actual) | Interventional | 2006-09-14 | Completed |
| A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer [NCT00004125] | Phase 3 | 0 participants | Interventional | 1999-11-16 | Completed |
| A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma [NCT04899570] | Phase 2 | 20 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
| Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy [NCT01897441] | | 132 participants (Anticipated) | Interventional | 2013-06-30 | Active, not recruiting |
| Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA [NCT03821987] | | 55 participants (Anticipated) | Interventional | 2018-12-17 | Recruiting |
| German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003) [NCT00198991] | Phase 4 | 1,883 participants (Actual) | Interventional | 2003-04-30 | Completed |
| Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine [NCT01542255] | Phase 2 | 7 participants (Actual) | Interventional | 2010-06-30 | Terminated(stopped due to Low accrual not allowing to support statistical endpoints) |
| A Phase II,Randomized Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in Stage IIIc and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC) [NCT02562365] | Phase 2 | 130 participants (Anticipated) | Interventional | 2015-11-30 | Active, not recruiting |
| A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma [NCT03758989] | Phase 2 | 40 participants (Anticipated) | Interventional | 2019-05-08 | Recruiting |
| Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients [NCT04836156] | Phase 1/Phase 2 | 46 participants (Anticipated) | Interventional | 2021-04-02 | Recruiting |
| Hyper-CVAD With Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia [NCT01319981] | Phase 2 | 31 participants (Actual) | Interventional | 2013-03-05 | Completed |
| Assessment of Safety and Immunogenicity of Intradermal Electroporation of tetwtCEA DNA in Patients With Colorectal Cancer [NCT01064375] | Phase 1/Phase 2 | 16 participants (Actual) | Interventional | 2009-12-31 | Completed |
| Hematopoietic Stem Cell Transplantation for Hurler Syndrome, Maroteaux Lamy Syndrome (MPS VI), and Alpha Mannosidase Deficiency (Mannosidosis) [NCT00176917] | Phase 2 | 41 participants (Actual) | Interventional | 1999-05-31 | Completed |
| Safety and Efficacy of Universal Chimeric Antigen Receptor-modified AT19 Cells in Patients With CD19+ Relapsed/Refractory Hematological Malignancies: a Single-center, Open-label, Single-arm Clinical Study [NCT04796688] | Phase 1 | 27 participants (Anticipated) | Interventional | 2021-03-10 | Recruiting |
| Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide [NCT01537029] | Phase 4 | 15 participants (Actual) | Interventional | 2012-02-29 | Completed |
| A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc) [NCT02980965] | Phase 3 | 249 participants (Actual) | Interventional | 2013-05-31 | Completed |
| UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy [NCT00083551] | Phase 3 | 668 participants (Actual) | Interventional | 1998-08-31 | Completed |
| BrUOG 299: Ixazomib, Oral Metronomic Cyclophosphamide and Dexamethasone for First-Line Treatment of Multiple Myeloma: A Phase II Brown University Oncology Group Study. [NCT02412228] | Phase 2 | 12 participants (Actual) | Interventional | 2015-08-31 | Active, not recruiting |
| A Study of Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel as Neoadjuvant Therapy for Resectable, Hormone Receptor Negative or Hormone Receptor Positive, HER-2/Neu Positive Breast Cancer Followed by a Novel Regi [NCT00194779] | Phase 2 | 50 participants (Actual) | Interventional | 2003-10-31 | Completed |
| A Phase I Study to Evaluate Safety, Feasibility and Immunologic Response of Adoptive T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Metastatic Melanoma [NCT01946373] | Phase 1 | 20 participants (Anticipated) | Interventional | 2013-10-31 | Recruiting |
| A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study) [NCT00040937] | Phase 2 | 147 participants (Actual) | Interventional | 2002-06-30 | Completed |
| Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies [NCT00048737] | Phase 1/Phase 2 | 70 participants (Actual) | Interventional | 2002-10-31 | Completed |
| A Multicenter Phase I-II Study of Tumor Vaccine Following Chemotherapy in Patients With Metastatic Breast Cancer Untreated With Chemo/Radiation in the Previous 18 Months: Vaccine-Induced Bias of T-Cell Repertoire Reconstitution After T-Cell Re-Infusion [NCT00048893] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2002-11-30 | Terminated(stopped due to The study was closed to accrual due to very poor enrollment.) |
| Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab in Patients With Low Grade Non-Hodgkins Lymphoma: An Analysis of Efficacy and Tolerability [NCT00208975] | Phase 2 | 15 participants (Actual) | Interventional | 2002-07-31 | Terminated(stopped due to slow accrual) |
| PS-341 and PS-341 + Epoch Chemotherapy and Molecular Profiling in Relapsed or Refractory Diffuse Large B-Cell Lymphomas [NCT00054665] | Phase 2 | 50 participants (Actual) | Interventional | 2003-02-28 | Completed |
| Clinical Study of Redirected Autologous T Cells With a BCMA-targeted Chimeric Antigen Receptor in Patients With Refractory or Relapsed Multiple Myeloma [NCT03380039] | | 6 participants (Actual) | Interventional | 2017-10-13 | Active, not recruiting |
| Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell Lymphoma [NCT00039195] | Phase 2 | 98 participants (Actual) | Interventional | 2006-11-30 | Completed |
| The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ER+/HER2- Breast Cancer [NCT04753177] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2021-01-28 | Active, not recruiting |
| Safety, Efficacy and Feasibility of Haploidentical Stem Cell Transplantation (Haplo-SCT) Using Post-Transplant Cyclophosphamide (PTCy) as an Alternative Donor Source for Patients Who Lack a Matched Sibling/Unrelated Donor Options [NCT03088709] | Phase 2 | 40 participants (Anticipated) | Interventional | 2017-01-18 | Recruiting |
| Phase I Clinical Trial of TSA-CTL (Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes) In the Treatment of Advanced Solid Tumors [NCT02959905] | Phase 1 | 11 participants (Actual) | Interventional | 2016-12-22 | Completed |
| HLA Matched Related and Unrelated Bone Marrow Transplantation With Busulfan/Cyclophosphamide and Post Transplantation Cyclophosphamide for Hematological Malignancies [NCT00134017] | Phase 2 | 142 participants (Actual) | Interventional | 2004-06-30 | Completed |
| A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Subjects With Refractory Diffuse Large B-Cell Lymphoma (DLBCL) [NCT02926833] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2016-09-29 | Completed |
| Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients - Phase I/II Study. [NCT01898039] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
| Protocol Title: An Open Label, Multi-centre Phase 1/2a Study of Modified and Unmodified Autologous Tumour Infiltrating Lymphocytes (TIL) in Patients With Platinum-resistant Ovarian Cancer [NCT04389229] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2020-07-01 | Withdrawn(stopped due to Sponsor decision) |
| Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas [NCT00118209] | Phase 3 | 524 participants (Actual) | Interventional | 2005-05-31 | Completed |
| A Phase I Clinical Trial of Combined Cryotherapy and Intra-tumoral Immunotherapy With Autologous Immature Dendritic Cells in Men With Castration Resistant Prostatic Cancer and Metastases to Lymph Nodes and/or Bone Pre or Post Chemotherapy [NCT02423928] | Phase 1 | 18 participants (Actual) | Interventional | 2015-05-31 | Completed |
| Autologous Transplantation for Multiple Myeloma [NCT00177047] | Phase 2/Phase 3 | 363 participants (Actual) | Interventional | 2004-04-20 | Completed |
| Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study [NCT00041119] | Phase 3 | 3,871 participants (Actual) | Interventional | 2002-05-31 | Completed |
| A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia [NCT00186875] | Phase 2 | 47 participants (Actual) | Interventional | 2003-11-30 | Completed |
| A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma [NCT01790737] | Phase 2 | 80 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Pilot Study of Total Marrow/Lymphoid Irradiation (TMLI) Conditioning Prior to Allogeneic Hematopoietic Stem Cell Transplant (HCT) Followed by Post Transplant Cyclophosphamide-Based Graft Versus Host Disease Prophylaxis for Acute Myelogenous Leukemia in Co [NCT03467386] | Phase 1 | 18 participants (Anticipated) | Interventional | 2018-03-19 | Recruiting |
| A Neoadjuvant Immunologic Study of Androgen Deprivation Therapy Combined With a Granulocytemacrophage-colony Stimulating Factor F-secreting Allogeneic Prostate Cancer Vaccine and Low-dose Cyclophosphamide in Men With High-risk Localized Prostate Cancer Un [NCT01696877] | Phase 1/Phase 2 | 29 participants (Actual) | Interventional | 2013-01-18 | Completed |
| Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC) [NCT02419170] | Early Phase 1 | 0 participants (Actual) | Interventional | 2016-07-31 | Withdrawn(stopped due to Investigator who manufactured the vaccine left the university.) |
| A Single-center, Single-arm Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-CD5 Chimeric Antigen Receptor T Cells (CT125A Cells) for the Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies [NCT04767308] | Early Phase 1 | 18 participants (Anticipated) | Interventional | 2021-03-31 | Not yet recruiting |
| An Adaptive, Randomized Phase II Trial to Determine Pathologic Complete Response With the Addition of Carboplatin With and Without Veliparib to Standard Chemotherapy in the Neoadjuvant Treatment of Triple-Negative Breast Cancer [NCT01818063] | Phase 2 | 9 participants (Actual) | Interventional | 2013-04-25 | Completed |
| Mesenchymal Stem Cell Infusion in Haploidentical Hematopoietic Stem Cell Transplantation in Patients With Hematological Malignancies [NCT03106662] | Phase 3 | 6 participants (Actual) | Interventional | 2014-10-31 | Completed |
| Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia [NCT00280241] | Phase 2 | 65 participants (Actual) | Interventional | 2004-06-30 | Completed |
| NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy [NCT03169764] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
| A Study of the Beta-blocker Propranolol Alone and With Chemotherapy in Patients Receiving Neoadjuvant Treatment for Newly Diagnosed Breast Cancer [NCT01847001] | Phase 2 | 10 participants (Actual) | Interventional | 2012-10-31 | Completed |
| Phase II Study in Metastatic Melanoma or Kidney Cancer Using Autologous Natural Killer Cells Plus Aldesleukin (IL-2) Following a Lymphodepleting Chemotherapy [NCT00328861] | Phase 2 | 8 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Phase II Study of Dose-Dense TC (Docetaxel + Cyclophosphamide) With Pegfilgrastim Support for Adjuvant Therapy of pN0, pN1 or Nx Breast Cancer [NCT01671319] | Phase 2 | 42 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Azacitidine and Chidamide Combined With CHOP (AC-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma With T-follicular Helper Phenotype (PTCL-TFH) [NCT05678933] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-01-01 | Enrolling by invitation |
| Adoptive Transfer of ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) in Combination With Lymphodepletion and Anti-PD-1 to Patients With Metastatic Melanoma [NCT04904185] | Phase 1 | 12 participants (Anticipated) | Interventional | 2021-08-17 | Recruiting |
| Safety and Efficacy of Metronomic Vinorelbine in Combination With Toripalimab for Patients With HER2- Metastatic Breast Cancer [NCT04389073] | Phase 2 | 138 participants (Anticipated) | Interventional | 2020-04-01 | Recruiting |
| A Phase I/II Trial of PD-1 Knockout EBV-CTLs for Advanced Stage EBV Associated Malignancies [NCT03044743] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2017-04-07 | Recruiting |
| Efficacy and Safety of Pyrotinib in Combination With Neoadjuvant Chemotherapy in Stage II-III HR+/HER2-, HER4 High Expression Breast Cancer Patients: A Phase II, Single-center, Randomized, Double-Blinded, Placebo-Controlled Trial [NCT04872985] | Phase 2 | 140 participants (Anticipated) | Interventional | 2021-04-20 | Recruiting |
| Lenalidomide Combined With Anti-CD20 Monoclonal Antibodies-CHOP in Untreated Diffuse Large B-Cell Lymphoma Patients With MYC and BCL2 Co-expression : An Open-lable，Multicenter，Phase II Study [NCT04842487] | Phase 2 | 80 participants (Anticipated) | Interventional | 2021-04-10 | Not yet recruiting |
| Slow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront Therapy [NCT04754945] | Phase 1 | 25 participants (Anticipated) | Interventional | 2021-04-28 | Recruiting |
| Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies [NCT05528887] | Phase 1 | 10 participants (Anticipated) | Interventional | 2021-09-16 | Recruiting |
| Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease [NCT05510323] | Phase 3 | 208 participants (Anticipated) | Interventional | 2022-08-31 | Not yet recruiting |
| Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (A [NCT02566993] | Phase 3 | 613 participants (Actual) | Interventional | 2016-08-30 | Completed |
| Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation [NCT02790515] | Phase 2 | 52 participants (Anticipated) | Interventional | 2016-07-14 | Recruiting |
| Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma [NCT01833767] | Phase 2 | 0 participants (Actual) | Interventional | 2012-10-31 | Withdrawn(stopped due to No participants enrolled) |
| Unrelated or Partially Matched Allogeneic Donor Stem Cells for Lymphoma, Myeloma, and Chronic Lymphocytic Leukemia [NCT00612716] | Phase 2 | 6 participants (Actual) | Interventional | 1999-10-06 | Completed |
| Superiority of the Triple Combinations of Bortezomib, Cyclophosphamide and Dexamethasone (VCD) Versus Cyclophosphamide, Thalidomide and Dexamethasone (CTD) in Patients With Newly Diagnose Multiple Myeloma, Eligible for Transplantation [NCT03402295] | Phase 3 | 311 participants (Actual) | Interventional | 2009-06-15 | Completed |
| Phase I/II Study Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Allogeneic Tumor-Reactive Lymphocyte Cell Line DMF5 in Metastatic Melanoma [NCT00924001] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to study was stopped due to low accrual) |
| A Phase I Clinical Trial of PD-1 Knockout Engineered T Cells Treating Patients With Advanced Non-small Cell Lung Cancer [NCT02793856] | Phase 1 | 12 participants (Actual) | Interventional | 2016-08-26 | Completed |
| Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC) [NCT00944047] | Phase 2 | 32 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Use of Natural Signals and Ambient Dendritic Cells to Culture-Expand Cancer Targeting T-Cells Directly From Unfractionated Peripheral Blood: A Phase 1 T-Cell Dose Escalation Trial Targeting Relapsed and Refractory MUC1-Expressing Multiple Myeloma [NCT05411497] | Phase 1 | 18 participants (Anticipated) | Interventional | 2022-06-20 | Recruiting |
| A Pilot Study of Post-transplant High Dose Cyclophosphamide (PTCY) as Part of Graft-Versus-Host Disease (GVHD) Prophylaxis in T-Cell Replete HLA-Mismatched Unrelated Donor (MMUD) Ablative and Reduced Intensity Hematopoietic Cell Transplantation (HCT) for [NCT03128359] | Phase 2 | 38 participants (Actual) | Interventional | 2017-05-30 | Active, not recruiting |
| Reduced Intensity, Partially HLA Mismatched Allogeneic BMT for Hematologic Malignancies Using Donors Other Than First-degree Relatives [NCT01203722] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2010-09-30 | Recruiting |
| Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated [NCT02870907] | Phase 2 | 185 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| Intravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung Disease [NCT01570764] | Phase 3 | 40 participants (Actual) | Interventional | 2013-01-14 | Completed |
| Subcutaneous Bortezomib, Cyclophosphamide and Rituximab (BCR) Versus Fludarabine, Cyclophosphamide and Rituximab (FCR) for Initial Therapy of Waldenstrőm's Macroglobulinaemia (WM): a Randomized Phase II Trial [NCT01592981] | Phase 2 | 60 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy [NCT01594177] | Phase 2 | 65 participants (Actual) | Interventional | 2012-05-31 | Completed |
| FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1) [NCT03841110] | Phase 1 | 37 participants (Actual) | Interventional | 2019-02-15 | Completed |
| A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma [NCT01746173] | Phase 2 | 5 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to Slow accrual and futility) |
| A Pilot Clinical Trial Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma [NCT02652455] | Early Phase 1 | 11 participants (Actual) | Interventional | 2016-03-08 | Completed |
| Low Dose Metronomic Cyclophosphamide and Methotrexate Chemotherapy in Combination With Aspirin in Patients With Stage II-III Breast Cancer Who Fail to Achieve a Pathologic Complete Response After Neoadjuvant Chemotherapy [NCT01612247] | | 13 participants (Anticipated) | Interventional | 2011-02-28 | Recruiting |
| A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine Alone or Followed by CRS-207 in Adults With Metastatic Pancreatic Adenocarcinoma [NCT01417000] | Phase 2 | 93 participants (Actual) | Interventional | 2011-09-21 | Completed |
| Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT04123392] | Phase 2/Phase 3 | 196 participants (Anticipated) | Interventional | 2019-10-31 | Recruiting |
| Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) [NCT03829566] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2019-11-30 | Withdrawn(stopped due to Discontinued by Investigator) |
| A Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma [NCT04392648] | Phase 1 | 0 participants (Actual) | Interventional | 2020-06-24 | Withdrawn(stopped due to Business Decision (no enrollment)) |
| Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma. [NCT02063022] | Phase 3 | 278 participants (Actual) | Interventional | 2009-01-22 | Completed |
| A Phase I Dose Escalation Study of Hydroxychloroquine With Infusional Cyclophosphamide, Pulse Dexamethasone and Rapamycin in Patients With Relapsed or Refractory Multiple Myeloma [NCT01689987] | Phase 1 | 18 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia [NCT00038610] | Phase 2 | 54 participants (Actual) | Interventional | 2001-03-31 | Completed |
| Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide With GMCSF Followed by Weekly Carboplatin/Nab-paclitaxel Plus or Minus Trastuzumab and Plus or Minus Bevacizumab in Treatment of Large or Inflammatory Breast Cancer-a Phase II Study [NCT00254592] | Phase 2 | 43 participants (Actual) | Interventional | 2005-10-31 | Completed |
| Non-Myeloablative Conditioning and Unrelated Umbilical Cord Blood Transplantation for Children and Adults With Serious Oncohematologic Diseases [NCT00255684] | | 16 participants (Actual) | Interventional | 2003-12-31 | Terminated(stopped due to low accrual) |
| High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy [NCT00258180] | Phase 2 | 3 participants (Actual) | Interventional | 2005-08-15 | Completed |
| Treatment of Lysosomal and Peroxisomal Inborn Errors of Metabolism by Bone Marrow Transplantation [NCT00176904] | Phase 2/Phase 3 | 135 participants (Actual) | Interventional | 1995-01-31 | Completed |
| A Multi-center, Prospective Clinical Study of Zanubrutinib, Rituximab and Combination Chemotherapy in Patients With Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma [NCT05164770] | Phase 3 | 160 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
| A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients With Hematologic Malignancies [NCT00134004] | Phase 2 | 210 participants (Actual) | Interventional | 2004-10-31 | Completed |
| A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas [NCT00634179] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen [NCT00305682] | Phase 2 | 295 participants (Actual) | Interventional | 2005-06-30 | Completed |
| A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Erbitux (Cetuximab) for the Treatment of Advanced Pancreatic Adenocarcinoma [NCT00305760] | Phase 2 | 60 participants (Actual) | Interventional | 2005-12-31 | Completed |
| A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma [NCT00365274] | Phase 2 | 6 participants (Actual) | Interventional | 2006-08-31 | Terminated |
| Phase II Study Using a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy and Intensive Total Body Irradiation Followed by Infusion of Tumor Reactive Lymphocytes and Reconstitution With CD34+ Stem Cells in Metastatic Melanoma [NCT00314106] | Phase 2 | 26 participants (Actual) | Interventional | 2006-04-30 | Completed |
| Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China [NCT02405676] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2015-01-31 | Active, not recruiting |
| A Randomized, Open-label, Phase II Study With Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Either Chemotherapy-naïve, Slowly Progressive, Asymptomatic Multiple Myeloma or With Stage II/III Multiple Myeloma in Stable Response/Plateau Phas [NCT01094548] | Phase 2 | 34 participants (Actual) | Interventional | 2008-01-31 | Completed |
| An Open-label, Phase I/II Study to Assess the Safety and Clinical Activity of NKR-2 Treatment Administration After a Non-myeloablative Preconditioning Chemotherapy in Relapse/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients. [NCT03466320] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2018-09-18 | Completed |
| Adoptive Transfer of Haploidentical Natural Killer Cells to Treat Refractory or Relapsed AML MT2010-02 [NCT01106950] | Phase 2 | 15 participants (Actual) | Interventional | 2010-07-31 | Terminated(stopped due to study drug (Ontak) no longer available) |
| Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial [NCT02460588] | Phase 3 | 120 participants (Actual) | Interventional | 2015-12-31 | Completed |
| A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patie [NCT04029688] | Phase 1/Phase 2 | 183 participants (Anticipated) | Interventional | 2020-01-27 | Recruiting |
| Haploidentical Transplant for Patients With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide [NCT03910452] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2019-10-28 | Recruiting |
| B-NHL 2013 - Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents [NCT03206671] | Phase 3 | 650 participants (Anticipated) | Interventional | 2017-08-03 | Recruiting |
| Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) After a Nonmyeloablative Conditioning Regimen, With Administration of NY-ESO-1157-165 Pulsed Dendritic Cells and Interleukin-2, in Patients With Advanced Malignancies [NCT01697527] | Phase 2 | 6 participants (Actual) | Interventional | 2012-11-02 | Active, not recruiting |
| Adjuvant Doxorubicin, Cyclophosphamide Followed by Avastin Given With Paclitaxel and Gemcitabine for Stage II and III Breast Cancer That Does Not Over-express Human Epidermal Growth Factor Receptor 2 (HER-2)/Neu [NCT00679029] | Phase 2 | 15 participants (Actual) | Interventional | 2008-05-02 | Terminated(stopped due to drug toxicity) |
| Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation [NCT00350181] | Phase 2 | 11 participants (Actual) | Interventional | 2006-08-31 | Completed |
| Dose-Finding Study for Cyclophosphamide as Conditioning Regimens for Bone Marrow Transplantation From Related Donors in Patients With Fanconi Anemia [NCT00317876] | Phase 1 | 25 participants (Actual) | Interventional | 1998-06-30 | Completed |
| Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results [NCT00324467] | Phase 2 | 150 participants (Actual) | Interventional | 2006-08-31 | Active, not recruiting |
| Phase I Study of In Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma [NCT00324623] | Phase 1 | 8 participants (Actual) | Interventional | 2005-09-30 | Completed |
| A Clinical Study to Evaluate the Safety and Effectiveness of CD19- BCMA CAR - T Cells Immunotherapy in Patients With Relapsed or Refractory Acute B Lymphocytic Leukemia [NCT04714593] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2021-01-15 | Recruiting |
| Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION] [NCT00427245] | Phase 3 | 400 participants (Anticipated) | Interventional | 2004-08-31 | Completed |
| Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells to Facilitate the Engraftment of a Single CCR5Δ32 Homozygous or Heterozygous Cord Blood Unit in Patients With HIV and Hematological Malignancies [NCT04083170] | Phase 2 | 10 participants (Anticipated) | Interventional | 2022-10-06 | Recruiting |
| A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory L [NCT03939026] | Phase 1 | 74 participants (Anticipated) | Interventional | 2019-05-01 | Active, not recruiting |
| A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL [NCT02626455] | Phase 3 | 547 participants (Actual) | Interventional | 2016-01-06 | Terminated(stopped due to The study did not meet the primary endpoint. The addition of copanlisib to standard immunochemo therapy did not improve progression-free survival compared to the control arm. Base on the study results, company decided to terminate the study.) |
| Neoadjuvant Docetaxel + Carboplatin Versus Epirubicin+Cyclophosphamide Followed by Docetaxel in Triple-Negative, Early-Stage Breast Cancer (NeoCART): Study Protocol for a Multicenter, Randomized Controlled, Open-Label, Phase 2 Trial [NCT03154749] | Phase 2 | 93 participants (Actual) | Interventional | 2016-09-01 | Completed |
| A Phase I/II Study of IL-15 Administration Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen and Autologous Lymphocyte Transfer in Metastatic Melanoma [NCT01369888] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2011-05-31 | Terminated(stopped due to Closed this protocol due to autoimmune toxicity.) |
| A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry [NCT03009058] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2017-05-24 | Terminated(stopped due to Commercial reasons) |
| Granulocyte Colony-stimulating Factor+Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT02744742] | Phase 2/Phase 3 | 202 participants (Actual) | Interventional | 2016-04-18 | Completed |
| A Pilot/ Phase 2 Study of Pentostatin Plus Cyclophosphamide Immune Depletion to Decrease Immunogenicity of SS1P in Patients With Mesothelioma, Lung Cancer or Pancreatic Cancer [NCT01362790] | Phase 1/Phase 2 | 55 participants (Actual) | Interventional | 2011-05-11 | Completed |
| HIGH-DOSE CHEMORADIOTHERAPY FOLLOWED BY RESCUE WITH MOBILIZED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH LOW-GRADE, TRANSFORMED, OR FOLLICULAR LARGE CELL NON-HODGKIN'S LYMPHOMA [NCT00002510] | Phase 1/Phase 2 | 0 participants | Interventional | 1992-04-30 | Completed |
| AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA [NCT00002552] | Phase 2 | 40 participants (Anticipated) | Interventional | 1993-10-31 | Completed |
| UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL [NCT00002582] | Phase 3 | 6,000 participants (Anticipated) | Interventional | 1993-06-30 | Completed |
| A PHASE I TRIAL OF HIGH DOSE CHEMOTHERAPY WITH AUTOLOGOUS BONE MARROW AND PERIPHERAL BLOOD PROGENITOR CELL RESCUE IN PATIENTS WITH PLATINUM-SENSITIVE, CHEMOTHERAPY-RESPONSIVE EPITHELIAL OVARIAN CARCINOMA [NCT00002600] | Phase 1 | 23 participants (Actual) | Interventional | 1994-10-21 | Completed |
| MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER [NCT00002696] | Phase 3 | 0 participants | Interventional | 1995-10-31 | Suspended |
| INFUSION OF ACTIVATED T CELLS AND LOW DOSE INTERLEUKIN 2 COMBINED WITH PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR THE TREATMENT OF WOMEN WITH METASTATIC BREAST CANCER: PHASE I/II [NCT00002780] | Phase 1/Phase 2 | 60 participants (Anticipated) | Interventional | 1996-05-31 | Active, not recruiting |
| Safety and Efficacy Study of Novel Mesothelin CAR-T Cell Therapy in Patients With Mesothelin-positive Advanced Refractory Solid Tumors [NCT05531708] | Phase 1 | 0 participants (Actual) | Interventional | 2021-04-02 | Withdrawn(stopped due to The study is not initiated and we want it to be withdrawn.) |
| ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS [NCT00002792] | Phase 2 | 20 participants (Anticipated) | Interventional | 1996-06-30 | Completed |
| Safety and Efficacy Study of Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies [NCT05513612] | Phase 1 | 0 participants (Actual) | Interventional | 2020-08-01 | Withdrawn(stopped due to The study is not initiated and we want it to be withdrawn.) |
| A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using Two Related Donors [NCT01532635] | Phase 2 | 4 participants (Actual) | Interventional | 2012-03-31 | Terminated(stopped due to Slow accrual) |
| Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer [NCT00379015] | Phase 2 | 38 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Double Umbilical Cord Blood Transplantation for Patients With Malignant and Non-Malignant Disorders [NCT00801931] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2007-09-06 | Terminated(stopped due to Poor accrual) |
| Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members [NCT00000703] | | 45 participants | Interventional | | Completed |
| Phase II Study of Intensive Carmustine and Etoposide With Cisplatin or Cyclophosphamide, Followed By Rescue With Autologous Bone Marrow Treated In Vitro With Etoposide and/or Peripheral Blood Stem Cells Mobilized With Filgrastim (G-CSF) or Sargramostim (G [NCT00002461] | Phase 2 | 35 participants (Actual) | Interventional | 1988-04-30 | Completed |
| A Randomized Trial of High-Dose Chemotherapy and Autologous Stem Cell Therapy Versus Standard Therapy in Women With Metastatic Breast Cancer Who Have Responded to Anthracycline or Taxane-Based Induction Chemotherapy [NCT00003032] | Phase 3 | 224 participants (Actual) | Interventional | 1997-04-25 | Completed |
| Weekly Paclitaxel During Radiation Therapy for Locally Advanced Breat Cancer [NCT00003050] | Phase 2 | 46 participants (Actual) | Interventional | 1997-04-30 | Completed |
| An Out Patient Dose Escalation Trial of High Dose Mitoxantrone, Thiotepa and Cyclophosphamide Plus Autologous Blood Cell Rescue and Amifostine Cytoprotection [NCT00003068] | Phase 2 | 30 participants (Anticipated) | Interventional | 1997-06-30 | Completed |
| Phase I/II Study of Samarium 153 as Part of a Double (Sequential) Autologous Bone Marrow Transplant (ABMT) for Patients With Stage IV Breast Cancer [NCT00003086] | Phase 1/Phase 2 | 12 participants (Anticipated) | Interventional | 1997-03-31 | Terminated(stopped due to no participants enrolled in a three year period) |
| HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER [NCT00002509] | Phase 1/Phase 2 | 0 participants | Interventional | 1991-11-30 | Completed |
| HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY NON-HODGKIN'S LYMPHOMA (INTERMEDIATE AND HIGH-GRADE HISTOLOGIES) [NCT00002521] | Phase 2 | 0 participants | Interventional | 1993-02-28 | Completed |
| Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies [NCT00003116] | Phase 2 | 66 participants (Actual) | Interventional | 1997-05-31 | Completed |
| Phase I/II Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Patients With Relapsed AML [NCT01640301] | Phase 1/Phase 2 | 47 participants (Actual) | Interventional | 2012-12-06 | Terminated(stopped due to Terminated due to slow accrual.) |
| A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS) [NCT00002798] | Phase 3 | 880 participants (Actual) | Interventional | 1996-08-31 | Completed |
| Multiple Cycles of High Dose Chemotherapy Supported With Filgrastim and Peripheral Blood Progenitor Cells in Patients With Metastatic Breast Cancer [NCT00003392] | Phase 2 | 61 participants (Actual) | Interventional | 1997-09-30 | Completed |
| Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34+ Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor [NCT00003398] | Phase 4 | 45 participants (Anticipated) | Interventional | 1998-09-30 | Completed |
| Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Fol [NCT00003152] | Phase 3 | 469 participants (Anticipated) | Interventional | 1997-03-31 | Terminated(stopped due to low accrual) |
| A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY [NCT00002870] | Phase 3 | 180 participants (Anticipated) | Interventional | 1994-12-31 | Completed |
| PROTOCOL FOR THE SCOTTISH POSTMENOPAUSAL CHEMO-ENDOCRINE TRIAL [NCT00002581] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 1993-06-30 | Completed |
| A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors. [NCT00003194] | Phase 1 | 24 participants (Anticipated) | Interventional | 1997-07-31 | Terminated(stopped due to Study enrollment did not meet expected goals) |
| MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL [NCT00002599] | Phase 3 | 750 participants (Anticipated) | Interventional | 1994-09-30 | Active, not recruiting |
| NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY [NCT00002611] | Phase 3 | 3,031 participants (Actual) | Interventional | 1995-07-31 | Completed |
| A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Suboptimally Debulked Stage III or IV Ovarian, Fallopian Tube or P [NCT00003944] | Phase 2 | 3 participants (Actual) | Interventional | 1998-08-31 | Completed |
| An Evaluation of the Immunological Parameters Associated With a Skin-Test and Immunization of Lung and Mesothelioma Cancer Patients With Autologous Lung Tumor Associated Antigen: Characterization of the Patients' Cytolytic and Helper T Cell Reactivity for [NCT00003974] | Phase 1 | 20 participants (Anticipated) | Interventional | 1997-08-31 | Completed |
| Pilot Trial of Paclitaxel-Herceptin Adjuvant Therapy for Early Stage Breast Cancer [NCT00003992] | Phase 2 | 200 participants (Actual) | Interventional | 1999-08-31 | Completed |
| VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE [NCT00002653] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 1993-09-30 | Active, not recruiting |
| TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE, WITH OR WITHOUT PIXY, IN PREVIOUSLY UNTREATED PATIENTS, FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FI [NCT00002665] | Phase 2 | 50 participants (Anticipated) | Interventional | 1995-07-31 | Completed |
| A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning [NCT05031897] | Phase 2 | 67 participants (Anticipated) | Interventional | 2021-10-25 | Recruiting |
| Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy [NCT00004010] | Phase 2 | 99 participants (Actual) | Interventional | 1999-10-31 | Completed |
| A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL [NCT00003578] | Phase 3 | 500 participants (Anticipated) | Interventional | 1993-01-31 | Active, not recruiting |
| INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LE [NCT00002701] | Phase 3 | 750 participants (Anticipated) | Interventional | 1995-10-31 | Active, not recruiting |
| A RANDOMIZED TRIAL COMPARING PREOPERATIVE DOXORUBICIN (ADRIAMYCIN)/CYCLOPHOSPHAMIDE (AC) TO PREOPERATIVE AC FOLLOWED BY PREOPERATIVE DOCETAXEL (TAXOTERE) AND TO PREOPERATIVE AC FOLLOWED BY POSTOPERATIVE DOCETAXEL IN PATIENTS WITH OPERABLE CARCINOMA OF THE [NCT00002707] | Phase 3 | 2,411 participants (Actual) | Interventional | 1995-12-31 | Completed |
| A Multi-Center Phase III Randomized, Controlled Study of Theratope Vaccine for Metastatic Breast Cancer [NCT00003638] | Phase 3 | 950 participants (Anticipated) | Interventional | 1999-01-31 | Completed |
| Phase III Study of Combination Chemotherapy in Children With T Cell and Pre-B Cell Non-Hodgkin's Lymphoma [NCT00003650] | Phase 3 | 179 participants (Actual) | Interventional | 1997-02-28 | Completed |
| PROSPECTIVE RANDOMISED EVALUATION OF HIGH-INTENSITY CHEMOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR SUPPORT IN PATIENTS WITH HIGH RISK BREAST CANCER [NCT00002755] | Phase 3 | 600 participants (Anticipated) | Interventional | 1995-11-30 | Completed |
| CAMP-010: PHASE I/II STUDY OF IN VIVO PURGING FOLLOWED BY HIGH DOSE CHEMOTHERAPY, AUTOLOGOUS HEMATOPOIETIC STEM CELL INFUSION AND IMMUNOTHERAPY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA [NCT00002761] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 1996-02-29 | Withdrawn(stopped due to PI left institution) |
| A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE [NCT00002773] | Phase 2 | 0 participants | Interventional | 1996-05-31 | Completed |
| A Randomised Comparative Trial of Highly Intensive Chemotherapy With Stem Cell Support vs. Relatively Intensive Chemotherapy (CMF 8 Cycles) in Breast Cancer Patients Node Positive Surgery, Having Received Primary Medical Therapy With an Anthracycline Regi [NCT00003680] | Phase 3 | 300 participants (Anticipated) | Interventional | 1998-11-30 | Active, not recruiting |
| Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Infants Less Than 1 Year of Age. [NCT00002785] | Phase 2 | 0 participants | Interventional | 1996-07-31 | Completed |
| Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine [NCT00003386] | Phase 2 | 0 participants | Interventional | 1999-07-31 | Terminated |
| The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenanc [NCT00003728] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 1998-12-31 | Active, not recruiting |
| "Phase I Study of T Cell Depleted (TCD) Partially Matched Related Donor (PMRD) Hematopoietic Stem Cell Transplantation for High Risk Hematologic Diseases Using Intense Pre and Post Transplant Immunosuppression and Megadose CD34 Veto Cells" [NCT00004904] | Phase 1 | 0 participants | Interventional | 1999-10-31 | Completed |
| Phase I/II Study of Low-Dose Cyclophosphamide, Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Imiquimod, in Patients With Progressive and/or Refractory Solid Malignancies [NCT02224599] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2017-07-28 | Terminated(stopped due to Sponsor decision to terminate study due to poor accrual) |
| A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic [NCT00005090] | Phase 3 | 11 participants (Actual) | Interventional | 2000-04-30 | Terminated(stopped due to poor accrual) |
| A Phase I/II Study of Intensive-Dose Etoposide, Topotecan and Carboplatin (ETC) Followed by Autologous Stem Cell Rescue in Chemosensitive Ovarian Cancer Patients With Either Minimal Residual Disease or at First Relapse [NCT00005612] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 1999-08-31 | Terminated(stopped due to Low accrual) |
| A Phase II Study of Cyclophosphamide, Thiotepa, and Carboplatin (CTC) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Breast Cancer [NCT00005798] | Phase 2 | 209 participants (Actual) | Interventional | 1995-07-31 | Completed |
| Treatment of Patients With Hematological Malignancies Using Marrow Transplantation From Unrelated Donors Incompatible for One HLA Locus Antigen [NCT00005804] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| PROSPECTIVE NON-RANDOMIZED STUDY WITH CHEMOTHERAPY FOR RELAPSED OR REFRACTORY HIV-RELATED NON-HODGKIN'S LYMPHOMA: VMP REGIMEN FOR RELAPSED PATIENTS, CDE REGIMEN FOR REFRACTORY PATIENTS [NCT00002905] | Phase 2 | 20 participants (Anticipated) | Interventional | 1995-06-30 | Active, not recruiting |
| A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma [NCT00002941] | Phase 2 | 69 participants (Actual) | Interventional | 1998-04-30 | Completed |
| A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer [NCT00002953] | Phase 3 | 704 participants (Anticipated) | Interventional | 1996-12-31 | Completed |
| Autologous Stem Cell Transplantation for Poor Prognosis, Relapsed, or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab (IDEC C2B8, Rituximab, Rituxan) and Consolidative Chemo [NCT00003397] | Phase 2 | 25 participants (Anticipated) | Interventional | 1998-09-30 | Completed |
| A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation (ALLO-SCT) for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse [NCT00002989] | Phase 3 | 207 participants (Anticipated) | Interventional | 1997-03-31 | Active, not recruiting |
| Actinomycin D and Vincristine With or Without Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma: IRS-V Protocol [NCT00002995] | Phase 3 | 483 participants (Actual) | Interventional | 1997-08-31 | Completed |
| A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer [NCT02132949] | Phase 2 | 401 participants (Actual) | Interventional | 2014-07-14 | Completed |
| Interferon Maintenance in Advanced Multiple Myeloma After Using High-Dose Melphalan as Myeloablative Chemotherapy: A Pilot Study [NCT00003007] | Phase 2 | 0 participants | Interventional | 1996-07-31 | Completed |
| COOPERATIVE MULTICENTER TRIAL FOR THE TREATMENT OF INFANTS WITH NEUROBLASTOMA [NCT00002803] | Phase 2 | 44 participants (Anticipated) | Interventional | 1995-07-31 | Completed |
| High Dose Combined Modality Therapy With Peripheral Blood Progenitor Cell Transplantation as Primary Treatment for Patients With Mantle Cell Lymphoma [NCT00003541] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 1998-06-30 | Completed |
| Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States [NCT00002809] | Phase 2 | 10 participants (Anticipated) | Interventional | 1996-08-31 | Completed |
| National Breast Cancer Study of Epirubicin + CMF v Classical CMF Adjuvant Therapy [NCT00003577] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 1996-03-31 | Completed |
| Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma [NCT00003595] | Phase 3 | 120 participants (Actual) | Interventional | 1999-01-31 | Completed |
| Phase III Prospective Randomized Study of Craniospinal RT Followed by One of Two Adjuvant Chemotherapy Regimens (CCNU, CDDP, VCR OR CPM, CDDP, VCR) for Newly-Diagnosed Average Risk MedulloblastomaMEDULLOBLASTOMA [NCT00002875] | Phase 3 | 421 participants (Actual) | Interventional | 1996-12-31 | Completed |
| A Phase II Trial of High Dose Paclitaxel, Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer [NCT00003943] | Phase 2 | 3 participants (Actual) | Interventional | 1998-09-30 | Completed |
| "A Phase II Up-Front Window Study of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study" [NCT00003955] | Phase 2 | 77 participants (Actual) | Interventional | 1999-09-30 | Completed |
| Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane With and Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma [NCT00003667] | Phase 2 | 0 participants | Interventional | 1998-09-30 | Completed |
| A Randomised Comparative Trial of Adriamycin + Taxotere vs. Adriamycin + Cyclophosphamide as Primary Medical Therapy for Patients With Potentially Operable Breast Cancer Greater Than or Equal to 3 cm Diameter, Locally Advanced, or Inflammatory Disease [NCT00003679] | Phase 3 | 350 participants (Anticipated) | Interventional | 1998-11-30 | Active, not recruiting |
| A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b [NCT00003715] | Phase 2 | 425 participants (Anticipated) | Interventional | 1998-12-31 | Terminated(stopped due to Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated) |
| Autotransplantation for Chronic Myelogenous Leukemia (CML) Followed by Immunotherapy With Ex-Vivo Expanded Autologous T Cells [NCT00003727] | Phase 2 | 22 participants (Anticipated) | Interventional | 1999-03-31 | Completed |
| Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy [NCT00004135] | Phase 2 | 19 participants (Actual) | Interventional | 1999-02-28 | Completed |
| A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-cell CLL [NCT00003829] | Phase 2 | 34 participants (Actual) | Interventional | 1999-08-31 | Completed |
| A Pilot Study of Dose Intensification of Methotrexate and Cyclophosphamide in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Non-Hodgkins Lymphoma and B-Cell All- A Limited Institution Phase III Pilot Study [NCT00003217] | Phase 1 | 20 participants (Actual) | Interventional | 1998-03-31 | Completed |
| Trial of Chemotherapy Utilizing Carboplatin, Vincristine, Cyclophosphamide and Etoposide for the Treatment of Central Nervous System Primitive Neurectodermal Tumors of Childhood [NCT00003859] | Phase 3 | 230 participants (Anticipated) | Interventional | 1992-04-30 | Completed |
| A Phase I/II Study in Metastatic Breast Cancer Patients Infused With Stromagen and Isolated, Mobilized, Autologous Peripheral Blood CD34+ Progenitor Cells After High-Dose Chemotherapy [NCT00003877] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 1998-09-30 | Completed |
| A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early Breast Cancer [NCT00004237] | Phase 2 | 0 participants | Interventional | 1998-10-31 | Completed |
| A Multicenter Study of Unrelated Umbilical Cord Blood as an Alternate Source of Stem Cells for Transplantation [NCT00003913] | Phase 2 | 390 participants (Anticipated) | Interventional | 1998-12-31 | Completed |
| A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia [NCT00004255] | Phase 2/Phase 3 | 0 participants | Interventional | 2000-03-31 | Completed |
| A Phase II Study of High Dose Late Intensification Therapy in Patients With Chemotherapy Sensitive Multiple Myeloma [NCT00004903] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Active, not recruiting |
| A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer [NCT00004921] | Phase 3 | 0 participants | Interventional | 1998-09-30 | Completed |
| Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma [NCT00005089] | Phase 2 | 71 participants (Actual) | Interventional | 2000-04-30 | Completed |
| T-Cell Depletion for Graft-Versus-Host Disease (GVHD) Prevention in High Risk Matched and Mismatched Allogeneic Bone Marrow Transplantation [NCT00005641] | Phase 2 | 0 participants | Interventional | 1997-09-30 | Terminated(stopped due to low study accrual) |
| Allogeneic Bone Marrow Transplantation for Hematologic Malignancies: A Treatment Approach Based on Risk of Relapse and Toxicity [NCT00005797] | Phase 2 | 125 participants (Actual) | Interventional | 1993-03-31 | Completed |
| Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial [NCT02116530] | Phase 3 | 401 participants (Actual) | Interventional | 2014-08-31 | Completed |
| A Phase I/II Study of the Treatment of Metastatic Cancer That Expresses MAGE-A3 Using Lymphodepleting Conditioning Followed by Infusion of HLA-DP0401/0402 Restricted Anti-MAGE-A3 TCR-Gene Engineered Lymphocytes and Aldesleukin [NCT02111850] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2014-02-07 | Completed |
| Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer [NCT01855828] | Phase 2 | 50 participants (Actual) | Interventional | 2013-09-30 | Completed |
| A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly [NCT01855750] | Phase 3 | 838 participants (Actual) | Interventional | 2013-09-03 | Completed |
| Bone Marrow Transplantation and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance (ITN054ST) [NCT02029638] | Phase 2 | 4 participants (Actual) | Interventional | 2014-01-07 | Terminated(stopped due to Slow accrual) |
| A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor [NCT01982682] | Phase 2 | 41 participants (Actual) | Interventional | 2013-11-04 | Completed |
| Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma [NCT02419469] | Phase 2 | 1 participants (Actual) | Interventional | 2015-11-13 | Terminated(stopped due to Slow Accrual) |
| A Protocol For Nonmetastatic Rhabdomyosarcoma [RMS-2005] [NCT00379457] | Phase 3 | 600 participants (Anticipated) | Interventional | 2006-06-30 | Recruiting |
| Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) [NCT03967223] | Phase 2 | 103 participants (Actual) | Interventional | 2019-12-31 | Active, not recruiting |
| SCD-Haplo: A Phase II Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease [NCT02013375] | Phase 2 | 2 participants (Actual) | Interventional | 2014-04-10 | Terminated |
| Phase II Trial of Intensive, Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkin's Lymphoma [NCT00002471] | Phase 2 | 0 participants | Interventional | 1990-02-28 | Completed |
| Phase III Randomized Study of Adjuvant Therapy With a Platinum-Containing Regimen (e.g., CBDCA or CAP: CTX/DOX/CDDP) vs No Adjuvant Therapy in Patients With Fully Resected Early Stage Ovarian Cancer [NCT00002477] | Phase 3 | 0 participants | Interventional | 1991-04-30 | Active, not recruiting |
| PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS [NCT00002489] | Phase 2 | 0 participants | Interventional | 1991-10-31 | Completed |
| A Pilot Trial of GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant [NCT02360111] | | 3 participants (Actual) | Interventional | 2015-02-28 | Terminated(stopped due to Lack of accrual) |
| RANDOMIZED PHASE III STUDY OF INDUCTION (ICE VS MICE VS DCE) AND INTENSIVE CONSOLIDATION (IDIA VS NOVIA VS DIA) FOLLOWED BY BONE MARROW TRANSPLANTATION IN ACUTE MYELOGENOUS LEUKEMIA: AML 10 PROTOCOL [NCT00002549] | Phase 3 | 1,520 participants (Anticipated) | Interventional | 1993-11-30 | Active, not recruiting |
| PROTOCOL FOR THE SCOTTISH CHEMO-ENDOCRINE TRIAL D [NCT00002579] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 1993-03-31 | Completed |
| PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH HIGH RISK STAGE II AND III BREAST CANCER [NCT00002627] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 1994-11-30 | Active, not recruiting |
| A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA [NCT00002675] | Phase 2 | 50 participants (Anticipated) | Interventional | 1995-05-31 | Completed |
| A PHASE III RANDOMIZED STUDY COMPARING G-CSF MOBILIZED PERIPHERAL BLOOD STEM CELLS WITH MARROW AS THE SOURCE OF STEM CELLS FOR ALLOGENEIC TRANSPLANTS FROM HLA IDENTICAL, RELATED DONORS FOR THE TREATMENT OF CHRONIC MYELOID LEUKEMIA [NCT00002789] | Phase 3 | 100 participants (Anticipated) | Interventional | 1996-05-31 | Completed |
| A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT) [NCT05289167] | Phase 1/Phase 2 | 74 participants (Anticipated) | Interventional | 2022-03-13 | Recruiting |
| High-Dose Cytarabine and Idarubicin Induction, High Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia [NCT00002945] | Phase 3 | 61 participants (Actual) | Interventional | 1996-12-31 | Completed |
| "Minimal Initial Therapy (MIT) for Early Supradiaphragmatic Hodgkin's Disease: A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy (VAPEC-B) Plus Involved Field Radiotherapy (MIT) Versus Mantle Radiotherapy" [NCT00002987] | Phase 3 | 400 participants (Anticipated) | Interventional | 1997-01-31 | Active, not recruiting |
| A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (O-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated [NCT06091865] | Phase 3 | 904 participants (Anticipated) | Interventional | 2023-12-11 | Recruiting |
| Phase I Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors in Participants With Metastatic Pancreatic, Colorectal and Non-Small Cell Lung Cancers With KRAS G12V Mutations [NCT06043713] | Phase 1 | 24 participants (Anticipated) | Interventional | 2024-01-01 | Recruiting |
| High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study [NCT00002943] | Phase 2 | 11 participants (Actual) | Interventional | 1993-02-28 | Completed |
| Randomized Trial of Busulfan or Total Body Irradiation Conditioning Regimens for Children With Acute Lymphoblastic Leukemia [NCT00002961] | Phase 3 | 43 participants (Actual) | Interventional | 1995-10-31 | Terminated(stopped due to poor accrual) |
| A Clinical Trial to Evaluate the Benefit of Adding Octreotide (SMS 201-995 PA LAR) to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Patients With Axillary Node-Negative, Estrogen-Receptor-Positive, Primary Invasive Breast Cancer [NCT00002967] | Phase 3 | 0 participants | Interventional | 1997-05-31 | Completed |
| Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study [NCT00003093] | Phase 3 | 573 participants (Actual) | Interventional | 1988-03-31 | Completed |
| A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors [NCT00003141] | Phase 1 | 94 participants (Actual) | Interventional | 1998-03-31 | Completed |
| A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma [NCT02243371] | Phase 2 | 93 participants (Actual) | Interventional | 2015-01-02 | Completed |
| Allogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 Study [NCT01570348] | Phase 2 | 2 participants (Actual) | Interventional | 2012-07-17 | Terminated(stopped due to Annual accrual goal not met) |
| A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy [NCT05649618] | Early Phase 1 | 42 participants (Anticipated) | Interventional | 2022-12-05 | Not yet recruiting |
| A Phase I-II Study of the Treatment of Metastatic Cancer That Expresses MAGE-A3 Using Lymphodepleting Conditioning Followed by Infusion of Anti-MAGE-A3 HLA-A*01 Restricted TCR-Gene Engineered Lymphocytes and Aldesleukin [NCT02153905] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2014-07-03 | Terminated(stopped due to Slow, insufficient accrual.) |
| Randomized Phase II Multinational Trial to Evaluate the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy in Patients With HER2-positive Breast Cancer: Caelyx + Cyclophosphamide + Trastuzumab (C+C+H) or Doxorubicin + Cyclophosphamid [NCT00550771] | Phase 2 | 181 participants (Actual) | Interventional | 2007-07-16 | Completed |
| A Phase I/II Study of T Cell Receptor Gene Therapy Targeting HPV-16 E6 for HPV-Associated Cancers [NCT02280811] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2014-10-14 | Completed |
| A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors [NCT05648994] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2022-12-31 | Not yet recruiting |
| A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial [NCT00085735] | Phase 3 | 549 participants (Actual) | Interventional | 2004-04-30 | Active, not recruiting |
| Safety and Efficacy of Anti-FLT3 CAR- T Cell (TAA05 Cell Injection) in the Treatment of Relapsed/ Refractory Acute Myeloid Leukemia [NCT05445011] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-06-14 | Recruiting |
| A Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic Anemia [NCT02833805] | Phase 2 | 21 participants (Actual) | Interventional | 2016-09-30 | Completed |
| A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects [NCT01980589] | Phase 1 | 22 participants (Actual) | Interventional | 2013-08-31 | Completed |
| A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients [NCT03066947] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2017-05-05 | Completed |
| A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) [NCT02049151] | Phase 3 | 35 participants (Actual) | Interventional | 2014-03-31 | Terminated(stopped due to The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC) |
| Evaluation of Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma [NCT05993299] | Phase 2 | 7 participants (Actual) | Interventional | 2019-12-31 | Active, not recruiting |
| Phase I Study to Evaluate the Safety and Efficacy of NK Cell Therapy in Acute Myeloid Leukemia (AML). [NCT05987696] | Phase 1 | 102 participants (Anticipated) | Interventional | 2023-08-10 | Not yet recruiting |
| Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma [NCT05470283] | Phase 1 | 30 participants (Anticipated) | Interventional | 2022-09-07 | Recruiting |
| A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma [NCT05000450] | Phase 1/Phase 2 | 136 participants (Anticipated) | Interventional | 2021-06-06 | Active, not recruiting |
| A Multicenter, Open-Label Feasibility Study of Daratumumab With Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV [NCT04139304] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2021-05-24 | Recruiting |
| A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma [NCT04093596] | Phase 1 | 132 participants (Anticipated) | Interventional | 2019-09-23 | Active, not recruiting |
| A Phase 2 Study of Eribulin Followed by Doxorubicin and Cyclophosphamide as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer [NCT02623972] | Phase 2 | 22 participants (Actual) | Interventional | 2016-02-26 | Active, not recruiting |
| A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer [NCT02488967] | Phase 3 | 782 participants (Anticipated) | Interventional | 2015-07-26 | Recruiting |
| A Phase I Trial of T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia [NCT01860937] | Phase 1 | 23 participants (Actual) | Interventional | 2013-05-31 | Active, not recruiting |
| Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma [NCT00338377] | Phase 2 | 1,230 participants (Actual) | Interventional | 2006-02-01 | Active, not recruiting |
| Short-Course EPOCH - Rituximab in Untreated CD-20+ HIV-Associated Lymphomas [NCT00006436] | Phase 2 | 68 participants (Actual) | Interventional | 2001-01-29 | Active, not recruiting |
| Autologous Transplantation With High Dose BCNU and Melphalan Followed by Consolidation With DCEP and Taxol/Cisplatin in Patients With Multiple Myeloma and < or = 12 Months of Standard Therapy [NCT00003399] | Phase 2 | 0 participants | Interventional | 1998-09-30 | Completed |
| A Phase I Trial of Combined Chemotherapy and Donor Lymphocyte Infusion for Aggressive Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation [NCT00003243] | Phase 1 | 0 participants | Interventional | 1998-01-31 | Completed |
| Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy [NCT04927884] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2021-09-27 | Terminated(stopped due to Study not meeting recruitment goals) |
| A Pilot/Phase 1 Study of Immunosuppression-free Regulatory T-cell Graft-engineered Haploidentical Hematopoietic Cell Transplantation in Relapsed/Refractory and Ultra-High-risk AML/MDS [NCT04678401] | Phase 1 | 20 participants (Anticipated) | Interventional | 2021-01-12 | Recruiting |
| A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients [NCT04304352] | Phase 2 | 162 participants (Anticipated) | Interventional | 2011-07-29 | Recruiting |
| Combination of Pembrolizumab With Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer (PERICLES): A Phase II Study [NCT03971045] | Phase 2 | 46 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
| A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Advanced Solid Cancers [NCT03935893] | Phase 2 | 240 participants (Anticipated) | Interventional | 2019-12-03 | Recruiting |
| A MULTIARM, OPEN LABEL, RANDOMIZED PHASE II STUDY OF MLN9708 PLUS ORAL DEXAMETHASONE or PLUS ORAL CYCLOPHOSPHAMIDE AND DEXAMETHASONE or PLUS ORAL THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY MAINTENANCE WITH MLN9708 IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOM [NCT02586038] | Phase 2 | 175 participants (Anticipated) | Interventional | 2015-10-31 | Active, not recruiting |
| Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL) [NCT01390584] | Phase 2 | 6 participants (Actual) | Interventional | 2013-05-24 | Terminated(stopped due to slow accrual) |
| Nonmyeloablative Hematopoietic Stem Cell Transplantation (SCT) for High-Risk Hematologic Malignancies With Related, HLA-Haploidentical Donors: A Phase II Trial of Immunosuppression With Cyclophosphamide Administered Before and After SCT [NCT01374841] | Phase 2 | 20 participants (Anticipated) | Interventional | 2010-08-31 | Recruiting |
| A Phase I/II, Multi-center, Open Label Study of Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma Relapsed and/or Refractory to Lenalidomide [NCT01166113] | Phase 1/Phase 2 | 67 participants (Actual) | Interventional | 2010-07-31 | Completed |
| A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-positive, Lymph Node-positive or -Negative Patients [NCT00309478] | Phase 3 | 1,099 participants (Actual) | Interventional | 1990-12-31 | Completed |
| Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [18F] FDG-PET Scanning [NCT00274924] | Phase 2 | 100 participants (Actual) | Interventional | 2006-09-26 | Completed |
| Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia [NCT00074282] | Phase 2 | 102 participants (Actual) | Interventional | 2005-04-14 | Completed |
| Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia [NCT00060346] | Phase 2 | 16 participants (Actual) | Interventional | 2004-10-05 | Terminated(stopped due to slow accrual) |
| A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease [NCT00003389] | Phase 3 | 854 participants (Actual) | Interventional | 1999-06-17 | Completed |
| CD45A-Depleted Haploidentical Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation [NCT02259348] | Phase 2 | 12 participants (Actual) | Interventional | 2014-10-31 | Terminated(stopped due to Investigator's decision.) |
| Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma [NCT03994705] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2019-08-06 | Active, not recruiting |
| Phase II Study of PD-1 Inhibition With Cemiplimab in Locally Advanced Hormone Receptor (HR) Positive HER2 Negative or Triple-Negative Breast Cancer Patients Undergoing Standard Neoadjuvant Chemotherapy [NCT04243616] | Phase 2 | 36 participants (Anticipated) | Interventional | 2020-03-05 | Recruiting |
| A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL). [NCT03743246] | Phase 1/Phase 2 | 121 participants (Anticipated) | Interventional | 2018-10-17 | Recruiting |
| Clinical Study of the Safety and Initial Efficacy of BGT007 Cells in the Treatment of Patients With Relapsed /Metastatic Nasopharyngeal Carcinoma [NCT05616468] | Early Phase 1 | 23 participants (Anticipated) | Interventional | 2022-12-30 | Recruiting |
| Hematopoietic Bone Marrow Transplantation for Patients With High-risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) Using Related HLA-Mismatched Donors: A Trial Using Radiolabeled Anti-CD45 Antibody Co [NCT00589316] | Phase 1 | 26 participants (Actual) | Interventional | 2007-10-05 | Terminated(stopped due to Terminated due to loss of funding) |
| Non-Hodgkin's Lymphoma T Cell Protocol [NCT00003423] | Phase 3 | 100 participants (Anticipated) | Interventional | 1995-05-31 | Active, not recruiting |
| Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotep [NCT00003273] | Phase 2 | 0 participants (Actual) | Interventional | 1997-11-30 | Withdrawn |
| Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma [NCT00361621] | Phase 2 | 3 participants (Actual) | Interventional | 2006-07-31 | Terminated(stopped due to Closed due to slow accrual) |
| Autologous and Allogeneic Bone Marrow Transplantation for Low Grade Lymphoma [NCT00002829] | Phase 2 | 45 participants (Actual) | Interventional | 1994-02-28 | Completed |
| A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835] | Phase 3 | 116 participants (Actual) | Interventional | 1995-10-30 | Completed |
| HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN [NCT00002865] | Phase 2 | 25 participants (Actual) | Interventional | 1995-04-30 | Completed |
| A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma) [NCT00003549] | Phase 2 | 80 participants (Actual) | Interventional | 1998-10-31 | Completed |
| A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkin's Lymphoma [NCT00003957] | Phase 2 | 3 participants (Actual) | Interventional | 1998-12-31 | Completed |
| A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma [NCT00003573] | Phase 2 | 53 participants (Actual) | Interventional | 1998-11-30 | Completed |
| A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma [NCT00003603] | Phase 3 | 660 participants (Anticipated) | Interventional | 1998-03-31 | Active, not recruiting |
| Pilot Study of Intensive Chemotherapy Followed by Peripheral Blood Stem Cell Harvesting for Autotransplantation of Adults With Chronic Myelogenous Leukemia and High Risk Acute Leukemia [NCT00004905] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study [NCT00004179] | Phase 3 | 475 participants (Actual) | Interventional | 1999-05-31 | Completed |
| A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcin [NCT00004221] | Phase 2 | 12 participants (Actual) | Interventional | 1999-11-30 | Terminated |
| [NCT00004323] | Phase 2 | 10 participants | Interventional | 1995-02-28 | Completed |
| ALinC 17: Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia (A.L.L.): A Pediatric Oncology Group Pilot Study [NCT00003783] | Phase 2 | 36 participants (Actual) | Interventional | 1999-03-31 | Completed |
| Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy [NCT00005589] | Phase 3 | 460 participants (Anticipated) | Interventional | 1999-10-31 | Completed |
| MK-3475 in Combination With Standard RCHOP Therapy for Previously Untreated Diffuse Large B-Cell Lymphoma [NCT02541565] | Phase 1 | 30 participants (Actual) | Interventional | 2015-11-24 | Completed |
| Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen [NCT00365287] | Phase 1/Phase 2 | 148 participants (Actual) | Interventional | 2000-06-30 | Completed |
| Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year [NCT00365755] | Phase 3 | 0 participants | Interventional | | Completed |
| A Phase I/II Study Using Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma (ATOMIC) [NCT01192555] | Phase 1/Phase 2 | 11 participants (Actual) | Interventional | 2010-09-30 | Active, not recruiting |
| G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With High-risk MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT05453552] | Phase 2/Phase 3 | 242 participants (Anticipated) | Interventional | 2022-07-01 | Recruiting |
| A Safety Pilot Study of High Risk Induction Chemotherapy for Neuroblastoma Without Prophylactic Administration of Myeloid Growth Factors [NCT02786719] | | 13 participants (Actual) | Interventional | 2016-06-30 | Completed |
| A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation [NCT03018223] | Phase 1 | 32 participants (Actual) | Interventional | 2017-01-31 | Completed |
| Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial [NCT03043105] | Phase 2 | 25 participants (Actual) | Interventional | 2017-01-01 | Active, not recruiting |
| Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma [NCT01632150] | Phase 2 | 51 participants (Actual) | Interventional | 2012-05-31 | Completed |
| G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT04713956] | Phase 2/Phase 3 | 242 participants (Anticipated) | Interventional | 2021-01-15 | Recruiting |
| Umbilical Cord Blood Transplant With Co-Infusion of T Regulatory Cells [NCT00376519] | Phase 1 | 3 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Slow accrual) |
| An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) [NCT01539083] | Phase 3 | 256 participants (Actual) | Interventional | 2012-01-13 | Completed |
| P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer [NCT04443348] | Phase 2 | 120 participants (Anticipated) | Interventional | 2020-12-16 | Recruiting |
| A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies [NCT02383212] | Phase 1 | 398 participants (Actual) | Interventional | 2015-02-02 | Completed |
| A Randomized Phase II Study of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer [NCT01527487] | Phase 2 | 76 participants (Actual) | Interventional | 2012-06-30 | Completed |
| A Phase I Study of T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728mR in HIV-Infected Patients, With or Without the CCR5 Delta-32 Mutation, Pre-treated With Cyclophosphamide [NCT02388594] | Phase 1 | 14 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Phase III Randomized Clinical Trial Evaluating the Sequencing of Anthracyclines and Taxanes in Neoadjuvant Therapy for Locally Advanced HER2-negative Breast Cancer [NCT04540692] | Phase 3 | 494 participants (Anticipated) | Interventional | 2021-01-12 | Recruiting |
| Efficacy of Palonosetron in the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Following Dose Dense Adriamycin-Cyclophosphamide Chemotherapy in Early Stage Breast Cancer Patients [NCT00343863] | | 41 participants (Actual) | Interventional | 2006-01-31 | Completed |
| A Exploratory Trial to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Immunogenicity, and Preliminary Efficacy of WTX221 Infusion in Patients With Refractory Gout [NCT05800041] | Early Phase 1 | 7 participants (Anticipated) | Interventional | 2023-04-10 | Not yet recruiting |
| Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Ne [NCT02881086] | Phase 3 | 1,000 participants (Actual) | Interventional | 2016-08-31 | Active, not recruiting |
| A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia [NCT00322101] | Phase 3 | 25 participants (Actual) | Interventional | 2006-01-31 | Completed |
| Phase Ib Study of Neoadjuvant DPX-Survivac, Aromatase Inhibition, and With/Without Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer [NCT04895761] | Phase 1 | 6 participants (Actual) | Interventional | 2021-09-10 | Active, not recruiting |
| A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination With Rituximab or Obinutuzumab in Subjects With Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia [NCT04245722] | Phase 1 | 98 participants (Actual) | Interventional | 2020-03-19 | Terminated(stopped due to The study was terminated by the Sponsor.) |
| A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma [NCT04023071] | Phase 1 | 72 participants (Actual) | Interventional | 2019-10-04 | Terminated(stopped due to The study was terminated by the Sponsor.) |
| Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adult [NCT03719105] | Early Phase 1 | 40 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting |
| A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invas [NCT03197935] | Phase 3 | 333 participants (Actual) | Interventional | 2017-07-24 | Completed |
| A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) [NCT03105336] | Phase 2 | 159 participants (Actual) | Interventional | 2017-06-20 | Active, not recruiting |
| Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia [NCT02845596] | | 40 participants (Anticipated) | Interventional | 2016-08-31 | Active, not recruiting |
| A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma [NCT02601313] | Phase 2 | 105 participants (Actual) | Interventional | 2015-11-09 | Completed |
| A Phase I Study of ABT-888 in Combination With Cyclophosphamide in Solid Tumors or Non-Hodgkin Lymphoma [NCT00740805] | Phase 1 | 81 participants (Actual) | Interventional | 2008-08-18 | Active, not recruiting |
| Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors [NCT00536601] | | 174 participants (Actual) | Interventional | 2006-06-29 | Completed |
| Multi-Center, Open-Label Randomized Study of Single or Double Myeloablative Cord Blood Transplantation With or Without Infusion of Off-The-Shelf Ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells in Patients With Hematologic Malignancies [NCT01690520] | Phase 2 | 163 participants (Actual) | Interventional | 2012-12-11 | Completed |
| A Phase I-II Study of R115777 (Tipifarnib, Zarnestra®) Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Stage IIB-IIIC Breast Cancer [NCT00470301] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Phase I Study to Evaluate the Safety and Effectiveness of Dual CD33-CLL1 CAR-T Therapy in Relapsed/Refractory Acute Myeloid Leukemia [NCT05016063] | Early Phase 1 | 32 participants (Anticipated) | Interventional | 2021-09-01 | Not yet recruiting |
| Phase II Neoadjuvant Trial of Eribulin Followed by Dose Dense Doxorubicin and Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer [NCT01498588] | Phase 2 | 7 participants (Actual) | Interventional | 2011-11-30 | Terminated(stopped due to Slow accrual) |
| A Phase I Open, Single-arm Study of JWCAR029 (CD19-targeted Chimeric Antigen Receptor T Cells) for Patients With Relapsed or Refractory in B-cell Acute Lymphoblastic Leukemia [NCT05727683] | Phase 1 | 33 participants (Anticipated) | Interventional | 2022-04-28 | Recruiting |
| BRE-01: Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel Followed by Doxorubicin and Cyclophosphamide in Triple Negative Breast Cancer [NCT04083963] | Phase 2 | 13 participants (Actual) | Interventional | 2019-08-09 | Active, not recruiting |
| Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk [NCT02461121] | Phase 3 | 156 participants (Actual) | Interventional | 2004-05-31 | Completed |
| Safety and Efficacy of Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for Relapsed/Refractory B Lymphoid Malignancies: a Single-center, Open-label, Single-arm Clinical Study [NCT04796675] | Phase 1 | 27 participants (Anticipated) | Interventional | 2021-04-10 | Recruiting |
| A Phase II Single-arm Clinical Trial of the Efficacy and Tolerability of Inetetamab Combined With Cyclophosphamide Metronomic Chemotherapy and Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer [NCT04941885] | Phase 2 | 78 participants (Anticipated) | Interventional | 2021-06-25 | Recruiting |
| HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN'S DISEASE [NCT00002522] | Phase 2 | 0 participants | Interventional | 1993-02-28 | Completed |
| The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma [NCT03045471] | | 50 participants (Anticipated) | Observational | 2017-03-01 | Not yet recruiting |
| NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma [NCT01451515] | Phase 2 | 23 participants (Actual) | Interventional | 2012-05-25 | Completed |
| Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma [NCT03042429] | Phase 3 | 360 participants (Actual) | Interventional | 2007-01-01 | Completed |
| An Open-label, Multi-center, Single-arm Phase 1/2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma [NCT04836507] | Phase 1/Phase 2 | 91 participants (Anticipated) | Interventional | 2021-03-02 | Recruiting |
| A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Rituximab Plus CHOP in Patients With Diffuse Large B-Cell Ly [NCT02596971] | Phase 1/Phase 2 | 91 participants (Actual) | Interventional | 2015-12-22 | Completed |
| Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Therapy of Pediatric Patients With Active Proliferative Lupus Nephritis: A Prospective, Randomized, Multicenter, Open-label, Parallel-arm Study [NCT05495893] | Phase 4 | 224 participants (Anticipated) | Interventional | 2022-07-25 | Recruiting |
| A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects With Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19) [NCT04314843] | Phase 1 | 6 participants (Actual) | Interventional | 2020-05-26 | Terminated(stopped due to Development program terminated.) |
| RANDOMISED CLINICAL TRIAL OF IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE (VICE) VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER (SCLC) AND GOOD PERFORMANCE STATUS [NCT00002822] | Phase 3 | 400 participants (Anticipated) | Interventional | 1996-03-31 | Completed |
| A Phase II Investigation of Pembrolizumab (Keytruda) in Combination With Radiation and an Immune Modulatory Cocktail in Patients With Cervical and Uterine Cancer (PRIMMO Trial) [NCT03192059] | Phase 2 | 43 participants (Actual) | Interventional | 2017-07-01 | Completed |
| A Phase I/II Trial Investigating the Combination of Pembrolizumab (Keytruda) With Cyclophosphamide and Lenalidomide for Patients With Relapsed Multiple Myeloma [NCT03191981] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-08-01 | Withdrawn(stopped due to Withdrawal of pharma support prior to opening to recruitment) |
| B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021) [NCT05518383] | Phase 4 | 300 participants (Anticipated) | Interventional | 2022-05-25 | Recruiting |
| Study of DC Vaccine Loaded Tumor Specific Antigen in Treating Patients With Gastrointestinal Solid Tumor [NCT03185429] | | 20 participants (Anticipated) | Interventional | 2017-12-31 | Not yet recruiting |
| Pilot Study of Infusion of Fucosylated Regulatory T Cells to Prevent Graft Versus Host Disease [NCT02423915] | Phase 1 | 5 participants (Actual) | Interventional | 2015-07-30 | Completed |
| A Prospective Randomized Trial Examining Low- or Intermediate-Dose Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy [NCT02139280] | Phase 2 | 58 participants (Actual) | Interventional | 2013-12-31 | Completed |
| High-dose Etoposide +G-CSF Versus High-dose Cyclophosphamide +G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma：a Multicenter,Randomized,Prospective Study [NCT05517213] | | 164 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
| Phase I/II Study Evaluating the Infusion of Tumor-Infiltrating Lymphocytes (TILs) & Low-Dose Interleukin-2 (IL-2) Therapy Following a Preparative Regimen of Non-myeloablative Lymphodepletion Using Cyclophosphamide & Fludarabine in Patients With Malignant [NCT02414945] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2015-05-15 | Completed |
| An Open-Label, Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma Requiring Systemic Treatment [NCT02046070] | Phase 2 | 148 participants (Actual) | Interventional | 2014-03-05 | Completed |
| An Open, Single-arm Clinical Study of Autologous T Cells (CAR-T) Targeting B7-H3 Chimeric Antigen Receptor Gene in the Treatment of Patients With Advanced Gastrointestinal Tumors [NCT05515185] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2022-09-09 | Not yet recruiting |
| Clinical Study of Rituximab or Cyclophosphamide Combined With Steroids in the Treatment of Idiopathic Membranous Nephropathy [NCT05514015] | Phase 4 | 72 participants (Anticipated) | Interventional | 2022-08-25 | Not yet recruiting |
| Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients [NCT03173417] | Phase 1/Phase 2 | 177 participants (Actual) | Interventional | 2017-05-23 | Completed |
| Clinical Study Comparing the Efficacy and Safety of Traditional Herbal Medicine for Cancer Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy in Patients With Stage II-III Breast Cancer. [NCT05483439] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-10-20 | Recruiting |
| NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Therapy [NCT03167177] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Trial not initiated) |
| A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients [NCT03166397] | Phase 2 | 30 participants (Anticipated) | Interventional | 2017-06-05 | Recruiting |
| A Multicenter, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-Line Treatment in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) [NCT02533401] | Phase 2 | 34 participants (Actual) | Interventional | 2006-02-28 | Completed |
| A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT C [NCT03959241] | Phase 3 | 428 participants (Anticipated) | Interventional | 2019-06-25 | Active, not recruiting |
| The CAPER Study: A Phase Ib Clinical Trial of Cyclophosphamide And PEmbrolizumab in Metastatic Renal Cell Carcinoma (RCC) (CAPER Trial) [NCT04262427] | Phase 1/Phase 2 | 21 participants (Anticipated) | Interventional | 2021-04-28 | Recruiting |
| A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell [NCT02055820] | Phase 1/Phase 2 | 267 participants (Actual) | Interventional | 2013-11-17 | Completed |
| A Phase 1 Study Using Simvastatin in Combination With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors [NCT02390843] | Phase 1 | 13 participants (Actual) | Interventional | 2015-02-28 | Completed |
| A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Adults and Children With Bone Marrow Failure Syndromes or Inherited Metabolic or Hematologic Diseases [NCT00003662] | Phase 2 | 90 participants (Anticipated) | Interventional | 1998-08-31 | Completed |
| A Randomized Phase I Study to Determine the Safety and Immunogenicity of ChAd-MVA Vaccination Compared to MVA Alone With and Without Low Dose Cyclophosphamide in Low and Intermediate Risk Localised Prostate Cancer [NCT02390063] | Phase 1 | 40 participants (Actual) | Interventional | 2015-06-30 | Completed |
| A Single-arm, Single-center Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT. [NCT04688021] | Phase 2 | 46 participants (Anticipated) | Interventional | 2020-12-03 | Recruiting |
| Randomized Open-label, Multicentric, Phase II Clinical Trial to Evaluate the Efficacy of a Neoadjuvant Chemotherapy Scheme Customized by Levels of BRCA1 in Women With Primary HER2 Negative Breast Cancer (The BERNAQ Clinical Trial) [NCT02365805] | Phase 2 | 30 participants (Actual) | Interventional | 2014-04-30 | Completed |
| Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis [NCT02339441] | | 320 participants (Actual) | Observational | 2010-06-30 | Completed |
| Allogeneic Hematopoietic Stem Cell Transplantation as Initial Salvage Therapy for Patients With Primary Induction Failure Acute Myeloid Leukemia Refractory to High-Dose Cytarabine-Based Induction Chemotherapy [NCT02441803] | Phase 2 | 11 participants (Actual) | Interventional | 2015-09-14 | Active, not recruiting |
| Pilot Safety Trial of Preoperative Chemotherapy Combined With Dendritic Cell Vaccine in Patients With Locally Advanced, Triple-Negative Breast Cancer or ER-Positive, Her2-Negative Breast Cancer [NCT02018458] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2014-05-31 | Completed |
| High Dose Chemotherapy and Combination Anti-HIV Therapy for HIV-Associated Hodgkin's and Non-Hodgkin's Lymphoma [NCT00641381] | Phase 1 | 25 participants (Anticipated) | Interventional | 2000-05-10 | Active, not recruiting |
| Efficacy of Consolidative Involved-site Radiotherapy Following Sufficient Chemotherapy for Patients With Limited-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center -NHL03 Trial [NCT02449265] | Phase 3 | 160 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
| T Cells Expressing a Fully-Human Anti-CD19 Chimeric Antigen Receptor for Treating B-cell Malignancies [NCT02659943] | Phase 1 | 27 participants (Actual) | Interventional | 2016-01-21 | Completed |
| Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial [NCT02406781] | Phase 2 | 227 participants (Anticipated) | Interventional | 2015-06-30 | Active, not recruiting |
| The Efficacy and Safety of Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH [NCT05120687] | | 200 participants (Anticipated) | Observational | 2021-10-15 | Recruiting |
| A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma [NCT06072131] | Phase 3 | 504 participants (Anticipated) | Interventional | 2023-10-04 | Recruiting |
| Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study [NCT00005581] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 2000-06-30 | Active, not recruiting |
| A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome [NCT04623541] | Phase 1/Phase 2 | 184 participants (Anticipated) | Interventional | 2020-11-25 | Recruiting |
| A Prospective Randomized and Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab [NCT02621021] | Phase 2 | 20 participants (Actual) | Interventional | 2015-12-04 | Suspended(stopped due to The team is revising the protocol design and has chosen to put the study on hold until those changes are approved.) |
| NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC [NCT03169777] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-08-31 | Withdrawn(stopped due to Trial not initiated) |
| A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS 207 Compared to Chemotherapy or to CRS-207 Alone in Adults With Previously-Treated Metastatic Pa [NCT02004262] | Phase 2 | 303 participants (Actual) | Interventional | 2014-02-05 | Completed |
| A Randomized Trial of Trastuzumab Deruxtecan and Biology-Driven Selection of Neoadjuvant Treatment for HER2-positive Breast Cancer: ARIADNE [NCT05900206] | Phase 2 | 370 participants (Anticipated) | Interventional | 2023-10-09 | Recruiting |
| A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma [NCT05899621] | | 332 participants (Anticipated) | Observational | 2023-06-01 | Recruiting |
| Immunostart: Prephase Tafasitamab, Retifanlimab, and Rituximab (TRR), Followed by TRR-CHOP, for Previously Untreated Diffuse Large B-Cell Lymphoma [NCT05455697] | Phase 1/Phase 2 | 35 participants (Anticipated) | Interventional | 2023-01-26 | Recruiting |
| A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS) [NCT03670966] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2019-07-10 | Recruiting |
| A Prospective Phase II Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy Followed by Allogeneic Stem Cell Transplantation as Treatment of Primary Progressive and Relapsed Aggressive Non-Hodgkin Lymphoma [NCT04121507] | Phase 2 | 60 participants (Actual) | Interventional | 2019-06-24 | Completed |
| A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children With Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology [NCT01228331] | Phase 2/Phase 3 | 745 participants (Actual) | Interventional | 2010-10-31 | Active, not recruiting |
| Phase I-II Single Cycle Melphalan/Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) Followed by Maintenance in Patients With High-Risk Myeloma and/or Poor Response to Induction Therapy Within 12 Months of Diagnosis [NCT03100877] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2018-01-31 | Withdrawn(stopped due to Feasibility Issues) |
| A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing [NCT00381173] | Phase 1 | 22 participants (Actual) | Interventional | 2006-11-30 | Completed |
| A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Respons [NCT00773695] | Phase 2 | 150 participants (Actual) | Interventional | 2008-11-07 | Completed |
| A Phase 3 Trial Comparing Cyclophosphamide,Bortezomib,and Dexamethasone (CyBorD) and Bortezomib,Doxorubicin,and Dexamethasone (PAD) in the Treatment of Newly Diagnosed Multiple Myeloma [NCT02362165] | Phase 3 | 236 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14. [NCT05049473] | Phase 2 | 100 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
| Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma. [NCT03146533] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2017-05-31 | Recruiting |
| A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma [NCT05633615] | Phase 2 | 396 participants (Anticipated) | Interventional | 2023-06-12 | Recruiting |
| Phase 1 Study of Lintivirally Transduced T Cells Engineered to Contain Anti-CD38 Linked to TCRζ and 4-1BB Signaling Domains in Subjects With Acute Myeloid Leukemia and Multiple Myeloma [NCT05442580] | Phase 1 | 36 participants (Anticipated) | Interventional | 2023-05-30 | Recruiting |
| Phase I Trial of GFRα4 CAR T Cells in Adult Patients With Recurrent or Metastatic Medullary Thyroid Cancer [NCT04877613] | Phase 1 | 18 participants (Anticipated) | Interventional | 2021-08-19 | Recruiting |
| A Multisite, Phase II Study of Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone (VICD) Induction in Transplant-Eligible Multiple Myeloma Patients [NCT04240054] | Phase 2 | 41 participants (Anticipated) | Interventional | 2021-11-02 | Recruiting |
| A Phase 1/2, Open Label, Multicenter Trial to Assess the Safety and Efficacy of MB-102 in Patients With Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm [NCT04109482] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2020-02-17 | Terminated(stopped due to Business reasons.) |
| A Phase 1 Study Evaluating the Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Subjects With Advanced Cancers [NCT03139370] | Phase 1 | 16 participants (Actual) | Interventional | 2017-12-27 | Terminated(stopped due to The study was terminated due to the sponsor's decision to discontinue the clinical trial.) |
| A Phase 2 Study of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients With CD30-Positive Peripheral T-Cell Lymphomas [NCT03113500] | Phase 2 | 48 participants (Actual) | Interventional | 2017-05-25 | Active, not recruiting |
| Phase I Study of CART-PSMA-TGFβRDN Cells in Patients With Advanced Castrate Resistant Prostate Cancer [NCT03089203] | Phase 1 | 19 participants (Anticipated) | Interventional | 2017-03-08 | Recruiting |
| Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast Cancer [NCT00003893] | Phase 3 | 2,250 participants (Anticipated) | Interventional | 1998-07-31 | Completed |
| A Phase I/IIa Trial For The Treatment of Relapsed or Chemotherapy Refractory Chronic Lymphocytic Leukemia or Indolent B Cell Lymphoma Using Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 [NCT00466531] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2007-03-21 | Active, not recruiting |
| A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of Multiple Myeloma [NCT00014508] | Phase 2 | 0 participants | Interventional | 2001-11-19 | Completed |
| Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia [NCT00006390] | Phase 2 | 0 participants | Interventional | 2001-07-05 | Completed |
| A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia [NCT00005962] | Phase 2 | 0 participants | Interventional | 2000-10-04 | Completed |
| A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma [NCT00003388] | Phase 2 | 38 participants (Anticipated) | Interventional | 1999-07-26 | Completed |
| "A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With Poor Risk Medulloblastoma, PNET, and Disseminated Ependymoma" [NCT00003309] | Phase 2 | 33 participants (Anticipated) | Interventional | 1999-05-04 | Completed |
| Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer [NCT06121570] | Phase 1 | 24 participants (Anticipated) | Interventional | 2023-11-01 | Recruiting |
| Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel (+/- Trastuzumab) Followed by Doxorubicin-cyclophosphamide in Patients With Locally Advanced Breast Cancer [NCT00574587] | Phase 1/Phase 2 | 55 participants (Actual) | Interventional | 2007-12-31 | Completed |
| Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-gp100:154-162 TCR-Gene Engineered Lymphocytes and ALVAC Virus Immunization [NCT00610311] | Phase 2 | 3 participants (Actual) | Interventional | 2008-01-31 | Terminated(stopped due to The study was terminated due to low accrual.) |
| Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients) [NCT00629499] | Phase 2 | 63 participants (Actual) | Interventional | 2008-04-30 | Completed |
| A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin, as Graft-versus-Host Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation [NCT00589563] | Phase 2 | 32 participants (Actual) | Interventional | 2007-05-31 | Completed |
| A Phase II, Trial of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Myeloma [NCT01438177] | Phase 2 | 11 participants (Actual) | Interventional | 2011-10-31 | Terminated(stopped due to PI left institution.) |
| A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy [NCT01414855] | Phase 2 | 100 participants (Actual) | Interventional | 2011-08-31 | Completed |
| A Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC) [NCT03821610] | Phase 2 | 242 participants (Anticipated) | Interventional | 2018-11-22 | Active, not recruiting |
| A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma [NCT03110640] | Phase 1 | 20 participants (Anticipated) | Interventional | 2016-10-01 | Recruiting |
| Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb) [NCT01445821] | Phase 3 | 44 participants (Actual) | Interventional | 2011-09-15 | Terminated(stopped due to Developed a better regimen: DIAD. Cast. 2018 NCT03593902) |
| Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia [NCT00281918] | Phase 3 | 817 participants (Actual) | Interventional | 2003-07-31 | Completed |
| A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck [NCT00210470] | Phase 2 | 27 participants (Actual) | Interventional | 2005-07-31 | Completed |
| A Pilot Study of Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicin, and Dexamethasone (Hyper-CVAD) With Sirolimus for the Treatment of Adult Acute Lymphoblastic Leukemia and Aggressive Lymphoid Malignancies [NCT01184885] | Early Phase 1 | 7 participants (Actual) | Interventional | 2010-07-31 | Completed |
| High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma [NCT00349778] | Phase 2 | 102 participants (Actual) | Interventional | 2006-08-31 | Completed |
| Total Body Irradiation Dose De-escalation Study in Patients With Fanconi Anemia Undergoing Alternate Donor Hematopoietic Cell Transplantation [NCT00352976] | Phase 2/Phase 3 | 83 participants (Actual) | Interventional | 2006-05-18 | Completed |
| An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy [NCT03218852] | Phase 4 | 133 participants (Actual) | Interventional | 2016-12-31 | Active, not recruiting |
| Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy [NCT02502864] | Phase 4 | 9 participants (Actual) | Interventional | 2016-02-09 | Completed |
| Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma [NCT01045460] | Phase 2 | 36 participants (Actual) | Interventional | 2010-01-15 | Completed |
| Comparison of Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy With or Without Doxycycline in Newly Diagnosed Mayo Stage II-III Light Chain Amyloidosis Patients: A Multi-center Randomized Controlled Trial [NCT03401372] | | 140 participants (Actual) | Interventional | 2018-04-21 | Completed |
| Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma [NCT02486952] | | 154 participants (Actual) | Observational | 2005-08-31 | Completed |
| Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies [NCT01685411] | | 5 participants (Actual) | Interventional | 2013-01-31 | Terminated |
| Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma [NCT03018626] | Phase 3 | 402 participants (Anticipated) | Interventional | 2017-07-27 | Recruiting |
| Phase II Trial of Pentostatin, Cyclophosphamide, and Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) [NCT01024010] | Phase 2 | 82 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I [NCT02553460] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2016-01-29 | Active, not recruiting |
| A Study of Umbilical Cord Blood-Derived Natural Killer Cells in Conjunction With Lymphodepleting Chemotherapy and Lenalidomide as Immunotherapy in Patients With Hematologic Malignancies [NCT02280525] | Phase 1 | 8 participants (Actual) | Interventional | 2015-03-05 | Completed |
| A Phase I/II Drug Withdrawal Study of Alloantigen-Specific Tregs in Liver Transplantation [NCT03654040] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2021-04-22 | Terminated(stopped due to The study was terminated by the Sponsor prior to any participants receiving the investigational product.) |
| A Prospective Study to Evaluate the Efficacy and Safety of Cyclophosphamide in the Treatment of Idiopathic Retroperitoneal Fibrosis [NCT04762810] | Phase 4 | 40 participants (Anticipated) | Interventional | 2020-01-03 | Recruiting |
| A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations [NCT01670500] | Phase 2 | 118 participants (Actual) | Interventional | 2012-10-31 | Active, not recruiting |
| A Phase II Study of Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children With Central Nervous System Atypical Teratoid/Rhabdoid Tumor (AT/RT) Tumor [NCT00084838] | Phase 2 | 25 participants (Actual) | Interventional | 2003-02-28 | Completed |
| A Phase I Dose Escalation Trial of Autologous Third-generation Anti-CD19 Chimeric Antigen Receptor T-cells (WZTL-002) for Relapsed and Refractory B-cell Lymphomas [NCT04049513] | Phase 1 | 30 participants (Anticipated) | Interventional | 2019-10-11 | Recruiting |
| Metro-PD1: a Phase I/II Trial Evaluating Anti-PD1 (Nivolumab) in Combination With Metronomic Chemotherapy in Children and Teenagers With Refractory / Relapsing Solid Tumors [NCT03585465] | Phase 1/Phase 2 | 102 participants (Anticipated) | Interventional | 2019-03-26 | Recruiting |
| A Two-Stage Phase 1 Open-Label Study of huJCAR014, CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells Bearing a Human Binding Domain, in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Acute Lymphocytic Leukemia [NCT03103971] | Phase 1 | 55 participants (Actual) | Interventional | 2017-11-03 | Active, not recruiting |
| A Phase 3, Intergroup Multicentre, Randomized, Controlled 3 Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Dexamethasone (RD) Versus Melphalan, Prednisone and Lenalidomide (MPR) Versus Cyclophosphamide, P [NCT01093196] | Phase 3 | 660 participants (Anticipated) | Interventional | 2009-10-31 | Active, not recruiting |
| A Phase 3, Multicentre, Randomized, Controlled Study to Determine the Efficacy and Safety of Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) Versus Melphalan (200 mg/m2) Followed By Stem Cell Transplant In Newly Diagnosed Multiple Myeloma Subjects [NCT01091831] | Phase 3 | 389 participants (Actual) | Interventional | 2009-07-31 | Active, not recruiting |
| A Phase I Vaccine Safety and Chemotherapy Dose-Finding Trial of an Allogeneic GM-CSF-Secreting Breast Cancer Vaccine Given in a Specifically Timed Sequence With Immunomodulatory Doses of Cyclophosphamide and Doxorubicin [NCT00093834] | Phase 1 | 60 participants (Anticipated) | Interventional | 2004-01-31 | Completed |
| Tandem Autotransplantation for Multiple Myeloma in Participants With Less Than 12 Months of Preceding Therapy, Incorporating Velcade (Bortezomib) With the Transplant Chemotherapy and During Maintenance [NCT01548573] | Phase 2 | 19 participants (Actual) | Interventional | 2012-05-31 | Terminated(stopped due to Met study stopping rules) |
| Phase II Trial of Primary Systemic Therapy for Locally Advanced Breast Cancer Using Sequential Doxil, Paclitaxel, and Cyclophosphamide With Concurrent Avastin [NCT00635050] | Phase 2 | 32 participants (Actual) | Interventional | 2008-03-31 | Completed |
| A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia [NCT01905943] | Phase 3 | 979 participants (Actual) | Interventional | 2013-11-04 | Completed |
| Clinical Study on QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia [NCT05601466] | Phase 1 | 18 participants (Anticipated) | Interventional | 2022-10-28 | Recruiting |
| Phase I Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas [NCT03036904] | Phase 1 | 31 participants (Actual) | Interventional | 2017-02-06 | Completed |
| Dasatinib Plus Multi-agent Chemotherapy for New Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia [NCT02523976] | Phase 2 | 30 participants (Actual) | Interventional | 2015-08-01 | Completed |
| Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial - [NCT02191930] | Phase 2 | 70 participants (Actual) | Interventional | 2015-09-30 | Active, not recruiting |
| A Study of Thymic Shielding in Recipients of Total Body Irradiation, Cyclophosphamide, and Fludarabine Followed by Alternate Donor Hematopoietic Stem Cell Transplantation in Patients With Fanconi Anemia [NCT00167206] | Phase 1/Phase 2 | 16 participants (Actual) | Interventional | 2004-03-31 | Terminated(stopped due to Treatment with thymic shielding found safe, another study started.) |
| Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Chemosensitive Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response or First Partial Response (BMT CTN #0202) [NCT00096460] | Phase 2/Phase 3 | 30 participants (Actual) | Interventional | 2004-08-31 | Terminated(stopped due to lower than anticipated accrual) |
| A Randomized Phase II Trial of EPOCH Given Either Concurrently or Sequentially With Rituximab in Patients With Intermediate- or High-Grade HIV-Associated B-cell Non-Hodgkin's Lymphoma [NCT00049036] | Phase 2 | 106 participants (Actual) | Interventional | 2003-03-31 | Completed |
| Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression Before and After Transplantation [NCT00049504] | Phase 2 | 53 participants (Actual) | Interventional | 2002-01-31 | Completed |
| A Randomized Controlled Study on the Efficacy and Safety of MA-BUCY2 Protocol in the Conditioning of Haploidentical Stem Cell Transplantation in Patients With High-risk Acute Myeloid Leukemia [NCT05814731] | | 264 participants (Anticipated) | Interventional | 2023-04-15 | Not yet recruiting |
| A Phase 1 Open-Label, Multi-Center First in Human Study of TnMUC1-Targeted Genetically-Modified Chimeric Antigen Receptor T Cells in Patients With Advanced TnMUC1-Positive Solid Tumors and Multiple Myeloma [NCT04025216] | Phase 1 | 16 participants (Actual) | Interventional | 2019-10-10 | Terminated(stopped due to The sponsor finds the risk/benefit analysis unfavorable and has terminated the study.) |
| A Randomized Controlled Study of High-dose Cyclophosphamide Induction Therapy in Adult Patients With HLH [NCT05936086] | | 160 participants (Anticipated) | Interventional | 2023-04-20 | Recruiting |
| A Phase II Study Evaluating the Safety and Efficacy of the Combination of Zanubrutinib Plus Lisocabtagene Maraleucel for Richter's Syndrome [NCT05873712] | Phase 2 | 24 participants (Anticipated) | Interventional | 2023-07-28 | Recruiting |
| Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus [NCT05666336] | Phase 4 | 30 participants (Anticipated) | Interventional | 2022-12-31 | Recruiting |
| Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial [NCT05165225] | Phase 2 | 48 participants (Anticipated) | Interventional | 2021-07-13 | Active, not recruiting |
| An Open-Label Phase 1/2 Multi-Arm Study of DS-1594b as a Single-Agent and in Combination With Azacitidine and Venetoclax or Mini-HCVD for the Treatment of Patients With Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) [NCT04752163] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2021-03-25 | Completed |
| Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblast [NCT03860844] | Phase 2 | 67 participants (Actual) | Interventional | 2019-08-06 | Terminated(stopped due to Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.) |
| A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma [NCT03721068] | Phase 1 | 18 participants (Anticipated) | Interventional | 2019-02-19 | Recruiting |
| Randomized Phase III Study Comparing a Non-myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Tumor Infiltrating Lymphocytes and Interleukin-2 to Standard Ipilimumab Treatment in Metastatic Melanoma [NCT02278887] | Phase 3 | 168 participants (Actual) | Interventional | 2014-09-23 | Active, not recruiting |
| CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML) [NCT04318678] | Phase 1 | 32 participants (Anticipated) | Interventional | 2020-07-29 | Active, not recruiting |
| A Phase 1b Trial of the IRX-2 Regimen and Nivolumab in Patients With Advanced Hepatocellular Cancer (HCC) [NCT03655002] | Phase 1 | 8 participants (Actual) | Interventional | 2019-02-21 | Active, not recruiting |
| Phase 2 Study of the Activity and Safety of Fludarabine, Cyclophosphamide, and Mitoxantrone Plus Rituximab (FCM-R) With Pegfilgrastim (Neulasta) as Frontline Therapy for Patients < 70 Years With Chronic Lymphocytic Leukemia [NCT00254410] | Phase 2 | 30 participants (Actual) | Interventional | 2005-03-14 | Completed |
| Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia [NCT00381004] | Phase 2 | 60 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Cyclophosphamide Followed by Intravenous Busulfan as Conditioning for Hematopoietic Cell Transplantation in Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome. [NCT00445744] | | 52 participants (Actual) | Interventional | 2006-12-31 | Completed |
| A Phase II Trial of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in Patients With Newly Diagnosed AIDS-Associated B-Cell Non-Hodgkin's Lymphoma [NCT00389818] | Phase 2 | 43 participants (Actual) | Interventional | 2007-01-31 | Completed |
| Nonmyeloablative Hematopoietic Cell Transplantation for Patients With Fanconi Anemia Using Alternative Marrow Donors: A Phase II Dose-Finding Study [NCT00453388] | Phase 2 | 6 participants (Actual) | Interventional | 2007-02-28 | Completed |
| Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in T and NK-Cell Lymphomas [NCT01445535] | Phase 1 | 15 participants (Actual) | Interventional | 2009-01-13 | Completed |
| A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Ca [NCT00513292] | Phase 3 | 280 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Efficacy and Safety of Paclitaxel/Cyclophosphamide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple MyelomaRefractory [NCT02985333] | Phase 2 | 0 participants (Actual) | Interventional | 2014-01-31 | Withdrawn |
| A Pilot Study to Test the Feasibility and Immunologic Impact of Sipuleucel-T (Provenge) Administered With or Without Anti-PD-1 mAb (CT-011) and Low Dose Cyclophosphamide in Men With Advanced Castrate-Resistant Prostate Cancer [NCT01420965] | Phase 2 | 7 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to Drug supply issues) |
| A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma. [NCT00211185] | Phase 2 | 49 participants (Actual) | Interventional | 2004-03-14 | Completed |
| Clinical Study on the Efficacy and Safety of Auto-HSCT in Adult Patients With Burkitt Lymphoma, Lymphoblastic Lymphoma, and Acute Lymphoblastic Leukemia Who Received TCCA Conditioning Regimen [NCT06060782] | Phase 1 | 28 participants (Anticipated) | Interventional | 2023-10-01 | Recruiting |
| Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction [NCT05909059] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| Evaluation of the Influence of Timing of Post-transplant Cyclophosphamide in Allogeneic Haematopoietic Stem Cell Transplant Patients. [NCT05886335] | | 200 participants (Anticipated) | Observational | 2023-06-26 | Recruiting |
| Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Selected CD19+ and CD20+ Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. [NCT05618925] | Phase 1 | 20 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
| Prospective Pilot Study of the Clinical Efficacy and Safety of the Method for Preventing a Graft-versus-host Disease Through the Agency of Using the Combination of Post-transplantation Cyclophosphamide With Abatacept, Vedolizumab and Calcineurin Inhibitor [NCT05515029] | Phase 3 | 56 participants (Actual) | Interventional | 2022-08-23 | Active, not recruiting |
| A Multi-centre Phase II Trial of GVHD Prophylaxis Following Unrelated Donor Stem Cell Transplantation Comparing Thymoglobulin vs. Calcineurin Inhibitor or Sirolimus-based Post-transplant Cyclophosphamide [NCT04888741] | Phase 2 | 400 participants (Anticipated) | Interventional | 2021-02-22 | Recruiting |
| A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma [NCT04106219] | Phase 1 | 71 participants (Anticipated) | Interventional | 2020-06-11 | Active, not recruiting |
| Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 [NCT03755804] | Phase 2 | 250 participants (Anticipated) | Interventional | 2018-12-12 | Recruiting |
| A Randomized Phase II/III Study of αβ T Cell-Depleted, Related, Haploidentical Hematopoietic Stem Cell Transplant (Haplo-HSCT) Plus Rivogenlecleucel vs. Haplo-HSCT Plus Post-Transplant Cyclophosphamide (PTCy) in Patients With AML or MDS [NCT03699475] | Phase 2/Phase 3 | 1 participants (Actual) | Interventional | 2018-12-27 | Terminated(stopped due to Funding, portfolio re-prioritization) |
| A Phase Ib/II Combination of Acalabrutinib With R-CHOP for Patient Diffuse Large B-cell Lymphoma (DLBCL) [NCT03571308] | Phase 1/Phase 2 | 39 participants (Actual) | Interventional | 2017-06-02 | Completed |
| Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE) [NCT03418779] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2019-07-04 | Active, not recruiting |
| NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With TNBC Wh [NCT03387085] | Phase 1/Phase 2 | 79 participants (Anticipated) | Interventional | 2018-03-16 | Active, not recruiting |
| Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma [NCT03117751] | Phase 2/Phase 3 | 790 participants (Actual) | Interventional | 2017-03-29 | Active, not recruiting |
| A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations [NCT02883049] | Phase 3 | 5,937 participants (Actual) | Interventional | 2012-02-29 | Active, not recruiting |
| LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma [NCT00610883] | Phase 2 | 17 participants (Actual) | Interventional | 1990-05-31 | Completed |
| An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma [NCT00574496] | Phase 2 | 25 participants (Actual) | Interventional | 2007-11-13 | Completed |
| Neoadjuvant Intratumoral Injection of Dendritic Cells in Breast Cancer Translation of Biotechnology Into the Clinic [NCT00499083] | Phase 2 | 17 participants (Actual) | Interventional | 2006-05-01 | Completed |
| Single Autologous Transplant Followed by Consolidation and Maintenance for Participants ≥ 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell Malignancy [NCT01849783] | Phase 2 | 41 participants (Actual) | Interventional | 2013-04-04 | Completed |
| "MT2009-09: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Stem Cell Transplantation and Off-the-shelf Mesenchymal Stem Cells" [NCT01033552] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2010-01-31 | Completed |
| "Phase II Study of Intensive TOTAL THERAPY for Untreated or Minimally Treated Patients With Multiple Myeloma" [NCT00580372] | Phase 2 | 231 participants (Actual) | Interventional | 2002-08-31 | Completed |
| Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation [NCT00626626] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2007-05-31 | Terminated(stopped due to Investigator decision) |
| Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab Followed by Consolidation With Lenalidomide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) [NCT00602836] | Phase 2 | 45 participants (Actual) | Interventional | 2008-02-29 | Completed |
| A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer [NCT02995330] | Phase 1 | 3 participants (Actual) | Interventional | 2017-02-09 | Terminated(stopped due to lack of accrual) |
| A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Hapl [NCT02999854] | Phase 3 | 63 participants (Actual) | Interventional | 2017-11-29 | Terminated(stopped due to Insufficient efficacy, terminated by Sponsor) |
| Phase II Study of Metastatic Cancer That Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes and Dendritic Cell Vaccination [NCT00704938] | Phase 2 | 3 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to Terminated due to withdrawal of support from our collaborator.) |
| A Phase I/IIa Trial of Combined Cryotherapy and Intra-tumoral Immunotherapy With Autologous Immature Dendritic Cells (VDC2008) in Chemo-naïve Men With Prostatic Adenocarcinoma and Limited Metastases to Lymph Nodes and/or Bone [NCT00753220] | Phase 1/Phase 2 | 7 participants (Actual) | Interventional | 2009-08-31 | Terminated(stopped due to Withdrew the IND with the FDA.) |
| A Rand. Trial Comp Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine, and Prednisone) in Patients With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment [NCT00774202] | Phase 2/Phase 3 | 17 participants (Actual) | Interventional | 2003-11-30 | Completed |
| Comparison of Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy and Neoadjuvant Chemotherapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Tria [NCT05640778] | Phase 2 | 120 participants (Anticipated) | Interventional | 2022-10-01 | Recruiting |
| A Multicentre, Randomised Phase II to Compare Epirubicin (E) & Cyclophosphamide (C) Treatment Plus Docetaxel (D) & Trastuzumab vs. E & C Treatment Plus D & Lapatinib in Women With Primary Resectable or Locally Advanced HER2+ Breast Cancer [NCT00841828] | Phase 2 | 102 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Phase I Study of Autologous Activated T-cells Targeting the CD19 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects With Relapsed/Refractory B-cell Lymphoma [NCT03696784] | Phase 1 | 30 participants (Anticipated) | Interventional | 2019-03-12 | Recruiting |
| Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage [NCT00890656] | Phase 2 | 90 participants (Actual) | Interventional | 2003-06-30 | Completed |
| Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma [NCT01857934] | Phase 2 | 153 participants (Actual) | Interventional | 2013-07-05 | Active, not recruiting |
| Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Malignancies [NCT04088890] | Phase 1 | 92 participants (Anticipated) | Interventional | 2019-09-12 | Recruiting |
| A Single Arm, Multicentre, Phase IIIB Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma ( [NCT01889069] | Phase 3 | 159 participants (Actual) | Interventional | 2013-07-31 | Completed |
| A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2 [NCT01593020] | Phase 2 | 54 participants (Actual) | Interventional | 2012-08-03 | Completed |
| A Phase I Study of Sirolimus in Combination With Oral Cyclophosphamide and Oral Topotecan in Children and Young Adults With Relapsed and Refractory Solid Tumors [NCT01670175] | Phase 1 | 21 participants (Actual) | Interventional | 2012-08-31 | Completed |
| A Multi-Centre Randomized Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer [NCT03705429] | Phase 3 | 51 participants (Actual) | Interventional | 2019-05-01 | Completed |
| Anti-PD-1 Antibody (Camrelizumab) Plus R-CHOP Regimen for the Primary Extranodal Treatment-Naive Diffuse Large B Cell Lymphoma (CREDIT): a Prospective, Multicenter, Single-Arm, Phase II Trial [NCT05093140] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-06-01 | Not yet recruiting |
| An Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With CD19+ B Cell Systemic Lupus Erythematosus (SLE) [NCT03030976] | Phase 1 | 5 participants (Anticipated) | Interventional | 2017-03-31 | Recruiting |
| A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma [NCT00088881] | Phase 2 | 62 participants (Actual) | Interventional | 2004-12-31 | Terminated |
| A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer [NCT03017404] | | 18 participants (Actual) | Interventional | 2015-05-31 | Completed |
| A Multicenter Randomized Open-label Trial Comparing the Efficacy and Safety of Infliximab Versus Cyclophosphamide in Subjects With Idiopathic Refractory Scleritis [NCT03088293] | Phase 3 | 0 participants (Actual) | Interventional | 2020-06-11 | Withdrawn(stopped due to recruiting difficulties) |
| ADMINISTRATION OF MOST CLOSELY MATCHED THIRD PARTY RAPIDLY GENERATED LMP, BARF1 and EBNA1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES TO PATIENTS WITH EBV-POSITIVE LYMPHOMA AND OTHER EBV-POSITIVE MALIGNANCIES [NCT02287311] | Phase 1 | 42 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
| Anti-CD30 CAR T Cells With Fully-human Binding Domains for Treating CD30-expressing Lymphomas Including Anaplastic Large Cell Lymphomas [NCT03049449] | Phase 1 | 26 participants (Actual) | Interventional | 2017-03-17 | Completed |
| A Phase II Study for Metastatic Melanoma Using High-Dose Chemotherapy Preparative Regimen Followed by Cell Transfer Therapy Using Tumor-Infiltrating Lymphocytes Plus IL-2 With the Administration of Pembrolizumab in the Retreatment Arm [NCT01993719] | Phase 2 | 33 participants (Actual) | Interventional | 2013-12-12 | Completed |
| A Randomized Phase II Trial Evaluating the Performance of Genomic Expression Profiles to Direct the Use of Preoperative Chemotherapy for Early Stage Breast Cancer [NCT00636441] | Phase 2 | 56 participants (Actual) | Interventional | 2008-04-30 | Terminated(stopped due to Study terminated due to reproducibility issues with genomics prediction model) |
| Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia [NCT00003816] | Phase 2/Phase 3 | 361 participants (Actual) | Interventional | 1998-10-19 | Completed |
| Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer [NCT00004092] | Phase 2 | 72 participants (Actual) | Interventional | 1999-05-31 | Completed |
| A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia [NCT06124157] | Phase 3 | 680 participants (Anticipated) | Interventional | 2024-01-22 | Not yet recruiting |
| Phase I/Ib Study of Adoptive NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Reactive Against the NY-ESO-1-specific Cord Blood-derived NK Cells (NY-ESO-1 TCR/IL-15 NK) in Conjunction With Lymphodepleting Chemotherapy for the Management of Advance [NCT06083883] | Phase 1 | 44 participants (Anticipated) | Interventional | 2024-02-01 | Not yet recruiting |
| Optimal Conditioning Regimen Protocol for Autologous Hematopoietic Stem Cell Transplantation of Relapsing Remitting Multiple Sclerosis [NCT05482542] | | 0 participants (Actual) | Interventional | 2023-01-01 | Withdrawn(stopped due to lack of funding for support staff) |
| A Phase I Trial Evaluating Escalating Doses of ²¹¹At-Labeled Anti-CD38 Monoclonal Antibody Followed by HLA-Matched or Haploidentical Donor Hematopoietic Cell Transplantation for High-Risk Multiple Myeloma [NCT04579523] | Phase 1 | 30 participants (Anticipated) | Interventional | 2024-02-01 | Not yet recruiting |
| A Phase 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation [NCT03842696] | Phase 1/Phase 2 | 49 participants (Anticipated) | Interventional | 2020-02-04 | Recruiting |
| A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgki [NCT03677141] | Phase 1/Phase 2 | 117 participants (Actual) | Interventional | 2019-03-08 | Completed |
| Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study [NCT03517137] | Phase 2 | 150 participants (Actual) | Interventional | 2019-08-01 | Active, not recruiting |
| T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy [NCT02957968] | Phase 2 | 46 participants (Actual) | Interventional | 2017-01-24 | Active, not recruiting |
| BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma [NCT00049595] | Phase 3 | 552 participants (Actual) | Interventional | 2002-08-31 | Completed |
| Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma [NCT00085098] | Phase 3 | 24 participants (Actual) | Interventional | 2007-01-31 | Completed |
| International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia [NCT01117441] | Phase 3 | 6,136 participants (Actual) | Interventional | 2010-06-30 | Completed |
| A Study Multicenter Randomized to Assess the Efficacy and Toxicity of Adding Metronomic Therapy to the Standard Treatment of Patients With High Grade Malignant Osteosarcoma With Metastatic Lung Disease at Diagnosis and Primary Resectable Tumor: A Study by [NCT03063983] | Phase 2 | 158 participants (Anticipated) | Interventional | 2017-01-02 | Recruiting |
| Haploidentical Donor Hematopoietic Stem Cell Transplantation [NCT02660281] | Phase 1 | 74 participants (Actual) | Interventional | 2015-10-31 | Completed |
| A Phase 1B Study to Evaluate the Safety and Induction of Immune Response of CRS-207 in Combination With Pemetrexed and Cisplatin as Front-line Therapy in Adults With Malignant Pleural Mesothelioma [NCT01675765] | Phase 1 | 60 participants (Actual) | Interventional | 2014-09-03 | Completed |
| A Pilot Study of Low-Dose Antiangiogenic Chemotherapy in Combination With Standard Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma Family of Tumors [NCT00061893] | Phase 2 | 38 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial [NCT02455141] | Phase 3 | 970 participants (Anticipated) | Interventional | 2015-07-31 | Recruiting |
| Phase II Study of Palifermin With Leuprolide Acetate or Degarelix For the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation [NCT01746849] | Phase 2 | 82 participants (Actual) | Interventional | 2012-12-31 | Active, not recruiting |
| Treatment of Anti-Interferon-Gamma Autoantibody Associated Acquired Immunodeficiency Syndrome With Bortezomib: Pilot Study [NCT03103555] | Phase 2 | 5 participants (Anticipated) | Interventional | 2017-02-27 | Recruiting |
| A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma [NCT05565105] | Phase 2 | 100 participants (Anticipated) | Interventional | 2024-03-31 | Not yet recruiting |
| A Phase I Pilot Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA) [NCT05269381] | Phase 1 | 36 participants (Anticipated) | Interventional | 2022-03-31 | Recruiting |
| The Safety and Clinical Efficacy of Human CD19/CD22 Bispecific Chimeric Antigen Receptor (CAR)-T Cell Therapy for Subjects With Measurable Residual Disease(MRD)-Positive B Cell Acute Lymphoblastic Leukemia [NCT03919526] | Phase 1 | 19 participants (Actual) | Interventional | 2019-08-11 | Completed |
| A Phase I/II Drug Withdrawal Study of Alloantigen-Specific Tregs in Liver Transplantation (ITN073ST) [NCT03577431] | Phase 1/Phase 2 | 9 participants (Anticipated) | Interventional | 2019-03-29 | Active, not recruiting |
| An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667) [NCT03407144] | Phase 2 | 340 participants (Anticipated) | Interventional | 2018-04-09 | Active, not recruiting |
| Oral Combination Chemotherapy in Conjunction With G-CSF in the Treatment of Elderly Patients With Intermediate and High Grade Non-Hodgkin's Lymphoma [NCT00003113] | Phase 2 | 6 participants (Actual) | Interventional | 1997-07-31 | Terminated |
| Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study [NCT00003119] | Phase 3 | 968 participants (Actual) | Interventional | 1998-03-31 | Completed |
| Autologous Transplantation With Gemcitabine and High Dose BCNU Plus Melphalan Followed by Consolidation With DCEP Plus Gemcitabine and Taxol/Cisplatin in Patients With Multiple Myeloma and >12 Months of Standard Therapy [NCT00003401] | Phase 2 | 0 participants | Interventional | 1999-01-31 | Completed |
| Phase I/II Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients [NCT00003425] | Phase 1/Phase 2 | 25 participants (Anticipated) | Interventional | 1997-12-31 | Completed |
| Medical Research Council Working Party on Leukaemia in Children UK National Lymphoblastic Leukaemia (ALL) Trial [NCT00003437] | Phase 3 | 1,800 participants (Anticipated) | Interventional | 1997-01-31 | Active, not recruiting |
| A RANDOMIZED, CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN, MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO [NCT00002819] | Phase 3 | 0 participants | Interventional | 1996-11-30 | Terminated |
| A Phase I/II Study of High-Dose Deoxyazacytidine, Busulfan, and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies [NCT00002831] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 1995-08-01 | Completed |
| Phase I-II Study of Dose Intense Doxorubicin, Paclitaxel And Cyclophosphamide With Peripheral Blood Progenitor Cells (PBPC) And Cytokine Support In Patients With Metastatic Breast Cancer [NCT00002837] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 1995-09-30 | Completed |
| Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion With Cyclophosphamide and Fludarabine for Patients With Metastatic Melanoma [NCT01807182] | Phase 2 | 11 participants (Actual) | Interventional | 2013-08-20 | Completed |
| Adoptive Immunotherapy of Glioblastoma Multiforme With Tumor-Sensitized, Ex Vivo Activated T Lymphocytes [NCT00003185] | Phase 2 | 40 participants (Anticipated) | Interventional | 1997-08-31 | Completed |
| A Phase II Study of Preoperative Dose-Dense Chemotherapy With Sequential Doxorubicin and Docetaxel for Initial Treatment of Operable and Inoperable Stage II-IIIB Breast Cancer [NCT00003953] | Phase 2 | 39 participants (Actual) | Interventional | 1999-02-28 | Completed |
| An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors [NCT00003203] | Phase 2 | 168 participants (Actual) | Interventional | 1998-03-31 | Completed |
| Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL) [NCT00003215] | Phase 3 | 400 participants (Anticipated) | Interventional | 1997-04-30 | Completed |
| A Randomized Double-Blind, Placebo-Controlled Trial of Recombinant Human Keratinocyte Growth Factor (rHuKGF) in Patients With Hematologic Malignancies Undergoing Total Body Irradiation (TBI) and High-Dose Chemotherapy With Autologous Peripheral Blood [NCT00004061] | Phase 2 | 111 participants (Anticipated) | Interventional | 1999-05-31 | Completed |
| A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol (AC-T) to That of Adriamycin and Cyclophosphamide Followed by Taxol Plus Herceptin (AC-T+H) in Node-Positive Breast Cancer Patients Who Have Tumors T [NCT00004067] | Phase 3 | 2,130 participants (Actual) | Interventional | 2000-02-29 | Completed |
| Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies [NCT00004145] | Phase 2 | 16 participants (Actual) | Interventional | 1998-11-30 | Completed |
| A Phase II, Open-Label, Trial Evaluating the Efficacy of Amifostine in Patients With Cancers Receiving Outpatient Dose-intensive Cyclophosphamide, Etoposide, and Cisplatin (DICEP) Chemotherapy [NCT00003269] | Phase 2 | 20 participants (Actual) | Interventional | 1998-02-28 | Completed |
| Phase II CCOP Trial of High Dose Methotrexate/ARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants [NCT00003311] | Phase 2 | 19 participants (Actual) | Interventional | 1998-05-20 | Completed |
| ALINC #17 Treatment for Patients With Low Risk Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Phase III Study [NCT00005585] | Phase 3 | 838 participants (Actual) | Interventional | 2000-04-30 | Completed |
| ALinC 17: Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia (ALL) - Evaluation of the Augmented BFM Regimen: A Phase III Study [NCT00005603] | Phase 3 | 276 participants (Actual) | Interventional | 2000-03-31 | Completed |
| Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study [NCT05128617] | | 20 participants (Actual) | Observational | 2021-11-04 | Completed |
| A Phase I Study of Anti-CD19 CAR T-cell Therapy With Axicabtagene Ciloleucel (Axi-cel) in Patients With Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphoma [NCT04608487] | Phase 1 | 18 participants (Actual) | Interventional | 2020-12-04 | Active, not recruiting |
| Pilot Study of JAK Inhibitor Therapy Followed by Reduced Intensity Haploidentical Transplantation for Patients With Myelofibrosis [NCT04370301] | Phase 2 | 10 participants (Anticipated) | Interventional | 2021-02-09 | Recruiting |
| Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study [NCT00003671] | Phase 2 | 59 participants (Actual) | Interventional | 1998-12-31 | Completed |
| A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups [NCT00003815] | Phase 3 | 0 participants | Interventional | 1994-06-30 | Active, not recruiting |
| High-Dose Consolidation With Escalating Doses of Melphalan and Thiotepa for Stage IV Breast Cancer [NCT00003899] | Phase 1 | 0 participants | Interventional | 1999-01-31 | Completed |
| A Pilot Study of CD19-Specific Car T Cells as Consolidation for Older Adults With Acute Lymphoblastic Leukemia in First Remission [NCT05707273] | Phase 1 | 21 participants (Anticipated) | Interventional | 2023-04-26 | Recruiting |
| Phase 2 Study of the Combination of Lisocabtagene Maraleucel, Nivolumab, and Ibrutinib in Richter's Transformation [NCT05672173] | Phase 2 | 20 participants (Anticipated) | Interventional | 2023-06-02 | Recruiting |
| Prospective Phase II Study of a High Dose, Short Course Regimen (R-CODOX-M/IVAC) Including CNS Penetration and Intensive IT Prophylaxis in HIV-Associated Burkitt's and Atypical Burkitt's Lymphoma [NCT00392834] | Phase 2 | 34 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas [NCT00379574] | Phase 1/Phase 2 | 49 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Adjuvant Therapy for High-Risk Localized Breast Cancer Using Weekly Adriamycin + Daily Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Abraxane™ for 12 Weeks With Concurrent Herceptin for Subjects With HER-2/Neu Positive Disease [NCT00407888] | Phase 2 | 60 participants (Actual) | Interventional | 2006-05-31 | Completed |
| A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord® [NCT05290662] | | 50 participants (Anticipated) | Observational [Patient Registry] | 2022-06-14 | Recruiting |
| A Multi-center Phase II Trial Randomizing Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN #1203; Progress I) [NCT02208037] | Phase 2 | 279 participants (Actual) | Interventional | 2014-08-31 | Completed |
| Compassionate Use Administration of Autologous CAR T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase 9 Safety Switch [NCT03594162] | | 0 participants | Expanded Access | | No longer available |
| A Phase II Trial to Assess the Activity of NY-ESO-1 Targeted T Cells in Advanced Oesophagogastric Cancer [NCT01795976] | Phase 2 | 2 participants (Actual) | Interventional | 2014-10-31 | Terminated(stopped due to Withdrawal of funding) |
| A Randomized Phase II Study of Tecemotide in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Untreated, Intermediate and High Risk Prostate Cancer Patients [NCT01496131] | Phase 2 | 28 participants (Actual) | Interventional | 2011-10-24 | Completed |
| Phase II Trial of HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia Following Allogeneic Hematopoietic Stem Cell Transplant [NCT00526292] | Phase 2 | 12 participants (Actual) | Interventional | 2007-08-31 | Completed |
| A Randomised Multicentre Trial of Involved Field Radiotherapy Versus Involved Field Radiotherapy Plus Chemotherapy in Combination With Rituximab (Mabthera®) for Stage I - II Low Grade Follicular Lymphoma [NCT00115700] | Phase 3 | 150 participants (Actual) | Interventional | 2000-02-29 | Completed |
| Phase 1/2 Study Of Ixazomib In Combination With Cyclophosphamide And Dexamethasone In Patients With Newly Diagnosed Immunoglobulin Light Chain AL Amyloidosis [NCT03236792] | Phase 1/Phase 2 | 28 participants (Actual) | Interventional | 2017-06-12 | Completed |
| Busulfan, Fludarabine, Donor Stem Cell Transplant, and Cyclophosphamide in Treating Participants With Multiple Myeloma or Myelofibrosis [NCT03303950] | Phase 2 | 6 participants (Actual) | Interventional | 2018-03-30 | Terminated(stopped due to Slow accrual) |
| Treatment of Lysosomal and Peroxisomal Inborn Errors of Metabolism by Hematopoietic Cell Transplantation [NCT00668564] | Phase 2 | 18 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to Replaced by another study) |
| In-Vivo Activated T-Cell Depletion to Prevent GVHD [NCT00594308] | | 10 participants (Actual) | Interventional | 2007-10-31 | Terminated(stopped due to Treatment ineffective) |
| Combination Immunotherapy for Lung Cancer [NCT00601796] | Phase 2 | 24 participants (Actual) | Interventional | 2006-10-31 | Completed |
| A Pilot Study of an Immunosuppressive and Myeloablative Preparative Regimen for Allogeneic Unrelated Donor Hematopoietic Stem Cell Transplantation (HSCT) for Severe Sickle Cell Disease [NCT01279616] | Phase 2 | 8 participants (Actual) | Interventional | 2010-09-30 | Terminated(stopped due to PI moving to a different institution.) |
| A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies in Remission From HLA Partially-Matched Related Donors [NCT01350245] | Phase 2 | 28 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide [NCT00809276] | Phase 1/Phase 2 | 92 participants (Actual) | Interventional | 2009-05-31 | Completed |
| A Phase II Trial of Cyclophosphamide, Topotecan, and Bevacizumab (CTB) in Patients With Relapsed/Refractory Ewing's Sarcoma and Neuroblastoma [NCT01492673] | Phase 2 | 9 participants (Actual) | Interventional | 2011-12-31 | Completed |
| A Multi-center, Randomized, Open-label, Mechanism of Action Trial on the Biological Effects of the Therapeutic Cancer Vaccine Stimuvax® (L-BLP25) in Rectal Cancer Subjects Undergoing Neoadjuvant Chemoradiotherapy [NCT01507103] | Phase 2 | 124 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Evaluation of Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide in Patients With Relapsed and Refractory Myeloma [NCT01432600] | Phase 1/Phase 2 | 80 participants (Actual) | Interventional | 2011-11-30 | Completed |
| A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy [NCT01925612] | Phase 2 | 87 participants (Actual) | Interventional | 2013-08-31 | Terminated(stopped due to Sponsor decision based on portfolio prioritization and changing treatment landscape in frontline DLBCL) |
| Randomized, Phase II Trial of CHOP vs. Oral Chemotherapy With Concomitant Antiretroviral Therapy in Patients With HIV-Associated Lymphoma in Sub-Saharan Africa [NCT01775475] | Phase 2 | 7 participants (Actual) | Interventional | 2016-09-15 | Completed |
| A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma [NCT05600686] | Phase 2 | 24 participants (Anticipated) | Interventional | 2023-05-24 | Recruiting |
| A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) [NCT05244070] | Phase 1 | 5 participants (Actual) | Interventional | 2022-09-14 | Terminated(stopped due to Business objectives have changed.) |
| A Multicenter Phase II Study of Subcutaneous Velcade Plus Oral Melphalan and Prdnisone or Plus Cycloposphamide and Prednisone or Plus Prednisone in Newly Diagnosed Elderly Multiple Myeloma Patients [NCT01190787] | Phase 2 | 150 participants (Anticipated) | Interventional | 2010-07-31 | Active, not recruiting |
| Potentiation of Cetuximab by Tregs Depletion With Metronomic Cyclophosphamide in Metastatic Squamous Cell Cancers of Head and Neck [NCT01581970] | Phase 2 | 7 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-mesothelin Gene Engineered Lymphocytes [NCT01583686] | Phase 1/Phase 2 | 15 participants (Actual) | Interventional | 2012-05-04 | Terminated(stopped due to Study terminated due to slow/insufficient accrual.) |
| A Phase I Trial of Indoximod and Temozolomide-Based Therapy for Children With Progressive Primary Brain Tumors [NCT02502708] | Phase 1 | 81 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Neurovascular Changes Provoked by Acute Administration Doxorubicin and Cyclophosphamide in Patients With Breast Cancer [NCT03339804] | | 16 participants (Actual) | Interventional | 2016-02-22 | Completed |
| Clofarabine Pre-conditioning Followed by Hematopoietic Stem Cell Transplant With Post-Transplant Cyclophosphamide for Non-remission Acute Myeloid Leukemia [NCT04002115] | Phase 2 | 2 participants (Actual) | Interventional | 2020-06-03 | Terminated(stopped due to terminated due to low accrual) |
| A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy [NCT03959085] | Phase 3 | 4,772 participants (Anticipated) | Interventional | 2019-10-31 | Recruiting |
| Mature B-Cell Lymphoma And Leukemia Study III [NCT01046825] | Phase 2/Phase 3 | 128 participants (Actual) | Interventional | 2010-09-09 | Active, not recruiting |
| A Randomized Controlled Study of AC (Doxorubicin Hydrochloride Liposome/Cyclophosphamide) vs TC (Docetaxel/Cyclophosphamide) Regimens for Postoperative Adjuvant Chemotherapy in Patients With HR-positive, HER2-negative Early Breast Cancer [NCT05302336] | Phase 4 | 402 participants (Anticipated) | Interventional | 2022-05-01 | Recruiting |
| Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma [NCT00553306] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2007-09-30 | Completed |
| A Phase II Study of Neoadjuvant Carboplatin/Paclitaxel Followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients With Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer [NCT03301350] | Phase 2 | 29 participants (Actual) | Interventional | 2017-11-07 | Completed |
| Phase Ib/II Study of Toripalimab In Combination With Rituximab Followed by R-CHOP Regimen (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) for Elderly Naïve Patients With Diffuse Large B-cell Lymphoma [NCT04058470] | Phase 1/Phase 2 | 140 participants (Anticipated) | Interventional | 2020-04-24 | Recruiting |
| Adjuvant Six Cycles of Docetaxel and Cyclophosphamide or Three Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by Three Cycles of Docetaxel Versus Four Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast [NCT04127019] | Phase 3 | 2,079 participants (Actual) | Interventional | 2010-06-01 | Completed |
| A Randomized Phase II Trial of Metronomic Oral Vinorelbine Plus Cyclophosphamide and Capecitabine (VEX) Versus Weekly Paclitaxel as First-line or Second-line Treatment in Patients With ER-positive/HER2-negative Advanced or Metastatic Breast Cancer [NCT02954055] | Phase 2 | 140 participants (Actual) | Interventional | 2017-09-13 | Active, not recruiting |
| Phase II Study of LCL161 Alone and in Combination With Cyclophosphamide in Patients With Relapsed or Refractory Multiple Myeloma [NCT01955434] | Phase 2 | 25 participants (Actual) | Interventional | 2013-11-30 | Completed |
| An Open-labeled, Multi-center, Randomized, Prospective Phase III Study Comparing CMAB304 in Combination With CHOP to CHOP Alone With CMAB304 Maintenance in Patients With DLBCL [NCT01459887] | Phase 3 | 278 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma [NCT02727387] | Phase 2 | 155 participants (Actual) | Interventional | 2009-06-01 | Completed |
| A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgki [NCT01724021] | Phase 3 | 743 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Pre-Transplant Immunosuppression and Related Haploidentical Hematopoietic Cell Transplantation for Patients With Severe Hemoglobinopathies [NCT04776850] | Early Phase 1 | 0 participants (Actual) | Interventional | 2020-12-29 | Withdrawn(stopped due to Competing protocol opened in Adult SCT that will include pediatric patients and is now multi-center. No patients enrolled on study.) |
| Phase 1 Study of Lentivirally Transduced T Cells Engineered to Contain Anti-CD123 Linked to TCRζ and 4-1BB Signaling Domains in Pediatric Subjects With Refractory or Relapsed Acute Myeloid Leukemia [NCT04678336] | Phase 1 | 12 participants (Anticipated) | Interventional | 2021-02-15 | Active, not recruiting |
| Risk-stratified Sequential Treatment of Post-transplant Lymphoproliferative Disease (PTLD) With 4 Courses of Rituximab SC Followed by 4 Courses of Rituximab SC, 4 Courses of Rituximab SC Combined With CHOP-21 or 6 Courses of Rituximab SC Combined With Alt [NCT02042391] | Phase 2 | 60 participants (Actual) | Interventional | 2015-02-03 | Completed |
| Next Generation Sequencing to Evaluate Breast Cancer Subtypes and Genomic Predictors of Response to Therapy in the Preoperative Setting for Stage II-III Breast Cancer [NCT01959490] | Phase 2 | 16 participants (Actual) | Interventional | 2013-09-24 | Completed |
| Phase I Study to Assess Feasibility and Safety of Adoptive Transfer of Autologous Tumor-Infiltrating Lymphocytes in Combination With Interleukin-2 Followed by Nivolumab Rescue for Advanced Metastatic Melanoma [NCT03475134] | Phase 1 | 18 participants (Actual) | Interventional | 2018-02-21 | Active, not recruiting |
| A Study of CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-cell Acute Lymphoblastic Leukemia [NCT03263208] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2017-08-16 | Recruiting |
| An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With HER2+ Locally Advanced and/ or Metastatic Solid Tumors [NCT06101082] | Phase 1 | 9 participants (Anticipated) | Interventional | 2023-10-25 | Not yet recruiting |
| A Phase 1 Study of FT522 in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Lymphoma [NCT05950334] | Phase 1 | 322 participants (Anticipated) | Interventional | 2023-11-01 | Recruiting |
| A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults With Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia [NCT05303792] | Phase 2 | 66 participants (Anticipated) | Interventional | 2023-02-27 | Recruiting |
| PRESERVE: A Multi-Center Trial Using Banked, Cryopreserved HLA-Mismatched Unrelated Donor Bone Marrow and Post-Transplantation Cyclophosphamide in Allogeneic Transplantation for Patients With Hematologic Malignancies [NCT05170828] | Phase 1 | 0 participants (Actual) | Interventional | 2022-09-30 | Withdrawn(stopped due to Change in Study Design) |
| A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas [NCT04803201] | Phase 2 | 170 participants (Anticipated) | Interventional | 2021-07-30 | Recruiting |
| A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma [NCT04674813] | Phase 1 | 180 participants (Anticipated) | Interventional | 2021-02-24 | Recruiting |
| Phase 1 Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma [NCT04119024] | Phase 1 | 24 participants (Anticipated) | Interventional | 2019-11-27 | Recruiting |
| Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease [NCT03077542] | Phase 1/Phase 2 | 55 participants (Actual) | Interventional | 2017-04-06 | Active, not recruiting |
| Phase II Study in Patients With Metastatic Ocular Melanoma Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Autologous Tumor-Infiltrating Lymphocytes With or Without High Dose Aldesleukin [NCT01814046] | Phase 2 | 24 participants (Actual) | Interventional | 2013-03-01 | Terminated(stopped due to Investigator left the National Institutes of Health (NIH)) |
| A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas [NCT01777152] | Phase 3 | 452 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Phase I/II Study of the Combination of Low-Intensity Chemotherapy and Venetoclax (ABT-199) in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) [NCT03808610] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2019-04-03 | Recruiting |
| Pilot Study: Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (Dilanubicel) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies [NCT03399773] | Phase 2 | 15 participants (Anticipated) | Interventional | 2022-05-10 | Recruiting |
| Clinical Study to Evaluate the Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients [NCT06155331] | Phase 4 | 44 participants (Anticipated) | Interventional | 2023-12-31 | Recruiting |
| Phase I- II Study of in Vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for the Treatment of Steroid-refractory Acute Graft-versus-host Disease [NCT01453140] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2011-08-31 | Terminated(stopped due to Dose Limiting Toxicities) |
| A Phase I Study of SGT-53, a TfRscFv-Liposome-p53 Complex, in Children With Refractory or Recurrent Solid Tumors [NCT02354547] | Phase 1 | 18 participants (Anticipated) | Interventional | 2014-12-31 | Suspended |
| Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD [NCT02298283] | Phase 2 | 40 participants (Actual) | Interventional | 2015-04-30 | Completed |
| A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer [NCT01516307] | Phase 2 | 349 participants (Actual) | Interventional | 2011-12-31 | Completed |
| A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine [NCT01071239] | Phase 2 | 1 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated [NCT02285062] | Phase 3 | 570 participants (Actual) | Interventional | 2015-02-17 | Completed |
| TCH (Docetaxel/Carboplatin/Trastuzumab) Versus EC -TH(Epirubicin/Cyclophosphamide Followed by Docetaxe/Trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer [NCT03140553] | Phase 2 | 140 participants (Actual) | Interventional | 2016-09-01 | Completed |
| Immunotherapy With CD19/22 CAR Redirected T-cells for High Risk, Relapsed Paediatric CD19+ and/or CD22+ Acute Lymphoblastic Leukaemia and Other Haematological Malignancies [NCT02443831] | Phase 1 | 33 participants (Anticipated) | Interventional | 2016-04-30 | Active, not recruiting |
| A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC [NCT03752723] | Phase 1/Phase 2 | 84 participants (Actual) | Interventional | 2019-03-27 | Completed |
| Pre-Transplant Immune Suppression With Hematopoietic Cell Transplantation From Haploidentical Donors for Adults and Children With Sickle Cell Disease or ß-Thalassemia (Haplo PTCy) [NCT05736419] | Phase 2 | 24 participants (Anticipated) | Interventional | 2023-02-09 | Recruiting |
| A Single-Arm, Open-Label, Phase I Trial to Assess the Safety of Genetically Engineered Autologous T Cells Targeting the Cell Surface Antigen Mesothelin With Cell-Intrinsic Checkpoint Inhibition in Patients With Mesothelioma [NCT04577326] | Phase 1 | 30 participants (Anticipated) | Interventional | 2020-09-30 | Recruiting |
| UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma Ages 65 and Under: A Trial Enrolling Subjects to Standard Total Therapy 3 (S-TT3) [NCT00734877] | Phase 3 | 382 participants (Actual) | Interventional | 2008-07-31 | Active, not recruiting |
| Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NY ESO 1 and LAGE 1a, and Co-expressing the dnTGF-βRII (GSK3845097) in Participants With NY ESO 1 and/or LAGE 1a Positive Previously [NCT05943990] | Phase 1 | 5 participants (Actual) | Interventional | 2020-12-21 | Terminated(stopped due to The study was terminated due to a change in GSK's R&D priorities.) |
| High-Dose Chemoradiotherapy With Stem Cell Allogeneic Cellular Rescue in Patients With Relapsed or Refractory Hematologic Malignancy - A Phase I/II Study [NCT00004907] | Phase 1/Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma [NCT00004181] | Phase 2 | 0 participants | Interventional | 1999-10-31 | Completed |
| Phase II Study of Taxotere, Doxorubicin and Cyclophosphamide (TAC) Primary Therapy in Stage III Breast Cancer [NCT00004175] | Phase 2 | 0 participants | Interventional | 1998-11-30 | Completed |
| High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease [NCT00004169] | Phase 2 | 0 participants | Interventional | 1993-11-30 | Completed |
| A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation [NCT03531281] | Phase 1 | 0 participants (Actual) | Interventional | 2018-12-30 | Withdrawn(stopped due to Administratively withdrawn) |
| Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease [NCT00692939] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2012-06-26 | Recruiting |
| CHEMOIMMUNE - A Phase II Study Evaluating an Anti-PD1 Monoclonal Antibody (Pembrolizumab) in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic Cyclophosphamide [NCT03139851] | Phase 2 | 36 participants (Actual) | Interventional | 2017-06-27 | Completed |
| The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) Who Had Lenalidomide Plus Dexamethasone (LD) Following Frontli [NCT03242460] | Phase 2 | 55 participants (Actual) | Interventional | 2015-05-12 | Completed |
| A MULTICENTER, OPEN LABEL STUDY OF WEEKLY CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (wCCyd) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS [NCT01857115] | Phase 1/Phase 2 | 63 participants (Actual) | Interventional | 2013-04-30 | Active, not recruiting |
| Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT) [NCT02193880] | | 7 participants (Actual) | Interventional | 2014-10-09 | Completed |
| A Phase III, Randomized, Open, Parallel-controlled, Multi-center Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis [NCT02457221] | Phase 3 | 314 participants (Actual) | Interventional | 2015-03-10 | Completed |
| International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma [NCT00006455] | Phase 3 | 885 participants (Actual) | Interventional | 1999-11-26 | Completed |
| Reduced Intensity Conditioning Regimen for Elderly or High Comorbidity Burden Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation [NCT03412409] | Phase 2 | 50 participants (Anticipated) | Interventional | 2018-02-01 | Recruiting |
| A Pilot Study of Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease [NCT02678143] | Phase 1 | 1 participants (Actual) | Interventional | 2016-04-26 | Terminated(stopped due to Closed early due to competing studies) |
| Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease [NCT03371095] | Phase 3 | 53 participants (Actual) | Interventional | 2018-05-25 | Completed |
| Pathological Complete Response Rate in Locally Advanced Breast Cancer With Neoadjuvant Fluorourcil/Epirubicin/Cyclophosphamide, Epirubicin/Cyclophosphamide Followed by Docetaxel, or Docetaxel/Cyclophosphamide as Neoadjuvant Chemotherapy [NCT03349177] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2017-11-27 | Not yet recruiting |
| COX Inhibition and Biomarkers of Response During Neoadjuvant Chemoendocrine Therapy for Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Stage I-III Breast Cancer [NCT04038489] | Phase 2 | 0 participants (Actual) | Interventional | 2019-10-18 | Withdrawn(stopped due to Lack of accrual) |
| Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial [NCT05131893] | | 300 participants (Anticipated) | Observational [Patient Registry] | 2022-03-31 | Not yet recruiting |
| Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer [NCT06121557] | Phase 1 | 24 participants (Anticipated) | Interventional | 2023-11-01 | Recruiting |
| Phase Ib Clinical Trial of Autologous Anti-NY-ESO-1 TCR-Engineered T Cells in Patients With Relapsed/Refractory Locally Advanced or Metastatic NY-ESO-1-Expressing Triple Negative Breast Cancer [NCT05989828] | Phase 1 | 20 participants (Anticipated) | Interventional | 2023-11-27 | Not yet recruiting |
| SJiMB21: Phase 2 Study of Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma [NCT05535166] | Phase 2 | 120 participants (Anticipated) | Interventional | 2022-12-20 | Recruiting |
| "A Phase I/II Clinical Trial of Off-the-shelf NK Cell Administration in Combination With Allogeneic SCT to Decrease Disease Relapse in Patients With High-risk Myeloid Malignancies Undergoing Matched Related, Matched Unrelated, One Antigen Mismatched Unrel [NCT05115630] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2022-04-08 | Recruiting |
| Phase I Dose Escalation Trial of CD19 Directed Chimeric Antigen Receptor T Cell Therapy in the Treatment of Relapsed/Refractory B Cell Malignancies [NCT04892277] | Phase 1 | 25 participants (Anticipated) | Interventional | 2022-07-14 | Recruiting |
| An Open-label Phase II Trial Evaluating the Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer（NeoSACT） [NCT04877821] | Phase 2 | 31 participants (Anticipated) | Interventional | 2021-09-15 | Recruiting |
| A Phase IB-II Study Of High-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus for the Prevention of Graft-Versus-Host Disease (GvHD) Following Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) [NCT04503616] | Phase 1/Phase 2 | 46 participants (Actual) | Interventional | 2020-09-16 | Active, not recruiting |
| A Randomized Phase II Pilot of Tailored Prednisone Reduction Versus Usual Care for the Treatment of Hyperglycemia During R-CHOP Chemotherapy [NCT03505762] | Phase 2 | 80 participants (Anticipated) | Interventional | 2018-07-19 | Recruiting |
| Phase I/II Study of Sorafenib Added to Busulfan and Fludarabine Conditioning Regimen in Patients With Relapsed/Refractory AML Undergoing Stem Cell Transplantation [NCT03247088] | Phase 1/Phase 2 | 74 participants (Anticipated) | Interventional | 2017-07-30 | Recruiting |
| A Phase II Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease [NCT03121001] | Phase 2 | 50 participants (Anticipated) | Interventional | 2017-03-20 | Recruiting |
| Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents [NCT03020030] | Phase 3 | 560 participants (Actual) | Interventional | 2017-03-03 | Active, not recruiting |
| A Study of T-Cell Replete, HLA-Mismatched Haploidentical Bone Marrow Transplantation With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related Donor [NCT02828592] | Phase 2 | 20 participants (Anticipated) | Interventional | 2016-09-09 | Recruiting |
| A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS) [NCT02567435] | Phase 3 | 321 participants (Actual) | Interventional | 2016-06-01 | Active, not recruiting |
| Phase I Trial of Low-Dose Cyclophosphamide in Combination With Veliparib (ABT-888) in HER2/Neu-Negative Metastatic Breast Cancer [NCT01351909] | Phase 1 | 35 participants (Actual) | Interventional | 2011-05-02 | Active, not recruiting |
| A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLE [NCT02080195] | Phase 1/Phase 2 | 1 participants (Actual) | Interventional | 2016-09-13 | Terminated(stopped due to Study was unable to accrue subjects) |
| Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia in Individuals With Higher Risk of Transplant Failure [NCT02105766] | Phase 2 | 162 participants (Anticipated) | Interventional | 2014-04-21 | Recruiting |
| Study Comparing the Efficacy and Safety of Epirubicin Combined With Cyclophosphamide Followed by Docetaxel (EC-T) Verses Paclitaxel Combined With Carboplatin (PCb) in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer [NCT04193059] | Phase 3 | 1,560 participants (Anticipated) | Interventional | 2018-08-01 | Recruiting |
| The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma [NCT03022123] | | 270 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
| Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen (A Multi-Center Trial Coordinated by the FHCRC) [NCT00723099] | Phase 2 | 73 participants (Actual) | Interventional | 2008-06-25 | Completed |
| A Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy [NCT01236456] | Phase 2 | 0 participants (Actual) | Interventional | 2003-10-31 | Withdrawn(stopped due to I am relocating to Johns Hopkins Medical Center) |
| Phase Ib Trial of Pembrolizumab Administered in Combination With or Following Adoptive Cell Therapy- A Multiple Cohort Study; The ACTIVATE (Adoptive Cell Therapy InVigorated to Augment Tumor Eradication) Trial [NCT03158935] | Phase 1 | 8 participants (Actual) | Interventional | 2017-07-07 | Completed |
| A Phase I/II Study of Autologous Stem Cell Transplantation Followed by Nonmyeloablative Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Lymphoma - A Multi-center Trial [NCT00005803] | Phase 1/Phase 2 | 76 participants (Actual) | Interventional | 1999-09-30 | Completed |
| Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After the Same-Day, Varying Dosing Time Schedules of Eflapegrastim Administration in Patients With Breast-Cancer Receiving Docetaxel and Cyclophosphamide [NCT04187898] | Phase 1 | 90 participants (Anticipated) | Interventional | 2020-03-11 | Recruiting |
| Phase I Study to Evaluate the Safety and Effectiveness of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma [NCT05008536] | Early Phase 1 | 27 participants (Anticipated) | Interventional | 2021-10-01 | Recruiting |
| Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone, in Combination With Lenalidomide or Oral Cyclophosphamide in Patients With Newly Diagnosed Multiple Myeloma [NCT01881789] | Phase 1/Phase 2 | 22 participants (Actual) | Interventional | 2013-10-28 | Terminated(stopped due to A program evaluation identified that the safety profile and pharmacokinetic (PK) characteristics of the formulation used in all oprozomib studies required further optimization and thus enrollment in OPZ003 was halted during dose-escalation.) |
| A Phase I/II Study of the Safety and Feasibility of Administering T Cells Expressing Anti-EGFRvIII Chimeric Antigen Receptor to Patients With Malignant Gliomas Expressing EGFRvIII [NCT01454596] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2012-05-16 | Completed |
| A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma [NCT02215967] | Phase 1 | 30 participants (Actual) | Interventional | 2014-08-12 | Completed |
| A Phase I/II Study of the SV-BR-1-GM Regimen in HLA Matched Metastatic Breast Cancer Patients in Combination With Pembrolizumab [NCT04418219] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2020-12-21 | Withdrawn(stopped due to Funding Discontinued) |
| A Phase 3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincr [NCT02162771] | Phase 3 | 140 participants (Actual) | Interventional | 2014-07-14 | Completed |
| A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children With Juvenile Myelomonocytic Leukemia (JMML) [NCT01824693] | Phase 2 | 30 participants (Actual) | Interventional | 2013-06-24 | Completed |
| A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failu [NCT02117024] | Phase 2 | 66 participants (Actual) | Interventional | 2014-07-31 | Terminated(stopped due to Sponsor Decision; strategic - based on changing treatment landscape) |
| A Phase I Trial of Post-Transplant Bortezomib and High Dose Cyclophosphamide as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT) [NCT01860170] | Phase 1/Phase 2 | 28 participants (Actual) | Interventional | 2012-04-30 | Completed |
| Investigation of the Potential Beneficial Effect of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO) [NCT04170465] | Phase 2 | 70 participants (Actual) | Interventional | 2019-10-29 | Completed |
| CHAIROS - Effect of Early Brief Intensification by Chemoimmunotherapy With FCR Followed by FR and Rituximab Maintenance on Clinical Response in Chemo-naïve Patients With B-CLL [NCT02013817] | Phase 2 | 43 participants (Actual) | Interventional | 2005-10-11 | Completed |
| A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in Patients With HER2+ Early Breast Cancer [NCT03013504] | Phase 3 | 503 participants (Actual) | Interventional | 2018-02-19 | Completed |
| A Prospective, Multi-cohort, Exploratory Phase II Study of Trilaciclib Combined With Standard Chemotherapy in The Adjuvant Treatment of Hormone Receptor (HR) Negative Breast Cancer [NCT05978648] | Phase 2 | 116 participants (Anticipated) | Interventional | 2023-09-20 | Recruiting |
| A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE) [NCT05406401] | Phase 2 | 60 participants (Anticipated) | Interventional | 2022-07-14 | Recruiting |
| A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amy [NCT04504825] | Phase 3 | 124 participants (Anticipated) | Interventional | 2021-02-02 | Active, not recruiting |
| CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis [NCT04304144] | Phase 2 | 25 participants (Actual) | Interventional | 2020-03-18 | Completed |
| A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) [NCT04245839] | Phase 2 | 213 participants (Anticipated) | Interventional | 2020-07-14 | Active, not recruiting |
| A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors [NCT03861403] | Phase 1 | 10 participants (Actual) | Interventional | 2019-05-20 | Terminated(stopped due to Product development discontinued unrelated to safety.) |
| Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CS1-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in [NCT03710421] | Phase 1 | 30 participants (Anticipated) | Interventional | 2019-04-23 | Recruiting |
| Allogeneic Hematopoietic Stem Cell Transplantation of α/β T-Lymphocyte Depleted Graft Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia [NCT03531736] | Phase 1 | 17 participants (Actual) | Interventional | 2018-05-09 | Active, not recruiting |
| Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible caspase9 Safety Switch in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia [NCT03016377] | Phase 1/Phase 2 | 54 participants (Anticipated) | Interventional | 2012-03-22 | Recruiting |
| A MULTICENTER, RANDOMIZED, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (CCyd) as Pre Transplant INDUCTION and Post Transplant Consolidation or CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (CRd) as Pre Transplant INDUCTION a [NCT02203643] | Phase 2 | 477 participants (Actual) | Interventional | 2015-02-28 | Active, not recruiting |
| Phase II Multicenter Randomized Study to Compare Neoadjuvant FDC With Melatonin or Metformin Versus FDC Alone in The Therapy of Locally Advanced Breast Cancer. [NCT02506777] | Phase 2 | 96 participants (Anticipated) | Interventional | 2015-07-31 | Recruiting |
| A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma [NCT03322735] | Phase 1/Phase 2 | 10 participants (Anticipated) | Interventional | 2017-12-08 | Recruiting |
| An Randomized, Open-label, Phase III Study Comparing Thalidomide Combined With R-CHOP and R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients [NCT03318835] | Phase 3 | 162 participants (Anticipated) | Interventional | 2017-08-22 | Recruiting |
| The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma [NCT03101709] | Phase 1 | 30 participants (Anticipated) | Interventional | 2016-08-31 | Recruiting |
| PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer [NCT02299999] | Phase 2 | 1,460 participants (Actual) | Interventional | 2014-04-07 | Active, not recruiting |
| Pilot Study of Autologous T-cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer [NCT02465983] | Phase 1 | 4 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to Lack of efficacy and funding to continue investigation) |
| Adoptive Cell Therapy Across Cancer Diagnoses [NCT03296137] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2017-10-13 | Active, not recruiting |
| A Phase II One-arm Open-label Neoadjuvant Study of Pembrolizumab in Combination With Nab-paclitaxel Followed by Pembrolizumab in Combination With Epirubicin and Cyclophosphamide in Patients With Triple Negative Breast Cancer [NCT03289819] | Phase 2 | 53 participants (Actual) | Interventional | 2018-03-23 | Completed |
| A Phase 3, Randomized Study to Evaluate Plinabulin Versus Pegfilgrastim in the Prevention of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) (Protective 2) [NCT03294577] | Phase 3 | 221 participants (Actual) | Interventional | 2019-10-23 | Active, not recruiting |
| Phase I Study of MCS110 Combined With Neoadjuvant Dose-Dense Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer [NCT03285607] | Phase 1 | 0 participants (Actual) | Interventional | 2018-09-30 | Withdrawn(stopped due to Drug provider decided not to move forward with the study.) |
| Safety and Efficacy Evaluation of IM19 Chimeric Antigen Receptor-modified T Cells (IM19CAR-T) In CD19+ B Cell Malignancies [NCT03344705] | Phase 1 | 20 participants (Anticipated) | Interventional | 2017-08-21 | Recruiting |
| Study of Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as Perioperative Treatment in Participants With HER2 Negative Breast Cancer [NCT04498793] | Phase 2 | 55 participants (Anticipated) | Interventional | 2020-09-30 | Not yet recruiting |
| A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma [NCT01731886] | Phase 4 | 60 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Phase II Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia [NCT05645718] | Phase 2 | 27 participants (Anticipated) | Interventional | 2023-07-14 | Recruiting |
| Phase II Single-Arm Open-Label Study Of Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus for the Prevention of Graft-Versus-Host Disease (GVHD) Following Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) [NCT05621759] | Phase 2 | 92 participants (Anticipated) | Interventional | 2022-08-23 | Recruiting |
| Phase Ib Study of Cellular Adoptive Immunotherapy Using Autologous Cd8+ Antigen-Specific T Cells and Anti-Ctla4 for Patients With Metastatic Uveal Melanoma [NCT03068624] | Phase 1 | 34 participants (Actual) | Interventional | 2017-09-08 | Active, not recruiting |
| Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP) [NCT03225924] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2017-07-26 | Terminated(stopped due to Stop of drug development) |
| Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin, Thiotepa and Cyclophosphamide (STMP V) ± Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast [NCT00182793] | Phase 2 | 32 participants (Actual) | Interventional | 2005-07-31 | Completed |
| Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL [NCT00090051] | Phase 3 | 552 participants (Actual) | Interventional | 2003-07-31 | Completed |
| Phase II Study of CTLA-4 Blockade and Low Dose Cyclophosphamide in Patients With Advanced Malignant Melanoma [NCT01740401] | Phase 2 | 10 participants (Actual) | Interventional | 2012-10-31 | Terminated(stopped due to Primary Endpoint not met) |
| Phase 3 Randomized Clinical Trial Evaluating the Use of the Laser-Assisted Immunotherapy (LIT) System in Advanced Breast Cancer [NCT03202446] | Phase 3 | 18 participants (Actual) | Interventional | 2016-06-13 | Terminated |
| A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) [NCT05681260] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-02-06 | Recruiting |
| Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) +/- Rituximab (R) + Tafasitamab-cxix for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative (Ph-) B-cell Lymphoblastic Lymphoma/Leuke [NCT05453500] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-03-27 | Recruiting |
| A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Chemotherapy Regimens With Weekly Paclitaxel or Eribulin Followed by Doxorubicin and Cyclophosphamide in Women With Locally Advanced HER2-Negative Breast Cancer [NCT01705691] | Phase 2 | 50 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Fluorouracil, Epirubicin and Cyclophosphamide Versus Concurrent Epirubicin and Paclitaxel in Node Positive Early Breast Cancer Patients: a Randomized, Phase III Trial of Gruppo Oncologico Nord-Ovest - Mammella Intergruppo Group [NCT02450058] | Phase 3 | 1,055 participants (Actual) | Interventional | 1996-11-30 | Completed |
| The Palliative Benefit of Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center - NHL04 Trial [NCT02449278] | Phase 3 | 120 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
| Tandem High-Dose Therapy With Melphalan and Total Marrow Irradiation (TMI) With Peripheral Blood Progenitor Cell Support and Lenalidomide Maintenance in Multiple Myeloma: A Phase I/II Trial [NCT00112827] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2004-11-30 | Completed |
| Phase 2 Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL [NCT04594798] | Phase 2 | 39 participants (Anticipated) | Interventional | 2021-09-20 | Recruiting |
| International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Subprotocol C Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric [NCT05745714] | Phase 1/Phase 2 | 26 participants (Anticipated) | Interventional | 2023-10-01 | Not yet recruiting |
| Elucidation of Factors Predicting Efficacy and Toxicity of Post Transplantation Cyclophosphamide (PTCy) as a Strategy for Graft Versus Host Disease Prevention in Haploidentical, Matched Related Donor and Matched Unrelated Donor Peripheral Blood Hematopoie [NCT03555851] | | 120 participants (Anticipated) | Observational | 2018-07-13 | Recruiting |
| Pediatric Blood & Marrow Transplant Consortium (PBMTC) Phase II Myeloablative Haploidentical BMT With Post-transplantation Cyclophosphamide for Pediatric Patients With Hematologic Malignancies [NCT02120157] | Phase 2 | 35 participants (Actual) | Interventional | 2015-07-02 | Completed |
| T-cell Therapy in Combination With Vemurafenib for Patients With BRAF Mutated Metastatic Melanoma [NCT02354690] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Decitabine Followed by Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Neoplasms [NCT01707004] | Phase 2 | 20 participants (Actual) | Interventional | 2013-05-16 | Completed |
| Autologous Peripheral Blood Stem Cell Transplant for Acute Non-Lymphocytic Leukemia (ANLL) [NCT00630565] | Phase 2/Phase 3 | 11 participants (Actual) | Interventional | 2006-07-26 | Terminated(stopped due to Slow Accrual) |
| Phase 2, Open-Label, Dose-Ranging Study of SPI-2012 (HM10460A) or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophosphamide (TC) Re [NCT01724866] | Phase 2 | 148 participants (Actual) | Interventional | 2013-03-25 | Completed |
| A Phase 1/2, Open-Label Study to Assess the Safety and Tolerability of Repeat Doses of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects Following Cyclophosphamide Conditioning [NCT02225665] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2014-08-31 | Completed |
| Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934] | Phase 2 | 43 participants (Actual) | Interventional | 2015-07-09 | Completed |
| Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL [NCT04835870] | Phase 2 | 78 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00001832 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00001832 (2) [back to overview] | Clinical Response |
| NCT00002766 (1) [back to overview] | Complete Remission (CR) |
| NCT00003042 (2) [back to overview] | Five-year Overall Survival |
| NCT00003042 (2) [back to overview] | Three-year Relapse-free Survival |
| NCT00003270 (1) [back to overview] | Progression-free Survival |
| NCT00003389 (3) [back to overview] | Failure-free Survival at 5 Years |
| NCT00003389 (3) [back to overview] | 5-year Overall Survival |
| NCT00003389 (3) [back to overview] | Incidence of Second Cancers |
| NCT00003631 (1) [back to overview] | Objective Response |
| NCT00003659 (3) [back to overview] | Overall Survival Status |
| NCT00003659 (3) [back to overview] | Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease |
| NCT00003659 (3) [back to overview] | Overall Response Rate |
| NCT00003782 (1) [back to overview] | Overall Survival |
| NCT00003816 (4) [back to overview] | Toxicity/TRM at Day 100 |
| NCT00003816 (4) [back to overview] | 4 yr OS |
| NCT00003816 (4) [back to overview] | 4 Year PFS |
| NCT00003816 (4) [back to overview] | CR Rate |
| NCT00003910 (2) [back to overview] | Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX |
| NCT00003910 (2) [back to overview] | Proportion of Patients With Complete or Partial Response to Treatment With MTX |
| NCT00004031 (3) [back to overview] | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs |
| NCT00004031 (3) [back to overview] | 2 Year Progression-free Survival |
| NCT00004031 (3) [back to overview] | 2-year Overall Survival Rates |
| NCT00004088 (2) [back to overview] | Progression-free Survival |
| NCT00004088 (2) [back to overview] | Three-year Overall Survival |
| NCT00004092 (2) [back to overview] | Five-Year Relapse-free Survival |
| NCT00004092 (2) [back to overview] | Five-Year Overall Survival |
| NCT00004228 (2) [back to overview] | Event-free Survival |
| NCT00004228 (2) [back to overview] | Percentage of Patients With Overall Survival as Assessed by Time to Death |
| NCT00004563 (3) [back to overview] | Total Lung Capacity |
| NCT00004563 (3) [back to overview] | Forced Vital Capacity |
| NCT00004563 (3) [back to overview] | DLCO |
| NCT00005780 (10) [back to overview] | Overall Survival (OS) |
| NCT00005780 (10) [back to overview] | Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) |
| NCT00005780 (10) [back to overview] | Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0). |
| NCT00005780 (10) [back to overview] | Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH) |
| NCT00005780 (10) [back to overview] | Percentage of Participants With Induction of Type 1 Cytokine T-cell Response |
| NCT00005780 (10) [back to overview] | Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine |
| NCT00005780 (10) [back to overview] | Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine |
| NCT00005780 (10) [back to overview] | Percentage of Participants With an Antibody Response to Idiotype Vaccine |
| NCT00005780 (10) [back to overview] | Time to Recovery of CD4 T Lymphocytes (CD4+) |
| NCT00005780 (10) [back to overview] | Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) |
| NCT00005803 (4) [back to overview] | Non-Relapse Mortality |
| NCT00005803 (4) [back to overview] | Engraftment of HLA Identical PBSC Allografts |
| NCT00005803 (4) [back to overview] | Overall Survival (OS) |
| NCT00005803 (4) [back to overview] | Progression Free-survival (PFS) |
| NCT00005908 (4) [back to overview] | Complementary Deoxyribonucleic Acid (cDNA) Expression |
| NCT00005908 (4) [back to overview] | Number of Participants With Adverse Events |
| NCT00005908 (4) [back to overview] | Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models |
| NCT00005908 (4) [back to overview] | Overall Clinical Response Rate |
| NCT00006110 (3) [back to overview] | Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®. |
| NCT00006110 (3) [back to overview] | Overall Response |
| NCT00006110 (3) [back to overview] | Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC. |
| NCT00006184 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00006184 (2) [back to overview] | Immune Response |
| NCT00006436 (16) [back to overview] | Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia |
| NCT00006436 (16) [back to overview] | Median Progression Free Survival (PFS) |
| NCT00006436 (16) [back to overview] | Median Overall Survival |
| NCT00006436 (16) [back to overview] | 1 Year Overall Survival |
| NCT00006436 (16) [back to overview] | Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity |
| NCT00006436 (16) [back to overview] | Percentage of Participants With Complete Response |
| NCT00006436 (16) [back to overview] | Progression Free Survival at 1 Year |
| NCT00006436 (16) [back to overview] | Recovery of CD4 T Cells (CD4) Counts |
| NCT00006436 (16) [back to overview] | Recovery of Human Immunodeficiency Virus (HIV) Viral Load |
| NCT00006436 (16) [back to overview] | 1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) |
| NCT00006436 (16) [back to overview] | Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS) |
| NCT00006436 (16) [back to overview] | Number of Cycles of Hematologic Toxicity |
| NCT00006436 (16) [back to overview] | Overall Response |
| NCT00006436 (16) [back to overview] | Median Duration of Complete Response/Complete Response Unconfirmed |
| NCT00006436 (16) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0) |
| NCT00006436 (16) [back to overview] | Percentage of Participants With CR/CRu Lasting 1 Year |
| NCT00006721 (6) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00006721 (6) [back to overview] | Objective Response (Confirmed and Unconfirmed Complete and Partial Responses) |
| NCT00006721 (6) [back to overview] | Overall Survival at 2 Years |
| NCT00006721 (6) [back to overview] | Progression-free Survival at 2 Years |
| NCT00006721 (6) [back to overview] | Overall Survival at 5 Years |
| NCT00006721 (6) [back to overview] | Progression-free Survival at 5 Years |
| NCT00007475 (2) [back to overview] | Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange. |
| NCT00007475 (2) [back to overview] | Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide. |
| NCT00014222 (2) [back to overview] | Disease Free Survival |
| NCT00014222 (2) [back to overview] | Overall Survival |
| NCT00021255 (3) [back to overview] | Percentage of Participants With Disease Free Survival at 5 Years |
| NCT00021255 (3) [back to overview] | Percentage of Participants With Disease Free Survival at 10 Years |
| NCT00021255 (3) [back to overview] | Overall Survival- Percentage of Participants Who Survived at 10 Years |
| NCT00022516 (4) [back to overview] | Overall Survival |
| NCT00022516 (4) [back to overview] | Disease-free Survival |
| NCT00022516 (4) [back to overview] | Distant Recurrence-free Interval |
| NCT00022516 (4) [back to overview] | Breast Cancer-free Interval |
| NCT00025259 (4) [back to overview] | Grade 3 or 4 Non-hematologic Toxicity |
| NCT00025259 (4) [back to overview] | Disease Response Assessed by Modified RECIST Criteria |
| NCT00025259 (4) [back to overview] | Event-free Survival |
| NCT00025259 (4) [back to overview] | Overall Survival |
| NCT00026208 (7) [back to overview] | Second Hodgkin's Disease Progression |
| NCT00026208 (7) [back to overview] | Early Treatment-related Toxicity |
| NCT00026208 (7) [back to overview] | Overall Survival (OS) |
| NCT00026208 (7) [back to overview] | Progression-free Survival (PFS) |
| NCT00026208 (7) [back to overview] | Late Treatment-related Toxicity |
| NCT00026208 (7) [back to overview] | Survival at 5 and 10 Years |
| NCT00026208 (7) [back to overview] | Frequency of Complete Response |
| NCT00027846 (6) [back to overview] | Event-free Survival (EFS) |
| NCT00027846 (6) [back to overview] | Overall Survival |
| NCT00027846 (6) [back to overview] | Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy |
| NCT00027846 (6) [back to overview] | Event-free Survival |
| NCT00027846 (6) [back to overview] | Event-free Survival (EFS) |
| NCT00027846 (6) [back to overview] | Local Control and Patterns of Failure |
| NCT00031590 (1) [back to overview] | Long Term Survival |
| NCT00033293 (5) [back to overview] | Tumor Outcome in Terms of Overall Survival (OS) Rate |
| NCT00033293 (5) [back to overview] | Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing |
| NCT00033293 (5) [back to overview] | Number of Responders |
| NCT00033293 (5) [back to overview] | Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS) |
| NCT00033293 (5) [back to overview] | Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death |
| NCT00038610 (3) [back to overview] | Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate |
| NCT00038610 (3) [back to overview] | Disease-Free Survival Rate at 2-year and 5-year. |
| NCT00038610 (3) [back to overview] | Overall Survival Rate at 2-year and 5-year. |
| NCT00039130 (3) [back to overview] | 2 Year Overall Survival |
| NCT00039130 (3) [back to overview] | 2 Year Event Free Survival |
| NCT00039130 (3) [back to overview] | Complete Response Rate |
| NCT00039195 (1) [back to overview] | Progression Free Survival |
| NCT00039377 (5) [back to overview] | 5 Year Overall Survival for Autologous & Allogeneic Transplant Groups |
| NCT00039377 (5) [back to overview] | 5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups |
| NCT00039377 (5) [back to overview] | Number of Participants Who Achieved a BCR-ABL Response at 12 Months |
| NCT00039377 (5) [back to overview] | Overall Survival |
| NCT00039377 (5) [back to overview] | Disease Free Survival |
| NCT00040937 (2) [back to overview] | Overall Survival |
| NCT00040937 (2) [back to overview] | Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen. |
| NCT00041119 (7) [back to overview] | Duration of Disease Free Survival (RFS) |
| NCT00041119 (7) [back to overview] | Adverse Events |
| NCT00041119 (7) [back to overview] | Relapse Free Survival (RFS) 4 vs. 6 Cycles |
| NCT00041119 (7) [back to overview] | Time to Distant Metastases |
| NCT00041119 (7) [back to overview] | Local Control |
| NCT00041119 (7) [back to overview] | Overall Survival (OS) for 4 vs. 6 Cycles |
| NCT00041119 (7) [back to overview] | Overall Survival (OS) |
| NCT00041132 (3) [back to overview] | Response |
| NCT00041132 (3) [back to overview] | Overall Survival |
| NCT00041132 (3) [back to overview] | Progression-free Survival |
| NCT00043979 (14) [back to overview] | Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy |
| NCT00043979 (14) [back to overview] | Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin) |
| NCT00043979 (14) [back to overview] | Toxicity |
| NCT00043979 (14) [back to overview] | Early Post Transplantation Relapse |
| NCT00043979 (14) [back to overview] | Number of Participants With Engraftment |
| NCT00043979 (14) [back to overview] | Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant |
| NCT00043979 (14) [back to overview] | Number of Participants Who Experienced Graft Versus Tumor Effect (GVT) |
| NCT00043979 (14) [back to overview] | Number of Participants to Complete Conversion to >95% Donor Chimerism |
| NCT00043979 (14) [back to overview] | Number of Participants With Acute and Chronic GVHD |
| NCT00043979 (14) [back to overview] | Median Time to Reach Absolute Neutrophil Count of 500/mm(3) |
| NCT00043979 (14) [back to overview] | Median Time to Reach a Platelet Count of 50,000/mm(3) |
| NCT00043979 (14) [back to overview] | Cluster of Differentiation 4 (CD4) Reconstitution |
| NCT00043979 (14) [back to overview] | Median Progression Free Survival |
| NCT00043979 (14) [back to overview] | Median Survival From Date of Progression |
| NCT00048737 (1) [back to overview] | Number of Participants With Graft Failure |
| NCT00048893 (1) [back to overview] | Number of Participants With Adverse Events |
| NCT00049036 (1) [back to overview] | Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment |
| NCT00049504 (3) [back to overview] | Donor Engraftment (Chimerism) |
| NCT00049504 (3) [back to overview] | Incidence of Grades III-IV Acute GVHD |
| NCT00049504 (3) [back to overview] | Non-relapse-related Mortality |
| NCT00049517 (3) [back to overview] | Overall Survival (Consolidation Phase) |
| NCT00049517 (3) [back to overview] | Overall Survival (Induction Phase) |
| NCT00049517 (3) [back to overview] | Disease-free Survival (Consolidation Phase) |
| NCT00051311 (9) [back to overview] | Number of Recipients Evaluable Who Achieved Full Donor Chimerism at Day+100 |
| NCT00051311 (9) [back to overview] | Median Time to Platelet Recovery |
| NCT00051311 (9) [back to overview] | Median Time to Neutrophil Recovery |
| NCT00051311 (9) [back to overview] | Median Cycles of Induction Chemotherapy With Fludarabine, Cyclophosphamide, Etoposide, Doxorubicin, Vincristine, and Prednisone Given to Recipients |
| NCT00051311 (9) [back to overview] | Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST) |
| NCT00051311 (9) [back to overview] | Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis |
| NCT00051311 (9) [back to overview] | Percentage of Recipients Who Achieved Donor Chimerism at Day +14 |
| NCT00051311 (9) [back to overview] | Number of Recipients With Non-serious Adverse Events |
| NCT00051311 (9) [back to overview] | Number of Recipients Who Developed Chronic Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis |
| NCT00053989 (4) [back to overview] | OS |
| NCT00053989 (4) [back to overview] | PFS |
| NCT00053989 (4) [back to overview] | Acute GvHD |
| NCT00053989 (4) [back to overview] | Day 100 TRM |
| NCT00054327 (5) [back to overview] | Number of Patients With Overall Survival at 2 Years. |
| NCT00054327 (5) [back to overview] | Rates of Durable Engraftment |
| NCT00054327 (5) [back to overview] | Toxicity as Measured by CTC v2.0 |
| NCT00054327 (5) [back to overview] | Incidence of Recurrent Disease |
| NCT00054327 (5) [back to overview] | Graft-versus-host Disease (GVHD) |
| NCT00054665 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00054665 (2) [back to overview] | Clinical Response Rate |
| NCT00057811 (4) [back to overview] | Minimal Residual Disease |
| NCT00057811 (4) [back to overview] | Response Rate |
| NCT00057811 (4) [back to overview] | Grade ≥ 3 Stomatitis |
| NCT00057811 (4) [back to overview] | Toxic Death |
| NCT00058422 (1) [back to overview] | Incidence of Adverse Experiences |
| NCT00060346 (1) [back to overview] | Objective Response to Treatment |
| NCT00061893 (2) [back to overview] | Occurrence of Severe Toxicity |
| NCT00061893 (2) [back to overview] | Event Free Survival |
| NCT00061945 (6) [back to overview] | Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II) |
| NCT00061945 (6) [back to overview] | Overall Survival |
| NCT00061945 (6) [back to overview] | Disease-free Survival, for Only Complete Response Patients |
| NCT00061945 (6) [back to overview] | Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I) |
| NCT00061945 (6) [back to overview] | Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II) |
| NCT00061945 (6) [back to overview] | Number of Participants Achieving Complete Remission |
| NCT00064337 (2) [back to overview] | Overall Survival |
| NCT00064337 (2) [back to overview] | Hematologic Response |
| NCT00066469 (1) [back to overview] | Event-free Survival |
| NCT00067002 (5) [back to overview] | Number of Participants Severity of Acute GVHD by Treatment Arm |
| NCT00067002 (5) [back to overview] | Rate of Acute Graft Versus Host Disease (GVHD) |
| NCT00067002 (5) [back to overview] | Rate of Chronic GVHD |
| NCT00067002 (5) [back to overview] | Number of Participants With Engraftment |
| NCT00067002 (5) [back to overview] | Time To Neutrophil Engraftment |
| NCT00068601 (3) [back to overview] | Rate of Ovarian Dysfunction at 2 Years |
| NCT00068601 (3) [back to overview] | Rate of Ovarian Dysfunction at 1 Year |
| NCT00068601 (3) [back to overview] | Rate of Premature Ovarian Failure at 2 Years |
| NCT00069238 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00069238 (2) [back to overview] | Maximum Tolerated Dose (MTD) of Alemtuzumab |
| NCT00070018 (1) [back to overview] | Progression-free Survival |
| NCT00070564 (9) [back to overview] | Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group |
| NCT00070564 (9) [back to overview] | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs |
| NCT00070564 (9) [back to overview] | Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group |
| NCT00070564 (9) [back to overview] | Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group. |
| NCT00070564 (9) [back to overview] | Overall Survival |
| NCT00070564 (9) [back to overview] | Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group |
| NCT00070564 (9) [back to overview] | Disease-free Survival |
| NCT00070564 (9) [back to overview] | Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group |
| NCT00070564 (9) [back to overview] | Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group |
| NCT00072280 (1) [back to overview] | "Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm" |
| NCT00072566 (3) [back to overview] | Median Overall Survival |
| NCT00072566 (3) [back to overview] | Median Time to Progression |
| NCT00072566 (3) [back to overview] | Response Rate Based on the RECIST |
| NCT00073918 (4) [back to overview] | Response Rate |
| NCT00073918 (4) [back to overview] | Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0 |
| NCT00073918 (4) [back to overview] | 5 Year Overall Survival |
| NCT00073918 (4) [back to overview] | Progression-free Survival |
| NCT00074165 (1) [back to overview] | Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years. |
| NCT00074282 (5) [back to overview] | Number of Patients Who After PCR (or During PCR for PD), Only Achieve a PR, SD, or PD and Who Subsequently Convert to a Higher Response Category After Campath-1H |
| NCT00074282 (5) [back to overview] | Overall Survival (OS) |
| NCT00074282 (5) [back to overview] | Progression-free Survival (PFS) |
| NCT00074282 (5) [back to overview] | Response Rate |
| NCT00074282 (5) [back to overview] | Molecular Complete Remission (MCR) Rate |
| NCT00074490 (4) [back to overview] | Percentage of Patients With Opportunistic Infection |
| NCT00074490 (4) [back to overview] | Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) |
| NCT00074490 (4) [back to overview] | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) |
| NCT00074490 (4) [back to overview] | Percentage of Patients to Receive T Cell Infusion |
| NCT00075582 (6) [back to overview] | Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry |
| NCT00075582 (6) [back to overview] | Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry |
| NCT00075582 (6) [back to overview] | Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry |
| NCT00075582 (6) [back to overview] | Percentage of Patients With Delayed Surgical Procedures |
| NCT00075582 (6) [back to overview] | Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy |
| NCT00075582 (6) [back to overview] | Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose |
| NCT00075725 (7) [back to overview] | Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). |
| NCT00075725 (7) [back to overview] | Correlation of Early Marrow Response Status With MRD Negative. |
| NCT00075725 (7) [back to overview] | Correlation of Early Marrow Response Status With MRD Positive. |
| NCT00076752 (16) [back to overview] | Relapse-free Complete Clinical Response |
| NCT00076752 (16) [back to overview] | Absolute Lymphocyte Count |
| NCT00076752 (16) [back to overview] | Absolute Neutrophil Count |
| NCT00076752 (16) [back to overview] | Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody |
| NCT00076752 (16) [back to overview] | Anti-Nuclear Antibody |
| NCT00076752 (16) [back to overview] | Anti-Smith-Ribonuclear Protein Antibody |
| NCT00076752 (16) [back to overview] | Cluster of Differentiation 19 (CD19) + Cells |
| NCT00076752 (16) [back to overview] | Number of Participants With Adverse Events |
| NCT00076752 (16) [back to overview] | Cluster of Differentiation 4 (CD4) + Cells |
| NCT00076752 (16) [back to overview] | Cluster of Differentiation 8 (CD8) + Cells |
| NCT00076752 (16) [back to overview] | Extractable Nuclear Antigen (ENA) |
| NCT00076752 (16) [back to overview] | Platelet Count |
| NCT00076752 (16) [back to overview] | Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) |
| NCT00076752 (16) [back to overview] | Cluster of Differentiation 3 (CD3) + Cells |
| NCT00076752 (16) [back to overview] | Natural Killer Cells |
| NCT00076752 (16) [back to overview] | White Blood Cells |
| NCT00083551 (1) [back to overview] | Overall Survival |
| NCT00084838 (19) [back to overview] | Grade 3-4 Metabolic/Laboratory Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Muscloskeletal Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Neurology Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Infection/Febrile Neutropenia Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Pulmonary Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Renal/Genitourinary Events |
| NCT00084838 (19) [back to overview] | Grade 3/4 Events |
| NCT00084838 (19) [back to overview] | 2-yr Overall Survival |
| NCT00084838 (19) [back to overview] | Pre-Radiation Therapy Chemotherapeutic Response |
| NCT00084838 (19) [back to overview] | Grade 3-4 Allergy/Immunology |
| NCT00084838 (19) [back to overview] | Grade 3-4 Auditory/Hearing Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Blood/Bone Marrow Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Cardiovascular Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Constitutional Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Dermatology Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Gastrointestinal Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Hemorrhage Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Hepatic Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Pain Events |
| NCT00085098 (4) [back to overview] | Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |
| NCT00085098 (4) [back to overview] | Quality of Life (QOL) and Neurocognitive Assessment (NP) |
| NCT00085098 (4) [back to overview] | Event-free Survival |
| NCT00085098 (4) [back to overview] | Number of Participants With a Response to Regimen B |
| NCT00085202 (11) [back to overview] | Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors |
| NCT00085202 (11) [back to overview] | Frequency of Mutations Associated With SHH and WNT Tumors |
| NCT00085202 (11) [back to overview] | Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. |
| NCT00085202 (11) [back to overview] | Processing Speed for Two Risk Group at Enrollment |
| NCT00085202 (11) [back to overview] | Perceptual Speed for Two Risk Group at Enrollment |
| NCT00085202 (11) [back to overview] | Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa |
| NCT00085202 (11) [back to overview] | Associative Memory for Two Risk Group at Enrollment |
| NCT00085202 (11) [back to overview] | Associative Memory for Two Risk Group at 5 Years After Enrollment |
| NCT00085202 (11) [back to overview] | Perceptual Speed for Two Risk Group at 5 Years After Enrollment |
| NCT00085202 (11) [back to overview] | Reading Decoding Composite Scores in the Intervention and Standard of Care Groups |
| NCT00085202 (11) [back to overview] | Processing Speed for Two Risk Group at 5 Years After Enrollment |
| NCT00085423 (3) [back to overview] | Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST |
| NCT00085423 (3) [back to overview] | Time to Progression as Measured by RECIST |
| NCT00085423 (3) [back to overview] | Number of Participants With Lymphocyte Recovery as Measured by Blood Count |
| NCT00085735 (22) [back to overview] | Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays |
| NCT00085735 (22) [back to overview] | Overall Survival (OS) |
| NCT00085735 (22) [back to overview] | Overall Survival (OS) |
| NCT00085735 (22) [back to overview] | Event-free Survival (EFS) |
| NCT00085735 (22) [back to overview] | Event-free Survival (EFS) |
| NCT00085735 (22) [back to overview] | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis). |
| NCT00085735 (22) [back to overview] | Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4 |
| NCT00085735 (22) [back to overview] | Post-treatment Endocrine Function by CSI Group |
| NCT00085735 (22) [back to overview] | Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays |
| NCT00085735 (22) [back to overview] | Non-posterior Fossa (NPF) Failure Rate |
| NCT00085735 (22) [back to overview] | Local Posterior Fossa (LPF) Failure Rate |
| NCT00085735 (22) [back to overview] | Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4 |
| NCT00085735 (22) [back to overview] | Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group |
| NCT00085735 (22) [back to overview] | Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis) |
| NCT00085735 (22) [back to overview] | Non-local Posterior Fossa (NLPF) Failure Rate |
| NCT00087178 (8) [back to overview] | Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation |
| NCT00087178 (8) [back to overview] | Quality of Life-Functional Assessment of Cancer Therapy |
| NCT00087178 (8) [back to overview] | Survival |
| NCT00087178 (8) [back to overview] | Recurrence-free Interval |
| NCT00087178 (8) [back to overview] | Post Chemotherapy Amenorrhea |
| NCT00087178 (8) [back to overview] | Distant Recurrence-free Interval |
| NCT00087178 (8) [back to overview] | Disease Free Survival |
| NCT00087178 (8) [back to overview] | Adverse Events |
| NCT00088530 (4) [back to overview] | Overall Response Rate (ORR) Lasting at Least 4 Months |
| NCT00088530 (4) [back to overview] | Overall Survival |
| NCT00088530 (4) [back to overview] | Progression-Free Survival (PFS) |
| NCT00088530 (4) [back to overview] | Complete Response (CR) and Complete Response Unconfirmed (CRu) |
| NCT00088881 (4) [back to overview] | Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™. |
| NCT00088881 (4) [back to overview] | 3-year Time to Treatment Failure (TTF) Rate |
| NCT00088881 (4) [back to overview] | 3-year Overall Survival (OS) Rate |
| NCT00088881 (4) [back to overview] | Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™. |
| NCT00090051 (15) [back to overview] | Number of Participants With Event-free Survival (EFS) Events |
| NCT00090051 (15) [back to overview] | Disease-free Survival (DFS) |
| NCT00090051 (15) [back to overview] | Event-free Survival (EFS) |
| NCT00090051 (15) [back to overview] | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) |
| NCT00090051 (15) [back to overview] | Overall Survival (OS) |
| NCT00090051 (15) [back to overview] | Final Analysis: Time to Progression-Free Survival Event |
| NCT00090051 (15) [back to overview] | Final Analysis: Time to Overall Survival Event |
| NCT00090051 (15) [back to overview] | Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment |
| NCT00090051 (15) [back to overview] | Final Analysis: Time to Event-Free Survival Event |
| NCT00090051 (15) [back to overview] | Final Analysis: Time to Disease-Free Survival Event |
| NCT00090051 (15) [back to overview] | Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC) |
| NCT00090051 (15) [back to overview] | Final Analysis: Percentage of Participants With Complete Response |
| NCT00090051 (15) [back to overview] | Final Analysis: Duration of Response |
| NCT00090051 (15) [back to overview] | Number of Participants With Disease-free Survival (DFS) Events |
| NCT00090051 (15) [back to overview] | Number of Participants With Overall Survival (OS) Events |
| NCT00093795 (5) [back to overview] | Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer |
| NCT00093795 (5) [back to overview] | Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only |
| NCT00093795 (5) [back to overview] | Overall Survival |
| NCT00093795 (5) [back to overview] | Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence |
| NCT00093795 (5) [back to overview] | Toxicity |
| NCT00096135 (1) [back to overview] | Event-free Survival |
| NCT00096382 (2) [back to overview] | Safety |
| NCT00096382 (2) [back to overview] | Clinical Tumor Regression |
| NCT00096460 (1) [back to overview] | Lymphoma Progression-free Survival |
| NCT00098839 (4) [back to overview] | Pharmacokinetics |
| NCT00098839 (4) [back to overview] | Remission Re-induction (CR2) Rate |
| NCT00098839 (4) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% |
| NCT00098839 (4) [back to overview] | Event-free Survival Rate |
| NCT00101010 (2) [back to overview] | Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses |
| NCT00101010 (2) [back to overview] | Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses |
| NCT00101101 (3) [back to overview] | Median Event Free Survival (EFS) |
| NCT00101101 (3) [back to overview] | Occurrence of Related Serious Adverse Events (SAEs) |
| NCT00101101 (3) [back to overview] | Rate of Immunological Response to Vaccination |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-Average ALL Patients |
| NCT00103285 (10) [back to overview] | Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative) |
| NCT00103285 (10) [back to overview] | Early Marrow Status (EMS) by MRD Status End Induction (Day 29) |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-Average ALL Patients |
| NCT00103285 (10) [back to overview] | Event-Free Survival Probability According to MRD Status End Induction (Day 29) |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-High Patients. |
| NCT00103285 (10) [back to overview] | Overall Survival Probability (OS) According to Induction Day 29 MRD Status |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-Low Patients |
| NCT00103285 (10) [back to overview] | Health-related Quality of Life Relative to Physical, Social and Emotional Impairment |
| NCT00103285 (10) [back to overview] | Optimal Time Point for Advance Health Related Quality of Life Intervention |
| NCT00104299 (8) [back to overview] | The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups |
| NCT00104299 (8) [back to overview] | Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy |
| NCT00104299 (8) [back to overview] | Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization |
| NCT00104299 (8) [back to overview] | Number of Subjects Experiencing Serious Adverse Events |
| NCT00104299 (8) [back to overview] | The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups |
| NCT00104299 (8) [back to overview] | Disease Remission |
| NCT00104299 (8) [back to overview] | Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups |
| NCT00104299 (8) [back to overview] | Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups |
| NCT00107198 (5) [back to overview] | Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients |
| NCT00107198 (5) [back to overview] | Failure-free Survival (FFS) |
| NCT00107198 (5) [back to overview] | Event-free Survival |
| NCT00107198 (5) [back to overview] | Cure by Surgery Alone in Stage I Resected Patients |
| NCT00107198 (5) [back to overview] | Grade 3 or 4 Toxicity |
| NCT00107276 (3) [back to overview] | Progression-free Survival and Overall Survival |
| NCT00107276 (3) [back to overview] | Response Rate (Complete and Partial, Confirmed and Unconfirmed) |
| NCT00107276 (3) [back to overview] | Toxicity |
| NCT00107380 (3) [back to overview] | Response Rate (Complete, Complete Unconfirmed, and Partial) |
| NCT00107380 (3) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00107380 (3) [back to overview] | Progression-free Survival (PFS) at 2 Years |
| NCT00109031 (7) [back to overview] | Number of Participants With WHO Grade 4 Oral Mucositis |
| NCT00109031 (7) [back to overview] | Duration of WHO Grade 2, 3 or 4 Oral Mucositis |
| NCT00109031 (7) [back to overview] | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) |
| NCT00109031 (7) [back to overview] | Area Under the Curve (AUC) of Mouth and Throat Soreness Score |
| NCT00109031 (7) [back to overview] | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis |
| NCT00109031 (7) [back to overview] | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) |
| NCT00109031 (7) [back to overview] | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use |
| NCT00109837 (2) [back to overview] | Toxicity |
| NCT00109837 (2) [back to overview] | Continuous Complete Remission at 1 Year |
| NCT00112827 (3) [back to overview] | Maximum Tolerated Dose (MTD) |
| NCT00112827 (3) [back to overview] | Number of Subjects With Response |
| NCT00112827 (3) [back to overview] | Overall Survival |
| NCT00114530 (30) [back to overview] | Global Rank Composite Score (GRCS) (Month 54, ITT) |
| NCT00114530 (30) [back to overview] | Global Rank Composite Score (GRCS) (Month 48, PP) |
| NCT00114530 (30) [back to overview] | Documented Myositis (PP) |
| NCT00114530 (30) [back to overview] | Documented Myositis (ITT) |
| NCT00114530 (30) [back to overview] | All-Cause Mortality (Month 54, PP) |
| NCT00114530 (30) [back to overview] | All-Cause Mortality (Month 54, ITT) |
| NCT00114530 (30) [back to overview] | All-Cause Mortality (Month 48, PP) |
| NCT00114530 (30) [back to overview] | All-Cause Mortality (Month 48, ITT) |
| NCT00114530 (30) [back to overview] | Global Rank Composite Score (GRCS) (Month 48, ITT) |
| NCT00114530 (30) [back to overview] | Regimen-Related Toxicities |
| NCT00114530 (30) [back to overview] | Number of Subjects With Regimen-Related Toxicities |
| NCT00114530 (30) [back to overview] | New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (PP) |
| NCT00114530 (30) [back to overview] | New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (ITT) |
| NCT00114530 (30) [back to overview] | Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (PP) |
| NCT00114530 (30) [back to overview] | Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (ITT) |
| NCT00114530 (30) [back to overview] | Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (ITT) |
| NCT00114530 (30) [back to overview] | Treatment-Related Mortality (Month 54, PP) |
| NCT00114530 (30) [back to overview] | Treatment-Related Mortality (Month 54, ITT) |
| NCT00114530 (30) [back to overview] | Treatment-Related Mortality (Month 48, PP) |
| NCT00114530 (30) [back to overview] | Treatment-Related Mortality (Month 48, ITT) |
| NCT00114530 (30) [back to overview] | Time to Absolute Neutrophil Count Engraftment |
| NCT00114530 (30) [back to overview] | Occurrence of Scleroderma Renal Crisis (PP) |
| NCT00114530 (30) [back to overview] | Occurrence of Scleroderma Renal Crisis (ITT) |
| NCT00114530 (30) [back to overview] | Number of Subjects With Infectious Complications |
| NCT00114530 (30) [back to overview] | New or Worsening Pulmonary Hypertension (PP) |
| NCT00114530 (30) [back to overview] | New or Worsening Pulmonary Hypertension (ITT) |
| NCT00114530 (30) [back to overview] | Initiating Use of Disease-Modifying Antirheumatic Drugs by Month 54 (DMARDs) (PP) |
| NCT00114530 (30) [back to overview] | Initiating Use of Disease-Modifying Antirheumatic Drugs (DMARDs) by Month 54 (ITT) |
| NCT00114530 (30) [back to overview] | Infectious Complications |
| NCT00114530 (30) [back to overview] | Global Rank Composite Score (GRCS) (Month 54, PP) |
| NCT00118209 (3) [back to overview] | Progression-Free Survival Rate at 2 and 5 Years |
| NCT00118209 (3) [back to overview] | Overall Survival Rate at 2 and 5 Years |
| NCT00118209 (3) [back to overview] | Response Rate |
| NCT00118274 (2) [back to overview] | Immunogenicity (CD8+ T Cell Response to 12 Melanoma Peptides, 12MP) as Measured by Elispot Assay, up to Day 50 |
| NCT00118274 (2) [back to overview] | Safety of the Peptide Vaccines |
| NCT00119262 (3) [back to overview] | Congestive Heart Failure Rate |
| NCT00119262 (3) [back to overview] | Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC) |
| NCT00119262 (3) [back to overview] | Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab |
| NCT00121134 (1) [back to overview] | The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts |
| NCT00121199 (4) [back to overview] | Progression-free Survival at 2 Year |
| NCT00121199 (4) [back to overview] | Progression-free Survival at 1 Year |
| NCT00121199 (4) [back to overview] | Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)) |
| NCT00121199 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00121992 (8) [back to overview] | The Number of Participants Who Experienced Adverse Events (AE) |
| NCT00121992 (8) [back to overview] | Overall Survival (OS) |
| NCT00121992 (8) [back to overview] | Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup |
| NCT00121992 (8) [back to overview] | Disease-free Survival (DFS) Events |
| NCT00121992 (8) [back to overview] | Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup |
| NCT00121992 (8) [back to overview] | Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup |
| NCT00121992 (8) [back to overview] | Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup |
| NCT00121992 (8) [back to overview] | Best Score During Study for Global Health Status Scale |
| NCT00126191 (2) [back to overview] | Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt |
| NCT00126191 (2) [back to overview] | Disease Free Survival |
| NCT00129376 (3) [back to overview] | Pathological Complete Response (pCR) Rate |
| NCT00129376 (3) [back to overview] | Number of Participants With Over-expression of Survivin (>1% Cells With Nuclear Staining) |
| NCT00129376 (3) [back to overview] | Number of Participants With Over-expression of p27 (>75% Cells With Nuclear Staining) |
| NCT00129389 (2) [back to overview] | Disease-free Survival (DFS) Event |
| NCT00129389 (2) [back to overview] | Overall Survival (OS) Event |
| NCT00129935 (4) [back to overview] | Number of Participants With Overall Survival (OS) Event |
| NCT00129935 (4) [back to overview] | The Number of Participants Who Experienced Adverse Events (AE) |
| NCT00129935 (4) [back to overview] | Quality of Life Questionnaire: Time to Taking Off the Wig |
| NCT00129935 (4) [back to overview] | Number of Participants With Disease-free Survival (DFS) Event |
| NCT00132691 (17) [back to overview] | Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg |
| NCT00132691 (17) [back to overview] | Uveitis Activity |
| NCT00132691 (17) [back to overview] | Mortality |
| NCT00132691 (17) [back to overview] | Macular Edema |
| NCT00132691 (17) [back to overview] | Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up. |
| NCT00132691 (17) [back to overview] | Intraocular Pressure - IOP-lowering Surgery |
| NCT00132691 (17) [back to overview] | Cataract - Incident Cataract |
| NCT00132691 (17) [back to overview] | Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg |
| NCT00132691 (17) [back to overview] | Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline |
| NCT00132691 (17) [back to overview] | Change in SF-36 Mental Component Score From Baseline to 24 Months |
| NCT00132691 (17) [back to overview] | Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis |
| NCT00132691 (17) [back to overview] | Hyperlipidemia - Incident |
| NCT00132691 (17) [back to overview] | Diabetes Mellitus |
| NCT00132691 (17) [back to overview] | Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months |
| NCT00132691 (17) [back to overview] | Glaucoma - Incident |
| NCT00132691 (17) [back to overview] | Change in SF-36 Physical Component Score From Baseline to 24 Months |
| NCT00132691 (17) [back to overview] | Hypertension Diagnosis Requiring Treatment |
| NCT00133991 (5) [back to overview] | Relapse Pattern |
| NCT00133991 (5) [back to overview] | Overall Survival |
| NCT00133991 (5) [back to overview] | Overall Response Rate |
| NCT00133991 (5) [back to overview] | Event-free Survival |
| NCT00133991 (5) [back to overview] | Percentage of Participants Experiencing Grade 3-5 Toxicity |
| NCT00134004 (5) [back to overview] | Progression-free Survival |
| NCT00134004 (5) [back to overview] | Relapse Rate |
| NCT00134004 (5) [back to overview] | Transplant-related Mortality |
| NCT00134004 (5) [back to overview] | Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation |
| NCT00134004 (5) [back to overview] | Graft Failure Rate |
| NCT00134017 (5) [back to overview] | Relapse |
| NCT00134017 (5) [back to overview] | Days to Engraftment |
| NCT00134017 (5) [back to overview] | Non-relapse Mortality |
| NCT00134017 (5) [back to overview] | Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD) |
| NCT00134017 (5) [back to overview] | Chimerism |
| NCT00134082 (3) [back to overview] | Survival |
| NCT00134082 (3) [back to overview] | Number of Participants With Grade 3-5 Adverse Events |
| NCT00134082 (3) [back to overview] | Days to Neutrophil and Platelet Engraftment |
| NCT00136084 (7) [back to overview] | To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy |
| NCT00136084 (7) [back to overview] | To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy |
| NCT00136084 (7) [back to overview] | Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) |
| NCT00136084 (7) [back to overview] | Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO |
| NCT00136084 (7) [back to overview] | Minimal Residual Disease (MRD). |
| NCT00136084 (7) [back to overview] | Relationship of Inhibition of DNA Synthesis and Clinical Response |
| NCT00136084 (7) [back to overview] | Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. |
| NCT00137111 (7) [back to overview] | Minimal Residual Disease (MRD) |
| NCT00137111 (7) [back to overview] | Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells |
| NCT00137111 (7) [back to overview] | Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells |
| NCT00137111 (7) [back to overview] | Overall Event-free Survival (EFS) |
| NCT00137111 (7) [back to overview] | Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) |
| NCT00137111 (7) [back to overview] | Continuous Complete Remission Since Week 56 Therapy. |
| NCT00137111 (7) [back to overview] | Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). |
| NCT00145626 (13) [back to overview] | Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation |
| NCT00145626 (13) [back to overview] | Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD) |
| NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Median Age of Donor at HSCT |
| NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Median Dose of CD34 |
| NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Median Dose of NK Cells |
| NCT00145626 (13) [back to overview] | Number of Transplant-Related Adverse Outcomes: Engraftment Failure |
| NCT00145626 (13) [back to overview] | Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality |
| NCT00145626 (13) [back to overview] | One-year Survival |
| NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Disease Status at HSCT |
| NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Donor Type |
| NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Match N/6 HLA Loci |
| NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Minimal Residual Disease (MRD) |
| NCT00145626 (13) [back to overview] | Kinetics of Lymphohematopoietic Reconstitution |
| NCT00149214 (5) [back to overview] | Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery |
| NCT00149214 (5) [back to overview] | Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy |
| NCT00149214 (5) [back to overview] | Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy |
| NCT00149214 (5) [back to overview] | Number of Participants With a Pathological Complete Response |
| NCT00149214 (5) [back to overview] | Disease-free Survival |
| NCT00151281 (4) [back to overview] | Dynamic Levels of Plasma VEGF |
| NCT00151281 (4) [back to overview] | Overall Survival and Progression Free Survival |
| NCT00151281 (4) [back to overview] | Asses the Toxicity Profiles |
| NCT00151281 (4) [back to overview] | The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment |
| NCT00157196 (3) [back to overview] | Survival Time |
| NCT00157196 (3) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs) |
| NCT00157196 (3) [back to overview] | Progression Free Survival (PFS) Time |
| NCT00157209 (5) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4 |
| NCT00157209 (5) [back to overview] | Number of Participants With Elevated CA27-29 Antigen Levels |
| NCT00157209 (5) [back to overview] | Overall Survival Time |
| NCT00157209 (5) [back to overview] | Number of Participants With Positive T-cell Proliferation |
| NCT00157209 (5) [back to overview] | Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score |
| NCT00167180 (5) [back to overview] | Number of Patients Alive Without Disease |
| NCT00167180 (5) [back to overview] | Number of Patients Alive |
| NCT00167180 (5) [back to overview] | Number of Participants With Complete Remission |
| NCT00167180 (5) [back to overview] | Number of Patients With Acute Graft-Versus-Host Disease |
| NCT00167180 (5) [back to overview] | Number of Patients With Bone Marrow Aplasia |
| NCT00167206 (9) [back to overview] | Number of Patients Who Exhibited Secondary Graft Failure |
| NCT00167206 (9) [back to overview] | Number of Patients With Chronic Graft Versus-Host Disease (GVHD) |
| NCT00167206 (9) [back to overview] | Number of Patients With Acute Graft Versus-Host Disease (aGVHD) |
| NCT00167206 (9) [back to overview] | Number of Patients Who Exhibited Regimen-related Toxicity (RRT) |
| NCT00167206 (9) [back to overview] | Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment |
| NCT00167206 (9) [back to overview] | Number of Patients Alive at 2 Years |
| NCT00167206 (9) [back to overview] | Immune Reconstitution - Mean Value (2 Years) |
| NCT00167206 (9) [back to overview] | Number of Patients Alive at 1 Year |
| NCT00167206 (9) [back to overview] | Immune Reconstitution - Mean Value (1 Year) |
| NCT00176462 (1) [back to overview] | Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years |
| NCT00176605 (2) [back to overview] | Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer. |
| NCT00176605 (2) [back to overview] | PSA Response Rate |
| NCT00176839 (6) [back to overview] | Probability of Long-term Disease-free Survival (DFS) |
| NCT00176839 (6) [back to overview] | Incidence Chronic Graft-versus-host Disease (GVHD) |
| NCT00176839 (6) [back to overview] | Incidence of Acute Graft-versus-host Disease (GVHD) |
| NCT00176839 (6) [back to overview] | Incidence of Regimen-related Toxicity 100 Days Post Transplant |
| NCT00176839 (6) [back to overview] | Incidence of Relapse |
| NCT00176839 (6) [back to overview] | Probability of Engraftment |
| NCT00176852 (15) [back to overview] | Number of Patients Who Experienced Grade 3-5 Treatment Related Toxicity |
| NCT00176852 (15) [back to overview] | Disease Free Survival |
| NCT00176852 (15) [back to overview] | Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment |
| NCT00176852 (15) [back to overview] | Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment |
| NCT00176852 (15) [back to overview] | The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD) |
| NCT00176852 (15) [back to overview] | The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD) |
| NCT00176852 (15) [back to overview] | The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD) |
| NCT00176852 (15) [back to overview] | The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD) |
| NCT00176852 (15) [back to overview] | Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment |
| NCT00176852 (15) [back to overview] | The Incidence of Chimerism at 6 Months |
| NCT00176852 (15) [back to overview] | The Incidence of Chimerism at 100 Days |
| NCT00176852 (15) [back to overview] | The Incidence of Chimerism at 1 Year |
| NCT00176852 (15) [back to overview] | Overall Survival |
| NCT00176852 (15) [back to overview] | Overall Survival |
| NCT00176852 (15) [back to overview] | Disease Free Survival |
| NCT00176904 (5) [back to overview] | Number of Patients With Grade II-IV Acute Graft-Versus-Host Disease |
| NCT00176904 (5) [back to overview] | Number of Patients With Chronic Graft-Versus-Host Disease |
| NCT00176904 (5) [back to overview] | Overall Survival |
| NCT00176904 (5) [back to overview] | Overall Donor Engraftment |
| NCT00176904 (5) [back to overview] | Number of Patients With Grade III-IV Acute Graft-Versus-Host Disease |
| NCT00176917 (4) [back to overview] | Number of Patients Surviving on Study |
| NCT00176917 (4) [back to overview] | Number of Patients Who Failed Engraftment. |
| NCT00176917 (4) [back to overview] | Number of Patients With Grade III-IV Acute Graft-versus-host Disease (aGVHD). |
| NCT00176917 (4) [back to overview] | Mean Percentage of Donor Cells in Study Population (Chimerism). |
| NCT00176930 (10) [back to overview] | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant |
| NCT00176930 (10) [back to overview] | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant |
| NCT00176930 (10) [back to overview] | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant |
| NCT00176930 (10) [back to overview] | Number of Participants Who Were Alive at 5 Year Post Transplant |
| NCT00176930 (10) [back to overview] | Number of Participants With Neutrophil Engraftment |
| NCT00176930 (10) [back to overview] | Number of Participants With Chronic Graft-Versus-Host Disease |
| NCT00176930 (10) [back to overview] | Number of Participants With Acute Graft-versus-host Disease (GVHD) |
| NCT00176930 (10) [back to overview] | Number of Participants Who Were Alive at 2 Year Post Transplant |
| NCT00176930 (10) [back to overview] | Number of Participants Experiencing Engraftment Failure |
| NCT00176930 (10) [back to overview] | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant |
| NCT00177047 (17) [back to overview] | Time to Progression |
| NCT00177047 (17) [back to overview] | Time to Attainment of CR+PR |
| NCT00177047 (17) [back to overview] | Time to Attainment of CR |
| NCT00177047 (17) [back to overview] | Number of Participants With Toxicities |
| NCT00177047 (17) [back to overview] | Number of Participants With Overall Survival |
| NCT00177047 (17) [back to overview] | Number of Participants With Overall Survival |
| NCT00177047 (17) [back to overview] | Number of Participants With Overall Survival |
| NCT00177047 (17) [back to overview] | Number of Participants With Infections |
| NCT00177047 (17) [back to overview] | Number of Participants With Disease Progression |
| NCT00177047 (17) [back to overview] | Number of Participants With Absolute Neutrophil Recovery |
| NCT00177047 (17) [back to overview] | Number of Patients With Extended Disease-free Survival |
| NCT00177047 (17) [back to overview] | Number of Participants Experiencing Incidence of Relapse |
| NCT00177047 (17) [back to overview] | Number of Participants Achieving a Complete Response |
| NCT00177047 (17) [back to overview] | Number of Participants Achieving a Complete Response |
| NCT00177047 (17) [back to overview] | Number of Participants Achieving a Complete Response |
| NCT00177047 (17) [back to overview] | Count of Participants Experiencing Transplant Related Mortality |
| NCT00177047 (17) [back to overview] | Time to Relapse |
| NCT00182793 (2) [back to overview] | 5-Year Overall Survival Rate |
| NCT00182793 (2) [back to overview] | 5-Year Relapse-free Survival Rate |
| NCT00184002 (2) [back to overview] | Percentage of Patients With Complete Response to the Combination Chemotherapy |
| NCT00184002 (2) [back to overview] | Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability |
| NCT00185614 (4) [back to overview] | Relapse Rate |
| NCT00185614 (4) [back to overview] | Overall Survival (OS) |
| NCT00185614 (4) [back to overview] | Event-free Survival (EFS) |
| NCT00185614 (4) [back to overview] | Acute Graft-vs-Host-Disease (aGvHD) |
| NCT00186875 (4) [back to overview] | Overall Survival (OS) |
| NCT00186875 (4) [back to overview] | Response Rate |
| NCT00186875 (4) [back to overview] | Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111) |
| NCT00186875 (4) [back to overview] | Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111) |
| NCT00186888 (27) [back to overview] | Mean Primary Visual Cortex Function: Maximum T-value |
| NCT00186888 (27) [back to overview] | Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification |
| NCT00186888 (27) [back to overview] | Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment |
| NCT00186888 (27) [back to overview] | Ocular Survival of Eyes of Stratum B Patients |
| NCT00186888 (27) [back to overview] | Assessment of School Readiness |
| NCT00186888 (27) [back to overview] | Ocular Survival of Stratum A Patients |
| NCT00186888 (27) [back to overview] | Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification |
| NCT00186888 (27) [back to overview] | Change in Cognitive Functioning |
| NCT00186888 (27) [back to overview] | Change in Parent Report of Social-Emotional Factors |
| NCT00186888 (27) [back to overview] | Event-free Survival of Stratum A Patients |
| NCT00186888 (27) [back to overview] | Change in Relevant Daily Living Skills |
| NCT00186888 (27) [back to overview] | Ocular Survival of Stratum B Patients Responding to Window Treatment |
| NCT00186888 (27) [back to overview] | Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification |
| NCT00186888 (27) [back to overview] | Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants. |
| NCT00186888 (27) [back to overview] | Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification |
| NCT00186888 (27) [back to overview] | Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment |
| NCT00186888 (27) [back to overview] | Change in Distortion Product Otoacoustic Emissions (DPOAEs) |
| NCT00186888 (27) [back to overview] | Change in Parenting Stress Index (PSI) |
| NCT00186888 (27) [back to overview] | Number of Participants With Change in Size of Pineal Gland |
| NCT00186888 (27) [back to overview] | Number of Participants With Development of Pineal Cysts |
| NCT00186888 (27) [back to overview] | Number of Patients Recommended for and Utilizing Rehabilitation Services |
| NCT00186888 (27) [back to overview] | Stratum B Response Rate of Early Stage Eyes to Window Therapy |
| NCT00186888 (27) [back to overview] | Event-free Survival of Eyes of Stratum B Patients |
| NCT00186888 (27) [back to overview] | Stratum B Response to Window Therapy |
| NCT00186888 (27) [back to overview] | Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants. |
| NCT00186888 (27) [back to overview] | Event-free Survival of Stratum B Patients Responding to Window Treatment |
| NCT00186888 (27) [back to overview] | Mean Primary Visual Cortex Function: Cluster Size |
| NCT00187096 (10) [back to overview] | Day That Maximum NK Cell Engraftment Was Reached |
| NCT00187096 (10) [back to overview] | Duration of Engraftment of Natural Killer (NK) Cells |
| NCT00187096 (10) [back to overview] | Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant |
| NCT00187096 (10) [back to overview] | Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562) |
| NCT00187096 (10) [back to overview] | Percent of Peak NK Cell Chimerism |
| NCT00187096 (10) [back to overview] | Relapse-free Survival |
| NCT00187096 (10) [back to overview] | Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant |
| NCT00187096 (10) [back to overview] | Number of KIR-mismatched NK Cells |
| NCT00187096 (10) [back to overview] | Percent of Detectable Donor NK Cells at Day 28 |
| NCT00187096 (10) [back to overview] | Overall Survival |
| NCT00190671 (8) [back to overview] | Pharmacokinetics - Half-Life (t½) |
| NCT00190671 (8) [back to overview] | Best Tumor Response |
| NCT00190671 (8) [back to overview] | Pharmacokinetics - Volume of Distribution |
| NCT00190671 (8) [back to overview] | Pharmacokinetics - Area Under the Curve (AUC) |
| NCT00190671 (8) [back to overview] | Pharmacokinetics - Maximum Observed Drug Concentration (Cmax) |
| NCT00190671 (8) [back to overview] | Progression Free Survival |
| NCT00190671 (8) [back to overview] | Time to Progressive Disease |
| NCT00190671 (8) [back to overview] | Pharmacokinetics - Clearance (CL) |
| NCT00193479 (1) [back to overview] | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
| NCT00194779 (6) [back to overview] | Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy |
| NCT00194779 (6) [back to overview] | Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation |
| NCT00194779 (6) [back to overview] | Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR) |
| NCT00194779 (6) [back to overview] | Disease-free Survival |
| NCT00194779 (6) [back to overview] | OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN |
| NCT00194779 (6) [back to overview] | Time to Progression |
| NCT00203502 (5) [back to overview] | Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer |
| NCT00203502 (5) [back to overview] | Percentage of Participants With Pathological Complete Response. |
| NCT00203502 (5) [back to overview] | To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline |
| NCT00203502 (5) [back to overview] | Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab. |
| NCT00203502 (5) [back to overview] | Percentage of Participants With Grade 3 or 4 Adverse Events |
| NCT00206518 (3) [back to overview] | Overall Survival |
| NCT00206518 (3) [back to overview] | Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC) |
| NCT00206518 (3) [back to overview] | Disease Relapse |
| NCT00208975 (1) [back to overview] | Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. |
| NCT00210470 (8) [back to overview] | Patient Tolerance of Surgery and Post-operative Adjuvant Therapy; |
| NCT00210470 (8) [back to overview] | Overall Survival |
| NCT00210470 (8) [back to overview] | Number of Participants With Adverse Events and Serious Adverse Events |
| NCT00210470 (8) [back to overview] | Immune Competence as Measured by Skin Test Reactivity |
| NCT00210470 (8) [back to overview] | Disease-free Survival |
| NCT00210470 (8) [back to overview] | Clinical and Histological Tumor Responses |
| NCT00210470 (8) [back to overview] | Relationship Between Overall Survival (OS) and Immune Competence (Lymphocyte Infiltration, LI) in Participants With High LI and Low LI |
| NCT00210470 (8) [back to overview] | Number of Participants With High Lymphocyte Infiltration (LI) According to the Visual Analog Scale (VAS) |
| NCT00211185 (9) [back to overview] | Duration of Response |
| NCT00211185 (9) [back to overview] | Overall Response in the Efficacy Analyzable (EA) Population |
| NCT00211185 (9) [back to overview] | Overall Response in the Intent To Treat (ITT) Population |
| NCT00211185 (9) [back to overview] | Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants |
| NCT00211185 (9) [back to overview] | Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events |
| NCT00211185 (9) [back to overview] | Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class |
| NCT00211185 (9) [back to overview] | Percentage of Participants With Overall Survival |
| NCT00211185 (9) [back to overview] | Progression-Free Survival |
| NCT00211185 (9) [back to overview] | Summary of All Treatment-Related Adverse Events by Frequency in Greater Than 10% of Treated Participants |
| NCT00217425 (3) [back to overview] | Overall Response Rate |
| NCT00217425 (3) [back to overview] | 3-Year Overall Survival |
| NCT00217425 (3) [back to overview] | 12-Month Progression-Free Survival (PFS) |
| NCT00230282 (2) [back to overview] | Duration of Response |
| NCT00230282 (2) [back to overview] | Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR) |
| NCT00233987 (4) [back to overview] | 2-year Progression-free Survival |
| NCT00233987 (4) [back to overview] | Response Rate |
| NCT00233987 (4) [back to overview] | Overall Survival |
| NCT00233987 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00254163 (9) [back to overview] | Progression-free Survival (PFS) Rate at 2-year |
| NCT00254163 (9) [back to overview] | Infective Event Rate |
| NCT00254163 (9) [back to overview] | Infection Rate |
| NCT00254163 (9) [back to overview] | Complete Remission (CR) |
| NCT00254163 (9) [back to overview] | Hematologic Recovery |
| NCT00254163 (9) [back to overview] | Mean Absolute Neutrophil Count (ANC) at Post-treatment |
| NCT00254163 (9) [back to overview] | Objective Remission Rate (ORR) |
| NCT00254163 (9) [back to overview] | Percentage of Patients Hospitalized |
| NCT00254163 (9) [back to overview] | Progression-free Survival (PFS) Rate at 1-year |
| NCT00254410 (4) [back to overview] | Molecular Response Rate at 6 Months |
| NCT00254410 (4) [back to overview] | Clinical Response Rate at 6 Months |
| NCT00254410 (4) [back to overview] | Molecular Response Rate at 3 Months |
| NCT00254410 (4) [back to overview] | Clinical Response Rate at 3 Months |
| NCT00254592 (1) [back to overview] | Overall Clinical Response to the Dose Dense Regimen |
| NCT00255684 (2) [back to overview] | Number of Participants Who Developed Acute Graft Versus Host Disease |
| NCT00255684 (2) [back to overview] | Number of Participants Who Survived 100 Days or Longer |
| NCT00256243 (2) [back to overview] | Clinical Response Rate |
| NCT00256243 (2) [back to overview] | Microscopic Pathological Response Rate |
| NCT00258180 (2) [back to overview] | Number of Participants Experiencing Intervention-related Adverse Events, as Defined by CTCAE at 1 Month |
| NCT00258180 (2) [back to overview] | Number of Participants With Treatment-free Remission at 1 Year After Study Completion |
| NCT00258206 (1) [back to overview] | Event-free Survival |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Acute Graft-Versus-Host Disease |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Relapse |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Overall Survival |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Major Infections |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Graft Failure |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Chronic Graft-Versus-Host Disease |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Chronic Graft-Versus-Host Disease |
| NCT00258427 (8) [back to overview] | Number of Participants Experiencing Acute Graft-Versus-Host Disease |
| NCT00258960 (5) [back to overview] | Overall Survival (OS) |
| NCT00258960 (5) [back to overview] | Response Duration |
| NCT00258960 (5) [back to overview] | Time to Treatment Failure (TTF) |
| NCT00258960 (5) [back to overview] | Objective Response Rate (ORR) |
| NCT00258960 (5) [back to overview] | Time to Progression (TTP) |
| NCT00265889 (3) [back to overview] | Response Rate |
| NCT00265889 (3) [back to overview] | Progression-free Survival |
| NCT00265889 (3) [back to overview] | Number of Patients That Experience Pulmonary Toxicity |
| NCT00270894 (7) [back to overview] | Left Ventricular Ejection Fraction (LVEF) |
| NCT00270894 (7) [back to overview] | Clinical Response Prior to Surgery |
| NCT00270894 (7) [back to overview] | Overall Survival (OS) |
| NCT00270894 (7) [back to overview] | Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule |
| NCT00270894 (7) [back to overview] | Pathologic Response |
| NCT00270894 (7) [back to overview] | Progression-free Survival (PFS) |
| NCT00270894 (7) [back to overview] | Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities |
| NCT00274846 (4) [back to overview] | Median Time to Disease Relapse (Months) |
| NCT00274846 (4) [back to overview] | Overall Survival Time of Patients With Complete Remission |
| NCT00274846 (4) [back to overview] | Number of Patients With Complete Remission |
| NCT00274846 (4) [back to overview] | Number of Patients With Natural Killer (NK) Cell Expansion |
| NCT00274924 (2) [back to overview] | 5-year Overall Survival |
| NCT00274924 (2) [back to overview] | 2-year Progression-Free Survival (PFS) |
| NCT00278109 (1) [back to overview] | Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity |
| NCT00278161 (3) [back to overview] | Non-relapse Mortality |
| NCT00278161 (3) [back to overview] | Engraftment |
| NCT00278161 (3) [back to overview] | Event-free Survival |
| NCT00278512 (1) [back to overview] | Survival |
| NCT00278564 (1) [back to overview] | Survival |
| NCT00280241 (4) [back to overview] | Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL |
| NCT00280241 (4) [back to overview] | Overall Survival Rate |
| NCT00280241 (4) [back to overview] | Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL |
| NCT00280241 (4) [back to overview] | Duration of Response |
| NCT00281918 (11) [back to overview] | Event-free Survival (EFS) |
| NCT00281918 (11) [back to overview] | Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL) |
| NCT00281918 (11) [back to overview] | Final Analysis: Time to Overall Survival Event |
| NCT00281918 (11) [back to overview] | Final Analysis: Time to Progression-free Survival Event |
| NCT00281918 (11) [back to overview] | Overall Survival (OS) |
| NCT00281918 (11) [back to overview] | Progression-free Survival (PFS) |
| NCT00281918 (11) [back to overview] | Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). |
| NCT00281918 (11) [back to overview] | Final Analysis: Duration of Response |
| NCT00281918 (11) [back to overview] | Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR) |
| NCT00281918 (11) [back to overview] | Final Analysis: Time to Event-free Survival Event |
| NCT00281918 (11) [back to overview] | Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response |
| NCT00282412 (1) [back to overview] | Survival |
| NCT00290433 (1) [back to overview] | 3 Year Progression-Free Survival Rate |
| NCT00290498 (2) [back to overview] | Response Rate R-HCVAD vs. R-CHOP |
| NCT00290498 (2) [back to overview] | Progression Free Survival (Rate) |
| NCT00293384 (4) [back to overview] | Toxicity Grade 3, 4, or 5 |
| NCT00293384 (4) [back to overview] | Proportion of Participants With Controlled Acute Vomiting |
| NCT00293384 (4) [back to overview] | Overall Nausea Controlled |
| NCT00293384 (4) [back to overview] | Delayed Vomiting Controlled |
| NCT00295893 (2) [back to overview] | Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1. |
| NCT00295893 (2) [back to overview] | Count of Patients With Pathologic Complete Response (pCR) |
| NCT00295932 (2) [back to overview] | Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma |
| NCT00295932 (2) [back to overview] | Maximum Tolerated Dose |
| NCT00299182 (2) [back to overview] | Days Platelets Count of < 100K/μL |
| NCT00299182 (2) [back to overview] | Platelet (PLT) Nadir |
| NCT00301821 (4) [back to overview] | Overall Survival |
| NCT00301821 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT00301821 (4) [back to overview] | Event-free Survival After 12 Months |
| NCT00301821 (4) [back to overview] | Overall Response Rate (ORR) |
| NCT00302003 (4) [back to overview] | Overall Survival |
| NCT00302003 (4) [back to overview] | Intensive Therapy Free Survival (ITFS). |
| NCT00302003 (4) [back to overview] | Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). |
| NCT00302003 (4) [back to overview] | Event Free Survival (EFS) |
| NCT00303667 (9) [back to overview] | Incidence of Post-transplant Lymphoproliferative Disorder (PTLD) |
| NCT00303667 (9) [back to overview] | Incidence of Grade III-IV Acute Graft Versus Host Disease |
| NCT00303667 (9) [back to overview] | Number of Patients With Treatment-Related Mortality |
| NCT00303667 (9) [back to overview] | Incidence of Chronic Graft Versus Host Disease |
| NCT00303667 (9) [back to overview] | In Vivo Expansion of a Donor NK Cells NK Cell Product |
| NCT00303667 (9) [back to overview] | Disease-free Survival at 1 Year |
| NCT00303667 (9) [back to overview] | Disease-free Survival at 6 Months |
| NCT00303667 (9) [back to overview] | Number of Patients With Disease Relapse |
| NCT00303667 (9) [back to overview] | Number of Patients With Graft Failure |
| NCT00303719 (5) [back to overview] | Overall Survival |
| NCT00303719 (5) [back to overview] | Neutrophil and Donor Cell Engraftment |
| NCT00303719 (5) [back to overview] | Acute Graft-Versus-Host Disease |
| NCT00303719 (5) [back to overview] | Serious Adverse Events |
| NCT00303719 (5) [back to overview] | Transplant Related Mortality |
| NCT00305682 (15) [back to overview] | Number of Participants Who Were Alive at 1 Year Post Transplant |
| NCT00305682 (15) [back to overview] | Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years |
| NCT00305682 (15) [back to overview] | Number of Participants Experiencing Relapse (Incidence of Relapse) |
| NCT00305682 (15) [back to overview] | Number of Participants Experiencing Progression-free Survival at 2 Years |
| NCT00305682 (15) [back to overview] | Number of Participants Experiencing Progression-free Survival |
| NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 180 Days |
| NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 365 Days |
| NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 21 Days |
| NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 100 Days |
| NCT00305682 (15) [back to overview] | Number of Participants With Platelet Engraftment |
| NCT00305682 (15) [back to overview] | Number of Participants With Neutrophil Engraftment |
| NCT00305682 (15) [back to overview] | Number of Participants With Chronic Graft-Versus-Host Disease |
| NCT00305682 (15) [back to overview] | Number of Participants With Acute Graft-versus-host Disease (GVHD) |
| NCT00305682 (15) [back to overview] | Number of Participants Who Were Dead at 6 Months After Study Completion |
| NCT00305682 (15) [back to overview] | Number of Participants Who Were Alive at 2 Years Post Transplant |
| NCT00305760 (1) [back to overview] | Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population |
| NCT00309842 (11) [back to overview] | Number of Participants With Platelet Engraftment |
| NCT00309842 (11) [back to overview] | Number of Participants With Chronic Graft-Versus-Host Disease |
| NCT00309842 (11) [back to overview] | Percentage Chimerism at 6 Months |
| NCT00309842 (11) [back to overview] | Percentage Chimerism at 2 Years |
| NCT00309842 (11) [back to overview] | Percentage Chimerism at 1 Year |
| NCT00309842 (11) [back to overview] | Number of Participants With Neutrophil Engraftment |
| NCT00309842 (11) [back to overview] | Percentage Chimerism on Day 100 |
| NCT00309842 (11) [back to overview] | Number of Participants Who Died Due to Transplant |
| NCT00309842 (11) [back to overview] | Number of Participants Who Were Alive at 1 Year Transplant Overall Survival |
| NCT00309842 (11) [back to overview] | Percentage Chimerism on Day 21 |
| NCT00309842 (11) [back to overview] | Number of Participants With Acute Graft-Versus-Host Disease |
| NCT00312208 (2) [back to overview] | Death From Any Cause (Overall Survival) |
| NCT00312208 (2) [back to overview] | Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) |
| NCT00314106 (2) [back to overview] | Complete Response |
| NCT00314106 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00315705 (16) [back to overview] | Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1 |
| NCT00315705 (16) [back to overview] | Time to Remission for Participants Who Had a Response in Phase 2 |
| NCT00315705 (16) [back to overview] | Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1 |
| NCT00315705 (16) [back to overview] | Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2 |
| NCT00315705 (16) [back to overview] | Summary of Participants With Adverse Events (AEs) in Phase 1 |
| NCT00315705 (16) [back to overview] | Summary of Participants With Adverse Events (AEs) in Phase 2 |
| NCT00315705 (16) [back to overview] | Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1 |
| NCT00315705 (16) [back to overview] | Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2 |
| NCT00315705 (16) [back to overview] | Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2 |
| NCT00315705 (16) [back to overview] | Maximum Tolerated Dose (MTD) in Phase 1 |
| NCT00315705 (16) [back to overview] | Number of Participants With 4-month Event Free Survival in Phase 1 |
| NCT00315705 (16) [back to overview] | Number of Participants With 4-month Event Free Survival in Phase 2 |
| NCT00315705 (16) [back to overview] | Participants With Dose Limiting Toxicity in Phase 1 |
| NCT00315705 (16) [back to overview] | Time to Remission for Participants Who Had a Response in Phase 1 |
| NCT00315705 (16) [back to overview] | Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1 |
| NCT00315705 (16) [back to overview] | Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2 |
| NCT00322101 (6) [back to overview] | Donor Cell Engraftment |
| NCT00322101 (6) [back to overview] | Incidence and Severity of Acute and Chronic Graft-vs-host Disease |
| NCT00322101 (6) [back to overview] | Overall Survival |
| NCT00322101 (6) [back to overview] | Non-relapse Mortality |
| NCT00322101 (6) [back to overview] | Progression-free Survival |
| NCT00322101 (6) [back to overview] | Incidence of Disease Progression/Relapse |
| NCT00326417 (5) [back to overview] | Overall Survival (OS) |
| NCT00326417 (5) [back to overview] | Disease-free Survival (DFS) |
| NCT00326417 (5) [back to overview] | Chronic GVHD |
| NCT00326417 (5) [back to overview] | Acute Graft vs Host Disease (GVHD) |
| NCT00326417 (5) [back to overview] | Cumulative Incidence of Graft Failure |
| NCT00328861 (2) [back to overview] | Objective Response |
| NCT00328861 (2) [back to overview] | Safety |
| NCT00331552 (8) [back to overview] | Time to Progression (Phase II) |
| NCT00331552 (8) [back to overview] | Comparison of Clinical Benefit Rate in 2 Subgroups--heavily Pre-treated (1 or More Regimens for Advanced Disease) vs Less Heavily Pre-treated (no Regimens for Advanced Disease) (Phase II) |
| NCT00331552 (8) [back to overview] | Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I) |
| NCT00331552 (8) [back to overview] | Overall Survival (Phase II) |
| NCT00331552 (8) [back to overview] | Progression-free Survival (Phase II) |
| NCT00331552 (8) [back to overview] | Treatment-related Toxicity (Phase I) |
| NCT00331552 (8) [back to overview] | Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation |
| NCT00331552 (8) [back to overview] | Efficacy as Assessed by the Overall Clinical Benefit Rate |
| NCT00335556 (6) [back to overview] | Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors |
| NCT00335556 (6) [back to overview] | Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization |
| NCT00335556 (6) [back to overview] | Response Rate |
| NCT00335556 (6) [back to overview] | Toxicity Rate |
| NCT00335556 (6) [back to overview] | Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT) |
| NCT00335556 (6) [back to overview] | Event Free Survival Probability |
| NCT00336024 (10) [back to overview] | Number of Participants With Chronic Central Hypothyroidism |
| NCT00336024 (10) [back to overview] | Number of Participants With Chronic Diabetes Insipidus |
| NCT00336024 (10) [back to overview] | Number of Participants With Chronic Low Somatomedin C |
| NCT00336024 (10) [back to overview] | Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism |
| NCT00336024 (10) [back to overview] | Number of Participants With Secondary Malignancies |
| NCT00336024 (10) [back to overview] | Percentage of Participants With Any Acute Adverse Events |
| NCT00336024 (10) [back to overview] | Percentage of Participants With Event Free Survival (EFS) |
| NCT00336024 (10) [back to overview] | Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI). |
| NCT00336024 (10) [back to overview] | Rates of Gastrointestinal Toxicities |
| NCT00336024 (10) [back to overview] | Rates of Nutritional Toxicities |
| NCT00337987 (2) [back to overview] | Number of Patients That Achieved a Complete Response or a Partial Response (PR) |
| NCT00337987 (2) [back to overview] | Number of Patients That Achieved a Complete Response (CR) |
| NCT00343785 (3) [back to overview] | Incidence of Chronic GVHD |
| NCT00343785 (3) [back to overview] | Number of Days to Neutrophil Recovery to >500/uL |
| NCT00343785 (3) [back to overview] | Overall Survival |
| NCT00343863 (8) [back to overview] | Count of Patients Achieving Complete Response |
| NCT00343863 (8) [back to overview] | Number of Participants That Had Emesis Within 48 Hours of Chemotherapy |
| NCT00343863 (8) [back to overview] | Number of Participants That Had First Administration of Rescue Medication Within 48 Hours |
| NCT00343863 (8) [back to overview] | Severity of Nausea |
| NCT00343863 (8) [back to overview] | Number of Days With Emetic Episodes and Rescue Medicines |
| NCT00343863 (8) [back to overview] | Side Effects of Antiemetic Medications Used |
| NCT00343863 (8) [back to overview] | Quality of Life |
| NCT00343863 (8) [back to overview] | Count of Patients Achieving a Complete Response |
| NCT00345865 (5) [back to overview] | Number of Participants With 2 Years Progression Free Survival |
| NCT00345865 (5) [back to overview] | Number of Participants With 1 Year Progression Free Survival |
| NCT00345865 (5) [back to overview] | Number of Participants With 2 Years Overall Survival |
| NCT00345865 (5) [back to overview] | Number of Participants With Hematopoietic Recovery After Transplantation |
| NCT00345865 (5) [back to overview] | Number of Participants With 1 Year Overall Survival |
| NCT00349778 (3) [back to overview] | Number of Participants That Relapse After Autologous Transplantation |
| NCT00349778 (3) [back to overview] | Number of Participants With Pulmonary Toxicity |
| NCT00349778 (3) [back to overview] | Overall Participant Survival (OS) |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Worry |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0: Total Score |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), Symptom Distress Scale |
| NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Age |
| NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram) |
| NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram) |
| NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function) |
| NCT00352027 (76) [back to overview] | Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) |
| NCT00352027 (76) [back to overview] | Local and Distant Failure for Children Treated With Tailored-field Radiation |
| NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Gender |
| NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Histology |
| NCT00352027 (76) [back to overview] | Prognostic Factors for Treatment Failure: Stage |
| NCT00352027 (76) [back to overview] | Toxicities With Grade >1 |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning |
| NCT00352027 (76) [back to overview] | 3-year Event-free Survival (EFS) Probability |
| NCT00352027 (76) [back to overview] | 3-year Event-Free Survival Probability |
| NCT00352027 (76) [back to overview] | 3-year Local Failure-free Survival Probability |
| NCT00352027 (76) [back to overview] | 3-year Overall Survival (OS) Probability |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning |
| NCT00352027 (76) [back to overview] | Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning |
| NCT00352027 (76) [back to overview] | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score |
| NCT00352027 (76) [back to overview] | Disease Failure Rate Within Radiation Fields |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning |
| NCT00352027 (76) [back to overview] | Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Communication |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Nausea |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety |
| NCT00352027 (76) [back to overview] | Patient Quality of Life (QoL), PedsQL v.3.0: Total Score |
| NCT00352976 (18) [back to overview] | Average IgG Levels as a Measure of Immune Reconstitution After Transplant by 365 Days |
| NCT00352976 (18) [back to overview] | Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 365 Days |
| NCT00352976 (18) [back to overview] | Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 180 Days |
| NCT00352976 (18) [back to overview] | Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 100 Days |
| NCT00352976 (18) [back to overview] | Number of Participants Experiencing Chronic GVHD |
| NCT00352976 (18) [back to overview] | Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 180 Days |
| NCT00352976 (18) [back to overview] | Average IgG Levels as a Measure of Immune Reconstitution After Transplant, by 180 Days |
| NCT00352976 (18) [back to overview] | Number of Participants With Secondary Graft Failure at 100 Days |
| NCT00352976 (18) [back to overview] | Number of Participants Experiencing Overall Survival |
| NCT00352976 (18) [back to overview] | Number of Participants Experiencing Infections by Day 180 |
| NCT00352976 (18) [back to overview] | Number of Participants Experiencing Infections by Day 365 |
| NCT00352976 (18) [back to overview] | Number of Participants Experiencing Grade ≥3 Regimen Related Toxicity |
| NCT00352976 (18) [back to overview] | Number of Participants Experiencing Infections by Day 100 |
| NCT00352976 (18) [back to overview] | Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD) |
| NCT00352976 (18) [back to overview] | Number of Participant With Neutrophil Recovery |
| NCT00352976 (18) [back to overview] | Average Immunoglobulin G (IgG) Levels as a Measure of Immune Reconstitution After Transplant, by 100 Days |
| NCT00352976 (18) [back to overview] | Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 365 Days |
| NCT00352976 (18) [back to overview] | Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 100 Days |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Experienced Relapse by 24 Months |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) With Chronic Graft-Versus-Host Disease |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) With Successful Natural Killer Cell Expansion |
| NCT00354172 (15) [back to overview] | Number of Patients Who Were Disease-free and Alive at 24 Months |
| NCT00354172 (15) [back to overview] | Chimerism After Double Umbilical Cord Blood Transplant (UCBT) |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Attained Neutrophil Engraftment |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Attained Platelet Engraftment |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Died by 12 Months |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Died by 24 Months |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Died Due to Transplant. |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV |
| NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Experienced Relapse by 12 Months |
| NCT00354744 (3) [back to overview] | Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy |
| NCT00354744 (3) [back to overview] | Percentage of Patients Event Free at 4 Years Following Study Entry |
| NCT00354744 (3) [back to overview] | Number of Patients With Complete or Partial Response Assessed by RECIST Criteria |
| NCT00354835 (13) [back to overview] | Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype |
| NCT00354835 (13) [back to overview] | Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15 |
| NCT00354835 (13) [back to overview] | Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4 |
| NCT00354835 (13) [back to overview] | Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison |
| NCT00354835 (13) [back to overview] | Overall Survival (OS) |
| NCT00354835 (13) [back to overview] | Local Failure |
| NCT00354835 (13) [back to overview] | Incidence of Toxicity |
| NCT00354835 (13) [back to overview] | Incidence of Bladder Dysfunction |
| NCT00354835 (13) [back to overview] | Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison |
| NCT00354835 (13) [back to overview] | Event Free Survival (EFS) by PAX Status |
| NCT00354835 (13) [back to overview] | Response Rate (RR) |
| NCT00354835 (13) [back to overview] | Event Free Survival (EFS) |
| NCT00354835 (13) [back to overview] | Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC |
| NCT00357500 (4) [back to overview] | 27-Week Overall Survival |
| NCT00357500 (4) [back to overview] | 27-Week Progression-Free Survival |
| NCT00357500 (4) [back to overview] | Best Response |
| NCT00357500 (4) [back to overview] | Therapy Completion Rate |
| NCT00358657 (9) [back to overview] | Graft Failure |
| NCT00358657 (9) [back to overview] | Incidence of Grade I/II Acute Graft Versus Host Disease (GVHD) |
| NCT00358657 (9) [back to overview] | Incidence of Chronic GVHD |
| NCT00358657 (9) [back to overview] | Immune Reconstitution |
| NCT00358657 (9) [back to overview] | Graft Rejection |
| NCT00358657 (9) [back to overview] | Proportion of Patients Who Achieve Greater Than 5% Donor T-cell Chimerism |
| NCT00358657 (9) [back to overview] | Number of Patients With Transplant Related Mortality |
| NCT00358657 (9) [back to overview] | Number of Patients With Infections |
| NCT00358657 (9) [back to overview] | Incidence of Grade III/IV Acute Graft Versus Host Disease (GVHD) |
| NCT00365274 (1) [back to overview] | Objective Response Rate (ORR) |
| NCT00365365 (3) [back to overview] | Safety - Number of Participants With Adverse Events (AE) |
| NCT00365365 (3) [back to overview] | Disease-free Survival (DFS) Rate |
| NCT00365365 (3) [back to overview] | Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF) |
| NCT00365417 (8) [back to overview] | Reported Adverse Events |
| NCT00365417 (8) [back to overview] | Pathologic Complete Response (pCR) in the Breast |
| NCT00365417 (8) [back to overview] | pCR in the Breast and Nodes |
| NCT00365417 (8) [back to overview] | Overall Survival |
| NCT00365417 (8) [back to overview] | Progression-free Survival |
| NCT00365417 (8) [back to overview] | Number of Patients With at Least One Surgical Complications (Wound Dehiscence, Infection, Seroma, or Hematoma). |
| NCT00365417 (8) [back to overview] | Clinical Response Rate (cRR) of the Sequential Regimen |
| NCT00365417 (8) [back to overview] | Cardiac Events |
| NCT00368355 (3) [back to overview] | Severe GVHD Rate |
| NCT00368355 (3) [back to overview] | Early Post BMT Toxicities |
| NCT00368355 (3) [back to overview] | Engraftment Rate After Transplant |
| NCT00376805 (4) [back to overview] | Number of Patients Who Died While on Study |
| NCT00376805 (4) [back to overview] | Number of Patients Who Had Expansion of Natural Killer Cells |
| NCT00376805 (4) [back to overview] | Overall Median Number of Days Patients Alive After Treatment |
| NCT00376805 (4) [back to overview] | Number of Patients by Disease Response |
| NCT00376961 (4) [back to overview] | 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) |
| NCT00376961 (4) [back to overview] | 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) |
| NCT00376961 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00376961 (4) [back to overview] | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). |
| NCT00377637 (14) [back to overview] | Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval |
| NCT00377637 (14) [back to overview] | Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein |
| NCT00377637 (14) [back to overview] | Induction Phase: Change From Baseline to Week 24 in Serum Albumin |
| NCT00377637 (14) [back to overview] | Induction Phase: Change From Baseline to Week 24 in Serum Creatinine |
| NCT00377637 (14) [back to overview] | Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score |
| NCT00377637 (14) [back to overview] | Induction Phase: Number of Participants Achieving Complete Remission |
| NCT00377637 (14) [back to overview] | Induction Phase: Number of Patients Showing Treatment Response |
| NCT00377637 (14) [back to overview] | Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy |
| NCT00377637 (14) [back to overview] | Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD) |
| NCT00377637 (14) [back to overview] | Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine |
| NCT00377637 (14) [back to overview] | Maintenance Phase: Participants With Major Extra-renal Flare |
| NCT00377637 (14) [back to overview] | Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores |
| NCT00377637 (14) [back to overview] | Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval |
| NCT00377637 (14) [back to overview] | Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths |
| NCT00378534 (5) [back to overview] | Number of Participants Who Developed Limited Chronic GVHD |
| NCT00378534 (5) [back to overview] | Number of Participants Who Developed Acute GVHD Grades I, II, III, IV |
| NCT00378534 (5) [back to overview] | Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System |
| NCT00378534 (5) [back to overview] | Number of Participants With Relapse of Disease |
| NCT00378534 (5) [back to overview] | Number of Participants Who Develop Extensive GVHD |
| NCT00379340 (4) [back to overview] | Event Free Survival Probability |
| NCT00379340 (4) [back to overview] | Event Free Survival Probability |
| NCT00379340 (4) [back to overview] | Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease |
| NCT00379340 (4) [back to overview] | Event Free Survival (EFS) Probability |
| NCT00379574 (2) [back to overview] | Number of Patients Who Experienced Adverse Events |
| NCT00379574 (2) [back to overview] | Number of Patients Who Achieved Complete Response |
| NCT00381004 (3) [back to overview] | Number of Participants Progression-free |
| NCT00381004 (3) [back to overview] | Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. |
| NCT00381004 (3) [back to overview] | Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. |
| NCT00381680 (6) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 |
| NCT00381680 (6) [back to overview] | Event Free Survival. EFS |
| NCT00381680 (6) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 |
| NCT00381680 (6) [back to overview] | Adjusted Event Free Survival |
| NCT00381680 (6) [back to overview] | Event Free Survival (EFS) |
| NCT00381680 (6) [back to overview] | Frequency and Severity of Adverse Effects |
| NCT00382109 (6) [back to overview] | Estimated Percentage of Participants With Event Free Survival |
| NCT00382109 (6) [back to overview] | Estimated Rate of Acute Graft VS Host Disease (GVHD) |
| NCT00382109 (6) [back to overview] | Rate of Relapses |
| NCT00382109 (6) [back to overview] | Estimated Transplant Related Mortality Percentage |
| NCT00382109 (6) [back to overview] | Estimated Rate of Overall Chronic Graft VS Host Disease |
| NCT00382109 (6) [back to overview] | Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Post Transplantation (Correlating Development of aGVHD With Relapse) |
| NCT00387959 (1) [back to overview] | Survival at 1 Year After Transplantation |
| NCT00388349 (5) [back to overview] | Relapse Post-transplant |
| NCT00388349 (5) [back to overview] | Pulmonary Toxicity (BCNU Pneumonitis) |
| NCT00388349 (5) [back to overview] | Survival Measures |
| NCT00388349 (5) [back to overview] | Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity |
| NCT00388349 (5) [back to overview] | Overall Survival (OS) |
| NCT00389818 (1) [back to overview] | Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI . |
| NCT00392327 (14) [back to overview] | The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients |
| NCT00392327 (14) [back to overview] | Tumor Response to Radiation Therapy for Patients With Medulloblastoma |
| NCT00392327 (14) [back to overview] | Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) |
| NCT00392327 (14) [back to overview] | The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for SPNET Patients |
| NCT00392327 (14) [back to overview] | Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for SPNET Patients |
| NCT00392327 (14) [back to overview] | Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients |
| NCT00392327 (14) [back to overview] | Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients |
| NCT00392327 (14) [back to overview] | Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for SPNET Patients |
| NCT00392327 (14) [back to overview] | Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma |
| NCT00392327 (14) [back to overview] | Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) |
| NCT00392327 (14) [back to overview] | Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma |
| NCT00392327 (14) [back to overview] | Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET) |
| NCT00392327 (14) [back to overview] | The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for SPNET Patients |
| NCT00392327 (14) [back to overview] | The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients |
| NCT00392834 (1) [back to overview] | Overall Survival (OS) at 1 Year |
| NCT00392990 (4) [back to overview] | Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen |
| NCT00392990 (4) [back to overview] | Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen |
| NCT00392990 (4) [back to overview] | Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) |
| NCT00392990 (4) [back to overview] | Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen |
| NCT00393029 (3) [back to overview] | In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants |
| NCT00393029 (3) [back to overview] | Clinical Tumor Regression |
| NCT00393029 (3) [back to overview] | The Number of Participants With Adverse Events |
| NCT00394251 (9) [back to overview] | Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays |
| NCT00394251 (9) [back to overview] | Percent of Protocol Taxane Dose |
| NCT00394251 (9) [back to overview] | Summary of Participants' Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles) |
| NCT00394251 (9) [back to overview] | Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation |
| NCT00394251 (9) [back to overview] | Mean Taxane Dose Intensity Per Week |
| NCT00394251 (9) [back to overview] | The Cumulative Dose of Taxane Delivered During Study |
| NCT00394251 (9) [back to overview] | Myelosuppression During Taxane Dosing Cycles |
| NCT00394251 (9) [back to overview] | Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy |
| NCT00394251 (9) [back to overview] | Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy |
| NCT00399529 (3) [back to overview] | Number of Participants With Clinical Benefit |
| NCT00399529 (3) [back to overview] | Number of Participants With Delayed Type Hypersensitivity (Immunological Response) |
| NCT00399529 (3) [back to overview] | Number of Participants With Adverse Events |
| NCT00400946 (10) [back to overview] | 5-Year Disease-Free Survival by MRD Day 32 Status |
| NCT00400946 (10) [back to overview] | Asparaginase-Related Toxicity Rate |
| NCT00400946 (10) [back to overview] | Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate |
| NCT00400946 (10) [back to overview] | 5-Year Disease-Free Survival |
| NCT00400946 (10) [back to overview] | Post-Induction Nadir Serum Asparaginase Activity Level |
| NCT00400946 (10) [back to overview] | Induction Infection Toxicity Rate |
| NCT00400946 (10) [back to overview] | 5-Year Disease-Free Survival by Bone Marrow Day 18 Status |
| NCT00400946 (10) [back to overview] | 5-year Disease-Free Survival by CNS Directed Treatment Group |
| NCT00400946 (10) [back to overview] | Induction Therapeutic Nadir Serum Asparaginase Activity Rate |
| NCT00400946 (10) [back to overview] | Induction Serum Asparaginase Activity Level |
| NCT00404066 (2) [back to overview] | Disease-free Survival (DFS) |
| NCT00404066 (2) [back to overview] | Percentage of Participants With Pathologic Complete Response (pCR) |
| NCT00407888 (5) [back to overview] | Overall Survival |
| NCT00407888 (5) [back to overview] | Delivered Dose Intensity of the Regimen |
| NCT00407888 (5) [back to overview] | Time to Treatment Failure |
| NCT00407888 (5) [back to overview] | Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin |
| NCT00407888 (5) [back to overview] | Toxicity Associated With This Regimen |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort |
| NCT00408005 (8) [back to overview] | Cumulative Incidence of CNS Relapse for T-ALL by Risk Group |
| NCT00408005 (8) [back to overview] | Cumulative Incidence of CNS Relapse for T-ALL by Risk Group |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV) |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV) |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV) |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV) |
| NCT00408408 (9) [back to overview] | Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy |
| NCT00408408 (9) [back to overview] | Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone |
| NCT00408408 (9) [back to overview] | Surgical Complication |
| NCT00408408 (9) [back to overview] | pCR in the Breast and Nodes |
| NCT00408408 (9) [back to overview] | Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens |
| NCT00408408 (9) [back to overview] | Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy |
| NCT00408408 (9) [back to overview] | Pathologic Complete Response (pCR) of the Primary Tumor in the Breast |
| NCT00408408 (9) [back to overview] | Disease-free Survival (DFS) |
| NCT00408408 (9) [back to overview] | Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens |
| NCT00409188 (5) [back to overview] | Time To Progression (TTP) |
| NCT00409188 (5) [back to overview] | Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) |
| NCT00409188 (5) [back to overview] | Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions |
| NCT00409188 (5) [back to overview] | One-, Two- and Three-year Survival Rate |
| NCT00409188 (5) [back to overview] | Overall Survival |
| NCT00410163 (18) [back to overview] | Number of Participants With Progression or Death |
| NCT00410163 (18) [back to overview] | Duration of Response |
| NCT00410163 (18) [back to overview] | Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion |
| NCT00410163 (18) [back to overview] | Progression-Free Survival |
| NCT00410163 (18) [back to overview] | Number of Participants With Positive Human Anti-human Anti Bodies (HAHA) at Visits 1, 21, 35, and 39 |
| NCT00410163 (18) [back to overview] | Number of Participants Classified as Responders Having CR Who Tested Negative for Minimal Residual Disease (MRD) |
| NCT00410163 (18) [back to overview] | Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia) |
| NCT00410163 (18) [back to overview] | Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4) |
| NCT00410163 (18) [back to overview] | Number of Participants (Par.) Who Were Classified as Responders and Non-responders |
| NCT00410163 (18) [back to overview] | Median Percent Change in Tumor Size From Baseline (Visit 2, Wk 0) at Visits 9, 21, 25, 29, 33, 34, 35, and 37 |
| NCT00410163 (18) [back to overview] | Median Percent Change in CD5+CD19+ and CD5+CD20+ Cells in Peripheral Blood From Onset of Course 3 Throughout Follow-up (FU) Compared to Screening |
| NCT00410163 (18) [back to overview] | Ctrough and Cmax at the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
| NCT00410163 (18) [back to overview] | CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
| NCT00410163 (18) [back to overview] | Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60) |
| NCT00410163 (18) [back to overview] | AUC(0-inf) and AUC(0-672) After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
| NCT00410163 (18) [back to overview] | Vss After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
| NCT00410163 (18) [back to overview] | t1/2 After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
| NCT00410163 (18) [back to overview] | Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death |
| NCT00412243 (1) [back to overview] | Maximum Tolerated Dose for Cyclophosphamide (MTD) |
| NCT00412360 (9) [back to overview] | Percentage of Participants With Chronic GVHD |
| NCT00412360 (9) [back to overview] | Percentage of Participants With Acute Graft-versus-host Disease (GVHD) |
| NCT00412360 (9) [back to overview] | Percentage of Participants With Overall Survival |
| NCT00412360 (9) [back to overview] | Percentage of Participants With Disease-free Survival |
| NCT00412360 (9) [back to overview] | Percentage of Participants With Relapse |
| NCT00412360 (9) [back to overview] | Percentage of Participants With Neutrophil and Platelet Engraftment |
| NCT00412360 (9) [back to overview] | Number of Participants With Engraftment Syndrome |
| NCT00412360 (9) [back to overview] | Percentage of Participants With Treatment-related Mortality |
| NCT00412360 (9) [back to overview] | Time to Neutrophil and Platelet Engraftment |
| NCT00413959 (2) [back to overview] | Overall Survival |
| NCT00413959 (2) [back to overview] | Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. |
| NCT00424489 (1) [back to overview] | Survival |
| NCT00425802 (8) [back to overview] | Time to Platelet Engraftment |
| NCT00425802 (8) [back to overview] | Time to Neutrophil Engraftment |
| NCT00425802 (8) [back to overview] | Overall Survival at 1 Year |
| NCT00425802 (8) [back to overview] | Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days |
| NCT00425802 (8) [back to overview] | Immune Reconstruction/CD4+ Count at 6 Months |
| NCT00425802 (8) [back to overview] | Immune Reconstruction/CD4+ Count at 3 Months |
| NCT00425802 (8) [back to overview] | Immune Reconstruction/CD4+ Count at 1 Year |
| NCT00425802 (8) [back to overview] | Incidence of Chronic GVHD at 1 Year |
| NCT00427336 (1) [back to overview] | Number of Patients With Engraftment Response |
| NCT00429143 (5) [back to overview] | Lymphoid Recovery |
| NCT00429143 (5) [back to overview] | Incidence of Grades III-IV GVHD |
| NCT00429143 (5) [back to overview] | Engraftment Rates |
| NCT00429143 (5) [back to overview] | Overall Survival of Participants |
| NCT00429143 (5) [back to overview] | Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD |
| NCT00429182 (2) [back to overview] | Median Progression Free Survival (PFS) |
| NCT00429182 (2) [back to overview] | Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products |
| NCT00429299 (8) [back to overview] | Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography |
| NCT00429299 (8) [back to overview] | Number of Variations/Somatic Mutation in PI3KCA at Baseline |
| NCT00429299 (8) [back to overview] | Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants |
| NCT00429299 (8) [back to overview] | Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes |
| NCT00429299 (8) [back to overview] | Number of Participants With Treatment Failure |
| NCT00429299 (8) [back to overview] | Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment |
| NCT00429299 (8) [back to overview] | Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS |
| NCT00429299 (8) [back to overview] | Time to Treatment Failure From the Start of Primary Therapy |
| NCT00429416 (5) [back to overview] | Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) |
| NCT00429416 (5) [back to overview] | Rate of Serious Infectious Complications |
| NCT00429416 (5) [back to overview] | Rate of Engraftment of Non-Myeloablative Transplants |
| NCT00429416 (5) [back to overview] | Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality |
| NCT00429416 (5) [back to overview] | Number of Patients Who Achieve a CD4 Count > 200/Micro-liters |
| NCT00432172 (1) [back to overview] | Clinical Response Rate |
| NCT00433511 (3) [back to overview] | 5-year Overall Survival (OS) |
| NCT00433511 (3) [back to overview] | Invasive Disease-free Survival (IDFS) Rate at 5 Years |
| NCT00433511 (3) [back to overview] | The Association Between IDFS and Genotype |
| NCT00433537 (3) [back to overview] | 3-year Overall Survival (OS) |
| NCT00433537 (3) [back to overview] | 2-year Progression-free Survival (PFS) |
| NCT00433537 (3) [back to overview] | Complete Response (CR) Rate |
| NCT00436566 (9) [back to overview] | Adverse Event Profile as Measured by NCI CTCAE v 3.0 |
| NCT00436566 (9) [back to overview] | Percentage of Participants With Disease-Free Survival (DFS) |
| NCT00436566 (9) [back to overview] | Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements |
| NCT00436566 (9) [back to overview] | Percentage of Participants With Overall Survival (OS) |
| NCT00436566 (9) [back to overview] | Cumulative Incidence (CI) of Cardiac Events |
| NCT00436566 (9) [back to overview] | Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL |
| NCT00436566 (9) [back to overview] | Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment |
| NCT00436566 (9) [back to overview] | Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) |
| NCT00436566 (9) [back to overview] | Incidence of Pulmonary Events |
| NCT00439296 (3) [back to overview] | Number of Patients That Achieved Complete Response to ABT-751 |
| NCT00439296 (3) [back to overview] | Number of Patients That Experienced Dose Limiting Toxicity From ABT-751 |
| NCT00439296 (3) [back to overview] | Number of Patients With Occurrence of Toxic Death |
| NCT00445744 (2) [back to overview] | Non-relapse Mortality (NRM) (Patients With AML/MDS) |
| NCT00445744 (2) [back to overview] | Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity |
| NCT00446030 (1) [back to overview] | Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF) |
| NCT00448019 (3) [back to overview] | Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL) |
| NCT00448019 (3) [back to overview] | Progression Free Survival (PFS) Rate |
| NCT00448019 (3) [back to overview] | Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL |
| NCT00450385 (1) [back to overview] | Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies. |
| NCT00450801 (4) [back to overview] | Response Rate |
| NCT00450801 (4) [back to overview] | Progression-free Survival Rate |
| NCT00450801 (4) [back to overview] | Overall Survival Rate |
| NCT00450801 (4) [back to overview] | Number of Patients Experiencing Adverse Events. |
| NCT00450814 (12) [back to overview] | Progression-free Survival (Phase II) |
| NCT00450814 (12) [back to overview] | Progression-free Survival (Phase II) |
| NCT00450814 (12) [back to overview] | Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) |
| NCT00450814 (12) [back to overview] | Time to Progression (TTP) (Phase II) |
| NCT00450814 (12) [back to overview] | Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better (Phase II) |
| NCT00450814 (12) [back to overview] | Progression-free Survival (Phase II) |
| NCT00450814 (12) [back to overview] | Maximum Tolerated Dose (MTD) (Phase I) |
| NCT00450814 (12) [back to overview] | Failure-free Survival (Phase II) |
| NCT00450814 (12) [back to overview] | Number of Patients With Clinical Responses (Phase I) |
| NCT00450814 (12) [back to overview] | Overall Survival (Phase II) |
| NCT00450814 (12) [back to overview] | Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I) |
| NCT00450814 (12) [back to overview] | Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II) |
| NCT00451178 (11) [back to overview] | Overall Survival (OS) |
| NCT00451178 (11) [back to overview] | Event-Free Survival (EFS) |
| NCT00451178 (11) [back to overview] | Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate) |
| NCT00451178 (11) [back to overview] | Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan) |
| NCT00451178 (11) [back to overview] | PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS |
| NCT00451178 (11) [back to overview] | PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS |
| NCT00451178 (11) [back to overview] | Percentage of Participants With a PET-Negative Scan (PET-Negative Rate) |
| NCT00451178 (11) [back to overview] | Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin) |
| NCT00451178 (11) [back to overview] | Progression-Free Survival (PFS) Time |
| NCT00451178 (11) [back to overview] | Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate) |
| NCT00451178 (11) [back to overview] | Duration of Complete Response (CR or CRu) |
| NCT00453388 (4) [back to overview] | Incidence of Transplant-related Mortality |
| NCT00453388 (4) [back to overview] | Number of Patients Who Engraft at Each Dose of TBI Used |
| NCT00453388 (4) [back to overview] | Incidence of Grades III-IV Acute GVHD |
| NCT00453388 (4) [back to overview] | Incidence of Adverse Events |
| NCT00455312 (10) [back to overview] | Incidence of Pulmonary Complications |
| NCT00455312 (10) [back to overview] | Incidence of Chronic GVHD |
| NCT00455312 (10) [back to overview] | Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD) |
| NCT00455312 (10) [back to overview] | Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD) |
| NCT00455312 (10) [back to overview] | Incidence of Late Secondary Malignancies |
| NCT00455312 (10) [back to overview] | Incidence of Chronic GVHD |
| NCT00455312 (10) [back to overview] | Incidence of Regimen Related Mortality at 100 Days |
| NCT00455312 (10) [back to overview] | Neutrophil Engraftment |
| NCT00455312 (10) [back to overview] | Overall Survival |
| NCT00455312 (10) [back to overview] | Overall Survival |
| NCT00455533 (22) [back to overview] | Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations |
| NCT00455533 (22) [back to overview] | Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants |
| NCT00455533 (22) [back to overview] | Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds |
| NCT00455533 (22) [back to overview] | Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants) |
| NCT00455533 (22) [back to overview] | Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 |
| NCT00455533 (22) [back to overview] | Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR |
| NCT00455533 (22) [back to overview] | Reason for First Dose Reduction of AC |
| NCT00455533 (22) [back to overview] | Reason for First Dose Reduction of Ixabepilone/Paclitaxel |
| NCT00455533 (22) [back to overview] | Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds |
| NCT00455533 (22) [back to overview] | Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class |
| NCT00455533 (22) [back to overview] | Percentage of Participants Achieving Clinical Objective Response |
| NCT00455533 (22) [back to overview] | Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1 |
| NCT00455533 (22) [back to overview] | Percentage of Participants Achieving Pathologic Complete Response (pCR) |
| NCT00455533 (22) [back to overview] | Percentage of Participants Requiring Breast Conservation Surgery |
| NCT00455533 (22) [back to overview] | Number of Participants by Dose for AC |
| NCT00455533 (22) [back to overview] | Number of Participants by Dose for Ixabepilone/Paclitaxel |
| NCT00455533 (22) [back to overview] | Number of Participants With Course Delay and Reason for Delay for AC |
| NCT00455533 (22) [back to overview] | Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel |
| NCT00455533 (22) [back to overview] | On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase |
| NCT00455533 (22) [back to overview] | On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase |
| NCT00455533 (22) [back to overview] | On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase |
| NCT00455533 (22) [back to overview] | Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants |
| NCT00464646 (8) [back to overview] | Recurrence-free Survival |
| NCT00464646 (8) [back to overview] | Percentage of Participants With Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A) |
| NCT00464646 (8) [back to overview] | Overall Survival |
| NCT00464646 (8) [back to overview] | Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A) |
| NCT00464646 (8) [back to overview] | Number of Participants With no Histologic Evidence of Invasive Tumor Cells in the Surgical Breast Specimen. |
| NCT00464646 (8) [back to overview] | Number of Participants With Cardiac Events |
| NCT00464646 (8) [back to overview] | Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT) |
| NCT00464646 (8) [back to overview] | Clinical Complete Response (cCR) |
| NCT00470301 (2) [back to overview] | Number of Participants Analyzed for Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I) |
| NCT00470301 (2) [back to overview] | Pathologic Complete Response Rate (pCR) |
| NCT00477412 (4) [back to overview] | Time to Failure (Phase II) |
| NCT00477412 (4) [back to overview] | Overall Survival |
| NCT00477412 (4) [back to overview] | Number of Participants With Overall Response Rate |
| NCT00477412 (4) [back to overview] | Maximum Tolerated Dose of Bortezomib (Phase I) |
| NCT00478218 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT00478218 (4) [back to overview] | Overall Survival (OS) |
| NCT00478218 (4) [back to overview] | Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment |
| NCT00478218 (4) [back to overview] | Duration of Response (DOR) |
| NCT00478244 (10) [back to overview] | Number of Patients With Donor Derived Cells in Skin |
| NCT00478244 (10) [back to overview] | Number of Patients With Platelet Engraftment |
| NCT00478244 (10) [back to overview] | Overall Survival |
| NCT00478244 (10) [back to overview] | Number of Patients With >70% Donor Chimerism |
| NCT00478244 (10) [back to overview] | Number of Patients With Acute Graft-Versus-Host Disease (GVHD) |
| NCT00478244 (10) [back to overview] | Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD) |
| NCT00478244 (10) [back to overview] | Number of Patients With Detectable Collagen Type VII |
| NCT00478244 (10) [back to overview] | Number of Patients With Neutrophil Engraftment |
| NCT00478244 (10) [back to overview] | Number of Patients With Transplant-Related Mortality |
| NCT00478244 (10) [back to overview] | Number of Patients With Resistance to Blister Formation |
| NCT00481832 (10) [back to overview] | Overall Mortality Rate |
| NCT00481832 (10) [back to overview] | Event-free Survival (EFS) |
| NCT00481832 (10) [back to overview] | Achieving Full Donor Chimerism |
| NCT00481832 (10) [back to overview] | Relapse Rate |
| NCT00481832 (10) [back to overview] | Overall Survival (OS) |
| NCT00481832 (10) [back to overview] | Incidence of Chemotherapy-associated Pneumonitis |
| NCT00481832 (10) [back to overview] | Median Time to Platelet Engraftment |
| NCT00481832 (10) [back to overview] | Median Time to Neutrophile Engraftment |
| NCT00481832 (10) [back to overview] | Incidence of Chronic Graft Versus Host Disease (GvHD) |
| NCT00481832 (10) [back to overview] | Incidence of Acute Graft Versus Host Disease (GvHD) |
| NCT00482053 (7) [back to overview] | Incidence of Chronic Graft vs Host Disease (GvHD) |
| NCT00482053 (7) [back to overview] | Median Time to Neutrophil Engraftment After Allogeneic Transplant |
| NCT00482053 (7) [back to overview] | Median Time to Neutrophil Engraftment After Autologous Transplant |
| NCT00482053 (7) [back to overview] | Median Time to Platelet Engraftment After Allogeneic Transplant |
| NCT00482053 (7) [back to overview] | Overall Survival (OS) |
| NCT00482053 (7) [back to overview] | Median Time to Platelet Engraftment After Autologous Transplant |
| NCT00482053 (7) [back to overview] | Event-free Survival (EFS) Per Protocol |
| NCT00482391 (2) [back to overview] | Number of Patients Who Completed All Planned Therapy |
| NCT00482391 (2) [back to overview] | Number of Patients Who Were Evaluated for Toxicity |
| NCT00482911 (2) [back to overview] | Response Rate (Complete and Partial Response) |
| NCT00482911 (2) [back to overview] | Toxicity |
| NCT00489281 (3) [back to overview] | Donor Chimerism at 30 Days |
| NCT00489281 (3) [back to overview] | Donor Chimerism at 1 Year |
| NCT00489281 (3) [back to overview] | Transplant-related Mortality |
| NCT00490529 (5) [back to overview] | Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT) |
| NCT00490529 (5) [back to overview] | Detection of Tumor-specific CD8-positve Memory T-cells Before and After Vaccination |
| NCT00490529 (5) [back to overview] | Overall Survival (OS) |
| NCT00490529 (5) [back to overview] | Detection of Tumor-specific CD4-positve T-cells Before and After Vaccination |
| NCT00490529 (5) [back to overview] | Time-to-progression (TTP) |
| NCT00492921 (2) [back to overview] | Maximum Tolerated Dose of High-dose Cyclophosphamide as Determined by Number of Participants Who Tolerated Each Dose of Cyclophosphamide |
| NCT00492921 (2) [back to overview] | GVHD Response Rate |
| NCT00493649 (4) [back to overview] | Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. |
| NCT00493649 (4) [back to overview] | DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. |
| NCT00493649 (4) [back to overview] | Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. |
| NCT00493649 (4) [back to overview] | OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. |
| NCT00493870 (7) [back to overview] | Number and Frequency of Participants by TOP2A Status by Study Treatment |
| NCT00493870 (7) [back to overview] | 3-year DFS-DCIS, OS and RFI Among Per-protocol Patients. |
| NCT00493870 (7) [back to overview] | 3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients |
| NCT00493870 (7) [back to overview] | 3-year DFS Stratified by TOP2A Among TAC Arm |
| NCT00493870 (7) [back to overview] | 3-year DFS Stratified by TOP2A Among TC Arm |
| NCT00493870 (7) [back to overview] | 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients |
| NCT00493870 (7) [back to overview] | 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients |
| NCT00494780 (15) [back to overview] | Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 |
| NCT00494780 (15) [back to overview] | Progression-Free Survival (PFS) |
| NCT00494780 (15) [back to overview] | Time to New Anti-follicular Lymphoma (FL) Therapy |
| NCT00494780 (15) [back to overview] | Vss at the Sixth Infusion (Week 15, Visit 22) |
| NCT00494780 (15) [back to overview] | AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) |
| NCT00494780 (15) [back to overview] | Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) |
| NCT00494780 (15) [back to overview] | Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab) |
| NCT00494780 (15) [back to overview] | Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22) |
| NCT00494780 (15) [back to overview] | Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) |
| NCT00494780 (15) [back to overview] | Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab) |
| NCT00494780 (15) [back to overview] | Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion) |
| NCT00494780 (15) [back to overview] | Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22 |
| NCT00494780 (15) [back to overview] | Duration of Response |
| NCT00494780 (15) [back to overview] | CL After the Sixth Infusion (Week 15, Visit 22) |
| NCT00494780 (15) [back to overview] | Number of Participants With Complete Remission (CR) at Visit 26 |
| NCT00496873 (3) [back to overview] | 3-Year Progression-Free Survival |
| NCT00496873 (3) [back to overview] | Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy |
| NCT00496873 (3) [back to overview] | Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 |
| NCT00499083 (1) [back to overview] | Number of Patients With Pathological Complete Response |
| NCT00499122 (3) [back to overview] | Correlation Between Myeloid Derived Suppressor Cell (MDSC) Levels and Pathologic Complete Response (pCR) and Non-Responders |
| NCT00499122 (3) [back to overview] | Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy |
| NCT00499122 (3) [back to overview] | Definition of the Safety Profiles of Protocol Therapy |
| NCT00499603 (3) [back to overview] | Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours |
| NCT00499603 (3) [back to overview] | Participant Responses Per Treatment Arm at 12 Weeks |
| NCT00499603 (3) [back to overview] | Participant Responses Per Treatment Arm at 24 Weeks |
| NCT00499616 (14) [back to overview] | Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma |
| NCT00499616 (14) [back to overview] | Second-event-free Survival (E2FS) |
| NCT00499616 (14) [back to overview] | Neurologic Symptoms |
| NCT00499616 (14) [back to overview] | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates |
| NCT00499616 (14) [back to overview] | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate |
| NCT00499616 (14) [back to overview] | Definitive Determination of the Prognostic Ability of 1p and 11q |
| NCT00499616 (14) [back to overview] | Definitive Determination of the Prognostic Ability of 1p and 11q |
| NCT00499616 (14) [back to overview] | Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment |
| NCT00499616 (14) [back to overview] | Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961 |
| NCT00499616 (14) [back to overview] | Image Defined Risk Factor (IDRF) |
| NCT00499616 (14) [back to overview] | Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS) |
| NCT00499616 (14) [back to overview] | Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961 |
| NCT00499616 (14) [back to overview] | Second-Overall Survival |
| NCT00499616 (14) [back to overview] | Overall Survival (OS) Rates |
| NCT00501995 (2) [back to overview] | Improvement in the Modified Rodnan Skin Score. |
| NCT00501995 (2) [back to overview] | Change in the HAQ-DI, PGA, FVC and DLCO |
| NCT00505921 (1) [back to overview] | Participant Progression Free Survival at 2 Years |
| NCT00507442 (11) [back to overview] | Number of Patients With Combined Complete Response and Very Good Partial Response |
| NCT00507442 (11) [back to overview] | Number of Patients With Complete Response Rate + Near Complete Response Rate |
| NCT00507442 (11) [back to overview] | Number of Patients With Overall Response |
| NCT00507442 (11) [back to overview] | Duration of Response |
| NCT00507442 (11) [back to overview] | Time to Disease Progression |
| NCT00507442 (11) [back to overview] | Progression-free Survival |
| NCT00507442 (11) [back to overview] | Probability of 1-year Survival |
| NCT00507442 (11) [back to overview] | Overall Survival |
| NCT00507442 (11) [back to overview] | Number of Patients With Adverse Events (AEs) |
| NCT00507442 (11) [back to overview] | Time to Response |
| NCT00507442 (11) [back to overview] | Number of Patients With Stringent Complete Response Rate |
| NCT00509288 (2) [back to overview] | Toxicity |
| NCT00509288 (2) [back to overview] | Clinical Tumor Regression. |
| NCT00509496 (2) [back to overview] | Clinical Tumor Regression. |
| NCT00509496 (2) [back to overview] | Toxicity |
| NCT00513292 (9) [back to overview] | Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy |
| NCT00513292 (9) [back to overview] | Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week |
| NCT00513292 (9) [back to overview] | Breast Conservation |
| NCT00513292 (9) [back to overview] | LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week |
| NCT00513292 (9) [back to overview] | Asymptomatic Decreases From Baseline in LVEF at Week 24 |
| NCT00513292 (9) [back to overview] | Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12 |
| NCT00513292 (9) [back to overview] | pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy |
| NCT00513292 (9) [back to overview] | Overall Survival (OS) |
| NCT00513292 (9) [back to overview] | Disease-free Survival (DFS) |
| NCT00513474 (3) [back to overview] | Uric Acid Levels |
| NCT00513474 (3) [back to overview] | Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD) |
| NCT00513474 (3) [back to overview] | Number of Participant With Adverse Events (AE) |
| NCT00513604 (2) [back to overview] | Clinical Response |
| NCT00513604 (2) [back to overview] | Toxicity |
| NCT00513695 (5) [back to overview] | Time to Disease Progression |
| NCT00513695 (5) [back to overview] | Relapse Rate |
| NCT00513695 (5) [back to overview] | Overall Survival |
| NCT00513695 (5) [back to overview] | Number and Percent of Subjects Reporting Adverse Events |
| NCT00513695 (5) [back to overview] | Microscopic Pathologic CR (pCR) Rate |
| NCT00516295 (2) [back to overview] | Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab |
| NCT00516295 (2) [back to overview] | The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient. |
| NCT00518206 (4) [back to overview] | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine |
| NCT00518206 (4) [back to overview] | Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine |
| NCT00518206 (4) [back to overview] | Number of Subjects With Treatment-emergent Adverse Events |
| NCT00518206 (4) [back to overview] | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions |
| NCT00525603 (1) [back to overview] | Overall Participant Response |
| NCT00525876 (1) [back to overview] | Overall Survival at 100 Days Post Transplant (Number of Surviving Participants) |
| NCT00526292 (1) [back to overview] | Treatment Efficacy as Defined by Complete or Partial Remission |
| NCT00531453 (2) [back to overview] | Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT) |
| NCT00531453 (2) [back to overview] | Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction |
| NCT00536601 (8) [back to overview] | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) |
| NCT00536601 (8) [back to overview] | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) |
| NCT00536601 (8) [back to overview] | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) |
| NCT00536601 (8) [back to overview] | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) |
| NCT00536601 (8) [back to overview] | Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) |
| NCT00536601 (8) [back to overview] | Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) |
| NCT00536601 (8) [back to overview] | Response Rate (Complete Remission) |
| NCT00536601 (8) [back to overview] | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) |
| NCT00538031 (3) [back to overview] | Overall Response |
| NCT00538031 (3) [back to overview] | Time to Treatment Failure |
| NCT00538031 (3) [back to overview] | Overall Survival |
| NCT00540644 (3) [back to overview] | Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria |
| NCT00540644 (3) [back to overview] | Treatment Related Adverse Events Grade 3 or Higher |
| NCT00540644 (3) [back to overview] | Quality of Life Using the FACT-G Data |
| NCT00542191 (1) [back to overview] | 1) Pathologic Response |
| NCT00544115 (2) [back to overview] | Two-year Overall Survival |
| NCT00544115 (2) [back to overview] | Neutrophil Engraftment - The Days Till ANC Recovery |
| NCT00544167 (1) [back to overview] | The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0. |
| NCT00545714 (14) [back to overview] | Percentage of Participants With Positive and Negative Zeta-Chain-Associated Protein Kinase 70 (ZAP-70) Expression |
| NCT00545714 (14) [back to overview] | Percentage of Participants With Immunoglobulin Heavy Locus (IgH) Rearrangement |
| NCT00545714 (14) [back to overview] | Percentage of Participants With Genetic Abnormalities |
| NCT00545714 (14) [back to overview] | Percentage of Participants With Cluster of Differentiation (CD) 38 Cells >/=30% in Peripheral Blood |
| NCT00545714 (14) [back to overview] | Percentage of Participants With Clinical Response of CR or PR as Assessed by Multiparameter Flow Cytometry |
| NCT00545714 (14) [back to overview] | Percentage of Participants With Clinical Response of CR or PR Among Participants With Negative Minimal Residual Disease (MRD) as Assessed by Multiparameter Flow Cytometry |
| NCT00545714 (14) [back to overview] | Progression-Free Survival (PFS) |
| NCT00545714 (14) [back to overview] | Percentage of Participants With PD or Death |
| NCT00545714 (14) [back to overview] | Percentage of Participants With CR With Incomplete Bone Marrow Recovery (CRi) |
| NCT00545714 (14) [back to overview] | Percentage of Participants Who Died |
| NCT00545714 (14) [back to overview] | Overall Survival (OS) |
| NCT00545714 (14) [back to overview] | Duration of Response (DOR) |
| NCT00545714 (14) [back to overview] | Treatment-Free Survival (TFS) |
| NCT00545714 (14) [back to overview] | Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen |
| NCT00546156 (2) [back to overview] | Decrease in Interstitial Fluid Pressure. |
| NCT00546156 (2) [back to overview] | Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population. |
| NCT00546377 (2) [back to overview] | Maximum Tolerated Dose (MTD) of Mitoxantrone |
| NCT00546377 (2) [back to overview] | Overall Response |
| NCT00547196 (2) [back to overview] | Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB) |
| NCT00547196 (2) [back to overview] | Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB) |
| NCT00549848 (6) [back to overview] | Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase. |
| NCT00549848 (6) [back to overview] | Probability of CNS Relapse |
| NCT00549848 (6) [back to overview] | Probability of Event-free Survival |
| NCT00549848 (6) [back to overview] | Probability of Overall Survival |
| NCT00549848 (6) [back to overview] | Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5% |
| NCT00549848 (6) [back to overview] | Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01% |
| NCT00550771 (3) [back to overview] | Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy |
| NCT00550771 (3) [back to overview] | Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy |
| NCT00550771 (3) [back to overview] | Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year |
| NCT00553202 (2) [back to overview] | Cumulative Incidence of NK Cell Reconstitution |
| NCT00553202 (2) [back to overview] | Overall Survival (OS) |
| NCT00554788 (3) [back to overview] | Event-free Survival (EFS) |
| NCT00554788 (3) [back to overview] | Response Rate to the Induction Phase of the Regimen |
| NCT00554788 (3) [back to overview] | Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
| NCT00555048 (7) [back to overview] | Overall Survival |
| NCT00555048 (7) [back to overview] | Disease Relapse |
| NCT00555048 (7) [back to overview] | Extensive Chronic GVHD |
| NCT00555048 (7) [back to overview] | Grades III-IV Acute Graft-vs-host Disease (GVHD) |
| NCT00555048 (7) [back to overview] | Graft Failure |
| NCT00555048 (7) [back to overview] | Life-threatening Infection |
| NCT00555048 (7) [back to overview] | Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality |
| NCT00557193 (10) [back to overview] | Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy |
| NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm A |
| NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2) |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2 |
| NCT00557193 (10) [back to overview] | Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm |
| NCT00557193 (10) [back to overview] | Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT) |
| NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00558519 (5) [back to overview] | Complete Response Rate |
| NCT00558519 (5) [back to overview] | Overall Survival |
| NCT00558519 (5) [back to overview] | Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity) |
| NCT00558519 (5) [back to overview] | Event-free Survival |
| NCT00558519 (5) [back to overview] | Disease-free Survival |
| NCT00559104 (3) [back to overview] | Short-term and Long-term Treatment-related Toxicities |
| NCT00559104 (3) [back to overview] | Progression |
| NCT00559104 (3) [back to overview] | Mortality |
| NCT00559845 (5) [back to overview] | Percentage of Participants With Disease-Free Interval |
| NCT00559845 (5) [back to overview] | Percentage of Participants With Breast-Conserving Surgery |
| NCT00559845 (5) [back to overview] | Objective Response Rate |
| NCT00559845 (5) [back to overview] | Percentage of Participants Experiencing Any Adverse Event |
| NCT00559845 (5) [back to overview] | Percentage of Participants With Pathological Complete Response Following Principle Investigator Review |
| NCT00562640 (4) [back to overview] | Number of Participants Assessed for Safety and Tolerability as Assessed by NCI CTCAE v3.0 |
| NCT00562640 (4) [back to overview] | Mean Overall Survival |
| NCT00562640 (4) [back to overview] | Best Response |
| NCT00562640 (4) [back to overview] | Total Number of Dose Limiting Toxicities/DLT's |
| NCT00562965 (7) [back to overview] | Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings |
| NCT00562965 (7) [back to overview] | Percentage of Participants With Objective Response (OR) |
| NCT00562965 (7) [back to overview] | Overall Survival Probability at Months 6, 12 and 24 |
| NCT00562965 (7) [back to overview] | Number of Participants With Clinically Significant Change From Baseline in Vital Signs |
| NCT00562965 (7) [back to overview] | Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings |
| NCT00562965 (7) [back to overview] | Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) |
| NCT00562965 (7) [back to overview] | Progression-Free Survival (PFS) |
| NCT00562978 (4) [back to overview] | Number of Patients With Grade 3 or Greater Toxicity |
| NCT00562978 (4) [back to overview] | Number of Patients Achieving Complete Response (CR) |
| NCT00562978 (4) [back to overview] | 5-Year Disease-free Survival (Phase II) |
| NCT00562978 (4) [back to overview] | 5-Year Overall Survival (Phase II) |
| NCT00564889 (5) [back to overview] | Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) |
| NCT00564889 (5) [back to overview] | Number of Participants With Severe Adverse Events |
| NCT00564889 (5) [back to overview] | Number of Patients With Organ Response |
| NCT00564889 (5) [back to overview] | Overall Survival (OS) |
| NCT00564889 (5) [back to overview] | Progression Free Survival (PFS) |
| NCT00566696 (7) [back to overview] | Event-free Survival (EFS) |
| NCT00566696 (7) [back to overview] | Disease-Free Survival (DFS) |
| NCT00566696 (7) [back to overview] | To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants. |
| NCT00566696 (7) [back to overview] | Overall Survival (OS) |
| NCT00566696 (7) [back to overview] | Incidence of Non-hematologic Regimen-related Toxicities |
| NCT00566696 (7) [back to overview] | To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment. |
| NCT00566696 (7) [back to overview] | Incidence of Regimen-related Mortality |
| NCT00567567 (14) [back to overview] | Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies |
| NCT00567567 (14) [back to overview] | Duration of Greater Than or Equal to Grade 3 Neutropenia |
| NCT00567567 (14) [back to overview] | Incidence Rate of Local Recurrence |
| NCT00567567 (14) [back to overview] | OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology |
| NCT00567567 (14) [back to overview] | Intraspinal Extension |
| NCT00567567 (14) [back to overview] | Event-free Survival Rate |
| NCT00567567 (14) [back to overview] | Proportion of Patients With a Polymorphism |
| NCT00567567 (14) [back to overview] | Topotecan Systemic Clearance |
| NCT00567567 (14) [back to overview] | EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology). |
| NCT00567567 (14) [back to overview] | Duration of Greater Than or Equal to Grade 3 Thrombocytopenia |
| NCT00567567 (14) [back to overview] | Surgical Response |
| NCT00567567 (14) [back to overview] | Response After Induction Therapy |
| NCT00567567 (14) [back to overview] | Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells |
| NCT00567567 (14) [back to overview] | Type of Surgical or Radiotherapy Complication |
| NCT00574496 (3) [back to overview] | Progression-free Survival at 1 Year |
| NCT00574496 (3) [back to overview] | Disease Relapse or Progression as Measured by CT Scan or PET |
| NCT00574496 (3) [back to overview] | Overall Survival |
| NCT00574587 (2) [back to overview] | Pathological Complete Response (CR) Rate in Patients With Her2/Neu Positive Locally Advanced Breast Cancer. |
| NCT00574587 (2) [back to overview] | Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab |
| NCT00576979 (1) [back to overview] | Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I) |
| NCT00577096 (10) [back to overview] | Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term) |
| NCT00577096 (10) [back to overview] | Total Number of Days of Stem Cell Collection (Short Term) |
| NCT00577096 (10) [back to overview] | Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) |
| NCT00577096 (10) [back to overview] | Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term) |
| NCT00577096 (10) [back to overview] | Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) |
| NCT00577096 (10) [back to overview] | Total Number of Days of Stem Cell Collection (Long Term) |
| NCT00577096 (10) [back to overview] | Number of Stem Cell Collection Attempts (Short Term) |
| NCT00577096 (10) [back to overview] | Number of Stem Cell Collection Attempts (Long Term) |
| NCT00577096 (10) [back to overview] | Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) |
| NCT00577096 (10) [back to overview] | Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term) |
| NCT00577122 (4) [back to overview] | MPA Trough Concentration |
| NCT00577122 (4) [back to overview] | MPA Trough Level > 50 ng/mL When Have Clinical Benefit |
| NCT00577122 (4) [back to overview] | Grade 3 or 4 Adverse Events Related to Treatment |
| NCT00577122 (4) [back to overview] | Clinical Benefit Rate (CR + PR + SD > 6 Months). |
| NCT00577629 (5) [back to overview] | Overall Survival |
| NCT00577629 (5) [back to overview] | 1 Year Progression-free Survival Rate |
| NCT00577629 (5) [back to overview] | Disease-free Survival |
| NCT00577629 (5) [back to overview] | Overall Response |
| NCT00577629 (5) [back to overview] | Secondary Malignancies |
| NCT00577993 (2) [back to overview] | Number of Participants With Overall Survival (10 Years) by Treatment |
| NCT00577993 (2) [back to overview] | Number of Participants With Progression Free Survival (10 Years) by Treatment |
| NCT00578292 (8) [back to overview] | Number of Participants With Stable Mixed Hematopoietic Chimerism (HC) |
| NCT00578292 (8) [back to overview] | Number of Participants With Infectious Complications |
| NCT00578292 (8) [back to overview] | Number of Participants With CHRONIC GVHD |
| NCT00578292 (8) [back to overview] | Immune Reconstitution |
| NCT00578292 (8) [back to overview] | Hematopoietic Reconstitution |
| NCT00578292 (8) [back to overview] | Event-free Survival |
| NCT00578292 (8) [back to overview] | Engraftment Rate After Transplant |
| NCT00578292 (8) [back to overview] | Number of Participants With Transient Mixed Hematopoietic Chimerism (HC) |
| NCT00578344 (2) [back to overview] | Number of Participants With Immune Response to Immunization After BMT in Participants With SCD, Hemoglobin SC, or Hemoglobin Sb0/+. |
| NCT00578344 (2) [back to overview] | Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan. |
| NCT00578461 (1) [back to overview] | Median Percentage of Treg Cells at 1 Year Post Transplant |
| NCT00578539 (1) [back to overview] | Median Percentage of Treg Cells at 1 Year Post Transplant |
| NCT00578643 (2) [back to overview] | Percentage of Participants With Engraftment |
| NCT00578643 (2) [back to overview] | Number of Patients That Have Complete Donor Chimerism After Transplant. |
| NCT00578864 (5) [back to overview] | Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors. |
| NCT00578864 (5) [back to overview] | Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen. |
| NCT00578864 (5) [back to overview] | Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy |
| NCT00578864 (5) [back to overview] | Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen. |
| NCT00578864 (5) [back to overview] | Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma. |
| NCT00578903 (6) [back to overview] | Number of Patients With Chronic GVHD at 2 Years Post Transplant |
| NCT00578903 (6) [back to overview] | Number of Patients With Engraftment Rate at 100 Days Post Transplant |
| NCT00578903 (6) [back to overview] | Number of Subjects Alive at 1 Year Post Transplant |
| NCT00578903 (6) [back to overview] | Number of Subjects Alive at 100 Days Post Transplant |
| NCT00578903 (6) [back to overview] | Number of Subjects Alive at 2 Years Post Transplant |
| NCT00578903 (6) [back to overview] | Number of Patients With Acute GVHD at 100 Days Post Transplant |
| NCT00580333 (4) [back to overview] | Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer. |
| NCT00580333 (4) [back to overview] | Patients With Miller-Payne (MP) Score 3, 4, or 5 Response |
| NCT00580333 (4) [back to overview] | Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy. |
| NCT00580333 (4) [back to overview] | Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab |
| NCT00580372 (1) [back to overview] | Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy |
| NCT00581776 (4) [back to overview] | 3 Year Overall Survival (OS) |
| NCT00581776 (4) [back to overview] | Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). |
| NCT00581776 (4) [back to overview] | Complete Response Rate (CR) at the End of Induction Chemotherapy |
| NCT00581776 (4) [back to overview] | 3 Year Progression Free Survival |
| NCT00589316 (1) [back to overview] | Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen |
| NCT00589563 (14) [back to overview] | Time to Absolute Neutrophil Count Recovery (Engraftment) |
| NCT00589563 (14) [back to overview] | Time to Platelet Count Recovery (Engraftment) |
| NCT00589563 (14) [back to overview] | Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation |
| NCT00589563 (14) [back to overview] | Severity of Acute GVHD |
| NCT00589563 (14) [back to overview] | Overall Survival at Two Years Post HSCT |
| NCT00589563 (14) [back to overview] | Occurrence of Thrombotic Microangiopathy |
| NCT00589563 (14) [back to overview] | Severity of Chronic GVHD |
| NCT00589563 (14) [back to overview] | Occurence of Sinusoidal Obstructive Syndrome (SOS) |
| NCT00589563 (14) [back to overview] | Non-relapse Mortality at Two Years Post HSCT |
| NCT00589563 (14) [back to overview] | Non-relapse Mortality at 100 Days Post HSCT |
| NCT00589563 (14) [back to overview] | Incidence of Disease Relapse/Progression at 2 Years Post HSCT |
| NCT00589563 (14) [back to overview] | Event Free Survival at Two Years Post HSCT |
| NCT00589563 (14) [back to overview] | Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100 |
| NCT00589563 (14) [back to overview] | Cumulative Incidence of Chronic GVHD |
| NCT00591851 (1) [back to overview] | Cardiac Saftey |
| NCT00594308 (5) [back to overview] | Number of Days for Absolute Neutrophil Count to Recover |
| NCT00594308 (5) [back to overview] | Number of Patients With Acute Grade II-IV GVHD |
| NCT00594308 (5) [back to overview] | Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria. |
| NCT00594308 (5) [back to overview] | Time to Resolution of Cytopenias: Platelet Transfusion Independence |
| NCT00594308 (5) [back to overview] | Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). |
| NCT00595127 (1) [back to overview] | Incidence & Quality of Engraftment & Hematopoietic Reconstitution |
| NCT00597519 (1) [back to overview] | Overall Response |
| NCT00601003 (1) [back to overview] | Number of Participants With Related Adverse Events as a Measure of Safety and Tolerability |
| NCT00601796 (4) [back to overview] | Median Overall Survival (OS) |
| NCT00601796 (4) [back to overview] | Median Time to Progression (TTP) |
| NCT00601796 (4) [back to overview] | Number of Evaluable Participants With Tumor Response |
| NCT00601796 (4) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
| NCT00602459 (6) [back to overview] | Time-to-progression in Patients With Del(11q22.3) |
| NCT00602459 (6) [back to overview] | 2-Year Progression Free Survival (PFS) Rate |
| NCT00602459 (6) [back to overview] | Overall Response Rate in Patients Without Del(11q22.3) |
| NCT00602459 (6) [back to overview] | Overall Response Rates in Patients With Del(11q22.3) |
| NCT00602459 (6) [back to overview] | PFS Rate of Patients With Del(11q22.3) |
| NCT00602459 (6) [back to overview] | Time-to-progression in Patients Without Del(11q22.3) |
| NCT00602667 (62) [back to overview] | Topotecan Apparent Oral Clearance in Maintenance Chemotherapy |
| NCT00602667 (62) [back to overview] | Erlotinib Apparent Volume of Central Compartment |
| NCT00602667 (62) [back to overview] | Rate of Local Disease Progression |
| NCT00602667 (62) [back to overview] | Numbers of Patients With Gene Alterations |
| NCT00602667 (62) [back to overview] | Rate of Distant Disease Progression |
| NCT00602667 (62) [back to overview] | Percentage of Patients With Objective Responses Rate to Induction Chemotherapy |
| NCT00602667 (62) [back to overview] | Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup |
| NCT00602667 (62) [back to overview] | Erlotinib AUC0-24h |
| NCT00602667 (62) [back to overview] | Event-free Survival (EFS) Compared to Historical Controls |
| NCT00602667 (62) [back to overview] | Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients |
| NCT00602667 (62) [back to overview] | Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients |
| NCT00602667 (62) [back to overview] | Percent of PET Scans With Loss of Signal Intensity |
| NCT00602667 (62) [back to overview] | Percent of Patients With Sustained Objective Responses Rate After Consolidation |
| NCT00602667 (62) [back to overview] | Numbers of Patients With Molecular Abnormalities by Tumor Type |
| NCT00602667 (62) [back to overview] | Pharmacogenetic Variation on Central Nervous System Transmitters |
| NCT00602667 (62) [back to overview] | Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan |
| NCT00602667 (62) [back to overview] | Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan |
| NCT00602667 (62) [back to overview] | Overall Survival (OS) Compared to Historical Controls |
| NCT00602667 (62) [back to overview] | OSI-420 AUC0-24h |
| NCT00602667 (62) [back to overview] | Methotrexate Volume of Central Compartment in Induction Cycle 4 |
| NCT00602667 (62) [back to overview] | Methotrexate Volume of Central Compartment in Induction Cycle 2 |
| NCT00602667 (62) [back to overview] | Methotrexate Volume of Central Compartment in Induction Cycle 1 |
| NCT00602667 (62) [back to overview] | Methotrexate Volume of Central Compartment in Induction Cycle 3 |
| NCT00602667 (62) [back to overview] | Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4 |
| NCT00602667 (62) [back to overview] | Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3 |
| NCT00602667 (62) [back to overview] | Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2 |
| NCT00602667 (62) [back to overview] | Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1 |
| NCT00602667 (62) [back to overview] | 4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2 |
| NCT00602667 (62) [back to overview] | 4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1 |
| NCT00602667 (62) [back to overview] | Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1 |
| NCT00602667 (62) [back to overview] | 4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy |
| NCT00602667 (62) [back to overview] | Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity |
| NCT00602667 (62) [back to overview] | Number and Type of Genetic Polymorphisms |
| NCT00602667 (62) [back to overview] | Number of Participants With Chromosomal Abnormalities |
| NCT00602667 (62) [back to overview] | Methotrexate Clearance in Induction Cycle 4 |
| NCT00602667 (62) [back to overview] | Methotrexate Clearance in Induction Cycle 3 |
| NCT00602667 (62) [back to overview] | Methotrexate Clearance in Induction Cycle 2 |
| NCT00602667 (62) [back to overview] | Methotrexate Clearance in Induction Cycle 1 |
| NCT00602667 (62) [back to overview] | 4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1 |
| NCT00602667 (62) [back to overview] | CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1 |
| NCT00602667 (62) [back to overview] | CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2 |
| NCT00602667 (62) [back to overview] | CEPM AUC0-24h in Induction Chemotherapy |
| NCT00602667 (62) [back to overview] | Methotrexate AUC0-66h in Induction Cycle 4 |
| NCT00602667 (62) [back to overview] | Methotrexate AUC0-66h in Induction Cycle 3 |
| NCT00602667 (62) [back to overview] | Number of Successful Collections for Frozen and Fixed Tumor Samples |
| NCT00602667 (62) [back to overview] | Concentration of Cerebrospinal Fluid Neurotransmitters |
| NCT00602667 (62) [back to overview] | CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1 |
| NCT00602667 (62) [back to overview] | Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1 |
| NCT00602667 (62) [back to overview] | Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1 |
| NCT00602667 (62) [back to overview] | Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2 |
| NCT00602667 (62) [back to overview] | Cyclophosphamide AUC0-24h in Induction Chemotherapy |
| NCT00602667 (62) [back to overview] | Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1 |
| NCT00602667 (62) [back to overview] | Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2 |
| NCT00602667 (62) [back to overview] | Cyclophosphamide Clearance in Induction Chemotherapy |
| NCT00602667 (62) [back to overview] | Erlotinib Apparent Oral Clearance |
| NCT00602667 (62) [back to overview] | Topotecan Clearance in Consolidation Chemotherapy |
| NCT00602667 (62) [back to overview] | Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received |
| NCT00602667 (62) [back to overview] | Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity |
| NCT00602667 (62) [back to overview] | Methotrexate AUC0-66h in Induction Cycle 1 |
| NCT00602667 (62) [back to overview] | Methotrexate AUC0-66h in Induction Cycle 2 |
| NCT00602667 (62) [back to overview] | Topotecan AUC0-24h in Maintenance Chemotherapy |
| NCT00602667 (62) [back to overview] | Topotecan AUC0-24h in Consolidation Chemotherapy |
| NCT00602836 (6) [back to overview] | Treatment Free Survival (TFS) |
| NCT00602836 (6) [back to overview] | Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide |
| NCT00602836 (6) [back to overview] | Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide |
| NCT00602836 (6) [back to overview] | Number of Participants With a Response (CR, nPR, PR) |
| NCT00602836 (6) [back to overview] | Overall Survival (OS) |
| NCT00602836 (6) [back to overview] | Number of Participants With Complete Response (CR) |
| NCT00605566 (5) [back to overview] | Progression-free Survival (PFS) |
| NCT00605566 (5) [back to overview] | 1-year Survival Rate |
| NCT00605566 (5) [back to overview] | Efficacy of Combination Sorafenib Plus Metronomic Cyclophosphamide in Advanced, Progressive NET, as Measured by the Objective Response Rate (ORR). |
| NCT00605566 (5) [back to overview] | Overall Survival (OS) |
| NCT00605566 (5) [back to overview] | Association Between p-Shift Changes and Treatment Efficacy of Individual Dose Adjustment of Sorafenib |
| NCT00608517 (7) [back to overview] | Number of Participants Who Relapsed at 1 Year |
| NCT00608517 (7) [back to overview] | Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells |
| NCT00608517 (7) [back to overview] | Number of Participants With Chronic Graft Versus Host Disease (GVHD) |
| NCT00608517 (7) [back to overview] | Number of Participants With Acute Graft-versus-host Disease (GVHD) |
| NCT00608517 (7) [back to overview] | Number of Participants With 100-day Non-relapse Mortality |
| NCT00608517 (7) [back to overview] | Overall Survival |
| NCT00608517 (7) [back to overview] | Number of Subjects With All-cause Mortality |
| NCT00609167 (8) [back to overview] | Duration of Response |
| NCT00609167 (8) [back to overview] | Progression Free Survival (PFS) |
| NCT00609167 (8) [back to overview] | Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant |
| NCT00609167 (8) [back to overview] | Overall Survival (OS) |
| NCT00609167 (8) [back to overview] | Number of Participants With Severe Adverse Events |
| NCT00609167 (8) [back to overview] | Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles |
| NCT00609167 (8) [back to overview] | Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles |
| NCT00609167 (8) [back to overview] | Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment |
| NCT00610311 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00610311 (2) [back to overview] | Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR) |
| NCT00610883 (1) [back to overview] | Complete Remission |
| NCT00611351 (4) [back to overview] | Transplantation-related Mortality at 100 Days Post-transplantation |
| NCT00611351 (4) [back to overview] | Overall Survival |
| NCT00611351 (4) [back to overview] | Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) |
| NCT00611351 (4) [back to overview] | Event-free Survival |
| NCT00612222 (2) [back to overview] | Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR) |
| NCT00612222 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00612716 (9) [back to overview] | Number of Participants With 1 Year Overall Survival |
| NCT00612716 (9) [back to overview] | Number of Participants With Engraftment Failure |
| NCT00612716 (9) [back to overview] | Number of Participants With Relapse of Malignancy |
| NCT00612716 (9) [back to overview] | Number of Participants With Platelet Engraftment |
| NCT00612716 (9) [back to overview] | Number of Participants With Persistence Disease |
| NCT00612716 (9) [back to overview] | Number of Participants With of Chronic GVHD. |
| NCT00612716 (9) [back to overview] | Number of Participants With Neutrophil Engraftment |
| NCT00612716 (9) [back to overview] | Number of Participants With Grade 3-4 Acute Graft-versus-host Disease |
| NCT00612716 (9) [back to overview] | Number of Participants With 2 Year Overall Survival |
| NCT00615901 (1) [back to overview] | The Number of Patients Who Completed 8 Cycles. |
| NCT00616122 (4) [back to overview] | Duration of Response |
| NCT00616122 (4) [back to overview] | Maximum Tolerated Dose of Sunitinib (Phase I) |
| NCT00616122 (4) [back to overview] | Patients With Progression-free Survival (PFS) Greater Than or Equal to 12 Weeks (Phase II) |
| NCT00616122 (4) [back to overview] | Overall Response Rate |
| NCT00618813 (5) [back to overview] | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37 |
| NCT00618813 (5) [back to overview] | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28 |
| NCT00618813 (5) [back to overview] | Incidence of Death |
| NCT00618813 (5) [back to overview] | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12 |
| NCT00618813 (5) [back to overview] | Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22 |
| NCT00625729 (6) [back to overview] | Number of Patients Whose Disease Progressed After Treatment |
| NCT00625729 (6) [back to overview] | Number of Patients With Adequate Natural Killer Cells Infused |
| NCT00625729 (6) [back to overview] | Number of Patients With Interleukin-15 Production and NK Cell Expansion |
| NCT00625729 (6) [back to overview] | Number of Patients With Overall Survival |
| NCT00625729 (6) [back to overview] | Number of Patients Exhibiting Natural Killer Cell Expansion |
| NCT00625729 (6) [back to overview] | Number of Patients With Overall Response |
| NCT00626197 (6) [back to overview] | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit |
| NCT00626197 (6) [back to overview] | Number of Participants Who Achieved Complete Renal Response (CRR) |
| NCT00626197 (6) [back to overview] | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit |
| NCT00626197 (6) [back to overview] | Percentage of Participants Who Achieved Overall Response |
| NCT00626197 (6) [back to overview] | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit |
| NCT00626197 (6) [back to overview] | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) |
| NCT00626626 (1) [back to overview] | Engraftment of Allogeneic Blood Cells. |
| NCT00629499 (3) [back to overview] | Overall Survival |
| NCT00629499 (3) [back to overview] | Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel |
| NCT00629499 (3) [back to overview] | Disease-free Survival |
| NCT00630032 (6) [back to overview] | Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup |
| NCT00630032 (6) [back to overview] | Number of Event-free Survival |
| NCT00630032 (6) [back to overview] | Overall Survival |
| NCT00630032 (6) [back to overview] | Percentage of Participants With Disease-free Survival (DFS) |
| NCT00630032 (6) [back to overview] | Number of Disease-free Survival Events for Triple-negative Subgroup |
| NCT00630032 (6) [back to overview] | Number of Distant Metastasis-free Survival Events for the Whole Population |
| NCT00630253 (5) [back to overview] | Number of Participants With Chronic Graft-Versus-Host Disease (GVHD) |
| NCT00630253 (5) [back to overview] | Number of Participants With Acute Graft-Versus-Host Disease (GVHD) |
| NCT00630253 (5) [back to overview] | Number of Participants Experiencing Overall Survival |
| NCT00630253 (5) [back to overview] | Number of Participants Experiencing Graft Failure |
| NCT00630253 (5) [back to overview] | Number of Participants With Transplant Related Deaths |
| NCT00632827 (4) [back to overview] | Progression Free Survival |
| NCT00632827 (4) [back to overview] | Complete Response Rate |
| NCT00632827 (4) [back to overview] | Median Time to Response |
| NCT00632827 (4) [back to overview] | Overall Survival Rate |
| NCT00634179 (2) [back to overview] | Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I) |
| NCT00634179 (2) [back to overview] | An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria |
| NCT00635050 (4) [back to overview] | Number of Participant With Clinical or Subclinical Cardiotoxicity |
| NCT00635050 (4) [back to overview] | Rate of Achievement of Pathological Complete Response (pCR) |
| NCT00635050 (4) [back to overview] | Calculate Progression Free Survival |
| NCT00635050 (4) [back to overview] | Assess Toxicities of Regimen Including Hand Foot Syndrome |
| NCT00636155 (3) [back to overview] | Overall Survival |
| NCT00636155 (3) [back to overview] | Number of Patients With an Overall Response (Complete Response + Partial Response) |
| NCT00636155 (3) [back to overview] | Progression Free Survival |
| NCT00636441 (6) [back to overview] | Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer |
| NCT00636441 (6) [back to overview] | Overall Survival |
| NCT00636441 (6) [back to overview] | Sites of Recurrence |
| NCT00636441 (6) [back to overview] | Disease-free Survival |
| NCT00636441 (6) [back to overview] | Clinical Response Using WHO Criteria |
| NCT00636441 (6) [back to overview] | To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt. |
| NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group |
| NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group |
| NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group |
| NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group |
| NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group |
| NCT00651755 (6) [back to overview] | Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group |
| NCT00652899 (4) [back to overview] | Median Number of Days to Progression |
| NCT00652899 (4) [back to overview] | Number of Patients Per Disease Response |
| NCT00652899 (4) [back to overview] | Median Overall Survival Number of Days Patients Alive After Treatment |
| NCT00652899 (4) [back to overview] | Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product |
| NCT00653068 (4) [back to overview] | Toxic Death |
| NCT00653068 (4) [back to overview] | Overall Survival (OS) |
| NCT00653068 (4) [back to overview] | Event-free Survival |
| NCT00653068 (4) [back to overview] | Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy |
| NCT00656669 (4) [back to overview] | Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy |
| NCT00656669 (4) [back to overview] | Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy |
| NCT00656669 (4) [back to overview] | To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy |
| NCT00656669 (4) [back to overview] | Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer |
| NCT00665457 (1) [back to overview] | Number of Participants With Grade 4 Adverse Events |
| NCT00667615 (2) [back to overview] | Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation. |
| NCT00667615 (2) [back to overview] | Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma |
| NCT00668564 (2) [back to overview] | Overall Survival |
| NCT00668564 (2) [back to overview] | Number of Patients Achieving Engraftment |
| NCT00669877 (2) [back to overview] | Complete Remission Rate: Percentage of Participants With Complete Remission (CR) |
| NCT00669877 (2) [back to overview] | Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) |
| NCT00670358 (3) [back to overview] | Progression-free > Survival at 24 Months (Phase 2, Transformed/Composite) |
| NCT00670358 (3) [back to overview] | Toxicity as Assessed by NCI CTCAE v3.0 (Phase I) |
| NCT00670358 (3) [back to overview] | Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3) |
| NCT00670748 (3) [back to overview] | Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) |
| NCT00670748 (3) [back to overview] | Number of Participants With Serious and Non-Serious Adverse Events |
| NCT00670748 (3) [back to overview] | Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells |
| NCT00671034 (9) [back to overview] | Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy) |
| NCT00671034 (9) [back to overview] | Plasma and CSF Concentrations of Asparagine in ug/ml |
| NCT00671034 (9) [back to overview] | Toxicities During Post Induction Intensification Therapy (All Grades) |
| NCT00671034 (9) [back to overview] | Pharmacodynamics (PD) |
| NCT00671034 (9) [back to overview] | Asparaginase Level |
| NCT00671034 (9) [back to overview] | Immunogenicity |
| NCT00671034 (9) [back to overview] | Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction |
| NCT00671034 (9) [back to overview] | Percentage of Participants With Event-free Survival (EFS) |
| NCT00671034 (9) [back to overview] | Percentage of Participants With Complete Remission at the End of Induction |
| NCT00671658 (1) [back to overview] | Number of Participants With a Response |
| NCT00676806 (6) [back to overview] | Proportion of Subjects With Platelet Engraftment |
| NCT00676806 (6) [back to overview] | Infectious Complications in UCB Recipients. |
| NCT00676806 (6) [back to overview] | Incidence of Chronic GVHD |
| NCT00676806 (6) [back to overview] | Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation |
| NCT00676806 (6) [back to overview] | Incidence of Acute GVHD |
| NCT00676806 (6) [back to overview] | Number of Participants With Neutrophil Engraftment |
| NCT00679029 (4) [back to overview] | Overall Survival as Assessed by the Kaplan and Meier Method |
| NCT00679029 (4) [back to overview] | Count of Participants With Related Serious Adverse Events (SAEs) by NCI Common Toxicity Criteria v3.0 |
| NCT00679029 (4) [back to overview] | Disease-free Survival |
| NCT00679029 (4) [back to overview] | Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions |
| NCT00688740 (3) [back to overview] | Number of Participants With Disease-Free Survival Events |
| NCT00688740 (3) [back to overview] | Number of Participants With Overall Survival Events |
| NCT00688740 (3) [back to overview] | Number of Participants With Second Primary Malignancies (Toxicity) |
| NCT00691015 (8) [back to overview] | Karnofsky Performance Status Performance Status |
| NCT00691015 (8) [back to overview] | Overall Survival. |
| NCT00691015 (8) [back to overview] | Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment. |
| NCT00691015 (8) [back to overview] | Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] ) |
| NCT00691015 (8) [back to overview] | Incidence of Acute Graft-versus-host Disease (GVHD) |
| NCT00691015 (8) [back to overview] | Incidence of Chronic GVHD. |
| NCT00691015 (8) [back to overview] | Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders) |
| NCT00691015 (8) [back to overview] | Severity of Acute Graft-versus-host Disease (GVHD) |
| NCT00704938 (2) [back to overview] | Clinical Response (Complete Response + Partial Response) |
| NCT00704938 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00711828 (6) [back to overview] | Duration of Response |
| NCT00711828 (6) [back to overview] | Adverse Events |
| NCT00711828 (6) [back to overview] | Overall Survival |
| NCT00711828 (6) [back to overview] | Progression-free Survival |
| NCT00711828 (6) [back to overview] | Time to Treatment Failure |
| NCT00711828 (6) [back to overview] | Proportion of Responses (Complete Response or Partial Response) |
| NCT00712582 (2) [back to overview] | 2-year PFS From the Start of Induction Therapy Conditional |
| NCT00712582 (2) [back to overview] | Overall Survival at 1 Year |
| NCT00715208 (5) [back to overview] | Percentage of Participants With Progression-free Survival (PFS) at 1 Year |
| NCT00715208 (5) [back to overview] | Duration of Response |
| NCT00715208 (5) [back to overview] | Number of Patients Who Experienced at Least One Serious Adverse Event |
| NCT00715208 (5) [back to overview] | Number of Patients With Complete Response (CR) |
| NCT00715208 (5) [back to overview] | Number of Participants With Overall Response (OR) |
| NCT00718549 (11) [back to overview] | Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 29 |
| NCT00718549 (11) [back to overview] | Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL |
| NCT00718549 (11) [back to overview] | Percentage of Participants With Disease Progression (PD), Relapse, or Death Due to Any Cause Assessed According to the National Cancer Institute (NCI) Revised Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia (CLL) |
| NCT00718549 (11) [back to overview] | Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL |
| NCT00718549 (11) [back to overview] | PFS Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors |
| NCT00718549 (11) [back to overview] | Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 129 |
| NCT00718549 (11) [back to overview] | Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR |
| NCT00718549 (11) [back to overview] | Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR |
| NCT00718549 (11) [back to overview] | Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 29 |
| NCT00718549 (11) [back to overview] | Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 129 |
| NCT00718549 (11) [back to overview] | Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL |
| NCT00719472 (6) [back to overview] | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 |
| NCT00719472 (6) [back to overview] | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) |
| NCT00719472 (6) [back to overview] | Duration of Rituximab Infusion Including Dose Interruption Times |
| NCT00719472 (6) [back to overview] | Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8) |
| NCT00719472 (6) [back to overview] | Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle) |
| NCT00719472 (6) [back to overview] | Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2 |
| NCT00719849 (16) [back to overview] | Incidence of Clinically Significant Infections at 1 Year |
| NCT00719849 (16) [back to overview] | Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year |
| NCT00719849 (16) [back to overview] | Chimerism |
| NCT00719849 (16) [back to overview] | Probability of Survival at 2 Years |
| NCT00719849 (16) [back to overview] | Probability of Survival at 1 Year |
| NCT00719849 (16) [back to overview] | Probability of Progression-free Survival at 2 Years |
| NCT00719849 (16) [back to overview] | Probability of Progression-free Survival at 1 Year |
| NCT00719849 (16) [back to overview] | Incidence of Relapse at 2 Years |
| NCT00719849 (16) [back to overview] | Incidence of Relapse at 1 Year |
| NCT00719849 (16) [back to overview] | Incidence of Platelet Engraftment at 6 Months |
| NCT00719849 (16) [back to overview] | Incidence of Non-relapse Mortality at 6 Months |
| NCT00719849 (16) [back to overview] | Incidence of Neutrophil Engraftment at Day 42 |
| NCT00719849 (16) [back to overview] | Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100 |
| NCT00719849 (16) [back to overview] | Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100 |
| NCT00719849 (16) [back to overview] | Incidence of Clinically Significant Infections at 6 Months |
| NCT00719849 (16) [back to overview] | Incidence of Clinically Significant Infections at 2 Years |
| NCT00720109 (5) [back to overview] | Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy |
| NCT00720109 (5) [back to overview] | Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy |
| NCT00720109 (5) [back to overview] | Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation |
| NCT00720109 (5) [back to overview] | Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib) |
| NCT00720109 (5) [back to overview] | Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events |
| NCT00722137 (11) [back to overview] | Time to Next Anti-lymphoma Treatment (TTNT) |
| NCT00722137 (11) [back to overview] | Treatment-free Interval (TFI) |
| NCT00722137 (11) [back to overview] | Time to Progression (TTP) |
| NCT00722137 (11) [back to overview] | Duration of Response |
| NCT00722137 (11) [back to overview] | Overall Complete Response (CR + CRu) |
| NCT00722137 (11) [back to overview] | Overall Survival (OS) |
| NCT00722137 (11) [back to overview] | 18-Month Survival |
| NCT00722137 (11) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) |
| NCT00722137 (11) [back to overview] | Overall Response Rate (ORR) |
| NCT00722137 (11) [back to overview] | Overall Survival (OS) in Long Term Follow-up Period |
| NCT00722137 (11) [back to overview] | Progression Free Survival (PFS) |
| NCT00723099 (9) [back to overview] | Time to Platelet Engraftment of > 20,000 Cells Per mm3 |
| NCT00723099 (9) [back to overview] | Percent of Patients With Non-relapse Mortality |
| NCT00723099 (9) [back to overview] | Percent of Patients With Non-relapse Mortality |
| NCT00723099 (9) [back to overview] | Percent of Patients With Grade II-IV Acute Graft Versus Host Disease |
| NCT00723099 (9) [back to overview] | Percent of Patients With Chronic GVHD |
| NCT00723099 (9) [back to overview] | Percent of Patients With Acute GVHD Grades III-IV |
| NCT00723099 (9) [back to overview] | Overall Survival |
| NCT00723099 (9) [back to overview] | Number of Participants With Graft Failure/Rejection |
| NCT00723099 (9) [back to overview] | Median Time to ANC > 500 |
| NCT00727415 (6) [back to overview] | Maximum Tolerated Dose of Lenalidomide (Phase I) |
| NCT00727415 (6) [back to overview] | Number of Patients With Severe Infections |
| NCT00727415 (6) [back to overview] | Number of Patients Reaching Disease-free Survival (DSF) Overall |
| NCT00727415 (6) [back to overview] | Toxicity as Assessed by NCI CTCAE v3.0 |
| NCT00727415 (6) [back to overview] | Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.). |
| NCT00727415 (6) [back to overview] | Overall Complete Response (CR) Rate (Phase II) |
| NCT00727441 (3) [back to overview] | Disease Free Survival |
| NCT00727441 (3) [back to overview] | Overall Survival |
| NCT00727441 (3) [back to overview] | Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0 |
| NCT00736450 (2) [back to overview] | Number of Participants With Microarray Testing Results Are Completed Within 7 Days. |
| NCT00736450 (2) [back to overview] | Time to Perform Microarray Study After Receipt of Tissue |
| NCT00739141 (4) [back to overview] | Number of Participants With Neutrophil Recovery Post Allograft for Haplo-dCBT Recipients |
| NCT00739141 (4) [back to overview] | Progression Free Survival/PFS at 1 Year Post UCBT. |
| NCT00739141 (4) [back to overview] | Percentage of Participants With Sustained CB-derived Neutrophil Engraftment |
| NCT00739141 (4) [back to overview] | Percentage of Participants With Sustained CB-derived Platelet Engraftment |
| NCT00741455 (3) [back to overview] | Number of Participants With Successful Bone Marrow Engraftment |
| NCT00741455 (3) [back to overview] | Overall Survival Measured in Participants |
| NCT00741455 (3) [back to overview] | Number of Participants Who Achieve Complete Donor Chimerism |
| NCT00743509 (2) [back to overview] | Median Overall Survival Time |
| NCT00743509 (2) [back to overview] | Number of Patients Alive Without Disease Progression |
| NCT00750815 (4) [back to overview] | Phase II: Two Year Overall Survival (OS) |
| NCT00750815 (4) [back to overview] | Phase II: Progression-Free Survival (PFS) |
| NCT00750815 (4) [back to overview] | Phase I - Maximum Planned Dose (MPD) Level |
| NCT00750815 (4) [back to overview] | Phase II: Overall Response Rate (ORR) |
| NCT00753220 (1) [back to overview] | Maximum Tolerated Dose (MTD) |
| NCT00756470 (2) [back to overview] | Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy |
| NCT00756470 (2) [back to overview] | Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population) |
| NCT00759798 (1) [back to overview] | Number of Participants With Complete Remission (CR) |
| NCT00770224 (4) [back to overview] | 5-year Progression-free Survival |
| NCT00770224 (4) [back to overview] | 5-year Overall Survival |
| NCT00770224 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00770224 (4) [back to overview] | Percentage of Participants With 3-year Progression-free Survival (PFS) |
| NCT00772668 (3) [back to overview] | Rate of Toxicity in Study Participants |
| NCT00772668 (3) [back to overview] | Overall Survival (OS) |
| NCT00772668 (3) [back to overview] | Progression-free Survival (PFS) |
| NCT00774202 (2) [back to overview] | Relative Efficacy of the 2 Groups |
| NCT00774202 (2) [back to overview] | Number of Participants With SAEs |
| NCT00774852 (17) [back to overview] | Proportion of Vaccinated Participants With a Competent Immune Response |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - SF-36 Scores Percent Change From Baseline |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - SF-36 Scores |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - Total BILAG-2004 |
| NCT00774852 (17) [back to overview] | Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response |
| NCT00774852 (17) [back to overview] | Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response |
| NCT00774852 (17) [back to overview] | Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52 |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - Presence of Hypocomplementemia |
| NCT00774852 (17) [back to overview] | Number of Participants With a Complete or Partial Response |
| NCT00774852 (17) [back to overview] | Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - Negative Anti-dsDNA |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104 |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - Patient Global Assessment |
| NCT00774852 (17) [back to overview] | Number of Participants With Complete Response |
| NCT00774852 (17) [back to overview] | Lupus Disease Activity - Frequency of Flares |
| NCT00774852 (17) [back to overview] | Number of Participants With Partial Response |
| NCT00775931 (4) [back to overview] | Incidence of Grade II - IV Acute Graft-versus-host Disease |
| NCT00775931 (4) [back to overview] | Number of Patients Who Achieved Donor Cell Engraftment |
| NCT00775931 (4) [back to overview] | Transplant Related Toxicity |
| NCT00775931 (4) [back to overview] | Transplant Related Mortality at 100 Days |
| NCT00782379 (11) [back to overview] | Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT) |
| NCT00782379 (11) [back to overview] | Overall Survival at 12 Months |
| NCT00782379 (11) [back to overview] | Disease Free Survival at Day 100 |
| NCT00782379 (11) [back to overview] | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation |
| NCT00782379 (11) [back to overview] | Disease Free Survival at 12 Months |
| NCT00782379 (11) [back to overview] | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation |
| NCT00782379 (11) [back to overview] | Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4) |
| NCT00782379 (11) [back to overview] | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation |
| NCT00782379 (11) [back to overview] | Incidence of Graft Rejection for Patients at Day 100 |
| NCT00782379 (11) [back to overview] | Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT) |
| NCT00782379 (11) [back to overview] | Overall Survival at Day 100 |
| NCT00784927 (5) [back to overview] | Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia). |
| NCT00784927 (5) [back to overview] | Assessment of Tumor Response |
| NCT00784927 (5) [back to overview] | Time to Treatment Failure |
| NCT00784927 (5) [back to overview] | Survival Time |
| NCT00784927 (5) [back to overview] | Progression-free Survival Time |
| NCT00787527 (3) [back to overview] | Phase II MTD of Vorinostat |
| NCT00787527 (3) [back to overview] | Phase I Maximum Tolerated Dose (MTD) of Vorinostat |
| NCT00787527 (3) [back to overview] | Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat |
| NCT00787722 (6) [back to overview] | Quality of Life (QOL) Short Form - 36 (SF-36) |
| NCT00787722 (6) [back to overview] | Survival |
| NCT00787722 (6) [back to overview] | NMO-IgG Aquaporin- 4 Autoantibody Titer |
| NCT00787722 (6) [back to overview] | Disability Score: Expanded Disability Status Scale (EDSS) |
| NCT00787722 (6) [back to overview] | Number of Patients Who Require No Device Assistance for Ambulation |
| NCT00787722 (6) [back to overview] | Post HSCT Immune -Modulating Medication and Relapse |
| NCT00787761 (8) [back to overview] | Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease |
| NCT00787761 (8) [back to overview] | T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism) |
| NCT00787761 (8) [back to overview] | Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD) |
| NCT00787761 (8) [back to overview] | Overall Survival (OS) at 24 Months |
| NCT00787761 (8) [back to overview] | T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%) |
| NCT00787761 (8) [back to overview] | Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation |
| NCT00787761 (8) [back to overview] | Disease-free Survival (DFS) at 24 Months |
| NCT00787761 (8) [back to overview] | Non-relapse Mortality (NRM) at Day 180 Post-transplantation |
| NCT00789581 (2) [back to overview] | Overall Survival |
| NCT00789581 (2) [back to overview] | Disease-free Survival |
| NCT00789776 (7) [back to overview] | Number of Subjects Surviving Post-transplant. |
| NCT00789776 (7) [back to overview] | Number of Non-relapse Participant Mortalities |
| NCT00789776 (7) [back to overview] | Number of Participants Who Experienced Graft Failure |
| NCT00789776 (7) [back to overview] | Number of Participants With Dose Limiting Toxicities |
| NCT00789776 (7) [back to overview] | Number of Participants With Grades III-IV Acute GVHD |
| NCT00789776 (7) [back to overview] | Number of Participants Who Experienced Chronic Extensive GVHD |
| NCT00789776 (7) [back to overview] | Number of Participants With Relapsed Disease |
| NCT00791037 (4) [back to overview] | Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT |
| NCT00791037 (4) [back to overview] | Development of CD4+ and CD8+ Epitope Spreading |
| NCT00791037 (4) [back to overview] | Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 |
| NCT00791037 (4) [back to overview] | Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC) |
| NCT00792948 (3) [back to overview] | Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation |
| NCT00792948 (3) [back to overview] | Overall Survival (OS) |
| NCT00792948 (3) [back to overview] | Continuous Complete Remission (CCR) Rate |
| NCT00794820 (3) [back to overview] | Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months |
| NCT00794820 (3) [back to overview] | Overall Survival (OS) Rate |
| NCT00794820 (3) [back to overview] | Remission Duration/Time to Progression (TTP) |
| NCT00796562 (6) [back to overview] | Non-relapse Mortality |
| NCT00796562 (6) [back to overview] | Chronic GVHD |
| NCT00796562 (6) [back to overview] | Survival |
| NCT00796562 (6) [back to overview] | Acute GVHD |
| NCT00796562 (6) [back to overview] | Relapse |
| NCT00796562 (6) [back to overview] | Engraftment as Measured by Donor Chimerism |
| NCT00800839 (6) [back to overview] | Cumulative Incidence of Grade III to IV Acute GVHD |
| NCT00800839 (6) [back to overview] | Day-100 Treatment-Related Mortality |
| NCT00800839 (6) [back to overview] | Cumulative Incidence of Grade II to IV Acute GVHD |
| NCT00800839 (6) [back to overview] | 2-year Progression-Free Survival |
| NCT00800839 (6) [back to overview] | 2-year Overall Survival |
| NCT00800839 (6) [back to overview] | Rate of Engraftment |
| NCT00801632 (8) [back to overview] | Percentage of Participants Surviving Through 156 Weeks |
| NCT00801632 (8) [back to overview] | Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks |
| NCT00801632 (8) [back to overview] | Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection |
| NCT00801632 (8) [back to overview] | Change in Renal Function |
| NCT00801632 (8) [back to overview] | Percentage of Participants Experiencing Acute Rejection |
| NCT00801632 (8) [back to overview] | Time to Platelet Recovery Following Transplant |
| NCT00801632 (8) [back to overview] | Time to Neutrophil Recovery Following Transplant |
| NCT00801632 (8) [back to overview] | Percentage of Participants With Graft Survival Through 156 Weeks |
| NCT00809276 (1) [back to overview] | To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD |
| NCT00813150 (4) [back to overview] | Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria |
| NCT00813150 (4) [back to overview] | Progression-Free Survival (PFS) |
| NCT00813150 (4) [back to overview] | Time to Progression of Disease |
| NCT00813150 (4) [back to overview] | Overall Survival (OS) |
| NCT00816595 (3) [back to overview] | Complete and Overall Response Rate |
| NCT00816595 (3) [back to overview] | Progression-free Survival |
| NCT00816595 (3) [back to overview] | Overall Survival |
| NCT00818961 (11) [back to overview] | Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism |
| NCT00818961 (11) [back to overview] | Survival at Day 100 |
| NCT00818961 (11) [back to overview] | Platelet Engraftment |
| NCT00818961 (11) [back to overview] | Overall Survival at 1 Year |
| NCT00818961 (11) [back to overview] | Non-relapse Mortality at 1 Year Post-transplant |
| NCT00818961 (11) [back to overview] | Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant |
| NCT00818961 (11) [back to overview] | Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant |
| NCT00818961 (11) [back to overview] | Number of Patients Experiencing Chronic Graft Versus Host Disease |
| NCT00818961 (11) [back to overview] | Non-relapse Mortality at Day 100 |
| NCT00818961 (11) [back to overview] | Neutrophil Recovery |
| NCT00818961 (11) [back to overview] | Complete Donor Chimerism |
| NCT00822120 (8) [back to overview] | Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00822120 (8) [back to overview] | Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging. |
| NCT00822120 (8) [back to overview] | Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. |
| NCT00822120 (8) [back to overview] | Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging |
| NCT00822120 (8) [back to overview] | Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. |
| NCT00822120 (8) [back to overview] | Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT00822120 (8) [back to overview] | Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD |
| NCT00822120 (8) [back to overview] | Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS |
| NCT00828009 (3) [back to overview] | Proportion of Patients With Target Adverse Events for the Step 2 Treatment |
| NCT00828009 (3) [back to overview] | Overall Survival |
| NCT00828009 (3) [back to overview] | Progression-free Survival |
| NCT00833560 (4) [back to overview] | Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set) |
| NCT00833560 (4) [back to overview] | Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set) |
| NCT00833560 (4) [back to overview] | Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set) |
| NCT00833560 (4) [back to overview] | Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set) |
| NCT00841828 (2) [back to overview] | Overall Clinical Response Rate (ORR) |
| NCT00841828 (2) [back to overview] | Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D). |
| NCT00847171 (3) [back to overview] | Safety as Assessed by Number of Participants Experiencing Toxicity |
| NCT00847171 (3) [back to overview] | Clinical Benefit as Assessed by Number of Participants With Progression-free Survival |
| NCT00847171 (3) [back to overview] | Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides |
| NCT00849251 (2) [back to overview] | Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1) [MTD Cyclophosphamide, MTD Bortezmib, MTD Docxorubicin] |
| NCT00849251 (2) [back to overview] | Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1). [Dexamethasone MTD] |
| NCT00849472 (11) [back to overview] | Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods |
| NCT00849472 (11) [back to overview] | Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period |
| NCT00849472 (11) [back to overview] | Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods |
| NCT00849472 (11) [back to overview] | Number of Participants With the Indicated Radiotherapy-related Complications |
| NCT00849472 (11) [back to overview] | Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period |
| NCT00849472 (11) [back to overview] | Number of Participants With Pathologic Complete Response (pCR) in the Breast |
| NCT00849472 (11) [back to overview] | Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes |
| NCT00849472 (11) [back to overview] | Invasive Recurrence-free Interval (IRFI) |
| NCT00849472 (11) [back to overview] | Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods |
| NCT00849472 (11) [back to overview] | Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period |
| NCT00849472 (11) [back to overview] | Number of Participants With Recurrence Events |
| NCT00856180 (5) [back to overview] | Grade 3-5 Gastrointestinal Perforation |
| NCT00856180 (5) [back to overview] | Clinical Benefit Response Rate |
| NCT00856180 (5) [back to overview] | Progression-Free Survival (PFS) |
| NCT00856180 (5) [back to overview] | Therapy Completion Rate |
| NCT00856180 (5) [back to overview] | Overall Survival (OS) |
| NCT00856492 (4) [back to overview] | Event-free Survival |
| NCT00856492 (4) [back to overview] | Number of Patients With Pathological Complete Response Rate |
| NCT00856492 (4) [back to overview] | Overall Survival |
| NCT00856492 (4) [back to overview] | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug |
| NCT00857389 (7) [back to overview] | Overall Survival Rate |
| NCT00857389 (7) [back to overview] | Relapse Rate of Participants Treated With Thiotepa, Busulfan, and Clofarabine |
| NCT00857389 (7) [back to overview] | Engraftment |
| NCT00857389 (7) [back to overview] | Graft vs Host Disease (GVHD) |
| NCT00857389 (7) [back to overview] | Number of Participants With Disease Free Survival |
| NCT00857389 (7) [back to overview] | Number of Participants With Serious Adverse Events |
| NCT00857389 (7) [back to overview] | Number of Participants With Survival Rate at 100 Days Post-transplant |
| NCT00861705 (7) [back to overview] | Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0). |
| NCT00861705 (7) [back to overview] | Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0). |
| NCT00861705 (7) [back to overview] | Overall Survival |
| NCT00861705 (7) [back to overview] | Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence. |
| NCT00861705 (7) [back to overview] | Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6) |
| NCT00861705 (7) [back to overview] | Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). |
| NCT00861705 (7) [back to overview] | Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). |
| NCT00866307 (2) [back to overview] | AALL08P1 Safety Outcome |
| NCT00866307 (2) [back to overview] | AALL08P1 Feasibility Outcome |
| NCT00866749 (4) [back to overview] | 3-Year Event-Free Survival (EFS) |
| NCT00866749 (4) [back to overview] | Participants Achieving Negative Minimal Residual Disease (MRD) |
| NCT00866749 (4) [back to overview] | Participants With a Complete Response (CR) |
| NCT00866749 (4) [back to overview] | Overall Survival |
| NCT00866905 (4) [back to overview] | Overall Survival |
| NCT00866905 (4) [back to overview] | Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain |
| NCT00866905 (4) [back to overview] | Pathologic Complete Response Rate (pCR) |
| NCT00866905 (4) [back to overview] | Disease Free Survival |
| NCT00871689 (8) [back to overview] | Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease |
| NCT00871689 (8) [back to overview] | Number of Patients With Neutrophil Engraftment |
| NCT00871689 (8) [back to overview] | Number of Patients With Successful Natural Killer Expansion |
| NCT00871689 (8) [back to overview] | Number of Patients With Transplant-Related Death (TRD) |
| NCT00871689 (8) [back to overview] | Incidence of Primary Graft Failure |
| NCT00871689 (8) [back to overview] | Median Overall Survival |
| NCT00871689 (8) [back to overview] | Number of Patients With Acute Graft-Versus-Host (GVHD) Disease |
| NCT00871689 (8) [back to overview] | Number of Patients With Complete Remission of Disease |
| NCT00873093 (7) [back to overview] | Toxic Death Rate |
| NCT00873093 (7) [back to overview] | Severe Adverse Events (SAE) Rate. |
| NCT00873093 (7) [back to overview] | Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy |
| NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 |
| NCT00873093 (7) [back to overview] | Event Free Survival |
| NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 |
| NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 |
| NCT00877006 (17) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period |
| NCT00877006 (17) [back to overview] | Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period |
| NCT00877006 (17) [back to overview] | Percentage of Participants With Complete Response (CR) at End of Treatment Period |
| NCT00877006 (17) [back to overview] | Therapeutic Classification of Concomitant Medications |
| NCT00877006 (17) [back to overview] | Therapeutic Classification of Prior Medications |
| NCT00877006 (17) [back to overview] | Percentage of Participants With Overall Response at End of Treatment Period |
| NCT00877006 (17) [back to overview] | Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results |
| NCT00877006 (17) [back to overview] | Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period |
| NCT00877006 (17) [back to overview] | Overall Survival (OS) |
| NCT00877006 (17) [back to overview] | Kaplan-Meier Estimate for Progression-free Survival (PFS) |
| NCT00877006 (17) [back to overview] | Kaplan-Meier Estimate for Duration of Response (DOR) |
| NCT00877006 (17) [back to overview] | Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30) |
| NCT00877006 (17) [back to overview] | Worst Overall CTCAE Grade for Hematology Laboratory Test Results |
| NCT00877006 (17) [back to overview] | Potentially Clinically Significant Abnormal Weight |
| NCT00877006 (17) [back to overview] | Kaplan-Meier Estimate for Event-free Survival (EFS) |
| NCT00877006 (17) [back to overview] | Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period |
| NCT00877006 (17) [back to overview] | Clinically Significant Abnormal Vital Signs |
| NCT00883129 (9) [back to overview] | Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI) |
| NCT00883129 (9) [back to overview] | Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value |
| NCT00883129 (9) [back to overview] | Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure. |
| NCT00883129 (9) [back to overview] | Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT) |
| NCT00883129 (9) [back to overview] | Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value |
| NCT00883129 (9) [back to overview] | Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS) |
| NCT00883129 (9) [back to overview] | Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death |
| NCT00883129 (9) [back to overview] | Transitional Dyspnea Index Score |
| NCT00883129 (9) [back to overview] | Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value |
| NCT00890656 (1) [back to overview] | Number of Participants With Complete Remission |
| NCT00899847 (8) [back to overview] | Event-free Survival (EFS) |
| NCT00899847 (8) [back to overview] | Complete Response Rate (CRR) |
| NCT00899847 (8) [back to overview] | Overall Response Rate (ORR) |
| NCT00899847 (8) [back to overview] | Median Time to Engraftment After Auto-PBSC Transplant |
| NCT00899847 (8) [back to overview] | Partial Response Rate (PRR) |
| NCT00899847 (8) [back to overview] | Median Time to Engraftment After Allo-PBSC Transplant |
| NCT00899847 (8) [back to overview] | Incidence of Graft Versus Host Disease (GvHD) |
| NCT00899847 (8) [back to overview] | Overall Survival (OS) |
| NCT00908232 (6) [back to overview] | Median Time to First Confirmed Response |
| NCT00908232 (6) [back to overview] | Overall Best Confirmed Response |
| NCT00908232 (6) [back to overview] | One Year Survival |
| NCT00908232 (6) [back to overview] | Progression Free Survival |
| NCT00908232 (6) [back to overview] | Overall Survival |
| NCT00908232 (6) [back to overview] | Time to Progression |
| NCT00911183 (4) [back to overview] | Number of Participants in Complete Remission 6 Months After Randomization |
| NCT00911183 (4) [back to overview] | Number of Participants With Severe Toxicity |
| NCT00911183 (4) [back to overview] | Overall Survival Time |
| NCT00911183 (4) [back to overview] | Progression-free Survival Time |
| NCT00918723 (4) [back to overview] | To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat |
| NCT00918723 (4) [back to overview] | Percentage of Patients With Progression-free Survival at 2 Years |
| NCT00918723 (4) [back to overview] | Overall Survival |
| NCT00918723 (4) [back to overview] | Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I) |
| NCT00923195 (2) [back to overview] | Toxicity Profile |
| NCT00923195 (2) [back to overview] | Complete Response Rates for Patients With Metastatic Melanoma |
| NCT00923364 (7) [back to overview] | Number of Participants With Disease Free Survival |
| NCT00923364 (7) [back to overview] | Overall Survival |
| NCT00923364 (7) [back to overview] | Days to Neutrophil Engraftment |
| NCT00923364 (7) [back to overview] | Days to Platelet Engraftment |
| NCT00923364 (7) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
| NCT00923364 (7) [back to overview] | Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2) |
| NCT00923364 (7) [back to overview] | Incidence of Acute and Chronic Graft-versus-host Disease (GVHD) |
| NCT00923845 (16) [back to overview] | Count of Participants With Adverse Events |
| NCT00923845 (16) [back to overview] | Count of Patients Having Neutropenia Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen |
| NCT00923845 (16) [back to overview] | Count of Patients Having an Infectious Complication Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen |
| NCT00923845 (16) [back to overview] | Count of Patients With Grade II or Greater Acute Graft Versus Host Disease (GVHD) in First 100 Days Post-Transplant |
| NCT00923845 (16) [back to overview] | Count of Patients With Late Acute Graft Versus Host Disease (GVHD) After Day 100 Post-Transplant |
| NCT00923845 (16) [back to overview] | Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR)) |
| NCT00923845 (16) [back to overview] | Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution |
| NCT00923845 (16) [back to overview] | Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution |
| NCT00923845 (16) [back to overview] | Engraftment Donor T Cell and Myeloid Cell Chimerism |
| NCT00923845 (16) [back to overview] | Immune Depletion in Cluster of Differentiation 4 (CD4) Cells |
| NCT00923845 (16) [back to overview] | Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells |
| NCT00923845 (16) [back to overview] | Immune Suppression |
| NCT00923845 (16) [back to overview] | Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3)) |
| NCT00923845 (16) [back to overview] | Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet |
| NCT00923845 (16) [back to overview] | Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3) |
| NCT00923845 (16) [back to overview] | Count of Patients With Chronic Graft Versus Host Disease (GVHD) |
| NCT00924001 (3) [back to overview] | Number of Participiants With In-vivo Survival of Infused Cells |
| NCT00924001 (3) [back to overview] | Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria |
| NCT00924001 (3) [back to overview] | Number of Participants With Adverse Events |
| NCT00924170 (17) [back to overview] | Area Under the Plasma Concentration (AUC) - LMB2 |
| NCT00924170 (17) [back to overview] | Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders |
| NCT00924170 (17) [back to overview] | Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry |
| NCT00924170 (17) [back to overview] | Percentage of Participants With a Minimally Durable Clinical Response Rate |
| NCT00924170 (17) [back to overview] | Count of Participants With Grades 3-5 Adverse Events of > 1 Adult T-Cell Leukemia (ATL) Patients Treated With 20+200, 25+250, and 30+300 mg/m^2 LMB-2/Fludarabine and Cyclophosphamide |
| NCT00924170 (17) [back to overview] | Count of Participants With Adverse Events Attributed At Least Possibly to Patients Treated With Fludarabine and Cyclophosphamide Dose Levels 20+200, 25+250, and 30+300 mg/m^2 |
| NCT00924170 (17) [back to overview] | Volume of Distribution of LMB-2 |
| NCT00924170 (17) [back to overview] | Progression Free Survival (PFS) |
| NCT00924170 (17) [back to overview] | Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders |
| NCT00924170 (17) [back to overview] | Plasma Clearance (CL) of LMB-2 |
| NCT00924170 (17) [back to overview] | Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2 |
| NCT00924170 (17) [back to overview] | Peak Level of LMB-2 in Adult T-Cell Lymphoma |
| NCT00924170 (17) [back to overview] | Overall Survival (OS) |
| NCT00924170 (17) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
| NCT00924170 (17) [back to overview] | Number of Participants With Dose Limiting Toxicity (DLT) |
| NCT00924170 (17) [back to overview] | Half Life (t1/2) of LMB-2 |
| NCT00924170 (17) [back to overview] | Duration of Response (Complete Response + Partial Response) |
| NCT00924287 (2) [back to overview] | Number of Participants With In Vivo Survival of Transfused Cells |
| NCT00924287 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT00924326 (2) [back to overview] | Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma |
| NCT00924326 (2) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). |
| NCT00925652 (4) [back to overview] | Number of Serious Adverse Event of Bevacizumab |
| NCT00925652 (4) [back to overview] | Number of Serious Adverse Event (AE) of Lifestyle |
| NCT00925652 (4) [back to overview] | Median 3-year Recurrence-free Survival (RFS) |
| NCT00925652 (4) [back to overview] | Number of Serious Adverse Event of Metronomic Chemotherapy |
| NCT00931918 (10) [back to overview] | Progression-Free Survival Rate |
| NCT00931918 (10) [back to overview] | Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL) |
| NCT00931918 (10) [back to overview] | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category |
| NCT00931918 (10) [back to overview] | Duration of Response |
| NCT00931918 (10) [back to overview] | Time to Progression (TTP) |
| NCT00931918 (10) [back to overview] | Overall Survival |
| NCT00931918 (10) [back to overview] | Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher |
| NCT00931918 (10) [back to overview] | Overall Response Rate (ORR) |
| NCT00931918 (10) [back to overview] | Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate |
| NCT00931918 (10) [back to overview] | Complete Response Rate |
| NCT00939653 (2) [back to overview] | Achievement of Complete Remission (CR) at Reinduction |
| NCT00939653 (2) [back to overview] | Death |
| NCT00941720 (3) [back to overview] | Relapse-free Survival |
| NCT00941720 (3) [back to overview] | Pulmonary Toxicity |
| NCT00941720 (3) [back to overview] | Overall Survival |
| NCT00944047 (1) [back to overview] | Pathologic Complete Response |
| NCT00946023 (12) [back to overview] | Graft Failure |
| NCT00946023 (12) [back to overview] | Incidence of Chronic GVHD |
| NCT00946023 (12) [back to overview] | Incidence of Grades II-IV Acute Graft-versus-Host-Disease (GVHD) |
| NCT00946023 (12) [back to overview] | Incidence of Grades III-IV Acute GVHD |
| NCT00946023 (12) [back to overview] | Non-relapse Mortality |
| NCT00946023 (12) [back to overview] | Engraftment |
| NCT00946023 (12) [back to overview] | Relapse |
| NCT00946023 (12) [back to overview] | Progression-free Survival |
| NCT00946023 (12) [back to overview] | Progression-free Survival |
| NCT00946023 (12) [back to overview] | Overall Survival |
| NCT00946023 (12) [back to overview] | Overall Survival |
| NCT00946023 (12) [back to overview] | Relapse |
| NCT00948090 (4) [back to overview] | Overall Response Rate |
| NCT00948090 (4) [back to overview] | Number of Transplant-related Death Events Until Day 100. |
| NCT00948090 (4) [back to overview] | Number of Progression Events in 2 Years. |
| NCT00948090 (4) [back to overview] | Number of Death Events in 2 Years. |
| NCT00950300 (22) [back to overview] | Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab |
| NCT00950300 (22) [back to overview] | Tmax of Trastuzumab After Surgery |
| NCT00950300 (22) [back to overview] | AUC21d of Trastuzumab After Surgery |
| NCT00950300 (22) [back to overview] | Cmax of Trastuzumab After Surgery |
| NCT00950300 (22) [back to overview] | Event-Free Survival (EFS) |
| NCT00950300 (22) [back to overview] | Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery |
| NCT00950300 (22) [back to overview] | Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery |
| NCT00950300 (22) [back to overview] | Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery |
| NCT00950300 (22) [back to overview] | Observed Ctrough of Trastuzumab After Surgery |
| NCT00950300 (22) [back to overview] | Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery |
| NCT00950300 (22) [back to overview] | Overall Survival (OS) |
| NCT00950300 (22) [back to overview] | Percentage of Participants Who Died |
| NCT00950300 (22) [back to overview] | Percentage of Participants Who Experienced a Protocol-Defined Event |
| NCT00950300 (22) [back to overview] | Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline |
| NCT00950300 (22) [back to overview] | Percentage of Participants With Pathological Complete Response (pCR) |
| NCT00950300 (22) [back to overview] | Percentage of Participants With Total Pathological Complete Response (tpCR) |
| NCT00950300 (22) [back to overview] | Number of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20) |
| NCT00950300 (22) [back to overview] | Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery |
| NCT00950300 (22) [back to overview] | Predicted Ctrough of Trastuzumab After Surgery |
| NCT00950300 (22) [back to overview] | Predicted Ctrough of Trastuzumab Prior to Surgery |
| NCT00950300 (22) [back to overview] | Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery |
| NCT00950300 (22) [back to overview] | Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline |
| NCT00950846 (6) [back to overview] | Overall Survival at 1 Year After Umbilical Cord Blood Transplant in Pediatric Patients. |
| NCT00950846 (6) [back to overview] | Incidence of Severe Grade III-IV Acute GvHD at Day 100. |
| NCT00950846 (6) [back to overview] | Number of Participants With Chronic GvHD |
| NCT00950846 (6) [back to overview] | Overall Survival at 100 Days After Umbilical Cord Blood Transplant in Pediatric Patients. |
| NCT00950846 (6) [back to overview] | Overall Survival at 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients. |
| NCT00950846 (6) [back to overview] | Number of Participants With Donor Engraftment After Transplant. |
| NCT00958256 (1) [back to overview] | Response Rate |
| NCT00960063 (3) [back to overview] | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) |
| NCT00960063 (3) [back to overview] | Number of Participants With Dose Limiting Toxicities |
| NCT00960063 (3) [back to overview] | Number of Participants Who Developed Anti-robatumumab Antibodies |
| NCT00960115 (4) [back to overview] | Overall Survival (OS) Time |
| NCT00960115 (4) [back to overview] | Time To Progression (TTP) - Investigator Read |
| NCT00960115 (4) [back to overview] | Time to Treatment Failure (TTF) |
| NCT00960115 (4) [back to overview] | Progression Free Survival (PFS) Time - Investigator Read |
| NCT00963872 (20) [back to overview] | Bone Marrow Chimerism |
| NCT00963872 (20) [back to overview] | Neutrophil Engraftment |
| NCT00963872 (20) [back to overview] | Number of Patients With the Complement 3a (C3a) Unit Predominating |
| NCT00963872 (20) [back to overview] | Overall Survival at Day 720 |
| NCT00963872 (20) [back to overview] | Overall Survival |
| NCT00963872 (20) [back to overview] | Platelet Recovery |
| NCT00963872 (20) [back to overview] | Relapse of Disease |
| NCT00963872 (20) [back to overview] | Relapse of Disease |
| NCT00963872 (20) [back to overview] | Non-relapse Mortality |
| NCT00963872 (20) [back to overview] | Non-Relapse Mortality |
| NCT00963872 (20) [back to overview] | Incidence of Grades III-IV Graft-vs-host Disease |
| NCT00963872 (20) [back to overview] | Incidence of Grades II-IV Graft-vs-host Disease |
| NCT00963872 (20) [back to overview] | Donor Chimerism in Blood |
| NCT00963872 (20) [back to overview] | Donor Chimerism in Blood |
| NCT00963872 (20) [back to overview] | Donor Chimerism |
| NCT00963872 (20) [back to overview] | Donor Chimerism |
| NCT00963872 (20) [back to overview] | Donor Chimerism |
| NCT00963872 (20) [back to overview] | Disease Progression |
| NCT00963872 (20) [back to overview] | Disease Progression |
| NCT00963872 (20) [back to overview] | Chronic Graft-Versus-Host Disease |
| NCT00968253 (3) [back to overview] | Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg) |
| NCT00968253 (3) [back to overview] | Overall Response Rate (OR) Where OR = CR + CRp + CRi |
| NCT00968253 (3) [back to overview] | Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT) |
| NCT00971737 (3) [back to overview] | Toxicity as Assessed by Number of Grade 3 or 4 Adverse Events |
| NCT00971737 (3) [back to overview] | HER-2/Neu-specific Immune Responses as Measured by Number of Participants With Positive for Delayed-type Hypersensitivity (DTH) Response |
| NCT00971737 (3) [back to overview] | Clinical Benefit (CB) as Assessed by Progression Free Survival at Six Months |
| NCT00972478 (5) [back to overview] | Progression-free Survival (Phase II) |
| NCT00972478 (5) [back to overview] | Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL |
| NCT00972478 (5) [back to overview] | Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II) |
| NCT00972478 (5) [back to overview] | Overall Survival (Phase II) |
| NCT00972478 (5) [back to overview] | Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I) |
| NCT00977691 (10) [back to overview] | Number of Participants That Experienced a Transplant-related Mortality |
| NCT00977691 (10) [back to overview] | Number of Participants Who Develop Extensive GVHD |
| NCT00977691 (10) [back to overview] | Number of Participants Who Developed Limited Chronic GVHD |
| NCT00977691 (10) [back to overview] | Number of Participants With Disease-free Survival |
| NCT00977691 (10) [back to overview] | Number of Participants With Graft Failure |
| NCT00977691 (10) [back to overview] | Participants Who Engrafted or Rejected and Type of Haploidentical Donors |
| NCT00977691 (10) [back to overview] | Number of Stem Cell Transplant Participants That Experienced Rejection at Each Dose of Post-transplant Cyclophosphamide |
| NCT00977691 (10) [back to overview] | Number of Participants Who Developed Acute GVHD Grades I, II, III, IV |
| NCT00977691 (10) [back to overview] | Chimeric Value That is Required to Maintain Graft Survival and Hematologic Normalcy. |
| NCT00977691 (10) [back to overview] | Patients With Donor Type Hemoglobin |
| NCT00981799 (2) [back to overview] | To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL. |
| NCT00981799 (2) [back to overview] | To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. |
| NCT00987480 (4) [back to overview] | The Incidence of Acute GvHD |
| NCT00987480 (4) [back to overview] | The Incidence of Early Transplant Related Mortality |
| NCT00987480 (4) [back to overview] | Disease-free Survival at 3 Years |
| NCT00987480 (4) [back to overview] | Overall Survival at 3 Years |
| NCT01000285 (8) [back to overview] | Time to Progression |
| NCT01000285 (8) [back to overview] | Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events |
| NCT01000285 (8) [back to overview] | Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads |
| NCT01000285 (8) [back to overview] | Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence |
| NCT01000285 (8) [back to overview] | Effects of HTLV-1 Integration Sites After Treatment |
| NCT01000285 (8) [back to overview] | Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA |
| NCT01000285 (8) [back to overview] | Efficacy of Treatment as Measured by Best Overall Response |
| NCT01000285 (8) [back to overview] | Relation of NFκB Gene Expression Profile on Response |
| NCT01004991 (1) [back to overview] | Complete Response |
| NCT01008150 (6) [back to overview] | Pathologic Complete Response in Breast and Axillary Lymph Nodes. |
| NCT01008150 (6) [back to overview] | Clinical Complete Response, as Measured by Physical Exam |
| NCT01008150 (6) [back to overview] | Recurrence-free Interval (RFI) |
| NCT01008150 (6) [back to overview] | Adverse Events Experienced by Participants as a Measure of Toxicity |
| NCT01008150 (6) [back to overview] | Pathologic Complete Response in Breast. |
| NCT01008150 (6) [back to overview] | Overall Survival |
| NCT01008462 (7) [back to overview] | Event-Free Survival (EFS) |
| NCT01008462 (7) [back to overview] | Number of Patients Who Engrafted |
| NCT01008462 (7) [back to overview] | Number of Patients Who Had Infections |
| NCT01008462 (7) [back to overview] | Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease |
| NCT01008462 (7) [back to overview] | Number of Patients With Relapsed/Progressive Disease |
| NCT01008462 (7) [back to overview] | Overall Survival |
| NCT01008462 (7) [back to overview] | Non-relapse Mortality (NRM) |
| NCT01010217 (6) [back to overview] | cGVHD |
| NCT01010217 (6) [back to overview] | Disease Free Survival |
| NCT01010217 (6) [back to overview] | Engraftments |
| NCT01010217 (6) [back to overview] | Grade III-IV aGVHD |
| NCT01010217 (6) [back to overview] | Number of Participants With Non Related Mortality (NRM) |
| NCT01010217 (6) [back to overview] | Number of Participants With Non-relapse Mortality (NRM) |
| NCT01015443 (6) [back to overview] | Progression Free Survival (PFS) |
| NCT01015443 (6) [back to overview] | Time to Progression (TTP) |
| NCT01015443 (6) [back to overview] | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death |
| NCT01015443 (6) [back to overview] | Time to Treatment Failure (TTF) |
| NCT01015443 (6) [back to overview] | Overall Survival (OS) Time |
| NCT01015443 (6) [back to overview] | Time to Symptom Progression (TTSP) |
| NCT01022138 (3) [back to overview] | Overall Response Rate |
| NCT01022138 (3) [back to overview] | Number of Participant Who Were Alive Without Progression at 4 Months |
| NCT01022138 (3) [back to overview] | Overall Survival |
| NCT01024010 (5) [back to overview] | Arm B: Treatment-free Survival at 18 Months |
| NCT01024010 (5) [back to overview] | Treatment-free Survival |
| NCT01024010 (5) [back to overview] | Arm A: Percentage of Complete Responses |
| NCT01024010 (5) [back to overview] | Depth of Response After Ofatumumab Consolidation |
| NCT01024010 (5) [back to overview] | Overall Response Rate |
| NCT01026220 (7) [back to overview] | Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy |
| NCT01026220 (7) [back to overview] | Relapse-free Survival |
| NCT01026220 (7) [back to overview] | Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative |
| NCT01026220 (7) [back to overview] | Overall Survival |
| NCT01026220 (7) [back to overview] | Event Free Survival |
| NCT01026220 (7) [back to overview] | Safety Analysis and Monitoring of Toxic Death |
| NCT01026220 (7) [back to overview] | Second-event-free Survival |
| NCT01027000 (1) [back to overview] | 2-year Progression-free Survival in Early Disease Participants |
| NCT01028716 (12) [back to overview] | Time to Platelet Recovery |
| NCT01028716 (12) [back to overview] | Time to Neutrophil Recovery |
| NCT01028716 (12) [back to overview] | Relapse of Malignancy After Transplantation |
| NCT01028716 (12) [back to overview] | Point Estimate of Overall Survival at 3 Years |
| NCT01028716 (12) [back to overview] | Percentage of Participants With Chronic Graft Versus Host Disease |
| NCT01028716 (12) [back to overview] | Number of Red Blood Cell Transfusions |
| NCT01028716 (12) [back to overview] | Non-relapse Mortality at 1 Year |
| NCT01028716 (12) [back to overview] | Incidence of Primary Graft Failure |
| NCT01028716 (12) [back to overview] | Incidence of Grades III/IV Acute Graft Versus Host Disease |
| NCT01028716 (12) [back to overview] | Disease-free Survival |
| NCT01028716 (12) [back to overview] | Number of Platelet Transfusions |
| NCT01028716 (12) [back to overview] | Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System |
| NCT01030900 (4) [back to overview] | Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) |
| NCT01030900 (4) [back to overview] | Progression Free Survival (PFS) |
| NCT01030900 (4) [back to overview] | Overall Survival (OS) |
| NCT01030900 (4) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
| NCT01036087 (2) [back to overview] | Number of Participants With Treatment-related Adverse Events (AEs) |
| NCT01036087 (2) [back to overview] | Number of Participants That Achieved Pathologic Complete Response (CR) |
| NCT01040871 (7) [back to overview] | Rate of Durable Complete Response |
| NCT01040871 (7) [back to overview] | Progression-free Survival (PFS)Rate at 1-year |
| NCT01040871 (7) [back to overview] | Rate of Durable Response |
| NCT01040871 (7) [back to overview] | Overall Survival Rate at 1-year |
| NCT01040871 (7) [back to overview] | Subsequent Anti-lymphoma Therapy Rate at 1-year |
| NCT01040871 (7) [back to overview] | Complete Response (CR) Rate |
| NCT01040871 (7) [back to overview] | Overall Response Rate |
| NCT01043640 (12) [back to overview] | Donor Cell Chimerism Following Transplant |
| NCT01043640 (12) [back to overview] | Donor Cell Chimerism Following Transplant |
| NCT01043640 (12) [back to overview] | Donor Cell Chimerism Following Transplant |
| NCT01043640 (12) [back to overview] | Donor Cell Chimerism Following Transplant |
| NCT01043640 (12) [back to overview] | Number of Patients Who Died Peri-Transplant |
| NCT01043640 (12) [back to overview] | Number of Patients With Donor Derived Engraftment |
| NCT01043640 (12) [back to overview] | Number of Patients With Grade 0 Graft-Versus-Host Disease (GVHD) |
| NCT01043640 (12) [back to overview] | Number of Patients With Grade 1 Graft-Versus-Host Disease (GVHD) |
| NCT01043640 (12) [back to overview] | Number of Patients With Grade 3 Graft-Versus-Host Disease (GVHD) |
| NCT01043640 (12) [back to overview] | Number of Patients With Grade 4 Graft-Versus-Host Disease (GVHD) |
| NCT01043640 (12) [back to overview] | Number of Patients With Grade 2 Graft-Versus-Host Disease (GVHD) |
| NCT01043640 (12) [back to overview] | Donor Cell Chimerism Following Transplant |
| NCT01044745 (4) [back to overview] | Event-free Survival |
| NCT01044745 (4) [back to overview] | Number of Participants With Grades II-IV Acute GVHD |
| NCT01044745 (4) [back to overview] | Overall Survival |
| NCT01044745 (4) [back to overview] | Transplant-related Mortality (TRM) |
| NCT01045460 (5) [back to overview] | Feasibility as Measured by Participant Withdrawal or Removal |
| NCT01045460 (5) [back to overview] | Overall Survival |
| NCT01045460 (5) [back to overview] | Progression-free Survival |
| NCT01045460 (5) [back to overview] | Safety as Measured by Grade 3-5 Adverse Events |
| NCT01045460 (5) [back to overview] | Response Rates by Blade Criteria |
| NCT01055314 (5) [back to overview] | Response Rate (CR + PR) |
| NCT01055314 (5) [back to overview] | Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment |
| NCT01055314 (5) [back to overview] | Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0 |
| NCT01055314 (5) [back to overview] | Event-Free Survival |
| NCT01055314 (5) [back to overview] | Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment |
| NCT01055496 (17) [back to overview] | Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2 |
| NCT01055496 (17) [back to overview] | Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1 |
| NCT01055496 (17) [back to overview] | Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts |
| NCT01055496 (17) [back to overview] | Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts |
| NCT01055496 (17) [back to overview] | Percentage of Participants With a Treatment Emergent AE |
| NCT01055496 (17) [back to overview] | Mean Inotuzumab Ozogamicin Serum Concentrations |
| NCT01055496 (17) [back to overview] | Mean Inotuzumab Ozogamicin Serum Concentrations |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts. |
| NCT01055496 (17) [back to overview] | Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts |
| NCT01055496 (17) [back to overview] | Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts |
| NCT01055496 (17) [back to overview] | Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts |
| NCT01057225 (11) [back to overview] | Stem Cell Collection and Engraftment (Phase II) |
| NCT01057225 (11) [back to overview] | Progression-free Survival (Phase II) |
| NCT01057225 (11) [back to overview] | Survival Time (Phase II) |
| NCT01057225 (11) [back to overview] | Maximum Tolerated Dose (Phase I) |
| NCT01057225 (11) [back to overview] | Overall Survival (12 Month) |
| NCT01057225 (11) [back to overview] | Complete Response (Phase II) |
| NCT01057225 (11) [back to overview] | Time to Treatment Failure |
| NCT01057225 (11) [back to overview] | Overall Survival (24 Month) |
| NCT01057225 (11) [back to overview] | Progression Free Survival (12 Month) |
| NCT01057225 (11) [back to overview] | Progession Free Survival (24 Month) |
| NCT01057225 (11) [back to overview] | Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II) |
| NCT01072773 (5) [back to overview] | Overall Survival |
| NCT01072773 (5) [back to overview] | Time to Disease Progression |
| NCT01072773 (5) [back to overview] | Number of Participants With a Confirmed Hematologic Response |
| NCT01072773 (5) [back to overview] | Number of Participants With Treatment Related Adverse Events. |
| NCT01072773 (5) [back to overview] | Number of Participants With an Organ Response. |
| NCT01078441 (1) [back to overview] | One-year Survival in Patients Treated With This Regimen. |
| NCT01082939 (1) [back to overview] | Number of Participants With an Overall Response |
| NCT01092182 (5) [back to overview] | Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval |
| NCT01092182 (5) [back to overview] | Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2 |
| NCT01092182 (5) [back to overview] | Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval |
| NCT01092182 (5) [back to overview] | Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval |
| NCT01092182 (5) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
| NCT01093183 (4) [back to overview] | Overall Survival |
| NCT01093183 (4) [back to overview] | Proportion of Patients Achieving CR |
| NCT01093183 (4) [back to overview] | Maximum Tolerated Dose of Lenalidomide Administered in Combination With Oral Cyclophosphamide (Phase I) |
| NCT01093183 (4) [back to overview] | Number of Patients Achieving Objective PSA Response (50% Decrease in PSA Levels Sustained for at Least 4 Weeks) as Defined by PSA Working Group Criteria |
| NCT01093586 (14) [back to overview] | Overall Survival |
| NCT01093586 (14) [back to overview] | Overall Survival |
| NCT01093586 (14) [back to overview] | Overall Survival |
| NCT01093586 (14) [back to overview] | Hematologic Engraftment |
| NCT01093586 (14) [back to overview] | Disease Free |
| NCT01093586 (14) [back to overview] | Occurrence of Serious Infections |
| NCT01093586 (14) [back to overview] | Incidence of Chronic GVHD |
| NCT01093586 (14) [back to overview] | Transplant Related Mortality |
| NCT01093586 (14) [back to overview] | Recurrence or Relapse |
| NCT01093586 (14) [back to overview] | Transplant Related Mortality |
| NCT01093586 (14) [back to overview] | Recurrence or Relapse |
| NCT01093586 (14) [back to overview] | Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0 |
| NCT01093586 (14) [back to overview] | Disease Free |
| NCT01093586 (14) [back to overview] | Incidence of Acute Graft-versus-host Disease (GVHD) |
| NCT01094548 (7) [back to overview] | Time to Anti-tumor Therapy |
| NCT01094548 (7) [back to overview] | Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response |
| NCT01094548 (7) [back to overview] | Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type |
| NCT01094548 (7) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs) |
| NCT01094548 (7) [back to overview] | Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR] |
| NCT01094548 (7) [back to overview] | Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response |
| NCT01094548 (7) [back to overview] | Time to Progression (TTP) |
| NCT01096368 (10) [back to overview] | EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy |
| NCT01096368 (10) [back to overview] | EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation |
| NCT01096368 (10) [back to overview] | EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only |
| NCT01096368 (10) [back to overview] | Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only |
| NCT01096368 (10) [back to overview] | OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only. |
| NCT01096368 (10) [back to overview] | OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy |
| NCT01096368 (10) [back to overview] | OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only |
| NCT01096368 (10) [back to overview] | OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation |
| NCT01096368 (10) [back to overview] | EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only |
| NCT01096368 (10) [back to overview] | Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only |
| NCT01100944 (21) [back to overview] | Time to Maximum Plasma Concentration (Tmax) |
| NCT01100944 (21) [back to overview] | Time to Response |
| NCT01100944 (21) [back to overview] | Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat |
| NCT01100944 (21) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
| NCT01100944 (21) [back to overview] | Relative Change Observed in Total Protein Hyperacetylation of Cluster of Differentiation 3 (CD3)+T Cells With Belinostat |
| NCT01100944 (21) [back to overview] | Total Clearance (CL) of Belinostat |
| NCT01100944 (21) [back to overview] | Treatment-related Grade 3 and 4 Adverse Events (Highest Grade Per Event Per Patient) |
| NCT01100944 (21) [back to overview] | Relative Changes in the Number of Tregs With Treatment |
| NCT01100944 (21) [back to overview] | Relative Changes in T Cell Immunoglobulin Domain and Mucin Domain-3 (TIM3)-Expressing Cluster of Differentiation 8 (CD8)+Tcells |
| NCT01100944 (21) [back to overview] | Duration of Response |
| NCT01100944 (21) [back to overview] | Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)) |
| NCT01100944 (21) [back to overview] | Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)/Dose |
| NCT01100944 (21) [back to overview] | Disease Control Rate (DCR) |
| NCT01100944 (21) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Belinostat |
| NCT01100944 (21) [back to overview] | Maximum Plasma Concentration (Cmax)/Dose |
| NCT01100944 (21) [back to overview] | Maximum Tolerated Dose (MTD) of Belinostat |
| NCT01100944 (21) [back to overview] | Clinical Response |
| NCT01100944 (21) [back to overview] | Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies |
| NCT01100944 (21) [back to overview] | Overall Survival (OS) |
| NCT01100944 (21) [back to overview] | Progression Free Survival (PFS) |
| NCT01100944 (21) [back to overview] | Time to Half Life (t1/2) of Belinostat |
| NCT01105650 (4) [back to overview] | Number of Participants With Progressive Disease at One Year |
| NCT01105650 (4) [back to overview] | Time to Disease Progression |
| NCT01105650 (4) [back to overview] | Response Rate |
| NCT01105650 (4) [back to overview] | Overall Survival |
| NCT01106898 (1) [back to overview] | Recurrence-free Survival |
| NCT01106950 (6) [back to overview] | Percent of Patients With Complete Remission of Disease |
| NCT01106950 (6) [back to overview] | Percent of Patients With Disease Free Survival |
| NCT01106950 (6) [back to overview] | Percent of Patients With Incidence of Relapse |
| NCT01106950 (6) [back to overview] | Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion |
| NCT01106950 (6) [back to overview] | Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion |
| NCT01106950 (6) [back to overview] | Number of Patients With Treatment-Related Death |
| NCT01119066 (6) [back to overview] | The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens. |
| NCT01119066 (6) [back to overview] | Survival and Disease-free Survival (DFS) |
| NCT01119066 (6) [back to overview] | Survival and Disease-free Survival (DFS) |
| NCT01119066 (6) [back to overview] | Survival and Disease-free Survival (DFS) |
| NCT01119066 (6) [back to overview] | Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System. |
| NCT01119066 (6) [back to overview] | Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System. |
| NCT01132807 (3) [back to overview] | 36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation. |
| NCT01132807 (3) [back to overview] | Complete Response Rate |
| NCT01132807 (3) [back to overview] | Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD |
| NCT01135329 (1) [back to overview] | Graft Failure |
| NCT01144403 (4) [back to overview] | Overall Response Rate (ORR) |
| NCT01144403 (4) [back to overview] | Overall Survival (OS) |
| NCT01144403 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT01144403 (4) [back to overview] | Number of Participant With Adverse Event (AE) |
| NCT01145209 (6) [back to overview] | Median Relationship of CD20 Expression With MRD Negativity Rate |
| NCT01145209 (6) [back to overview] | Number of Grade 3 and 4 Treatment Related Adverse Events |
| NCT01145209 (6) [back to overview] | Progression Free Survival Rate 2 Years After Initiation of Induction Therapy |
| NCT01145209 (6) [back to overview] | Participants With MRD Negativity at the Completion of Consolidation Immunotherapy Who Failed to Achieve MRD Negativity |
| NCT01145209 (6) [back to overview] | Participants With Minimal Residual Disease (MRD) Negativity |
| NCT01145209 (6) [back to overview] | Participants With Complete Response Rates Following Induction Chemoimmunotherapy. |
| NCT01146834 (3) [back to overview] | Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections. |
| NCT01146834 (3) [back to overview] | Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant |
| NCT01146834 (3) [back to overview] | Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant |
| NCT01147016 (2) [back to overview] | Progression-free Survival |
| NCT01147016 (2) [back to overview] | Overall Deaths |
| NCT01175356 (3) [back to overview] | Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131 |
| NCT01175356 (3) [back to overview] | Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG |
| NCT01175356 (3) [back to overview] | Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy |
| NCT01181258 (4) [back to overview] | Serious Adverse Events |
| NCT01181258 (4) [back to overview] | Number of Patients With an Objective Response |
| NCT01181258 (4) [back to overview] | Patients With Expansion of NK Cells |
| NCT01181258 (4) [back to overview] | Time to Disease Progression |
| NCT01181271 (12) [back to overview] | Cumulative Incidence of Disease Relapse |
| NCT01181271 (12) [back to overview] | Cumulative Incidence of Extensive Chronic Graft-versus-host-disease |
| NCT01181271 (12) [back to overview] | Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant |
| NCT01181271 (12) [back to overview] | Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD) |
| NCT01181271 (12) [back to overview] | Cumulative Incidence of Non-relapse Mortality |
| NCT01181271 (12) [back to overview] | Estimated Two Year Overall Survival Rate for All Participants |
| NCT01181271 (12) [back to overview] | Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants |
| NCT01181271 (12) [back to overview] | Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant |
| NCT01181271 (12) [back to overview] | Estimated Two Year Progression Free Survival Rate for All Participants |
| NCT01181271 (12) [back to overview] | Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants |
| NCT01181271 (12) [back to overview] | Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL |
| NCT01181271 (12) [back to overview] | Peripheral Blood All-cell Donor Chimerism |
| NCT01184885 (2) [back to overview] | Complete Response |
| NCT01184885 (2) [back to overview] | Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival |
| NCT01187017 (4) [back to overview] | Number of Participants With Clonal Evolution |
| NCT01187017 (4) [back to overview] | Number of Patients Who Experienced Disease Relapse |
| NCT01187017 (4) [back to overview] | Participant Survival Following Fludarabine/ Cyclophosphamide in Participants With Severe Aplastic Anemia |
| NCT01187017 (4) [back to overview] | Response Rate at 6 Months |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional |
| NCT01190930 (41) [back to overview] | Sample Collection of Central Path Review Slides in B-LLy Patients |
| NCT01190930 (41) [back to overview] | Overall Survival (OS) for B-LLy Patients |
| NCT01190930 (41) [back to overview] | Event Free Survival (EFS) for B-LLy Patients |
| NCT01190930 (41) [back to overview] | Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left |
| NCT01190930 (41) [back to overview] | DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens |
| NCT01190930 (41) [back to overview] | DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization |
| NCT01190930 (41) [back to overview] | DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right |
| NCT01193283 (1) [back to overview] | Blood Counts and Adverse Event Profile After 6 Months of Treatment. |
| NCT01193842 (14) [back to overview] | Overall Survival (OS) (Phase II) |
| NCT01193842 (14) [back to overview] | Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II) |
| NCT01193842 (14) [back to overview] | Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I) |
| NCT01193842 (14) [back to overview] | Change in CD8 Cell Counts (Phase I) |
| NCT01193842 (14) [back to overview] | Pharmacokinetic Clearance (Phase I) |
| NCT01193842 (14) [back to overview] | Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I) |
| NCT01193842 (14) [back to overview] | Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II) |
| NCT01193842 (14) [back to overview] | Changes in Absolute CD4 Cell Counts (Phase I) |
| NCT01193842 (14) [back to overview] | Changes in Human Herpes Virus (HHV)-8 Viral Load |
| NCT01193842 (14) [back to overview] | Changes in Human Immunodeficiency Virus (HIV) Viral Load |
| NCT01193842 (14) [back to overview] | Event-free Survival (EFS) (Phase II) |
| NCT01193842 (14) [back to overview] | Tumor Response (Phase I) |
| NCT01193842 (14) [back to overview] | Changes in Epstein-Barr Virus (EBV) Viral Load |
| NCT01193842 (14) [back to overview] | Changes in Human Herpes Virus (HHV)-8 Viral Load |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab |
| NCT01200758 (26) [back to overview] | Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Percentage of Participants Who Died |
| NCT01200758 (26) [back to overview] | Overall Survival (OS) |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle |
| NCT01200758 (26) [back to overview] | Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase |
| NCT01200758 (26) [back to overview] | Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase |
| NCT01200758 (26) [back to overview] | Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL) |
| NCT01200758 (26) [back to overview] | Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab |
| NCT01200758 (26) [back to overview] | Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20 |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL |
| NCT01200758 (26) [back to overview] | Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL |
| NCT01205503 (5) [back to overview] | Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy |
| NCT01205503 (5) [back to overview] | Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy |
| NCT01205503 (5) [back to overview] | Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy |
| NCT01205503 (5) [back to overview] | B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy |
| NCT01205503 (5) [back to overview] | TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy |
| NCT01218867 (2) [back to overview] | Number of Participants With a Response to Therapy |
| NCT01218867 (2) [back to overview] | Number of Participants With Serious and Non-Serious Adverse Events |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Breast Cancer Pathological Response |
| NCT01220128 (28) [back to overview] | Number of Patients With Adverse Events (AEs) |
| NCT01220128 (28) [back to overview] | Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response |
| NCT01220128 (28) [back to overview] | Number of Subjects With Serious Adverse Events SAE(s) |
| NCT01220128 (28) [back to overview] | Number of Subjects With Severe Toxicities |
| NCT01220128 (28) [back to overview] | Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported |
| NCT01220128 (28) [back to overview] | Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported |
| NCT01220128 (28) [back to overview] | Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Anemia, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade |
| NCT01220128 (28) [back to overview] | Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported |
| NCT01220128 (28) [back to overview] | Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported |
| NCT01220128 (28) [back to overview] | Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade |
| NCT01220297 (5) [back to overview] | Veno-occlusive Disease (VoD) |
| NCT01220297 (5) [back to overview] | Overall Survival |
| NCT01220297 (5) [back to overview] | Disease-free Survival (DFS) |
| NCT01220297 (5) [back to overview] | Acute GvHD (Grade 3 to 4) |
| NCT01220297 (5) [back to overview] | Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4) |
| NCT01222715 (3) [back to overview] | Response Rate (CR + PR) |
| NCT01222715 (3) [back to overview] | Rate of Dose-Limiting Toxicities |
| NCT01222715 (3) [back to overview] | Event Free Survival Probability |
| NCT01231906 (1) [back to overview] | Event-Free Survival |
| NCT01236573 (3) [back to overview] | Response (Complete Response (CR) + Partial Response (PR)) to Therapy |
| NCT01236573 (3) [back to overview] | Maximum Tolerated Dose (MTD) |
| NCT01236573 (3) [back to overview] | Number of Participants With Adverse Events |
| NCT01247701 (7) [back to overview] | Overall Survival at 100 Days, 1 Year, and 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients. |
| NCT01247701 (7) [back to overview] | Number of Participants With Donor Engraftment After Transplant. |
| NCT01247701 (7) [back to overview] | Number of Participants With Severe Acute GVHD Grade III-IV |
| NCT01247701 (7) [back to overview] | Number of Participants With Platelet Engraftment |
| NCT01247701 (7) [back to overview] | Number of Participants With Neutrophil Engraftment |
| NCT01247701 (7) [back to overview] | Number of Participants With Chronic GvHD |
| NCT01247701 (7) [back to overview] | Number of Participants With Relapse Rate After Transplant |
| NCT01253460 (2) [back to overview] | Overall Response Rate (ORR) |
| NCT01253460 (2) [back to overview] | Overall Survival |
| NCT01256398 (6) [back to overview] | Disease Free Survival (DFS) |
| NCT01256398 (6) [back to overview] | Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause |
| NCT01256398 (6) [back to overview] | Response |
| NCT01256398 (6) [back to overview] | Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR) |
| NCT01256398 (6) [back to overview] | Overall Survival (OS) |
| NCT01256398 (6) [back to overview] | Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring. |
| NCT01263704 (6) [back to overview] | Quality of Life (QoL): Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire |
| NCT01263704 (6) [back to overview] | Percentage of Participants With Neutropenic Fever, Infection, >/= Grade 3 Drug-Related Neutropenia, >/= Grade 3 Drug-Related Thrombocytopenia, Hospitalizations |
| NCT01263704 (6) [back to overview] | Progression-free Survival (PFS) |
| NCT01263704 (6) [back to overview] | Overall Response Rate |
| NCT01263704 (6) [back to overview] | Hospitalization Days |
| NCT01263704 (6) [back to overview] | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT01265849 (16) [back to overview] | PFS in Low Risk Subjects |
| NCT01265849 (16) [back to overview] | Overall Survival (OS) |
| NCT01265849 (16) [back to overview] | OS in Low Risk Subjects |
| NCT01265849 (16) [back to overview] | LRC in Low Risk Subjects |
| NCT01265849 (16) [back to overview] | Local Regional Control (LRC) |
| NCT01265849 (16) [back to overview] | Tumor Response by RECIST 1.0 in Low Risk Subjects |
| NCT01265849 (16) [back to overview] | EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36 |
| NCT01265849 (16) [back to overview] | EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2 |
| NCT01265849 (16) [back to overview] | Statistical Comparisons of Time-to-event Outcomes (OS, LRC, PFS) Were Repeated for Varying Levels of Histopathology (HP) Markers in Low Risk Subjects |
| NCT01265849 (16) [back to overview] | Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36 |
| NCT01265849 (16) [back to overview] | Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2 |
| NCT01265849 (16) [back to overview] | Progression Free Survival (PFS) |
| NCT01265849 (16) [back to overview] | Tumor Response by RECIST 1.0 |
| NCT01265849 (16) [back to overview] | Survival by Objective Response (CR+PR) |
| NCT01265849 (16) [back to overview] | Overall Survival by Objective Response (CR+PR) in Low Risk Subjects |
| NCT01265849 (16) [back to overview] | Survival by Objective Response (CR+PR) in Low Risk Subjects |
| NCT01271010 (10) [back to overview] | Percentage of Participants With Stable Disease |
| NCT01271010 (10) [back to overview] | Overall Survival |
| NCT01271010 (10) [back to overview] | Duration of Response |
| NCT01271010 (10) [back to overview] | Percentage of Participants With Complete Remission |
| NCT01271010 (10) [back to overview] | Percentage of Participants With Disease Progression |
| NCT01271010 (10) [back to overview] | Event-free Survival |
| NCT01271010 (10) [back to overview] | Percentage of Participants With Partial Remission |
| NCT01271010 (10) [back to overview] | Percentage of Participants With Phenotypic Remission |
| NCT01271010 (10) [back to overview] | Percentage of Participants With Adverse Events (AEs) and Serious AEs |
| NCT01271010 (10) [back to overview] | Progression-free Survival |
| NCT01271907 (2) [back to overview] | Clinical Response |
| NCT01271907 (2) [back to overview] | Safety of Drosophila Generated PBL Administered in Combination With a Lymphodepleting Preparative Regimen and Supportive Systemic Aldesleukin |
| NCT01273181 (2) [back to overview] | Toxicity Profile |
| NCT01273181 (2) [back to overview] | Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer |
| NCT01275677 (7) [back to overview] | Percentage of Patients Alive and Recurrence-Free (RFI) |
| NCT01275677 (7) [back to overview] | Percentage of Patients Alive and Free From Invasive Disease (IDFS) |
| NCT01275677 (7) [back to overview] | Percentage of Patients Alive and Free From Distant Recurrence (DRFI) |
| NCT01275677 (7) [back to overview] | Percentage of Patients Alive and Free From Breast Cancer (BCFS) |
| NCT01275677 (7) [back to overview] | Percentage of Patients Alive and Disease-Free (DFS-DCIS) |
| NCT01275677 (7) [back to overview] | Toxicity Assessed by Adverse Events |
| NCT01275677 (7) [back to overview] | Percentage of Patients Alive (Overall Survival) |
| NCT01283386 (10) [back to overview] | Event-free Survival |
| NCT01283386 (10) [back to overview] | Overall Survival |
| NCT01283386 (10) [back to overview] | Percentage of Participants With Complete Remission |
| NCT01283386 (10) [back to overview] | Percentage of Participants With Disease Progression |
| NCT01283386 (10) [back to overview] | Percentage of Participants With Partial Remission |
| NCT01283386 (10) [back to overview] | Percentage of Participants With Phenotypic Remission |
| NCT01283386 (10) [back to overview] | Percentage of Participants With Stable Disease |
| NCT01283386 (10) [back to overview] | Progression-free Survival |
| NCT01283386 (10) [back to overview] | Percentage of Participants With Adverse Events (AEs) and Serious AEs |
| NCT01283386 (10) [back to overview] | Duration of Response |
| NCT01287741 (18) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores |
| NCT01287741 (18) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score |
| NCT01287741 (18) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score |
| NCT01287741 (18) [back to overview] | Overall Response Rate (ORR), IRC-Assessed |
| NCT01287741 (18) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores |
| NCT01287741 (18) [back to overview] | Time to Next Anti-Lymphoma Treatment (TTNALT) |
| NCT01287741 (18) [back to overview] | Percentage of Participants With Adverse Events (AEs) |
| NCT01287741 (18) [back to overview] | Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT01287741 (18) [back to overview] | Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed |
| NCT01287741 (18) [back to overview] | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab |
| NCT01287741 (18) [back to overview] | Duration of Response (DOR), Investigator-Assessed |
| NCT01287741 (18) [back to overview] | Median Time to Disease-Free Survival (DFS), Investigator-Assessed |
| NCT01287741 (18) [back to overview] | Overall Response Rate (ORR), Investigator-Assessed |
| NCT01287741 (18) [back to overview] | Complete Response (CR) at the End of Treatment, IRC-Assessed |
| NCT01287741 (18) [back to overview] | Complete Response (CR) at the End of Treatment, Investigator-Assessed |
| NCT01287741 (18) [back to overview] | Median Time to Event-Free Survival (EFS), Investigator-Assessed |
| NCT01287741 (18) [back to overview] | Median Time to Overall Survival (OS) |
| NCT01287741 (18) [back to overview] | Median Time to Progression-Free Survival (PFS), Investigator-Assessed |
| NCT01292603 (15) [back to overview] | Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6 |
| NCT01292603 (15) [back to overview] | Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration |
| NCT01292603 (15) [back to overview] | Part 1: Percentage of Participants With Anti-Rituximab Antibodies |
| NCT01292603 (15) [back to overview] | Part 1: Percentage of Participants With Total B-Cell Depletion by Visit |
| NCT01292603 (15) [back to overview] | Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit |
| NCT01292603 (15) [back to overview] | Part 2: Percentage of Participants With Anti-Rituximab Antibodies |
| NCT01292603 (15) [back to overview] | Part 2: Percentage of Participants With Total B-Cell Depletion by Visit |
| NCT01292603 (15) [back to overview] | Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV |
| NCT01292603 (15) [back to overview] | Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6 |
| NCT01292603 (15) [back to overview] | Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6 |
| NCT01292603 (15) [back to overview] | Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV |
| NCT01292603 (15) [back to overview] | Part 2: Total CD19+ B-Cell Counts by Visit |
| NCT01292603 (15) [back to overview] | Part 2: Terminal Half-Life of Rituximab at Cycle 6 |
| NCT01292603 (15) [back to overview] | Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab |
| NCT01292603 (15) [back to overview] | Part 2: Rituximab C Trough Levels at Cycle 5 |
| NCT01300247 (7) [back to overview] | Percentage of Participants Who Had B-Cell Depletion |
| NCT01300247 (7) [back to overview] | Percentage of Participants Who Were Alive |
| NCT01300247 (7) [back to overview] | Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines |
| NCT01300247 (7) [back to overview] | Percentage of Participants Who Were Alive and Progression Free |
| NCT01300247 (7) [back to overview] | Number of Participants With Human Anti-Human Antibodies (HAHAs) |
| NCT01300247 (7) [back to overview] | Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines |
| NCT01300247 (7) [back to overview] | Percentage of Participants Who Had B-Cell Recovery |
| NCT01306032 (6) [back to overview] | Number of Participants With Deleterious Mutations in DNA Repair Genes |
| NCT01306032 (6) [back to overview] | Number of Participants With Adverse Events |
| NCT01306032 (6) [back to overview] | Change in ϓH2AX- Positive Circulating Tumor Cells (CTCs) in Whole Blood |
| NCT01306032 (6) [back to overview] | Change in Poly-ADP Ribose (PAR) Concentration Levels From Baseline |
| NCT01306032 (6) [back to overview] | Progression Free Survival |
| NCT01306032 (6) [back to overview] | Percentage of Participants With an Overall Response Rate |
| NCT01319981 (3) [back to overview] | Number of Patients With Complete Remission at One Year |
| NCT01319981 (3) [back to overview] | Overall Survival |
| NCT01319981 (3) [back to overview] | Complete Response Duration |
| NCT01332968 (32) [back to overview] | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed |
| NCT01332968 (32) [back to overview] | Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) |
| NCT01332968 (32) [back to overview] | Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Disease-Free Survival (Overall Study Population) |
| NCT01332968 (32) [back to overview] | Duration of Response (DOR) (Overall Study Population), Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Overall Response (Overall Study Population), IRC-Assessed |
| NCT01332968 (32) [back to overview] | Overall Response (Overall Study Population), Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Overall Response (Follicular Lymphoma Population), IRC-Assessed |
| NCT01332968 (32) [back to overview] | Event-Free Survival (Follicular Lymphoma Population) |
| NCT01332968 (32) [back to overview] | Event-Free Survival (Overall Study Population) |
| NCT01332968 (32) [back to overview] | Overall Survival (Follicular Lymphoma Population) |
| NCT01332968 (32) [back to overview] | Overall Survival (Overall Study Population) |
| NCT01332968 (32) [back to overview] | Progression-Free Survival in the Overall Study Population, Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) |
| NCT01332968 (32) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) |
| NCT01332968 (32) [back to overview] | Percentage of Participants With Adverse Events |
| NCT01332968 (32) [back to overview] | Time to Next Anti-Lymphoma Treatment (Overall Study Population) |
| NCT01332968 (32) [back to overview] | Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) |
| NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase |
| NCT01332968 (32) [back to overview] | Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) |
| NCT01332968 (32) [back to overview] | Overall Response (Follicular Lymphoma Population), Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase |
| NCT01332968 (32) [back to overview] | Complete Response (Overall Study Population), IRC-Assessed |
| NCT01332968 (32) [back to overview] | Complete Response (Overall Study Population), Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase |
| NCT01332968 (32) [back to overview] | Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase |
| NCT01332968 (32) [back to overview] | Complete Response (Follicular Lymphoma Population), IRC-Assessed |
| NCT01332968 (32) [back to overview] | Complete Response (Follicular Lymphoma Population), Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) |
| NCT01332968 (32) [back to overview] | Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed |
| NCT01332968 (32) [back to overview] | Disease-Free Survival (Follicular Lymphoma Population) |
| NCT01336933 (6) [back to overview] | Percent of Patients Who Proceeded With Transplant |
| NCT01336933 (6) [back to overview] | To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events |
| NCT01336933 (6) [back to overview] | Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment |
| NCT01336933 (6) [back to overview] | Overall Survival (OS) |
| NCT01336933 (6) [back to overview] | Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR)) |
| NCT01336933 (6) [back to overview] | Event Free Survival (EFS) |
| NCT01338987 (4) [back to overview] | Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT) |
| NCT01338987 (4) [back to overview] | Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4 |
| NCT01338987 (4) [back to overview] | Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT) |
| NCT01338987 (4) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
| NCT01339910 (10) [back to overview] | Percentage of Participants With Chronic GVHD |
| NCT01339910 (10) [back to overview] | Number of Participants With Donor Cell Engraftment |
| NCT01339910 (10) [back to overview] | Number of Participants With Primary Graft Failure |
| NCT01339910 (10) [back to overview] | Percentage of Participants With Neutrophil and Platelet Engraftment |
| NCT01339910 (10) [back to overview] | Percentage of Participants With Acute Graft Versus Host Disease (GVHD) |
| NCT01339910 (10) [back to overview] | Percentage of Participants With Treatment-related Mortality |
| NCT01339910 (10) [back to overview] | Percentage of Participants With Relapse-Free Survival (RFS) |
| NCT01339910 (10) [back to overview] | Percentage of Participants With Overall Survival (OS) |
| NCT01339910 (10) [back to overview] | Percentage of Participants With Disease Relapse |
| NCT01339910 (10) [back to overview] | Number of Participants With Secondary Graft Failure |
| NCT01341301 (1) [back to overview] | Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT) |
| NCT01343043 (8) [back to overview] | Objective Response Rate (ORR) |
| NCT01343043 (8) [back to overview] | Overall Survival |
| NCT01343043 (8) [back to overview] | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) |
| NCT01343043 (8) [back to overview] | Progression Free Survival |
| NCT01343043 (8) [back to overview] | Best Overall Response |
| NCT01343043 (8) [back to overview] | Time to Maximum Persistence of NY-ESO-1 Genetically Engineered T Cells |
| NCT01343043 (8) [back to overview] | Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-infused (NY-ESO-1 Genetically Engineered T) Cell Antibody Result |
| NCT01343043 (8) [back to overview] | Duration of Overall Response |
| NCT01350245 (2) [back to overview] | Disease-Free Survival (DFS) |
| NCT01350245 (2) [back to overview] | Probability of Overall Survival at 15 Months Post-treatment |
| NCT01358877 (30) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3 |
| NCT01358877 (30) [back to overview] | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores |
| NCT01358877 (30) [back to overview] | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Secondary Cardiac Event |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores |
| NCT01358877 (30) [back to overview] | Trough Serum Concentration (Cmin) of Pertuzumab |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Primary Cardiac Event |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Peak Serum Concentration (Cmax) of Pertuzumab |
| NCT01358877 (30) [back to overview] | Cmin of Trastuzumab |
| NCT01358877 (30) [back to overview] | Cmax of Trastuzumab |
| NCT01358877 (30) [back to overview] | Change From Baseline in LVEF to Worst Post-Baseline Value |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain |
| NCT01358877 (30) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score |
| NCT01358877 (30) [back to overview] | Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score |
| NCT01358877 (30) [back to overview] | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Percentage of Participants Who Died |
| NCT01358877 (30) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01358877 (30) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings |
| NCT01359592 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT01359592 (4) [back to overview] | Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT01359592 (4) [back to overview] | Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT01359592 (4) [back to overview] | Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL) |
| NCT01362790 (8) [back to overview] | Response Assessment |
| NCT01362790 (8) [back to overview] | Count of Participants SS1P Cycles Received Following Onstudy |
| NCT01362790 (8) [back to overview] | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide |
| NCT01362790 (8) [back to overview] | Count of Participants With SS1P Antibody Formation |
| NCT01362790 (8) [back to overview] | Duration of Response |
| NCT01362790 (8) [back to overview] | Overall Survival |
| NCT01362790 (8) [back to overview] | Progression-free Survival |
| NCT01362790 (8) [back to overview] | Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01 |
| NCT01363128 (3) [back to overview] | 4-year Event Free Survival |
| NCT01363128 (3) [back to overview] | 4-Year Overall Survival |
| NCT01363128 (3) [back to overview] | Number of Participants With Complete Remission (CR) |
| NCT01369875 (2) [back to overview] | Number of Participants With Serious and Non-Serious Adverse Events |
| NCT01369875 (2) [back to overview] | Number of Participants With Clinical Tumor Regression. |
| NCT01369888 (2) [back to overview] | Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL. |
| NCT01369888 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT01370694 (2) [back to overview] | Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy |
| NCT01370694 (2) [back to overview] | Clinical Response of Tumor to MK-8808/CVP Combination Therapy |
| NCT01390584 (5) [back to overview] | Proportion of Patients Who Are PET Negative After Induction Treatment |
| NCT01390584 (5) [back to overview] | Progression-free Survival Rate |
| NCT01390584 (5) [back to overview] | Overall Survival |
| NCT01390584 (5) [back to overview] | Complete Response (CR) Rate After Induction Treatment |
| NCT01390584 (5) [back to overview] | Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment |
| NCT01410344 (7) [back to overview] | Percentage of Participants With Non-Relapse Mortality |
| NCT01410344 (7) [back to overview] | Percentage of Participants With Overall Survival |
| NCT01410344 (7) [back to overview] | Chimerism |
| NCT01410344 (7) [back to overview] | Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD) |
| NCT01410344 (7) [back to overview] | Percentage of Participants Recovering Hematologic Function |
| NCT01410344 (7) [back to overview] | Percentage of Participants With Relapse/Progression |
| NCT01410344 (7) [back to overview] | Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD) |
| NCT01412879 (4) [back to overview] | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
| NCT01412879 (4) [back to overview] | Progression-Free Survival (PFS) at 2 Years |
| NCT01412879 (4) [back to overview] | Response Rate (Complete and Partial Response) |
| NCT01412879 (4) [back to overview] | 5-year Overall Survival (OS) |
| NCT01414855 (13) [back to overview] | Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab |
| NCT01414855 (13) [back to overview] | Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment |
| NCT01414855 (13) [back to overview] | Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment |
| NCT01414855 (13) [back to overview] | Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment |
| NCT01414855 (13) [back to overview] | Duration of Response (DOR) |
| NCT01414855 (13) [back to overview] | Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment |
| NCT01414855 (13) [back to overview] | Percentage of Participants With Adverse Events as a Measure of Safety |
| NCT01414855 (13) [back to overview] | Progression-Free Survival (PFS) as Assessed by the Investigator |
| NCT01414855 (13) [back to overview] | Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI) |
| NCT01414855 (13) [back to overview] | Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab |
| NCT01414855 (13) [back to overview] | Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day) |
| NCT01414855 (13) [back to overview] | Pharmacokinetics: Clearance (Cl) for Obinutuzumab |
| NCT01414855 (13) [back to overview] | Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab |
| NCT01417000 (2) [back to overview] | Overall Survival (OS) in Subjects Receiving Test Treatments (FAS) |
| NCT01417000 (2) [back to overview] | To Assess Safety of the Cyclophosphamide, GVAX Pancreas Vaccine, and CRS-207 Treatment Regimen |
| NCT01421017 (2) [back to overview] | Local Skin Tumor Response Rates (Complete Response + Partial Response) |
| NCT01421017 (2) [back to overview] | Systemic Tumor Response Rates (Complete Response+Partial Response) |
| NCT01427881 (9) [back to overview] | Disease-free Survival |
| NCT01427881 (9) [back to overview] | Hematologic Recovery |
| NCT01427881 (9) [back to overview] | Grades II-IV and III-IV Acute GVHD |
| NCT01427881 (9) [back to overview] | Persistent or Recurrent Malignancy After HCT |
| NCT01427881 (9) [back to overview] | Overall Survival |
| NCT01427881 (9) [back to overview] | Non-relapse Mortality |
| NCT01427881 (9) [back to overview] | Graft Failure |
| NCT01427881 (9) [back to overview] | Donor Engraftment |
| NCT01427881 (9) [back to overview] | Chronic GVHD Requiring Systemic Immunosuppressive Treatment |
| NCT01432600 (5) [back to overview] | Phase II - Occurrence of Possibly Related Adverse Events (AEs) |
| NCT01432600 (5) [back to overview] | Phase II - Overall Response Rate (ORR) |
| NCT01432600 (5) [back to overview] | Phase II - Median Progression Free Survival (PFS) |
| NCT01432600 (5) [back to overview] | Phase II - Median Overall Survival (OS) |
| NCT01432600 (5) [back to overview] | Phase I - Maximum Tolerated Dose (MTD) |
| NCT01438177 (3) [back to overview] | Number of Participants With Adverse Events of Grade 3 or Higher |
| NCT01438177 (3) [back to overview] | Response Rate (CR + PR After 2 Cycles) |
| NCT01438177 (3) [back to overview] | Median Duration of Response of This Regimen |
| NCT01445535 (6) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
| NCT01445535 (6) [back to overview] | Number of Dose-Limiting Toxicities (DLT) |
| NCT01445535 (6) [back to overview] | Maximum Tolerated Dose (MTD) of Siplizumab |
| NCT01445535 (6) [back to overview] | Number of Participants With a Response to Therapy |
| NCT01445535 (6) [back to overview] | Overall Survival (OS) |
| NCT01445535 (6) [back to overview] | Overall Progression Free Survival (PFS) |
| NCT01445821 (2) [back to overview] | Number of Participants With Treatment Failure |
| NCT01445821 (2) [back to overview] | Survival of Treatment |
| NCT01451515 (4) [back to overview] | Minimal Disseminated Disease (MDD) |
| NCT01451515 (4) [back to overview] | Probability of Overall Survival (OS) |
| NCT01451515 (4) [back to overview] | Probability of Event-free Survival (EFS) |
| NCT01451515 (4) [back to overview] | Minimal Residual Disease (MRD) |
| NCT01453140 (1) [back to overview] | Response Rate of Patients With Steroid-refractory Graft-versus-host Disease (GVHD) Using Cyclophospahmide and Sirolimus Combined With 3 Variations of Low-dose IL 2 and Low-dose Vidaza. |
| NCT01454596 (5) [back to overview] | Number of Patients With an Objective Response |
| NCT01454596 (5) [back to overview] | Progression Free Survival |
| NCT01454596 (5) [back to overview] | Number of Treatment Related Adverse Events |
| NCT01454596 (5) [back to overview] | Circulating Chimeric Antigen Receptor (CAR+) Cells in Peripheral Blood at 1 Month Post Treatment |
| NCT01454596 (5) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
| NCT01462253 (6) [back to overview] | The Primary End-point is the Number of Patients in CR After Induction Therapy. |
| NCT01462253 (6) [back to overview] | Overall Survival (OS) |
| NCT01462253 (6) [back to overview] | Number of Participants With Toxicity of Grade 2 or Greater |
| NCT01462253 (6) [back to overview] | Number of Participants With Minimal Residual Disease (MRD) Response in Remission. |
| NCT01462253 (6) [back to overview] | Disease-free Survival (DFS) |
| NCT01462253 (6) [back to overview] | Cumulative Incidence of Relapse (CIR) |
| NCT01464359 (9) [back to overview] | Clinical Disease Response |
| NCT01464359 (9) [back to overview] | Clinical Disease Response |
| NCT01464359 (9) [back to overview] | Disease Free Survival |
| NCT01464359 (9) [back to overview] | Duration of Survival |
| NCT01464359 (9) [back to overview] | Duration of Survival |
| NCT01464359 (9) [back to overview] | Duration of Survival |
| NCT01464359 (9) [back to overview] | Incidence of Acute Graft-Versus-Host Disease |
| NCT01464359 (9) [back to overview] | Incidence of Graft Failure |
| NCT01464359 (9) [back to overview] | Transplant-Related Mortality |
| NCT01468818 (1) [back to overview] | Objective Response in Patients With Metastatic Melanoma |
| NCT01492673 (1) [back to overview] | Number of Participants With Adverse Events |
| NCT01495572 (2) [back to overview] | Clinical Tumor Response |
| NCT01495572 (2) [back to overview] | Number of Participants With Adverse Events |
| NCT01496131 (5) [back to overview] | Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT) |
| NCT01496131 (5) [back to overview] | Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT) |
| NCT01496131 (5) [back to overview] | Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels |
| NCT01496131 (5) [back to overview] | Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation) |
| NCT01496131 (5) [back to overview] | Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation) |
| NCT01498588 (2) [back to overview] | Pathologic Complete Response Rate at the Time of Surgery |
| NCT01498588 (2) [back to overview] | Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events) |
| NCT01507103 (3) [back to overview] | Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial) |
| NCT01507103 (3) [back to overview] | Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category |
| NCT01507103 (3) [back to overview] | Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) |
| NCT01527149 (9) [back to overview] | Number of Participants With at Least One Serious Adverse Event |
| NCT01527149 (9) [back to overview] | Percentage of Participants With Autologous Stem Cell Transplantation |
| NCT01527149 (9) [back to overview] | Median Progression-free Survival (PFS) |
| NCT01527149 (9) [back to overview] | Median Overall Survival (OS) |
| NCT01527149 (9) [back to overview] | Proportion of Patients Experiencing a Complete Response |
| NCT01527149 (9) [back to overview] | Median of Serum Complement CD20 Levels |
| NCT01527149 (9) [back to overview] | Time-to-tumor Progression (TTP) at 3 Years |
| NCT01527149 (9) [back to overview] | Proportion of Patients Who Experience Complete Remission as Assessed by HSFCM |
| NCT01527149 (9) [back to overview] | Change From Baseline in Percentage of Cells Positive for Ki67 |
| NCT01527487 (4) [back to overview] | The Number of Adverse Events as a Measure of Safety and Tolerability. |
| NCT01527487 (4) [back to overview] | Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery |
| NCT01527487 (4) [back to overview] | Disease-Free Survival (DFS) at 2 Years |
| NCT01527487 (4) [back to overview] | Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy |
| NCT01537029 (1) [back to overview] | Clearance (Cl) for Doxorubicin and Cyclophosphamide |
| NCT01539083 (8) [back to overview] | Overall Survival (OS) |
| NCT01539083 (8) [back to overview] | Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12 |
| NCT01539083 (8) [back to overview] | Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase |
| NCT01539083 (8) [back to overview] | Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12 |
| NCT01539083 (8) [back to overview] | Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase |
| NCT01539083 (8) [back to overview] | Progression Free Survival (PFS) |
| NCT01539083 (8) [back to overview] | Disease-free Survival (DFS) |
| NCT01539083 (8) [back to overview] | Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12 |
| NCT01542255 (1) [back to overview] | Progression Free Survival |
| NCT01543152 (4) [back to overview] | Effect of SB-728-T on Plasma HIV-1 RNA Levels Following HAART Interruption |
| NCT01543152 (4) [back to overview] | Treatment-emergent Adverse Events |
| NCT01543152 (4) [back to overview] | Change From Baseline to Month 12 in CD4+ T-cell Counts in Peripheral Blood After Repeat Treatments With SB-728-T. (i.e. Month 12 Value - Baseline Value) |
| NCT01543152 (4) [back to overview] | Effect of Escalating Doses of Cyclophosphamide on SB-728-T Engraftment as Measured by CCR5 Modified CD4 Cells in Blood. |
| NCT01548573 (4) [back to overview] | Event-Free Survival (EFS) |
| NCT01548573 (4) [back to overview] | Identification of Drug Resistant Genes |
| NCT01548573 (4) [back to overview] | Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens. |
| NCT01548573 (4) [back to overview] | Overall Survival |
| NCT01554371 (6) [back to overview] | Number of Participants With Dose Limiting Toxicity (DLT) for Participants With Any Solid Tumor (Phase 1b) |
| NCT01554371 (6) [back to overview] | Number of Participants With Treatment-related Toxicities |
| NCT01554371 (6) [back to overview] | Maximum Tolerated Dose (MTD) in Participants With Any Solid Tumor (Phase Ib) |
| NCT01554371 (6) [back to overview] | Time to Progression for Participants With Advanced Breast Cancer (Phase II) |
| NCT01554371 (6) [back to overview] | Overall Response Rate (ORR) for Participants With Advanced Breast Cancer (Phase II) |
| NCT01554371 (6) [back to overview] | Clinical Benefit Rate for Patients With Advanced Breast Cancer (ABC) (Phase II) |
| NCT01570348 (11) [back to overview] | Development of Infectious Complications |
| NCT01570348 (11) [back to overview] | Event-free Survival (EFS) |
| NCT01570348 (11) [back to overview] | EFS |
| NCT01570348 (11) [back to overview] | Overall Survival |
| NCT01570348 (11) [back to overview] | Incidence of Graft Rejection |
| NCT01570348 (11) [back to overview] | Quality of Life Measured Using the Previously Validated Short Inflammatory Bowel Disease Questionnaire |
| NCT01570348 (11) [back to overview] | Incidence of Disease-modifying Drugs for CD Initiated Post-transplant |
| NCT01570348 (11) [back to overview] | Regimen-related Toxicity Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4 |
| NCT01570348 (11) [back to overview] | Treatment-related Mortality (TRM) |
| NCT01570348 (11) [back to overview] | Disease Activity |
| NCT01570348 (11) [back to overview] | Incidence and Severity of GVHD |
| NCT01581970 (4) [back to overview] | Overall Survival |
| NCT01581970 (4) [back to overview] | Aggregate Ratio of Tregs to Effector Cells for All Participants |
| NCT01581970 (4) [back to overview] | Aggregate Ratio of Tregs to Natural Killer (NK) Cells for All Participants |
| NCT01581970 (4) [back to overview] | Progression |
| NCT01583686 (1) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
| NCT01585428 (1) [back to overview] | Number of Patients With Serious and Non-serious Adverse Events |
| NCT01593020 (3) [back to overview] | Overall Survival (OS) |
| NCT01593020 (3) [back to overview] | Pathologic Complete Response (pCR) |
| NCT01593020 (3) [back to overview] | 5 Year Event Free Survival (EFS) |
| NCT01614197 (1) [back to overview] | Minimum Residual Disease (MRD) Levels Present at End of Cycle 1 Therapy in Patients |
| NCT01621477 (7) [back to overview] | Disease-Free Survival (DFS) |
| NCT01621477 (7) [back to overview] | Event-Free Survival (EFS) |
| NCT01621477 (7) [back to overview] | Incidence and Severity of Chronic Graft Versus Host Disease (GVHD) |
| NCT01621477 (7) [back to overview] | Number of Participants With Transplant Related Mortality (TRM) |
| NCT01621477 (7) [back to overview] | Incidence of Malignant Relapse |
| NCT01621477 (7) [back to overview] | Incidence and Severity of Acute Graft Versus Host Disease (GVHD) |
| NCT01621477 (7) [back to overview] | One-year Survival (OS) |
| NCT01632150 (4) [back to overview] | Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) |
| NCT01632150 (4) [back to overview] | Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) |
| NCT01632150 (4) [back to overview] | Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event |
| NCT01632150 (4) [back to overview] | Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event |
| NCT01640301 (11) [back to overview] | Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II) |
| NCT01640301 (11) [back to overview] | Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I) |
| NCT01640301 (11) [back to overview] | Treatment-related Toxicity Rate (Arm II) |
| NCT01640301 (11) [back to overview] | Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II) |
| NCT01640301 (11) [back to overview] | Treatment-related Toxicity Rate (Arm I) |
| NCT01640301 (11) [back to overview] | Incidence of Relapse After T Cell Therapy (Arm II) |
| NCT01640301 (11) [back to overview] | Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II) |
| NCT01640301 (11) [back to overview] | Maintenance of Function of Transduced T Cells (Arm I) |
| NCT01640301 (11) [back to overview] | Maintenance of T Cell Receptor (TCR) Expression of Transduced T Cells (Arm I) i.e. Persistence |
| NCT01640301 (11) [back to overview] | Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I) |
| NCT01640301 (11) [back to overview] | Disease-free Survival After T Cell Therapy |
| NCT01659151 (3) [back to overview] | Percentage of Participants With Overall Response (OR) |
| NCT01659151 (3) [back to overview] | Number of Participants With Progression Free Survival (PFS) |
| NCT01659151 (3) [back to overview] | Percentage of Participant Drop Out Rate |
| NCT01659658 (21) [back to overview] | Percentage of Participants With Overall Hematologic Response |
| NCT01659658 (21) [back to overview] | Percentage of Participants With Complete Hematologic Response |
| NCT01659658 (21) [back to overview] | Percentage of Participants With Best Vital Organ (Cardiac and/or Kidney) Response |
| NCT01659658 (21) [back to overview] | Overall Survival |
| NCT01659658 (21) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
| NCT01659658 (21) [back to overview] | Number of Hospitalizations |
| NCT01659658 (21) [back to overview] | Hematologic Disease Progression Free Survival |
| NCT01659658 (21) [back to overview] | EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analogue Scale Score |
| NCT01659658 (21) [back to overview] | Duration of Hematologic Response |
| NCT01659658 (21) [back to overview] | Change From Baseline in SF-36 Physical Component Summary Score at Week 28 of the PFS Follow-up |
| NCT01659658 (21) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Score at Week 28 of the PFS Follow-up |
| NCT01659658 (21) [back to overview] | Change From Baseline in Amyloidosis Symptom Scale Total Score at Week 28 of the PFS Follow-up |
| NCT01659658 (21) [back to overview] | Change From Baseline in 36-item Short Form General Health Survey (SF-36) Mental Component Summary Score at Week 28 of the PFS Follow-up |
| NCT01659658 (21) [back to overview] | 2-Year Vital Organ (Heart or Kidney) Deterioration and Mortality Rate |
| NCT01659658 (21) [back to overview] | Vital Organ Progression Free Survival |
| NCT01659658 (21) [back to overview] | Plasma Concentration of Ixazomib |
| NCT01659658 (21) [back to overview] | Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score |
| NCT01659658 (21) [back to overview] | Time to Vital Organ (Heart or Kidney) Deterioration and Mortality Rate |
| NCT01659658 (21) [back to overview] | Time To Treatment Failure (TTF) |
| NCT01659658 (21) [back to overview] | Time To Subsequent Anticancer Treatment |
| NCT01659658 (21) [back to overview] | Progression Free Survival (PFS) |
| NCT01670500 (5) [back to overview] | Rate of Pathologic Complete Response (pCR) |
| NCT01670500 (5) [back to overview] | Clinical Response Rate |
| NCT01670500 (5) [back to overview] | Rate of Residual Cancer Burden (RCB) 0/1 |
| NCT01670500 (5) [back to overview] | Rate of Miller Payne 4 and 5 |
| NCT01670500 (5) [back to overview] | Number of Grade 3 and Grade 4 Adverse Events |
| NCT01671319 (2) [back to overview] | Incidence of Febrile Neutropenia |
| NCT01671319 (2) [back to overview] | Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy |
| NCT01675765 (2) [back to overview] | Number of Subjects Reporting Adverse Events |
| NCT01675765 (2) [back to overview] | Objective Tumor Response |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Treatment-Related Toxicity |
| NCT01685411 (15) [back to overview] | Number of Participant Who Were Alive at 7 Years Post Transplant |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Chronic Graft-Versus-Host Disease |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Chronic Graft-Versus-Host Disease |
| NCT01685411 (15) [back to overview] | Number of Participant Who Were Alive at 5 Years Post Transplant |
| NCT01685411 (15) [back to overview] | Count of Participants Who Achieved Neutrophil Engraftment |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Relapse |
| NCT01685411 (15) [back to overview] | Count of Participants With Disease Free Survival |
| NCT01685411 (15) [back to overview] | Count of Participants With Disease Free Survival |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Engraftment Failure |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Relapse |
| NCT01685411 (15) [back to overview] | Number of Participant Who Were Alive at 2 Years Post Transplant |
| NCT01685411 (15) [back to overview] | Counts of Participants With Disease Free Survival |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Treatment-Related Toxicity |
| NCT01685411 (15) [back to overview] | Percentage of Participants With Acute Graft-Versus-Host Disease by Grade |
| NCT01690520 (6) [back to overview] | Proportion of Patients With Severe Acute Graft Versus Host Disease |
| NCT01690520 (6) [back to overview] | Non-relapse Mortality |
| NCT01690520 (6) [back to overview] | Overall Survival |
| NCT01690520 (6) [back to overview] | Time to Platelet Engraftment (20k) |
| NCT01690520 (6) [back to overview] | Proportion of Participants With Chronic Graft Versus Host Disease |
| NCT01690520 (6) [back to overview] | Time to Neutrophil Engraftment |
| NCT01696877 (4) [back to overview] | Pathological Complete Responses |
| NCT01696877 (4) [back to overview] | Intraprostatic CD8+ T Cell Infiltration |
| NCT01696877 (4) [back to overview] | Prostate-specific Antigen Response Rate |
| NCT01696877 (4) [back to overview] | Percentage of Participants Without Prostate Specific Antigen Recurrence at 24 Months After Surgery |
| NCT01700946 (4) [back to overview] | 3-year Overall Survival Rate of Patients With Relapsed ALL |
| NCT01700946 (4) [back to overview] | Median CD20 Expression Levels |
| NCT01700946 (4) [back to overview] | Mean of CD20 Expression Levels |
| NCT01700946 (4) [back to overview] | 3-year Event-free Survival Rates in Patients With Relapsed ALL |
| NCT01701674 (4) [back to overview] | Progression Free Survival (PFS) |
| NCT01701674 (4) [back to overview] | Occurrence of Dose Limiting Toxicity (DLT) Events |
| NCT01701674 (4) [back to overview] | Rate of Meeting Feasibility Requirements |
| NCT01701674 (4) [back to overview] | Overall Response Rate (ORR) |
| NCT01705691 (7) [back to overview] | Clinical Overall Response (cOR)(Complete and Partial) Assessed by MRI at the Completion of WP or Eribulin (Before AC) |
| NCT01705691 (7) [back to overview] | Clinical Complete Response (ycCR) Following Neoadjuvant Therapy Assessed by Physical Exam at the Completion of Neoadjuvant Chemotherapy |
| NCT01705691 (7) [back to overview] | Adverse Events Experienced by Participants as a Measure of Toxicity. |
| NCT01705691 (7) [back to overview] | 2-year Overall Survival (OS): Death From Any Cause From Time of Randomization Through 2 Years After Randomization. |
| NCT01705691 (7) [back to overview] | ypCR Nodes |
| NCT01705691 (7) [back to overview] | Recurrence Free Interval (RFI): The Time to Occurrence of Inoperable Progressive Disease and Local, Regional, and Distant Recurrence. |
| NCT01705691 (7) [back to overview] | Pathologic Complete Response Rate (ypCR) Following Neoadjuvant Therapy in Breast and Axillary Lymph Nodes |
| NCT01706666 (3) [back to overview] | Survival Time |
| NCT01706666 (3) [back to overview] | Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months |
| NCT01706666 (3) [back to overview] | Progression-free Survival |
| NCT01707004 (8) [back to overview] | Cumulative Incidence of Grade III-IV Acute GVHD |
| NCT01707004 (8) [back to overview] | Number of Participants With Complete Remission After Transplantation |
| NCT01707004 (8) [back to overview] | Overall Survival (OS) |
| NCT01707004 (8) [back to overview] | Percentage of Participants With Platelet Recovery by Day 30 |
| NCT01707004 (8) [back to overview] | Progression Free Survival |
| NCT01707004 (8) [back to overview] | Number of Participants With Primary Graft Failure |
| NCT01707004 (8) [back to overview] | Time to Neutrophil Recovery |
| NCT01707004 (8) [back to overview] | Cumulative Incidence of Chronic GVHD According to BMTCTN |
| NCT01723839 (2) [back to overview] | Overall Response Rate |
| NCT01723839 (2) [back to overview] | Complete Response |
| NCT01724021 (14) [back to overview] | Cancer Therapy Satisfaction Questionnaire (CTSQ) Score |
| NCT01724021 (14) [back to overview] | Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time |
| NCT01724021 (14) [back to overview] | Rituximab Administration Satisfaction Questionnaire (RASQ) Score |
| NCT01724021 (14) [back to overview] | Progression-free Survival (PFS) |
| NCT01724021 (14) [back to overview] | Summary of Observed Serum Rituximab Concentration |
| NCT01724021 (14) [back to overview] | Overall Survival (OS) |
| NCT01724021 (14) [back to overview] | Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8 |
| NCT01724021 (14) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (AEs) |
| NCT01724021 (14) [back to overview] | Event-free Survival (EFS) |
| NCT01724021 (14) [back to overview] | Percentage of Participants With Anti-Rituximab Antibodies Over Time |
| NCT01724021 (14) [back to overview] | Disease-free Survival (DFS) |
| NCT01724021 (14) [back to overview] | Complete Response (CR) Rate |
| NCT01724021 (14) [back to overview] | Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV]) |
| NCT01724021 (14) [back to overview] | Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 |
| NCT01724866 (28) [back to overview] | Duration of DSN in Cycle 2 |
| NCT01724866 (28) [back to overview] | Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities |
| NCT01724866 (28) [back to overview] | Depth of ANC Nadir in Cycle 4 |
| NCT01724866 (28) [back to overview] | Depth of ANC Nadir in Cycle 3 |
| NCT01724866 (28) [back to overview] | Depth of ANC Nadir in Cycle 2 |
| NCT01724866 (28) [back to overview] | Depth of ANC Nadir in Cycle 1 |
| NCT01724866 (28) [back to overview] | Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312) |
| NCT01724866 (28) [back to overview] | Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1 |
| NCT01724866 (28) [back to overview] | Absolute ANC Nadir Overtime in Cycle 4 |
| NCT01724866 (28) [back to overview] | Absolute ANC Nadir Overtime in Cycle 3 |
| NCT01724866 (28) [back to overview] | Absolute ANC Nadir Overtime in Cycle 2 |
| NCT01724866 (28) [back to overview] | Time to Reach Maximum Concentration of SPI-2012 (Tmax) |
| NCT01724866 (28) [back to overview] | Time to ANC Recovery in Cycle 4 |
| NCT01724866 (28) [back to overview] | Maximum Concentration of SPI-2012 (Cmax) |
| NCT01724866 (28) [back to overview] | Time to ANC Recovery in Cycle 1 |
| NCT01724866 (28) [back to overview] | Time to ANC Nadir in Cycle 4 |
| NCT01724866 (28) [back to overview] | Time to ANC Nadir in Cycle 3 |
| NCT01724866 (28) [back to overview] | Time to ANC Nadir in Cycle 2 |
| NCT01724866 (28) [back to overview] | Time to ANC Nadir in Cycle 1 |
| NCT01724866 (28) [back to overview] | Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4 |
| NCT01724866 (28) [back to overview] | Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4 |
| NCT01724866 (28) [back to overview] | Number of Participants With Positive Antibodies for SPI-2012 |
| NCT01724866 (28) [back to overview] | Half-life of SPI-2012 (t1/2) |
| NCT01724866 (28) [back to overview] | Duration of Severe Neutropenia (DSN) in Cycle 1 |
| NCT01724866 (28) [back to overview] | Duration of DSN in Cycle 4 |
| NCT01724866 (28) [back to overview] | Duration of DSN in Cycle 3 |
| NCT01724866 (28) [back to overview] | Time to ANC Recovery in Cycle 2 |
| NCT01724866 (28) [back to overview] | Time to ANC Recovery in Cycle 3 |
| NCT01729338 (11) [back to overview] | Severe Adverse Event Rate |
| NCT01729338 (11) [back to overview] | Overall Response Rate (ORR) During Induction Therapy |
| NCT01729338 (11) [back to overview] | Median Time to Response |
| NCT01729338 (11) [back to overview] | Median Progression-free Survival |
| NCT01729338 (11) [back to overview] | Median Overall Survival |
| NCT01729338 (11) [back to overview] | Median Duration of Response |
| NCT01729338 (11) [back to overview] | Maximum Depth of Response During Maintenance Therapy |
| NCT01729338 (11) [back to overview] | QLQ-C30 Question 30 |
| NCT01729338 (11) [back to overview] | QLQ-C30 Question 29 |
| NCT01729338 (11) [back to overview] | Maximum Depth of Response During Induction Therapy |
| NCT01729338 (11) [back to overview] | Functionality as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool |
| NCT01731886 (5) [back to overview] | Complete Response Rate |
| NCT01731886 (5) [back to overview] | Overall Survival Rate (OS) |
| NCT01731886 (5) [back to overview] | Overall Survival Rate (OS) |
| NCT01731886 (5) [back to overview] | Progression Free Survival (PFS) |
| NCT01731886 (5) [back to overview] | Progression Free Survival (PFS) |
| NCT01740401 (1) [back to overview] | The Anti-tumor Activity of the Combination of Low Dose Cyclophosphamide and CTLA-4 Blockade Using Objective Response Rate (ORR) |
| NCT01746173 (2) [back to overview] | 24-month Progression-Free Survival Rate |
| NCT01746173 (2) [back to overview] | Induction Response |
| NCT01749293 (3) [back to overview] | Number of Participants That Engrafted and the Number of Participants That Had Full Donor Chimerism at Day 60 |
| NCT01749293 (3) [back to overview] | Number of Participants That Had an Event Free Survival Rate |
| NCT01749293 (3) [back to overview] | Number of Participants That Had an Overall Survival Rate |
| NCT01750073 (3) [back to overview] | Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0 |
| NCT01750073 (3) [back to overview] | Overall Incidence of Toxicities, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
| NCT01750073 (3) [back to overview] | Number of Participants in the Subgroups Who Had a Pathologic Complete Response (pCR) |
| NCT01775475 (8) [back to overview] | Participants Who Experienced an Adverse Event |
| NCT01775475 (8) [back to overview] | Overall Survival |
| NCT01775475 (8) [back to overview] | Overall Response Rate |
| NCT01775475 (8) [back to overview] | Number of Patients Who Complete Treatment |
| NCT01775475 (8) [back to overview] | Change in Absolute CD4 Count From Baseline to Post-treatment |
| NCT01775475 (8) [back to overview] | Proportion of Patients Who Are Adherent to Chemotherapy |
| NCT01775475 (8) [back to overview] | Proportion of Patients Who Are Adherent to Antiretroviral Therapy |
| NCT01775475 (8) [back to overview] | Progression-free Survival |
| NCT01777152 (7) [back to overview] | Overall Survival (OS) |
| NCT01777152 (7) [back to overview] | Incidence of Laboratory Abnormalities |
| NCT01777152 (7) [back to overview] | Incidence of Adverse Events (AEs) |
| NCT01777152 (7) [back to overview] | Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) |
| NCT01777152 (7) [back to overview] | Progression-free Survival Per Independent Review Facility (IRF) |
| NCT01777152 (7) [back to overview] | Objective Response Rate (ORR) Per IRF at End of Treatment |
| NCT01777152 (7) [back to overview] | Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) |
| NCT01779050 (2) [back to overview] | Number of Participants With Disease Recurrence |
| NCT01779050 (2) [back to overview] | Death Rate |
| NCT01796197 (7) [back to overview] | Median Time to Treatment Failure |
| NCT01796197 (7) [back to overview] | Number of Participants With Congestive Heart Failure |
| NCT01796197 (7) [back to overview] | Percentages of Participants With Pathologic Complete Response |
| NCT01796197 (7) [back to overview] | Residual Cancer Burden Rate |
| NCT01796197 (7) [back to overview] | Predictive Accuracy Rate of Pre-Treatment Versus On-Treatment Tumor Biopsy RNA Sequencing Profiles |
| NCT01796197 (7) [back to overview] | Median Overall Survival |
| NCT01796197 (7) [back to overview] | Median Disease Free Survival |
| NCT01798004 (1) [back to overview] | The Tolerability of BuMel Regimen |
| NCT01807182 (3) [back to overview] | Number of Participants Who Experienced in Vivo Persistence of Adoptively Transferred T Cells Following TIL Infusion |
| NCT01807182 (3) [back to overview] | A Count of Participants With Biomarker Expression Above Threshold |
| NCT01807182 (3) [back to overview] | Count of Participants Who Experienced Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
| NCT01807611 (6) [back to overview] | Overall Survival |
| NCT01807611 (6) [back to overview] | Event-free Survival |
| NCT01807611 (6) [back to overview] | Number of Transplant Recipients With Acute and/or Chronic Graft Versus Host Disease (GVHD) |
| NCT01807611 (6) [back to overview] | Number of Transplant Recipients With Malignant Relapse |
| NCT01807611 (6) [back to overview] | Number of Transplant Recipients With Transplant-related Mortality (TRM) |
| NCT01807611 (6) [back to overview] | Number of Transplant Recipients With Successful Engraftment |
| NCT01814046 (3) [back to overview] | Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR)) |
| NCT01814046 (3) [back to overview] | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) |
| NCT01814046 (3) [back to overview] | Count of Participants With Changes in Visual Symptoms |
| NCT01818063 (1) [back to overview] | Count of Participants That Achieve Pathologic Complete Response (PCR) |
| NCT01824693 (4) [back to overview] | Number of Participants Who Experience Treatment-Related Mortality (TRM) by Day 100 |
| NCT01824693 (4) [back to overview] | Percentage of Participants Who Experience Primary Graft Failure Event Between Arms |
| NCT01824693 (4) [back to overview] | Percent Probability of Event-free Survival (EFS) |
| NCT01824693 (4) [back to overview] | Percent Probability of 18 Months-relapse Event Between Arms |
| NCT01847001 (3) [back to overview] | Total Number of Participants Who Reached The Target Propranolol Dosing |
| NCT01847001 (3) [back to overview] | Mean Adherence to Propranolol |
| NCT01847001 (3) [back to overview] | Number of Patients With Pathologic Complete Response |
| NCT01849783 (4) [back to overview] | Mean Change in Quality-Of-Life Indicators Post-Transplant |
| NCT01849783 (4) [back to overview] | Percentage of Participants With Serious Treatment-Related Complications |
| NCT01849783 (4) [back to overview] | Percentage of Participants Able to Complete Full Course Therapy |
| NCT01849783 (4) [back to overview] | Median Progression Free Survival (mPFS) |
| NCT01855750 (6) [back to overview] | Event-Free Survival (EFS) - Activated B-Cell (ABC) Population |
| NCT01855750 (6) [back to overview] | Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population |
| NCT01855750 (6) [back to overview] | Percentage of Participants Who Achieved Complete Response (CR) |
| NCT01855750 (6) [back to overview] | Progression-Free Survival (PFS) |
| NCT01855750 (6) [back to overview] | Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) |
| NCT01855750 (6) [back to overview] | Overall Survival |
| NCT01855828 (4) [back to overview] | Proportion of Participants With a Pathologic Complete Response Rate |
| NCT01855828 (4) [back to overview] | Residual Cancer Burden Score |
| NCT01855828 (4) [back to overview] | Count of Patients With Clinical Response |
| NCT01855828 (4) [back to overview] | Cardiac Safety |
| NCT01856192 (4) [back to overview] | Overall Survival Rate at 3 Years |
| NCT01856192 (4) [back to overview] | Proportion of Patients With Response |
| NCT01856192 (4) [back to overview] | 3-year Progression-free Survival Rate |
| NCT01856192 (4) [back to overview] | Proportion of Patients With Complete Response |
| NCT01857934 (6) [back to overview] | Local Failure Rate and Pattern of Failure |
| NCT01857934 (6) [back to overview] | Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)] |
| NCT01857934 (6) [back to overview] | Event-free Survival (EFS) |
| NCT01857934 (6) [back to overview] | Dose Limiting Toxicity (DLT) |
| NCT01857934 (6) [back to overview] | Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation |
| NCT01857934 (6) [back to overview] | Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy |
| NCT01860170 (3) [back to overview] | GVHD |
| NCT01860170 (3) [back to overview] | Dose Limiting Toxicity |
| NCT01860170 (3) [back to overview] | Engraftment |
| NCT01864018 (7) [back to overview] | Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) |
| NCT01864018 (7) [back to overview] | Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I) |
| NCT01864018 (7) [back to overview] | Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A) |
| NCT01864018 (7) [back to overview] | Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
| NCT01864018 (7) [back to overview] | Progression-free Survival (PFS) |
| NCT01864018 (7) [back to overview] | Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B) |
| NCT01864018 (7) [back to overview] | Survival Time |
| NCT01869192 (2) [back to overview] | Pathological Response |
| NCT01869192 (2) [back to overview] | Overall Response Rate |
| NCT01871441 (2) [back to overview] | Number of Participants With Disease-free Survival (DFS) |
| NCT01871441 (2) [back to overview] | Number of Participants With Relapse of Disease |
| NCT01873833 (5) [back to overview] | Overall Survival (OS) |
| NCT01873833 (5) [back to overview] | Overall Response Rate (ORR) |
| NCT01873833 (5) [back to overview] | Number of Participants With Any Adverse Events as a Measure of Safety and Tolerability |
| NCT01873833 (5) [back to overview] | Clinical Benefit Rate (CBR) |
| NCT01873833 (5) [back to overview] | Progression Free Survival (PFS) |
| NCT01881789 (6) [back to overview] | Progression-Free Survival (PFS) |
| NCT01881789 (6) [back to overview] | Number of Participants With Dose-Limiting Toxicities (DLTs) |
| NCT01881789 (6) [back to overview] | Duration of Response (DOR) |
| NCT01881789 (6) [back to overview] | Plasma Oprozomib Concentration |
| NCT01881789 (6) [back to overview] | Overall Response Rate (ORR) |
| NCT01881789 (6) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (AEs) |
| NCT01889069 (23) [back to overview] | Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores |
| NCT01889069 (23) [back to overview] | Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores |
| NCT01889069 (23) [back to overview] | Percentage of Participants With Administration-Associated Reactions (AAR) |
| NCT01889069 (23) [back to overview] | DLBCL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab |
| NCT01889069 (23) [back to overview] | DLBCL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu) |
| NCT01889069 (23) [back to overview] | DLBCL: Apparent Total Clearance (CL/F) of Rituximab |
| NCT01889069 (23) [back to overview] | DLBCL: Area Under the Plasma Concentration-Time Curve (AUC) of Rituximab |
| NCT01889069 (23) [back to overview] | DLBCL: Maximum Plasma Concentration (Cmax) of Rituximab |
| NCT01889069 (23) [back to overview] | FL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab |
| NCT01889069 (23) [back to overview] | Percentage of Participants With At Least One Grade ≥ 3 Infusion/ Injection Related Reactions (IIRRs) |
| NCT01889069 (23) [back to overview] | Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) |
| NCT01889069 (23) [back to overview] | Percentage of Participants With Overall Survival (OS) |
| NCT01889069 (23) [back to overview] | Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events |
| NCT01889069 (23) [back to overview] | Percentage of Participants With Complete Response (CR) According to IWG Response Criteria |
| NCT01889069 (23) [back to overview] | Percentage of Participants With Disease-Free Survival (DFS) According to IWG Response Criteria |
| NCT01889069 (23) [back to overview] | Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria |
| NCT01889069 (23) [back to overview] | DLBCL: Plasma Trough Concentrations of Rituximab |
| NCT01889069 (23) [back to overview] | DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21 |
| NCT01889069 (23) [back to overview] | DLBCL: Plasma Concentrations of Rituximab |
| NCT01889069 (23) [back to overview] | Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria |
| NCT01889069 (23) [back to overview] | DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21 |
| NCT01889069 (23) [back to overview] | FL: Plasma Trough Concentrations of Rituximab |
| NCT01889069 (23) [back to overview] | FL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu) |
| NCT01898793 (8) [back to overview] | Time to Progression (Phase I, Phase II, and Pediatric) |
| NCT01898793 (8) [back to overview] | Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) |
| NCT01898793 (8) [back to overview] | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) |
| NCT01898793 (8) [back to overview] | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) |
| NCT01898793 (8) [back to overview] | Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II) |
| NCT01898793 (8) [back to overview] | Overall Survival (OS) (Phase I, Phase II, and Pediatric) |
| NCT01898793 (8) [back to overview] | Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric) |
| NCT01898793 (8) [back to overview] | Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I) |
| NCT01905943 (12) [back to overview] | Median Time to Event-Free Survival (EFS) |
| NCT01905943 (12) [back to overview] | Median Time to Duration of Response (DoR) |
| NCT01905943 (12) [back to overview] | Number of Participants With Adverse Events of Particular Interest (AEPIs) |
| NCT01905943 (12) [back to overview] | Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry |
| NCT01905943 (12) [back to overview] | Number of Participants With Adverse Events of Special Interest (AESIs) |
| NCT01905943 (12) [back to overview] | Number of Participants With Adverse Events (AEs) |
| NCT01905943 (12) [back to overview] | Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA) |
| NCT01905943 (12) [back to overview] | Percentage of Participants With Best Overall Response (BOR) |
| NCT01905943 (12) [back to overview] | Median Time to Response (TTR) |
| NCT01905943 (12) [back to overview] | Median Time to Progression-Free Survival (PFS) |
| NCT01905943 (12) [back to overview] | Median Time to Overall Survival (OS) |
| NCT01905943 (12) [back to overview] | Median Time to New Anti-Leukemia Therapy (TTNT) |
| NCT01920932 (11) [back to overview] | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) |
| NCT01920932 (11) [back to overview] | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) |
| NCT01920932 (11) [back to overview] | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) |
| NCT01920932 (11) [back to overview] | Descriptive of Neuropathic Adverse Events |
| NCT01920932 (11) [back to overview] | Descriptive of Infectious Adverse Events |
| NCT01920932 (11) [back to overview] | Descriptive of Hematological Adverse Events |
| NCT01920932 (11) [back to overview] | Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control |
| NCT01920932 (11) [back to overview] | Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control |
| NCT01920932 (11) [back to overview] | Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac. |
| NCT01920932 (11) [back to overview] | Complete Response Rate Estimate for All Evaluable Participants |
| NCT01920932 (11) [back to overview] | Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2). |
| NCT01925131 (3) [back to overview] | MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia |
| NCT01925131 (3) [back to overview] | Frequency and Severity of Toxicities |
| NCT01925131 (3) [back to overview] | Response Rate (CR+CRi) Among Expansion Cohort |
| NCT01925612 (6) [back to overview] | Complete Remission Rate |
| NCT01925612 (6) [back to overview] | Incidence of Laboratory Abnormalities |
| NCT01925612 (6) [back to overview] | Overall Survival |
| NCT01925612 (6) [back to overview] | Incidence of Adverse Events |
| NCT01925612 (6) [back to overview] | Objective Response Rate |
| NCT01925612 (6) [back to overview] | Progression-free Survival |
| NCT01946529 (1) [back to overview] | Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants |
| NCT01955434 (5) [back to overview] | Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment) |
| NCT01955434 (5) [back to overview] | Overall Survival |
| NCT01955434 (5) [back to overview] | Event-free Survival |
| NCT01955434 (5) [back to overview] | Confirmed Overall Response Rate (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) With Single Agent SMAC Mimetic LCL161 |
| NCT01955434 (5) [back to overview] | Combination Agent Response Rate |
| NCT01959490 (1) [back to overview] | Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes. |
| NCT01963481 (3) [back to overview] | Progression-free Survival (PFS) Rate at 3 Months |
| NCT01963481 (3) [back to overview] | Response Rate (RR) - Complete Response and Partial Response |
| NCT01963481 (3) [back to overview] | Clinical Benefit Rate Score |
| NCT01966471 (12) [back to overview] | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score |
| NCT01966471 (12) [back to overview] | Overall Survival (OS) |
| NCT01966471 (12) [back to overview] | Invasive Disease-Free Survival (IDFS) in the Overall Population |
| NCT01966471 (12) [back to overview] | Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation |
| NCT01966471 (12) [back to overview] | IDFS Plus Second Primary Non-Breast Cancer |
| NCT01966471 (12) [back to overview] | Distant Recurrence-Free Interval (DRFI) |
| NCT01966471 (12) [back to overview] | Disease-Free Survival (DFS) |
| NCT01966471 (12) [back to overview] | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time |
| NCT01966471 (12) [back to overview] | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment |
| NCT01966471 (12) [back to overview] | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score |
| NCT01966471 (12) [back to overview] | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score |
| NCT01966471 (12) [back to overview] | Percentage of Participants With Adverse Events |
| NCT01967823 (6) [back to overview] | Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells |
| NCT01967823 (6) [back to overview] | Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells |
| NCT01967823 (6) [back to overview] | Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells |
| NCT01967823 (6) [back to overview] | Percentage of Participants With a Response |
| NCT01967823 (6) [back to overview] | Number of Participants With Serious and Non-serious Treatment Related Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
| NCT01967823 (6) [back to overview] | Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells |
| NCT01974440 (14) [back to overview] | Primary Analysis: Progression Free Survival (PFS): Stratified Analysis |
| NCT01974440 (14) [back to overview] | Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL |
| NCT01974440 (14) [back to overview] | Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire |
| NCT01974440 (14) [back to overview] | Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL |
| NCT01974440 (14) [back to overview] | Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL |
| NCT01974440 (14) [back to overview] | Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL |
| NCT01974440 (14) [back to overview] | Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL |
| NCT01974440 (14) [back to overview] | Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) |
| NCT01974440 (14) [back to overview] | Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL |
| NCT01974440 (14) [back to overview] | Primary Analysis: Overall Response Rate (ORR): Stratified Analysis |
| NCT01974440 (14) [back to overview] | Primary Analysis: Overall Survival (OS): Stratified Analysis |
| NCT01974440 (14) [back to overview] | Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
| NCT01974440 (14) [back to overview] | Primary Analysis: Duration of Response (DOR): Stratified Analysis |
| NCT01974440 (14) [back to overview] | Primary Analysis: Complete Response Rate (CRR): Stratified Analysis |
| NCT01979536 (3) [back to overview] | Event Free Survival (EFS) |
| NCT01979536 (3) [back to overview] | Prognostic Significance of Minimal Residual Disease |
| NCT01979536 (3) [back to overview] | Occurrence of Grade 3+ Non-hematologic Adverse Events |
| NCT01980589 (4) [back to overview] | Number of Participants With Dose-limiting Toxicities (DLTs) |
| NCT01980589 (4) [back to overview] | Overall Response Rate (ORR) |
| NCT01980589 (4) [back to overview] | Time To Response (TTR) |
| NCT01980589 (4) [back to overview] | Number of Participants With Adverse Events |
| NCT01982682 (5) [back to overview] | Median Pace of T Cell Immune Recovery at 90 Days Post Hematopoietic Stem Cell Transplantation (HSCT) |
| NCT01982682 (5) [back to overview] | Count of Participants That Experienced Death as a Result of Graft-versus-host Disease (GVHD) |
| NCT01982682 (5) [back to overview] | Count of Participants That Experience 1 Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplantation (HSCT) Using the Thomas Jefferson University 2 Step Approach |
| NCT01982682 (5) [back to overview] | Number of Participants With Successful Engraftment |
| NCT01982682 (5) [back to overview] | Median Pace of T Cell Immune Recovery at 28 Days Post Hematopoietic Stem Cell Transplantation (HSCT) |
| NCT01992653 (29) [back to overview] | Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population |
| NCT01992653 (29) [back to overview] | Overall Survival for DLBCL Population |
| NCT01992653 (29) [back to overview] | Overall Survival for Non-DLBCL Population |
| NCT01992653 (29) [back to overview] | Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
| NCT01992653 (29) [back to overview] | Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
| NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score |
| NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score |
| NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score |
| NCT01992653 (29) [back to overview] | Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score |
| NCT01992653 (29) [back to overview] | Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
| NCT01992653 (29) [back to overview] | Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population |
| NCT01992653 (29) [back to overview] | Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
| NCT01992653 (29) [back to overview] | Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin |
| NCT01992653 (29) [back to overview] | Clearance (CL) of Polatuzumab Vedotin |
| NCT01992653 (29) [back to overview] | Plasma Levels of Cyclophosphamide |
| NCT01992653 (29) [back to overview] | Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin |
| NCT01992653 (29) [back to overview] | Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
| NCT01992653 (29) [back to overview] | Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
| NCT01992653 (29) [back to overview] | Plasma Levels of Doxorubicin |
| NCT01992653 (29) [back to overview] | Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population |
| NCT01992653 (29) [back to overview] | Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population |
| NCT01992653 (29) [back to overview] | Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population |
| NCT01992653 (29) [back to overview] | Terminal Half-Life (t1/2) of Polatuzumab Vedotin |
| NCT01992653 (29) [back to overview] | Maximum Concentration (Cmax) of Polatuzumab Vedotin |
| NCT01992653 (29) [back to overview] | Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population |
| NCT01992653 (29) [back to overview] | Number of Participants With Anti-Obinutuzumab Antibodies |
| NCT01992653 (29) [back to overview] | Number of Participants With Anti-Polatuzumab Vedotin Antibodies |
| NCT01992653 (29) [back to overview] | Number of Participants With DLTs in Non-DLBCL Population |
| NCT01992653 (29) [back to overview] | Number of Participants With Adverse Events in Non-DLBCL Population |
| NCT01993719 (13) [back to overview] | Progression-free Survival (PFS) |
| NCT01993719 (13) [back to overview] | Progression-free Survival (PFS) |
| NCT01993719 (13) [back to overview] | Overall Response Rate (ORR) |
| NCT01993719 (13) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
| NCT01993719 (13) [back to overview] | Number of Treatment-related Adverse Events for Participants Who Received Pembrolizumab |
| NCT01993719 (13) [back to overview] | Overall Progression Free Survival (PFS) |
| NCT01993719 (13) [back to overview] | Overall Survival |
| NCT01993719 (13) [back to overview] | Overall Survival |
| NCT01993719 (13) [back to overview] | Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) |
| NCT01993719 (13) [back to overview] | Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P |
| NCT01993719 (13) [back to overview] | Overall Response Rate (ORR) |
| NCT01993719 (13) [back to overview] | Overall Response Rate (ORR) |
| NCT01993719 (13) [back to overview] | Progression-free Survival (PFS) |
| NCT02004262 (4) [back to overview] | Primary Cohort: OS (All Data, FAS) |
| NCT02004262 (4) [back to overview] | Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set) |
| NCT02004262 (4) [back to overview] | 2nd-line Cohort: OS (All Data, FAS) |
| NCT02004262 (4) [back to overview] | Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen |
| NCT02013375 (1) [back to overview] | Engraftment Rate |
| NCT02013817 (6) [back to overview] | Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) |
| NCT02013817 (6) [back to overview] | Percentage of Participants With Adverse Events (AEs) |
| NCT02013817 (6) [back to overview] | Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment) |
| NCT02013817 (6) [back to overview] | Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment) |
| NCT02013817 (6) [back to overview] | Time to Next Treatment - Time to Event |
| NCT02013817 (6) [back to overview] | Time to Next Treatment - Percentage of Participants With an Event |
| NCT02017964 (5) [back to overview] | Percentage of Patients With Responses at 273 Days |
| NCT02017964 (5) [back to overview] | Progression-free Survival (PFS) |
| NCT02017964 (5) [back to overview] | Event-free Survival (EFS) |
| NCT02017964 (5) [back to overview] | Overall Survival (OS) |
| NCT02017964 (5) [back to overview] | Percentage of Patients With Responses at 189 Days |
| NCT02018458 (2) [back to overview] | Safety of DC Vaccine Combined With Chemotherapy |
| NCT02018458 (2) [back to overview] | Disease-free Survival |
| NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed |
| NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Acute Renal Allograft Rejection |
| NCT02029638 (18) [back to overview] | Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery |
| NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection |
| NCT02029638 (18) [back to overview] | Number of Days From Transplant to Platelet Count Recovery |
| NCT02029638 (18) [back to overview] | Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment |
| NCT02029638 (18) [back to overview] | Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant |
| NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal |
| NCT02029638 (18) [back to overview] | Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
| NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation |
| NCT02029638 (18) [back to overview] | Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
| NCT02029638 (18) [back to overview] | Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
| NCT02029638 (18) [back to overview] | Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology |
| NCT02029638 (18) [back to overview] | Percent of Participants Who Achieved Operational Tolerance |
| NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Engraftment Syndrome |
| NCT02029638 (18) [back to overview] | Number of Participants Free From Return to Immunosuppression for the Duration of the Study |
| NCT02029638 (18) [back to overview] | Duration in Days of Graft-versus-Host Disease in Transplanted Participants |
| NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Died |
| NCT02046070 (25) [back to overview] | AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in RRMM Participants |
| NCT02046070 (25) [back to overview] | Number of Participants With AEs, SAEs, AEs Resulting in Discontinuation and AEs Resulting in Dose Reduction in NDMM Participants Remaining on Treatment After 13 Cycles |
| NCT02046070 (25) [back to overview] | Tmax: Time to First Occurrence of Cmax for Ixazomib in RRMM Participants |
| NCT02046070 (25) [back to overview] | Tmax: Time to First Occurrence of Cmax for Ixazomib in NDMM Participants |
| NCT02046070 (25) [back to overview] | Percentage of Participants With CR + VGR + PR (ORR), CR, VGPR, and PR in NDMM Participants Remaining on Treatment After 13 Cycles |
| NCT02046070 (25) [back to overview] | Percentage of Participants With CR + VGPR + PR (ORR), CR, VGPR, PR and Stable Disease (SD), Progressive Disease (PD) During the Induction Phase |
| NCT02046070 (25) [back to overview] | Percentage of Participants With CR + VGPR + PR (ORR), CR + VGPR, CR, VGPR, PR, SD and PD Throughout the Entire Treatment Period in NDMM Participants |
| NCT02046070 (25) [back to overview] | Percentage of Participants With (CR + VGPR), CR, VGPR, PR, SD and PD in RRMM Participants |
| NCT02046070 (25) [back to overview] | Number of Participants With AEs, Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction, SAEs in RRMM Participants |
| NCT02046070 (25) [back to overview] | Number of Participants With Adverse Events (AEs), Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction and Serious Adverse Events (SAEs) in NDMM Participants |
| NCT02046070 (25) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Ixazomib in RRMM Participants |
| NCT02046070 (25) [back to overview] | Cmax: Maximum Observed Plasma Concentration for Ixazomib in NDMM Participants |
| NCT02046070 (25) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) During the Induction Phase in NDMM Participants |
| NCT02046070 (25) [back to overview] | Change From Baseline in EORTC Quality of Life Questionnaire (QLQ-C30) in RRMM Participants |
| NCT02046070 (25) [back to overview] | AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in NDMM Participants |
| NCT02046070 (25) [back to overview] | Time to Response (TTR) in RRMM Participants |
| NCT02046070 (25) [back to overview] | Time to Response (TTR) in NDMM Participants During the Induction Phase |
| NCT02046070 (25) [back to overview] | Time to Progression (TTP) in RRMM Participants |
| NCT02046070 (25) [back to overview] | Time to Progression (TTP) in NDMM Participants |
| NCT02046070 (25) [back to overview] | Progression Free Survival (PFS) in RRMM Participants |
| NCT02046070 (25) [back to overview] | Progression Free Survival (PFS) in NDMM Participants |
| NCT02046070 (25) [back to overview] | Overall Response Rate (ORR) in Relapsed and/or Refractory Multiple Myeloma (RRMM) Participants |
| NCT02046070 (25) [back to overview] | Duration of Response (DOR) in RRMM Participants |
| NCT02046070 (25) [back to overview] | Duration of Response (DOR) in NDMM Participants |
| NCT02046070 (25) [back to overview] | Combined Response Rate During the Induction Phase in Newly Diagnosed Multiple Myeloma (NDMM) Participants |
| NCT02048813 (2) [back to overview] | Progression-free Survival (PFS) Rate at 3 Years |
| NCT02048813 (2) [back to overview] | Overall Survival (OS) Rate at 3 Years |
| NCT02049151 (2) [back to overview] | Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs) |
| NCT02049151 (2) [back to overview] | Overall Survival |
| NCT02054104 (4) [back to overview] | Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs |
| NCT02054104 (4) [back to overview] | Number of Participants With an Immunologic Responses |
| NCT02054104 (4) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
| NCT02054104 (4) [back to overview] | Fold Change From Baseline of Percent Tregs |
| NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC) |
| NCT02055820 (22) [back to overview] | Safety: Percentage of Participants With Adverse Events |
| NCT02055820 (22) [back to overview] | Safety: Number of Participants With Dose-Limiting Toxicities (DLTs) |
| NCT02055820 (22) [back to overview] | Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC) |
| NCT02055820 (22) [back to overview] | Rituximab PK: Cmin Within the Dosing Interval |
| NCT02055820 (22) [back to overview] | Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification |
| NCT02055820 (22) [back to overview] | Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC |
| NCT02055820 (22) [back to overview] | Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC |
| NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax) |
| NCT02055820 (22) [back to overview] | Vincristine PK: Cmax |
| NCT02055820 (22) [back to overview] | Prednisone Plasma PK: AUC |
| NCT02055820 (22) [back to overview] | Prednisone Plasma PK: Cmax |
| NCT02055820 (22) [back to overview] | Prednisone Plasma PK: Tmax |
| NCT02055820 (22) [back to overview] | Relative Dose Intensity of Venetoclax |
| NCT02055820 (22) [back to overview] | Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy |
| NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval |
| NCT02055820 (22) [back to overview] | Cyclophosphamide PK: Cmax |
| NCT02055820 (22) [back to overview] | Doxorubicin PK: Cmax |
| NCT02055820 (22) [back to overview] | Obinutuzumab PK: Cmax |
| NCT02055820 (22) [back to overview] | Percentage of Participants Who Are Alive and Without Disease Progression at Month 12 |
| NCT02055820 (22) [back to overview] | Rituximab PK: Cmax |
| NCT02055820 (22) [back to overview] | Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax) |
| NCT02062359 (1) [back to overview] | Number of Participants With Adverse Events |
| NCT02065154 (5) [back to overview] | Regimen Related Toxicity |
| NCT02065154 (5) [back to overview] | Overall Survival |
| NCT02065154 (5) [back to overview] | Relapse Rate |
| NCT02065154 (5) [back to overview] | Disease-free Survival |
| NCT02065154 (5) [back to overview] | Grade II-IV Acute GVHD |
| NCT02080195 (5) [back to overview] | Graft Failure |
| NCT02080195 (5) [back to overview] | Acute Graft Versus Host Disease (GVHD) |
| NCT02080195 (5) [back to overview] | Survival |
| NCT02080195 (5) [back to overview] | The Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide in Refractory SLE Patients With Donors Having Various Degrees of Matching |
| NCT02080195 (5) [back to overview] | Chronic Graft Versus Host Disease (GVHD) |
| NCT02096588 (2) [back to overview] | Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
| NCT02096588 (2) [back to overview] | Change in Echocardiographic Global Longitudinal Strain (GLS) |
| NCT02101853 (4) [back to overview] | Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients |
| NCT02101853 (4) [back to overview] | Overall Survival (OS) of LR Relapse Patients |
| NCT02101853 (4) [back to overview] | Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients |
| NCT02101853 (4) [back to overview] | Overall Survival (OS) of HR and IR Relapse Patients |
| NCT02111850 (6) [back to overview] | Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks |
| NCT02111850 (6) [back to overview] | Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment |
| NCT02111850 (6) [back to overview] | Number of Participants With Dose-limiting Toxicity (DLT) |
| NCT02111850 (6) [back to overview] | Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin |
| NCT02111850 (6) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). |
| NCT02111850 (6) [back to overview] | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) |
| NCT02111863 (3) [back to overview] | Objective Response Rate of Patients With Metastatic Melanoma |
| NCT02111863 (3) [back to overview] | Overall Survival (OS) of Patients Receiving a Lymphocyte Depleting Preparative Regimen |
| NCT02111863 (3) [back to overview] | Count of Participants With Serious and Non-Serious Adverse Events |
| NCT02112916 (6) [back to overview] | EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 |
| NCT02112916 (6) [back to overview] | EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) |
| NCT02112916 (6) [back to overview] | Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase |
| NCT02112916 (6) [back to overview] | Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) |
| NCT02112916 (6) [back to overview] | EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond |
| NCT02112916 (6) [back to overview] | Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients |
| NCT02116530 (5) [back to overview] | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire |
| NCT02116530 (5) [back to overview] | Median Nausea Scores |
| NCT02116530 (5) [back to overview] | Proportion of Patients With Complete Response |
| NCT02116530 (5) [back to overview] | Proportion of Patients With no Nausea |
| NCT02116530 (5) [back to overview] | Frequency of Rescue Medication |
| NCT02117024 (6) [back to overview] | Survival at 12 Months |
| NCT02117024 (6) [back to overview] | Time to Progression (TTP) |
| NCT02117024 (6) [back to overview] | Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) |
| NCT02117024 (6) [back to overview] | Survival at 6 Months |
| NCT02117024 (6) [back to overview] | Overall Survival (OS) |
| NCT02117024 (6) [back to overview] | Progression-Free Survival (PFS) |
| NCT02120157 (11) [back to overview] | Time to Neutrophil and Platelet Recovery |
| NCT02120157 (11) [back to overview] | Cumulative Incidence of Non-relapse Mortality |
| NCT02120157 (11) [back to overview] | Cumulative Incidence of Chronic GVHD |
| NCT02120157 (11) [back to overview] | Incidence of Donor Cell Engraftment |
| NCT02120157 (11) [back to overview] | Number of Participants With Donor Cell Engraftment |
| NCT02120157 (11) [back to overview] | Cumulative Incidence of Acute Graft Versus Host Disease (GVHD) Grades 2-4 and Grades 3-4 |
| NCT02120157 (11) [back to overview] | Primary and Secondary Graft Failure |
| NCT02120157 (11) [back to overview] | Steroid and Non-steroid Immunosuppressants |
| NCT02120157 (11) [back to overview] | Steroid and Non-steroid Immunosuppressants Use Duration |
| NCT02120157 (11) [back to overview] | Survival |
| NCT02120157 (11) [back to overview] | Survival |
| NCT02128230 (1) [back to overview] | The Remission Rate for Participants With High-risk Myeloma |
| NCT02132949 (15) [back to overview] | Percentage of Participants With Total Pathologic Complete Response (tpCR), Evaluated After Surgery |
| NCT02132949 (15) [back to overview] | Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Treatment-Free Follow-Up Period |
| NCT02132949 (15) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1 to 5 Years, Determined by the Investigator According to RECIST v1.1 |
| NCT02132949 (15) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1 to 5 Years |
| NCT02132949 (15) [back to overview] | Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period |
| NCT02132949 (15) [back to overview] | Overview of the Number of Participants With at Least One Adverse Event During the Neoadjuvant Period |
| NCT02132949 (15) [back to overview] | Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period |
| NCT02132949 (15) [back to overview] | Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline |
| NCT02132949 (15) [back to overview] | Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Adjuvant Treatment Period |
| NCT02132949 (15) [back to overview] | Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Neoadjuvant Treatment Period |
| NCT02132949 (15) [back to overview] | Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Invasive Disease-Free Survival (iDFS) at 1 to 4 Years, Determined by the Investigator According to RECIST v1.1 |
| NCT02132949 (15) [back to overview] | Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period |
| NCT02132949 (15) [back to overview] | Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period |
| NCT02132949 (15) [back to overview] | Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period |
| NCT02132949 (15) [back to overview] | Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Period |
| NCT02139280 (5) [back to overview] | Number of Nucleated Cells Collected Within the Apheresis Products |
| NCT02139280 (5) [back to overview] | Toxicities During the Mobilization and Apheresis Processes |
| NCT02139280 (5) [back to overview] | Resource Utilization- Incidence of Febrile Neutropenia |
| NCT02139280 (5) [back to overview] | Resource Utilization- Hospitalizations |
| NCT02139280 (5) [back to overview] | Number of CD34+ Cells Collected Within the Apheresis Products |
| NCT02145039 (4) [back to overview] | Number of Patients With Hematopoietic Engraftment |
| NCT02145039 (4) [back to overview] | Number of Patients Experiencing Transplant Related Mortality (TRM) |
| NCT02145039 (4) [back to overview] | Number of Patients Experiencing Acute Graft-versus-host Disease by 100 Days |
| NCT02145039 (4) [back to overview] | 2 Year Survival |
| NCT02153905 (4) [back to overview] | Number of Participants With Dose-Limiting Toxicity (DLT) |
| NCT02153905 (4) [back to overview] | Number of Participants With Serious and Non-Serious Adverse Events |
| NCT02153905 (4) [back to overview] | Number of Patients With Objective Tumor Regression |
| NCT02153905 (4) [back to overview] | Number of Treatment Related Adverse Events Related to T-Cell Receptor (TCR) Gene-Engineered Cells |
| NCT02158091 (2) [back to overview] | Number of Patients Who Had a Minimal Residual Disease (MRD) Negative Complete Response (CR) 2 Months After Chemotherapy |
| NCT02158091 (2) [back to overview] | Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I |
| NCT02162771 (4) [back to overview] | Area Under the Serum Concentration-time Curve at Steady State (AUCtau) |
| NCT02162771 (4) [back to overview] | Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria |
| NCT02162771 (4) [back to overview] | B-cell Kinetics (B-cell Depletion and Recovery) |
| NCT02162771 (4) [back to overview] | Maximum Serum Concentration at Steady State (Cmax,ss) |
| NCT02166463 (3) [back to overview] | Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review |
| NCT02166463 (3) [back to overview] | Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death |
| NCT02166463 (3) [back to overview] | Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale |
| NCT02193880 (2) [back to overview] | Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) |
| NCT02193880 (2) [back to overview] | Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) |
| NCT02199041 (9) [back to overview] | Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT |
| NCT02199041 (9) [back to overview] | Number of Participants With Event-free Survival (EFS) |
| NCT02199041 (9) [back to overview] | Number of Participants With Malignant Relapse |
| NCT02199041 (9) [back to overview] | Number of Participants With Neutrophil Engraftment |
| NCT02199041 (9) [back to overview] | Number of Participants With Overall Survival (OS) |
| NCT02199041 (9) [back to overview] | Number of Participants With Secondary Graft Failure |
| NCT02199041 (9) [back to overview] | Number of Participants With Transplant-related Morbidity |
| NCT02199041 (9) [back to overview] | Number of Participants With Transplant-related Mortality (TRM) |
| NCT02199041 (9) [back to overview] | Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Chronic GVHD Requiring Immunosupressive Therapy |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Disease-free Survival |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Grade III-IV Acute GVHD |
| NCT02208037 (13) [back to overview] | Percentage of Participants With GVHD-free Survival |
| NCT02208037 (13) [back to overview] | Percentage of Participants With GVHD/Relapse or Progression-free Survival (GRFS) |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Overall Survival |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Transplant-Related Mortality (TRM) |
| NCT02208037 (13) [back to overview] | Donor Cell Engraftment |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Neutrophil Recovery |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Platelet Recovery |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Grade II-IV Acute GVHD |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Chronic GVHD |
| NCT02208037 (13) [back to overview] | Percentage of Participants With Disease Relapse or Progression |
| NCT02215967 (3) [back to overview] | Number of Participants With Dose Limiting Toxicities |
| NCT02215967 (3) [back to overview] | Number of Participants With Best Response |
| NCT02215967 (3) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
| NCT02222155 (15) [back to overview] | Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85 |
| NCT02222155 (15) [back to overview] | Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85 |
| NCT02222155 (15) [back to overview] | Change in Estimated Glomerular Filtration Rate at Day 85 |
| NCT02222155 (15) [back to overview] | Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L |
| NCT02222155 (15) [back to overview] | Change From Baseline to Day 85 in the VDI |
| NCT02222155 (15) [back to overview] | Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85 |
| NCT02222155 (15) [back to overview] | Percentage Change in Estimated Glomerular Filtration Rate at Day 85 |
| NCT02222155 (15) [back to overview] | Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 |
| NCT02222155 (15) [back to overview] | Proportion of Patients Achieving Disease Response Based on BVAS at Day 85 |
| NCT02222155 (15) [back to overview] | Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85. |
| NCT02222155 (15) [back to overview] | Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85. |
| NCT02222155 (15) [back to overview] | Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85 |
| NCT02222155 (15) [back to overview] | Incidence of Adverse Events |
| NCT02222155 (15) [back to overview] | Percent Change From Baseline to Day 85 in BVAS. |
| NCT02222155 (15) [back to overview] | Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85 |
| NCT02224872 (11) [back to overview] | Participants That Were GVHD Free, Relapse Free Survival (GRFS) |
| NCT02224872 (11) [back to overview] | Number of Patients With Primary or Secondary Graft Failure Following Transplant |
| NCT02224872 (11) [back to overview] | Number of Patients That Expired Due to Transplant Related Mortality |
| NCT02224872 (11) [back to overview] | Number of Patients That Have Acheived Full Donor Chimerism by Day 60 After Transplant |
| NCT02224872 (11) [back to overview] | Number of Patients That Have Survived at One Year |
| NCT02224872 (11) [back to overview] | Participants With Chronic GVHD at One Year |
| NCT02224872 (11) [back to overview] | Is This Type of Transplantation for Severe Aplastic Anemia Feasible and Safe? |
| NCT02224872 (11) [back to overview] | Number of Patients That Expired Due to Non-relapsed-related Mortality Following Transplant |
| NCT02224872 (11) [back to overview] | Number of Participants With Major Toxicities Related to Transplant |
| NCT02224872 (11) [back to overview] | Number of Participants With Grade II-IV or Grade III-IV Acute GVHD |
| NCT02224872 (11) [back to overview] | Length of Time Required for Patients to Recover ANC and Platelet Counts After Transplant |
| NCT02225665 (4) [back to overview] | Secondary Outcome Measure |
| NCT02225665 (4) [back to overview] | Primary Outcome Measure |
| NCT02225665 (4) [back to overview] | Secondary Outcome Measure |
| NCT02225665 (4) [back to overview] | Secondary Outcome Measure |
| NCT02243371 (7) [back to overview] | Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity |
| NCT02243371 (7) [back to overview] | Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients |
| NCT02243371 (7) [back to overview] | Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration |
| NCT02243371 (7) [back to overview] | Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients |
| NCT02243371 (7) [back to overview] | Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients |
| NCT02243371 (7) [back to overview] | Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients |
| NCT02243371 (7) [back to overview] | Overall Survival (OS) |
| NCT02248597 (5) [back to overview] | 12 Month Disease Free Survival Probability |
| NCT02248597 (5) [back to overview] | Relapse-free Mortality |
| NCT02248597 (5) [back to overview] | Rate of Acute GvHD |
| NCT02248597 (5) [back to overview] | Progression Free Survival |
| NCT02248597 (5) [back to overview] | Overall Survival |
| NCT02251548 (12) [back to overview] | Partial Response Rate (PRR) |
| NCT02251548 (12) [back to overview] | Median Progression-Free Survival (PFS) |
| NCT02251548 (12) [back to overview] | Rate of MRD Negative CR After 3 Cycles of iFCR |
| NCT02251548 (12) [back to overview] | Median Time to Bone Marrow MRD Negativity |
| NCT02251548 (12) [back to overview] | 1-year Combined Response With MRD From Bone Marrow |
| NCT02251548 (12) [back to overview] | Number of Participants Who Convert From Bone Marrow MRD Negative PR to Bone Marrow MRD Negative CR After 1 Year of Ibrutinib Maintenance |
| NCT02251548 (12) [back to overview] | Number of Participants Who Convert From Bone Marrow MRD Negative PR to Bone Marrow MRD Negative CR After 2 Years on Treatment |
| NCT02251548 (12) [back to overview] | Overall Response Rate |
| NCT02251548 (12) [back to overview] | Participants Who Convert From Bone Marrow MRD Negativity to MRD Positivity in Participants Who Discontinue Ibrutinib |
| NCT02251548 (12) [back to overview] | Median Overall Survival (OS) |
| NCT02251548 (12) [back to overview] | Part I: Participants Who Achieve a Minimal Residual Disease (MRD) Negative Complete Response (CR) in the Bone Marrow at 2 Months Post FCR |
| NCT02251548 (12) [back to overview] | Complete Response Rate (CRR) |
| NCT02259348 (9) [back to overview] | Mean of Days to Absolute Neutrophil Count (ANC) Engraftment |
| NCT02259348 (9) [back to overview] | Incidence and Severity of Acute GvHD |
| NCT02259348 (9) [back to overview] | Incidence of Malignant Relapse |
| NCT02259348 (9) [back to overview] | Rate of Transplant-related Mortality (TRM) |
| NCT02259348 (9) [back to overview] | Event-free Survival (EFS) |
| NCT02259348 (9) [back to overview] | Incidence and Severity of Chronic GvHD |
| NCT02259348 (9) [back to overview] | Percentage of Participants Engrafted by Day 42 Post-transplant |
| NCT02259348 (9) [back to overview] | Overall Survival (OS) |
| NCT02259348 (9) [back to overview] | Median Days to Absolute Neutrophil Count (ANC) Engraftment |
| NCT02260934 (15) [back to overview] | Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants With a Sustained Complete Response |
| NCT02260934 (15) [back to overview] | Count of Participants: Frequency of Non-renal Flares by Week 24 |
| NCT02260934 (15) [back to overview] | Count of Participants: Frequency of Non-renal Flares by Week 48 |
| NCT02260934 (15) [back to overview] | Count of Participants: Frequency of Non-renal Flares by Week 96 |
| NCT02260934 (15) [back to overview] | Frequency of Specific Adverse Events of Interest By Event by Week 96 |
| NCT02260934 (15) [back to overview] | Frequency of Specific Adverse Events of Interest By Participant, By Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96 |
| NCT02260934 (15) [back to overview] | Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96 |
| NCT02280811 (7) [back to overview] | Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells |
| NCT02280811 (7) [back to overview] | Number of Participants With a Dose Limiting Toxicity (DLT) |
| NCT02280811 (7) [back to overview] | Maximum Tolerated Dose (MTD) |
| NCT02280811 (7) [back to overview] | Duration of Response |
| NCT02280811 (7) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
| NCT02280811 (7) [back to overview] | Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders |
| NCT02280811 (7) [back to overview] | Objective Tumor Response Rate (Complete or Partial Response) |
| NCT02282514 (3) [back to overview] | Short-form 36 Quality of Life Questionnaire (SF-36 QOL) |
| NCT02282514 (3) [back to overview] | Overall Survival |
| NCT02282514 (3) [back to overview] | Reduction of Muscle Relaxation Anti-spasmatic Medications |
| NCT02282904 (2) [back to overview] | To Determine the Efficacy of This Allogeneic Transplant Approach in Reconstituting Normal Hematopoiesis and Reversing the Clinical Phenotype of CGD |
| NCT02282904 (2) [back to overview] | To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. |
| NCT02285062 (15) [back to overview] | Percentage of Participants Who Achieved an Objective Response |
| NCT02285062 (15) [back to overview] | K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) |
| NCT02285062 (15) [back to overview] | Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire |
| NCT02285062 (15) [back to overview] | Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire |
| NCT02285062 (15) [back to overview] | Percentage of Participants Who Achieved a Complete Response (CR) |
| NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI) |
| NCT02285062 (15) [back to overview] | K-M Estimate of Overall Survival (OS) |
| NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale |
| NCT02285062 (15) [back to overview] | Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) |
| NCT02285062 (15) [back to overview] | K-M Estimate of Duration of Complete Response |
| NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale |
| NCT02285062 (15) [back to overview] | Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale |
| NCT02285062 (15) [back to overview] | Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score |
| NCT02285062 (15) [back to overview] | Kaplan-Meier Estimate of Progression Free Survival (PFS) |
| NCT02285062 (15) [back to overview] | Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS) |
| NCT02298946 (6) [back to overview] | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
| NCT02298946 (6) [back to overview] | Count of Participants With Post-Treatment Biopsies |
| NCT02298946 (6) [back to overview] | Number of Participants in Which Specimens Were Collected for Pre and Post Pharmacokinetic (PK) AMP-224 Analyses |
| NCT02298946 (6) [back to overview] | Overall Survival in Patients With Colorectal Cancer Following Treatment With AMP-224 in Combination With SBRT |
| NCT02298946 (6) [back to overview] | Objective Response Rate |
| NCT02298946 (6) [back to overview] | Median Progression-free Survival in Patients With Colorectal Cancer |
| NCT02306161 (3) [back to overview] | Overall Survival |
| NCT02306161 (3) [back to overview] | Frequency of Toxicity-events |
| NCT02306161 (3) [back to overview] | Event-free Survival |
| NCT02345850 (20) [back to overview] | Health-Related Quality of Life (HQL) - Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) |
| NCT02345850 (20) [back to overview] | Health-Related Quality of Life (HQL) - MDASI |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Secondary Graft Failure |
| NCT02345850 (20) [back to overview] | Participants With Grade ≥ 3 Toxicity |
| NCT02345850 (20) [back to overview] | Health-Related Quality of Life (HQL) - Medical Outcomes Study Short Form 36 (SF36) |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Acute GVHD |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Chronic GVHD |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Chronic GVHD-free Survival |
| NCT02345850 (20) [back to overview] | Participants With Primary Graft Failure |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Relapse-free Survival |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Treatment-related Mortality |
| NCT02345850 (20) [back to overview] | Health-Related Quality of Life (HQL) - PedsQL |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Platelet Recovery |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Neutrophil Engraftment |
| NCT02345850 (20) [back to overview] | Participants With Immunosuppression-free Survival |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Overall Survival (OS) |
| NCT02345850 (20) [back to overview] | Participants Infected Post Transplant |
| NCT02345850 (20) [back to overview] | Incidence of Infections |
| NCT02345850 (20) [back to overview] | Chronic GVHD-free, Relapse-free Survival (CRFS) Probability |
| NCT02345850 (20) [back to overview] | Percentage of Participants With Disease Relapse |
| NCT02348216 (29) [back to overview] | Phase 2: Progression-Free Survival (PFS) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma |
| NCT02348216 (29) [back to overview] | Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 4 and Grade 3 or Higher Resulting From Increased Parameter Value |
| NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokines (Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1) in Serum (Phase 2 Cohorts 4, 5, and 6) |
| NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6) |
| NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3) |
| NCT02348216 (29) [back to overview] | Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007 |
| NCT02348216 (29) [back to overview] | Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades |
| NCT02348216 (29) [back to overview] | Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades |
| NCT02348216 (29) [back to overview] | Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades |
| NCT02348216 (29) [back to overview] | Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades |
| NCT02348216 (29) [back to overview] | Phase 2 Safety Management Study: EQ-5D Visual Analogue Scale (VAS) Score |
| NCT02348216 (29) [back to overview] | Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 4 and Grade 3 or Higher Resulting From Decreased Parameter Value |
| NCT02348216 (29) [back to overview] | Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score |
| NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokine (CRP) in Serum |
| NCT02348216 (29) [back to overview] | Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood |
| NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 2 Cohort 3) |
| NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 1 and Phase 2 Cohorts 1 and 2) |
| NCT02348216 (29) [back to overview] | Phase 2: Duration of Response (DOR) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma |
| NCT02348216 (29) [back to overview] | Percentage of Participants With Positive Replication Competent Retrovirus (RCR) |
| NCT02348216 (29) [back to overview] | Phase 2 Pivotal Study (Cohorts 1 and 2): Duration of Response (DOR) Using IRRC Per Cheson 2007 |
| NCT02348216 (29) [back to overview] | Phase 2 Pivotal Study (Cohorts 1 and 2): ORR Per Independent Radiological Review Committee (IRRC) |
| NCT02348216 (29) [back to overview] | Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma |
| NCT02348216 (29) [back to overview] | Phase 2 Pivotal Study (Cohorts 1 and 2): PFS Using IRRC Per Cheson 2007 |
| NCT02348216 (29) [back to overview] | Percentage of Participants With Anti-Axicabtagene Ciloleucel Antibodies |
| NCT02348216 (29) [back to overview] | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
| NCT02348216 (29) [back to overview] | Phase 2 Safety Management Study (Cohorts 3, 4, 5, and 6): ORR as Assessed by Investigator Per the Revised IWG Response Criteria for Malignant Lymphoma |
| NCT02348216 (29) [back to overview] | Phase 1 Study: ORR as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma |
| NCT02348216 (29) [back to overview] | Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) |
| NCT02348216 (29) [back to overview] | Phase 2: Overall Survival (OS) |
| NCT02349178 (1) [back to overview] | Minimal Residual Disease |
| NCT02354690 (5) [back to overview] | Overall Survival |
| NCT02354690 (5) [back to overview] | Progression Free Survival |
| NCT02354690 (5) [back to overview] | Number of Reported Adverse Events |
| NCT02354690 (5) [back to overview] | Treatment Related Immune Responses |
| NCT02354690 (5) [back to overview] | Objective Response Rate |
| NCT02379195 (5) [back to overview] | Overall Survival |
| NCT02379195 (5) [back to overview] | Number of Participants With Adverse Events/Serious Adverse Events |
| NCT02379195 (5) [back to overview] | Progression Free Survival |
| NCT02379195 (5) [back to overview] | Objective Response Rate |
| NCT02379195 (5) [back to overview] | Treatment Related Immune Responses |
| NCT02408016 (3) [back to overview] | Count of Patients for Which T Cells Are Successfully Generated and Infused and Whether Only TN or TCM Could be Generated |
| NCT02408016 (3) [back to overview] | Number of Participants With Adverse Events |
| NCT02408016 (3) [back to overview] | Persistence of Transduced T Cells |
| NCT02412228 (2) [back to overview] | Evaluation of the Response Rate of Ixazomib With Metronomic Cyclophosphamide and Dexamethasone for First-line Treatment of Multiple Myeloma. |
| NCT02412228 (2) [back to overview] | Evaluation of the Toxicities Associated With Ixazomib With Metronomic Cyclophosphamide and Dexamethasone. |
| NCT02413320 (2) [back to overview] | Number of Participants With Pathological Complete Response |
| NCT02413320 (2) [back to overview] | Number of Participants With Minimal Residual Disease |
| NCT02419469 (1) [back to overview] | Event Free Survival (EFS) |
| NCT02419742 (5) [back to overview] | Percentage of Participants With Adverse Events |
| NCT02419742 (5) [back to overview] | Overall Survival (OS) |
| NCT02419742 (5) [back to overview] | Disease Free Survival (DFS) |
| NCT02419742 (5) [back to overview] | Clinically Significant Changes in Cardiac Function As Determined by Left Ventricular Ejection Fraction (LVEF) Measurements Using Echocardiography |
| NCT02419742 (5) [back to overview] | Clinically Significant Changes in Cardiac Function As Determined by Left Ventricular Ejection Fraction (LVEF) Measurements Using Echocardiography |
| NCT02420717 (4) [back to overview] | Overall Survival |
| NCT02420717 (4) [back to overview] | Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) |
| NCT02420717 (4) [back to overview] | Progression-free Survival |
| NCT02420717 (4) [back to overview] | Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I) |
| NCT02425306 (3) [back to overview] | Immunogenicity-CD4+ T Cell Responses |
| NCT02425306 (3) [back to overview] | Number of Participants With Adverse Events |
| NCT02425306 (3) [back to overview] | Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only) |
| NCT02481310 (2) [back to overview] | 12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II) |
| NCT02481310 (2) [back to overview] | To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R. |
| NCT02486952 (2) [back to overview] | Probability of Event Free Survival (EFS) |
| NCT02486952 (2) [back to overview] | Percentage of Participants Who Were Alive |
| NCT02502864 (2) [back to overview] | Rate of Achieving Targeted Area Under the Curve (AUC) |
| NCT02502864 (2) [back to overview] | Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia |
| NCT02512679 (5) [back to overview] | Number of Participants Who Were Disease Progression-Free and Death-Free at 1 Year Post-transplant |
| NCT02512679 (5) [back to overview] | Number of Participants Who Developed Severe Mucositis, Veno-occlusive Disease (VOD), Toxicity of the Kidney, Liver, or Gastrointestinal (GI) Tract up to 1 Year Post-transplant |
| NCT02512679 (5) [back to overview] | Number of Participants With Neutrophil Engraftment (=/>500 Cells/uL) and Platelet Engraftment (>20K Cell/uL) at 30 Days |
| NCT02512679 (5) [back to overview] | Number of Participants With Disease Recurrence at 1 Year Post-transplant |
| NCT02512679 (5) [back to overview] | Number of Participants Who Developed Graft-Versus-Host-Disease (GVHD) as Determined by the Glucksberg Scale |
| NCT02533401 (5) [back to overview] | Progression-Free Survival (PFS) |
| NCT02533401 (5) [back to overview] | Percentage of Participants With Death or Disease Progression |
| NCT02533401 (5) [back to overview] | Percentage of Participants Who Died |
| NCT02533401 (5) [back to overview] | Overall Survival (OS) |
| NCT02533401 (5) [back to overview] | Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR) |
| NCT02541565 (1) [back to overview] | Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
| NCT02553460 (1) [back to overview] | Percentage of Treatment-related Mortality (TRM) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Disease Relapse, Days 60-180 (D60) |
| NCT02556931 (22) [back to overview] | Number of Number of Participants With Severe Chronic GVHD, Day 360 (D60) |
| NCT02556931 (22) [back to overview] | Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort) |
| NCT02556931 (22) [back to overview] | Number of Number of Participants Who Experience Graft Failure, Day 360 (D60) |
| NCT02556931 (22) [back to overview] | Number of Number of Participants Who Experience Graft Failure, Day 360 (D90) |
| NCT02556931 (22) [back to overview] | Number of Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D60) |
| NCT02556931 (22) [back to overview] | Number of Number of Participants With Severe Chronic GVHD, Day 360 (D90) |
| NCT02556931 (22) [back to overview] | Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort) |
| NCT02556931 (22) [back to overview] | Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90) |
| NCT02556931 (22) [back to overview] | Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60) |
| NCT02556931 (22) [back to overview] | Number of Participants With Chronic GVHD, Days 90-180 (D90) |
| NCT02556931 (22) [back to overview] | Number of Participants With Chronic GVHD, Days 60-180 (D60) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Relapse, Day 360 (D90) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Relapse, Day 360 (D60) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Non-relapse Mortality, Days 60-180 (D60) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Non-relapse Mortality, Day 360 (D90) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Non-relapse Mortality, Day 360 (D60) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Graft Failure, Days 90-180 (D90) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Graft Failure, Days 60-180 (D60) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D90) |
| NCT02556931 (22) [back to overview] | Number of Participants Who Experience Disease Relapse, Days 90-180 (D90) |
| NCT02561273 (7) [back to overview] | Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) |
| NCT02561273 (7) [back to overview] | Number of Participants With Adverse Events Graded According to CTC (Phase II) |
| NCT02561273 (7) [back to overview] | Progression-free Survival |
| NCT02561273 (7) [back to overview] | Complete Response Rate (Phase II) |
| NCT02561273 (7) [back to overview] | Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP |
| NCT02561273 (7) [back to overview] | Overall Response Rate |
| NCT02561273 (7) [back to overview] | Overall Survival |
| NCT02561832 (1) [back to overview] | Part A: Number of Subjects Reporting Adverse Events (AEs) |
| NCT02566993 (25) [back to overview] | Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days |
| NCT02566993 (25) [back to overview] | Overall Survival in Patients Without Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days |
| NCT02566993 (25) [back to overview] | Overall Survival in Patients With Chemotherapy-free Interval < 90 Days |
| NCT02566993 (25) [back to overview] | Overall Survival (OS) |
| NCT02566993 (25) [back to overview] | Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days |
| NCT02566993 (25) [back to overview] | Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days |
| NCT02566993 (25) [back to overview] | Overall Response Rate in Patients With Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Overall Response Rate by Independent Review Committee |
| NCT02566993 (25) [back to overview] | Duration of Response in Patients Without Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days |
| NCT02566993 (25) [back to overview] | Duration of Response in Patients With Chemotherapy-free Interval <90 Days |
| NCT02566993 (25) [back to overview] | Duration of Response in Patients With Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Progression-free Survival (PFS) by Independent Review Committee |
| NCT02566993 (25) [back to overview] | Progression-free Survival Rate at 6 Months by Independent Review Committee |
| NCT02566993 (25) [back to overview] | Progression-free Survival Rate at 12 Months by Independent Review Committee |
| NCT02566993 (25) [back to overview] | Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Overall Survival in Patients With Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days |
| NCT02566993 (25) [back to overview] | Progression-free Survival in Patients With Central Nervous System Involvement at Baseline |
| NCT02566993 (25) [back to overview] | Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months |
| NCT02566993 (25) [back to overview] | Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months |
| NCT02566993 (25) [back to overview] | Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months |
| NCT02566993 (25) [back to overview] | Duration of Response by Independent Review Committee |
| NCT02581007 (4) [back to overview] | Relapse Incidence |
| NCT02581007 (4) [back to overview] | Overall Survival |
| NCT02581007 (4) [back to overview] | GVHD Incidence |
| NCT02581007 (4) [back to overview] | Graft Rejection |
| NCT02588612 (10) [back to overview] | Overall Response Rate (ORR) |
| NCT02588612 (10) [back to overview] | Disease Control Rate (DCR) |
| NCT02588612 (10) [back to overview] | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings |
| NCT02588612 (10) [back to overview] | Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT02588612 (10) [back to overview] | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline |
| NCT02588612 (10) [back to overview] | Number of Participants With Any Grade Increase in Clinical Chemistry Parameters |
| NCT02588612 (10) [back to overview] | Duration of Response |
| NCT02588612 (10) [back to overview] | Change From Baseline in Oxygen Saturation |
| NCT02588612 (10) [back to overview] | Time to Response |
| NCT02588612 (10) [back to overview] | Progression-Free Survival (PFS) by Investigator Assessment |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria |
| NCT02596971 (18) [back to overview] | Observed Serum Rituximab Concentration |
| NCT02596971 (18) [back to overview] | Observed Serum Atezolizumab Concentration |
| NCT02596971 (18) [back to overview] | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria |
| NCT02596971 (18) [back to overview] | Observed Serum Obinutuzumab Concentration |
| NCT02596971 (18) [back to overview] | Observed Serum Atezolizumab Concentration |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Adverse Events |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria |
| NCT02596971 (18) [back to overview] | Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria |
| NCT02596971 (18) [back to overview] | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria |
| NCT02596971 (18) [back to overview] | Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria |
| NCT02597062 (2) [back to overview] | Overall Survival |
| NCT02597062 (2) [back to overview] | Progression-free Survival |
| NCT02601313 (8) [back to overview] | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score |
| NCT02601313 (8) [back to overview] | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score |
| NCT02601313 (8) [back to overview] | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score |
| NCT02601313 (8) [back to overview] | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score |
| NCT02601313 (8) [back to overview] | Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score |
| NCT02601313 (8) [back to overview] | Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score |
| NCT02601313 (8) [back to overview] | Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2 |
| NCT02601313 (8) [back to overview] | Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1 |
| NCT02614066 (18) [back to overview] | Phase 2: MRD Negative Rate Among Complete Remission (CR) Participants |
| NCT02614066 (18) [back to overview] | Phase 2: Overall Survival (OS) |
| NCT02614066 (18) [back to overview] | Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review |
| NCT02614066 (18) [back to overview] | Phase 2: OCR Rate (CR + CRi) Per Investigator Review |
| NCT02614066 (18) [back to overview] | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale |
| NCT02614066 (18) [back to overview] | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value |
| NCT02614066 (18) [back to overview] | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value |
| NCT02614066 (18) [back to overview] | Phase 2: Change From Baseline Over Time in EQ-5D: Visual Analogue Scale (VAS) |
| NCT02614066 (18) [back to overview] | Phase 2: Relapse-free Survival (RFS) |
| NCT02614066 (18) [back to overview] | Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies |
| NCT02614066 (18) [back to overview] | Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) |
| NCT02614066 (18) [back to overview] | Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
| NCT02614066 (18) [back to overview] | Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) |
| NCT02614066 (18) [back to overview] | Phase 2: Complete Remission (CR) Rate Per Independent Review |
| NCT02614066 (18) [back to overview] | Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review |
| NCT02614066 (18) [back to overview] | Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate |
| NCT02614066 (18) [back to overview] | Phase 2: Duration of Remission (DOR) Per Independent Review |
| NCT02614066 (18) [back to overview] | Phase 2: MRD Negative Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants |
| NCT02617485 (12) [back to overview] | AUC (W1-W26) |
| NCT02617485 (12) [back to overview] | Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4]) |
| NCT02617485 (12) [back to overview] | T1/2 (Post 5th and 8th Infusions) |
| NCT02617485 (12) [back to overview] | Kel (Post 5th and 8th Infusions) |
| NCT02617485 (12) [back to overview] | Immunogenicity |
| NCT02617485 (12) [back to overview] | Efficacy Assessment at Week 26 |
| NCT02617485 (12) [back to overview] | CLss (Post 5th and 8th Infusions) |
| NCT02617485 (12) [back to overview] | Adverse Events |
| NCT02617485 (12) [back to overview] | Ctrough (Before 8th Infusion) |
| NCT02617485 (12) [back to overview] | AUC (W1-W26) B-cell |
| NCT02617485 (12) [back to overview] | Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26]) |
| NCT02617485 (12) [back to overview] | Cmax (Post 5th and 8th Infusion) |
| NCT02622074 (13) [back to overview] | Number of Participants Who Experienced an Adverse Event (AE) |
| NCT02622074 (13) [back to overview] | Event-Free Survival (EFS) Rate at Month 6 |
| NCT02622074 (13) [back to overview] | Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 (No Invasive Residual in Breast or Nodes; Noninvasive Breast Residuals Allowed) |
| NCT02622074 (13) [back to overview] | Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0 (No Invasive or Noninvasive Residual in Breast or Nodes) |
| NCT02622074 (13) [back to overview] | Overall Survival (OS) Rate at Month 6 |
| NCT02622074 (13) [back to overview] | Overall Survival (OS) Rate at Month 24 |
| NCT02622074 (13) [back to overview] | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) |
| NCT02622074 (13) [back to overview] | Overall Survival (OS) Rate at Month 12 |
| NCT02622074 (13) [back to overview] | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: Second Combination Regimen |
| NCT02622074 (13) [back to overview] | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: First Combination Regimen |
| NCT02622074 (13) [back to overview] | Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) |
| NCT02622074 (13) [back to overview] | Event-Free Survival (EFS) Rate at Month 12 |
| NCT02622074 (13) [back to overview] | Event-Free Survival (EFS) Rate at Month 24 |
| NCT02623972 (2) [back to overview] | Pathologic Complete Response Rate |
| NCT02623972 (2) [back to overview] | Residual Cancer Burden (RCB) |
| NCT02643420 (9) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
| NCT02643420 (9) [back to overview] | Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4 |
| NCT02643420 (9) [back to overview] | Number of Participants With Neutropenic Complications in Cycle 1 |
| NCT02643420 (9) [back to overview] | Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1 |
| NCT02643420 (9) [back to overview] | Duration of Severe Neutropenia (DSN) in Cycle 1 |
| NCT02643420 (9) [back to overview] | Number of Participants With Febrile Neutropenia (FN) in Cycle 1 |
| NCT02643420 (9) [back to overview] | Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 |
| NCT02643420 (9) [back to overview] | Duration of Severe Neutropenia in Cycle 2, 3 and 4 |
| NCT02643420 (9) [back to overview] | Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4 |
| NCT02648282 (2) [back to overview] | Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities |
| NCT02648282 (2) [back to overview] | Distant Metastasis Free Survival (DMFS) |
| NCT02650986 (2) [back to overview] | Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells |
| NCT02650986 (2) [back to overview] | Number of Participants With Dose Limiting Toxicities |
| NCT02652468 (7) [back to overview] | Number of Participants With Severe Chronic GVHD |
| NCT02652468 (7) [back to overview] | Overall Survival (OS) |
| NCT02652468 (7) [back to overview] | Progression-free Survival |
| NCT02652468 (7) [back to overview] | Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days |
| NCT02652468 (7) [back to overview] | Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria |
| NCT02652468 (7) [back to overview] | Number of Participants With Graft Failure |
| NCT02652468 (7) [back to overview] | Number of Participants With Treatment-related Mortality |
| NCT02659943 (12) [back to overview] | Number of Participants With a Duration of Best Response in Months |
| NCT02659943 (12) [back to overview] | Number of Participants With Evidence of Immunogenicity of the Chimeric Antigen Receptor (CAR) T-cell Product |
| NCT02659943 (12) [back to overview] | Maximum Feasible Dose |
| NCT02659943 (12) [back to overview] | Median Peak Chimeric Antigen Receptor (CAR) T Cells Level for Participants Treated |
| NCT02659943 (12) [back to overview] | MTD |
| NCT02659943 (12) [back to overview] | Number of Participants Who Had Anti-Lymphoma Activity |
| NCT02659943 (12) [back to overview] | Number of Participants With a Dose-Limiting Toxicity (DLT) |
| NCT02659943 (12) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
| NCT02659943 (12) [back to overview] | Percentage of Enrolled Participants Who Actually Get Treated |
| NCT02659943 (12) [back to overview] | Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events |
| NCT02659943 (12) [back to overview] | Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD) |
| NCT02659943 (12) [back to overview] | Number of Participants Who Had a Second or Third Infusion of Chimeric Antigen Receptor (CAR)+ T Cells |
| NCT02706405 (14) [back to overview] | Area Under the Curve (AUC) of JCAR014 by Flow Cytometry |
| NCT02706405 (14) [back to overview] | Objective Response Rate by Investigator Assessment Using Lugano Criteria |
| NCT02706405 (14) [back to overview] | Maximum JCAR014 Cmax by Flow Cytometry |
| NCT02706405 (14) [back to overview] | Maximum JCAR014 Cmax in Blood by Quantitative Polymerase Chain Reaction (qPCR) Analysis |
| NCT02706405 (14) [back to overview] | AUC of JCAR014 Cells by qPCR Analysis |
| NCT02706405 (14) [back to overview] | Count of Participants Who Experienced Adverse Events |
| NCT02706405 (14) [back to overview] | Dose Limiting Toxicity (DLT) Rates |
| NCT02706405 (14) [back to overview] | Duration of Response |
| NCT02706405 (14) [back to overview] | Highest Treatment Dose Administered on Study |
| NCT02706405 (14) [back to overview] | Overall Survival |
| NCT02706405 (14) [back to overview] | Progression Free Survival |
| NCT02706405 (14) [back to overview] | Time to Loss of JCAR014 Detection in Blood by qPCR Analysis |
| NCT02706405 (14) [back to overview] | Rate of Partial Response (PR) by Investigator Assessment Using Lugano Criteria |
| NCT02706405 (14) [back to overview] | Rate of Complete Response (CR) by Investigator Assessment Using Lugano Criteria |
| NCT02737475 (69) [back to overview] | Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected |
| NCT02737475 (69) [back to overview] | AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t |
| NCT02737475 (69) [back to overview] | Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected |
| NCT02737475 (69) [back to overview] | Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) |
| NCT02737475 (69) [back to overview] | Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) |
| NCT02737475 (69) [back to overview] | Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) |
| NCT02737475 (69) [back to overview] | Cmax: Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | Cmax: Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | Cmax: Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | Cmax: Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | CLT: Total Body Clearance |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau) |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau) |
| NCT02737475 (69) [back to overview] | CLT: Total Body Clearance |
| NCT02737475 (69) [back to overview] | CLT: Total Body Clearance |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau) |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax) |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax) |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax) |
| NCT02737475 (69) [back to overview] | AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval |
| NCT02737475 (69) [back to overview] | AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval |
| NCT02737475 (69) [back to overview] | Tmax: Time of Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC) |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC) |
| NCT02737475 (69) [back to overview] | The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |
| NCT02737475 (69) [back to overview] | Frequency of Positive Anti-Drug Antibodies (ADA) to Ipilimumab. |
| NCT02737475 (69) [back to overview] | AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC) |
| NCT02737475 (69) [back to overview] | Frequency of Positive Anti-Drug Antibodies (ADA) to Nivolumab |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Objective Response Rate (ORR) |
| NCT02737475 (69) [back to overview] | Progression Free Survival (PFS) Rate at 24 Weeks |
| NCT02737475 (69) [back to overview] | The Number of Participant Deaths |
| NCT02737475 (69) [back to overview] | The Number of Participants Experiencing Adverse Events (AEs) |
| NCT02737475 (69) [back to overview] | AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval |
| NCT02737475 (69) [back to overview] | AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval |
| NCT02737475 (69) [back to overview] | AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t |
| NCT02737475 (69) [back to overview] | AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t |
| NCT02737475 (69) [back to overview] | Tmax: Time of Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | Tmax: Time of Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | Tmax: Time of Maximum Observed Serum Concentration |
| NCT02737475 (69) [back to overview] | The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING ) |
| NCT02737475 (69) [back to overview] | The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING ) |
| NCT02737475 (69) [back to overview] | The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION) |
| NCT02737475 (69) [back to overview] | The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology) |
| NCT02737475 (69) [back to overview] | The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8 |
| NCT02737475 (69) [back to overview] | T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax) |
| NCT02737475 (69) [back to overview] | T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax) |
| NCT02737475 (69) [back to overview] | T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax) |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | The Number of Participants Experiencing Serious Adverse Events (SAEs) |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctrough: Trough Observed Plasma Concentration |
| NCT02737475 (69) [back to overview] | Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected |
| NCT02737475 (69) [back to overview] | Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected |
| NCT02737475 (69) [back to overview] | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
| NCT02737475 (69) [back to overview] | Duration of Response (DOR) |
| NCT02737475 (69) [back to overview] | Frequency of Positive Anti-Drug Antibodies (ADA) to BMS-986178 |
| NCT02737475 (69) [back to overview] | AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t |
| NCT02757885 (12) [back to overview] | Late Graft Rejection Rate |
| NCT02757885 (12) [back to overview] | Overall Survival Rate |
| NCT02757885 (12) [back to overview] | Primary Graft Rejection Rate |
| NCT02757885 (12) [back to overview] | Frequency of Stroke |
| NCT02757885 (12) [back to overview] | Rate of Central Nervous System (CNS) Toxicity |
| NCT02757885 (12) [back to overview] | Rate of Disease Recurrence |
| NCT02757885 (12) [back to overview] | Veno-occlusive Disease (VOD) Rate |
| NCT02757885 (12) [back to overview] | Frequency of Idiopathic Pneumonia Syndrome (IPS) |
| NCT02757885 (12) [back to overview] | Event-free Survival (EFS) Rate |
| NCT02757885 (12) [back to overview] | Cumulative Incidence of Neutrophil Engraftment and Platelet Engraftment. |
| NCT02757885 (12) [back to overview] | Chimerism Rate Following Hematopoietic Cell Transplantation for Sickle Cell Disease |
| NCT02757885 (12) [back to overview] | Infection Rate |
| NCT02761915 (7) [back to overview] | 1RG-CART Counts in the Peripheral Blood |
| NCT02761915 (7) [back to overview] | To Evaluate Anti-tumour Activity (Progression Free Survival) |
| NCT02761915 (7) [back to overview] | Safety and Tolerability of 1RG-CART Therapy |
| NCT02761915 (7) [back to overview] | Assessment of Tumour Response From Baseline (RECIST) |
| NCT02761915 (7) [back to overview] | Assessment of Tumour Response From Baseline (irRC) |
| NCT02761915 (7) [back to overview] | To Evaluate Anti-tumour Activity (Overall Survival) |
| NCT02761915 (7) [back to overview] | To Determine Recommended Phase II Regimen by Assessing the Number of DLTs at Each Dose Level |
| NCT02768701 (7) [back to overview] | Treatment Associated Toxicity |
| NCT02768701 (7) [back to overview] | The Progression Free Survival (PFS) |
| NCT02768701 (7) [back to overview] | Disease Control Rate (DCR) |
| NCT02768701 (7) [back to overview] | Overall Survival (OS) |
| NCT02768701 (7) [back to overview] | Quantification of the Change in Regulatory T Cells (Tregs) During the Study Treatment. |
| NCT02768701 (7) [back to overview] | Duration of Response (DOR) |
| NCT02768701 (7) [back to overview] | Overall Response Rate (ORR) |
| NCT02774291 (1) [back to overview] | Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0 |
| NCT02786719 (2) [back to overview] | Delay in Chemotherapy Administration Due to Prolonged Neutrophil Recovery |
| NCT02786719 (2) [back to overview] | Incidence of Infection |
| NCT02793856 (12) [back to overview] | Interleukin-10 Change in the Peripheral Blood. |
| NCT02793856 (12) [back to overview] | Interleukin-10 Change in the Peripheral Blood. |
| NCT02793856 (12) [back to overview] | Overall Survival (OS) |
| NCT02793856 (12) [back to overview] | Number of Patients With Overall Response |
| NCT02793856 (12) [back to overview] | Number of Patients With Disease Control at 8 Weeks |
| NCT02793856 (12) [back to overview] | Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA) |
| NCT02793856 (12) [back to overview] | Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients |
| NCT02793856 (12) [back to overview] | Interleukin-6 Change in the Peripheral Blood. |
| NCT02793856 (12) [back to overview] | Progression Free Survival (PFS) |
| NCT02793856 (12) [back to overview] | Tumor Necrosis Factor-a Change in the Peripheral Blood. |
| NCT02793856 (12) [back to overview] | Tumor Necrosis Factor-a Change in the Peripheral Blood. |
| NCT02793856 (12) [back to overview] | Interleukin-6 Change in the Peripheral Blood. |
| NCT02805725 (4) [back to overview] | Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1) |
| NCT02805725 (4) [back to overview] | Phase I: Number of Patients Who Experienced Dose-Limiting Toxicities (DLTs) |
| NCT02805725 (4) [back to overview] | Phase I: Percentage of Patients With Objective Response (RECIST V1.1) |
| NCT02805725 (4) [back to overview] | Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP. |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R) |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine |
| NCT02833805 (12) [back to overview] | GVHD-free Relapse-free Survival (GRFS) |
| NCT02833805 (12) [back to overview] | Transplant-related Mortality |
| NCT02833805 (12) [back to overview] | Number of Participants Who Experience Grades III-IV Acute GVHD |
| NCT02833805 (12) [back to overview] | Probability of Platelet Recovery as Assessed by Number of Participants Who Have Recovered Platelet Counts |
| NCT02833805 (12) [back to overview] | Number of Participants Who Experience Chronic GVHD |
| NCT02833805 (12) [back to overview] | Number of Participants Who Experience Grades II-IV Acute GVHD |
| NCT02833805 (12) [back to overview] | Number of Participants Who Experience Primary Graft Failure |
| NCT02833805 (12) [back to overview] | Number of Participants Who Experience Secondary Graft Failure |
| NCT02833805 (12) [back to overview] | Number of Participants With Full Donor Chimerism |
| NCT02833805 (12) [back to overview] | Overall Survival and Engraftment at One Year |
| NCT02833805 (12) [back to overview] | Overall Survival at One Year |
| NCT02833805 (12) [back to overview] | Probability of Neutrophil Recovery as Assessed by the Number of Participants Who Have Recovered Neutrophil Counts |
| NCT02853318 (4) [back to overview] | Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events |
| NCT02853318 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT02853318 (4) [back to overview] | Duration of Overall Survival |
| NCT02853318 (4) [back to overview] | Objective Tumor Response Assessed by Modified RECIST Version 1.1 Criteria |
| NCT02855359 (2) [back to overview] | Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities |
| NCT02855359 (2) [back to overview] | Part A and Part B Outcome Measure: Incidence of Adverse Events |
| NCT02918292 (15) [back to overview] | Immune Reconstitution of Flow Cytometry |
| NCT02918292 (15) [back to overview] | Immune Reconstitution of Quantitative Immunoglobulins |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Graft-Failure-Free Survival |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Primary Graft Failure |
| NCT02918292 (15) [back to overview] | Frequencies of Infections Categorized by Infection Type |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Acute Graft-vs-host-disease (GVHD) |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Chronic GVHD |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Overall Survival (OS) |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Platelet Recovery |
| NCT02918292 (15) [back to overview] | Health Related Quality of Life (HR-QoL) - Medical Outcomes Study Short Form (MOS SF-36) |
| NCT02918292 (15) [back to overview] | Participants With Grade 3-5 Toxicities by SOC |
| NCT02918292 (15) [back to overview] | Health Related Quality of Life (HR-QoL) - PedsQL Stem Cell Transplant Module |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Neutrophil Recovery |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Cytomegalovirus (CMV), Epstein Barr Virus (EBV) or Post-Transplant Lymphoproliferative Disease (PTLD) |
| NCT02918292 (15) [back to overview] | Percentage of Participants With Secondary Graft Failure |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Percentage of Participants Experiencing Adverse Events (AEs) |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Atezolizumab Levels in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Peak Serum Levels of C-Reactive Protein (CRP) in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Overall Survival (OS) |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Complete Response Rate (CRR) |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Duration of Response (DOR) |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Objective Response Rate (ORR) |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Atezolizumab Levels in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Atezolizumab Levels in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Peak Serum Levels of Ferritin in Blood |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Atezolizumab Levels in Blood |
| NCT02926833 (22) [back to overview] | Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Progression-Free Survival (PFS) |
| NCT02926833 (22) [back to overview] | Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values |
| NCT02951819 (9) [back to overview] | Overall Survival (OS) |
| NCT02951819 (9) [back to overview] | Percentage of Participants With Treatment Emergent-Adverse Event |
| NCT02951819 (9) [back to overview] | Time to Disease Progression (TTP) |
| NCT02951819 (9) [back to overview] | Duration of Response (DOR) |
| NCT02951819 (9) [back to overview] | Progression Free Survival (PFS) |
| NCT02951819 (9) [back to overview] | Time to Partial Response (PR) or Better |
| NCT02951819 (9) [back to overview] | Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR) |
| NCT02951819 (9) [back to overview] | Time to Very Good Partial Response (VGPR) or Better |
| NCT02951819 (9) [back to overview] | Overall Response Rate (ORR) |
| NCT02953340 (10) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death |
| NCT02953340 (10) [back to overview] | Relative Dose Intensity (RDI) of TC Chemotherapy |
| NCT02953340 (10) [back to overview] | Depth of ANC Nadir in Cycle 1 |
| NCT02953340 (10) [back to overview] | Duration of Severe Neutropenia (DSN) in Cycle 1 |
| NCT02953340 (10) [back to overview] | Number of Participants With Febrile Neutropenia (FN) in Cycle 1 |
| NCT02953340 (10) [back to overview] | Number of Participants With Neutropenic Complications in Cycle 1 |
| NCT02953340 (10) [back to overview] | Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 |
| NCT02953340 (10) [back to overview] | Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4 |
| NCT02953340 (10) [back to overview] | Number of Participants With Clinically Significant Laboratory Abnormalities |
| NCT02953340 (10) [back to overview] | Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4 |
| NCT02957968 (7) [back to overview] | Evaluation of Myeloid-derived Suppressor Cells (MDSC) Identified in Blood Samples Post-pembrolizumab Compared to MDSC Found in Blood Samples Collected at Baseline. |
| NCT02957968 (7) [back to overview] | The Percentage of Increase in Tumor and Stroma With Infiltrating Lymphocytes (TIL) From Baseline Pre-treatment Biopsy to Post-immunotherapy Biopsy Following Administration of Decitabine Followed by Pembrolizumab. |
| NCT02957968 (7) [back to overview] | Evaluation of Expression of Protein Programmed Death-Ligand 1 (PD-L1) Within Tumor, Stroma, and Infiltrating Immune Cells Combined, at Baseline and Following Immunotherapy. |
| NCT02957968 (7) [back to overview] | Number of Adverse Events (AEs) Reported During and After Immune Treatment (ie, Decitabine and Pembrolizumab) |
| NCT02957968 (7) [back to overview] | Number of Patients Meeting Criteria for Lymphocyte-predominant Breast Cancer (LPBC) Following Treatment With Decitabine and Pembrolizumab |
| NCT02957968 (7) [back to overview] | Number of Patients With Pathologic Complete Response (pCR) in the Breast and Post-therapy Lymph Nodes. |
| NCT02957968 (7) [back to overview] | Evaluation of Myeloid-derived Suppressor Cells (MDSC) Identified in Blood Samples Post-decitabine Compared to MDSC Found in Blood Samples Collected at Baseline. |
| NCT02963831 (4) [back to overview] | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) |
| NCT02963831 (4) [back to overview] | Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method |
| NCT02963831 (4) [back to overview] | Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method |
| NCT02963831 (4) [back to overview] | Median Progression-free Survival (PFS) as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) Using Kaplan-Meier Method |
| NCT02981524 (4) [back to overview] | Objective Response Rate (ORR) |
| NCT02981524 (4) [back to overview] | Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
| NCT02981524 (4) [back to overview] | Progression Free Survival (PFS) |
| NCT02981524 (4) [back to overview] | Overall Survival (OS) |
| NCT02992743 (22) [back to overview] | Duration of Response (DOR) Assessed by Independent Reviewer |
| NCT02992743 (22) [back to overview] | Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794 |
| NCT02992743 (22) [back to overview] | Time to Cmax (Tmax) |
| NCT02992743 (22) [back to overview] | Progression Free Survival (PFS) Assessed by Investigator |
| NCT02992743 (22) [back to overview] | Number of Participants With Positive Anti-drug Antibodies (ADAs) |
| NCT02992743 (22) [back to overview] | Number of Participants With Insertional Oncogenesis |
| NCT02992743 (22) [back to overview] | Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval |
| NCT02992743 (22) [back to overview] | Number of Participants With Replication Competent Lentivirus (RCL) |
| NCT02992743 (22) [back to overview] | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer |
| NCT02992743 (22) [back to overview] | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment |
| NCT02992743 (22) [back to overview] | Progression Free Survival (PFS) Assessed by Independent Reviewer |
| NCT02992743 (22) [back to overview] | Maximum Transgene Expansion (Cmax) of GSK3377794 |
| NCT02992743 (22) [back to overview] | Duration of Response (DOR) Assessed by Investigator |
| NCT02992743 (22) [back to overview] | Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline |
| NCT02992743 (22) [back to overview] | Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline |
| NCT02992743 (22) [back to overview] | Number of Participants With Adverse Event of Special Interest (AESI) |
| NCT02992743 (22) [back to overview] | Change From Baseline in ECG Mean Heart Rate |
| NCT02992743 (22) [back to overview] | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment |
| NCT02992743 (22) [back to overview] | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment |
| NCT02992743 (22) [back to overview] | Time to Response (TTR) Assessed by Investigator |
| NCT02992743 (22) [back to overview] | Time to Response (TTR) Assessed by Independent Reviewer |
| NCT02992743 (22) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs |
| NCT02994927 (28) [back to overview] | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period |
| NCT02994927 (28) [back to overview] | Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index |
| NCT02994927 (28) [back to overview] | Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points |
| NCT02994927 (28) [back to overview] | Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI |
| NCT02994927 (28) [back to overview] | In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks |
| NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (5/5) |
| NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2) |
| NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5) |
| NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5) |
| NCT02994927 (28) [back to overview] | Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity |
| NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5) |
| NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5) |
| NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2) |
| NCT02994927 (28) [back to overview] | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks |
| NCT02994927 (28) [back to overview] | In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks |
| NCT02994927 (28) [back to overview] | Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator |
| NCT02994927 (28) [back to overview] | Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs |
| NCT02994927 (28) [back to overview] | Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study |
| NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (1/5) |
| NCT02994927 (28) [back to overview] | Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5) |
| NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (2/5) |
| NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (3/5) |
| NCT02994927 (28) [back to overview] | Percentage of Subjects Achieving Sustained Disease Remission at Week 52 |
| NCT02994927 (28) [back to overview] | Change From Baseline in Vital Signs (4/5) |
| NCT02994927 (28) [back to overview] | Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study |
| NCT02994927 (28) [back to overview] | Percentage of Subjects Achieving Disease Remission at Week 26 |
| NCT02994927 (28) [back to overview] | Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC |
| NCT02994927 (28) [back to overview] | Number of Subjects With Clinically Significant ECG Changes From Baseline |
| NCT02999854 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT02999854 (4) [back to overview] | Transplant-related Mortality (TRM) |
| NCT02999854 (4) [back to overview] | Graft-versus-host Disease-free, Relapse-free Survival (GRFS) |
| NCT02999854 (4) [back to overview] | Overall Survival (OS) |
| NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells |
| NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density |
| NCT03003520 (8) [back to overview] | Participants With Treatment Emergent Adverse Events (TEAE) |
| NCT03003520 (8) [back to overview] | Participants With Treatment Emergent Adverse Events (TEAE) |
| NCT03003520 (8) [back to overview] | Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018) |
| NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy |
| NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data |
| NCT03003520 (8) [back to overview] | Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage |
| NCT03003676 (1) [back to overview] | Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE). |
| NCT03018223 (4) [back to overview] | Incidence of Grade II-IV Acute Graft vs. Host Disease (GVHD) |
| NCT03018223 (4) [back to overview] | Overall Survival (OS) |
| NCT03018223 (4) [back to overview] | Progression Free Survival (PFS) |
| NCT03018223 (4) [back to overview] | Incidence of Chronic GVHD |
| NCT03023046 (5) [back to overview] | Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate |
| NCT03023046 (5) [back to overview] | Event-free Survival |
| NCT03023046 (5) [back to overview] | Number of Participants With Morphological Complete Response Rate |
| NCT03023046 (5) [back to overview] | Overall Survival |
| NCT03023046 (5) [back to overview] | Number of Participants With Adverse Events |
| NCT03043105 (6) [back to overview] | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade) |
| NCT03043105 (6) [back to overview] | Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade) |
| NCT03043105 (6) [back to overview] | Number of Patients With Durable Tumor and Symptomatic Response |
| NCT03043105 (6) [back to overview] | Overall Survival |
| NCT03043105 (6) [back to overview] | Progression-free Survival |
| NCT03043105 (6) [back to overview] | Change in SF-36 Score |
| NCT03049449 (10) [back to overview] | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells |
| NCT03049449 (10) [back to overview] | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells |
| NCT03049449 (10) [back to overview] | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells |
| NCT03049449 (10) [back to overview] | Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression as Their Best Response |
| NCT03049449 (10) [back to overview] | Number of Participants With a Dose Limiting Toxicity (DLT) |
| NCT03049449 (10) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
| NCT03049449 (10) [back to overview] | Maximum Tolerated Dose of Anti-Tumor Necrosis Factor (TNF) Receptor Superfamily Member 8 (CD30) Chimeric Antigen Receptor (CAR) in Participants With Advanced CD30-expressing Lymphomas |
| NCT03049449 (10) [back to overview] | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells |
| NCT03049449 (10) [back to overview] | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells |
| NCT03049449 (10) [back to overview] | Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells |
| NCT03066947 (6) [back to overview] | Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety] |
| NCT03066947 (6) [back to overview] | Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety] |
| NCT03066947 (6) [back to overview] | Duration of Treatment Emergent Adverse Events [Safety] |
| NCT03066947 (6) [back to overview] | Durability of Tumor Response |
| NCT03066947 (6) [back to overview] | Rate of Non-progression of Tumors |
| NCT03066947 (6) [back to overview] | Objective Tumor Response Rate |
| NCT03085914 (3) [back to overview] | Phases 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) |
| NCT03085914 (3) [back to overview] | Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
| NCT03085914 (3) [back to overview] | Phases 1 and 2: Objective Response Rate (ORR) |
| NCT03096782 (3) [back to overview] | Overall Survival |
| NCT03096782 (3) [back to overview] | Disease-free Survival |
| NCT03096782 (3) [back to overview] | Time to Engraftment |
| NCT03113500 (2) [back to overview] | Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy |
| NCT03113500 (2) [back to overview] | Overall Survival at 1 Year |
| NCT03128359 (3) [back to overview] | Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) at 1 Year |
| NCT03128359 (3) [back to overview] | Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading |
| NCT03128359 (3) [back to overview] | Overall Survival (OS) at 1 Year |
| NCT03168438 (13) [back to overview] | Maximum Persistence (Cmax) of GSK3377794 |
| NCT03168438 (13) [back to overview] | Progression-free Survival |
| NCT03168438 (13) [back to overview] | Number of Participants With Worst-case Results for Coagulation Parameters Relative to Normal Range Post-Baseline Relative to Baseline |
| NCT03168438 (13) [back to overview] | Number of Participants With Worst-case Hematology Results by Any Grade Increase Post-Baseline Relative to Baseline |
| NCT03168438 (13) [back to overview] | Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC[0-28]) |
| NCT03168438 (13) [back to overview] | Number of Participants With Treatment Limiting Toxicities-GSK3377794+Pembrolizumab Arm Only |
| NCT03168438 (13) [back to overview] | Duration of Response |
| NCT03168438 (13) [back to overview] | Number of Participants With Worst-case Chemistry Results by Any Grade Increase Post-Baseline Relative to Baseline |
| NCT03168438 (13) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT03168438 (13) [back to overview] | Time to Response |
| NCT03168438 (13) [back to overview] | Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings |
| NCT03168438 (13) [back to overview] | Time to Maximum Persistence |
| NCT03168438 (13) [back to overview] | Overall Response Rate |
| NCT03187756 (6) [back to overview] | Event Free Survival (EFS) |
| NCT03187756 (6) [back to overview] | Cumulative Incidences of Systemic Steroid Initiation |
| NCT03187756 (6) [back to overview] | Number of Participants With Chronic GVHD and Grades I-IV GVHD |
| NCT03187756 (6) [back to overview] | Time to Platelet Recovery |
| NCT03187756 (6) [back to overview] | Time to Neutrophil Recovery |
| NCT03187756 (6) [back to overview] | Graft Failure Frequency |
| NCT03190265 (2) [back to overview] | Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) |
| NCT03190265 (2) [back to overview] | Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs) |
| NCT03197935 (14) [back to overview] | Maximum Observed Serum Atezolizumab Concentration (Cmax) |
| NCT03197935 (14) [back to overview] | Disease-Free Survival (DFS) in All Participants Who Undergo Surgery |
| NCT03197935 (14) [back to overview] | Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery |
| NCT03197935 (14) [back to overview] | Minimum Observed Serum Atezolizumab Concentration (Cmin) |
| NCT03197935 (14) [back to overview] | Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status |
| NCT03197935 (14) [back to overview] | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab |
| NCT03197935 (14) [back to overview] | Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population |
| NCT03197935 (14) [back to overview] | Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System |
| NCT03197935 (14) [back to overview] | Overall Survival (OS) in All Participants |
| NCT03197935 (14) [back to overview] | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 |
| NCT03197935 (14) [back to overview] | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 |
| NCT03197935 (14) [back to overview] | Percentage of Participants With at Least One Adverse Events (AEs) |
| NCT03197935 (14) [back to overview] | Event-Free Survival (EFS) in All Participants |
| NCT03197935 (14) [back to overview] | Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status |
| NCT03201965 (1) [back to overview] | Percentage of Participants With Overall Complete Hematologic Response (CHR) |
| NCT03215810 (2) [back to overview] | Rate of Dose Limiting Toxicity (DLT) |
| NCT03215810 (2) [back to overview] | Number of Participants With Objective Response |
| NCT03287674 (4) [back to overview] | Progression Free Survival |
| NCT03287674 (4) [back to overview] | Overall Survival |
| NCT03287674 (4) [back to overview] | Treatment Related Immune Responses |
| NCT03287674 (4) [back to overview] | Number of Participants With Reported Adverse Events by Type |
| NCT03301350 (5) [back to overview] | Total Dose of Chemotherapy Administered |
| NCT03301350 (5) [back to overview] | Number of Treatment-related Toxicities Experienced by Participants |
| NCT03301350 (5) [back to overview] | Number of Cycles of Chemotherapy Administered |
| NCT03301350 (5) [back to overview] | Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate |
| NCT03301350 (5) [back to overview] | Delays of Administered Chemotherapy |
| NCT03303950 (8) [back to overview] | Non-relapse Mortality (NRM) at Day 365 |
| NCT03303950 (8) [back to overview] | Non-relapse Mortality (NRM) at Day 100 |
| NCT03303950 (8) [back to overview] | Incidence of Chronic GVHD |
| NCT03303950 (8) [back to overview] | Number of Participants With Minimal Residual Disease (MRD) Response |
| NCT03303950 (8) [back to overview] | Incidence of Acute Graft Versus Host Disease (GVHD) |
| NCT03303950 (8) [back to overview] | Overall Survival at One Year |
| NCT03303950 (8) [back to overview] | Disease Free Survival at One Year |
| NCT03303950 (8) [back to overview] | Number of Participants With Different Clinical Responses |
| NCT03318861 (8) [back to overview] | Overall Survival (OS) |
| NCT03318861 (8) [back to overview] | Objective Response Rate (ORR) as Determined by Study Investigators According to the International Myeloma Working Group (IMWG) Consensus Panel 1 Criteria |
| NCT03318861 (8) [back to overview] | Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities |
| NCT03318861 (8) [back to overview] | Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) |
| NCT03318861 (8) [back to overview] | Progression Free Survival (PFS) as Determined by Study Investigators According to the IMWG Consensus Panel 1 |
| NCT03318861 (8) [back to overview] | Time to Next Treatment (TTNT) |
| NCT03318861 (8) [back to overview] | Duration of Response (DOR) as Determined by Study Investigators According to the IMWG Consensus Panel 1 |
| NCT03318861 (8) [back to overview] | Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
| NCT03329378 (5) [back to overview] | Number of Non-cardiac Toxicities |
| NCT03329378 (5) [back to overview] | Number of Participants With Breast Conservation |
| NCT03329378 (5) [back to overview] | Number of Participants With Pathologic Complete Response (pCR) |
| NCT03329378 (5) [back to overview] | Number of Participants Alive at the End of the Study |
| NCT03329378 (5) [back to overview] | Number of Cardiac Toxicity Events |
| NCT03338972 (7) [back to overview] | Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells |
| NCT03338972 (7) [back to overview] | Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28 |
| NCT03338972 (7) [back to overview] | Count of Patients That Experienced Adverse Events |
| NCT03338972 (7) [back to overview] | Dose-limiting Toxicities (DLT) Rate |
| NCT03338972 (7) [back to overview] | Objective Response Rate (ORR) |
| NCT03338972 (7) [back to overview] | Overall Survival (OS) |
| NCT03338972 (7) [back to overview] | Progression-free Survival (PFS) |
| NCT03384654 (13) [back to overview] | Overall Response Rate (ORR) |
| NCT03384654 (13) [back to overview] | Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL |
| NCT03384654 (13) [back to overview] | Event-free Survival (EFS) |
| NCT03384654 (13) [back to overview] | Concentration of Daratumumab in Cerebrospinal Fluid (CSF) |
| NCT03384654 (13) [back to overview] | Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) |
| NCT03384654 (13) [back to overview] | Overall Survival (OS) |
| NCT03384654 (13) [back to overview] | Relapse-free Survival (RFS) |
| NCT03384654 (13) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Daratumumab |
| NCT03384654 (13) [back to overview] | Number of Participants With Anti-daratumumab Antibodies |
| NCT03384654 (13) [back to overview] | Minimum Observed Serum Concentration (Cmin) of Daratumumab |
| NCT03384654 (13) [back to overview] | Minimal Residual Disease (MRD) Negative Rate |
| NCT03384654 (13) [back to overview] | Concentration of Daratumumab in Cerebrospinal Fluid (CSF) |
| NCT03384654 (13) [back to overview] | Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL) |
| NCT03417154 (5) [back to overview] | Stage 1: Dosing Schedule of Low-dose Cyclophosphamide |
| NCT03417154 (5) [back to overview] | Progression Free Survival (PFS) |
| NCT03417154 (5) [back to overview] | Overall Survival (OS) |
| NCT03417154 (5) [back to overview] | Objective Response Rate (ORR) |
| NCT03417154 (5) [back to overview] | Clinical Benefit and Immunologic Response of the Combination Therapy |
| NCT03440411 (1) [back to overview] | Overall Survival (OS) |
| NCT03488225 (5) [back to overview] | Event-Free Survival |
| NCT03488225 (5) [back to overview] | Number of Participants With Adverse Events |
| NCT03488225 (5) [back to overview] | Participants to Achieve Complete Remission (CR): |
| NCT03488225 (5) [back to overview] | Overall Survival |
| NCT03488225 (5) [back to overview] | Number of Participants With Minimal Residual Disease (MRD) Negativity |
| NCT03493854 (7) [back to overview] | Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8) |
| NCT03493854 (7) [back to overview] | Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8) |
| NCT03493854 (7) [back to overview] | Number of Participants With a Primary Cardiac Event |
| NCT03493854 (7) [back to overview] | Number of Participants With a Secondary Cardiac Event |
| NCT03493854 (7) [back to overview] | Number of Participants With Laboratory Test Abnormalities at the Highest NCI CTCAE v4 Grade Post-Baseline |
| NCT03493854 (7) [back to overview] | Summary of the Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 (NCI CTCAE v4) |
| NCT03493854 (7) [back to overview] | Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment |
| NCT03518112 (5) [back to overview] | Duration of Response |
| NCT03518112 (5) [back to overview] | Number of Participants Negative for Minimal Residual Disease (MRD) |
| NCT03518112 (5) [back to overview] | Participants With a Response |
| NCT03518112 (5) [back to overview] | Overall Survival |
| NCT03518112 (5) [back to overview] | Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death |
| NCT03556358 (2) [back to overview] | Objective Response Rate (ORR) |
| NCT03556358 (2) [back to overview] | Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR) |
| NCT03593902 (2) [back to overview] | Survival of Treatment |
| NCT03593902 (2) [back to overview] | Change in Skin Score by mRSS |
| NCT03602612 (3) [back to overview] | Number of Participants at Each Dose Level Who Experience a Dose-Limiting Toxicity (DLT) |
| NCT03602612 (3) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). |
| NCT03602612 (3) [back to overview] | Maximum Tolerated Dose (MTD) of Anti-B Cell Maturation Antigen (BCMA) - Chimeric Antigen Receptor (CAR)-T Cells |
| NCT03624036 (4) [back to overview] | Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
| NCT03624036 (4) [back to overview] | Peak Level of Anti-CD19 CAR T-Cells in Blood |
| NCT03624036 (4) [back to overview] | Objective Response Rate (ORR) Per Investigator Review Assessed by International Workshop on CLL (IWCLL) 2018 Criteria |
| NCT03624036 (4) [back to overview] | Number of Participants Experiencing Dose Limiting Toxicities (DLTs) |
| NCT03699475 (1) [back to overview] | Number of Subjects Experiencing 3 or More Dose Limiting Toxicities [Phase 2] Within a 100-day DLT Window After Receiving BPX-501 |
| NCT03726879 (16) [back to overview] | Number of Participants With Treatment-Emergent ADAs to Pertuzumab |
| NCT03726879 (16) [back to overview] | Number of Participants With Treatment-Emergent ADAs to Trastuzumab |
| NCT03726879 (16) [back to overview] | Number of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) to Atezolizumab |
| NCT03726879 (16) [back to overview] | Percentage of Participants With pCR Based on Hormone Receptor Status |
| NCT03726879 (16) [back to overview] | Percentage of Participants With pCR Based on PIK3CA Mutation Status |
| NCT03726879 (16) [back to overview] | Trough Concentration (Ctrough) for Pertuzumab and Trastuzumab in Serum |
| NCT03726879 (16) [back to overview] | Percentage of Participants With pCR in the PD-L1-Negative Population |
| NCT03726879 (16) [back to overview] | Mean Changes From Baseline in Function (Role, Physical) |
| NCT03726879 (16) [back to overview] | Mean Changes From Baseline in Function (Role, Physical) |
| NCT03726879 (16) [back to overview] | Mean Changes From Baseline in Global Health Status |
| NCT03726879 (16) [back to overview] | Mean Changes From Baseline in Global Health Status |
| NCT03726879 (16) [back to overview] | pCR in the ITT Population |
| NCT03726879 (16) [back to overview] | Minimum Serum Concentration (Cmin) of Atezolizumab |
| NCT03726879 (16) [back to overview] | Maximum Serum Concentration (Cmax) of Atezolizumab |
| NCT03726879 (16) [back to overview] | Percentage of Participants With Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3) |
| NCT03726879 (16) [back to overview] | Percentage of Participants With Adverse Events |
| NCT03742986 (2) [back to overview] | Number of Participants Who Had a Pathological Complete Response (pCR) |
| NCT03742986 (2) [back to overview] | Number of Participants Who Had a Pathological Complete Response (pCR) |
| NCT03761056 (15) [back to overview] | Relapse With Central Nervous Disease (CNS) Disease |
| NCT03761056 (15) [back to overview] | Progression-Free Survival (PFS) |
| NCT03761056 (15) [back to overview] | Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood |
| NCT03761056 (15) [back to overview] | Peak Serum Level of Ferritin |
| NCT03761056 (15) [back to overview] | Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators |
| NCT03761056 (15) [back to overview] | Duration of Response (DOR) Per the Lugano Classification |
| NCT03761056 (15) [back to overview] | Event-Free Survival (EFS) |
| NCT03761056 (15) [back to overview] | Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators |
| NCT03761056 (15) [back to overview] | Overall Survival (OS) |
| NCT03761056 (15) [back to overview] | Peak Serum Level of C-Reactive Protein (CRP) |
| NCT03761056 (15) [back to overview] | Time to Peak Serum Level of Granzyme B, Interferon-gamma (IFNg), Interleukin (IL)-2, IL-5, IL-6, IL-8, CRP, and Ferritin |
| NCT03761056 (15) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (SAE) |
| NCT03761056 (15) [back to overview] | Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value |
| NCT03761056 (15) [back to overview] | Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value |
| NCT03761056 (15) [back to overview] | Peak Serum Level of Granzyme B, Interferon-gamma (IFNg), Interleukin (IL)-2, IL-5, IL-6, IL-8 |
| NCT03786783 (5) [back to overview] | Overall Survival |
| NCT03786783 (5) [back to overview] | Percentage of Participants With Unacceptable Toxicity |
| NCT03786783 (5) [back to overview] | "Percentage of Participants Who Are Feasibility Failure" |
| NCT03786783 (5) [back to overview] | Event-free Survival |
| NCT03786783 (5) [back to overview] | Response Rate |
| NCT03817853 (8) [back to overview] | Percentage of Participants With Adverse Events (AEs) |
| NCT03817853 (8) [back to overview] | Time to IRR From Infusion to Onset of the IRR During Cycle 2 |
| NCT03817853 (8) [back to overview] | Duration (In Minutes) of Obinutuzumab Administration by Cycle |
| NCT03817853 (8) [back to overview] | Objective Response Rate (ORR) at the End of Induction (EOI) Therapy |
| NCT03817853 (8) [back to overview] | Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle |
| NCT03817853 (8) [back to overview] | Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle |
| NCT03817853 (8) [back to overview] | Percentage of Grade >=3 Infusion-Related Reactions (IRRs) During Cycle 2 in Patients Who Had Previously Received Obinutuzumab at the Standard Infusion Rate During Cycle 1 Without Experiencing a Grade 3 or 4 IRR |
| NCT03817853 (8) [back to overview] | Percentage of IRRs Regardless of Grade by Cycle |
| NCT03860844 (13) [back to overview] | Number of Participants With Infusion Reactions (IRs) |
| NCT03860844 (13) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
| NCT03860844 (13) [back to overview] | B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab |
| NCT03860844 (13) [back to overview] | AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough) |
| NCT03860844 (13) [back to overview] | Percentage of Participants With Complete Response (CR) Rate |
| NCT03860844 (13) [back to overview] | B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough) |
| NCT03860844 (13) [back to overview] | Overall Response Rate (ORR) |
| NCT03860844 (13) [back to overview] | CD38 Receptor Occupancy |
| NCT03860844 (13) [back to overview] | AML: Ceoi of Isatuximab |
| NCT03860844 (13) [back to overview] | CD38 Receptor Occupancy |
| NCT03860844 (13) [back to overview] | B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab |
| NCT03860844 (13) [back to overview] | AML: AUC of Isatuximab |
| NCT03860844 (13) [back to overview] | Cluster of Differentiation (CD)38 Receptor Density |
| NCT03873805 (2) [back to overview] | Number of Participants Experiencing a Dose-limiting Toxicity (DLT) |
| NCT03873805 (2) [back to overview] | Grade 3 Toxicity Profile |
| NCT03912831 (1) [back to overview] | Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs) |
| NCT03918499 (3) [back to overview] | Overall Response |
| NCT03918499 (3) [back to overview] | Overall Survival |
| NCT03918499 (3) [back to overview] | Progression-free Survival |
| NCT03945591 (2) [back to overview] | Percentage of Participants Who Experience Acute GvHD |
| NCT03945591 (2) [back to overview] | Percentage of Participants Who Experience Moderate to Severe Chronic GvHD |
| NCT03958656 (3) [back to overview] | Number of Participants With a Response |
| NCT03958656 (3) [back to overview] | Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR) |
| NCT03958656 (3) [back to overview] | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
| NCT04002115 (7) [back to overview] | Non-relapse Related Mortality |
| NCT04002115 (7) [back to overview] | Complete Remission (CR) Rate at Day 30 Post HSCT |
| NCT04002115 (7) [back to overview] | Neutrophil Engraftment |
| NCT04002115 (7) [back to overview] | Rate of Chronic GVHD |
| NCT04002115 (7) [back to overview] | Severity of Chronic GVHD |
| NCT04002115 (7) [back to overview] | Severity of Acute Graft-versus-host Disease (GVHD) |
| NCT04002115 (7) [back to overview] | Rate of Acute Graft-versus-host Disease (GVHD) |
| NCT04024462 (3) [back to overview] | Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment |
| NCT04024462 (3) [back to overview] | Serum Trough Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8) |
| NCT04024462 (3) [back to overview] | Serum Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8) |
| NCT04030195 (4) [back to overview] | Objective Response Rate |
| NCT04030195 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT04030195 (4) [back to overview] | Number of Participants With Dose-Limiting Toxicities |
| NCT04030195 (4) [back to overview] | Maximum Tolerated Dose (MTD) |
| NCT04081389 (4) [back to overview] | Recurrence-free Survival (RFS) |
| NCT04081389 (4) [back to overview] | Overall Survival (OS) |
| NCT04081389 (4) [back to overview] | Number of Patients With Pathological Complete Response (pCR) |
| NCT04081389 (4) [back to overview] | Number of Patients With Dose Limiting Toxicities |
| NCT04119336 (2) [back to overview] | Objective Response Rate (ORR) |
| NCT04119336 (2) [back to overview] | Progression Free Survival |
| NCT04160195 (7) [back to overview] | Percentage of Peak Blood Chimeric Antigen Receptors (CAR) T Cells |
| NCT04160195 (7) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
| NCT04160195 (7) [back to overview] | Maximum Tolerated Dose (MTD) of Chimeric Antigen Receptors (CAR) T Cells |
| NCT04160195 (7) [back to overview] | Last Time-Point at Which Chimeric Antigen Receptors (CAR) T Cells Were Detected in the Blood |
| NCT04160195 (7) [back to overview] | Number of Participants Administered T Cells Expressing a Novel Fully- Human Anti-cluster of Differentiation 19 (CD19) and Anti-cluster of Differentiation 20 (CD20) Chimeric Antigen Receptors (CAR) Who Experienced a Dose-limiting Toxicity (DLT) |
| NCT04160195 (7) [back to overview] | Number of Participants With Clinical Response |
| NCT04160195 (7) [back to overview] | Percentage of Peripheral Blood Mononuclear Cells (PBMC) of Chimeric Antigen Receptors (CAR) T Cells |
| NCT04205240 (2) [back to overview] | Number of Patients With a Partial Response |
| NCT04205240 (2) [back to overview] | Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD) |
| NCT04503616 (1) [back to overview] | Percentage of Participants With Grade II-IV Acute GvHD by Day +120 |
| NCT04639245 (6) [back to overview] | Count of Participants That Experienced Treatment-related Unexpected Grade 3 or Higher Adverse Events |
| NCT04639245 (6) [back to overview] | Peripheral Blood Concentration of Infused Transgenic T Cells Over Time |
| NCT04639245 (6) [back to overview] | Progression-free Survival |
| NCT04639245 (6) [back to overview] | Participants That Displayed Transgenic T Cells in Tumor Tissue |
| NCT04639245 (6) [back to overview] | Overall Survival |
| NCT04639245 (6) [back to overview] | Objective Response Rates |
| NCT04660799 (14) [back to overview] | Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma |
| NCT04660799 (14) [back to overview] | CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines |
| NCT04660799 (14) [back to overview] | CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma |
| NCT04660799 (14) [back to overview] | Number of Participants With Rituximab Administration-related Reactions (ARRs) |
| NCT04660799 (14) [back to overview] | Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV) |
| NCT04660799 (14) [back to overview] | Area Under the Curve (AUC) of Rituximab |
| NCT04660799 (14) [back to overview] | Maximum Observed Serum Concentration (Cmax) of Rituximab |
| NCT04660799 (14) [back to overview] | Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab |
| NCT04660799 (14) [back to overview] | Number of Participants Positive for Anti-rHuPH20 Antibodies |
| NCT04660799 (14) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT04660799 (14) [back to overview] | Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma |
| NCT04660799 (14) [back to overview] | Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv) |
| NCT04660799 (14) [back to overview] | Time to Cmax (Tmax) of Rituximab |
| NCT04660799 (14) [back to overview] | Trough Serum Concentration (Ctrough) of Rituximab |
| NCT04745832 (2) [back to overview] | Number of SAEs (Zandelisib When Combined With Rituximab) |
| NCT04745832 (2) [back to overview] | Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab) |
| NCT05993299 (5) [back to overview] | Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) |
| NCT05993299 (5) [back to overview] | Disease Control Rate (DCR) |
| NCT05993299 (5) [back to overview] | Maximum Transgene Expansion (Cmax) |
| NCT05993299 (5) [back to overview] | Time to Cmax (Tmax) |
| NCT05993299 (5) [back to overview] | Overall Response Rate (ORR) |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00001832)
Timeframe: 10.5 months
| Intervention | Participants (Number) |
|---|
| Abl Cells IV + Cyclophosphamide 30 mg/kg | 3 |
| Abl Cells IV + Cyclophosphamide 60 mg/kg | 3 |
| Abl Cells IV+Low Dose IV IL-2 (Initial) | 3 |
| Abl Cells IV+High Dose IV IL-2 (Initial) | 6 |
| Abl Cells IV + MTD IL-2 | 50 |
| Abl Cells IA + MTD (Prior Cells IV on 6) | 4 |
| Abl Cells IA + MTD IL-2 | 7 |
| Abl Cells IA+MTD IL-2 (MART-1 Reactive) | 8 |
| Abl Cells IV + MTD IL-2 no GCSF | 6 |
| Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive) | 1 |
| Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive) | 7 |
| Abl Cells IV + SQ IL-2 With GCSF | 6 |
| Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive) | 3 |
| Abl Cells IV + SQ IL-2 With GCSF (no Reactivity) | 2 |
Clinical Response
Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2. (NCT00001832)
Timeframe: Every three to four weeks after the treatment, for up to 5 years.
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response | Minor Response | Progressive Disease | Mixed Response | No Response | Stable Disease |
|---|
| Abl Cells IA + MTD (Prior Cells IV on 6) | 0 | 0 | 0 | 0 | 0 | 4 | 0 |
,| Abl Cells IA + MTD IL-2 | 1 | 0 | 0 | 0 | 0 | 5 | 0 |
,| Abl Cells IA+MTD IL-2 (MART-1 Reactive) | 1 | 1 | 0 | 0 | 1 | 5 | 0 |
,| Abl Cells IV + Cyclophosphamide 30 mg/kg | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
,| Abl Cells IV + Cyclophosphamide 60 mg/kg | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
,| Abl Cells IV + MTD IL-2 | 3 | 14 | 0 | 0 | 0 | 32 | 1 |
,| Abl Cells IV + MTD IL-2 no GCSF | 1 | 1 | 0 | 0 | 0 | 4 | 0 |
,| Abl Cells IV + SQ IL-2 With GCSF | 0 | 3 | 0 | 0 | 0 | 3 | 0 |
,| Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive) | 0 | 1 | 0 | 0 | 0 | 2 | 0 |
,| Abl Cells IV + SQ IL-2 With GCSF (no Reactivity) | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
,| Abl Cells IV+High Dose IV IL-2 (Initial) | 0 | 0 | 0 | 0 | 0 | 6 | 0 |
,| Abl Cells IV+Low Dose IV IL-2 (Initial) | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
,| Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive) | 0 | 2 | 0 | 0 | 0 | 5 | 0 |
,| Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive) | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Complete Remission (CR)
complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia. (NCT00002766)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Complete Remission | Complete Response (CR) | Failure | Failure-Progression | Relapse |
|---|
| All-2 | 50 | 14 | 5 | 8 | 1 |
,| L-20 | 50 | 11 | 14 | 10 | 0 |
Five-year Overall Survival
Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause. (NCT00003042)
Timeframe: From date of mastectomy until date of death, 5 years post mastectomy.
| Intervention | percentage of participants (Number) |
|---|
| Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 69.2 |
| High-dose Chemo With Rescue | 70.4 |
Three-year Relapse-free Survival
Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. (NCT00003042)
Timeframe: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.
| Intervention | percentage of participants (Number) |
|---|
| Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 61.5 |
| High-dose Chemo With Rescue | 77.8 |
Progression-free Survival
time to disease progression or death due to any cause (NCT00003270)
Timeframe: 1 year
| Intervention | % of participants (Number) |
|---|
| Arm 1 | 50 |
Failure-free Survival at 5 Years
"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission." (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5
| Intervention | Proportion of patients (Number) |
|---|
| Arm A (ABVD) | 0.74 |
| Arm B (Stanford V) | 0.71 |
5-year Overall Survival
Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years. (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years
| Intervention | Proportion of patients (Number) |
|---|
| Arm A (ABVD) | 0.88 |
| Arm B (Stanford V) | 0.88 |
Incidence of Second Cancers
Number of patients who developed second primary cancers (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years
| Intervention | participants (Number) |
|---|
| Arm A (ABVD) | 15 |
| Arm B (Stanford V) | 19 |
Objective Response
Determine the overall objective response. CR rate [as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated (NCT00003631)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Failure | Minor Response (MR) | Partial Response (PR) | Progression Free (P-Free) | Complete Response (CR) | Progression of Disease (POD) |
|---|
| Group A - Favorable Prognostic Group | 3 | 2 | 1 | 41 | 0 | 0 |
,| Group B - Intermediate Prognostic Group | 6 | 1 | 2 | 31 | 2 | 1 |
,| Group C - Unfavorable Prognostic Group | 3 | 0 | 4 | 7 | 1 | 0 |
Overall Survival Status
The 5 year survival rate. The survival of patients with this disease is dependent on the stage of disease. Two useful staging systems are: Three-stage Rai System Clinical Feature and the Binet System. (NCT00003659)
Timeframe: up to 5 years
| Intervention | participants (Number) |
|---|
| Intermediate or High Risk Chronic Lymphocytic Leukemia | 26 |
Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease
The flow cytometric response and the molecular polymerase chain reaction (PCR) response was captured as indicated in the protocol. Immunophenotypic analysis of bone marrow and/ or peripheral blood demonstrate a normal k:λ ratio and a normal number of CD5/CD19 (or CD5/CD20) dual staining cells (<5% of the lymphocyte gate). (NCT00003659)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Flow cytometric complete response | Molencular (PCR) complete response |
|---|
| Intermediate or High Risk Chronic Lymphocytic Leukemia | 20 | 12 |
Overall Response Rate
Response was determined as indicated in the protocol. The categories are: complete response, nodular partial response, partial response and failure. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. The laboratory and radiographic studies which were abnormal pre-study, will be repeated to document the degree of maximal response. (NCT00003659)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Complete Response | Nodular Partial Response | Partial Response | Failure |
|---|
| Intermediate or High Risk Chronic Lymphocytic Leukemia | 22 | 2 | 8 | 4 |
Overall Survival
(NCT00003782)
Timeframe: 8 years
| Intervention | percentage of patients alive (Number) |
|---|
| Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel | 83 |
| Arm 2: Doxorubicin + Docetaxel | 79 |
| Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide | 79 |
Toxicity/TRM at Day 100
Death due to treatment related causes before day +100 after BMT (NCT00003816)
Timeframe: Day +100
| Intervention | Participants (Count of Participants) |
|---|
| BuCy | 3 |
| CyTBI | 4 |
| FluMel | 31 |
| VpCyTBI | 4 |
| Other | 4 |
4 yr OS
Overall survival estimate at 4 years post BMT (NCT00003816)
Timeframe: 4-year
| Intervention | percentage of participants (Number) |
|---|
| BuCy | 56.4 |
| CyTBI | 56.5 |
| FluMel | 38.2 |
| VpCyTBI | 39.1 |
| Other | 53.3 |
4 Year PFS
progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause) (NCT00003816)
Timeframe: 4 years
| Intervention | percentage of participants (Number) |
|---|
| BuCy | 49.1 |
| CyTBI | 52.2 |
| FluMel | 33.2 |
| VpCyTBI | 26.1 |
| Other | 40 |
CR Rate
Rate of Complete Remission by Day +100 (NCT00003816)
Timeframe: day 100
| Intervention | Participants (Count of Participants) |
|---|
| BuCy | 42 |
| CyTBI | 55 |
| FluMel | 134 |
| VpCyTBI | 18 |
| Other | 7 |
Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX
We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. (NCT00003910)
Timeframe: Assessed during the first 4 months of treatment and followed until reaching full study stop date
| Intervention | proportion of participants (Number) |
|---|
| Cyclophosphamide (Cy) | 0.64 |
Proportion of Patients With Complete or Partial Response to Treatment With MTX
We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. (NCT00003910)
Timeframe: Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.
| Intervention | proportion of participants (Number) |
|---|
| Methotrexate | 0.39 |
2 Year Progression-free Survival
Percentage of participants without disease progression up to 2 years post-registration. (NCT00004031)
Timeframe: From registration until death
| Intervention | percentage of participants (Number) |
|---|
| CHOP/CHOP-R x 3 | 55.4 |
| CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant | 69.1 |
2-year Overall Survival Rates
Percentage of participants surviving 2 years post registration (NCT00004031)
Timeframe: up to 2 years post registration
| Intervention | percentage of participants (Number) |
|---|
| CHOP/CHOP-R x 3 | 71.1 |
| CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant | 73.7 |
Progression-free Survival
"Kaplan-Meier estimate at three years post-first transplant of survival. Event of interest is the first of Death or Progression. Censoring is Alive in Continuous Complete Remission at date of last follow-up.~95 percent confidence interval of the point estimate is calculated using Greenwood's variance." (NCT00004088)
Timeframe: Estimate reported at three years after day 0 of the first cycle of infusion of cells of the tandem transplant.
| Intervention | proportion of participants (Number) |
|---|
| HD Chemo Followed by PBPC Rescue | 0.456 |
Three-year Overall Survival
Kaplan-Meier estimate at three years post-first transplant of survival. Outcome is death or alive at follow-up (censored). 95 percent confidence interval of the point estimate is calculated using Greenwood's variance. (NCT00004088)
Timeframe: Estimate reported at three years after day 0 of the first cycle of infusion of cells of the tandem transplant.
| Intervention | proportion of participants (Number) |
|---|
| HD Chemo Followed by PBPC Rescue | 0.662 |
Five-Year Relapse-free Survival
RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method. (NCT00004092)
Timeframe: Five years
| Intervention | percentage of participants (Number) |
|---|
| Arm I (ACT) | 47 |
| Arm II (STAMP V) | 55 |
Five-Year Overall Survival
Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method. (NCT00004092)
Timeframe: Five Years
| Intervention | percentage of participants (Number) |
|---|
| Arm I (ACT) | 63 |
| Arm II (STAMP V) | 75 |
Event-free Survival
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification. (NCT00004228)
Timeframe: 5 years
| Intervention | percentage of particpants (Number) |
|---|
| A0 (Localized Disease Stg I/II) Modified CCG BFM | 88 |
| A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 82 |
| A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens | 80 |
| B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | 63 |
| B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | 82 |
| B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | 84 |
| B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | 90 |
Percentage of Patients With Overall Survival as Assessed by Time to Death
Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors. (NCT00004228)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| A0 (Localized Disease Stg I/II) Modified CCG BFM | 96 |
| A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens | 84 |
| A2 (Disseminated, No CNS - CCG Mod BFM w/Intens | 88 |
| B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy | 81 |
| B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens | 85 |
| B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens | 85 |
| B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment | 92 |
Total Lung Capacity
expressed as a percentage of the predicted value (NCT00004563)
Timeframe: 12 months
| Intervention | % of predicted (Mean) |
|---|
| Cylophosphamide | 70.5 |
| Placebo | 64.7 |
Forced Vital Capacity
The primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC. (NCT00004563)
Timeframe: 12 months
| Intervention | % of predicted (Mean) |
|---|
| Cylophosphamide | 66.6 |
| Placebo | 65.6 |
DLCO
diffusing capacity of the lungs for carbon monoxide (NCT00004563)
Timeframe: 12 months
| Intervention | % of predicted (Mean) |
|---|
| Cylophosphamide | 42.8 |
| Placebo | 44.3 |
Overall Survival (OS)
OS was determined by the Kaplan-Meier method and is defined as the time from treatment start date until date of death or last follow-up. (NCT00005780)
Timeframe: Time from treatment start date until date of death or date last follow-up, up to 250 months
| Intervention | Months (Median) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 89.7 |
Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0).
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00005780)
Timeframe: Up to 30 days after last intervention, up to 12.5 months or 1.04 years
| Intervention | Participants (Count of Participants) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 26 |
Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH)
Participants with an immune response against carrier molecule KLH measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. (NCT00005780)
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 months
| Intervention | percentage of participants (Number) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 74 |
Percentage of Participants With Induction of Type 1 Cytokine T-cell Response
Participants with tumor specific T-cell responses during B-cell recovery was assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab and were measured by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT). A positive response required the response to be at least twice the negative controls. (NCT00005780)
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 months
| Intervention | percentage of participants (Number) |
|---|
| Peripheral blood mononuclear cells (PBMC) | Granulocyte macrophage colony-stimulating factor (GM-CSF) | Tumor necrosis factor α (TNFα) | Interferon-gamma (IFN-γ) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 87 | 65 | 52 | 74 |
Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine
PFS is defined as the time from start of treatment until disease relapse or progression, death, or last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion (NCT00005780)
Timeframe: Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months
| Intervention | Months (Median) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 25.0 |
Percentage of Participants With an Antibody Response to Idiotype Vaccine
Participants with an immune response to idiotype vaccine measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. (NCT00005780)
Timeframe: Weeks 12 to 32
| Intervention | percentage of participants (Number) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 30 |
Time to Recovery of CD4 T Lymphocytes (CD4+)
Recovery of CD4+ was measured by flow cytometry. Blood samples were collected via apheresis and analyzed by multicolor flow cytometry in peripheral blood mononuclear cells (PBMCs) for cluster of differentiation 4 (CD4). Time to recovery of CD4 T lymphocytes was defined as the time required for CD4 T lymphocytes to increase above the lower limit of normal of the normal laboratory value range of 359 cells/mcL (NCT00005780)
Timeframe: After chemotherapy before vaccination, up to 6 months
| Intervention | Months (Median) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 3 |
Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
Response was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma. Complete Response (CR) is a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., Lactate dehydrogenase (LDH) definitely assignable to the lymphoma. Complete Response Unconfirmed (CRu) is as per CR criteria except that if a residual node is > 1.5cm, it must have regressed by > 75% in the sum of the products of the greatest diameters (SPD). Partial Response (PR) is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Stable Disease (SD) is defined as less than a PR but not progressive disease. Progression is ≥50% increase from nadir in the SPD of any previously involved node or the appearance of any new lesion. (NCT00005780)
Timeframe: After 6 cycles of EPOCH-R therapy, an average of 18 weeks
| Intervention | percentage of participants (Number) |
|---|
| Complete Response | Complete Response Unconfirmed | Partial Response | Stable Disease | Progression |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | 80.8 | 7.7 | 7.7 | 0 | 3.8 |
Non-Relapse Mortality
"The rates and accompanying confidence intervals associated with transplant-related mortality will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)." (NCT00005803)
Timeframe: Day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Tandem Transplantation) | 3 |
Engraftment of HLA Identical PBSC Allografts
"Number of patients who engrafted by Day 56 post allogeneic transplant. Failure to engraft is defined as the absence of detectable donor cells in the marrow. The rates and accompanying confidence intervals associated with failure of engraftment at day +56 will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)." (NCT00005803)
Timeframe: Day 56
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Tandem Transplantation) | 53 |
Overall Survival (OS)
Number of patients surviving by interval. Chemosensitive and chemoresistant subjects will be analyzed separately. (NCT00005803)
Timeframe: From the date of autologous transplant until the time of death, assessed up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| 6 Months | 1 Year | 1.5 Years | 2 Years | 3 Years |
|---|
| Chemoresistant Group | 14 | 10 | 9 | 8 | 8 |
,| Chemosensitive Group | 39 | 31 | 27 | 26 | 23 |
,| Unknown Chemosensitivity Group | 1 | 0 | 0 | 0 | 0 |
Progression Free-survival (PFS)
Number of patients surviving without disease by interval. Chemosensitive and chemoresistant subjects will be analyzed separately. (NCT00005803)
Timeframe: From the date of autologous transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, assessed up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| 6 Months | 1 Year | 1.5 Years | 2 Years | 3 Years |
|---|
| Chemoresistant Group | 12 | 8 | 8 | 8 | 8 |
,| Chemosensitive Group | 36 | 27 | 25 | 25 | 22 |
,| Unknown Chemosensitivity Group | 1 | 0 | 0 | 0 | 0 |
Complementary Deoxyribonucleic Acid (cDNA) Expression
Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. (NCT00005908)
Timeframe: 6 years
| Intervention | Participants (Number) |
|---|
| Responders | Non-responders |
|---|
| Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine | 8 | 2 |
,| Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine | 7 | 13 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00005908)
Timeframe: 6 years
| Intervention | Participants (Number) |
|---|
| Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine | 9 |
| Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine | 20 |
Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models
Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. (NCT00005908)
Timeframe: 6 years
| Intervention | Participants (Number) |
|---|
| Responders | Non-responders |
|---|
| Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine | 8 | 13 |
Overall Clinical Response Rate
Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module. (NCT00005908)
Timeframe: 6 years
| Intervention | Percentage of participants (Number) |
|---|
| Complete Response | Partial Response | Complete pathologic response |
|---|
| Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine | 31 | 59 | 10 |
Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®.
Percent of patients receiving and not receiving Herceptin who are alive and disease-free at 5 years. (NCT00006110)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Experimental: Herceptin With or Without Radiation | 69 |
| Experimental: Non-Herceptin With or Without Radiation | 60 |
Overall Response
Measured by the Overall Response. Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00006110)
Timeframe: 78 weeks (1.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| Patients Treated Neoadjuvantly With AC-TP | 32 |
| Patients Treated With AC-P (Without Herceptin) | 24 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00006184)
Timeframe: 9 years
| Intervention | Participants (Count of Participants) |
|---|
| Recipient - Chemotherapy Group | 10 |
| Donor - Vaccination Generation Group | 10 |
Immune Response
Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells. (NCT00006184)
Timeframe: 105 days
| Intervention | Particpants (Number) |
|---|
| Recipient - Chemotherapy Group | 7 |
Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia
Toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Febrile neutropenia is defined as a life-threatening complication requiring hospitalization and urgent broad-spectrum antibiotics. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 18 |
1 Year Overall Survival
Overall survival is time from treatment start date until date of death or date last known alive. (NCT00006436)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 83.7 |
Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.
| Intervention | Participants (Count of Participants) |
|---|
| Serious infection | Neurologic event | Syncope | Confusion | Motor neuropathy | Vision disturbance | Hyperglycemia | Hypophosphatemia | Hypocalcemia | Hypokalemia | Hyponatremia | Dehydration | Mucositis/Stomatitis | Liver test abnormalities | Pancreatitis | Diarrhea | Constipation | Serious hemorrhage | Fatigue | Headache | Bone pain | Nausea | Anorexia | Hypoxia | Myelodysplastic syndrome |
|---|
| Grade 3 | 17 | 0 | 1 | 1 | 0 | 1 | 4 | 2 | 2 | 1 | 1 | 1 | 6 | 6 | 1 | 2 | 1 | 5 | 2 | 5 | 1 | 0 | 0 | 0 | 0 |
,| Grade 4 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 4 | 0 |
,| Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Percentage of Participants With Complete Response
Complete response was assessed by the Cheson Response Criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). (NCT00006436)
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.
| Intervention | percentage of participants (Number) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 95 |
Progression Free Survival at 1 Year
PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). (NCT00006436)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 79.1 |
Recovery of CD4 T Cells (CD4) Counts
Participants with human immunodeficiency virus (HIV) who undergo chemotherapy may have a delay in the recovery of their normal CD4+ T-cells. This delay could result in an increased risk of infection. Recovery of CD4 cells counts is the time from end of therapy until the time that the CD4 counts first reached above 200 cells/uL. (NCT00006436)
Timeframe: From the end of chemotherapy every 3 months for the first 2 years
| Intervention | months (Median) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 2.5 |
Recovery of Human Immunodeficiency Virus (HIV) Viral Load
The HIV viral load is a measure of actively replicating virus in the blood. If no anti-retroviral therapy is given, then reduction of this HIV viral load to manageable levels might risk infection. In our study, the recovery of HIV viral load was measured the time from the initiation of antiretroviral therapy until the viral load was undetectable or < 50 copies. (NCT00006436)
Timeframe: Either following or concurrently with combination chemo and biological therapy, approximately every 6 to 8 weeks after therapy was completed up to 16 months
| Intervention | months (Median) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 2 |
1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
"1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans.~PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival." (NCT00006436)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Interim PET scan positive 1-year PFS | Interim PET scan negative 1 year PFS |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 61.5 | 89.3 |
Number of Cycles of Hematologic Toxicity
Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). (NCT00006436)
Timeframe: Up to 112 cycles (each cycle is 21 days + 7 days window)
| Intervention | cycles (Number) |
|---|
| Febrile neutropenia | Neutropenia with a Nadir <500 cells/mm^3 | Neutropenia with a Nadir <100 cells/mm^3 | Thrombocytopenia with a Nadir <50,000 platelets/mm^3 | Thrombocytopenia with a Nadir <25,000 platelets/mm^3 | Anemia: hemoglobin <8 g/dL |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 25 | 112 | 77 | 40 | 6 | 36 |
Overall Response
Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. (NCT00006436)
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Complete Response Unconfirmed | Partial Response | Non-Responder - Stable Disease | Non-Responder - Progressive Disease |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 53 | 10 | 1 | 1 | 1 |
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 66 |
Percentage of Participants With CR/CRu Lasting 1 Year
"Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy).~Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR." (NCT00006436)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Arm 1-Combination Chemo and Biological Therapy | 82.5 |
Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00006721)
Timeframe: Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death
| Intervention | participants (Number) |
|---|
| CHOP + Rituximab | 224 |
| CHOP + Tositumomab | 223 |
Overall Survival at 2 Years
Measured from date of registration to date of death due to any cause (NCT00006721)
Timeframe: 0-2 years
| Intervention | percentage of participants (Number) |
|---|
| CHOP + Rituximab | 97 |
| CHOP + Tositumomab | 93 |
Progression-free Survival at 2 Years
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00006721)
Timeframe: 0-2 years
| Intervention | percentage of participants (Number) |
|---|
| CHOP + Rituximab | 76 |
| CHOP + Tositumomab | 80 |
Overall Survival at 5 Years
Measured from date of registration to date of death due to any cause (NCT00006721)
Timeframe: 0-5 years
| Intervention | percentage of participants (Number) |
|---|
| CHOP + Rituximab | 92 |
| CHOP + Tositumomab | 86 |
Progression-free Survival at 5 Years
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00006721)
Timeframe: 0-5 years
| Intervention | percentage of participants (Number) |
|---|
| CHOP + Rituximab | 60 |
| CHOP + Tositumomab | 66 |
Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange.
"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined." (NCT00007475)
Timeframe: End of study
| Intervention | 1- albumin glomerular permeability ratio (Mean) |
|---|
| FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 0.41 |
| FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 0.865 |
Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide.
"Outcomes for FSGS occurring in native kidneys:~A. Complete remission: proteinuria <0.3 g/d ; B. Partial remission: proteinuria between 0.3 and 2 g/d ; C. Incomplete response: proteinuria between 2 and 3.5 g/d ; D. Relapse: return to proteinuria ≥3.5 g/d ; Note that counts within each category A-D may be summarized relative to remaining categories, as a proportion (relative to complement of the whole group count) with calculations implicitly based on zero/one valued binary variables, whose means are proportions, so to report 95% confidence intervals calculated using an exact binomial distribution." (NCT00007475)
Timeframe: every 3 months up to a year followed with native kidneys
| Intervention | proportion of participants with outcome (Mean) |
|---|
| A. Complete remission: proteinuria <0.3 g/d | B. Partial remission: proteinuria in [0.3,2] g/d | C. Incomplete response: proteinuria in (2,3.5) g/d | D. Relapse: return to proteinuria ≥3.5 g/d |
|---|
| FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed | 0.5 | 0 | 0 | 0 |
,| FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed | 0 | 0 | 0 | 1 |
,| FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed | 0 | 0.25 | 0 | 0.1667 |
Disease Free Survival
Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence. (NCT00014222)
Timeframe: 13 years
| Intervention | Participants (Count of Participants) |
|---|
| Disease Recurrence | No recurrence |
|---|
| Arm 1: CEF | 141 | 560 |
,| Arm 2: EC/T | 135 | 566 |
,| Arm 3: AC/T | 191 | 511 |
Overall Survival
Overall survival was defined as the time from randomization to the time of death from any cause, with censoring at longest follow-up. (NCT00014222)
Timeframe: 13 years
| Intervention | Participants (Count of Participants) |
|---|
| Death | Alive |
|---|
| Arm 1: CEF | 123 | 578 |
,| Arm 2: EC/T | 107 | 594 |
,| Arm 3: AC/T | 146 | 556 |
Percentage of Participants With Disease Free Survival at 5 Years
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method. (NCT00021255)
Timeframe: From randomization until relapse or death or up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 75.5 |
| AC Followed by Docetaxel + Herceptin (AC→TH) | 83.2 |
| Docetaxel + Carboplatin + Herceptin (TCH) | 81.0 |
Percentage of Participants With Disease Free Survival at 10 Years
Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method. (NCT00021255)
Timeframe: From randomization until relapse or death or up to 10 years
| Intervention | percentage of participants (Number) |
|---|
| Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 67.2 |
| AC Followed by Docetaxel + Herceptin (AC→TH) | 73.4 |
| Docetaxel + Carboplatin + Herceptin (TCH) | 72.3 |
Overall Survival- Percentage of Participants Who Survived at 10 Years
Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method. (NCT00021255)
Timeframe: From randomization until death or up to 10 years
| Intervention | percentage of particpants (Number) |
|---|
| Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 78.9 |
| AC Followed by Docetaxel + Herceptin (AC→TH) | 86.0 |
| Docetaxel + Carboplatin + Herceptin (TCH) | 83.4 |
Overall Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive. (NCT00022516)
Timeframe: 5-year estimates, reported at a median follow-up of 6.9 years
| Intervention | percentage of participants (Number) |
|---|
| No-CM | 85.0 |
| CM-Maintenance | 85 |
Disease-free Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up. (NCT00022516)
Timeframe: 5-year estimates, reported at a median follow-up of 6.9 years
| Intervention | percentage of participants (Number) |
|---|
| No-CM | 74.7 |
| CM-Maintenance | 78.1 |
Distant Recurrence-free Interval
Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up. (NCT00022516)
Timeframe: 5-year estimates, reported at a median follow-up of 6.9 years
| Intervention | percentage of participants (Number) |
|---|
| No-CM | 83.5 |
| CM-Maintenance | 85.5 |
Breast Cancer-free Interval
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up. (NCT00022516)
Timeframe: 5-year estimates, reported at a median follow-up of 6.9 years
| Intervention | percentage of participants (Number) |
|---|
| No-CM | 77.3 |
| CM-Maintenance | 81.0 |
Grade 3 or 4 Non-hematologic Toxicity
Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
| Intervention | Number of participants (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 10 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 153 |
| Arm III (RER With CR [ABVE-PC]) | 130 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 216 |
| Arm V (RER With PD) | 11 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 62 |
| Arm VII (SER [ABVE-PC, IFRT]) | 45 |
Disease Response Assessed by Modified RECIST Criteria
Number of participants with complete response and very good partial response at the end of protocol therapy. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
| Intervention | Number of participants (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 5 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 370 |
| Arm III (RER With CR [ABVE-PC]) | 380 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 538 |
| Arm V (RER With PD) | 29 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 105 |
| Arm VII (SER [ABVE-PC, IFRT]) | 100 |
Event-free Survival
Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. (NCT00025259)
Timeframe: 5 years
| Intervention | Probability of survival (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 0.89 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 0.87 |
| Arm III (RER With CR [ABVE-PC]) | 0.84 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 0.87 |
| Arm V (RER With PD) | 0.70 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 0.79 |
| Arm VII (SER [ABVE-PC, IFRT]) | 0.74 |
Overall Survival
Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. (NCT00025259)
Timeframe: 5 years
| Intervention | Probability of survival (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 0.93 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 0.98 |
| Arm III (RER With CR [ABVE-PC]) | 0.98 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 0.98 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 0.96 |
| Arm VII (SER [ABVE-PC, IFRT]) | 0.93 |
Second Hodgkin's Disease Progression
Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis. (NCT00026208)
Timeframe: 16 years
| Intervention | Participants (Count of Participants) |
|---|
| Stanford V-C + Low-dose Radiotherapy | 3 |
| Stanford V-C Only | 1 |
Overall Survival (OS)
Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation. (NCT00026208)
Timeframe: 16 years
| Intervention | years (Median) |
|---|
| Stanford V-C + Low-dose Radiotherapy | 10.4 |
| Stanford V-C Only | 13.2 |
Progression-free Survival (PFS)
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression. (NCT00026208)
Timeframe: up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| Stanford V-C + Low-dose Radiotherapy | 89.7 |
| Stanford V-C Only | 50 |
Survival at 5 and 10 Years
Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints. (NCT00026208)
Timeframe: 5 and 10 years
| Intervention | Participants (Count of Participants) |
|---|
| 5 years | 10 years |
|---|
| Stanford V-C + Low-dose Radiotherapy | 67 | 41 |
,| Stanford V-C Only | 3 | 3 |
Frequency of Complete Response
"The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as complete regression of all palpable and radiographic demonstrable disease by computed tomography (CT) scan or positron emission tomography-CT (PET-CT)." (NCT00026208)
Timeframe: 5 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Stanford V-C + Low-dose Radiotherapy | 31 |
Event-free Survival (EFS)
EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years. (NCT00027846)
Timeframe: At 5 years since the time of radiation therapy
| Intervention | Probability of EFS at 5 years (Number) |
|---|
| Differentiated Ependymoma | 0.746 |
| Anaplastic Ependymoma | 0.607 |
Overall Survival
Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years. (NCT00027846)
Timeframe: Up to 5 years after completion of study treatment
| Intervention | Probability of OS at 5 years (Number) |
|---|
| GTR1 Differentiated Histology Supratentorial (Group 1) | 1 |
| Radiation (Group 2) | 0.862 |
| Sub-Total Resection Any Histology or Location (STR) (Group 3) | 0.702 |
Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy
The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment. (NCT00027846)
Timeframe: At the time of second surgery
| Intervention | percentage of participants (Number) |
|---|
| Sub-Total Resection Any Histology or Location (STR) (Group 3) | 76 |
Event-free Survival
Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years. (NCT00027846)
Timeframe: Up to 5 years after completion of study treatment
| Intervention | Probability of EFS at 5 years (Number) |
|---|
| GTR1 Differentiated Histology Supratentorial (Group 1) | 0.614 |
| Radiation (Group 2) | 0.685 |
| Sub-Total Resection Any Histology or Location (STR) (Group 3) | 0.372 |
Event-free Survival (EFS)
EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability. (NCT00027846)
Timeframe: At 5 years since the time of radiation therapy.
| Intervention | Probability of EFS at 5 years (Number) |
|---|
| Differentiated Ependymoma | 0.424 |
| Anaplastic Ependymoma | 0.298 |
Local Control and Patterns of Failure
Documented and analyzed qualitatively and quantitatively. (NCT00027846)
Timeframe: Up to 5 years after completion of study treatment
| Intervention | Participant (Number) |
|---|
| Local control | Pattern of failure local | Pattern of failure Metastatic | Pattern of failure local & metastatic |
|---|
| GTR1 Differentiated Histology Supratentorial (Group 1) | 6 | 4 | 0 | 1 |
,| Radiation (Group 2) | 217 | 57 | 26 | 7 |
,| Sub-Total Resection Any Histology or Location (STR) (Group 3) | 29 | 31 | 5 | 4 |
Long Term Survival
"Survival Endpoints:~Event free survival and overall survival were assessed at 5 years from time of study enrollment" (NCT00031590)
Timeframe: Up to 5 years from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
| Intervention | Percentage of participants (Number) |
|---|
| 5 year Overall Survival (OS) | 5 year Event Free Survival (EFS) |
|---|
| Study Treatment | 87.5 | 70 |
Tumor Outcome in Terms of Overall Survival (OS) Rate
OS rate from time of study enrollment. (NCT00033293)
Timeframe: Up to 3 years
| Intervention | 3 year OS (Number) |
|---|
| Arm I (Chemotherapy, Immunoglobulin Therapy) | 100 |
| Arm II (Chemotherapy, Observation) | 96.0 |
Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing
"The Bayley Scales of infant development mental scale best score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline." (NCT00033293)
Timeframe: Changes from baseline to the better of 6 months or 1 year
| Intervention | Change in Bayley's score (Mean) |
|---|
| Arm I (Chemotherapy, Immunoglobulin Therapy) | 117.5 |
| Arm II (Chemotherapy, Observation) | 100.75 |
Number of Responders
A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA. (NCT00033293)
Timeframe: Changes from baseline to 2 months, 6 months, and 1 year
| Intervention | participants (Number) |
|---|
| Arm I (Chemotherapy, Immunoglobulin Therapy) | 21 |
| Arm II (Chemotherapy, Observation) | 11 |
Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)
"The best score at the two time points will be used in this analysis. For a given patient, this best score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated." (NCT00033293)
Timeframe: Changes from baseline to the better of 6 months or 1 year
| Intervention | Change in VABS score (Mean) |
|---|
| Arm I (Chemotherapy, Immunoglobulin Therapy) | 84.53 |
| Arm II (Chemotherapy, Observation) | 144.73 |
Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death
EFS rate for neuroblastoma event from time of study enrollment. (NCT00033293)
Timeframe: Up to 3 years
| Intervention | 3 year EFS (Number) |
|---|
| Arm I (Chemotherapy, Immunoglobulin Therapy) | 92.3 |
| Arm II (Chemotherapy, Observation) | 96.0 |
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
"Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.~Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.~Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease." (NCT00038610)
Timeframe: Baseline to 6 months
| Intervention | participants (Number) |
|---|
| Complete Remission | Partial Remission | Molecular Complete Remission | Induction Death |
|---|
| Hyper-CVAD + Imatinib | 42 | 1 | 17 | 1 |
Disease-Free Survival Rate at 2-year and 5-year.
Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause. (NCT00038610)
Timeframe: Baseline to 2-year and 5-year
| Intervention | percentage of participants (Number) |
|---|
| 2-year DFS rate | 5-year DFS rate |
|---|
| Hyper-CVAD + Imatinib | 49 | 43 |
Overall Survival Rate at 2-year and 5-year.
Overall survival (OS) was calculated from the date of initiation of therapy until death. (NCT00038610)
Timeframe: Baseline to 2-year and 5-year
| Intervention | percentage of participants (Number) |
|---|
| 2-year OS rate | 5-year OS rate |
|---|
| Hyper-CVAD + Imatinib | 57 | 43 |
2 Year Overall Survival
Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method. (NCT00039130)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab With High Intensity Chemotherapy | 80 |
2 Year Event Free Survival
Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure. (NCT00039130)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab With High Intensity Chemotherapy | 78 |
Complete Response Rate
Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease. (NCT00039130)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|
| Rituximab With High Intensity Chemotherapy | 83 |
Progression Free Survival
Kaplan-Meier estimates will be used to verify the progression free survival. (NCT00039195)
Timeframe: 2 years
| Intervention | percentage of patients progression free (Number) |
|---|
| Induction R-CHOPac Therapy | 79 |
5 Year Overall Survival for Autologous & Allogeneic Transplant Groups
Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method. (NCT00039377)
Timeframe: 5 years from registration
| Intervention | percentage of patients (Number) |
|---|
| Patients With HLA-matched Sibling Donor | 53 |
| Patients Without HLA-matched Sibling Donors | 51 |
5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups
Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method. (NCT00039377)
Timeframe: 5 years from CR
| Intervention | percentage of patients (Number) |
|---|
| Patients With HLA-matched Sibling Donor | 46 |
| Patients Without HLA-matched Sibling Donors | 47 |
Number of Participants Who Achieved a BCR-ABL Response at 12 Months
"BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).~Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene~MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally)." (NCT00039377)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Complete Molecular Response | Major Molecular Response |
|---|
| Entire Cohort | 9 | 4 |
Overall Survival
Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method. (NCT00039377)
Timeframe: Duration of study (up to 10 years)
| Intervention | years (Median) |
|---|
| Entire Cohort | 3.6 |
Disease Free Survival
"Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.~A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month." (NCT00039377)
Timeframe: Duration of treatment (up to 10 years)
| Intervention | years (Median) |
|---|
| Entire Cohort | 1.7 |
Overall Survival
(NCT00040937)
Timeframe: 4-7 years
| Intervention | proportion surviving at 4 years (Number) |
|---|
| Treatment Arm | .64 |
Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen. (NCT00040937)
Timeframe: Induction
| Intervention | Participants (Number) |
|---|
| Induction/PBSC Mobilization | 2 |
Duration of Disease Free Survival (RFS)
To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. Objective progression is defined as the appearance of local (chest wall, axillary, supraclavicular nodes) or distant metastases. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis. (NCT00041119)
Timeframe: from baseline up to 6.4 years
| Intervention | months (Median) |
|---|
| Arm V (Arm I and Arm II Combined) | NA |
| Arm VI (Arm III and Arm IV) Combined | NA |
Adverse Events
To compare toxicities of short course CA and paclitaxel with long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer. The percentage of patients that received a grade 3 or higher hematologic event will be reported here. We will be combining arm I with arm III, as well as arm II with arm IV. For a complete list of adverse events, please refer to the adverse events section. (NCT00041119)
Timeframe: from baseline up to 6 weeks post-treatment
| Intervention | percentage of patients (Number) |
|---|
| 6 Cycles | 38 |
| 4 Cycles | 29 |
Relapse Free Survival (RFS) 4 vs. 6 Cycles
To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together. (NCT00041119)
Timeframe: from baseline up to 4 years
| Intervention | years (Median) |
|---|
| 4 Cycles (Arm I and Arm III Combined) | NA |
| 6 Cycles (Arm II and Arm IV Combined) | NA |
Local Control
Local control will be calculated as the cumulative incidence of first local relapse. (NCT00041119)
Timeframe: from baseline up to 15 years
| Intervention | years (Median) |
|---|
| Cyclophosphamide and Doxorubicin Hydrochloride | NA |
| Paclitaxel | NA |
Overall Survival (OS) for 4 vs. 6 Cycles
To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for overall survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together. (NCT00041119)
Timeframe: from baseline up to 4 years
| Intervention | percentage of patients at 4 years (Number) |
|---|
| 6 Cycles | 90.9 |
| 4 Cycles | 91.8 |
Overall Survival (OS)
To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for overall survival. OS will be measured from study entry until death due to any cause. Survivors will be censored at the date of last follow-up.. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis. (NCT00041119)
Timeframe: from baseline up to 5 years
| Intervention | percentage of participants at 5 years (Number) |
|---|
| Cyclophosphamide and Doxorubicin Hydrochloride | 95 |
| Paclitaxel | 94 |
Response
Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of nodes; no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. CRU is complete disappearance of all measurable and non-measurable disease; regressed, non-palpable organs; and one or more exceptions not qualifying for CR (see protocol section 10). PR applies to patients with at least one measurable lesion who do not qualify for CR or CRU. PR is a 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD. (NCT00041132)
Timeframe: assessed after cycle 4 and after completion of treatment (168 days)
| Intervention | participants (Number) |
|---|
| Hyper-CVAD + MTX/Ara-C + Rituximab | 42 |
Overall Survival
Overall Survival rate at 1 year. Time to death is from date of registration to date of death due to any cause. (NCT00041132)
Timeframe: assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years
| Intervention | percentage of participants (Number) |
|---|
| Hyper-CVAD + MTX/Ara-C + Rituximab | 92 |
Progression-free Survival
Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression. (NCT00041132)
Timeframe: assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration
| Intervention | percentage of participants (Number) |
|---|
| Hyper-CVAD + MTX/Ara-C + Rituximab | 90 |
Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria. (NCT00043979)
Timeframe: up to 6 cycles or 168 days
| Intervention | Participants (Count of Participants) |
|---|
| Chest wall; G2 skin | Abdomen; G4 GI | Pancreas; G4 LFTs, G4 pancreatitis | Pleura, mediastinum; G4 LFTs, G2 mucositis | Chest wall; G4 skin, G3 mucositis | Spine, skull; G2 nausea+vomiting, G2 fatigue | Pelvis; G4 enteritis | Pulmonary (cyberknife) | Brain; B3 mucositis | Whole lung; G3 mucositis, G3 skin, G5 lung | L arm, R shoulder, B/L femur |
|---|
| Arm 2-Recipients | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is >75% reduction in disease) was also employed. (NCT00043979)
Timeframe: up to 10 cycles of therapy or 280 days
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Progressive Disease (PD) | Partial Response (PR) | Very Good Partial Response (VGPR) |
|---|
| Arm 2-Recipients | 2 | 4 | 4 | 2 |
Toxicity
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00043979)
Timeframe: 16.5 months
| Intervention | Participants (Number) |
|---|
| Arm 2-Recipients | 30 |
Early Post Transplantation Relapse
Participants who experienced recurrence or progression of disease following transplant. (NCT00043979)
Timeframe: up to 300 days
| Intervention | Days (Median) |
|---|
| Arm 2-Recipients | 100 |
Number of Participants With Engraftment
Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients. (NCT00043979)
Timeframe: 100 days
| Intervention | Participants (Number) |
|---|
| Arm 2-Recipients | 23 |
Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant
Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant. (NCT00043979)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| From date of enrollment | From date of transplantation |
|---|
| Arm 2-Recipients | 39.1 | 34.8 |
Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)
GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy. (NCT00043979)
Timeframe: up to day 100
| Intervention | Participants (Count of Participants) |
|---|
| Arm 2-Recipients | 0 |
Number of Participants to Complete Conversion to >95% Donor Chimerism
Participants who tolerated the transplantation regimen and accepted >95% of the donors blood, marrow, and/or tissue. (NCT00043979)
Timeframe: up to 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Day +14 | Day +28 |
|---|
| Arm 2-Recipients | 23 | 23 |
Number of Participants With Acute and Chronic GVHD
Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100. (NCT00043979)
Timeframe: up to 5 years or death
| Intervention | participants (Number) |
|---|
| acute GVHD | chronic GVHD |
|---|
| Recipients -Cyclosporine GVHD Prophylaxis | 12 | 12 |
,| Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis | 5 | 5 |
Cluster of Differentiation 4 (CD4) Reconstitution
The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing. (NCT00043979)
Timeframe: Day +28-42
| Intervention | mm(3) (Median) |
|---|
| Arm 2-Recipients | 284 |
Number of Participants With Graft Failure
Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells. (NCT00048737)
Timeframe: 100 days
| Intervention | participants (Number) |
|---|
| 90Y Zevalin in ASCT | 1 |
Number of Participants With Adverse Events
Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00048893)
Timeframe: 91 months
| Intervention | Participants (Number) |
|---|
| Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 11 |
Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment
Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma (NCT00049036)
Timeframe: 60 days
| Intervention | proportion (Number) |
|---|
| EPOCH + Concurrent Rituximab | 0.69 |
| EPOCH Followed by Rituximab | 0.53 |
Donor Engraftment (Chimerism)
Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population (NCT00049504)
Timeframe: At day +84 after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Nonmyeloablative HSCT) | 34 |
Incidence of Grades III-IV Acute GVHD
Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity (NCT00049504)
Timeframe: At any time within 200 days after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Nonmyeloablative HSCT) | 4 |
Overall Survival (Consolidation Phase)
Overall survival is defined as the time from randomization in the consolidation phase to death. (NCT00049517)
Timeframe: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.
| Intervention | Months (Median) |
|---|
| Autologous HCT | 35.5 |
| Go/Autologous HCT | 27.9 |
Overall Survival (Induction Phase)
Overall survival is defined as the time from randomization in the induction phase to death. (NCT00049517)
Timeframe: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.
| Intervention | months (Median) |
|---|
| Standard Daunorubicin | 15.7 |
| High-dose Daunorubicin | 23.7 |
Disease-free Survival (Consolidation Phase)
Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease. (NCT00049517)
Timeframe: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.
| Intervention | Months (Median) |
|---|
| Autologous HCT | 15.0 |
| Go/Autologous HCT | 13.6 |
Number of Recipients Evaluable Who Achieved Full Donor Chimerism at Day+100
Recipients who achieved engraftment with donor chimerism. Engraftment is defined as a target peripheral blood cluster of differentiation 4 (CD4) count of 100 cells/ul after induction therapy. (NCT00051311)
Timeframe: Day+100
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 29 |
Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST)
Complete remission (CR) is complete disappearance of all detectable signs and symptoms of lymphoma for a period of at least one month. Complete remission unconfirmed (CRu) is a residual lymph node mass > 1.5 cm in greatest transverse diameter will be considered CRu if it has regressed by more than 75% in the SPD, does not change over at least one month, is negative by PET or gallium, and is negative on any biopsies obtained (biopsy not required). Progressive disease (PD) is a 25% or greater increase in SPD of all measured lesions compared to the smallest previous measurements, or appearance of any new lesion(s). (NCT00051311)
Timeframe: At least 100 days after post reduced-intensity stem cell transplantation (RIST).
| Intervention | Participants (Count of Participants) |
|---|
| Complete Remission or Complete Remission Unconfirmed | Progressive Disease |
|---|
| Recipient | 15 | 16 |
Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis
Here is the number of recipients who developed grades I-IV acute graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV acute GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV acute GVHD can occur in the skin, liver, and/or gut. Grade 1: rash < 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea >1500 ml/d. Grade 4: desquamation and bullae, total bilirubin >15 mg/dl, and pain +/- ileus. (NCT00051311)
Timeframe: At least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)
| Intervention | Participants (Count of Participants) |
|---|
| Grade I GVHD | Grade II GVHD | Grade III GVHD | Grade IV GVHD |
|---|
| Recipient | 1 | 7 | 6 | 0 |
Percentage of Recipients Who Achieved Donor Chimerism at Day +14
Recipients who achieved engraftment with donor chimerism. Engraftment is defined as a target peripheral blood cluster of differentiation 4 (CD4) count of 100 cells/ul after induction therapy. (NCT00051311)
Timeframe: Day+14
| Intervention | percentage of recipients (Number) |
|---|
| Recipient | 90 |
Number of Recipients With Non-serious Adverse Events
Here is the number of recipients with non-serious adverse events assessed by the Common Toxicity Criteria version 2.0. A non-serious adverse event is any untoward medical occurrence. (NCT00051311)
Timeframe: Date treatment consent signed to date off study, approximately 58 months and 13 days.
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 31 |
Number of Recipients Who Developed Chronic Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis
Here is the number of recipients who developed chronic graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV chronic GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV chronic GVHD can occur in the skin, liver, and/or gut. Grade 1: rash < 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea >1500 ml/d. Grade 4: desquamation and bullae, total bilirubin >15 mg/dl, and pain +/- ileus. (NCT00051311)
Timeframe: At least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 23 |
OS
Overall survival with events defined as death due to any cause and censored patients are alive as of 1 year post HSC infusion (NCT00053989)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| All Patients | 44 |
PFS
Progression free survival defined as time from HSC infusion (day 0) until progression of disease or death due to any cause. Patients are censored if alive without disease progression through 1 year after HSC infusion (NCT00053989)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| All Patients | 27 |
Acute GvHD
overall grade II-IV acute GvHD (NCT00053989)
Timeframe: Day +100
| Intervention | Participants (Count of Participants) |
|---|
| All Patients | 16 |
Day 100 TRM
treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0 (NCT00053989)
Timeframe: from start or conditioning (day -6 or -5) through day +100 after HSC infusion
| Intervention | Participants (Count of Participants) |
|---|
| All Patients | 4 |
Number of Patients With Overall Survival at 2 Years.
(NCT00054327)
Timeframe: at 2 years from transplant
| Intervention | participants (Number) |
|---|
| Regimen A | 5 |
| Regimen B-1 | 2 |
| Regimen B-2 | 2 |
| Regimen B-3 | 1 |
| Regimen C | 5 |
| Regimen D | 1 |
Rates of Durable Engraftment
Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support. (NCT00054327)
Timeframe: at day 42
| Intervention | days (Mean) |
|---|
| Regimen A | 17.9 |
| Regimen B-1 | 15.75 |
| Regimen B-2 | 13 |
| Regimen B-3 | 18.25 |
| Regimen C | 13.9 |
| Regimen D | 10.5 |
Toxicity as Measured by CTC v2.0
Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities. (NCT00054327)
Timeframe: at 100 days post transplant
| Intervention | participants (Number) |
|---|
| Regimen A | 0 |
| Regimen B-1 | 0 |
| Regimen B-2 | 1 |
| Regimen B-3 | 2 |
| Regimen C | 2 |
| Regimen D | 0 |
Incidence of Recurrent Disease
Number of patients that have disease recurrence. (NCT00054327)
Timeframe: at day 100 post transplant
| Intervention | participants (Number) |
|---|
| Regimen A | 4 |
| Regimen B-1 | 2 |
| Regimen B-2 | 0 |
| Regimen B-3 | 1 |
| Regimen C | 2 |
| Regimen D | 0 |
Graft-versus-host Disease (GVHD)
Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe. (NCT00054327)
Timeframe: at 100 days post transplant
| Intervention | participants (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|
| Regimen A | 0 | 2 | 6 | 2 | 0 |
,| Regimen B-1 | 1 | 1 | 2 | 0 | 0 |
,| Regimen B-2 | 1 | 0 | 1 | 0 | 1 |
,| Regimen B-3 | 1 | 0 | 0 | 3 | 0 |
,| Regimen C | 1 | 1 | 5 | 3 | 0 |
,| Regimen D | 0 | 0 | 0 | 0 | 2 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00054665)
Timeframe: 43 months
| Intervention | Participants (Number) |
|---|
| Part A: PS-341 Alone | 23 |
| Part B: PS-341 & EPOCH | 44 |
Clinical Response Rate
Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease (NCT00054665)
Timeframe: 18 weeks
| Intervention | Participants (Number) |
|---|
| Partial response | Complete response |
|---|
| Part A: PS-341 Alone | 1 | 0 |
,| Part B: PS-341 & EPOCH | 7 | 8 |
Minimal Residual Disease
The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided
| Intervention | percentage of samples analyzed (Number) |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 22 |
| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 70 |
Response Rate
Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years
| Intervention | percentage of participants analyzed (Number) |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 88 |
| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 83 |
Grade ≥ 3 Stomatitis
The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year
| Intervention | participants (Number) |
|---|
| Incidence of grade ≥ 3 stomatitis | No incidence of grade ≥ 3 stomatitis |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 4 | 41 |
,| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 6 | 34 |
Toxic Death
Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year
| Intervention | participants (Number) |
|---|
| Toxic death | No toxic death |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 0 | 45 |
,| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 2 | 38 |
Incidence of Adverse Experiences
Determine the incidence of adverse experiences, hematologic toxicity (WBC, hemoglobin, and platelet nadirs; and transfusion requirements), cardiac toxicity (incidence of left ventricular dysfunction and cardiomyopathy by echocardiography), and the development of human antimouse antibody/human anti-chimeric antibody in patients treated with this regimen. (NCT00058422)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| R-CHOP and Ibritumomab Tiuxetan (Zevalin) | 65 |
Objective Response to Treatment
Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks. (NCT00060346)
Timeframe: Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry
| Intervention | proportion of participants (Number) |
|---|
| Rituximab + CHOP | 0.938 |
Occurrence of Severe Toxicity
An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity. (NCT00061893)
Timeframe: The first two cycles (6 weeks) of protocol chemotherapy
| Intervention | participants (Number) |
|---|
| Grade 3 or Higher Infection | Grade 3 or Higher Sensory Neuropathy |
|---|
| Combination Chemotherapy | 1 | 1 |
Event Free Survival
(NCT00061893)
Timeframe: 24 months after start of protocol therapy
| Intervention | percentage of participants (Number) |
|---|
| Combination Chemotherapy | 35 |
Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)
The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV. (NCT00061945)
Timeframe: 8 months
| Intervention | participants (Number) |
|---|
| Phase II - Alemtuzumab and Combination Chemotherapy | 30 |
Overall Survival
Overall Survival is defines as the time from registration to death due to any cause. It is estimated using the Kaplan-Meier method with confidence intervals presented. (NCT00061945)
Timeframe: 9 years 4 months
| Intervention | months (Median) |
|---|
| Phase I - Alemtuzumab and Combination Chemotherapy | 33.6 |
| Phase II - Alemtuzumab and Combination Chemotherapy | 23.1 |
Disease-free Survival, for Only Complete Response Patients
Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented. (NCT00061945)
Timeframe: 9 years 4 months
| Intervention | months (Median) |
|---|
| Phase I - Alemtuzumab and Combination Chemotherapy | 58.6 |
| Phase II - Alemtuzumab and Combination Chemotherapy | 19.8 |
Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)
The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data. (NCT00061945)
Timeframe: 6 weeks
| Intervention | mg (Number) |
|---|
| Phase I - Alemtuzumab and Combination Chemotherapy | 30 |
Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)
Minimal Residual Disease measures the presence of of circulating leukemia cells in the body. Patients that report a Complete Response (CR) during treatment are further tested to determine the presence of small amounts of circulating leukemia cells. Here we report the number of patients who were MRD negative. (NCT00061945)
Timeframe: 9 years 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase II - Alemtuzumab and Combination Chemotherapy | 16 |
Number of Participants Achieving Complete Remission
A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) > 1500/μl, no circulating blasts, platelets > 100,000/μl; bone marrow cellularity > 20% with trilineage hematopoiesis, and < 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement). (NCT00061945)
Timeframe: 9 years
| Intervention | participants (Number) |
|---|
| Phase I - Alemtuzumab and Combination Chemotherapy | 92 |
| Phase II - Alemtuzumab and Combination Chemotherapy | 145 |
Overall Survival
Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration. (NCT00064337)
Timeframe: 5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years
| Intervention | Months (Median) |
|---|
| Treatment | 68 |
Hematologic Response
(NCT00064337)
Timeframe: Until off study
| Intervention | Participants (Count of Participants) |
|---|
| Treatment | 8 |
Event-free Survival
Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method. (NCT00066469)
Timeframe: 2 years
| Intervention | percentage of participants analyzed (Number) |
|---|
| Cyclophosphamide, Prednisone, Rituximab | 71 |
Number of Participants Severity of Acute GVHD by Treatment Arm
The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. The stages of individual organ involvement is assessed using Glucksberg grade (I-IV) where Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT00067002)
Timeframe: Following first 100 days, up to one year
| Intervention | Participants (Count of Participants) |
|---|
| Grade ≤ 2 | Grade ≥ 3 | No GVHD |
|---|
| Expanded CB Arm | 15 | 2 | 27 |
,| Un-Manipulated CB Arm | 20 | 6 | 19 |
Rate of Acute Graft Versus Host Disease (GVHD)
Number of participants who display features of acute GVHD within 100 days of transplant. (NCT00067002)
Timeframe: Review over first 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Un-Manipulated CB Arm | 29 |
| Expanded CB Arm | 24 |
Rate of Chronic GVHD
Number of participants who present GVHD post-transplant and display features of chronic GVHD. Diagnostic and distinctive features of chronic GVHD are present. There are no features of acute GVHD. (NCT00067002)
Timeframe: Up to one year
| Intervention | Participants (Count of Participants) |
|---|
| Overall Chronic GVHD | Limited | Extensive |
|---|
| Expanded CB Arm | 20 | 14 | 13 |
,| Un-Manipulated CB Arm | 16 | 10 | 9 |
Number of Participants With Engraftment
Engraftment defined as a sustained absolute neutrophil count (ANC) > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC <500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination. (NCT00067002)
Timeframe: First 100 days, evaluation and blood tests twice weekly
| Intervention | Participants (Count of Participants) |
|---|
| Un-Manipulated CB Arm | 45 |
| Expanded CB Arm | 44 |
Time To Neutrophil Engraftment
Engraftment is defined as a sustained ANC > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment date is the first of the 3 days with sustained absolute neutrophil count (ANC) >/= 0.5 x 10^9/L. (NCT00067002)
Timeframe: First 100 days, evaluation and blood tests twice weekly
| Intervention | Days (Median) |
|---|
| Un-Manipulated CB Arm | 17 |
| Expanded CB Arm | 15 |
Rate of Ovarian Dysfunction at 2 Years
Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range. (NCT00068601)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Standard Chemotherapy | 22 |
| Chemotherapy Plus Goserelin | 9 |
Rate of Ovarian Dysfunction at 1 Year
Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range. (NCT00068601)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Standard Chemotherapy | 28 |
| Chemotherapy Plus Goserelin | 18 |
Rate of Premature Ovarian Failure at 2 Years
Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range. (NCT00068601)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Standard Chemotherapy | 15 |
| Chemotherapy Plus Goserelin | 5 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00069238)
Timeframe: 67 months and 9 days
| Intervention | Participants (Count of Participants) |
|---|
| All Participants | 31 |
Maximum Tolerated Dose (MTD) of Alemtuzumab
MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT). (NCT00069238)
Timeframe: up to 2 cycles of therapy, approximately 42 days
| Intervention | mg (Number) |
|---|
| All Participants | 30 |
Progression-free Survival
Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. (NCT00070018)
Timeframe: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter
| Intervention | percentage of participants (Number) |
|---|
| CHOP + RT + Zevalin | 89 |
Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5. (NCT00070564)
Timeframe: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 91 |
| Arm II | 92 |
| Arm III | 91 |
| Arm IV | 90 |
Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5. (NCT00070564)
Timeframe: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 85 |
| Arm II | 76 |
| Arm III | 78 |
| Arm IV | 82 |
Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5. (NCT00070564)
Timeframe: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 94 |
| Arm II | 89 |
| Arm III | 89 |
| Arm IV | 88 |
Overall Survival
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5. (NCT00070564)
Timeframe: Every 6 months for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 90 |
| Arm II | 87 |
| Arm III | 87 |
| Arm IV | 87 |
| Arm V | 90 |
| Arm VI | 91 |
Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5. (NCT00070564)
Timeframe: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 85 |
| Arm II | 83 |
| Arm III | 82 |
| Arm IV | 80 |
Disease-free Survival
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5. (NCT00070564)
Timeframe: every 6 months (annually for mammograms) for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 83 |
| Arm II | 79 |
| Arm III | 81 |
| Arm IV | 81 |
| Arm V | 84 |
| Arm VI | 85 |
Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5. (NCT00070564)
Timeframe: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 83 |
| Arm II | 71 |
| Arm III | 72 |
| Arm IV | 75 |
Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5. (NCT00070564)
Timeframe: Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 82 |
| Arm II | 82 |
| Arm III | 86 |
| Arm IV | 85 |
"Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm"
Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section). (NCT00072280)
Timeframe: Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)
| Intervention | participants (Number) |
|---|
| Failed | Failure-free through 5 years of follow-up | Failure-free at cutoff (if < 5 years follow-up) | Withdrew from study | Lost to follow-up |
|---|
| Chemotherapy Plus Possible Surgery | 1 | 0 | 1 | 0 | 0 |
Response Rate Based on the RECIST
Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks. (NCT00072566)
Timeframe: Up to 3 years
| Intervention | percentage of responding patients (Number) |
|---|
| Treatment (Bevacizumab, Cyclophosphamide) | 24 |
Response Rate
Response rates will be estimated as the percentage of patients (NCT00073918)
Timeframe: From date of transplant through date of relapse/progression or death, assessed up to 15 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy) | 41.4 |
Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0
Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25% (NCT00073918)
Timeframe: From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years
| Intervention | events (Number) |
|---|
| Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy) | 9 |
5 Year Overall Survival
Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis. (NCT00073918)
Timeframe: Up to 15 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy) | 72 |
Progression-free Survival
Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy. (NCT00073918)
Timeframe: At year 3
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy) | 56 |
Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions. (NCT00074165)
Timeframe: 2 years
| Intervention | Participants (Number) |
|---|
| Rituximab and Carboplatin | 1 |
Number of Patients Who After PCR (or During PCR for PD), Only Achieve a PR, SD, or PD and Who Subsequently Convert to a Higher Response Category After Campath-1H
(NCT00074282)
Timeframe: From re-registration up to 5 years (followed for response until progression)
| Intervention | Participants (Count of Participants) |
|---|
Arm C (Alemtuzumab: PR, | 4 | |
Overall Survival (OS)
OS is defined as the time from registration until death from any cause. (NCT00074282)
Timeframe: Up to 5 years from registration
| Intervention | months (Median) |
|---|
| Arm A (PCR) | 27.6 |
Progression-free Survival (PFS)
PFS is defined as the time from registration until induction failure, institution of non-protocol therapy, relapse or death from any cause in the absence of relapse. (NCT00074282)
Timeframe: Up to 5 years from registration
| Intervention | months (Median) |
|---|
| Arm A (PCR) | 12.2 |
Response Rate
Percent with response (CR, nPR, PR) with two-stage 90% confidence interval (NCT00074282)
Timeframe: 8 weeks after Cycle 6
| Intervention | percentage (Number) |
|---|
| Arm A (PCR) | 55.2 |
Molecular Complete Remission (MCR) Rate
Percent of patients who have MCR (clinical CR with flow negative and RT-PCR negative) (NCT00074282)
Timeframe: 3 months post alemtuzumab
| Intervention | percentage (Number) |
|---|
| Arm B (Alemtuzumab: CR, nPR) | 44.4 |
Percentage of Patients With Opportunistic Infection
Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease. (NCT00074490)
Timeframe: First 100 days post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Arm IVD Cohort 1 (Th2 DLI) | 0 |
| Arm IVD Cohort 3 (Multiple Th2 DLI) | 11.11 |
| Arm IVA (12-day Expanded Th2 DLI) | 7.50 |
| Arm IVB (6-day Expanded Th2 DLI) | 9.09 |
| Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 11.90 |
Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)
GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1. (NCT00074490)
Timeframe: first 100 days post-transplant
| Intervention | percentage of patients (Number) |
|---|
| Arm IVD Cohort 1 (Th2 DLI) | 0 |
| Arm IVD Cohort 3 (Multiple Th2 DLI) | 11.11 |
| Arm IVA (12-day Expanded Th2 DLI) | 10 |
| Arm IVB (6-day Expanded Th2 DLI) | 40.91 |
| Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 40.48 |
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00074490)
Timeframe: Date treatment consent signed to date off study, approximately 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm IVD Cohort 1 (Th2 DLI) | 1 |
| Arm IVD Cohort 3 (Multiple Th2 DLI) | 27 |
| Arm IVA (12-day Expanded Th2 DLI) | 40 |
| Arm IVB (6-day Expanded Th2 DLI) | 44 |
| Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 42 |
Percentage of Patients to Receive T Cell Infusion
T cells administered by intravenous infusion after patient received transplant. (NCT00074490)
Timeframe: first 100 days post-transplant
| Intervention | percentage of patients (Number) |
|---|
| Arm IVD Cohort 1 (Th2 DLI) | 100 |
| Arm IVD Cohort 3 (Multiple Th2 DLI) | 100 |
| Arm IVA (12-day Expanded Th2 DLI) | 100 |
| Arm IVB (6-day Expanded Th2 DLI) | 100 |
| Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 100 |
Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first. (NCT00075582)
Timeframe: From enrollment up to 5 years
| Intervention | Estimated percentage of participants (Number) |
|---|
| Regimen I (Chemotherapy, Radiotherapy) | 90 |
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first. (NCT00075582)
Timeframe: From enrollment up to 5 years
| Intervention | Estimated percentage of participants (Number) |
|---|
| Regimen II (Chemotherapy, Radiotherapy, Surgery) | 67 |
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first. (NCT00075582)
Timeframe: From enrollment up to 5 years
| Intervention | Estimated percentage of participants (Number) |
|---|
| Regimen I (Chemotherapy, Radiotherapy) | 87 |
| Regimen II (Chemotherapy, Radiotherapy, Surgery) | 67 |
Percentage of Patients With Delayed Surgical Procedures
The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated. (NCT00075582)
Timeframe: At 13 weeks after induction
| Intervention | percentage of participants (Number) |
|---|
| Regimen II (Stage I Group III Nonorbit or Stage III Group I/II | 0.49 |
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
The local failure rate will be estimated using cumulative incidence curves. (NCT00075582)
Timeframe: From enrollment up to 5 years
| Intervention | stimated percentage of participants (Number) |
|---|
| Regimen I (Chemotherapy, Radiotherapy) | 0.081 |
| Regimen II (Chemotherapy, Radiotherapy, Surgery) | 0.115 |
Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose
The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection. (NCT00075582)
Timeframe: From enrollment up to 20 weeks
| Intervention | Estimated percentage of participants (Number) |
|---|
| Regimen II (Stage I Group III Nonorbit or Stage III Group I/II | 0 |
Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
Event Free Probability. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 83.2 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 81.6 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 69.1 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 91.2 |
| Prednisone, Capizzi Methotrexate <10 Years | 82.1 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 73.5 |
| Predisone and High Dose Methotrexate < 10 Yrs Old | 80.8 |
| Prenisone and High Dose Methotrexate >=10 Years | 75.8 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 77.0 |
| Prenisone, Capezzi Methotrexate (Down's Syndrome) | 61.8 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 44.4 |
Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 Years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 79.2 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 69.9 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 65.6 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 86.2 |
| Prednisone, Capizzi Methotrexate <10 Years | 93.8 |
| Prednisone, Capizzi Methotrexate >= 10 Years | 63.1 |
| Predisone and High Dose Methotrexate < 10 Yrs Old | 84.2 |
| Prednisone and High Dose Methotrexate >=10 Years | 73.6 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 74.6 |
Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 95.4 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 92.9 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 87.4 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 98.1 |
| Prednisone, Capizzi Methotrexate <10 Years | 93.3 |
| Prednisone, Capizzi Methotrexate >= 10 Years | 90.2 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 94.5 |
| Prednisone and High Dose Methotrexate >=10 Years | 90.5 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 91.6 |
| Prednisone, Capizzi Methotrexate (Down's Syndrome) | 78.3 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 25.0 |
Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 66.5 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 43.3 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 35.4 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 80 |
| Prednisone, Capizzi Methotrexate <10 Years | 34.7 |
| Prednisone, Capizzi Methotrexate >= 10 Years | 39 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 55 |
| Prednisone and High Dose Methotrexate >=10 Years | 47.8 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 49.4 |
Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 86.4 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 93.6 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 80.5 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 93.1 |
| Prednisone, Capizzi Methotrexate <10 Years | 86.5 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 83.4 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 84.2 |
| Prednisone and High Dose Methotrexate >=10 Years | 83.9 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 85.3 |
| Prednisone, Capezzi Methotrexate (Down's Syndrome) | 74.4 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 25 |
Correlation of Early Marrow Response Status With MRD Negative.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29
| Intervention | participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 182 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 72 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 198 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 188 |
| Prednisone, Capizzi Methotrexate <10 Years | 195 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 471 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 190 |
| Prednisone and High Dose Methotrexate >=10 Years | 479 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 208 |
| Prednisone, Capezzi Methotrexate (Down's Syndrome) | 25 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 3 |
| Prednisone and High Dose Methotrexate (Non Randomly Assigned) | 18 |
Correlation of Early Marrow Response Status With MRD Positive.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29
| Intervention | participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 26 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 12 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 43 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 14 |
| Prednisone, Capizzi Methotrexate <10 Years | 16 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 95 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 17 |
| Prednisone and High Dose Methotrexate >=10 Years | 98 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 39 |
| Prednisone, Capezzi Methotrexate (Down's Syndrome) | 3 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 3 |
| Prednisone and High Dose Methotrexate (Non Randomly Assigned) | 3 |
Relapse-free Complete Clinical Response
Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later. (NCT00076752)
Timeframe: 60 months
| Intervention | Months (Median) |
|---|
| Autologous HSCT in SLE | 54 |
Absolute Lymphocyte Count
The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | K/uL (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years |
|---|
| Autologous HSCT in SLE | 0.54 | 0.0065 | 0.42 | 0.53 | 0.82 | 1.75 | 1.8 | 1.8 | 1.75 |
Absolute Neutrophil Count
The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | K/uL (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years |
|---|
| Autologous HSCT in SLE | 5.66 | 0.45 | 9.11 | 2.72 | 2.78 | 3.44 | 2.72 | 4.04 | 3.77 |
Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | IU (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years |
|---|
| Autologous HSCT in SLE | 17.3 | 8.8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Anti-Nuclear Antibody
Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | EU (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years 9 |
|---|
| Autologous HSCT in SLE | 5.4 | 4.7 | 3.7 | 3.2 | 2.7 | 2.6 | 2.8 | 2.5 | 2.5 |
Anti-Smith-Ribonuclear Protein Antibody
Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years.
| Intervention | EU (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years |
|---|
| Autologous HSCT in SLE | 49 | 51.6 | 31.5 | 29.8 | 28.5 | 20 | 16.67 | 25.67 |
Cluster of Differentiation 19 (CD19) + Cells
The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.
| Intervention | cells/mL^3 (Mean) |
|---|
| Day 0 | 1 month | 3 months | 6 months | 1 year | 3 years |
|---|
| Autologous HSCT in SLE | 0.01 | 0.23 | 6.7 | 45.32 | 142.69 | 246.83 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00076752)
Timeframe: 18 months
| Intervention | participants (Number) |
|---|
| Autologous HSCT in SLE | 8 |
Cluster of Differentiation 4 (CD4) + Cells
The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.
| Intervention | cells/mL^3 (Mean) |
|---|
| Day 0 | 1 month | 3 months | 6 months | 1 year | 2 years |
|---|
| Autologous HSCT in SLE | 2.58 | 103.37 | 112.8 | 316.25 | 702.87 | 958.03 |
Cluster of Differentiation 8 (CD8) + Cells
The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.
| Intervention | cells/mL^3 (Mean) |
|---|
| Day 0 | 1 month | 3 months | 6 months | 1 year | 2 years |
|---|
| Autologous HSCT in SLE | 0.34 | 138.68 | 318.47 | 334.91 | 736.67 | 674.69 |
Extractable Nuclear Antigen (ENA)
Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | EU (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years |
|---|
| Autologous HSCT in SLE | 66.9 | 64.8 | 61.5 | 58.5 | 51.3 | 57.2 | 60.6 | 50.6 | 26.3 |
Platelet Count
The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | K/uL (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years |
|---|
| Autologous HSCT in SLE | 251 | 113 | 166 | 187 | 170 | 226 | 210 | 308 | 272 |
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score <3 and prednisone <10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome. (NCT00076752)
Timeframe: Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | scores on a scale. (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years |
|---|
| Autologous HSCT in SLE | 4.25 | 4.13 | 3.63 | 1.6 | 0 | 0 | 0 | 0 | 0 |
Cluster of Differentiation 3 (CD3) + Cells
The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.
| Intervention | cells/mL^3 (Mean) |
|---|
| Day 0 | 1 month | 3 months | 6 months | 1 year | 2 years |
|---|
| Autologous HSCT in SLE | 2.99 | 239.47 | 435.97 | 699.47 | 1493.29 | 1678.76 |
Natural Killer Cells
The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.
| Intervention | cells/mL^3 (Mean) |
|---|
| Day 0 | 1 month | 3 months | 6 months | 1 year | 3 years |
|---|
| Autologous HSCT in SLE | 0.03 | 117.06 | 116.57 | 123.18 | 158.9 | 115.18 |
White Blood Cells
The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.
| Intervention | K/uL (Mean) |
|---|
| Day -7 | Day 0 | 1 month | 3 months | 6 months | 1 year | 18 months | 2 years | 3 years |
|---|
| Autologous HSCT in SLE | 6.89 | 0.47 | 10.32 | 3.84 | 4.21 | 5.81 | 5.24 | 7.17 | 6.34 |
Overall Survival
Overall Survival at six years after initiating protocol therapy (NCT00083551)
Timeframe: 6 Years
| Intervention | percentage of participants (Number) |
|---|
| Thalidomide | 65 |
| No Thalidomide | 58 |
Grade 3-4 Muscloskeletal Events
All Grade 3-4 Muscloskeletal events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 8 |
Grade 3-4 Neurology Events
All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 45 |
Grade 3-4 Infection/Febrile Neutropenia Events
All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 49 |
Grade 3-4 Pulmonary Events
All Grade 3-4 Pulmonary events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 4 |
Grade 3-4 Renal/Genitourinary Events
All Grade 3-4 Renal/Genitourinary events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 4 |
Grade 3/4 Events
All Grade 3-4 events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 1021 |
2-yr Overall Survival
Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up. (NCT00084838)
Timeframe: Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.
| Intervention | probability (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Modified IRS | 0.70 |
Pre-Radiation Therapy Chemotherapeutic Response
"Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR.~Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): >/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): <50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): >/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples." (NCT00084838)
Timeframe: Assessed at study entry and pre-RT/post-CT at week 7.
| Intervention | proportion of evaluable patients (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Modified IRS | 0.58 |
Grade 3-4 Allergy/Immunology
All Grade 3-4 Allergy/Immunology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 1 |
Grade 3-4 Auditory/Hearing Events
All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 8 |
Grade 3-4 Blood/Bone Marrow Events
"All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms.~Arm Name" (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 564 |
Grade 3-4 Cardiovascular Events
All Grade 3-4 Cardiovascular events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 6 |
Grade 3-4 Constitutional Events
All Grade 3-4 Constitutional events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 22 |
Grade 3-4 Dermatology Events
All Grade 3-4 Dermatology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 3 |
Grade 3-4 Gastrointestinal Events
All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 139 |
Grade 3-4 Hemorrhage Events
All Grade 3-4 Hemorrhage events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 1 |
Grade 3-4 Hepatic Events
All Grade 3-4 Hepatic events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 8 |
Grade 3-4 Pain Events
All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 31 |
Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. The list of toxicities of interest include Anemia or Febrile Neutropenia; Nausea or Vomiting; Infections and Infestations; Neutrophil or White blood count decrease; and Hypokalemia or Hyponatremia (NCT00085098)
Timeframe: From the beginning of treatment, assessed up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Anemia or Febrile Neutropenia | Nausea or Vomiting | Infections and Infestations | Neutorphil or White blood count decrease | Hypokalemia or Hyponatremia |
|---|
| Regimen B (Chemotherapy Plus Radiotherapy) | 2 | 2 | 2 | 7 | 3 |
Quality of Life (QOL) and Neurocognitive Assessment (NP)
The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. The scores range from 0 to 100 with higher score reflecting better QoL or neurocognitive assessment. (NCT00085098)
Timeframe: 2 years from beginning of treatment
| Intervention | Scores on a scale (Mean) |
|---|
| Overall IQ Score | Self Report Score-Internalizing Problems | Self Report Score-Emotional Problems | Self Report Score-Personal Adjustment Strengths | Parent Report QoL Total Score | Self Report QoL Total Score |
|---|
| Regimen A (Radiotherapy Only) | 98.60 | 41.00 | 44.00 | 51.50 | 88.04 | 95.65 |
,| Regimen B (Chemotherapy Plus Radiotherapy) | 92.43 | 42.50 | 42.00 | 60.50 | 79.35 | 90.76 |
Event-free Survival
"Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up.~QEs: 1)disease progression, defined as increase >= 40% in tumor volume or >= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause.~Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol's primary objective.~NOTE: Reported data are through May 2009 (see Caveats section)." (NCT00085098)
Timeframe: Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years
| Intervention | participants (Number) |
|---|
| Experienced a qualifying event | Event-free through 3 years of follow-up | Event-free at data cutoff (if < 3 years follow-up) | Withdrew from study prior to 3 years of follow-up | Lost to follow-up prior to 3 years of follow-up |
|---|
| Regimen A (Radiotherapy Only) | 1 | 0 | 9 | 0 | 0 |
,| Regimen B (Chemotherapy Plus Radiotherapy) | 1 | 0 | 11 | 0 | 0 |
Number of Participants With a Response to Regimen B
To assess the complete response rate to pre-radiotherapy chemotherapy (Reg B only). Response was determined after completing 2-4 cycles of chemotherapy on Reg B. Complete Response (CR) is defined as disappearance of all target lesions. (NCT00085098)
Timeframe: 5 years from beginning of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Regimen B (Chemotherapy Plus Radiotherapy) | 8 |
Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors
The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups. (NCT00085202)
Timeframe: 2 years after tumor cell analysis in 122 participants
| Intervention | probability of PFS at 2 years (Number) |
|---|
| Positive ERBB2 | Negative ERBB2 |
|---|
| Average-Risk Group | 83.3 | 93.5 |
,| High-Risk Group | 69.6 | 71.4 |
,| Overall Study | 79.2 | 86.7 |
Frequency of Mutations Associated With SHH and WNT Tumors
The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided. (NCT00085202)
Timeframe: within 3.5 years following completion of accrual
| Intervention | Participants (Count of Participants) |
|---|
| PTCH1 | DDX3X | TP53 | KMT2D | SUFU | CREBBP | GLI2 | TCF4 | PTEN | KMT2C | FBXW7 | GSE1 | CTNNB1 | SMARCA4 | PIK3CA | APC | EPHA7 | ARID1A | ARID2 | ATM | BRCA2 |
|---|
| SHH Pathway - In/Del Germline | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,| SHH Pathway - In/Del Somatic | 7 | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| SHH Pathway - SNV Germline | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| SHH Pathway - SNV Somatic | 4 | 3 | 5 | 0 | 0 | 0 | 0 | 1 | 3 | 2 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 0 |
,| WNT Pathway - In/Del Germline | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| WNT Pathway - In/Del Somatic | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
,| WNT Pathway - SNV Germline | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,| WNT Pathway - SNV Somatic | 0 | 7 | 3 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 4 | 0 | 18 | 4 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.
122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups. (NCT00085202)
Timeframe: 2 years after tumor cell analysis in 122 participants
| Intervention | probability of PFS at 2 years (Number) |
|---|
| ERBB2 Positive & Average Risk | 83.3 |
| ERBB2 Positive & High Risk | 69.6 |
| ERBB2 Negative & Average Risk | 93.5 |
| ERBB2 Negative & High Risk | 71.4 |
Processing Speed for Two Risk Group at Enrollment
Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better. (NCT00085202)
Timeframe: At enrollment
| Intervention | score on a scale (Mean) |
|---|
| Average Risk Group | 83.98 |
| High Risk Group | 87.29 |
Perceptual Speed for Two Risk Group at Enrollment
Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better. (NCT00085202)
Timeframe: At enrollment
| Intervention | score on a scale (Mean) |
|---|
| Average Risk Group | 82.06 |
| High Risk Group | 90.04 |
Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa
To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation. (NCT00085202)
Timeframe: Annually for 6 years post irradiation
| Intervention | Participants (Count of Participants) |
|---|
| Average-Risk Group | 6 |
Associative Memory for Two Risk Group at Enrollment
Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better. (NCT00085202)
Timeframe: At enrollment
| Intervention | score on a scale (Mean) |
|---|
| Average Risk Group | 93.61 |
| High Risk Group | 98.04 |
Associative Memory for Two Risk Group at 5 Years After Enrollment
Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better. (NCT00085202)
Timeframe: At 5 years after enrollment
| Intervention | score on a scale (Mean) |
|---|
| Average Risk Group | 98.73 |
| High Risk Group | 93.58 |
Perceptual Speed for Two Risk Group at 5 Years After Enrollment
Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better. (NCT00085202)
Timeframe: At 5 years after enrollment
| Intervention | score on a scale (Mean) |
|---|
| Average Risk Group | 78.68 |
| High Risk Group | 72.29 |
Reading Decoding Composite Scores in the Intervention and Standard of Care Groups
SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, & Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014). (NCT00085202)
Timeframe: 5 years postdiagnosis
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Change over time |
|---|
| Intervention | 104.1 | -1.51 |
,| Standard of Care | 102.4 | -1.17 |
Processing Speed for Two Risk Group at 5 Years After Enrollment
Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better. (NCT00085202)
Timeframe: At 5 years after enrollment
| Intervention | score on a scale (Mean) |
|---|
| Average Risk Group | 84.21 |
| High Risk Group | 75.71 |
Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST
Objective response as measured by radiological and physical examination using RECIST criteria. (NCT00085423)
Timeframe: Response at 12 weeks
| Intervention | participants (Number) |
|---|
| Group 1 | 3 |
Time to Progression as Measured by RECIST
Clinical outcome used the National Cancer Institute's Response Evaluation Criteria in Solid Tumors (RECIST)1.0. (NCT00085423)
Timeframe: From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months
| Intervention | years (Mean) |
|---|
| Group 1 | .3 |
Number of Participants With Lymphocyte Recovery as Measured by Blood Count
Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame. (NCT00085423)
Timeframe: on days 1-15, weekly for 2 weeks, and then every 2-3 months
| Intervention | participants (Number) |
|---|
| Group 1 | 18 |
Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays
PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. (NCT00085735)
Timeframe: 3 years
| Intervention | Percentage probability of PFS (Number) |
|---|
| Group 3 Medulloblastoma | 70.6 |
| Group 4 Medulloblastoma | 90.6 |
| Sonic Hedgehog (SHH) Medulloblastoma | 90.4 |
| Wingless (WNT) Medulloblastoma | 98.4 |
Overall Survival (OS)
OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy [IFRT]) are combined and compared to arms II, IV and VI (posterior fossa irradiation [PFRT]). (NCT00085735)
Timeframe: 3 years
| Intervention | Probability of 3 yr OS rate (Number) |
|---|
| LDCSI vs SDCSI |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 85.5 |
,| Standard-dose Craniospinal Radiation (SDCSI) | 90.4 |
Overall Survival (OS)
OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy [IFRT]) are combined and compared to arms II, IV and VI (posterior fossa irradiation [PFRT]). (NCT00085735)
Timeframe: 3 years
| Intervention | Probability of 3 yr OS rate (Number) |
|---|
| IFRT vs PFRT |
|---|
| Involved Field Radiation (IFRT) | 90.3 |
,| Posterior Fossa Radiation (PFRT) | 93.3 |
Event-free Survival (EFS)
EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's). (NCT00085735)
Timeframe: Assessed at 3 years
| Intervention | probability of 3 year EFS (Number) |
|---|
| LDCSI vs SDCSI |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 76.3 |
,| Standard-dose Craniospinal Radiation (SDCSI) | 84.9 |
Event-free Survival (EFS)
EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's). (NCT00085735)
Timeframe: Assessed at 3 years
| Intervention | probability of 3 year EFS (Number) |
|---|
| IFRT vs PFRT |
|---|
| Involved Field Radiation (IFRT) | 85.8 |
,| Posterior Fossa Radiation (PFRT) | 85.8 |
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. (NCT00085735)
Timeframe: 49 - 72 months post diagnosis
| Intervention | Scores on a scale (Mean) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 90.5 |
| Standard-dose Craniospinal Radiation (SDCSI) | 86.4 |
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better. (NCT00085735)
Timeframe: 27 - 48 months post diagnosis
| Intervention | Scores on a scale (Mean) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 92.2 |
| Standard-dose Craniospinal Radiation (SDCSI) | 90.5 |
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. (NCT00085735)
Timeframe: 4 -15 months post diagnosis
| Intervention | Scores on a scale (Mean) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 93.8 |
| Standard-dose Craniospinal Radiation (SDCSI) | 96.2 |
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. (NCT00085735)
Timeframe: 49 - 72 months post diagnosis
| Intervention | T-score (Mean) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 54.1 |
| Standard-dose Craniospinal Radiation (SDCSI) | 58.6 |
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. (NCT00085735)
Timeframe: 27-48 months post diagnosis
| Intervention | T-score (Mean) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 51.4 |
| Standard-dose Craniospinal Radiation (SDCSI) | 55.0 |
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. (NCT00085735)
Timeframe: 4 - 15 months post diagnosis
| Intervention | T-score (Mean) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 50.7 |
| Standard-dose Craniospinal Radiation (SDCSI) | 51.3 |
Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used. (NCT00085735)
Timeframe: Up to 3 years
| Intervention | Percentage of pts with g3+ hearing loss (Number) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 11 |
| Standard-dose Craniospinal Radiation (SDCSI) | 11 |
Post-treatment Endocrine Function by CSI Group
Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported. (NCT00085735)
Timeframe: Up to 3 years
| Intervention | uU/ml (Mean) |
|---|
| Low-dose Craniospinal Radiation (LDSCI) | 5.3 |
| Standard-dose Craniospinal Radiation (SDCSI) | 6.1 |
Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays
OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. (NCT00085735)
Timeframe: 3 years
| Intervention | Percent probability of overall survival (Number) |
|---|
| Group 3 Medulloblastoma | 76.3 |
| Group 4 Medulloblastoma | 97.3 |
| Sonic Hedgehog (SHH) Medulloblastoma | 92.0 |
| Wingless (WNT) Medulloblastoma | 98.3 |
Non-posterior Fossa (NPF) Failure Rate
NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events. (NCT00085735)
Timeframe: 3 years
| Intervention | Percentage of 3 yr cumulative incidence (Number) |
|---|
| Involved Field Radiation (IFRT) | 5.1 |
| Posterior Fossa Radiation (PFRT) | 6.2 |
Local Posterior Fossa (LPF) Failure Rate
LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events. (NCT00085735)
Timeframe: 3 years
| Intervention | percentage 3 yr cumulative incidence (Number) |
|---|
| Involved Field Radiation (IFRT) | 1.4 |
| Posterior Fossa Radiation (PFRT) | 2.7 |
Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated. (NCT00085735)
Timeframe: Up to 3 years
| Intervention | Percentage of pts with g3+ hearing loss (Number) |
|---|
| Involved Field Radiation (IFRT) | 8 |
| Posterior Fossa Radiation (PFRT) | 8 |
Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group
Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests. (NCT00085735)
Timeframe: Post-treatment up to 3 years
| Intervention | Percentage of patients (Number) |
|---|
| Involved Field Radiation (IFRT) | 0.0 |
| Posterior Fossa Radiation (PFRT) | 50.0 |
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 49 - 72 months post diagnosis. (NCT00085735)
Timeframe: 49 - 72 months post diagnosis
| Intervention | Percentage of Participants (Number) |
|---|
| Eligible and Evaluable Patients | 69 |
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 27 - 48 months post diagnosis. (NCT00085735)
Timeframe: 27-48 months post diagnosis
| Intervention | Percentage of Participants (Number) |
|---|
| Eligible and Evaluable Patients | 32 |
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 4 - 15 months post diagnosis. (NCT00085735)
Timeframe: 4-15 months post diagnosis
| Intervention | Percentage of Participants (Number) |
|---|
| Eligible and Evaluable Patients | 58 |
Non-local Posterior Fossa (NLPF) Failure Rate
NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events. (NCT00085735)
Timeframe: 3 years
| Intervention | Percentage of 3 yr cumulative incidence (Number) |
|---|
| Involved Field Radiation (IFRT) | 6.9 |
| Posterior Fossa Radiation (PFRT) | 2.7 |
Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation
Change in LVEF from randomization to 12 months (NCT00087178)
Timeframe: 12 months
| Intervention | Change in percent ejection fraction (Mean) |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | -2.61 |
| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | -2.65 |
Quality of Life-Functional Assessment of Cancer Therapy
Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL. (NCT00087178)
Timeframe: 12 months
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Score day 1 cycle 4 | Score 6 months | Score 12 months |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | 61.7 | 69.2 | 71.7 |
,| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | 60.3 | 66.9 | 71.1 |
Survival
Percentage of patients alive (NCT00087178)
Timeframe: 9 years
| Intervention | percentage of participants alive (Number) |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | 89.8 |
| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | 89.9 |
Recurrence-free Interval
Percentage of patients with local-regional recurrence or distant recurrence (NCT00087178)
Timeframe: 9 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | 10.8 |
| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | 10.4 |
Post Chemotherapy Amenorrhea
Percent with post chemotherapy amenorrhea (NCT00087178)
Timeframe: 18 months
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | 59.1 |
| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | 67.4 |
Distant Recurrence-free Interval
Percentage of patients with distant recurrence (NCT00087178)
Timeframe: 9 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | 8.3 |
| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | 7.2 |
Disease Free Survival
Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer (NCT00087178)
Timeframe: 9 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | 80.1 |
| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | 79.4 |
Adverse Events
Percentage of patients with at least one grade 2 or higher adverse event reported (NCT00087178)
Timeframe: 9 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Adriamycin + Cyclophosphamide | 28.5 |
| Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide | 45.0 |
Overall Response Rate (ORR) Lasting at Least 4 Months
The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months. (NCT00088530)
Timeframe: approximately 24 months
| Intervention | participants (Number) |
|---|
| Experimental Group | 12 |
| Comparator Group | 6 |
Overall Survival
The time between the date of randomization and the date of death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months
| Intervention | Months (Median) |
|---|
| Experimental Group | 10.2 |
| Comparator Group | 7.6 |
Progression-Free Survival (PFS)
The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months
| Intervention | months (Median) |
|---|
| Experimental Group | 5.3 |
| Comparator Group | 2.6 |
Complete Response (CR) and Complete Response Unconfirmed (CRu)
Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT) (NCT00088530)
Timeframe: EOT; approximately 6 months
| Intervention | percentage of randomized patients (Number) |
|---|
| END OF TREATMENT: CR/CRu, n (%) | END OF STUDY: CR/CRu, n (%) |
|---|
| Comparator Group | 5.7 | 7.1 |
,| Experimental Group | 20.0 | 24.3 |
Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). (NCT00088881)
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
| Intervention | proportion of participants (Number) |
|---|
| Treatment | 0.87 |
3-year Time to Treatment Failure (TTF) Rate
Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years. (NCT00088881)
Timeframe: Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.
| Intervention | probability (Number) |
|---|
| Treatment | 0.92 |
3-year Overall Survival (OS) Rate
Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years. (NCT00088881)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.
| Intervention | probability (Number) |
|---|
| Treatment | 0.98 |
Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease. (NCT00088881)
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
| Intervention | proportion of participants (Number) |
|---|
| Treatment | 0.89 |
Number of Participants With Event-free Survival (EFS) Events
Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | participants (Number) |
|---|
| Patients with event | Patients without events |
|---|
| Fludarabine+Cyclophosphamide (FC) | 162 | 114 |
,| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 134 | 142 |
Disease-free Survival (DFS)
Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 1285 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1204 |
Event-free Survival (EFS)
Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 586 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 874 |
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 660 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 813 |
Overall Survival (OS)
Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 1580 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | NA |
Final Analysis: Time to Progression-Free Survival Event
Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first. (NCT00090051)
Timeframe: Median observation time was approximately 5 years
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 683.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 969.0 |
Final Analysis: Time to Overall Survival Event
Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 2056.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 2167.0 |
Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death. (NCT00090051)
Timeframe: Median observation time was approximately 5 years
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 1085.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1625.0 |
Final Analysis: Time to Event-Free Survival Event
Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 630.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 932.0 |
Final Analysis: Time to Disease-Free Survival Event
Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 1285.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1803.0 |
Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | participants (Number) |
|---|
| Patients with event | Patients without events |
|---|
| Fludarabine+Cyclophosphamide (FC) | 148 | 128 |
,| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 137 | 139 |
Final Analysis: Percentage of Participants With Complete Response
Complete response was defined as the disappearance of all signs of cancer in response to treatment. (NCT00090051)
Timeframe: Median observation time was approximately 5 years
| Intervention | Percentage of participants (Number) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 13.4 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 25.0 |
Final Analysis: Duration of Response
Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 869.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1333.0 |
Number of Participants With Disease-free Survival (DFS) Events
Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | participants (Number) |
|---|
| Patients with event | Patients without event |
|---|
| Fludarabine+Cyclophosphamide (FC) | 10 | 26 |
,| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 19 | 48 |
Number of Participants With Overall Survival (OS) Events
Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months
| Intervention | participants (Number) |
|---|
| Patients with event | Patients without events |
|---|
| Fludarabine+Cyclophosphamide (FC) | 68 | 208 |
,| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 62 | 214 |
Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer
The percentage of patients alive and cancer-free. (NCT00093795)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Group 1: TAC X 6 | 80.1 |
| Group 2: AC X 4 Then P X 4 | 82.2 |
| Group 3: AC X 4 Then PG X 4 | 80.6 |
Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only
Percentage of patients distant recurrence-free (no distant disease recurrence only) (NCT00093795)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Group 1: TAC X 6 | 86.6 |
| Group 2: AC X 4 Then P X 4 | 87.4 |
| Group 3: AC X 4 Then PG X 4 | 86.6 |
Overall Survival
Percentage of participants alive at 5 years (NCT00093795)
Timeframe: 5 years
| Intervention | percentage of patients alive (Number) |
|---|
| Group 1: TAC X 6 | 89.6 |
| Group 2: AC X 4 Then P X 4 | 89.1 |
| Group 3: AC X 4 Then PG X 4 | 90.8 |
Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence
Percentage of patients recurrence-free (no first local, regional, or distant recurrence) (NCT00093795)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Group 1: TAC X 6 | 85.1 |
| Group 2: AC X 4 Then P X 4 | 86.2 |
| Group 3: AC X 4 Then PG X 4 | 84.8 |
Toxicity
Percentage of patients who ever experienced grade 2 or higher toxicities. (NCT00093795)
Timeframe: 30 days after the last dose of study therapy (about 7 months after study entry)
| Intervention | percentage of patients (Number) |
|---|
| Group 1: TAC X 6 | 82.7 |
| Group 2: AC X 4 Then P X 4 | 87.5 |
| Group 3: AC X 4 Then PG X 4 | 88.4 |
Event-free Survival
Monitoring of efficacy results will be performed in comparison with historical results. (NCT00096135)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| CNS Patients - Treatment (Combination Chemotherapy) | 64.9 |
| Testicular Relapse Patients (Combination Chemotherapy) | 70 |
Safety
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00096382)
Timeframe: 4 years
| Intervention | Participants (Number) |
|---|
| TBI 200cGy + TIL +HD IL-2, Prior IL-2 | 23 |
| TBI 200cGy + TIL +HD IL-2, No Prior IL-2 | 3 |
Clinical Tumor Regression
Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT00096382)
Timeframe: Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| TBI 200cGy + TIL +HD IL-2, No Prior IL-2 | 1 | 2 |
,| TBI 200cGy + TIL +HD IL-2, Prior IL-2 | 1 | 9 |
Lymphoma Progression-free Survival
(NCT00096460)
Timeframe: Three years post-Hematopoietic Stem Cell Transplant (HSCT)
| Intervention | participants (Number) |
|---|
| Autologous Hematopoietic Stem Cell Transplant (HSCT) | 13 |
| Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | 6 |
Pharmacokinetics
Mean trough serum concentration measured before final dose of epratuzumab. (NCT00098839)
Timeframe: Up to day 36
| Intervention | ug/mL (Mean) |
|---|
| Twice Weekly Dosing Schedule | 501 |
Remission Re-induction (CR2) Rate
The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)
| Intervention | proportion of participants (Number) |
|---|
| Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .646 |
| Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .660 |
Rate of Minimal Residual Disease (MRD) < 0.01%
Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)
| Intervention | Proportion of participants (Number) |
|---|
| Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .195 |
| Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .295 |
Event-free Survival Rate
Proportion of patients who were event free at 4 months (NCT00098839)
Timeframe: At 4 months after enrollment
| Intervention | Proportion of participants (Number) |
|---|
| Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .604 |
| Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .640 |
Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT & FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver & spleen, & all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic & liver lesions separately compared to baseline SPD. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. (NCT00101010)
Timeframe: Evaluation after 12 weeks (4 cycles of 21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Uncomfirmed Complete Response (CRu) | Partial Response (PD) |
|---|
| Rituximab - Combination Chemotherapy | 47 | 8 | 14 |
Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses
Ejection fraction ( EF) refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. Cardiology evaluation performed before second dose of pegylated liposomal doxorubicin or before entry onto trial, re-evaluation by cardiologist obtained in asymptomatic patients after chemotherapy cycle 4 and again after completion of therapy, and more often if symptomatic. Severe cardiac toxicity considered to be both Grade 3 and 4, and are graded according to NCI common toxicity criteria, CTCAE version 3.0. (NCT00101010)
Timeframe: Up to 24 weeks (8 cycles of 21 days)
| Intervention | participants (Number) |
|---|
| Rituximab - Combination Chemotherapy | 10 |
Rate of Immunological Response to Vaccination
"Immunological response to vaccination, as measured by in vitro testing of peripheral blood mononuclear cells (PBMCs) for interferon gamma secretion, delayed type hypersensitivity reaction (DTH) in response to irradiated autologous tumor cells, and lymphocyte accumulation at DTH and vaccine injection sites.~DTH Skin Testing was performed within 2 weeks prior to first vaccine, and again after fourth vaccine was administered. Aliquots containing 10^6 irradiated autologous tumor cells were re-suspended in 0.2 mL of Plasma-Lyte A and injected intradermally in the forearm and marked. 48 hours later, injection site was inspected for induration and erythema.~3mm punch biopsy of DTH injection site and vaccine site was obtained 48 hours after administration of irradiated tumor cells before and after the vaccine series. Vaccine site biopsy was obtained 2-5 days after the second vaccine had been given. Granulocytic and lymphocytic accumulation at these sites was graded by a pathologist." (NCT00101101)
Timeframe: 4 months per participant
| Intervention | participants (Number) |
|---|
| Clinical DTH | Increase in Interferon Gamma Secretion |
|---|
| Vaccine and Conventional Therapy | 0 | 15 |
Event-free Survival (EFS) for SR-Average ALL Patients
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | percent probability (Number) |
|---|
| Standard and Intensified therapy | Standard therapy |
|---|
| Group 2-SR-avg ALL, Arm I-combination Chemotherapy | 83.82 | 87.41 |
,| Group 2-SR-avg ALL, Arm II-combination Chemotherapy | 88.89 | 88.29 |
Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)
Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | Percent probability (Number) |
|---|
| Group 1-SR-low ALL, Arm I-combination Chemotherapy | 95.22 |
| Group 2-SR-avg ALL, Arm I-combination Chemotherapy | 88.52 |
Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative) (NCT00103285)
Timeframe: Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.
| Intervention | Participants (Count of Participants) |
|---|
| All Patients for Induction, MRD Negative | 4378 |
| All Patients for Induction, MRD Positive | 258 |
Event-free Survival (EFS) for SR-Average ALL Patients
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | percent probability (Number) |
|---|
| Standard and Intensified therapy |
|---|
| Group 2-SR-avg ALL, Arm III-combination Chemotherapy | 88.34 |
,| Group 2-SR-avg ALL, Arm IV-combination Chemotherapy | 90.51 |
Event-Free Survival Probability According to MRD Status End Induction (Day 29)
Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: MRD at Day 29 of therapy
| Intervention | Percent Probability (Number) |
|---|
| Induction Therapy, MRD Negative | 91.39 |
| Induction Therapy, MRD Positive | 79.86 |
Event-free Survival (EFS) for SR-High Patients.
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | percent probability (Number) |
|---|
| Group 3-SR-high ALL, Combination Chemotherapy | 85.58 |
Overall Survival Probability (OS) According to Induction Day 29 MRD Status
Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive. (NCT00103285)
Timeframe: Overall Survival Probability of 6 years
| Intervention | percent probability (Number) |
|---|
| Induction Therapy, MRD Negative | 97.07 |
| Induction Therapy, MRD Positive | 90.47 |
Event-free Survival (EFS) for SR-Low Patients
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | Percent probability (Number) |
|---|
| SR-low ALL, Arm I-combination Chemotherapy | 95.22 |
| SR-low ALL, Arm II-combination Chemotherapy | 93.96 |
The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. (NCT00104299)
Timeframe: 18 months post-randomization
| Intervention | Days (Number) |
|---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
|---|
| Control Group | 168 | NA | NA |
,| Rituximab | 246 | NA | NA |
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident (NCT00104299)
Timeframe: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)
| Intervention | participants (Number) |
|---|
| Death | Grade 2 or Higher Leukopenia | Grade 2 or Higher Thrombocytopenia | Grade 3 or Higher Infections | Hemorrhagic Cystitis (Grade 2 or Lower) | Malignancy | Venous Thromboembolic Event | Hospitalization Resulting from the Disease | Cerebrovascular Accident (CVA) | Infusion Reactions Leading to Infusion Disc. |
|---|
| Control Group | 2 | 23 | 1 | 16 | 1 | 2 | 8 | 7 | 1 | 0 |
,| Rituximab | 2 | 7 | 4 | 18 | 2 | 5 | 6 | 16 | 1 | 1 |
Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization
"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 6 months post-randomization
| Intervention | participants (Number) |
|---|
| Rituximab | 62 |
| Control Group | 51 |
Number of Subjects Experiencing Serious Adverse Events
Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC. (NCT00104299)
Timeframe: Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)
| Intervention | participants (Number) |
|---|
| # Participants with at least one SAE | Blood and Lymphatic System Disorders | Cardiac Disorders | Eye Disorders | Gastrointestinal Disorders | General Disorders and Administration Site | Immune System Disorders | Infections and Infestations | Injury, Poisoning, and Procedural Complications | Investigations | Metabolism and Nutrition Disorders | Musculoskeletal and Connective Tissue Disorders | Neoplasms Benign, Malignant, and Unspecified | Nervous System Disorders | Pregnancy, Puerperium, and Perinatal Conditions | Psychiatric Disorders | Renal and Urinary Disorders | Respiratory, Thoracic, and Mediastinal Disorders | Vascular Disorders |
|---|
| Control Group | 37 | 5 | 2 | 1 | 1 | 3 | 2 | 12 | 0 | 0 | 2 | 3 | 2 | 0 | 0 | 1 | 3 | 8 | 7 |
,| Rituximab | 42 | 4 | 2 | 1 | 4 | 5 | 2 | 12 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 4 | 8 | 1 |
The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization
| Intervention | Days (Number) |
|---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
|---|
| Control Group | 230 | NA | NA |
,| Rituximab | 243 | NA | NA |
Disease Remission
A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. (NCT00104299)
Timeframe: 6 months post-randomization
| Intervention | Participants (Number) |
|---|
| Rituximab | 63 |
| Control Group | 52 |
Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization
| Intervention | Days (Number) |
|---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
|---|
| Control Group | 29 | 43 | 112 |
,| Rituximab | 30 | 57 | 119 |
Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization
| Intervention | Days (Number) |
|---|
| 25% Quartile (95%CI) | 50% Quartile (95%CI) | 75% Quartile (95%CI) |
|---|
| Control Group | 177 | 183 | 266 |
,| Rituximab | 176 | 180 | 189 |
Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients
To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy. (NCT00107198)
Timeframe: At 5 years
| Intervention | Probability participants (Number) |
|---|
| Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.89 |
Failure-free Survival (FFS)
The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause. (NCT00107198)
Timeframe: At 5 years
| Intervention | Probability participants (Number) |
|---|
| Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.91 |
Event-free Survival
Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment. (NCT00107198)
Timeframe: At 5 years
| Intervention | Probability participants (Number) |
|---|
| Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.85 |
Cure by Surgery Alone in Stage I Resected Patients
To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone. (NCT00107198)
Timeframe: At 2 years
| Intervention | Probability participants (Number) |
|---|
| Surgery or Combination Chemotherapy, With/Without Radiotherapy | 0.82 |
Grade 3 or 4 Toxicity
(NCT00107198)
Timeframe: Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.
| Intervention | Participants (Number) |
|---|
| Surgery or Combination Chemotherapy, With/Without Radiotherapy | 26 |
Progression-free Survival and Overall Survival
"Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.~Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.~Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression." (NCT00107276)
Timeframe: two years
| Intervention | months (Median) |
|---|
| PFS | OS |
|---|
| Cyclophosphamide and Capecitabine | 5.9 | 18.8 |
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. (NCT00107276)
Timeframe: Patients assessed at least every six weeks while on protocol treatment
| Intervention | participants (Number) |
|---|
| Cyclophosphamide and Capecitabine | 29 |
Toxicity
Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00107276)
Timeframe: Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)
| Intervention | Participants (Number) |
|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Alkaline phosphatase | Dehydration | Diarrhea | Dyspnea (shortness of breath) | Fatigue (asthenia, lethargy, malaise) | Febrile neutropenia | Hemoglobin | Leukocytes (total WBC) | Lymphopenia | Mood alteration - depression | Nausea | Neuroendocrine: ADH secretion abnormality | Neutrophils/granulocytes (ANC/AGC) | Platelets | Potassium, serum-low (hypokalemia) | Pruritus/itching | Rash/desquamation | Rash: hand-foot skin reaction | Sodium, serum-low (hyponatremia) | Thrombosis/thrombus/embolism | Weight loss |
|---|
| Cyclophosphamide and Capecitabine | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 15 | 13 | 1 | 1 | 1 | 7 | 1 | 1 | 1 | 1 | 7 | 1 | 2 | 1 |
Response Rate (Complete, Complete Unconfirmed, and Partial)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00107380)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Partial Response | Confirmed Response | Unconfirmed Response | No Response |
|---|
| R-CHOP + I-131-tositumomab | 21 | 41 | 10 | 12 |
Progression-free Survival (PFS) at 2 Years
Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00107380)
Timeframe: 0-2 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP + I-131-tositumomab | 69 |
Number of Participants With WHO Grade 4 Oral Mucositis
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. (NCT00109031)
Timeframe: Up to Day 28
| Intervention | participants (Number) |
|---|
| Yes | No | Missing |
|---|
| Palifermin 180 μg/kg on Day -1 | 5 | 4 | 1 |
,| Palifermin 180 μg/kg on Day -2 | 2 | 11 | 0 |
,| Palifermin 180 μg/kg on Day -3 | 3 | 9 | 0 |
,| Palifermin 60 µg/kg for 3 Days | 5 | 6 | 0 |
Duration of WHO Grade 2, 3 or 4 Oral Mucositis
"The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study.~OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible." (NCT00109031)
Timeframe: Up to Day 28
| Intervention | days (Mean) |
|---|
| Palifermin 60 µg/kg for 3 Days | 10.3 |
| Palifermin 180 μg/kg on Day -1 | 9.0 |
| Palifermin 180 μg/kg on Day -2 | 4.7 |
| Palifermin 180 μg/kg on Day -3 | 9.4 |
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)
The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study. (NCT00109031)
Timeframe: Up to Day 28
| Intervention | days (Mean) |
|---|
| Palifermin 60 µg/kg for 3 Days | 6.0 |
| Palifermin 180 μg/kg on Day -1 | 4.4 |
| Palifermin 180 μg/kg on Day -2 | 1.9 |
| Palifermin 180 μg/kg on Day -3 | 5.1 |
Area Under the Curve (AUC) of Mouth and Throat Soreness Score
"The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS." (NCT00109031)
Timeframe: From the first day of study drug administration through Day 28
| Intervention | MTS score * days (Mean) |
|---|
| Palifermin 60 µg/kg for 3 Days | 26.4 |
| Palifermin 180 μg/kg on Day -1 | 45.1 |
| Palifermin 180 μg/kg on Day -2 | 30.4 |
| Palifermin 180 μg/kg on Day -3 | 30.9 |
Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. (NCT00109031)
Timeframe: Up to Day 28
| Intervention | participants (Number) |
|---|
| Yes | No | Missing |
|---|
| Palifermin 180 μg/kg on Day -1 | 8 | 1 | 1 |
,| Palifermin 180 μg/kg on Day -2 | 9 | 4 | 0 |
,| Palifermin 180 μg/kg on Day -3 | 12 | 0 | 0 |
,| Palifermin 60 µg/kg for 3 Days | 10 | 1 | 0 |
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. (NCT00109031)
Timeframe: Up to Day 28
| Intervention | participants (Number) |
|---|
| Yes | No | Missing |
|---|
| Palifermin 180 μg/kg on Day -1 | 6 | 3 | 1 |
,| Palifermin 180 μg/kg on Day -2 | 4 | 9 | 0 |
,| Palifermin 180 μg/kg on Day -3 | 9 | 3 | 0 |
,| Palifermin 60 µg/kg for 3 Days | 9 | 2 | 0 |
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use
Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia. (NCT00109031)
Timeframe: Up to Day 28
| Intervention | participants (Number) |
|---|
| Yes | No |
|---|
| Palifermin 180 μg/kg on Day -1 | 7 | 3 |
,| Palifermin 180 μg/kg on Day -2 | 7 | 6 |
,| Palifermin 180 μg/kg on Day -3 | 9 | 3 |
,| Palifermin 60 µg/kg for 3 Days | 7 | 4 |
Toxicity
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event (NCT00109837)
Timeframe: Patients were assessed for adverse events after the induction cycle
| Intervention | Participants with a given type of AE (Number) |
|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | AST, SGOT (serum glut oxaloacetic transaminase) | Albumin, serum-low (hypoalbuminemia) | Alkaline phosphatase | Anorexia | Ascites (non-malignant) | Bilirubin (hyperbilirubinemia) | Calcium, serum-low (hypocalcemia) | Cholecystitis | Cholesterol, serum-high (hypercholesterolemia) | Coagulation-Other (Specify) | Colitis, infectious (e.g., Clostridium difficile) | Constipation | DIC (disseminated intravascular coagulation) | Death not assoc with CTCAE term-Multi-organ fail | Edema: limb | Fatigue (asthenia, lethargy, malaise) | Febrile neutropenia | Fever (in the abs of neutropenia) | Fibrinogen | Glucose, serum-high (hyperglycemia) | Glucose, serum-low (hypoglycemia) | Hemoglobin | Hypertension | Hypotension | Hypoxia | Ileus, GI (functional obstruction of bowel) | Infec(doc clin or mibio) w/ Gr 3/4 neut-Anal | Infec(doc clin or mibio) w/ Gr 3/4 neut-Bladder | Infec(doc clin or mibio) w/ Gr 3/4 neut-Blood | Infec(doc clin or mibio) w/ Gr 3/4 neut-Bronchus | IInfec(doc clin or mibio) w/ Gr 3/4 neut-Catheter | Infec(doc clin or mibio) w/ Gr 3/4 neut-Eye NOS | Infec(doc clin or mibio) w/ Gr 3/4 neut-Lung | Infec(doc clin or mibio) w/ Gr 3/4 neut-Nose | Infec(doc clin or mibio) w/ Gr 3/4 neut-Pharynx | Infec(doc clin or mibio) w/ Gr 3/4 neut-Ur tract | Infec with nor ANC or Gr 1/2 neut-Lung (pneumonia) | Infection-Other (Specify) | Leukocytes (total WBC) | Lipase | Liver dysfunction/failure (clinical) | Lymphopenia | Magnesium, serum-high (hypermagnesemia) | Mucositis/stomatitis (clinical exam) - Oral cavity | Mucositis/stomatitis (funct/symp) - Oral cavity | Mucositis/stomatitis (func/symp) - Pharynx | Muscle weak,gen spec area-Whole body | Nausea | Neuropathy: motor | Neutrophils/granulocytes (ANC/AGC) | Pain - Abdomen NOS | Pain - Bone | Pain - Neck | Pancreatic endocrine: glucose intolerance | Pancreatitis | Phosphate, serum-low (hypophosphatemia) | Platelets | Potassium, serum-high (hyperkalemia) | Potassium, serum-low (hypokalemia) | Rash/desquamation | Renal failure | Sodium, serum-low (hyponatremia) | Thrombosis/thrombus/embolism | Thrombotic microangiopathy | Triglyceride, serum-high (hypertriglyceridemia) | Tumor lysis syndrome | Typhlitis (cecal inflammation) | Uric acid, serum-high (hyperuricemia) | Vomiting |
|---|
| Induction | 17 | 13 | 3 | 2 | 2 | 1 | 6 | 7 | 1 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 18 | 1 | 11 | 16 | 1 | 33 | 2 | 3 | 2 | 1 | 1 | 1 | 11 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 2 | 1 | 43 | 1 | 2 | 19 | 1 | 2 | 1 | 1 | 2 | 3 | 1 | 47 | 1 | 1 | 1 | 1 | 1 | 1 | 44 | 1 | 7 | 1 | 2 | 6 | 1 | 2 | 1 | 5 | 1 | 1 | 1 |
Continuous Complete Remission at 1 Year
A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study. (NCT00109837)
Timeframe: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year
| Intervention | participants (Number) |
|---|
| Treatment | 21 |
Maximum Tolerated Dose (MTD)
The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD. (NCT00112827)
Timeframe: 8 weeks from start of treatment, up to 2 years
| Intervention | cGy (Number) |
|---|
| Treatment Arm | 1600 |
Number of Subjects With Response
Response defined as complete response or very good partial response. Complete response defined as the absence of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval. Thus all evidence of serum and urinary M-components must disappear on electrophoresis as well as by immunofixation studies. The follow-up bone marrow may not contain more than 5% plasma cells on aspiration or core biopsy and no evidence of increasing anemia. Skeletal X-rays must either show recalcification or no change in osteolytic lesions. Resolution of soft tissue plasmocytomas. Very good partial response defined as reduction of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval by greater than or equal to 90%. (NCT00112827)
Timeframe: Evaluated after each course until completion of treatment.
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy) | 3 |
| Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) | 3 |
| Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) | 2 |
| Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) | 20 |
| Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) | 4 |
Overall Survival
Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause. (NCT00112827)
Timeframe: From date of treatment until the date of death from any cause, assessed up to 14 years
| Intervention | months (Median) |
|---|
| Treatment Arm | 95.8 |
Global Rank Composite Score (GRCS) (Month 54, ITT)
The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS). (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Sum of subject-pair comparison scores (Median) |
|---|
| mHSCT | 17.0 |
| Cyclophosphamide | -6.0 |
Global Rank Composite Score (GRCS) (Month 48, PP)
The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS). (NCT00114530)
Timeframe: 48 Months Post-Randomization
| Intervention | Sum of subject-pair comparison scores (Median) |
|---|
| mHSCT | 17.0 |
| Cyclophosphamide | -13.0 |
Documented Myositis (PP)
Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 1 |
| Cyclophosphamide | 0 |
Documented Myositis (ITT)
Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 1 |
| Cyclophosphamide | 0 |
All-Cause Mortality (Month 54, PP)
Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 3 |
| Cyclophosphamide | 8 |
All-Cause Mortality (Month 54, ITT)
Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 6 |
| Cyclophosphamide | 11 |
All-Cause Mortality (Month 48, PP)
Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization. (NCT00114530)
Timeframe: 48 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 3 |
| Cyclophosphamide | 8 |
All-Cause Mortality (Month 48, ITT)
Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization. (NCT00114530)
Timeframe: 48 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 6 |
| Cyclophosphamide | 11 |
Global Rank Composite Score (GRCS) (Month 48, ITT)
The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS). (NCT00114530)
Timeframe: 48 Months Post-Randomization
| Intervention | Sum of subject-pair comparison scores (Median) |
|---|
| mHSCT | 20.0 |
| Cyclophosphamide | -8.0 |
New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (PP)
Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening will be defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| Development of new or worsening arrhythmias | CHF requiring clinical treatment | Clinically significant pericardial effusion |
|---|
| Cyclophosphamide | 4 | 4 | 0 |
,| mHSCT | 6 | 0 | 2 |
New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (ITT)
Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening was defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication, or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| Development of new or worsening arrhythmias | CHF requiring clinical treatment | Clinically significant pericardial effusion |
|---|
| Cyclophosphamide | 4 | 4 | 1 |
,| mHSCT | 6 | 0 | 2 |
Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (ITT)
"HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities). The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. Analysis was based on an ordinal response variable, defined as follows: a decrease of >0.4 from baseline in the HAQ-DI score was considered disease improvement, an increase of >0.4 was considered disease worsening, and any change less than 0.4 was considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit." (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| Improvement | No Change | Worsening |
|---|
| Cyclophosphamide- EFS Failure | 0 | 11 | 9 |
,| Cyclophosphamide-EFS Survivor | 6 | 11 | 2 |
,| mHSCT- EFS Failure | 2 | 5 | 3 |
,| mHSCT- EFS Survivor | 17 | 8 | 1 |
Time to Absolute Neutrophil Count Engraftment
Time to absolute neutrophil count (ANC) engraftment is defined as the number of days post-transplant until required levels of ANC are attained (for the mHSCT arm only). If engraftment did not occur within 28 days post-transplant, then the variable was set to 28 days. ANC engraftment required an ANC of > 500 cells/microliter, maintained for 3 consecutive days. (NCT00114530)
Timeframe: 28 days post-transplant
| Intervention | Days (Median) |
|---|
| mHSCT | 10 |
Occurrence of Scleroderma Renal Crisis (PP)
Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 0 |
| Cyclophosphamide | 1 |
Occurrence of Scleroderma Renal Crisis (ITT)
Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 2 |
| Cyclophosphamide | 3 |
Number of Subjects With Infectious Complications
"Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of Infections and infestations or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections." (NCT00114530)
Timeframe: Randomization through end of study follow-up (up to Month 72 post-randomization).
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 33 |
| Cyclophosphamide | 31 |
New or Worsening Pulmonary Hypertension (PP)
Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization would be done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 0 |
| Cyclophosphamide | 5 |
New or Worsening Pulmonary Hypertension (ITT)
Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization was done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 0 |
| Cyclophosphamide | 5 |
Initiating Use of Disease-Modifying Antirheumatic Drugs by Month 54 (DMARDs) (PP)
Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 3 |
| Cyclophosphamide | 15 |
Initiating Use of Disease-Modifying Antirheumatic Drugs (DMARDs) by Month 54 (ITT)
Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs. (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Participants (Count of Participants) |
|---|
| mHSCT | 3 |
| Cyclophosphamide | 15 |
Infectious Complications
"Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of Infections and infestations or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections." (NCT00114530)
Timeframe: Randomization through end of study follow-up (up to Month 72 post-randomization).
| Intervention | Events (Number) |
|---|
| mHSCT | 131 |
| Cyclophosphamide | 112 |
Global Rank Composite Score (GRCS) (Month 54, PP)
The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS). (NCT00114530)
Timeframe: 54 Months Post-Randomization
| Intervention | Sum of subject-pair comparison scores (Median) |
|---|
| mHSCT | 16 |
| Cyclophosphamide | -11.0 |
Progression-Free Survival Rate at 2 and 5 Years
"Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse>~≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.>~Appearance of any new lesion during or after completion of therapy.>~PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.>~The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below." (NCT00118209)
Timeframe: Up to 5 years post-registration
| Intervention | percentage of participants (Number) |
|---|
| 2-year PFS | 5-year PFS |
|---|
| Arm A - R-CHOP | 75.5 | 66.0 |
,| Arm B - DA-EPOCH-R | 78.9 | 68.0 |
Overall Survival Rate at 2 and 5 Years
Overall survival is defined as the time from randomization to death due to any cause. The overall survival (OS) rate (percentage of participants who are still alive) at 2 and 5 years Kaplan Meier estimates and 95% confidence intervals are reported below. (NCT00118209)
Timeframe: Up to 5 years post-registration
| Intervention | percentage of participants (Number) |
|---|
| 2-year OS rate | 5-year OS rate |
|---|
| Arm A - R-CHOP | 85.7 | 78.5 |
,| Arm B - DA-EPOCH-R | 86.5 | 77.5 |
Response Rate
The overall response rate is defined as the percentage of participants with a response (Complete Response or Partial Response) (NCT00118209)
Timeframe: Up to 5 years post-registration
| Intervention | percentage of participants (Number) |
|---|
| Arm B - DA-EPOCH-R | 86.7 |
| Arm A - R-CHOP | 88.0 |
Immunogenicity (CD8+ T Cell Response to 12 Melanoma Peptides, 12MP) as Measured by Elispot Assay, up to Day 50
The primary end point was the maximum cumulative circulating CD8+ T cell response to 12 melanoma peptides (12MP) measured by ELISpot assay over the first six vaccines (to day 50). (NCT00118274)
Timeframe: 50 days
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 32 |
| Arm II | 29 |
| Arm III | 8 |
| Arm IV | 12 |
Safety of the Peptide Vaccines
Number of participants with dose-limiting toxicities (NCT00118274)
Timeframe: 30 days after receiving the last dose of study drug, up to week 52
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 4 |
| Arm II | 7 |
| Arm III | 2 |
| Arm IV | 1 |
Congestive Heart Failure Rate
Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis. (NCT00119262)
Timeframe: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry
| Intervention | percentage of participants (Number) |
|---|
| Arm A (ddBAC > BT > B) | 2.9 |
| Arm B (ddAC > BT > B) | 2.5 |
Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)
The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post doxorubicin and cyclophosphamide (AC) Day 1 Cycle 5 (DIC5). 207 patients who were treated and had baseline and DIC5 LVEF values were included in the analysis. (NCT00119262)
Timeframe: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment
| Intervention | percentage of participants (Number) |
|---|
| Arm A (ddBAC > BT > B) | 7.4 |
| Arm B (ddAC > BT > B) | 3.5 |
Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab
The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post bevacizumab (the end of treatment). 158 patients who were treated and had baseline and end of treatment LVEF values were included in the analysis. (NCT00119262)
Timeframe: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment
| Intervention | percentage of participants (Number) |
|---|
| Arm A (ddBAC > BT > B) | 15.3 |
| Arm B (ddAC > BT > B) | 11.6 |
The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts
(NCT00121134)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Group A- Bevacizumab Alone | 60 |
| Group B-Bevacizumab+Cyclophosphamide+Methotrexate | 58 |
| Group C-Bevacizumab + Capcitabine(18 Wks) | 49 |
| Group D-bevacizumab + Capecitibine (24wks) | 76 |
Progression-free Survival at 2 Year
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00121199)
Timeframe: 0-2 years
| Intervention | percentage of participants (Number) |
|---|
| CHOP + Rituximab + Bevacizumab | 69 |
Progression-free Survival at 1 Year
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00121199)
Timeframe: 0-1 year
| Intervention | percentage of participants (Number) |
|---|
| CHOP + Rituximab + Bevacizumab | 77 |
Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00121199)
Timeframe: After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Unconfirmed Complete Response (UCR) | Unconfirmed Partial Response (UPR) | No Response |
|---|
| CHOP + Rituximab + Bevacizumab | 22 | 20 | 6 | 1 | 15 |
The Number of Participants Who Experienced Adverse Events (AE)
Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 1.0. (NCT00121992)
Timeframe: Through study treatment, and average of 4 months
| Intervention | participants (Number) |
|---|
| Number patients with One AE | One G3-4 or severe treatment-emergent AE | One serious treatment-emergent AE | One serious G3-4 treatment-emergent AE | Number of patients discontinued due to AE | Number patients death due to AE |
|---|
| Arm A: FAC | 519 | 88 | 22 | 10 | 4 | 0 |
,| Arm B: TAC | 532 | 151 | 119 | 55 | 25 | 1 |
Overall Survival (OS)
"OS was determined from the date of randomization until the date of death for any reason.~OS is calculated from the date of randomization up to the first date of death by any cause." (NCT00121992)
Timeframe: 10 years
| Intervention | Participants with mortality event (Number) |
|---|
| Arm A: FAC | 57 |
| Arm B: TAC | 53 |
Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup
Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. (NCT00121992)
Timeframe: 10 year
| Intervention | events (Number) |
|---|
| Arm A: FAC | 6 |
| Arm B: TAC | 6 |
Disease-free Survival (DFS) Events
DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death. (NCT00121992)
Timeframe: 10 years
| Intervention | events (Number) |
|---|
| Arm A: FAC | 127 |
| Arm B: TAC | 112 |
Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup
"Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally.~Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first." (NCT00121992)
Timeframe: 10 year
| Intervention | events (Number) |
|---|
| Arm A: FAC | 50 |
| Arm B: TAC | 37 |
Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup
Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. (NCT00121992)
Timeframe: 10 year
| Intervention | events (Number) |
|---|
| Arm A: FAC | 6 |
| Arm B: TAC | 5 |
Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup
Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. (NCT00121992)
Timeframe: 10 year
| Intervention | events (Number) |
|---|
| Arm A: FAC | 29 |
| Arm B: TAC | 28 |
Best Score During Study for Global Health Status Scale
"The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was used.~Questionnaires were self-administered to patients during the 14 days prior to randomisation baseline, at six prospective time points corresponding to chemotherapy cycles, with the time window related to each chemotherapy cycle defined as the period between the day following the first chemotherapy dose of the corresponding cycle and the day of the first dose of the following cycle, and then at 44, 68 and 120 weeks of the study.~The Global Health Status Scale has been used, which is calculated with questions 29 and 30 from the EORTC QLQ-C30. From this scale, the best score is the highest score observed during study (of all the questionnaires completed by patient). In this scale, scores range from 0 to 100 and a high score represents a high level of functioning or HRQoL." (NCT00121992)
Timeframe: 120 weeks
| Intervention | score on a scale (Mean) |
|---|
| Arm A: FAC | 79.30 |
| Arm B: TAC | 77.78 |
Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt
"Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed.~Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable.~Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment." (NCT00126191)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Low Risk | 2 |
| High Risk | 7 |
Disease Free Survival
Participants are followed after completion of protocol therapy until disease progression to determine disease free survival. (NCT00126191)
Timeframe: Until disease progression up to 120 months
| Intervention | Months (Mean) |
|---|
| Low Risk | 84 |
| High Risk | 52 |
Pathological Complete Response (pCR) Rate
Pathological complete response was defined by the Miller & Payne criteria. pCR was defined as no invasive cells identifiable in breast sections at surgery. Response was measured by physical exam and breast imaging before surgery and was evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, was based on the proportion of remaining tumor and postchemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes. (NCT00129376)
Timeframe: Up to 29 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Doxorubicin + Cyclophosphamide Followed Docetaxel | 11 |
Number of Participants With Over-expression of Survivin (>1% Cells With Nuclear Staining)
Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Tumors with more than 1% of cells with nuclear staining were considered to be over-expressing this protein. (NCT00129376)
Timeframe: Up to 29 weeks
| Intervention | Participants (Count of Participants) |
|---|
| > 1 % | < 1% |
|---|
| Doxorubicin + Cyclophosphamide Followed Docetaxel | 18 | 26 |
Number of Participants With Over-expression of p27 (>75% Cells With Nuclear Staining)
Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Sections were rated according to the percentage of tumor cells nuclei with positive staining (1 = < 25%; 2 = between 25-75% and 3 = > 75%). (NCT00129376)
Timeframe: Up to 29 weeks
| Intervention | Participants (Count of Participants) |
|---|
| < 75% | > 75% |
|---|
| Doxorubicin + Cyclophosphamide Followed Docetaxel | 24 | 17 |
Disease-free Survival (DFS) Event
DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason. (NCT00129389)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: FAC | 98 |
| Arm B: FAC-wP | 71 |
Overall Survival (OS) Event
OS event is defined as the death from any cause. (NCT00129389)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: FAC | 40 |
| Arm B: FAC-wP | 31 |
Number of Participants With Overall Survival (OS) Event
A participant was considered to have had a OS event if patient died from any cause. (NCT00129935)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: EC-T | 70 |
| Arm B: ET-X | 83 |
The Number of Participants Who Experienced Adverse Events (AE)
Safety was assessed by standard clinical and laboratory tests, and were evaluated using NCI-CTC criteria v2.0 (NCT00129935)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: EC-T | 665 |
| Arm B: ET-X | 699 |
Quality of Life Questionnaire: Time to Taking Off the Wig
"Time to taking off the wig was assessed by a specific Hair Toxicity Questionnaire were patients answered when they stop to use the wig.~The questionnaire was evaluated up to two years after the end of chemotherapy." (NCT00129935)
Timeframe: Up to 30 months
| Intervention | Months (Median) |
|---|
| Arm A: EC-T | 8.35 |
| Arm B: ET-X | 6.03 |
Number of Participants With Disease-free Survival (DFS) Event
A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason. (NCT00129935)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: EC-T | 127 |
| Arm B: ET-X | 170 |
Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis at risk (Number) |
|---|
| Flucinolone Acetonide Implant | 32.8 |
| Systemic Therapy | 6.3 |
Uveitis Activity
Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess. (NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis (Number) |
|---|
| Fluocinolone Acetonide Implant | 12 |
| Systemic Therapy | 29 |
Mortality
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of participants (Number) |
|---|
| Flucinolone Acetonide Implant | 1.6 |
| Systemic Therapy | 0 |
Macular Edema
center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center (NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis (Number) |
|---|
| Flucinolone Acetonide Implant | 22 |
| Systemic Therapy | 30 |
Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.
The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported. (NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis at risk (Number) |
|---|
| Flucinolone Acetonide Implant | 61.1 |
| Systemic Therapy | 20.1 |
Intraocular Pressure - IOP-lowering Surgery
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis at risk (Number) |
|---|
| Flucinolone Acetonide Implant | 26.2 |
| Systemic Therapy | 3.7 |
Cataract - Incident Cataract
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis at risk (Number) |
|---|
| Fluocinolone Acetonide Implant | 90.7 |
| Systemic Therapy | 44.9 |
Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis at risk (Number) |
|---|
| Flucinolone Acetonide Implant | 53.1 |
| Systemic Therapy | 18.7 |
Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis at risk (Number) |
|---|
| Fluocinolone Acetonide Implant | 51.8 |
| Systemic Therapy | 15.5 |
Change in SF-36 Mental Component Score From Baseline to 24 Months
Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. (NCT00132691)
Timeframe: 24 months
| Intervention | units on a scale (Mean) |
|---|
| Flucinolone Acetonide Implant | 2.55 |
| Systemic Therapy | -1.1 |
Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis
Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful. (NCT00132691)
Timeframe: 24 months
| Intervention | letters (Mean) |
|---|
| Flucinolone Acetonide Implant | 6.0 |
| Systemic Therapy | 3.2 |
Hyperlipidemia - Incident
LDL greater than or equal to 160 mg/mL (NCT00132691)
Timeframe: 24 months
| Intervention | percentage of participants at risk (Number) |
|---|
| Flucinolone Acetonide Implant | 9.8 |
| Systemic Therapy | 11.0 |
Diabetes Mellitus
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of participants (Number) |
|---|
| Flucinolone Acetonide Implant | 1.0 |
| Systemic Therapy | 3.6 |
Glaucoma - Incident
Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images. (NCT00132691)
Timeframe: 24 months
| Intervention | percentage of eyes with uveitis at risk (Number) |
|---|
| Fluocinolone Acetonide Implant | 16.5 |
| Systemic Therapy | 4.0 |
Change in SF-36 Physical Component Score From Baseline to 24 Months
Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful. (NCT00132691)
Timeframe: 24 months
| Intervention | units on a scale (Mean) |
|---|
| Flucinolone Acetonide Implant | 1.15 |
| Systemic Therapy | -1.8 |
Hypertension Diagnosis Requiring Treatment
(NCT00132691)
Timeframe: 24 months
| Intervention | percentage of participants (Number) |
|---|
| Flucinolone Acetonide Implant | 4.6 |
| Systemic Therapy | 10.5 |
Relapse Pattern
Percentage of participants experiencing central nervous system (CNS) and systemic relapse. (NCT00133991)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Systemic relapse only | Systemic and CNS relapse |
|---|
| R-CVP + HiCy | 3 | 2 |
Overall Survival
Percentage of participants alive at 1 year and at 3 years. (NCT00133991)
Timeframe: 1 year and 3 years
| Intervention | percentage of participants (Number) |
|---|
| 1 year | 3 years |
|---|
| R-CVP + HiCy | 57 | 57 |
Overall Response Rate
Number of participants who have a complete or partial remission (2007 International Working Group criteria). (NCT00133991)
Timeframe: Up to 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete remission | Partial remission |
|---|
| R-CVP + HiCy | 11 | 2 |
Event-free Survival
Percentage of participants alive without relapse at 1 year and 3 years. (NCT00133991)
Timeframe: 1 year and 3 years
| Intervention | percentage of participants (Number) |
|---|
| 1 year | 3 years |
|---|
| R-CVP + HiCy | 52 | 52 |
Percentage of Participants Experiencing Grade 3-5 Toxicity
Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria). (NCT00133991)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| R-CVP + HiCy | 21 |
Progression-free Survival
Percentage of participants who do not experience disease relapse, disease progression, or death. (NCT00134004)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Mini-haplo BMT | 34 |
Relapse Rate
Percentage of participants who experience disease relapse. (NCT00134004)
Timeframe: Cumulative incidence for the entire study, up to 11 years
| Intervention | percentage of participants (Number) |
|---|
| Mini-haplo BMT | 55 |
Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation
Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables. (NCT00134004)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Mini-haplo BMT | 9.5 |
Graft Failure Rate
Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as <5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure. (NCT00134004)
Timeframe: Cumulative incidence for the entire study, up to 11 years
| Intervention | percentage of participants (Number) |
|---|
| Mini-haplo BMT | 13 |
Relapse
Percentage of participants who developed relapse or progressive disease. (NCT00134017)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Bone Marrow Transplant | 44 |
Days to Engraftment
Median number of days to neutrophil and platelet engraftment. (NCT00134017)
Timeframe: Up to one year
| Intervention | days (Median) |
|---|
| Neutrophil engraftment, related donors | Neutrophil engraftment, unrelated donors | Platelet engraftment, related donors | Platelet engraftment, unrelated donors |
|---|
| Bone Marrow Transplant | 23 | 25 | 31 | 35 |
Non-relapse Mortality
Percentage of participants who died for BMT-related reasons. (NCT00134017)
Timeframe: Day 100, 2 years
| Intervention | percentage of participants (Number) |
|---|
| Day 100 | 2 years |
|---|
| Bone Marrow Transplant | 6 | 15 |
Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)
Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). (NCT00134017)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Grades II-IV acute GVHD | Grades III-IV acute GVHD |
|---|
| Bone Marrow Transplant | 49 | 10 |
Chimerism
Number of patients who achieved 100% donor chimerism. (NCT00134017)
Timeframe: Day 30, Day 60
| Intervention | Participants (Count of Participants) |
|---|
| Day 30 | Day 60 |
|---|
| Bone Marrow Transplant | 99 | 101 |
Survival
Median number of months that participants were alive (overall survival) and alive without disease relapse or new diagnosis of myelodysplasia or acute leukemia (event-free survival). (NCT00134082)
Timeframe: Up to 6 years
| Intervention | months (Median) |
|---|
| Overall survival | Event-free survival |
|---|
| Immunotherapy | 31.5 | 24.1 |
Number of Participants With Grade 3-5 Adverse Events
Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention. (NCT00134082)
Timeframe: Up to 36 months
| Intervention | Participants (Count of Participants) |
|---|
| Immunotherapy | 6 |
Days to Neutrophil and Platelet Engraftment
Median number of days to absolute neutrophil count (ANC) >= 500/mcL and platelet count >=20000/mcL. (NCT00134082)
Timeframe: Up to 46 days
| Intervention | days (Median) |
|---|
| Days until ANC >= 500mcL | Days until Platelet Count >=20000/mcL |
|---|
| Immunotherapy | 17 | 21.5 |
To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy
Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment. (NCT00136084)
Timeframe: Measurements were assessed in Induction I chemotherapy
| Intervention | Percent Inhibition of DNA Synthesis (Mean) |
|---|
| Arm 1: (HDAC) | 60.6 |
| Arm 2:(LDAC) | 72.8 |
To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy
Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up (NCT00136084)
Timeframe: Five Year
| Intervention | Percentage of Participants (Number) |
|---|
| Overall | 62.4 |
Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)
To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO) (NCT00136084)
Timeframe: Consolidation I
| Intervention | Participants (Number) |
|---|
| Negative | Positive |
|---|
| Overall | 11 | 4 |
Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO
To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy. (NCT00136084)
Timeframe: Induction II
| Intervention | Participants (Number) |
|---|
| Decrease | Increase or no change |
|---|
| Overall | 27 | 2 |
Minimal Residual Disease (MRD).
Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%). (NCT00136084)
Timeframe: Day 22 MRD measurement
| Intervention | participants (Number) |
|---|
| MRD Positive | MRD Negative |
|---|
| Arm 1: (HDAC) | 31 | 68 |
,| Arm 2:(LDAC) | 43 | 63 |
Relationship of Inhibition of DNA Synthesis and Clinical Response
Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis. (NCT00136084)
Timeframe: Measurements were assessed in Induction I chemotherapy
| Intervention | Percent inhibition of DNA Synthesis (Mean) |
|---|
| Overall | 66.7 |
Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.
To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy (NCT00136084)
Timeframe: Induction II
| Intervention | Participants (Number) |
|---|
| Experienced Grade 3 or 4 toxicities | Did not experience Grade 3 or 4 toxicities |
|---|
| Overall | 27 | 3 |
Minimal Residual Disease (MRD)
Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%). (NCT00137111)
Timeframe: End of Induction (Day 46 MRD measurement)
| Intervention | participants (Number) |
|---|
| Negative <0.01% | Positive >= 0.01% |
|---|
| Total Therapy | 390 | 102 |
Overall Event-free Survival (EFS)
EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate. (NCT00137111)
Timeframe: Median follow-up time (range) 5.6 (1.3 to 8.9) years
| Intervention | Percentage of Participants (Number) |
|---|
| Total Therapy | 87.3 |
Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
"White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count~Measurement: Percentage change of leukemia cells from baseline" (NCT00137111)
Timeframe: Immediately before the methotrexate infusion and three days after subsequent infusion
| Intervention | Percent change (Mean) |
|---|
| 4 hr | -44 |
| 24 hr | -50 |
Continuous Complete Remission Since Week 56 Therapy.
CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate. (NCT00137111)
Timeframe: Median follow up time (range) 4.5 (1 to 7.8) years
| Intervention | Percentage of participants (Number) |
|---|
| Patients With High Risk of CNS Relapse | 92.2 |
Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells. (NCT00137111)
Timeframe: 42 hours after start of high dose methotrexate infusion (HDMTX)
| Intervention | pmol/1,000,000,000 cells (Mean) |
|---|
| 4 hr | 1688 |
| 24 hr | 2521 |
Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation
The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately. (NCT00145626)
Timeframe: Baseline before HSCT, 1 year post HSCT, and up to 5 years post HSCT
| Intervention | Participants (Count of Participants) |
|---|
| Patient 172467502 | Patient 172467503 | Patient 172467501 | Patient 272467501 | Patient 272467502 | Patient 272467503 | Patient 372467501 | Patient 372467502 | Patient 372467503 | Patient 472467501 | Patient 472467502 | Patient 472467503 |
|---|
| Data Not Collected | Positive MRD | Negative MRD |
|---|
| Study Participants: 1 Year Post HSCT | 1 |
| Study Participants: 5 Years Post HSCT | 1 |
| Study Participants: 1 Year Post HSCT | 0 |
| Study Participants: Before HSCT | 0 |
| Study Participants: Before HSCT | 1 |
| Study Participants: 5 Years Post HSCT | 0 |
One-year Survival
"The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system.~The Kaplan-Meier estimate for one-year survival is reported." (NCT00145626)
Timeframe: One year after transplant
| Intervention | percentage of participants (Number) |
|---|
| Study Participants | 50 |
Factors Affecting One-year Survival: Disease Status at HSCT
Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). (NCT00145626)
Timeframe: Up to one year after transplant
| Intervention | participants (Number) |
|---|
| Active Disease | Complete Remission-1 | Complete Remission-2 | Progressive Disease | Relapse |
|---|
| Alive | 0 | 6 | 0 | 1 | 0 |
,| Expired | 1 | 2 | 1 | 0 | 3 |
,| Study Participants | 1 | 8 | 1 | 1 | 3 |
Factors Affecting One-year Survival: Donor Type
Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). (NCT00145626)
Timeframe: Up to one year after transplant
| Intervention | participants (Number) |
|---|
| Father | Mother | Uncle |
|---|
| Alive | 2 | 5 | 0 |
,| Expired | 4 | 2 | 1 |
,| Study Participants | 6 | 7 | 1 |
Factors Affecting One-year Survival: Match N/6 HLA Loci
HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). (NCT00145626)
Timeframe: Up to one year after transplant
| Intervention | participants (Number) |
|---|
| 3/6 HLA Loci | 4/6 HLA Loci |
|---|
| Alive | 6 | 1 |
,| Expired | 3 | 4 |
,| Study Participants | 9 | 5 |
Factors Affecting One-year Survival: Minimal Residual Disease (MRD)
Detection of leukemia blasts in bone marrow by flow cytometry (NCT00145626)
Timeframe: Up to one year after transplant
| Intervention | participants (Number) |
|---|
| Negative for MRD | Positive for MRD |
|---|
| Alive | 2 | 1 |
,| Expired | 1 | 0 |
,| Study Participants | 3 | 1 |
Kinetics of Lymphohematopoietic Reconstitution
The lymphohematopoietic reconstitution will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly. (NCT00145626)
Timeframe: From 0-3 months after HSCT through 4-5 years after HSCT
| Intervention | cells *10^3/µl (Median) |
|---|
| CD3 Lymphocyte | CD3 Gamma Delta | CD4 Lymphocyte | CD8 Lymphocyte | CD19 Lymphocyte | CD56 Lymphocyte | CD4/CD8 Ratio | Absolute Lymphocyte Value |
|---|
| 0-3 Months After HSCT | 0.22 | 0.00 | 0.13 | 0.01 | 0.26 | 0.36 | 2.60 | 0.88 |
,| 1-2 Years After HSCT | 1.65 | 0.70 | 0.96 | 0.61 | 0.45 | 0.22 | 1.88 | 2.59 |
,| 2-3 Years After HSCT | 2.88 | 0.24 | 1.56 | 1.05 | 0.56 | 0.32 | 1.38 | 3.76 |
,| 3-4 Years After HSCT | 2.65 | 0.21 | 1.33 | 1.10 | 0.56 | 0.34 | 1.30 | 3.65 |
,| 3-6 Months After HSCT | 0.57 | 0.04 | 0.42 | 0.09 | 0.48 | 0.33 | 5.53 | 1.29 |
,| 4-5 Years After HSCT | 1.87 | 0.38 | 1.94 | 0.70 | 0.43 | 0.19 | 1.30 | 2.40 |
,| 6-9 Months After HSCT | 1.15 | 0.08 | 0.92 | 0.29 | 0.61 | 0.20 | 3.36 | 1.95 |
,| 9-12 Months After HSCT | 2.24 | 0.09 | 1.37 | 0.36 | 0.52 | 0.19 | 1.90 | 2.90 |
Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery
Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery. (NCT00149214)
Timeframe: surgery after eight 21-day cycles of chemotherapy
| Intervention | participants (Number) |
|---|
| Pemetrexed Plus Doxorubicin, Followed by Docetaxel | 64 |
| Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | 63 |
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol. (NCT00149214)
Timeframe: Cycles 1-4 (21-day cycles)
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Unknown | Not Done |
|---|
| Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | 9 | 43 | 44 | 2 | 17 | 4 |
,| Pemetrexed Plus Doxorubicin, Followed by Docetaxel | 8 | 45 | 49 | 3 | 17 | 9 |
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol. (NCT00149214)
Timeframe: Cycles 5-8 (21-day cycles)
| Intervention | participants (Number) |
|---|
| Complete Tumor Response | Partial Tumor Response | Stable Disease | Progressive Disease | Unknown | Not Done |
|---|
| Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | 21 | 60 | 24 | 1 | 10 | 3 |
,| Pemetrexed Plus Doxorubicin, Followed by Docetaxel | 19 | 59 | 35 | 2 | 9 | 7 |
Number of Participants With a Pathological Complete Response
pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy (NCT00149214)
Timeframe: surgery after eight 21-day cycles of chemotherapy
| Intervention | participants (Number) |
|---|
| Pathological Complete Response | Tumor Cells Still Present | Not evaluable |
|---|
| Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | 24 | 89 | 6 |
,| Pemetrexed Plus Doxorubicin, Followed by Docetaxel | 21 | 99 | 7 |
Disease-free Survival
Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date. (NCT00149214)
Timeframe: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)
| Intervention | months (Median) |
|---|
| Pemetrexed Plus Doxorubicin, Followed by Docetaxel | NA |
| Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | NA |
Dynamic Levels of Plasma VEGF
Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1. (NCT00151281)
Timeframe: 38 months
| Intervention | pg/mL (Median) |
|---|
| RT-PEPC Drug Therapy | 109.5 |
Overall Survival and Progression Free Survival
measured by overall Response Rate (ORR), which includes Complete response and partial response. (NCT00151281)
Timeframe: 38 months
| Intervention | percentage of patients (Number) |
|---|
| Study Treatment Arm | 73 |
Asses the Toxicity Profiles
Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0. (NCT00151281)
Timeframe: 38 months
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3 or 4 neutropenia | Anemia | Thrombocytopenia | Fatigue | Constipation | Cough | Nausea | Neuropathy | Dyspnea | Rash |
|---|
| RT-PEPC Drug Therapy | 14 | 1 | 4 | 22 | 14 | 14 | 13 | 13 | 11 | 10 |
The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment
"QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.~ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below." (NCT00151281)
Timeframe: baseline, every 2 months until Month 6, and every 6 months until disease progression
| Intervention | FACT-G score (Mean) |
|---|
| Mean FACT-G Score at baseline | Mean Total FACT-G Score between all time points |
|---|
| RT-PEPC Drug Therapy | 83.3 | 89.4 |
Survival Time
Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis. (NCT00157196)
Timeframe: Up to data cut-off date (17 September 2007)
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care | NA |
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported. (NCT00157196)
Timeframe: Up to data cut-off date (17 September 2007)
| Intervention | participants (Number) |
|---|
| TEAEs | Serious TEAEs | TEAEs with CALGB-ECTC Grade 3 or 4 | TEAEs leading to death | ISRs |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care | 22 | 4 | 13 | 1 | 11 |
Progression Free Survival (PFS) Time
PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment. (NCT00157196)
Timeframe: Up to data cut-off date (17 September 2007)
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care | NA |
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported. (NCT00157209)
Timeframe: From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)
| Intervention | participants (Number) |
|---|
| TEAEs | Serious TEAEs | TEAEs leading to death | TEAEs with CALGB toxicity Grade 3 or 4 |
|---|
| Best Supportive Care (BSC) Alone | 80 | 34 | 20 | 42 |
,| Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) | 88 | 29 | 13 | 42 |
Number of Participants With Elevated CA27-29 Antigen Levels
CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis. (NCT00157209)
Timeframe: Study entry, Week 8
| Intervention | participants (Number) |
|---|
| Study entry (n=84, 82) | Week 8 (n=82, 71) |
|---|
| Best Supportive Care (BSC) Alone | 21 | 18 |
,| Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) | 21 | 20 |
Overall Survival Time
Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier. (NCT00157209)
Timeframe: Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) | 17.2 |
| Best Supportive Care (BSC) Alone | 13.0 |
Number of Participants With Positive T-cell Proliferation
T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported. (NCT00157209)
Timeframe: Time from randomization until cut-off date (15 March 2006)
| Intervention | participants (Number) |
|---|
| Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) | 16 |
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score
"Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL." (NCT00157209)
Timeframe: At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.
| Intervention | Units on a scale (Mean) |
|---|
| Baseline (n=88, 78) | Week 4 (n=86, 75) | Week 8 (n=84, 73) | Week 19 (n=54, 55) | Week 31(n=34, 36) | Week 43 (n=31, 20) |
|---|
| Best Supportive Care (BSC) Alone | 106.4 | 104.1 | 101.6 | 100.1 | 103.5 | 111.6 |
,| Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) | 109.3 | 109.4 | 108.1 | 108.2 | 110.1 | 110.3 |
Number of Patients Alive Without Disease
The number of patients alive one year after treatment without any signs or symptoms of the cancer being treated or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. (NCT00167180)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg | 2 |
| DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg | 10 |
Number of Patients Alive
"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.~Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive." (NCT00167180)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg | 3 |
| DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg | 20 |
Number of Participants With Complete Remission
In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body. (NCT00167180)
Timeframe: one year
| Intervention | Participants (Count of Participants) |
|---|
| DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg | 7 |
| DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg | 22 |
Number of Patients With Acute Graft-Versus-Host Disease
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00167180)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg | 10 |
| DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg | 10 |
Number of Patients With Bone Marrow Aplasia
"Aplastic anemia is a disorder in which the bone marrow greatly decreases or stops production of blood cells.~In aplastic anemia, the basic structure of the marrow becomes abnormal, and those cells responsible for generating blood cells (hematopoietic cells) are greatly decreased in number or absent. These hematopoietic cells are replaced by large quantities of fat." (NCT00167180)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg | 0 |
| DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg | 1 |
Number of Patients Who Exhibited Secondary Graft Failure
Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. A complication after Bone Marrow Transplant in which the transplanted stem cells do not grow in the recipient's bone marrow and thus do not produce new blood cells. (NCT00167206)
Timeframe: Day 100 after hematopoietic cell transplant
| Intervention | Participants (Number) |
|---|
| Intent-To-Treat | 1 |
Number of Patients With Chronic Graft Versus-Host Disease (GVHD)
"Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack." (NCT00167206)
Timeframe: 1 year after hematopoietic cell transplant
| Intervention | Participants (Number) |
|---|
| Intent-To-Treat | 2 |
Number of Patients With Acute Graft Versus-Host Disease (aGVHD)
"Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack." (NCT00167206)
Timeframe: Day 100 after hematopoietic cell transplant
| Intervention | Participants (Number) |
|---|
| Intent-To-Treat | 8 |
Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment
Calculated from Day 1 of hematopoietic cell transplant to Day 42 post-transplant. Hematopoietic recovery and engraftment is defined as the first of three consecutive days the patient's absolute neutrophil count is greater than or equal to 0.5X10^9/Liter. (NCT00167206)
Timeframe: Day 42 after hematopoietic cell transplant
| Intervention | Participants (Number) |
|---|
| Intent-To-Treat | 15 |
Number of Patients Alive at 2 Years
Calculated from Day 1 of hematopoietic cell transplant to 2 years post-transplant. (NCT00167206)
Timeframe: 2 years after transplant
| Intervention | Participants (Number) |
|---|
| Intent-To-Treat | 10 |
Immune Reconstitution - Mean Value (2 Years)
Calculated mean value of patient CD4 values collected at intervals from Day 30 through 2 years post-transplant. (NCT00167206)
Timeframe: at 2 years after transplant
| Intervention | Number of CD4 cells per microliter (Mean) |
|---|
| Intent-To-Treat | 1100 |
Number of Patients Alive at 1 Year
Calculated from Day 1 of hematopoietic cell transplant to 1 year post-transplant. (NCT00167206)
Timeframe: 1 year after transplant
| Intervention | Participants (Number) |
|---|
| Intent-To-Treat | 11 |
Immune Reconstitution - Mean Value (1 Year)
Calculated mean value of patient CD4 values collected at intervals from Day 30 through 1 year post-transplant. (NCT00167206)
Timeframe: 1 year post-transplant.
| Intervention | Number of CD4 cells per microliter (Mean) |
|---|
| Intent-To-Treat | 860 |
Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years
This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission. (NCT00176462)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 2 High Risk | 64.9 |
PSA Response Rate
The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period. (NCT00176605)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 1 (Etoposide + Cyclophosphamide) | 15.4 |
Probability of Long-term Disease-free Survival (DFS)
Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. (NCT00176839)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Treatment Arm | 3 |
Incidence Chronic Graft-versus-host Disease (GVHD)
Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. (NCT00176839)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Treatment Arm | 0 |
Incidence of Acute Graft-versus-host Disease (GVHD)
Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. (NCT00176839)
Timeframe: 100 days post-transplant
| Intervention | participants (Number) |
|---|
| Treatment Arm | 7 |
Incidence of Regimen-related Toxicity 100 Days Post Transplant
Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. (NCT00176839)
Timeframe: 100 days post-transplant
| Intervention | participants (Number) |
|---|
| Treatment Arm | 3 |
Incidence of Relapse
Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. (NCT00176839)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Treatment Arm | 2 |
Probability of Engraftment
Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.. (NCT00176839)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Treatment Arm | 10 |
Disease Free Survival
Number of patients alive without disease 1 year after transplant. (NCT00176852)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 3 |
| MA Bu/Cy (B) | 5 |
| RIC Cy/Flu/TBI (A2) | 11 |
Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment
"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death." (NCT00176852)
Timeframe: pre-transplant
| Intervention | units on a scale (Median) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 100 |
| MA Bu/Cy (B) | 98 |
| RIC Cy/Flu/TBI (A2) | 99 |
Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment
"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death." (NCT00176852)
Timeframe: 2 years
| Intervention | units on a scale (Median) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 100 |
| MA Bu/Cy (B) | 100 |
| RIC Cy/Flu/TBI (A2) | 100 |
The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)
The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant. (NCT00176852)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 0 |
| MA Bu/Cy (B) | 0 |
| RIC Cy/Flu/TBI (A2) | 0 |
The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD)
The number of patients who experienced grades 3-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. IGrades 3-4 equate to moderate to severe disease. Symptoms typically appear within weeks after transplant. (NCT00176852)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 0 |
| MA Bu/Cy (B) | 0 |
| RIC Cy/Flu/TBI (A2) | 0 |
The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD)
The number of patients who experienced grades 2-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Grades 2-4 equate to mild to severe disease. Symptoms typically appear within weeks after transplant. (NCT00176852)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 0 |
| MA Bu/Cy (B) | 0 |
| RIC Cy/Flu/TBI (A2) | 0 |
The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)
The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant. (NCT00176852)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 0 |
| MA Bu/Cy (B) | 0 |
| RIC Cy/Flu/TBI (A2) | 0 |
Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment
"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death." (NCT00176852)
Timeframe: 1 year
| Intervention | units on a scale (Median) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 97 |
| MA Bu/Cy (B) | 100 |
| RIC Cy/Flu/TBI (A2) | 100 |
The Incidence of Chimerism at 6 Months
The number of patients whose blood and/or bone marrow contains > 10% donor cells. (NCT00176852)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 1 |
| MA Bu/Cy (B) | 5 |
| RIC Cy/Flu/TBI (A2) | 8 |
The Incidence of Chimerism at 100 Days
The number of patients whose blood and/or bone marrow contains > 10% donor cells. (NCT00176852)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 1 |
| MA Bu/Cy (B) | 5 |
| RIC Cy/Flu/TBI (A2) | 11 |
The Incidence of Chimerism at 1 Year
The number of patients whose blood and/or bone marrow contains > 10% donor cells. (NCT00176852)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 1 |
| MA Bu/Cy (B) | 5 |
| RIC Cy/Flu/TBI (A2) | 8 |
Overall Survival
Number of patients alive 100 days after transplant. (NCT00176852)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 3 |
| MA Bu/Cy (B) | 5 |
| RIC Cy/Flu/TBI (A2) | 12 |
Overall Survival
Number of patients alive 1 year after transplant. (NCT00176852)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 3 |
| MA Bu/Cy (B) | 5 |
| RIC Cy/Flu/TBI (A2) | 12 |
Disease Free Survival
Number of patients alive without disease 100 days after transplant. (NCT00176852)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| RIC Bu/Flu (A) (Discontinued) | 3 |
| MA Bu/Cy (B) | 5 |
| RIC Cy/Flu/TBI (A2) | 11 |
Number of Patients With Grade II-IV Acute Graft-Versus-Host Disease
Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening. (NCT00176904)
Timeframe: Day 100
| Intervention | Participants (Number) |
|---|
| Patients Treated With Stem Cell Transplant | 34 |
Number of Patients With Chronic Graft-Versus-Host Disease
Number of patients who exhibited chronic graft-versus-host disease by 1 Year post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Chronic GVHD is an extension of this syndrome. (NCT00176904)
Timeframe: 1 Year Post Transplant
| Intervention | Participants (Number) |
|---|
| Patients Treated With Stem Cell Transplant | 13 |
Overall Survival
Number of patients alive at designated timepoints after transplant. (NCT00176904)
Timeframe: 100 Days, 1 Year and 3 Years
| Intervention | Participants (Number) |
|---|
| Day 100 | 1 Year | 3 Years |
|---|
| Patients Treated With Stem Cell Transplant | 120 | 92 | 81 |
Overall Donor Engraftment
Number of patients with full donor chimerism (state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease) by Day 100 post-transplant of at least 90%. (NCT00176904)
Timeframe: Day 100
| Intervention | Participants (Number) |
|---|
| Patients Treated With Stem Cell Transplant | 123 |
Number of Patients With Grade III-IV Acute Graft-Versus-Host Disease
Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening. (NCT00176904)
Timeframe: Day 100
| Intervention | Participants (Number) |
|---|
| Patients Treated With Stem Cell Transplant | 13 |
Number of Patients Surviving on Study
Number of patients surviving (alive) at specified timepoints. (NCT00176917)
Timeframe: at 100 days, 1 year, and 3 years post transplant
| Intervention | Participants (Number) |
|---|
| Day 100 Post Transplant | 1 Year Post Transplant | 3 Years Post Transplant |
|---|
| Transplant Patients | 37 | 28 | 27 |
Number of Patients Who Failed Engraftment.
Toxicity (undesireable effect) of hematologic donor cell engraftment is determined by failure to engraft at Day 42. (NCT00176917)
Timeframe: Day 42 Post Transplant
| Intervention | Participants (Number) |
|---|
| Transplant Patients | 1 |
Number of Patients With Grade III-IV Acute Graft-versus-host Disease (aGVHD).
Toxicity (undesireable effect) of this stem cell transplant preparative regimen due to acute graft-versus-host disease. (NCT00176917)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Number) |
|---|
| Transplant Patients | 2 |
Mean Percentage of Donor Cells in Study Population (Chimerism).
Donor-derived engraftment determined by restriction fragment length polymorphism (RFLP). (NCT00176917)
Timeframe: at 21 days, 42 days, 60 days, 100 days, 6 months, and 1 year
| Intervention | Percentage (Mean) |
|---|
| 21 Days Post Transplant | 42 Days Post Transplant | 60 Days Post Transplant | 100 Days Post Transplant | 6 Months Post Transplant | 1 Year Post Transplant |
|---|
| Transplant Patients | 85.8 | 73.2 | 84.6 | 81.1 | 81.6 | 91.5 |
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working. (NCT00176930)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 4 |
| Marrow : No TBI | 9 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 100 |
| Marrow | 52 |
| Umbilical Cord Blood | 2 |
| Co-Enroll From MT0403 | 2 |
Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT00176930)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 4 |
| Marrow : No TBI | 4 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 69 |
| Marrow | 20 |
| Umbilical Cord Blood | 0 |
| Co-Enroll From MT0403 | 0 |
Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT00176930)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 3 |
| Marrow : No TBI | 4 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 63 |
| Marrow | 17 |
| Umbilical Cord Blood | 0 |
| Co-Enroll From MT0403 | 0 |
Number of Participants Who Were Alive at 5 Year Post Transplant
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. (NCT00176930)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 3 |
| Marrow : No TBI | 9 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 100 |
| Marrow | 54 |
| Umbilical Cord Blood | 2 |
| Co-Enroll From MT0403 | 2 |
Number of Participants With Neutrophil Engraftment
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater. (NCT00176930)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 11 |
| Marrow : No TBI | 13 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 1 |
| PBSC | 206 |
| Marrow | 83 |
| Umbilical Cord Blood | 2 |
| Co-Enroll From MT0403 | 2 |
Number of Participants With Chronic Graft-Versus-Host Disease
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. (NCT00176930)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 4 |
| Marrow : No TBI | 2 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 87 |
| Marrow | 14 |
| Umbilical Cord Blood | 0 |
| Co-Enroll From MT0403 | 1 |
Number of Participants With Acute Graft-versus-host Disease (GVHD)
"Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging.~Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level." (NCT00176930)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 6 |
| Marrow : No TBI | 2 |
| UCB : No TBI | 1 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 89 |
| Marrow | 23 |
| Umbilical Cord Blood | 0 |
| Co-Enroll From MT0403 | 0 |
Number of Participants Who Were Alive at 2 Year Post Transplant
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. (NCT00176930)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 5 |
| Marrow : No TBI | 11 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 122 |
| Marrow | 59 |
| Umbilical Cord Blood | 2 |
| Co-Enroll From MT0403 | 2 |
Number of Participants Experiencing Engraftment Failure
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets. (NCT00176930)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 0 |
| Marrow : No TBI | 0 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 1 |
| Marrow | 0 |
| Umbilical Cord Blood | 0 |
| Co-Enroll From MT0403 | 0 |
Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working. (NCT00176930)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| PBSC: No TBI | 3 |
| Marrow : No TBI | 9 |
| UCB : No TBI | 0 |
| UCB : No TBI/Bu/Cy/ATG | 0 |
| PBSC | 85 |
| Marrow | 48 |
| Umbilical Cord Blood | 2 |
| Co-Enroll From MT0403 | 2 |
Time to Progression
Mean number of days among patients progressing (NCT00177047)
Timeframe: 1 year
| Intervention | Days (Mean) |
|---|
| Chemotherapy and Transplant Treatment | 159.4 |
Time to Attainment of CR+PR
"Mean (STD) among patients achieving complete remission (CR) and partial remission (PR)~Myeloma Response Definitions - Using International Uniform Response Criteria:~Complete Response (CR):~Absence of the original monoclonal paraprotein~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas.~Partial Response (PR):~Greater than or equal to 50% reduction in the level of the serum monoclonal paraprotein and/or reduction in 24 hour urinary monoclonal paraprotein either by greater than or equal to 90% or to <200 mg/24 hours in light chain disease.~If the only measurable non-bone marrow parameter is FLC, greater than or equal to 50% reduction in the difference between involved and uninvolved FLC levels or a 50% decrease in level" (NCT00177047)
Timeframe: 12 months post transplant
| Intervention | months (Mean) |
|---|
| Chemotherapy and Transplant Treatment | 4.3 |
Time to Attainment of CR
"Mean (STD) among patients achieving complete remission (CR)~Myeloma Response Definitions - Using International Uniform Response Criteria:~Complete Response (CR):~Absence of the original monoclonal paraprotein~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas" (NCT00177047)
Timeframe: 12 months post transplant
| Intervention | months (Mean) |
|---|
| Chemotherapy and Transplant Treatment | 4.6 |
Number of Participants With Toxicities
Occurrence of toxicities by first 100 days of transplant (NCT00177047)
Timeframe: By first 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 68 |
Number of Participants With Overall Survival
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. (NCT00177047)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 301 |
Number of Participants With Overall Survival
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. (NCT00177047)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 328 |
Number of Participants With Overall Survival
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. (NCT00177047)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 349 |
Number of Participants With Infections
Occurrence of infections in the patients by the first 100 days of transplant (NCT00177047)
Timeframe: By first 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 68 |
Number of Participants With Disease Progression
"Myeloma Response Definitions - Using International Uniform Response Criteria:~Progressive Disease (PD)~For patients not in CR or sCR, progressive disease requires one or more of the following:~>25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL.~>25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours.~Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl), only in patients without measurable paraprotein in the serum and urine.~>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.~Definite increase in the size of existing bone lesions or soft tissue plasmacytomas." (NCT00177047)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 34 |
Number of Participants With Absolute Neutrophil Recovery
Hematologic recovery is defined by absolute neutrophil count (ANC) >2500/μl and platelets > 100,000/μl (NCT00177047)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 363 |
Number of Patients With Extended Disease-free Survival
Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression. (NCT00177047)
Timeframe: 36 Months
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 164 |
Number of Participants Experiencing Incidence of Relapse
The return of disease after its apparent recovery/cessation. (NCT00177047)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 69 |
Number of Participants Achieving a Complete Response
"Myeloma Response Definitions - Using International Uniform Response Criteria:~Stringent Complete Response (sCR)requires, plus CR:~Normal free light chain ratio~Absence of clonal cells in bone marrow~Complete Response (CR):~Absence of the original monoclonal paraprotein~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas." (NCT00177047)
Timeframe: 6 months post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 99 |
Number of Participants Achieving a Complete Response
"Myeloma Response Definitions - Using International Uniform Response Criteria:~Stringent Complete Response (sCR)requires, plus CR:~Normal free light chain ratio~Absence of clonal cells in bone marrow~Complete Response (CR):~Absence of the original monoclonal paraprotein~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas." (NCT00177047)
Timeframe: 12 months post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 123 |
Number of Participants Achieving a Complete Response
"Myeloma Response Definitions - Using International Uniform Response Criteria:~Stringent Complete Response (sCR)requires, plus CR:~Normal free light chain ratio~Absence of clonal cells in bone marrow~Complete Response (CR):~Absence of the original monoclonal paraprotein~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas." (NCT00177047)
Timeframe: 100 Days post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy and Transplant Treatment | 51 |
Time to Relapse
Mean number of days among patients relapsing (NCT00177047)
Timeframe: 1 year
| Intervention | Days (Mean) |
|---|
| Chemotherapy and Transplant Treatment | 182.9 |
5-Year Overall Survival Rate
Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up (NCT00182793)
Timeframe: From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment.
| Intervention | percentage of participants (Median) |
|---|
| All Patients | 75 |
5-Year Relapse-free Survival Rate
Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically. (NCT00182793)
Timeframe: From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment
| Intervention | percentage of participants (Median) |
|---|
| All Patients | 53 |
Percentage of Patients With Complete Response to the Combination Chemotherapy
"Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.~Response to the study treatment will be determined according to the criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al (23)." (NCT00184002)
Timeframe: At completion of cycle 4, 6, and 8
| Intervention | Percentage of participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| DR-COP | 75.0 | 23.0 |
Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom. (NCT00184002)
Timeframe: At end of every cycle
| Intervention | Participants (Count of Participants) |
|---|
| DR-COP | 35 |
Relapse Rate
Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase). (NCT00185614)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Auto-HCT only | Auto-HCT then Allo-HCT | All Participants |
|---|
| Auto- Then Allo-HCT | 2 | 29 | 31 |
Overall Survival (OS)
Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant. (NCT00185614)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Auto-HCT only | Auto-HCT then Allo-HCT | All Participants |
|---|
| Auto- Then Allo-HCT | 1 | 41 | 42 |
Event-free Survival (EFS)
"Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. Event was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years." (NCT00185614)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Auto-HCT only | Auto-HCT then Allo-HCT | All Participants |
|---|
| Auto- Then Allo-HCT | 0 | 24 | 24 |
Acute Graft-vs-Host-Disease (aGvHD)
Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT. (NCT00185614)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Auto- Then Allo-HCT | 7 |
Overall Survival (OS)
OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate. The probability of survival at 5 years after diagnosis is given. (NCT00186875)
Timeframe: 2 years after last patient completes therapy (approximately 4 years after enrollment)
| Intervention | probability (Mean) |
|---|
| Standard Risk | 0.654 |
| High Risk | 0.357 |
Response Rate
"The response rate is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology." (NCT00186875)
Timeframe: End of re-induction Block C (approximately 1 month after the start of therapy)
| Intervention | proportion of participants (Number) |
|---|
| Complete remission | Failure to reach complete remission |
|---|
| High Risk | 0.786 | 0.214 |
,| Standard Risk | 0.846 | 0.154 |
Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block B is defined as the proportion of MRD positives. (NCT00186875)
Timeframe: End of Block B therapy (Day 19)
| Intervention | Participants (Count of Participants) |
|---|
| Negative <0.01% | Positive ≥0.01% |
|---|
| High Risk | 2 | 10 |
,| Standard Risk | 11 | 11 |
,| TOTXV Participants | 191 | 297 |
Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block C is defined as the proportion of MRD positives. (NCT00186875)
Timeframe: End of Block Block C therapy (Day 46)
| Intervention | Participants (Count of Participants) |
|---|
| Negative <0.01% | Positive ≥0.01% |
|---|
| High Risk | 1 | 8 |
,| Standard Risk | 11 | 9 |
,| TOTXV Participants | 390 | 102 |
Mean Primary Visual Cortex Function: Maximum T-value
"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neurology, London). The maximum t-statistic in activated cluster (negative BOLD) is provided.~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time." (NCT00186888)
Timeframe: At diagnosis through 6 years after last patient enrollment
| Intervention | Maximum t-statistic (negative BOLD) (Mean) |
|---|
| Stratum A | 7.9 |
| Stratum B | 6.2 |
| Stratum C | 8.8 |
Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification
"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum A-Early Disease | 0.839 |
| Stratum A-Advanced Disease | 0.667 |
| Stratum B-Early Disease | 1.0 |
| Stratum B-Advanced Disease | 0.743 |
Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment
"To estimate the 5-year ocular survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival of eye will be defined per eye as the time interval from date on study to date of enucleation or date of last follow-up. Ocular survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum B | 0.763 |
Ocular Survival of Eyes of Stratum B Patients
"To estimate the 5-year ocular survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum B | 1.0 |
Assessment of School Readiness
The Bracken Basic Concepts Scale was used to assess school readiness. It is an examiner-administered measure that assesses per-academic skills including letter and number recognition, shapes, colors, and understanding of sizes and comparisons. Raw scores are converted into age-normed scaled scores (normative mean = 10, SD = 3) for the School Readiness Composite. Higher scores are indicative of stronger pre-academic skills, with scores from 7 to 13 within the Average range. (NCT00186888)
Timeframe: Patients were assessed at 5 years of age
| Intervention | units on a scale (Mean) |
|---|
| 5 Years | 8.96 |
Ocular Survival of Stratum A Patients
"To estimate the 5-year ocular survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum A | 0.688 |
Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification
"To describe the 5-year event-free survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately" (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum A-Early Disease | 0.857 |
| Stratum A-Advanced Disease | 0.500 |
| Stratum B-Early Disease | 1.0 |
| Stratum B-Advanced Disease | 0.719 |
Change in Cognitive Functioning
The Early Learning Composite was assessed with Mullen Scales of Early Learning, a measure of developmental functioning appropriate for use with children from birth through age 5. It is an examiner-administered instrument that uses toys, games, pictures, and other objects to elicit information about a child's language, fine and gross motor skills, and overall early learning capabilities. Raw scores are converted to an age-normed standard score (normative mean = 100, SD = 15) for the overall Early Learning Composite. This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range. (NCT00186888)
Timeframe: Baseline (at study entry) and at ages 6 months, 1 year, 2 years, 3 years and 5 years
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 91.61 |
| 6 Months | 90.96 |
| 1 Year | 95.91 |
| 2 Years | 88.40 |
| 3 Years | 82.12 |
| 5 Years | 86.00 |
Change in Parent Report of Social-Emotional Factors
This outcome was measured using the Ages and Stages Questionnaire which is a parent-completed measure of a child's social-emotional functioning. Raw scores are calculated and compared to cut-off points by age (6 months = 45; 1 year = 48; 2 years = 50; 3 years = 59; 5 years =70). Higher scores are indicative of more problems with scores above the cut-off indicating significant concerns warranting additional follow-up. Possible scores range from 0 to 200+, depending on the number of items administered, which varies by the age of the child (19 to 33 items). However, the primary use of this tool is as a screener. Thus, typically, scores are interpreted as they compare to the identified cut-offs, with children who score above the cut-off referred for further evaluation. This measure was given at all time points. (NCT00186888)
Timeframe: Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 40 |
| 6 Months | 19.42 |
| 1 Year | 26.28 |
| 2 Years | 29.67 |
| 3 Years | 40.61 |
| 5 Years | 39.93 |
Event-free Survival of Stratum A Patients
"To estimate the 5-year event-free survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum A | 0.688 |
Change in Relevant Daily Living Skills
The Adaptive Behavior composite was measured using the Vineland Scales of Adaptive Behavior (VABS) which is an examiner-administered semi-structured interview that assesses adaptive functioning from birth through adulthood. Subscales including motor skills, communication, socialization, and daily living skills combine into an overall adaptive behavior composite which is an age-normed standard score (normative mean = 100, SD = 15). This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range. (NCT00186888)
Timeframe: Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 97.48 |
| 6 Months | 104.73 |
| 1 Year | 106.06 |
| 2 Years | 94.22 |
| 3 Years | 96.45 |
| 5 Years | 93.03 |
Ocular Survival of Stratum B Patients Responding to Window Treatment
"To estimate the 5-year ocular survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival" (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum B | 0.667 |
Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification
"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma . The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately" (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum A-Early Disease | 0.857 |
| Stratum A-Advanced Disease | 0.500 |
| Stratum B-Early Disease | 1.0 |
| Stratum B-Advanced Disease | 0.719 |
Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants.
Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol. (NCT00186888)
Timeframe: Courses 1, 2, 5, and 8
| Intervention | Liters/hour/m^2 (Median) |
|---|
| Stratum B | 18.8 |
Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification
"To describe the 5-year event-free survival of the eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum A-Early Disease | 0.839 |
| Stratum A-Advanced Disease | 0.667 |
| Stratum B-Early Disease | 1.0 |
| Stratum B-Advanced Disease | 0.743 |
Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment
"To estimate the 5-year event-free survival (EFS) of eyes of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year EFS." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum B | 0.763 |
Change in Distortion Product Otoacoustic Emissions (DPOAEs)
For DP_amplitude to be considered valid, a baseline DP_SNR (Distortion Product for Signal-to-noise ratio) for each frequency (1000-8000 Hz) and for each ear (left and right) must be = 6 dB. Any ear with invalid amplitude at baseline for each frequency should be excluded. The DPOAEs amplitude levels were averaged across the right and left ears at each frequency in the patients exhibiting valid DPOAE amplitudes in both ears, resulting in mean DPOAE levels. Subsequently, comparisons between baseline and most recent evaluation (collapsed across ears) for each frequency were made to evaluate if a significant decrease in DPOAE amplitude exists between the two time points. (NCT00186888)
Timeframe: From Diagnosis through 5 years after completion of therapy
| Intervention | dB (Mean) |
|---|
| 1000 Hz | 1400 Hz | 2000 Hz | 2800 Hz | 4000 Hz | 6000 Hz | 8000 Hz |
|---|
| Additional Evaluation | 4.5 | 8.2 | 11.0 | 8.4 | 3.4 | 5.7 | -9.9 |
,| Baseline | 17.7 | 16.6 | 15.1 | 11.6 | 15.3 | 13.3 | 5.0 |
,| Interim Evaluation | 5.5 | 9.4 | 13.0 | 12.2 | 11.3 | 12.9 | -2.0 |
Change in Parenting Stress Index (PSI)
The PSI is a commonly used measure of parenting stress. In 101 questions, the PSI delineates between stress as a function of child characteristics (e.g., adaptability, demandingness, mood; Child Domain) and stress as a function of parent characteristics (e.g., depression, sense of competence, social isolation; Parent Domain), as well as an overall stress score (Total Stress). Raw scores are calculated (normative means: Child Doman = 98.4; Parent Domain = 122.7; Total Stress Score = 221.1). This measure was given at all time points. Scores range from 131-320 for Total Stress, 69-188 for Parent Domain, and 50-145 for Child Domain, with higher scores indicative of greater stress (Total: >260; Parent: >153, Child: >122). (NCT00186888)
Timeframe: Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years
| Intervention | units on a scale (Mean) |
|---|
| Child Domain | Parent Domain | Overall Total Stress |
|---|
| 1 Year | 93.27 | 105.84 | 200.51 |
,| 2 Years | 92.77 | 105.84 | 198.61 |
,| 3 Years | 94.60 | 105.92 | 200.23 |
,| 5 Years | 92.49 | 102.74 | 194.68 |
,| 6 Months | 93.08 | 101.56 | 194.84 |
,| Baseline | 96.76 | 109.38 | 207.25 |
Number of Participants With Change in Size of Pineal Gland
The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in pineal gland size is reported here. (NCT00186888)
Timeframe: From diagnosis through 6 years after last patient enrollment
| Intervention | Participants (Count of Participants) |
|---|
| Prominent or mildly enlarged pineal glands | Pineal growth over time | No change in pineal gland size |
|---|
| Participants With Bilateral Retinoblastoma | 12 | 8 | 23 |
Number of Participants With Development of Pineal Cysts
The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in primary visual cortex function from diagnosis through 6 years after last patient enrollment is reported here. (NCT00186888)
Timeframe: At diagnosis through 6 years after last patient enrollment
| Intervention | Participants (Count of Participants) |
|---|
| Developed new solitary cyst(s) | Developed multiple new cysts | Growth of pineal cyst | Decrease in size (resolution) of pineal cyst | No change |
|---|
| Participants With Bilateral Retinoblastoma | 12 | 15 | 5 | 1 | 11 |
Number of Patients Recommended for and Utilizing Rehabilitation Services
"Participants were evaluated by Occupational Therapy at diagnosis, and at 3, 6, 9, and 12 months from diagnosis with a battery of standardized and non-standardized measures. Assessments including the Battelle Developmental Inventory, the Sensory Profile, the Oregon Project for Visually Impaired Preschoolers, Pediatric Evaluation of Disability Inventory, and the Greenspan Social Emotional Growth Scale were utilized for developing the participants plan of care and making referrals for services in the home community. Recommendations for rehabilitation services in the home community were made based on the results of the occupational therapists evaluation.~A subsequent review of February 2013 subgroup definitions resulted in the reclassification of evaluable participants and subgroups in May 2015. This reclassification applies to the data for this outcome only." (NCT00186888)
Timeframe: At diagnosis, and at 3, 6, 9, and 12 months from diagnosis
| Intervention | participants (Number) |
|---|
| Received rehabilitation services | Did not receive rehabilitation services |
|---|
| Occupational Therapy Did Not Recommend Rehabilitation Services | 1 | 5 |
,| Occupational Therapy Recommended Rehabilitation Services | 12 | 4 |
Stratum B Response Rate of Early Stage Eyes to Window Therapy
To estimate the proportion of early stage eyes defined as Reese-Ellsworth Group I, II, or III eyes, that responded to 2 courses of window therapy which consisted of vincristine and topotecan (NCT00186888)
Timeframe: Six weeks post window therapy.
| Intervention | Participants (Number) |
|---|
| Partial response | Progressive Disease / New lesion | Failure due to Toxicity |
|---|
| Stratum B | 11 | 0 | 1 |
Event-free Survival of Eyes of Stratum B Patients
"To estimate the 5-year event-free survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum B | 1.0 |
Stratum B Response to Window Therapy
The primary outcome is to estimate the proportion of stratum B patients responding to 2 courses of window therapy consisting of vincristine and topotecan. Complete Response is the complete regression of all apparent tumor masses in the funduscopic examination and by MRI and ultrasound (US). Partial Response is defined as greater than 50% (but less than 100%) reduction of the tumor masses in the funduscopic examination and by US and MRI, without the appearance of any new lesions. The response must persist for at least 4 weeks. Stratum A and C did not receive window therapy. (NCT00186888)
Timeframe: Six weeks post window therapy
| Intervention | Participants (Number) |
|---|
| Partial response | Progressive Disease or New Lesion | Failure due to Toxicity |
|---|
| Stratum B | 24 | 2 | 1 |
Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants.
Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol. (NCT00186888)
Timeframe: Courses 1, 2, 5, and 8
| Intervention | Liters/hour/m^2 (Median) |
|---|
| Stratum B | 18.8 |
Event-free Survival of Stratum B Patients Responding to Window Treatment
"To estimate the 5-year event-free (EFS) survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up
| Intervention | probability (Number) |
|---|
| Stratum B | 0.667 |
Mean Primary Visual Cortex Function: Cluster Size
"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neuology, London).~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time." (NCT00186888)
Timeframe: At diagnosis through 6 years after last patient enrollment
| Intervention | number activated voxels (negative BOLD) (Mean) |
|---|
| Stratum A | 2372 |
| Stratum B | 1080 |
| Stratum C | 2105 |
Day That Maximum NK Cell Engraftment Was Reached
The time elapsed after transplantation in days until peak KIR-mismatched donor NK cell expansion was reached in recipients (NCT00187096)
Timeframe: Day 0 through Day 28 post NK cell transplantation
| Intervention | number of days (Median) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 14 |
Duration of Engraftment of Natural Killer (NK) Cells
NK cell engraftment defined as NK cell chimerism in recipients. (NCT00187096)
Timeframe: Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated
| Intervention | Days (Median) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 10 |
Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant
Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria. (NCT00187096)
Timeframe: Beginning at on therapy through 100 days post-transplant
| Intervention | participants (Number) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 2 |
| Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine | 3 |
| Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide | 11 |
Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562)
NK cells in recipient achieving ability to lyse target cell line (K562) within normal range established by donor NK cells. (NCT00187096)
Timeframe: Days 2, 7, 14, 21, and 28 after NK cell transplantation
| Intervention | participants (Number) |
|---|
| Lysed within normal range | Did not Lyse within normal range |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 10 | 0 |
Percent of Peak NK Cell Chimerism
The maximum percent of donor NK cell in recipients during a four-week period after NK cell infusion. (NCT00187096)
Timeframe: Days 2, 7, 14, 21 and 28 after NK cell transplantation
| Intervention | percent of NK cells (Median) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 7 |
Relapse-free Survival
For Arm 1, the efficacy of NK cell transplantation will be reported as the proportion of participants who achieve complete or partial remission. Kaplan-Meier estimates of relapse-free survival and confidence interval was determined by binomial distribution because no events were observed. The binomial interval is based on the number of patients at risk. (NCT00187096)
Timeframe: Up to 2 years post NK cell transplantation
| Intervention | Percent probability (Number) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 100 |
Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant
Document the proportion of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria. (NCT00187096)
Timeframe: Beginning at on therapy through 100 days post-transplant
| Intervention | proportion of patients (Number) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 0.20 |
| Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine | 1.00 |
| Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide | 0.917 |
Number of KIR-mismatched NK Cells
Number of KIR-mismatched donor NK cells in recipients' blood at day 2 and day 14 post NK cell infusion. (NCT00187096)
Timeframe: Day 2 and day 14 post NK cell transplantation
| Intervention | cells/µl (Median) |
|---|
| Day 2 | Day 14 |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 210 | 5,800 |
Percent of Detectable Donor NK Cells at Day 28
The percent of detectable donor NK cells in recipients at 28 days after NK cell infusion. Three of 10 participants had detectable donor cells at week 4. The results report the percent of detectable cells in the 3 participants. (NCT00187096)
Timeframe: At 28 days
| Intervention | percent of donor NK cells (Median) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 29 |
Overall Survival
"Overall survival is defined as the time relapse from on study date to death with those alive at last follow up date censored. The Kaplan-Meier method was used to compute survival probability estimates and confidence interval was determined by binomial distribution (for no events or all events) or by log hazard method. The binomial interval is based on the number of patients at risk.~The confidence intervals for Arm 1 and Arm 2a were determined by binomial distribution.~The confidence interval for Arm 2b was determined by log hazard method." (NCT00187096)
Timeframe: Up to 2 years post NK cell transplantation
| Intervention | Percent probability (Number) |
|---|
| Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine | 100 |
| Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine | 0 |
| Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide | 45.0 |
Pharmacokinetics - Half-Life (t½)
The half-life associated with the terminal elimination rate constant. (NCT00190671)
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)
| Intervention | hours (Geometric Mean) |
|---|
| Pemetrexed 600mg/m2 | 4.19 |
| Pemetrexed 1800mg/m2 | 3.79 |
Best Tumor Response
Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response. (NCT00190671)
Timeframe: baseline to measured progressive disease
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Unknown | Not Assessed |
|---|
| Pemetrexed 1800mg/m2 | 0 | 20 | 26 | 8 | 5 | 2 |
,| Pemetrexed 600mg/m2 | 0 | 8 | 18 | 13 | 3 | 0 |
Pharmacokinetics - Volume of Distribution
Central volume (V1) and peripheral volume (V2) of distribution. (NCT00190671)
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)
| Intervention | Liters (Geometric Mean) |
|---|
| Central Volume of Distribution (V1) | Peripheral Volume of Distribution (V2) |
|---|
| Pemetrexed 1800mg/m2 | 8.14 | 3.33 |
,| Pemetrexed 600mg/m2 | 7.46 | 3.58 |
Pharmacokinetics - Area Under the Curve (AUC)
Area under the gemcitabine concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] was calculated by combination of linear and logarithmic trapezoidal methods. Linear trapezoidal method was employed up to tmax (time to reach maximal concentration), and then log trapezoidal method was used for those data after tmax. (NCT00190671)
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)
| Intervention | hour times microgram per milliliter (Geometric Mean) |
|---|
| Pemetrexed 600mg/m2 | 375 |
| Pemetrexed 1800mg/m2 | 1050 |
Pharmacokinetics - Maximum Observed Drug Concentration (Cmax)
(NCT00190671)
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)
| Intervention | micrograms per milliliters (Geometric Mean) |
|---|
| Pemetrexed 600mg/m2 | 125 |
| Pemetrexed 1800mg/m2 | 369 |
Progression Free Survival
Defined as date of first treatment dose to first date of progressive disease or death from any cause. For patients not known to have died as of data cutoff date and who did not have progressive disease, the progression free survival date was censored at last contact date. (NCT00190671)
Timeframe: baseline to measured progressive disease
| Intervention | months (Median) |
|---|
| Pemetrexed 1800mg/m2 | 6.26 |
Time to Progressive Disease
Time to progressive disease was defined as the time from the date of the first treatment dose to the first date of progressive disease or death from study disease. (NCT00190671)
Timeframe: baseline to measured progressive disease
| Intervention | months (Median) |
|---|
| Pemetrexed 1800mg/m2 | 6.56 |
Pharmacokinetics - Clearance (CL)
Total body clearance of drug calculated after intravenous administration. (NCT00190671)
Timeframe: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)
| Intervention | milliliters per minute (Geometric Mean) |
|---|
| Pemetrexed 600mg/m2 | 45.9 |
| Pemetrexed 1800mg/m2 | 51.8 |
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00193479)
Timeframe: 18 Months
| Intervention | percentage of patients (Number) |
|---|
| CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab | 81 |
Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy
Count of patients that relapsed. (NCT00194779)
Timeframe: Up to 8 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 7 |
Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation
(NCT00194779)
Timeframe: From the initiation of study treatments to 30 days after the end of neoadjuvant treatment or adjuvant treatment if received
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 32 |
Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)
"Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer >= 1 cm.~Count of participants with either a pCR or mCR." (NCT00194779)
Timeframe: Up to 16 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 29 |
Disease-free Survival
Kaplan-Meier estimate of disease-free survival, assessed at 1, 2, and 5 years. (NCT00194779)
Timeframe: 1, 2, and 5 years
| Intervention | disease-free survival probability (Number) |
|---|
| 1 year | 2 years | 5 years |
|---|
| Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | .97 | .90 | .84 |
OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN
Kaplan-Meier estimate of overall survival, assessed at 1, 2, and 5 years. (NCT00194779)
Timeframe: 1, 2, and 5 years
| Intervention | survival probability (Number) |
|---|
| 1 year | 2 years | 5 years |
|---|
| Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | 1 | .94 | .90 |
Time to Progression
Median time to progression free survival. (NCT00194779)
Timeframe: Up to 5 years
| Intervention | months (Median) |
|---|
| Treatment (Neoadjuvant Therapy, Adjuvant Therapy) | NA |
Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer
pCR rate for triple negative patients--percent (NCT00203502)
Timeframe: at surgery, one day
| Intervention | % pCR among triple negative pts (Number) |
|---|
| Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin | 57 |
Percentage of Participants With Pathological Complete Response.
Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast. (NCT00203502)
Timeframe: Participants were assessed during surgery, an average of one hour
| Intervention | percentage of evaluable patients (Number) |
|---|
| Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin | 41 |
To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline
Absolute change in LVEF, where LVEF values are measured in percentage units (NCT00203502)
Timeframe: Immediately before treatment and 1 year after start of treatment
| Intervention | Percentage of LVEF (Mean) |
|---|
| Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin | -3.5 |
Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.
Clinical complete response was defined using RECIST response categories as the clinical response to chemotherapy (NCT00203502)
Timeframe: At completion of chemotherapy treatment, an average of one hour
| Intervention | percentage of pts w/ cCR (Number) |
|---|
| Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin | 53 |
Percentage of Participants With Grade 3 or 4 Adverse Events
Percent of participants who had at least one grade 3 or 4 adverse event (NCT00203502)
Timeframe: After each chemotherapy infusion, approximately one hour
| Intervention | percentage of pts w/ grade 3/4 AE (Number) |
|---|
| Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin | 79 |
Overall Survival
(NCT00206518)
Timeframe: 10 years
| Intervention | participants (Number) |
|---|
| deceased | alive |
|---|
| A: Taxotere/Docetaxel | 16 | 67 |
,| B: AC Adriamycin/Cytoxan | 19 | 65 |
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
"The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as:~Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR)~Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR)~Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively > 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively < 25% therapeutic effect OR Grade 4~No or few modification of tumoral appearance (pNR)." (NCT00206518)
Timeframe: 10 years
| Intervention | participants (Number) |
|---|
| 1 | 2 | 3A | 3B | 3C | 3D | 4 | N/A |
|---|
| A: Taxotere/Docetaxel | 3 | 2 | 18 | 15 | 18 | 10 | 3 | 14 |
,| B: AC Adriamycin/Cytoxan | 9 | 1 | 15 | 18 | 15 | 8 | 0 | 18 |
Disease Relapse
Data associated with relapse and progression will be obtained over the course of 10 years. Relapse/progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00206518)
Timeframe: 10 years
| Intervention | participants (Number) |
|---|
| relapsed | not relapsed |
|---|
| A: Taxotere/Docetaxel | 24 | 59 |
,| B: AC Adriamycin/Cytoxan | 25 | 59 |
Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab.
"Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of eight weeks and absence of any symptoms related to the tumor.~Partial Response (PR):50% decrease in the sum of the product diameters of all lesions that persist for at least four weeks. No lesion can increase in size and no new lesion can appear during this period.~Stable disease (SD):A tumor that is neither growing nor shrinking.No new tumors have developed" (NCT00208975)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Stable Disease |
|---|
| Chronic Lymphocytic Leukemia | 4 | 2 | 1 |
,| Non Hodgkin Lymphoma | 5 | 2 | 0 |
Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;
Patient Tolerance of Surgery and Post-operative Adjuvant Therapy as measured by median days spent in the hospital, intensive care unit, and step down unit. (NCT00210470)
Timeframe: Following surgery and post-operative therapy (up to 39 days post surgery)
| Intervention | days (Median) |
|---|
| Median Days in hospital | Median Days in intensive care unit | Median Days in step-down unit |
|---|
| IRX-2 Regimen | 8.5 | 0.5 | 0.5 |
Overall Survival
Estimate overall survival (OS) in patients receiving the IRX-2 regimen. IRX-2 is currently being studied in an on-going Phase 2b clinical trial in patients with newly diagnosed Stage II, III, and IVA squamous cell carcinoma of the oral cavity (INSPIRE) (NCT00210470)
Timeframe: Time from surgery to death or confirmed recurrent or progressive disease, assessed up to 3 years
| Intervention | percentage of subjects (Number) |
|---|
| First Year (%) | Second Year (%) | Third Year (%) |
|---|
| IRX-2 Regimen | 92 | 73 | 69 |
Number of Participants With Adverse Events and Serious Adverse Events
The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described. (NCT00210470)
Timeframe: Enrollment through 30 days post-surgery
| Intervention | Participants (Count of Participants) |
|---|
| Adverse Event: Injection Site Pain | Adverse Event: Headache | Adverse Event: Nausea | Adverse Event: Constipation | Adverse Event: Dizziness | Adverse Event: Fatigue | Adverse Event: Pneumonia Aspiration | Adverse Event: Anaemia | Adverse Event: Injection Site Discomfort | Adverse Event: Myalgia | Adverse Event: Contusion | Adverse Event: Dry Mouth | Adverse Event: Vomiting | Additional AE Categories w lower frequency | Serious Adverse Events |
|---|
| IRX-2 Regimen | 6 | 8 | 6 | 4 | 4 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 4 | 7 |
Immune Competence as Measured by Skin Test Reactivity
To assess measures of immune competence following administration of the IRX-2 regimen, including skin test reactivity. (NCT00210470)
Timeframe: At approx. 21 days, prior to surgery
| Intervention | Participants (Count of Participants) |
|---|
| Positive at both Baseline and at Day 21 (%) | Negative at both Baseline and Day 21 (%) | Positive at Baseline and Negative Day 21 (%) | Negative at Baseline and Positive at Day 21 | Induration at Day 21 |
|---|
| IRX-2 Regimen | 12 | 6 | 6 | 2 | 3 |
Disease-free Survival
Estimate disease-free survival (DFS) (time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy, assessed up to 3 years; margins of resection positive for tumor will not be considered disease recurrence). (NCT00210470)
Timeframe: Time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy, assessed up to 3 years; margins of resection positive for tumor will not be considered disease recurrence
| Intervention | DFS Probability (Number) |
|---|
| 1-year disease free survival probability | 2-year disease free survival probability | 3-year disease free survival probability |
|---|
| IRX-2 Regimen | 0.721 | 0.641 | 0.620 |
Clinical and Histological Tumor Responses
Number of participants with the specified percent change in size of target lesion is presented (NCT00210470)
Timeframe: On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery
| Intervention | Participants (Count of Participants) |
|---|
| -20% to < -10% | -10% to < 0% | 0% to < 10% | 10% to < 20% | 20% to < 30% | >= 30% |
|---|
| IRX-2 Regimen | 4 | 7 | 9 | 1 | 0 | 2 |
Relationship Between Overall Survival (OS) and Immune Competence (Lymphocyte Infiltration, LI) in Participants With High LI and Low LI
"After participants completed the IRX-2 regimen and the tumor resection was performed, tumor pathology was evaluated from tissue specimens obtained at tumor resection. Formalin-fixed, paraffin-embedded blocks, or unstained slides from the primary tumor were submitted to an independent pathology laboratory for hematoxylin and eosin staining, and evaluation of lymphocyte infiltration (LI). Participants were grouped into a low LI and high LI group based on the change in lymphocyte infiltration from the pretreatment tumor biopsy to the post-treatment tumor surgical resection. 5-year overall survival probabilities were then estimated (Kaplan-Meier) between the low LI and high LI groups" (NCT00210470)
Timeframe: At time of surgery, after treatment with IRX-2 Regimen, assessed up to 5 years
| Intervention | 5-Year OS Probability (Number) |
|---|
| High Lymphocyte Infiltration (LI) | 0.80 |
| Low Lymphocyte Infiltration | 0.50 |
Number of Participants With High Lymphocyte Infiltration (LI) According to the Visual Analog Scale (VAS)
"Immunologic response features were extracted and quantified using a VAS of 0-100 mm to provide for a more continuous variable than the 0-4+ scale that is often used to assess histological responses. The scoring was such that 100 represented the maximum for any sample and 0 represented the lack of any parameter of interest.~See publication of Berinstein, et al., 2012 for complete details." (NCT00210470)
Timeframe: On approximately Day 21 (last day of treatment) prior to undergoing post-treatment surgery
| Intervention | participants with high LI (>34 mm) VAS (Number) |
|---|
| IRX-2 Regimen | 18 |
Duration of Response
Duration of response was defined as the length of time from the first date at which the response criteria were met (taking the earliest date at which a PR, CRu, or the confirmed CR occurred) until the date that recurrent or PD or death was accurately documented, per the criteria defined for progression-free survival (PFS). All participants within the EA population who achieved a response per the criteria defined were included in the duration of the response analysis. Participants lost to follow-up prior to PD or death were censored at the date they were last known to still be responding to treatment. Duration of response was estimated using the Kaplan-Meier method with the median duration of response summarized. (NCT00211185)
Timeframe: From the date of the first documented CR (confirmed or unconfirmed) or PR until the date of first documentation of recurrent or PD or death, assessed up to 5 years 9 months
| Intervention | Months (Median) |
|---|
| Denileukin Diftitox in Combination With CHOP | 29.7 |
Overall Response in the Efficacy Analyzable (EA) Population
Response rate was defined as the percentage of the EA population who achieved a CR, CRu, or PR. The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease. (NCT00211185)
Timeframe: From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months
| Intervention | Percentage of participants (Number) |
|---|
| Confirmed complete response | Unconfirmed complete response | Partial response | Stable disease | Disease progression | Early death | Inadequate assessment |
|---|
| Denileukin Diftitox in Combination With CHOP | 67.6 | 5.4 | 13.5 | 8.1 | 5.4 | 0.0 | 0.0 |
Overall Response in the Intent To Treat (ITT) Population
Response rate was defined as the percentage of the ITT population who achieved a Complete Response (CR), Unconfirmed Complete Response (CRu), or Partial Response (PR). The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease. (NCT00211185)
Timeframe: From the start of the treatment to the date of participant's death assessed up to 5 years 9 months
| Intervention | Percentage of participants (Number) |
|---|
| Confirmed complete response | Unconfirmed complete response | Partial response | Stable disease | Disease progression | Early death | Inadequate assessment |
|---|
| Denileukin Diftitox in Combination With CHOP | 51.0 | 4.1 | 10.2 | 6.1 | 4.1 | 4.1 | 20.4 |
Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants
An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit. (NCT00211185)
Timeframe: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
| Intervention | Percentage of participants (Number) |
|---|
| Fatigue | Nausea | Hemoglobin | Neuropathy-sensory | Alanine transaminase | Hyperglycemia | Hypoalbuminemia | Leukocytes | Fever | Hypocalcemia | Lymphopenia | Aspartate transaminase | Dyspnea | Platelets | Alopecia | Neutrophils | Constipation | Edema-limb | Hyponatremia |
|---|
| Denileukin Diftitox in Combination With CHOP | 63.3 | 46.9 | 40.8 | 40.8 | 34.7 | 34.7 | 34.7 | 34.7 | 32.7 | 30.6 | 30.6 | 28.6 | 28.6 | 28.6 | 26.5 | 26.5 | 24.5 | 20.4 | 20.4 |
Percentage of Participants With Overall Survival
Overall Survival (OS) was defined as the time from the date of registration to the date of the participant's death. OS was determined by reviewing all participant's records every 6 months until the study was administratively closed or all participants died, whichever occurred first. Participants who were lost to follow-up but were still alive at the date of last contact were censored at the date of last contact. Participants who did not have a recorded date of death were censored for OS at the last date at which they were known to be alive. (NCT00211185)
Timeframe: From date of randomization until death, or administrative close of study, whichever came first, assessed up to 5 years 9 months
| Intervention | Percentage of participants (Number) |
|---|
| Denileukin Diftitox in Combination With CHOP | 63.3 |
Progression-Free Survival
PFS was defined as the period of time from treatment start to the first documentation of PD, recurrence, or death. PD was defined as a greater than or equal to 50% increase from baseline in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or non-responders, or the appearance of any new lesions during or at the end of therapy. PFS was censored at the last date for which the response assessment resulted in the absence of PD for participants who did not demonstrate objective progression or recurrence. Participants who withdrew prior to evidence of disease progression or recurrence, PFS was censored at the last date assessment showed an absence of PD. (NCT00211185)
Timeframe: From the date of first dose of study drug until date of first documentation of PD, recurrence, or death from any cause, assessed up to 5 years 9 months
| Intervention | Weeks (Mean) |
|---|
| Denileukin Diftitox in Combination With CHOP | 12.4 |
Overall Response Rate
Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Chesen, 1999). (NCT00217425)
Timeframe: Assessed after cycle 3, cycle 6, and cycle 8 (if given).
| Intervention | proportion (Number) |
|---|
| Treatment (A-CHOP Followed by MA) | 0.90 |
3-Year Overall Survival
3-year overall survival is defined as the probability of patients surviving at 3 years from study entry. (NCT00217425)
Timeframe: Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.
| Intervention | probability (Number) |
|---|
| Treatment (A-CHOP Followed by MA) | 0.39 |
12-Month Progression-Free Survival (PFS)
12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry. (NCT00217425)
Timeframe: Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.
| Intervention | probability (Number) |
|---|
| Treatment (A-CHOP Followed by MA) | 0.44 |
Duration of Response
(NCT00230282)
Timeframe: 105 months
| Intervention | months (Median) |
|---|
| Fludarabine and Cyclophosphamide, Followed by Alemtuzumab | 38 |
Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR)
"Response criteria as per the NCI-WG Revised Guidelines for B-CLL~Complete remission:~No lymphadenopathy by physical exam No hepatomegaly or splenomegaly Absence of constitutional symptoms Polymorphonuclear leukocytes > 1,500/uL, Platelets > 100,000/uL, Hemoglobin > 11.0 g/dL Bone marrow aspirate and biopsy normocellular with < 30% lymphocytes Absent lymphoid nodules~Partial remission:~50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value~50% reduction in lymphadenopathy and/or ≥ 50% reduction in the size of the liver and/or spleen AND one or more of the following Polymorphonuclear leukocytes > 1,500/uL or 50% improvement over baseline Platelets > 100,000/uL or 50% improvement over baseline Hemoglobin > 11.0 g/dL or 50% improvement over baseline" (NCT00230282)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Fludarabine and Cyclophosphamide, Followed by Alemtuzumab | 17 |
2-year Progression-free Survival
Measured from date of randomization to date of first observation of progressive disease, or death due to any cause (NCT00233987)
Timeframe: At day 60, then every 6 months for 2 years
| Intervention | percentage of participants (Number) |
|---|
| High-dose Therapy Plus Tandem Transplant | 59 |
Response Rate
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00233987)
Timeframe: At day 60, then every 6 months for 2 years
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Unconfirmed Complete Response | Unconfirmed Partial Response | No Response | Assessment Inadequate |
|---|
| High-dose Therapy Plus Tandem Transplant | 15 | 8 | 3 | 2 | 33 | 26 |
Overall Survival
Measured from date of registration to date of death due to any cause or last contact (NCT00233987)
Timeframe: At day 60, then every 6 months for 2 years, then annually for a total of 7 years
| Intervention | percentage of participants (Number) |
|---|
| High-dose Therapy Plus Tandem Transplant | 91 |
Progression-free Survival (PFS) Rate at 2-year
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. (NCT00254163)
Timeframe: 24 months after registered.
| Intervention | Probability of Progression-free Survival (Number) |
|---|
| FCR Arm | 0.72 |
| PCR Arm | 0.63 |
Infective Event Rate
infective events=temperature >101 without symptoms or temp <101 with symptoms (NCT00254163)
Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
| Intervention | percentage of infective events (Number) |
|---|
| FCR Arm | 38 |
| PCR Arm | 45 |
Infection Rate
infection=febrile events requiring treatment (NCT00254163)
Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
| Intervention | percentage of participants (Number) |
|---|
| FCR Arm | 31.4 |
| PCR Arm | 36.5 |
Complete Remission (CR)
"Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.~Complete remission (CR) requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be <1 cm.~No evidence of hepatomegaly or splenomegaly.~Absence of constitutional symptoms.~Normal CBC as exhibited by:~Polymorphonuclear leukocytes ≥ 1,500/mm^3~Platelets > 100,000/mm^3~Hemoglobin > 11.0 g/dL (untransfused)~Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.~Lymphoid nodules should be absent." (NCT00254163)
Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
| Intervention | percentage of participants (Number) |
|---|
| FCR Arm | 14.0 |
| PCR Arm | 7.1 |
Hematologic Recovery
defined as Hb >11g/dL and a platelet count >100 × 10^3/mm^3 (NCT00254163)
Timeframe: 2 months post-treatment
| Intervention | percentage of participants (Number) |
|---|
| FCR Arm | 3.5 |
| PCR Arm | 14.1 |
Mean Absolute Neutrophil Count (ANC) at Post-treatment
mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment (NCT00254163)
Timeframe: 2 months post-treatment
| Intervention | 10^3 cells/mm^3 (Mean) |
|---|
| FCR Arm | 1.7 |
| PCR Arm | 2.2 |
Objective Remission Rate (ORR)
"Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.~≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.~≥50% reduction in lymphadenopathy.~≥50% reduction in the size of the liver and/or spleen.~Polymorphonuclear leukocytes ≥ 1,500/mm^3 or 50% improvement over baseline.~Platelets >100,000/mm^3 or 50% improvement over baseline.~Hemoglobin >11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR." (NCT00254163)
Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
| Intervention | percentage of participants (Number) |
|---|
| FCR Arm | 59.3 |
| PCR Arm | 49.4 |
Percentage of Patients Hospitalized
Percentage of patients who were hospitalized due to any reasons during the study period. (NCT00254163)
Timeframe: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
| Intervention | percentage of participants (Number) |
|---|
| FCR Arm | 35 |
| PCR Arm | 43.5 |
Progression-free Survival (PFS) Rate at 1-year
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date (NCT00254163)
Timeframe: 12 months after registered.
| Intervention | probability of Progression-free Survival (Number) |
|---|
| FCR Arm | 0.86 |
| PCR Arm | 0.84 |
Molecular Response Rate at 6 Months
Molecular response rate (PCR for IgH rearrangements) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy. (NCT00254410)
Timeframe: End of 6 months
| Intervention | Participants (Count of Participants) |
|---|
| FCM-R + Pegylated Filgrastim | 10 |
Clinical Response Rate at 6 Months
Clinical Response Rate (combined morphological [NCI WG criteria] + flow cytometry criteria) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy. (NCT00254410)
Timeframe: End of Cycle 6
| Intervention | Participants (Count of Participants) |
|---|
| FCM-R + Pegylated Filgrastim | 28 |
Molecular Response Rate at 3 Months
Molecular response rate (PCR for immunoglobulin heavy chain (IgH) rearrangements) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy. (NCT00254410)
Timeframe: End of cycle 3
| Intervention | Participants (Count of Participants) |
|---|
| FCM-R + Pegylated Filgrastim | 17 |
Clinical Response Rate at 3 Months
Clinical Response Rate (combined morphological [NCI Working Group (WG) criteria] + flow cytometry criteria) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy. (NCT00254410)
Timeframe: End of cycle 3
| Intervention | Participants (Count of Participants) |
|---|
| FCM-R + Pegylated Filgrastim | 29 |
Overall Clinical Response to the Dose Dense Regimen
Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks). (NCT00254592)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy With GM-CSF | 43 |
Number of Participants Who Developed Acute Graft Versus Host Disease
(NCT00255684)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|
| Conditioning Therapy Followed by TBI | 0 |
Number of Participants Who Survived 100 Days or Longer
(NCT00255684)
Timeframe: 100 days
| Intervention | participants (Number) |
|---|
| Conditioning Therapy Followed by TBI | 13 |
Clinical Response Rate
Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange. (NCT00256243)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy With GM-CSF | 47 |
Microscopic Pathological Response Rate
pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen. (NCT00256243)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy With GM-CSF | 47 |
Number of Participants With Treatment-free Remission at 1 Year After Study Completion
Number of participants off therapy 1 year after study completion without relapse. (NCT00258180)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Severe Autoimmune Enteropathy | 2 |
Event-free Survival
Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse) (NCT00258206)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Cyclophosphamide | 29 |
Number of Participants Experiencing Acute Graft-Versus-Host Disease
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00258427)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 0 |
| USB Arm | 1 |
| Marrow Clinimacs | 0 |
| Sibling withoutCliniMACS | 0 |
Number of Participants Experiencing Relapse
Patients with leukemia will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. (NCT00258427)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 0 |
| USB Arm | 2 |
| Marrow Clinimacs | 1 |
| Sibling withoutCliniMACS | 0 |
Number of Participants Experiencing Overall Survival
Overall Survival - Number of patients alive at 1 year post transplant (NCT00258427)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 1 |
| USB Arm | 4 |
| Marrow Clinimacs | 1 |
| Sibling withoutCliniMACS | 1 |
Number of Participants Experiencing Major Infections
Number of participants experiencing Major Infections by the end of treatment (NCT00258427)
Timeframe: Day 1 through 1 year post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 3 |
| USB Arm | 8 |
| Marrow Clinimacs | 2 |
| Sibling withoutCliniMACS | 1 |
Number of Participants Experiencing Graft Failure
Graft failure is defined as absolute neutrophil count( ANC ) <5 x 10^8/L by day 30. (NCT00258427)
Timeframe: Day 30
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 1 |
| USB Arm | 0 |
| Marrow Clinimacs | 0 |
| Sibling withoutCliniMACS | 0 |
Number of Participants Experiencing Chronic Graft-Versus-Host Disease
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. (NCT00258427)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 0 |
| USB Arm | 0 |
| Marrow Clinimacs | 0 |
| Sibling withoutCliniMACS | 0 |
Number of Participants Experiencing Chronic Graft-Versus-Host Disease
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. (NCT00258427)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 0 |
| USB Arm | 0 |
| Marrow Clinimacs | 0 |
| Sibling withoutCliniMACS | 0 |
Number of Participants Experiencing Acute Graft-Versus-Host Disease
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00258427)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 0 |
| USB Arm | 0 |
| Marrow Clinimacs | 0 |
| Sibling withoutCliniMACS | 0 |
Overall Survival (OS)
OS was defined as the time elapsed from first treatment until death from any cause. (NCT00258960)
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeks
| Intervention | Months (Median) |
|---|
| Caelyx,Cyclophosphamide,Trastuzumab | 34.2 |
Response Duration
Response duration was defined as the time elapsed from the first evidence of tumor response (Complete response or Partial Response) until clinical evidence of disease progression or death occurred. (NCT00258960)
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeks
| Intervention | Months (Median) |
|---|
| Caelyx,Cyclophosphamide,Trastuzumab | 9.51 |
Time to Treatment Failure (TTF)
TTF was defined as the time elapsed from first treatment until patient discontinuation due to toxicity, disease progression, death or withdrawal of consent for any reason, whichever occurred first. (NCT00258960)
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeks
| Intervention | Months (Median) |
|---|
| Caelyx,Cyclophosphamide,Trastuzumab | 9.7 |
Objective Response Rate (ORR)
ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR. (NCT00258960)
Timeframe: Up to cycle 6 (24 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Caelyx,Cyclophosphamide,Trastuzumab | 33 |
Time to Progression (TTP)
TTP was defined as the time elapsed from first treatment until clinical evidence of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00258960)
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeks
| Intervention | Months (Median) |
|---|
| Caelyx,Cyclophosphamide,Trastuzumab | 12 |
Response Rate
Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions. (NCT00265889)
Timeframe: One year after second transplant
| Intervention | participants (Number) |
|---|
| Complete Response | Progression | Unknown | Expired | Partial Response |
|---|
| Poor Risk Patients | 18 | 14 | 2 | 3 | 0 |
Progression-free Survival
Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions. (NCT00265889)
Timeframe: one year after second transplant
| Intervention | participants (Number) |
|---|
| Poor Risk Patients | 18 |
Number of Patients That Experience Pulmonary Toxicity
Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs. (NCT00265889)
Timeframe: One year after second transplant
| Intervention | participants (Number) |
|---|
| Poor Risk Patients | 9 |
Left Ventricular Ejection Fraction (LVEF)
LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up. (NCT00270894)
Timeframe: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36
| Intervention | LVEF percent (Mean) |
|---|
| Screening | After Epirubicin/Cyclophosphamide | Pre-Surgery | Follow-up Month 6 | Follow-up Month 12 | Follow-up Month 24 | Follow-up Month 36 |
|---|
| Neoadjuvant Therapy | 63.55 | 61.94 | 56.88 | 57.68 | 58.15 | 59.38 | 55.00 |
Clinical Response Prior to Surgery
Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters. (NCT00270894)
Timeframe: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.
| Intervention | Participants (Number) |
|---|
| Clinical complete response | Clinical partial response | Clinical stable disease |
|---|
| Neoadjuvant Therapy | 20 | 5 | 2 |
Overall Survival (OS)
Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. (NCT00270894)
Timeframe: Measured from day 1 of treatment until time of death, assessed up to 48 months.
| Intervention | Months (Median) |
|---|
| Neoadjuvant Therapy | NA |
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose. (NCT00270894)
Timeframe: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Neoadjuvant Therapy | 60 |
Pathologic Response
Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters. (NCT00270894)
Timeframe: At completion of neoadjuvant treatment period, up to 24 weeks.
| Intervention | Participants (Number) |
|---|
| Pathologic complete response (pCR) | Pathologic partial response (pPR) | Stable disease (SD) |
|---|
| Neoadjuvant Therapy | 16 | 9 | 3 |
Progression-free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. (NCT00270894)
Timeframe: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.
| Intervention | Months (Median) |
|---|
| Neoadjuvant Therapy | NA |
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE. (NCT00270894)
Timeframe: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.
| Intervention | Events (Number) |
|---|
| CTCAE grade 3 hematologic events | CTCAE grade 3 non-hematologic events | CTCAE grade 4 hematologic events | CTCAE grade 4 non-hematologic events |
|---|
| Neoadjuvant Therapy | 2 | 11 | 0 | 0 |
Overall Survival Time of Patients With Complete Remission
Median number of months patients were alive after NK cell infusion. (NCT00274846)
Timeframe: From Day 1 of Treatment until death or patient received bone marrow transplant.
| Intervention | Months (Median) |
|---|
| Patients Achieving Complete Remission - Responders | 13 |
Number of Patients With Complete Remission
Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery). (NCT00274846)
Timeframe: Day 28-35
| Intervention | Participant (Number) |
|---|
| Patients With Relapsed/Refractory AML - Evaluable Group | 2 |
Number of Patients With Natural Killer (NK) Cell Expansion
Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14). (NCT00274846)
Timeframe: Study Day 14
| Intervention | Participants (Number) |
|---|
| Patients With Relapsed/Refractory AML - Evaluable Group | 2 |
5-year Overall Survival
5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival. (NCT00274924)
Timeframe: Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
| Intervention | probability (Number) |
|---|
| Group I (PET Negative) | 0.77 |
| Group II (PET Positive) | 0.69 |
2-year Progression-Free Survival (PFS)
2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS. (NCT00274924)
Timeframe: Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.
| Intervention | probability (Number) |
|---|
| Group I (PET Negative) | 0.76 |
| Group II (PET Positive) | 0.42 |
Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity
"Number of participants with Grade 4 toxicity as defined by the following criteria:~Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= Necrosis" (NCT00278109)
Timeframe: up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Experimental | 0 |
Non-relapse Mortality
Number of participants who died for reasons related to protocol treatment. (NCT00278161)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| R-HiCy | 0 |
Engraftment
Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count >= 500 cells per microliter; platelet recovery is defined as untransfused platelet count >= 20 * 10^9 cells per liter. (NCT00278161)
Timeframe: Up to 43 days
| Intervention | days (Median) |
|---|
| Neutrophil | Platelet |
|---|
| R-HiCy | 15 | 15 |
Event-free Survival
Percentage of participants alive without disease relapse. (NCT00278161)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Mantle-cell lymphoma | Other low-grade B-cell tumors |
|---|
| R-HiCy | 39 | 40 |
Survival
Survival (NCT00278512)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Autologous Stem Cell Transplant | 6 |
| Allogeneic Stem Cell Transplant | 0 |
Survival
Survival (NCT00278564)
Timeframe: up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Hematopoietic Stem Cell Transplantation | 7 |
Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL
The number of patients who experience any grade 3-5 toxicity. (NCT00280241)
Timeframe: Duration of treatment on study
| Intervention | participants (Number) |
|---|
| FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB | 42 |
Overall Survival Rate
The percentage of participants who are still alive. (NCT00280241)
Timeframe: Five years after starting rituximab, cyclophosphamide and fludarabine
| Intervention | percentage of participants (Number) |
|---|
| FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB | 85.5 |
Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL
The number of patients who experience a complete clinical response. (NCT00280241)
Timeframe: Three months after the sixth cycle (9 months)
| Intervention | participants (Number) |
|---|
| FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB | 46 |
Duration of Response
The length of time for which the complete response is maintained. (NCT00280241)
Timeframe: From complete response to the time of progressive disease, death or last clinical examination
| Intervention | Months (Median) |
|---|
| FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB | 22.3 |
Event-free Survival (EFS)
Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 947.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1212.0 |
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
The time from randomization to the start of a new treatment. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 1455.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 2082.0 |
Final Analysis: Time to Overall Survival Event
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 2613.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | NA |
Final Analysis: Time to Progression-free Survival Event
Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 998.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1703.0 |
Overall Survival (OS)
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months
| Intervention | Days (Number) |
|---|
| Minimum number of days to an event | Maximum number of days to an event |
|---|
| Fludarabine+Cyclophosphamide (FC) | 5 | 1373 |
,| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 4 | 1372 |
Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 981.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1212.0 |
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months
| Intervention | Days to an event (Number) |
|---|
| Minimum number of days to an event | Maximum number of days to an event |
|---|
| Fludarabine+Cyclophosphamide (FC) | 84 | 1164 |
,| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 91 | 1226 |
Final Analysis: Duration of Response
Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 1102.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1718.0 |
Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 1488.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1854.0 |
Final Analysis: Time to Event-free Survival Event
Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months
| Intervention | Days (Median) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 951.0 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1666.0 |
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months
| Intervention | Percentage of participants (Number) |
|---|
| Fludarabine+Cyclophosphamide (FC) | 72.4 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 85.8 |
Survival
The number of participants who survived treatment (NCT00282412)
Timeframe: up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Hematopoietic Stem Cell Transplantation | 2 |
3 Year Progression-Free Survival Rate
Percentage of participants out of total treated alive with disease progression 3 years following registration. Progression-free survival (PFS) was measured from the date of study registration to the date of documented disease progression or death of any cause. (NCT00290433)
Timeframe: From registration to disease progression or death, up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| HCVIDDOXIL Regimen | 30 |
Response Rate R-HCVAD vs. R-CHOP
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00290498)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Complete Remission | Inevaluable | Progressive Disease | Partial Remission | Complete Remission Unconfirmed |
|---|
| R-CHOP | 7 | 1 | 1 | 0 | 1 |
,| R-HCVAD | 40 | 2 | 1 | 4 | 2 |
Progression Free Survival (Rate)
Progression free survival (PFS) for three years following therapy with Rituxan-HCVAD alternating with Rituximab with high -dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin's lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features. (NCT00290498)
Timeframe: 3 years post-therapy
| Intervention | Participants (Count of Participants) |
|---|
| R-HCVAD/MA | 35 |
| R-CHOP | 7 |
Toxicity Grade 3, 4, or 5
(NCT00293384)
Timeframe: at 0-120 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 2 |
Proportion of Participants With Controlled Acute Vomiting
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration. (NCT00293384)
Timeframe: at 0-24 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 20 |
Overall Nausea Controlled
(NCT00293384)
Timeframe: at 0-120 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 31 |
Delayed Vomiting Controlled
(NCT00293384)
Timeframe: at 25-120 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 22 |
Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.
"RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes:~RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer" (NCT00295893)
Timeframe: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.
| Intervention | Participants (Count of Participants) |
|---|
| Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide | 11 |
| Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin | 10 |
| Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab | 28 |
Count of Patients With Pathologic Complete Response (pCR)
pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes. (NCT00295893)
Timeframe: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months
| Intervention | Participants (Count of Participants) |
|---|
| Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide | 6 |
| Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin | 4 |
| Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab | 22 |
Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma
Toxicity assessed using NCI-CTC v. 3.0 (NCT00295932)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 4 |
| 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide | 6 |
| 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 3 |
| 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide | 4 |
| Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 2 |
| Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid | 18 |
| Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 3 |
| Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami | 4 |
| Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham | 10 |
| Weekly Bortezomib Dosing Schedule | 12 |
| Twice-weekly Bortezomib Dosing Schedule | 13 |
Maximum Tolerated Dose
Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants (NCT00295932)
Timeframe: 2 years
| Intervention | mg/m^2 of Bortezomib (Number) |
|---|
| Weekly Bortezomib | Twice-Weekly Bortezomib |
|---|
| Arm I | 1.8 | 1.5 |
Days Platelets Count of < 100K/μL
The optimal biologic dose was defined as the dose of AMG 531 at which the greatest proportion of patients avoided grade 4 thrombocytopenia (Platelet nadir < 25K/μL) in the absence of platelet transfusion in the blinded study cycle. (NCT00299182)
Timeframe: Prior to start of treatment and then at least 2 times a week during treatment until end of cycle 2 (1 cycle = 21 days)
| Intervention | days (Mean) |
|---|
| Arm A 1mcg/kg | 5.5 |
| Arm A 3mcg/kg | 5.3 |
| Arm A 10mcg/kg | 8.3 |
| Arm B 1mcg/kg | 6.8 |
| Arm B 3mcg/kg | 8 |
| Arm B 10mcg/kg | 9.3 |
| Placebo | 9.8 |
Platelet (PLT) Nadir
Blood counts were performed at least two times a week and when clinically indicated during the study and daily when PLT count is < 50K/μL until recovery (two consecutive counts showing upward trend). The optimal biologic dose was defined as the dose of AMG 531 at which the greatest proportion of patients avoided grade 4 thrombocytopenia (Platelet nadir < 25K/μL) in the absence of platelet transfusion in the blinded study cycle. (NCT00299182)
Timeframe: Prior to start of treatment and then at least 2 times a week during treatment until end of cycle 2 (1 cycle = 21 days)
| Intervention | K/μL (Mean) |
|---|
| Arm A 1mcg/kg | 20.3 |
| ARM A 3mcg/kg | 26.3 |
| Arm A 10mcg/kg | 24.8 |
| Arm B 1mcg/kg | 22.5 |
| Arm B 3mcg/kg | 18.3 |
| Arm B 10mcg/kg | 8 |
| Placebo | 11.3 |
Overall Survival
Percentage of participants alive at different time points (NCT00301821)
Timeframe: time from study entry to 36 months
| Intervention | percentage of Participants (Number) |
|---|
| Overall Survival at 12 months | Overall Survival at 24 months | Overall Survival at 36 months |
|---|
| Epratuzumab + Rituximab + CHOP | 89 | 81 | 80 |
Progression-free Survival (PFS)
Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. (NCT00301821)
Timeframe: the time from study entry to 36 months
| Intervention | percentage of participants (Number) |
|---|
| Progression Free Survival at 12 months | Progression Free Survival at 24 months | Progression Free Survival at 36 months |
|---|
| Epratuzumab + Rituximab + CHOP | 85 | 77 | 76 |
Event-free Survival After 12 Months
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12). (NCT00301821)
Timeframe: From Baseline to 12 months
| Intervention | percentage of participants (Number) |
|---|
| Epratuzumab + Rituximab + CHOP | 78 |
Overall Response Rate (ORR)
Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. (NCT00301821)
Timeframe: Baseline to first 6 cycles of treatment
| Intervention | percentage of participants (Number) |
|---|
| Epratuzumab + Rituximab + CHOP | 95 |
Overall Survival
Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact. (NCT00302003)
Timeframe: At 60 months
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.99 |
Intensive Therapy Free Survival (ITFS).
Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy. (NCT00302003)
Timeframe: At 60 months
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.89 |
Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT). (NCT00302003)
Timeframe: At 60 months
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.49 |
Event Free Survival (EFS)
Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS). (NCT00302003)
Timeframe: At 60 months
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.79 |
Incidence of Post-transplant Lymphoproliferative Disorder (PTLD)
Post-transplant lymphoproliferative disorder (PTLD) is a virally-driven cancer of the lymphoid cells caused by immunosuppressive drugs taken after allogeneic stem cell transplantation to prevent or control graft versus host disease. (NCT00303667)
Timeframe: 1 Year
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Short Schema | 0 |
| SCT w/Donor Natural Killer Cells - Extended Schema | 3 |
Incidence of Grade III-IV Acute Graft Versus Host Disease
Grade III-IV acute graft versus host disease is a severe short term complication created by infusion of donor cells into a foreign host (NCT00303667)
Timeframe: Month 6
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Short Schema | 0 |
| SCT w/Donor Natural Killer Cells - Extended Schema | 0 |
Incidence of Chronic Graft Versus Host Disease
Chronic graft versus host disease is a severe long term complication created by infusion of donor cells into a foreign host (NCT00303667)
Timeframe: 1 Year
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Short Schema | 0 |
| SCT w/Donor Natural Killer Cells - Extended Schema | 0 |
In Vivo Expansion of a Donor NK Cells NK Cell Product
Number of patients with in vivo expansion of donor NK cells. In vivo expansion of NK cell is defined as detection of >100 donor-derived NK cells per microliter of blood. (NCT00303667)
Timeframe: 12 - 14 days after NK cell infusion
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Extended Schema | 19 |
Disease-free Survival at 1 Year
Number of patients alive without evidence of disease at 1 year after transplant (NCT00303667)
Timeframe: 1 Year
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Short Schema | 0 |
| SCT w/Donor Natural Killer Cells - Extended Schema | 3 |
Disease-free Survival at 6 Months
Number of patients alive without evidence of disease at 6 months after transplant (NCT00303667)
Timeframe: Month 6
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Short Schema | 0 |
| SCT w/Donor Natural Killer Cells - Extended Schema | 4 |
Number of Patients With Disease Relapse
Disease relapse is the recurrence of leukemia in patients who had cleared their leukemia after treatment. Patients with persistent leukemia are not evaluable for relapse. (NCT00303667)
Timeframe: 1 Year
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Short Schema | 5 |
| SCT w/Donor Natural Killer Cells - Extended Schema | 12 |
Number of Patients With Graft Failure
Number of patients with graft failure defined as <500 donor neutrophils count by day 28 in the absence of residual or relapsed leukemia (NCT00303667)
Timeframe: Day 28
| Intervention | participants (Number) |
|---|
| SCT w/Donor Natural Killer Cells - Short Schema | 1 |
| SCT w/Donor Natural Killer Cells - Extended Schema | 4 |
Overall Survival
(NCT00303719)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| High Risk Patients | 8 |
| Standard Risk Patients | 181 |
Neutrophil and Donor Cell Engraftment
"Successful sustained engraftment is defined as primary neutrophil engraftment by day 42 and e90% donor cells at day 100, with or without DLI.~Engraftment based on absolute neutrophil count of donor origin > 0.5 x 10e9 /L for 3 days by day 42" (NCT00303719)
Timeframe: Day 42 and Day 100
| Intervention | Participants (Count of Participants) |
|---|
| High Risk Patients | 12 |
| Standard Risk Patients | 289 |
Acute Graft-Versus-Host Disease
Grade III-IV graft versus host disease (NCT00303719)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| High Risk Patients | 2 |
| Standard Risk Patients | 79 |
Serious Adverse Events
Safety by development of severe adverse events within 100 days of transplant (NCT00303719)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| High Risk Patients | 0 |
| Standard Risk Patients | 47 |
Number of Participants Who Were Alive at 1 Year Post Transplant
Overall Survival - Number of patients alive at 1 year post transplant (NCT00305682)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 59 |
| Arm 2 - No Prior Autologous Transplant | 40 |
| Arm 3 - Refractory Leukemia/Lymphoma | 1 |
| Arm 4: MT2006-01 Coenrolling Patients | 26 |
| Arm 5 - Previous Autologous Transplant | 26 |
| Arm 6 - No Prior Autologous Transplant | 25 |
Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years
Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT00305682)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 49 |
| Arm 2 - No Prior Autologous Transplant | 19 |
| Arm 3 - Refractory Leukemia/Lymphoma | 4 |
| Arm 4: MT2006-01 Coenrolling Patients | 11 |
| Arm 5 - Previous Autologous Transplant | 20 |
| Arm 6 - No Prior Autologous Transplant | 4 |
Number of Participants Experiencing Relapse (Incidence of Relapse)
Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT00305682)
Timeframe: Year 1
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 43 |
| Arm 2 - No Prior Autologous Transplant | 14 |
| Arm 3 - Refractory Leukemia/Lymphoma | 4 |
| Arm 4: MT2006-01 Coenrolling Patients | 7 |
| Arm 5 - Previous Autologous Transplant | 20 |
| Arm 6 - No Prior Autologous Transplant | 2 |
Number of Participants Experiencing Progression-free Survival at 2 Years
Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression (NCT00305682)
Timeframe: 2 Years
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 36 |
| Arm 2 - No Prior Autologous Transplant | 25 |
| Arm 3 - Refractory Leukemia/Lymphoma | 1 |
| Arm 4: MT2006-01 Coenrolling Patients | 17 |
| Arm 5 - Previous Autologous Transplant | 16 |
| Arm 6 - No Prior Autologous Transplant | 20 |
Number of Participants Experiencing Progression-free Survival
Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression. Patients with leukemia and lymphoma involving the bone marrow (BM) and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT00305682)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 43 |
| Arm 2 - No Prior Autologous Transplant | 32 |
| Arm 3 - Refractory Leukemia/Lymphoma | 1 |
| Arm 4: MT2006-01 Coenrolling Patients | 21 |
| Arm 5 - Previous Autologous Transplant | 16 |
| Arm 6 - No Prior Autologous Transplant | 24 |
Percentage of Donor Chimerism at 180 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis. (NCT00305682)
Timeframe: 180 Days
| Intervention | percentage of donor cells (Mean) |
|---|
| Arm 1-Previous Autologous Transplant | 96 |
| Arm 2 - No Prior Autologous Transplant | 98 |
| Arm 3 - Refractory Leukemia/Lymphoma | 88 |
| Arm 4: MT2006-01 Coenrolling Patients | 94 |
| Arm 5 - Previous Autologous Transplant | 91 |
| Arm 6 - No Prior Autologous Transplant | 98 |
Percentage of Donor Chimerism at 365 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis. (NCT00305682)
Timeframe: 365 days
| Intervention | percentage of donor cells (Mean) |
|---|
| Arm 1-Previous Autologous Transplant | 99 |
| Arm 2 - No Prior Autologous Transplant | 98 |
| Arm 4: MT2006-01 Coenrolling Patients | 99 |
| Arm 5 - Previous Autologous Transplant | 87 |
| Arm 6 - No Prior Autologous Transplant | 100 |
Percentage of Donor Chimerism at 21 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis. (NCT00305682)
Timeframe: 21 days
| Intervention | percentage of donor cells (Mean) |
|---|
| Arm 1-Previous Autologous Transplant | 77 |
| Arm 2 - No Prior Autologous Transplant | 73 |
| Arm 3 - Refractory Leukemia/Lymphoma | 57 |
| Arm 4: MT2006-01 Coenrolling Patients | 77 |
| Arm 5 - Previous Autologous Transplant | 69 |
| Arm 6 - No Prior Autologous Transplant | 68 |
Percentage of Donor Chimerism at 100 Days
Chimerism studies will be performed on the blood and bone marrow (BM). BM chimerism days 21 and 100, at 6 months and 1 year to determine the relative contribution of donor and recipient hematopoiesis. (NCT00305682)
Timeframe: 100 days
| Intervention | percentage of donor cells (Mean) |
|---|
| Arm 1-Previous Autologous Transplant | 94 |
| Arm 2 - No Prior Autologous Transplant | 94 |
| Arm 3 - Refractory Leukemia/Lymphoma | 100 |
| Arm 4: MT2006-01 Coenrolling Patients | 93 |
| Arm 5 - Previous Autologous Transplant | 85 |
| Arm 6 - No Prior Autologous Transplant | 86 |
Number of Participants With Platelet Engraftment
Time to platelets > 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment >50,000 by day 100. (NCT00305682)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 75 |
| Arm 2 - No Prior Autologous Transplant | 47 |
| Arm 3 - Refractory Leukemia/Lymphoma | 3 |
| Arm 4: MT2006-01 Coenrolling Patients | 28 |
| Arm 5 - Previous Autologous Transplant | 34 |
| Arm 6 - No Prior Autologous Transplant | 25 |
Number of Participants With Neutrophil Engraftment
Time to 1st 3 consecutive days with absolute neutrophil count (ANC) > 5 x 10^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence). (NCT00305682)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 93 |
| Arm 2 - No Prior Autologous Transplant | 65 |
| Arm 3 - Refractory Leukemia/Lymphoma | 6 |
| Arm 4: MT2006-01 Coenrolling Patients | 32 |
| Arm 5 - Previous Autologous Transplant | 32 |
| Arm 6 - No Prior Autologous Transplant | 29 |
Number of Participants With Chronic Graft-Versus-Host Disease
Determine the incidence of chronic GVHD at 1 year after transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. (NCT00305682)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 18 |
| Arm 2 - No Prior Autologous Transplant | 20 |
| Arm 3 - Refractory Leukemia/Lymphoma | 0 |
| Arm 4: MT2006-01 Coenrolling Patients | 3 |
| Arm 5 - Previous Autologous Transplant | 3 |
| Arm 6 - No Prior Autologous Transplant | 3 |
Number of Participants With Acute Graft-versus-host Disease (GVHD)
"Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging.~Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level." (NCT00305682)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 45 |
| Arm 2 - No Prior Autologous Transplant | 24 |
| Arm 3 - Refractory Leukemia/Lymphoma | 1 |
| Arm 4: MT2006-01 Coenrolling Patients | 12 |
| Arm 5 - Previous Autologous Transplant | 13 |
| Arm 6 - No Prior Autologous Transplant | 13 |
Number of Participants Who Were Dead at 6 Months After Study Completion
Incidence of Non-relapse mortality - Number of Patients Dead at 6 Months after study completion (NCT00305682)
Timeframe: Month 6
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 10 |
| Arm 2 - No Prior Autologous Transplant | 20 |
| Arm 3 - Refractory Leukemia/Lymphoma | 2 |
| Arm 4: MT2006-01 Coenrolling Patients | 5 |
| Arm 5 - Previous Autologous Transplant | 3 |
| Arm 6 - No Prior Autologous Transplant | 6 |
Number of Participants Who Were Alive at 2 Years Post Transplant
Overall Survival - Number of patients alive at 2 years post transplant (NCT00305682)
Timeframe: 2 Years
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1-Previous Autologous Transplant | 50 |
| Arm 2 - No Prior Autologous Transplant | 31 |
| Arm 3 - Refractory Leukemia/Lymphoma | 1 |
| Arm 4: MT2006-01 Coenrolling Patients | 20 |
| Arm 5 - Previous Autologous Transplant | 21 |
| Arm 6 - No Prior Autologous Transplant | 23 |
Number of Participants With Platelet Engraftment
Determine the incidence of platelet engraftment (platelet recovery >50,000/uL) at 6 months after UCBT. (NCT00309842)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated UCBT for Blood Cancers | 159 |
Number of Participants With Chronic Graft-Versus-Host Disease
"Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria.~Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level." (NCT00309842)
Timeframe: Year 1
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated UCBT for Blood Cancers | 39 |
Percentage Chimerism at 6 Months
Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: Month 6
| Intervention | percentage of donor cells (Mean) |
|---|
| Unrelated UCBT for Blood Cancers | 98.1 |
Percentage Chimerism at 2 Years
Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: 2 Years
| Intervention | percentage of donor cells (Mean) |
|---|
| Unrelated UCBT for Blood Cancers | 100 |
Percentage Chimerism at 1 Year
Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: 1 Year
| Intervention | percentage of donor cells (Mean) |
|---|
| Unrelated UCBT for Blood Cancers | 99.1 |
Number of Participants With Neutrophil Engraftment
Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC > 5 x 10^8/L of donor origin by day +42) (NCT00309842)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated UCBT for Blood Cancers | 21 |
Percentage Chimerism on Day 100
Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: Day 100
| Intervention | percentage of donor cells (Mean) |
|---|
| Unrelated UCBT for Blood Cancers | 98.1 |
Number of Participants Who Died Due to Transplant
Determine the incidence of transplant-related mortality at 6 months after UCBT (NCT00309842)
Timeframe: At Month 6
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated UCBT for Blood Cancers | 58 |
Number of Participants Who Were Alive at 1 Year Transplant Overall Survival
Number of patients alive at 1 year after transplant. (NCT00309842)
Timeframe: at 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated UCBT for Blood Cancers | 130 |
Percentage Chimerism on Day 21
Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: Day 21
| Intervention | percentage of donor cells (Mean) |
|---|
| Unrelated UCBT for Blood Cancers | 92.6 |
Number of Participants With Acute Graft-Versus-Host Disease
"Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD.~Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level." (NCT00309842)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Grade II-IV | Grade III-IV |
|---|
| Unrelated UCBT for Blood Cancers | 106 | 49 |
Death From Any Cause (Overall Survival)
The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period. (NCT00312208)
Timeframe: Median follow-up of 65 months
| Intervention | Participants (Number) |
|---|
| Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T) | 187 |
| Docetaxel + Doxorubicin and Cyclophosphamide (TAC) | 202 |
Complete Response
"Determine if the combination of high dose aldesleukin, reinfused cells after lymphocyte depleting chemotherapy and 1200 cGy total body irradiation (TBI) is able to be associated with a modest fraction of patients with metastatic melanoma who can experience a complete response to therapy.~Complete response (CR) is a disappearance of all target lesions." (NCT00314106)
Timeframe: 33 months
| Intervention | Participants (Number) |
|---|
| TBI 1200 cGy + TIL +HD IL-2, Prior IL-2 | 7 |
| TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2 | 3 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00314106)
Timeframe: 33 months
| Intervention | Participants (Number) |
|---|
| TBI 1200 cGy + TIL +HD IL-2, Prior IL-2 | 18 |
| TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2 | 8 |
Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1
Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks. (NCT00315705)
Timeframe: Up to 2 years (Phase 1 portion of study)
| Intervention | weeks (Median) |
|---|
| Phase 1: Clofarabine, Etoposide, Cyclophosphamide | 19.3 |
Time to Remission for Participants Who Had a Response in Phase 2
The weeks between start of intervention and remission as assessed by the investigator in Phase 2. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included. (NCT00315705)
Timeframe: up to 8 weeks (Phase 2 portion of study)
| Intervention | weeks (Mean) |
|---|
| Phase 2: Clofarabine, Etoposide, Cyclophosphamide | 4.84 |
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1
Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ALL ≥75/ ≥0.75 [x 10^9/L]; AML ≥100/ ≥1.0 [x 10^9/L] 2) CR in absence of plt recovery (CRp): ALL plt ≥20 to <75 x 10^9/L; AML plt ≥20 to <100 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR. (NCT00315705)
Timeframe: Approximately 2 months (Phase 1 portion of study)
| Intervention | percentage of total participants (Number) |
|---|
| Complete remission (CR) | Complete remission/absence total platelet recovery | Partial remission (PR) | Overall remission (OR) | Any response (CR+CRp+PR) |
|---|
| Phase 1: Clofarabine, Etoposide, Cyclophosphamide | 40 | 24 | 0 | 64 | 64 |
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2
Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ≥75/ ≥0.75 [x 10^9/L] 2) CR in absence of plt recovery (CRp): plt ≥20 to <75 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR. (NCT00315705)
Timeframe: Approximately 28-56 days (Phase 2 portion of study)
| Intervention | percentage of total participants (Number) |
|---|
| Complete remission (CR) | Complete remission/absence total platelet recovery | Partial remission (PR) | Overall remission (OR) | Any response (CR+CRp+PR) |
|---|
| Phase 2: Clofarabine, Etoposide, Cyclophosphamide | 28 | 16 | 12 | 44 | 56 |
Summary of Participants With Adverse Events (AEs) in Phase 1
Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is:> Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE (NCT00315705)
Timeframe: Up to 9.5 months (Phase 1 portion of study)
| Intervention | participants (Number) |
|---|
| At least one AE | At least one AE related to clofarabine | At least one serious AE | At least one serious AE related to clofarabine | Discontinued study due to AE | Died | AE with the worst grade of: 1 | AE with the worst grade of: 2 | AE with the worst grade of: 3 | AE with the worst grade of: 4 | AE with the worst grade of: 5 |
|---|
| Phase 1 - Cohort 1 | 3 | 3 | 3 | 3 | 0 | 3 | 0 | 0 | 2 | 1 | 0 |
,| Phase 1 - Cohort 2 | 3 | 3 | 3 | 2 | 0 | 1 | 0 | 0 | 1 | 1 | 1 |
,| Phase 1 - Cohort 3 | 3 | 3 | 3 | 3 | 0 | 3 | 0 | 0 | 1 | 2 | 0 |
,| Phase 1 - Cohort 4 | 10 | 10 | 9 | 9 | 0 | 9 | 0 | 0 | 3 | 5 | 2 |
,| Phase 1 - Cohort 5 | 6 | 6 | 6 | 5 | 0 | 5 | 0 | 0 | 3 | 2 | 1 |
Summary of Participants With Adverse Events (AEs) in Phase 2
Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is:> Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE (NCT00315705)
Timeframe: Up to 9.5 months (Phase 2 portion of study)
| Intervention | participants (Number) |
|---|
| At least one AE | At least one AE related to clofarabine | At least one serious AE | At least one serious AE related to clofarabine | Discontinued study due to AE | Died | AE with the worst grade of: 1 | AE with the worst grade of: 2 | AE with the worst grade of: 3 | AE with the worst grade of: 4 | AE with the worst grade of: 5 |
|---|
| Phase 2: Clofarabine, Etoposide, Cyclophosphamide | 25 | 25 | 21 | 20 | 1 | 16 | 0 | 0 | 1 | 16 | 8 |
Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1
Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks. (NCT00315705)
Timeframe: Up to 2 years (Phase 1 portion of study)
| Intervention | weeks (Median) |
|---|
| Phase 1: Clofarabine, Etoposide, Cyclophosphamide | 27.1 |
Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2
Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks. (NCT00315705)
Timeframe: Up to 2 years (Phase 2 portion of study)
| Intervention | weeks (Median) |
|---|
| Phase 2: Clofarabine, Etoposide, Cyclophosphamide | 10.7 |
Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2
Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks. (NCT00315705)
Timeframe: Up to 2 years (Phase 2 portion of study)
| Intervention | weeks (Median) |
|---|
| Phase 2: Clofarabine, Etoposide, Cyclophosphamide | 10.7 |
Maximum Tolerated Dose (MTD) in Phase 1
"The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused <= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 as taken by Cohort 5 was to become the RP2D.~The rating scale used is 0 = not the MTD, 1 = the MTD." (NCT00315705)
Timeframe: Up to Day 42 (Phase 1 portion of study)
| Intervention | units on a scale (Number) |
|---|
| Phase 1 - Cohort 1 | 0 |
| Phase 1 - Cohort 2 | 0 |
| Phase 1 - Cohort 3 | 0 |
| Phase 1 - Cohort 4 | 0 |
| Phase 1 - Cohort 5 | 0 |
Number of Participants With 4-month Event Free Survival in Phase 1
Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse. (NCT00315705)
Timeframe: 4 months (Phase I portion of study)
| Intervention | participants (Number) |
|---|
| Phase 1: Clofarabine, Etoposide, Cyclophosphamide | 13 |
Number of Participants With 4-month Event Free Survival in Phase 2
Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse. (NCT00315705)
Timeframe: 4 months (Phase 2 portion of study)
| Intervention | participants (Number) |
|---|
| Phase 2: Clofarabine, Etoposide, Cyclophosphamide | 11 |
Participants With Dose Limiting Toxicity in Phase 1
The number of participants in each cohort that had dose limiting toxicity is summarized. Toxicities were reviewed by an independent Data Safety Monitoring Board (DSMB) who determined if additional participants should be added to the cohort and the criteria for escalating to the next cohort. (NCT00315705)
Timeframe: Up to Day 42 (Phase 1 portion of study)
| Intervention | participants (Number) |
|---|
| Phase 1 - Cohort 1 | 0 |
| Phase 1 - Cohort 2 | 0 |
| Phase 1 - Cohort 3 | 0 |
| Phase 1 - Cohort 4 | 1 |
| Phase 1 - Cohort 5 | 1 |
Time to Remission for Participants Who Had a Response in Phase 1
The weeks between start of intervention and remission as assessed by the investigator in Phase 1. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included. (NCT00315705)
Timeframe: up to 8 weeks (Phase 1 portion of study)
| Intervention | weeks (Mean) |
|---|
| Phase 1: Clofarabine, Etoposide, Cyclophosphamide | 4.96 |
Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1
Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks. (NCT00315705)
Timeframe: Up to 2 years (Phase 1 portion of study)
| Intervention | weeks (Median) |
|---|
| Phase 1: Clofarabine, Etoposide, Cyclophosphamide | 18.2 |
Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2
Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks. (NCT00315705)
Timeframe: Up to 2 years (Phase 2 portion of study)
| Intervention | weeks (Median) |
|---|
| Phase 2: Clofarabine, Etoposide, Cyclophosphamide | 67.3 |
Donor Cell Engraftment
Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%. (NCT00322101)
Timeframe: After stem cell infusion to day 28
| Intervention | participants (Number) |
|---|
| Arm I (Nonmyeloablative Regimen) | 11 |
| Arm II (Myeloablative Regimen) | 11 |
Incidence and Severity of Acute and Chronic Graft-vs-host Disease
(NCT00322101)
Timeframe: After transplantation
| Intervention | participants (Number) |
|---|
| Arm I (Nonmyeloablative Regimen) | 1 |
| Arm II (Myeloablative Regimen) | 4 |
Overall Survival
(NCT00322101)
Timeframe: At 2 years
| Intervention | participants (Number) |
|---|
| Arm I (Nonmyeloablative Regimen) | 6 |
| Arm II (Myeloablative Regimen) | 6 |
Non-relapse Mortality
(NCT00322101)
Timeframe: At 100 days
| Intervention | participants (Number) |
|---|
| Arm I (Nonmyeloablative Regimen) | 0 |
| Arm II (Myeloablative Regimen) | 0 |
Progression-free Survival
IWG criteria was used to determine disease progression (NCT00322101)
Timeframe: After stem cell infusion to date of last follow up.
| Intervention | participants (Number) |
|---|
| Arm I (Nonmyeloablative Regimen) | 7 |
| Arm II (Myeloablative Regimen) | 5 |
Incidence of Disease Progression/Relapse
Disease progression/relapse was defined by IWG criteria (NCT00322101)
Timeframe: After stem cell infusion to date of last follow up.
| Intervention | participants (Number) |
|---|
| Arm I (Nonmyeloablative Regimen) | 7 |
| Arm II (Myeloablative Regimen) | 2 |
Overall Survival (OS)
OS is defined as alive at 1 year, the event is death from any cause. Patients alive at the time of last observation, for statistical purposes, will have a survival time which is censored. (NCT00326417)
Timeframe: Day 365
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide 100mg | 80.5 |
| Cyclophosphamide 50mg | 97.4 |
Disease-free Survival (DFS)
DFS includes graft failure, regimen-related toxicity (RRT), and early death. Graft Failure is defined by lack of neutrophil engraftment (ANC less than 0.5 x 10^9/L for 3 consecutive days on different days). Major RRT is defined as severity of grade 4 in any organ system or grade 3 for pulmonary, cardiac, renal, oral mucosal or hepatic. Early death is defined as death prior to Day 100 post-transplant. (NCT00326417)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Graft Failure | Major RRT | Survival | Alive and engrafted |
|---|
| Cyclophosphamide 100mg | 6 | 9 | 39 | 35 |
,| Cyclophosphamide 50mg | 3 | 4 | 37 | 35 |
Chronic GVHD
Chronic GVHD is scored according to the BMT CTN MOP. The first day of chronic GVHD onset will be used to calculate cumulative incidence curves. (NCT00326417)
Timeframe: Day 365
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide 100mg | 31.7 |
| Cyclophosphamide 50mg | 22.5 |
Acute Graft vs Host Disease (GVHD)
All GVHD grades 2-4 will be graded according to the BMT CTN Manual of Procedures (MOP) (NCT00326417)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide 100mg | 26.8 |
| Cyclophosphamide 50mg | 23.7 |
Cumulative Incidence of Graft Failure
Primary and secondary graft failure are included, secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in the ANC to less than 0.5 x 10^9/L for three consecutive measurements on different days, unresponsive to growth factor. (NCT00326417)
Timeframe: Day 365
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide 100mg | 14.6 |
| Cyclophosphamide 50mg | 11.7 |
Objective Response
Objective response (complete response (CR) or partial response (PR)) is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT00328861)
Timeframe: very 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| NK Cells + IL-2: Melanoma | 0 | 0 |
,| NK Cells + IL-2: Renal Cell | 0 | 0 |
Safety
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00328861)
Timeframe: 11/30/2006 - 7/31/2007
| Intervention | Participants (Number) |
|---|
| NK Cells + IL-2: Melanoma | 7 |
| NK Cells + IL-2: Renal Cell | 1 |
Time to Progression (Phase II)
Median time to progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or new effusions. (NCT00331552)
Timeframe: Up to 2 years
| Intervention | months (Median) |
|---|
| Phase II: Cyclophosphamide, Doxil, Trastuzumab | 6.3 |
Comparison of Clinical Benefit Rate in 2 Subgroups--heavily Pre-treated (1 or More Regimens for Advanced Disease) vs Less Heavily Pre-treated (no Regimens for Advanced Disease) (Phase II)
Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease). (NCT00331552)
Timeframe: Up to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Heavily Pre-treated | 9 |
| Less Heavily Pre-treated | 7 |
Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)
The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment (NCT00331552)
Timeframe: Up to 24 weeks
| Intervention | mg/m^2 (Number) |
|---|
| Phase I: Cyclophosphamide, Doxil, Trastuzumab | 30 |
Overall Survival (Phase II)
Kaplan-Meier estimate assessed at 18 months (NCT00331552)
Timeframe: 18 months
| Intervention | survival probability (Number) |
|---|
| Phase II: Cyclophosphamide, Doxil, Trastuzumab | 0.49 |
Progression-free Survival (Phase II)
Kaplan-Meier estimate assessed at 18 months (NCT00331552)
Timeframe: 18 months
| Intervention | progression free survival probability (Number) |
|---|
| Phase II: Cyclophosphamide, Doxil, Trastuzumab | 0.16 |
Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Count of participants with grade 1, 2, 3, 4, fatal toxicity, need for dose reduction, treatment interruption, or treatment discontinuation (NCT00331552)
Timeframe: Periodically during study treatment, up to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3 adverse events | Grade 4 adverse events | At least one dose held or reduced | Discontinued due to toxicity |
|---|
| Cyclophosphamide, Doxil, Trastuzumab | 14 | 3 | 18 | 8 |
Efficacy as Assessed by the Overall Clinical Benefit Rate
Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease). (NCT00331552)
Timeframe: 18 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete response | Partial response | Stable disease | Progressive disease |
|---|
| Cyclophosphamide, Doxil, Trastuzumab | 0 | 6 | 15 | 7 |
Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors
The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610). (NCT00335556)
Timeframe: 4 years
| Intervention | Percentage of 4-year OS (Number) |
|---|
| UH-1 | 38.9 |
Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization
(NCT00335556)
Timeframe: At baseline
| Intervention | Count participants (Number) |
|---|
| UH-1 | 23 |
| Window/UH-1 | 1 |
Response Rate
Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non-index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy. (NCT00335556)
Timeframe: Up to 2 months
| Intervention | Percentage of participants (Number) |
|---|
| Combined Window/UH-1 and UH-2 | 71 |
Toxicity Rate
Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4. (NCT00335556)
Timeframe: Up to 4 years
| Intervention | Percentage of patients (Number) |
|---|
| Cardiac toxicities | Treatment-related deaths | Sinusoidal Obstruction Syndrome |
|---|
| Combined UH-2, UH-1, Window/UH-1 | 4.9 | 4.9 | 0 |
Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)
Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610). (NCT00335556)
Timeframe: 4 years
| Intervention | Percentage of 4-year OS (Number) |
|---|
| UH-1 | 76.1 |
| Window/UH-1 | 25.0 |
| UH-2 | 87.5 |
Event Free Survival Probability
Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610). (NCT00335556)
Timeframe: 4 years
| Intervention | Percent Probability 4 Year EFS (Number) |
|---|
| Regimen DD-4A | 100.0 |
Number of Participants With Chronic Central Hypothyroidism
"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than Institutional Normal with TSH less than or equal to Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 1 |
| Arm II (Patients Treated With MTX) | 1 |
Number of Participants With Chronic Diabetes Insipidus
"The number of patients who had Diabetes Insipidus and on DDAVP will be reported for this analysis due to small numbers.." (NCT00336024)
Timeframe: Beginning of off-treatment to up to 9 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 1 |
| Arm II (Patients Treated With MTX) | 1 |
Number of Participants With Chronic Low Somatomedin C
Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run. (NCT00336024)
Timeframe: Off-treatment up to 9 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 2 |
| Arm II (Patients Treated With MTX) | 5 |
Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism
"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than Institutional Normal or equal to Institutional Normal with TSH level greater than Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 3 |
| Arm II (Patients Treated With MTX) | 5 |
Number of Participants With Secondary Malignancies
The number of patients who had secondary malignancy will be reported for this analysis due to small numbers. (NCT00336024)
Timeframe: Off-treatment up to 9 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 1 |
| Arm II (Patients Treated With MTX) | 0 |
Percentage of Participants With Any Acute Adverse Events
Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation
| Intervention | percentage of participants (Number) |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 97.4 |
| Arm II (Patients Treated With MTX) | 97.2 |
Percentage of Participants With Event Free Survival (EFS)
EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 90% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1. (NCT00336024)
Timeframe: Baseline to up to 5 years
| Intervention | percentage of participants with EFS (Number) |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 43.6 |
| Arm II (Patients Treated With MTX) | 54.9 |
Rates of Gastrointestinal Toxicities
Rates of gastrointestinal toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation
| Intervention | Participants (Count of Participants) |
|---|
| GI Tox Induction Cycle I | No GI Tox Induction Cycle I | GI Tox Induction Cycle II | No GI Tox Induction Cycle II | GI Tox Induction Cycle III | No GI Tox Induction Cycle III | GI Tox Consolidation Cycle I | No GI Tox Consolidation Cycle I | GI Tox Consolidation Cycle II | No GI Tox Consolidation Phase II | GI Tox Consolidation Cycle III | No GI Tox Consolidation Cycle III |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 8 | 31 | 4 | 35 | 4 | 35 | 11 | 28 | 7 | 32 | 5 | 34 |
,| Arm II (Patients Treated With MTX) | 12 | 26 | 10 | 28 | 8 | 30 | 14 | 24 | 10 | 28 | 6 | 32 |
Rates of Nutritional Toxicities
Rates of nutritional toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with nutritional toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation
| Intervention | Participants (Count of Participants) |
|---|
| Nutritional Disorders Induction Cycle I | No Nutritional Disorders Induction Cycle I | Nutritional Disorders Induction Cycle II | No Nutritional Disorders Induction Cycle II | Nutritional Disorders Induction Cycle III | No Nutritional Disorders Induction Cycle III | Nutritional Disorders Consolidation Cycle I | No Nutritional Disorders Consolidation Cycle I | Nutritional Disorders Consolidation Cycle II | No Nutritional Disorders Consolidation Cycle II | Nutritional Disorders Consolidation Cycle III | No Nutritional Disorders Consolidation Cycle III |
|---|
| Arm I (Patients Treated Without Methotrexate (MTX)) | 10 | 29 | 13 | 26 | 7 | 32 | 12 | 27 | 9 | 30 | 10 | 29 |
,| Arm II (Patients Treated With MTX) | 17 | 21 | 13 | 25 | 12 | 26 | 8 | 30 | 5 | 33 | 5 | 33 |
Number of Patients That Achieved a Complete Response or a Partial Response (PR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00337987)
Timeframe: After 4 years
| Intervention | participants (Number) |
|---|
| Denileukin Diftitox/CHOP Administration | 32 |
Number of Patients That Achieved a Complete Response (CR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00337987)
Timeframe: After 4 years
| Intervention | participants (Number) |
|---|
| Denileukin Diftitox/CHOP Administration | 27 |
Incidence of Chronic GVHD
Analyzed using cumulative incidence estimates, treating death or rejection as competing risk events. (NCT00343785)
Timeframe: 2 years
| Intervention | number participants with chronic GVHD (Number) |
|---|
| Patients Receive a Conditioning Regimen Comprising Cyclophosph | 5 |
Number of Days to Neutrophil Recovery to >500/uL
First of 3 consecutive days of neutrophils >500/uL (NCT00343785)
Timeframe: 100 days post-transplant
| Intervention | days (Median) |
|---|
| Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis) | 26 |
Overall Survival
Number of patients alive at one year (NCT00343785)
Timeframe: From the time of enrollment until death from any cause up to one year
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis) | 21 |
Count of Patients Achieving Complete Response
(NCT00343863)
Timeframe: At 24-120 hours after weekly intravenous doxorubicin
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone + Ondansetron IV | 3 |
| Dexamethasone + Palonosetron IV | 15 |
Number of Participants That Had Emesis Within 48 Hours of Chemotherapy
Count of patients that had emesis within 48 hours of chemotherapy (NCT00343863)
Timeframe: Up to 48 hours of chemotherapy
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone + Ondansetron IV | 0 |
| Dexamethasone + Palonosetron IV | 1 |
Number of Participants That Had First Administration of Rescue Medication Within 48 Hours
Count of patients that had first administration of rescue medication within 48 Hours (NCT00343863)
Timeframe: up to 48 hours of chemotherapy
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone + Ondansetron IV | 1 |
| Dexamethasone + Palonosetron IV | 4 |
Severity of Nausea
Count of participants with severe nausea (NCT00343863)
Timeframe: Up to 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone + Ondansetron IV | 1 |
| Dexamethasone + Palonosetron IV | 4 |
Number of Days With Emetic Episodes and Rescue Medicines
(NCT00343863)
Timeframe: Up to 3 months
| Intervention | days (Median) |
|---|
| Vomiting during neoadjuvant chemotherapy | Took rescue medicines |
|---|
| Dexamethasone + Ondansetron IV | 0 | 2 |
,| Dexamethasone + Palonosetron IV | 0 | 9.5 |
Side Effects of Antiemetic Medications Used
(NCT00343863)
Timeframe: Up to 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Constipation | Headaches |
|---|
| Dexamethasone + Ondansetron IV | 2 | 0 |
,| Dexamethasone + Palonosetron IV | 15 | 2 |
Quality of Life
(NCT00343863)
Timeframe: Up to 3 months
| Intervention | FLIE questionnaires (Count of Units) |
|---|
| FLIE Nausea72045916 | FLIE Nausea72045917 | FLIE Vomiting72045916 | FLIE Vomiting72045917 |
|---|
| High impact (<36) | Medium impact (36-54) | No impact of daily life (>54) |
|---|
| Dexamethasone + Ondansetron IV | 4 |
| Dexamethasone + Palonosetron IV | 44 |
| Dexamethasone + Ondansetron IV | 5 |
| Dexamethasone + Palonosetron IV | 74 |
| Dexamethasone + Ondansetron IV | 26 |
| Dexamethasone + Palonosetron IV | 248 |
| Dexamethasone + Ondansetron IV | 1 |
| Dexamethasone + Palonosetron IV | 10 |
| Dexamethasone + Ondansetron IV | 3 |
| Dexamethasone + Palonosetron IV | 9 |
| Dexamethasone + Ondansetron IV | 31 |
| Dexamethasone + Palonosetron IV | 347 |
Count of Patients Achieving a Complete Response
(NCT00343863)
Timeframe: At 0-24 hours after weekly intravenous doxorubin
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone + Ondansetron IV | 3 |
| Dexamethasone + Palonosetron IV | 15 |
Number of Participants With 2 Years Progression Free Survival
"Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.~Definition is as follows:~At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy." (NCT00345865)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| NHL With Irradiation | 96 |
| HL Without Irradiation | 91 |
| NHL - HIV Infected With Irradiation | 1 |
| NHL - HIV Infected Without Irradiation | 1 |
| NHL Without Radiation and Cyclophosphamide | 106 |
Number of Participants With 1 Year Progression Free Survival
"Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows:~At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy." (NCT00345865)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| NHL With Irradiation | 112 |
| HL Without Irradiation | 102 |
| NHL - HIV Infected With Irradiation | 1 |
| NHL - HIV Infected Without Irradiation | 2 |
| NHL Without Radiation and Cyclophosphamide | 116 |
Number of Participants With 2 Years Overall Survival
(NCT00345865)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| NHL With Irradiation | 124 |
| HL Without Irradiation | 140 |
| NHL - HIV Infected With Irradiation | 1 |
| NHL - HIV Infected Without Irradiation | 4 |
| NHL Without Radiation and Cyclophosphamide | 121 |
Number of Participants With Hematopoietic Recovery After Transplantation
return to ANC (absolute neutrophil count) more than 500 cells/milliliter. (NCT00345865)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| NHL With Irradiation | 171 |
| HL Without Irradiation | 147 |
| NHL - HIV Infected With Irradiation | 2 |
| NHL - HIV Infected Without Irradiation | 5 |
| NHL Without Radiation and Cyclophosphamide | 145 |
Number of Participants With 1 Year Overall Survival
(NCT00345865)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| NHL With Irradiation | 139 |
| HL Without Irradiation | 144 |
| NHL - HIV Infected With Irradiation | 1 |
| NHL - HIV Infected Without Irradiation | 5 |
| NHL Without Radiation and Cyclophosphamide | 128 |
Number of Participants That Relapse After Autologous Transplantation
Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation (NCT00349778)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| High-Dose Sequential Therapy | 66 |
Number of Participants With Pulmonary Toxicity
Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis. (NCT00349778)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| High-Dose Sequential Therapy | 32 |
Overall Participant Survival (OS)
Survival status was assessed 5 years after transplant. (NCT00349778)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| High-Dose Sequential Therapy | 52 |
Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 89.2 |
| Week 12 | 82 |
| After Radiation | 89.4 |
| Off-therapy | 87.3 |
Patient Quality of Life (QoL), PedsQL v.3.0: Worry
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 71.2 |
| Week 12 | 72.2 |
| After Radiation | 74.5 |
| Off-therapy | 76.0 |
Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 72.6 |
| Week 8 | 75.3 |
| Week 12 | 75.7 |
| After Radiation | 84.5 |
| Off-therapy | 81.6 |
Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 79.3 |
| Week 8 | 77.6 |
| Week 12 | 78.6 |
| After Radiation | 84.3 |
| Off-therapy | 84.3 |
Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 73.1 |
| Week 8 | 69.5 |
| Week 12 | 72.6 |
| After Radiation | 78.4 |
| Off-therapy | 81.3 |
Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 80.9 |
| Week 8 | 74.4 |
| Week 12 | 75.3 |
| After Radiation | 83.1 |
| Off-therapy | 84.5 |
Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 90.9 |
| Week 8 | 88.6 |
| Week 12 | 88.0 |
| After Radiation | 90.1 |
| Off-therapy | 91.1 |
Patient Quality of Life (QoL), Symptom Distress Scale
"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 17.3 |
| Week 8 | 19.6 |
| Week 12 | 18.1 |
| After Radiation | 15.1 |
| Off-therapy | 14.3 |
Prognostic Factors for Treatment Failure: Age
Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. (NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
| Intervention | events (Number) |
|---|
| Stanford V Chemotherapy | 11 |
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)
Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
| Intervention | Participants (Count of Participants) |
|---|
| Normal | Abnormal |
|---|
| Year 1 Off Therapy | 68 | 0 |
,| Year 10 Off Therapy | 15 | 1 |
,| Year 2 Off Therapy | 57 | 1 |
,| Year 5 Off Therapy | 36 | 2 |
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)
Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
| Intervention | Participants (Count of Participants) |
|---|
| Normal | Abnormal |
|---|
| Year 1 Off Therapy | 51 | 5 |
,| Year 10 Off Therapy | 10 | 6 |
,| Year 2 Off Therapy | 44 | 8 |
,| Year 5 Off Therapy | 24 | 4 |
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)
Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
| Intervention | Participants (Count of Participants) |
|---|
| Normal | Abnormal |
|---|
| Year 1 Off Therapy | 46 | 20 |
,| Year 10 Off Therapy | 9 | 1 |
,| Year 2 Off Therapy | 41 | 20 |
,| Year 5 Off Therapy | 25 | 11 |
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)
For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy
| Intervention | Participants (Count of Participants) |
|---|
| Normal | Hypothyroid | Hyperthyroid | Thyroid Nodule |
|---|
| Year 1 Off Therapy | 60 | 8 | 2 | 0 |
,| Year 10 Off Therapy | 20 | 3 | 0 | 0 |
,| Year 2 Off Therapy | 54 | 11 | 1 | 0 |
,| Year 5 Off Therapy | 37 | 8 | 1 | 0 |
Local and Distant Failure for Children Treated With Tailored-field Radiation
The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field. (NCT00352027)
Timeframe: from first enrollment date up to 3 years follow-up
| Intervention | probability that the event occurs (Number) |
|---|
| Cumulative incidence of distant failure at 3 years | Cumulative incidence of local failure at 3 years |
|---|
| Stanford V Chemotherapy | 0.0375 | 0.1127 |
Prognostic Factors for Treatment Failure: Gender
Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up
| Intervention | events (Number) |
|---|
| Male | Female |
|---|
| Stanford V Chemotherapy | 5 | 6 |
Prognostic Factors for Treatment Failure: Histology
Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up
| Intervention | events (Number) |
|---|
| Classical, Nodular Sclerosing | Other |
|---|
| Stanford V Chemotherapy | 10 | 1 |
Prognostic Factors for Treatment Failure: Stage
Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
| Intervention | events (Number) |
|---|
| Stage | Stage ≥III | |
|---|
| Stanford V Chemotherapy | 8 | 3 |
Toxicities With Grade >1
Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT00352027)
Timeframe: 3 years
| Intervention | adverse events (Number) |
|---|
| Alanine transaminase (ALT) | Aspartate transaminase (AST) | Allergic reaction/hypersensitivity | Constipation | Febrile neutropenia | Fever (in the absence of neutropenia) | Glucose | GGT (gamma-Glutamyltranspeptidase) | Hemoglobin | Hypoxia | Ileus, GI (functional obstruction of bowel) | Infection with Grade 3 or 4 neutrophils | Infection - Other | Infection with normal ANC or Grade 1-2 neutrophils | Infection with unknown ANC | Insomnia | Leukocytes (total WBC) | Lymphopenia | Mucositis/stomatitis (functional/symptomatic) | Nausea | Neuropathy: motor | Neuropathy: sensory | Neutrophils/granulocytes (ANC/AGC) | Pain | Phosphate | Platelets | Potassium | Sodium | Syndromes - Other | Thrombosis/embolism (vascular access-related) | Thrombosis/thrombus/embolism | Vomiting |
|---|
| HOD05 - Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| HOD05 - Grade 3 | 1 | 1 | 4 | 0 | 7 | 2 | 0 | 1 | 26 | 1 | 1 | 2 | 1 | 3 | 0 | 1 | 41 | 22 | 0 | 1 | 0 | 1 | 24 | 5 | 1 | 0 | 2 | 1 | 1 | 2 | 0 | 2 |
,| HOD05 - Grade 4 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 7 | 0 | 0 | 0 | 0 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
,| HOD05 - Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| HOD99 - Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,| HOD99 - Grade 3 | 0 | 0 | 0 | 1 | 5 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 1 | 1 | 0 | 19 | 0 | 1 | 2 | 1 | 1 | 9 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 4 |
,| HOD99 - Grade 4 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 30 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| HOD99 - Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 83.2 |
| Week 8 | 68.4 |
| Week 12 | 69.1 |
| After Radiation | 80.8 |
| Off-therapy | 85.2 |
3-year Event-free Survival (EFS) Probability
Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years
| Intervention | probability (Number) |
|---|
| HOD05 Participants | 0.887 |
| HOD99 Participants | 0.844 |
3-year Event-Free Survival Probability
The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame. (NCT00352027)
Timeframe: 3 years
| Intervention | probability (Number) |
|---|
| Stanford V Chemotherapy | 0.887 |
3-year Local Failure-free Survival Probability
Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years
| Intervention | probability (Number) |
|---|
| HOD05 Participants | 0.887 |
| HOD99 Participants | 0.932 |
3-year Overall Survival (OS) Probability
Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3-years
| Intervention | probability (Number) |
|---|
| HOD05 Participants | 1.00 |
| HOD99 Participants | 0.978 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.46 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.35 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -2.31 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -2.52 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.20 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -0.87 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.41 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -0.96 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry
"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.06 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.56 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.9 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -0.92 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.21 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -0.79 |
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy
| Intervention | beta coefficient (Number) |
|---|
| QoL Participants | -1.46 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -1.0 |
| Parent and Patient Scores at Week 12 | 0.14 |
| Parent and Patient Scores at After Radiation | -8.0 |
| Parent and Patient Scores at Off-therapy | -4.0 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -0.3 |
| Parent and Patient Scores at Week 12 | -3.6 |
| Parent and Patient Scores at After Radiation | -7.4 |
| Parent and Patient Scores at Off-therapy | -6.3 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -1.2 |
| Parent and Patient Scores at Week 12 | -3.4 |
| Parent and Patient Scores at After Radiation | -3.0 |
| Parent and Patient Scores at Off-therapy | -1.1 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -2.0 |
| Parent and Patient Scores at Week 12 | -9.5 |
| Parent and Patient Scores at After Radiation | -5.6 |
| Parent and Patient Scores at Off-therapy | -5.4 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -2.5 |
| Parent and Patient Scores at Week 12 | -9.5 |
| Parent and Patient Scores at After Radiation | -5.9 |
| Parent and Patient Scores at Off-therapy | -9.3 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -0.2 |
| Parent and Patient Scores at Week 12 | -9.3 |
| Parent and Patient Scores at After Radiation | -2.2 |
| Parent and Patient Scores at Off-therapy | -8.7 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -1.5 |
| Parent and Patient Scores at Week 12 | -5.2 |
| Parent and Patient Scores at After Radiation | -4.5 |
| Parent and Patient Scores at Off-therapy | -5 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -6.1 |
| Parent and Patient Scores at Week 12 | -8.8 |
| Parent and Patient Scores at After Radiation | -7.9 |
| Parent and Patient Scores at Off-therapy | -6.6 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Week 8 | -0.7 |
| Parent and Patient Scores at Week 12 | -3.9 |
| Parent and Patient Scores at After Radiation | -2.7 |
| Parent and Patient Scores at Off-therapy | -0.5 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Pre-therapy | -4.9 |
| Parent and Patient Scores at Week 8 | -9.4 |
| Parent and Patient Scores at Week 12 | -8.0 |
| Parent and Patient Scores at After Radiation | -10.8 |
| Parent and Patient Scores at Off-therapy | -1.7 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Pre-therapy | -2.9 |
| Parent and Patient Scores at Week 8 | -2.3 |
| Parent and Patient Scores at Week 12 | -1.9 |
| Parent and Patient Scores at After Radiation | -5.4 |
| Parent and Patient Scores at Off-therapy | -2 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Pre-therapy | -2.8 |
| Parent and Patient Scores at Week 8 | -6.4 |
| Parent and Patient Scores at Week 12 | -6.3 |
| Parent and Patient Scores at After Radiation | -5.6 |
| Parent and Patient Scores at Off-therapy | -3.3 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Pre-therapy | 1.3 |
| Parent and Patient Scores at Week 8 | -5.3 |
| Parent and Patient Scores at Week 12 | -4.1 |
| Parent and Patient Scores at After Radiation | -3.4 |
| Parent and Patient Scores at Off-therapy | -4.3 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Pre-therapy | -5.3 |
| Parent and Patient Scores at Week 8 | -5.7 |
| Parent and Patient Scores at Week 12 | -7.4 |
| Parent and Patient Scores at After Radiation | -5.0 |
| Parent and Patient Scores at Off-therapy | -3.3 |
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Parent and Patient Scores at Pre-therapy | -2.9 |
| Parent and Patient Scores at Week 8 | -4.8 |
| Parent and Patient Scores at Week 12 | -4.8 |
| Parent and Patient Scores at After Radiation | -5 |
| Parent and Patient Scores at Off-therapy | -2.9 |
Disease Failure Rate Within Radiation Fields
Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT00352027)
Timeframe: 3 years
| Intervention | proportion of participants (Number) |
|---|
| Stanford V Chemotherapy | 0.1125 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 77.6 |
| Week 12 | 79.5 |
| After Radiation | 78.6 |
| Off-therapy | 79.9 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 79.2 |
| Week 12 | 80.4 |
| After Radiation | 80.3 |
| Off-therapy | 84.3 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 61.2 |
| Week 12 | 57.4 |
| After Radiation | 72.2 |
| Off-therapy | 83.2 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 61.2 |
| Week 12 | 61.8 |
| After Radiation | 73.1 |
| Off-therapy | 82.7 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 74.9 |
| Week 12 | 72.2 |
| After Radiation | 73.7 |
| Off-therapy | 76.3 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 70.0 |
| Week 12 | 60.0 |
| After Radiation | 63.1 |
| Off-therapy | 73.8 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 71.7 |
| Week 12 | 69.3 |
| After Radiation | 74.5 |
| Off-therapy | 80.0 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 81.9 |
| Week 12 | 72.6 |
| After Radiation | 78.5 |
| Off-therapy | 81.8 |
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 70 |
| Week 12 | 69.2 |
| After Radiation | 71.9 |
| Off-therapy | 78.7 |
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 67.7 |
| Week 8 | 65.4 |
| Week 12 | 68.1 |
| After Radiation | 73.0 |
| Off-therapy | 82.0 |
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 79.8 |
| Week 8 | 65.3 |
| Week 12 | 67.3 |
| After Radiation | 73.6 |
| Off-therapy | 84.6 |
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 76.2 |
| Week 8 | 71.0 |
| Week 12 | 74.1 |
| After Radiation | 79.0 |
| Off-therapy | 88.0 |
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 74.4 |
| Week 8 | 62.8 |
| Week 12 | 70.8 |
| After Radiation | 75.6 |
| Off-therapy | 78.9 |
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 86.1 |
| Week 8 | 83.0 |
| Week 12 | 80.7 |
| After Radiation | 85.1 |
| Off-therapy | 89.1 |
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Pre-therapy | 77.6 |
| Week 8 | 69.1 |
| Week 12 | 72.3 |
| After Radiation | 77.8 |
| Off-therapy | 83.5 |
Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 79.1 |
| Week 12 | 78.2 |
| After Radiation | 87.0 |
| Off-therapy | 82.0 |
Patient Quality of Life (QoL), PedsQL v.3.0: Communication
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 80.7 |
| Week 12 | 83.0 |
| After Radiation | 87.2 |
| Off-therapy | 89.0 |
Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 62.7 |
| Week 12 | 60.1 |
| After Radiation | 76.7 |
| Off-therapy | 81.6 |
Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 63.9 |
| Week 12 | 71.5 |
| After Radiation | 79.9 |
| Off-therapy | 88.0 |
Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 77.6 |
| Week 12 | 81.3 |
| After Radiation | 81.4 |
| Off-therapy | 84.7 |
Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 71.8 |
| Week 12 | 70.9 |
| After Radiation | 68.1 |
| Off-therapy | 80.1 |
Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | 74.1 |
| Week 12 | 74.2 |
| After Radiation | 81.7 |
| Off-therapy | 83.5 |
Average IgG Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
(NCT00352976)
Timeframe: by 365 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 724.0 |
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
(NCT00352976)
Timeframe: by 365 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 107.2 |
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 180 Days
(NCT00352976)
Timeframe: by 180 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 98.7 |
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 100 Days
(NCT00352976)
Timeframe: by 100 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 88.0 |
Number of Participants Experiencing Chronic GVHD
Number of participants experiencing chronic Graft Vs Host Disease by 1 year (NCT00352976)
Timeframe: at one year
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 6 |
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 180 Days
(NCT00352976)
Timeframe: by 180 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 77.0 |
Average IgG Levels as a Measure of Immune Reconstitution After Transplant, by 180 Days
(NCT00352976)
Timeframe: by 180 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 652.9 |
Number of Participants With Secondary Graft Failure at 100 Days
Secondary Graft Rejection by day 100 (NCT00352976)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 4 |
Number of Participants Experiencing Overall Survival
Number of participants experiencing overall survival by 1 year (NCT00352976)
Timeframe: at one year
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 70 |
Number of Participants Experiencing Infections by Day 180
(NCT00352976)
Timeframe: by day 180
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 55 |
Number of Participants Experiencing Infections by Day 365
(NCT00352976)
Timeframe: by day 365
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 56 |
Number of Participants Experiencing Infections by Day 100
(NCT00352976)
Timeframe: by day 100
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 53 |
Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD)
Number of participants experiencing acute GVHD (all grades) by day 100 (NCT00352976)
Timeframe: at 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 15 |
Number of Participant With Neutrophil Recovery
Number of participant with neutrophil recovery. Neutrophil recovery is defined as absolute neutrophil count ≥500/µL for three consecutive days (NCT00352976)
Timeframe: by day 42
| Intervention | Participants (Count of Participants) |
|---|
| Treatment With TBI | 78 |
Average Immunoglobulin G (IgG) Levels as a Measure of Immune Reconstitution After Transplant, by 100 Days
(NCT00352976)
Timeframe: by 100 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 550.6 |
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
(NCT00352976)
Timeframe: by 365 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 82.8 |
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 100 Days
(NCT00352976)
Timeframe: by 100 days
| Intervention | mg/dL (Mean) |
|---|
| Treatment With TBI | 71.1 |
Number of Participants (Patients) Who Experienced Relapse by 24 Months
Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 2 Years Post transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 11 |
Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. (NCT00354172)
Timeframe: 12 Months Post transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 1 |
Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. (NCT00354172)
Timeframe: 6 Months Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 2 |
Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 6 |
Number of Participants (Patients) With Chronic Graft-Versus-Host Disease
The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. (NCT00354172)
Timeframe: Day 100 through 1 Year Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 1 |
Number of Participants (Patients) With Successful Natural Killer Cell Expansion
Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population (NCT00354172)
Timeframe: 10-13 Days Post Infusion
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 3 |
Number of Patients Who Were Disease-free and Alive at 24 Months
Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. (NCT00354172)
Timeframe: 24 Months Post transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 0 |
Chimerism After Double Umbilical Cord Blood Transplant (UCBT)
Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). (NCT00354172)
Timeframe: Day 21, Day 100, 6 Months
| Intervention | Percentage of Engrafted Cells (Median) |
|---|
| Day 21 | Day 100 | 6 Months |
|---|
| Evaluable Patients | 92 | 100 | 96.5 |
Number of Participants (Patients) Who Attained Neutrophil Engraftment
"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)." (NCT00354172)
Timeframe: Day 42 Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 13 |
Number of Participants (Patients) Who Attained Platelet Engraftment
Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. (NCT00354172)
Timeframe: 1 Year Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 5 |
Number of Participants (Patients) Who Died by 12 Months
Number of patients who died after receiving treatment within 12 months post transplant. (NCT00354172)
Timeframe: 1 year Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 14 |
Number of Participants (Patients) Who Died by 24 Months
Number of patients who died after receiving treatment within 24 months post transplant. (NCT00354172)
Timeframe: 2 years post-transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 15 |
Number of Participants (Patients) Who Died Due to Transplant.
Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. (NCT00354172)
Timeframe: 6 Months Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 4 |
Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 post transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 1 |
Number of Participants (Patients) Who Experienced Relapse by 12 Months
Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 1 Year Post Transplant
| Intervention | Participants (Number) |
|---|
| Evaluable Patients | 10 |
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy
Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy. (NCT00354744)
Timeframe: From enrollment to up to 2 years
| Intervention | percentage of patients (Number) |
|---|
| Course 1 | Course 2 | Course 3 | Course 4 |
|---|
| High_Risk_Rhabdomyosarcoma | 53.3 | 68.4 | 79.3 | 55.7 |
Percentage of Patients Event Free at 4 Years Following Study Entry
Event-free survival: Time to recurrence, second malignancy, or death as a first event, estimated from a Kaplan Meier curve (NCT00354744)
Timeframe: 4 years
| Intervention | Percentage of patients (Number) |
|---|
| High_Risk_Rhabdomyosarcoma | 36 |
Number of Patients With Complete or Partial Response Assessed by RECIST Criteria
"Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the measurable mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as non-measurable. Complete Response (CR): Complete disappearance of the tumor confirmed at >4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning." (NCT00354744)
Timeframe: Protocol week 6 evaluation
| Intervention | percentage of participants (Number) |
|---|
| High_Risk_Rhabdomyosarcoma | 63 |
Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15
4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study) (NCT00354835)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| % Change in SUVmax From Baseline to Week 15 < 40% | 0.6667 |
| % Change in SUVmax From Baseline to Week 15 >= 40% | 0.5686 |
Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4
4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study). (NCT00354835)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| % Change in SUVmax From Baseline to Week 4 < 40% | 0.2857 |
| % Change in SUVmax From Baseline to Week 4 >= 40% | 0.6364 |
Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70. (NCT00354835)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.7293 |
Overall Survival (OS)
Probability of being alive after 4 years in the study. (NCT00354835)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.7293 |
| VAC Alternating With Vincristine, Irinotecan (VI) | 0.7223 |
Local Failure
Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13. (NCT00354835)
Timeframe: 2 years
| Intervention | Proportion of participants (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.1757 |
Incidence of Toxicity
Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3. (NCT00354835)
Timeframe: Up to 15 weeks
| Intervention | Probability (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.2072 |
| VAC Alternating With Vincristine, Irinotecan (VI) | 0.3673 |
Incidence of Bladder Dysfunction
Number of patients with a summary score greater than 8.5 (NCT00354835)
Timeframe: 3-6 years after enrollment
| Intervention | Participant (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 2 |
| VAC Alternating With Vincristine, Irinotecan (VI) | 1 |
Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65. (NCT00354835)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.6255 |
Event Free Survival (EFS) by PAX Status
(NCT00354835)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| PAX3 | 0.51 |
| PAX7 | 0.66 |
Response Rate (RR)
Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR. (NCT00354835)
Timeframe: Reporting Period 1 (Weeks 1 - 15)
| Intervention | Proportion (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.6667 |
| VAC Alternating With Vincristine, Irinotecan (VI) | 0.6726 |
Event Free Survival (EFS)
Probability of no relapse, secondary malignancy, or death after 4 year in the study (NCT00354835)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.6255 |
| VAC Alternating With Vincristine, Irinotecan (VI) | 0.5874 |
Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC
The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons. (NCT00354835)
Timeframe: Up to 43 weeks
| Intervention | participants (Number) |
|---|
| Anemia | Febrile Neutropenia | Nausea or Hepatopathy | Platelet Count Decreased | Vomiting |
|---|
| VAC (Weeks 1-15) | 58 | 30 | 6 | 27 | 9 |
,| VAC (Weeks 31 - 43) | 54 | 17 | 1 | 63 | 2 |
27-Week Overall Survival
27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods. (NCT00357500)
Timeframe: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
| Intervention | Probability (Number) |
|---|
| 5-drug Metronomic Antiangiogenic Regimen | 0.61 |
27-Week Progression-Free Survival
27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. (NCT00357500)
Timeframe: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
| Intervention | Probability (Number) |
|---|
| 5-drug Metronomic Antiangiogenic Regimen | 0.31 |
Best Response
As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. (NCT00357500)
Timeframe: Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Not Evaluable |
|---|
| 5-drug Metronomic Antiangiogenic Regimen | 1 | 12 | 36 | 47 | 1 |
Therapy Completion Rate
Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression. (NCT00357500)
Timeframe: 27 weeks
| Intervention | proportion of patients (Number) |
|---|
| 5-drug Metronomic Antiangiogenic Regimen | .25 |
Graft Failure
Number of patients with graft failure (grade IV thrombocytopenia and neutropenia after day 21 that lasts > 2 weeks andn is refractory to growth factor support). (NCT00358657)
Timeframe: Day 84
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 0 |
Incidence of Grade I/II Acute Graft Versus Host Disease (GVHD)
Number of patients diagnosed with overall GI/G2 acute GVHD by Day 100 (NCT00358657)
Timeframe: Day 100 post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 7 |
Incidence of Chronic GVHD
Number of patients diagnosed with chronic GVHD by 1 year post transplant (NCT00358657)
Timeframe: 1 year post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 11 |
Immune Reconstitution
Number of patients with normal range CD3 @ 1 year post transplant (NCT00358657)
Timeframe: 1 year post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 4 |
Graft Rejection
Number of patients with graft rejection (CD3 donor chimerisms <5%). (NCT00358657)
Timeframe: Day 84
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 1 |
Proportion of Patients Who Achieve Greater Than 5% Donor T-cell Chimerism
Number of patients who achieve greater than 5% donor T-cell (CD3+) chimerisms (NCT00358657)
Timeframe: By day 84
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 13 |
Number of Patients With Infections
Number of patients with clinically significant infections requiring treatment within 200 days after HCT (NCT00358657)
Timeframe: Through day 200 after HCT
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 11 |
Incidence of Grade III/IV Acute Graft Versus Host Disease (GVHD)
Number of patients diagnosed with overall GIII/IV acute GVHD by Day 100 (NCT00358657)
Timeframe: Day 100 post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemo, Total-body Irradiation, Transplant) | 5 |
Objective Response Rate (ORR)
Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed. (NCT00365274)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| SGN-30 + Combination Chemotherapy | 83 | 17 |
Safety - Number of Participants With Adverse Events (AE)
"An adverse event was any untoward medical occurrence in a participant of the clinical investigation, regardless of the relationship to study treatment.~A serious adverse event (SAE) was an AE that at any dose (including overdose) resulted in death, was life-threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect, and/or was medically important.~Treatment-emergent adverse events (TEAE) were defined as AEs that developed or worsened in severity during the on-treatment period." (NCT00365365)
Timeframe: from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.
| Intervention | participants (Number) |
|---|
| with TEAE | with serious TEAE | with any TEAE leading to death | with any TEAE leading to treatment discontinuation | with any Grade 3-4 Serious TEAE |
|---|
| Stratum 1 (AC->T + Bevacizumab) | 78 | 23 | 0 | 21 | 23 |
,| Stratum 2 (TAC + Bevacizumab) | 75 | 24 | 2 | 24 | 24 |
,| Stratum 3 (TCH + Bevacizumab).) | 59 | 12 | 0 | 16 | 9 |
Disease-free Survival (DFS) Rate
"DFS was defined as the time from the administration of the first-dose of study medication until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. DFS rate was the probability of being disease free and alive at a particular time. DFS rates were estimated using Kaplan-Meier Method, and 95% confidence intervals were computed using the method of Kalbfleisch and Prentice.~For participants who did have objective recurrence of tumor and who were still on study at the time of an analysis, or who were given antitumor treatment other than the study treatment, or who were removed from study follow-up prior to documentation of the tumor recurrence, DFS was censored at the last date the participant was known to be disease-free." (NCT00365365)
Timeframe: from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months
| Intervention | percentage of participants (Number) |
|---|
| DFS rate at 12 months | DFS rate at 24 months | DFS rate at 36 months |
|---|
| Stratum 1 (AC->T + Bevacizumab) | 93.6 | 87.1 | 85.5 |
,| Stratum 2 (TAC + Bevacizumab) | 95.9 | 94.1 | 90.4 |
,| Stratum 3 (TCH + Bevacizumab).) | 98.2 | 96.3 | 90.4 |
Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)
"Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy.~Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF." (NCT00365365)
Timeframe: from the first dose of study medication up to the end of follow-up (up to 3 yrs)
| Intervention | participants (Number) |
|---|
| Stratum 1 (AC->T + Bevacizumab) | 1 |
| Stratum 2 (TAC + Bevacizumab) | 3 |
| Stratum 3 (TCH + Bevacizumab).) | 1 |
Reported Adverse Events
Number of Adverse Events (NCT00365417)
Timeframe: Approximately 14 months
| Intervention | events (Number) |
|---|
| Neoadjuvant Study Treatment | 566 |
Pathologic Complete Response (pCR) in the Breast
Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen (NCT00365417)
Timeframe: Approximately 7 months
| Intervention | participants (Number) |
|---|
| pCR in the breast | No pCR in the breast | No data available |
|---|
| Neoadjuvant Study Treatment | 4 | 38 | 3 |
pCR in the Breast and Nodes
Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel nodes (NCT00365417)
Timeframe: Approximately 7 months
| Intervention | participants (Number) |
|---|
| pCR in the breast and nodes | No pCR in the breast and nodes | No data available |
|---|
| Neoadjuvant Study Treatment | 4 | 38 | 3 |
Overall Survival
Percentage of patients alive. (NCT00365417)
Timeframe: 2 years
| Intervention | percentage of patients (Number) |
|---|
| Chemo Plus Bevacizumab | 74.52 |
Progression-free Survival
Percentage of patients free from disease progression. Progression is determined using international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. At least a 20% increase in the sum of the longest diameter of the target lesions. Other manifestations of progressive disease would also be classified as disease progression, eg., appearance of one or more new lesions in the breast, regional lymph nodes or distant sites, unequivocal progression of existing non-target lesions, and appearance of inflammatory carcinoma on clinical exam. (NCT00365417)
Timeframe: 2 years
| Intervention | percentage of patients (Number) |
|---|
| Chemo Plus Bevacizumab | 57.69 |
Number of Patients With at Least One Surgical Complications (Wound Dehiscence, Infection, Seroma, or Hematoma).
Number of patients with at least one surgical complications (wound dehiscence, infection, seroma, or hematoma) (NCT00365417)
Timeframe: Two (2) years
| Intervention | participants (Number) |
|---|
| Chemo Plus Bevacizumab | 24 |
Clinical Response Rate (cRR) of the Sequential Regimen
Clinical tumor measurements were required before study entry & before cycle 5 of chemotherapy (between AC & TX). Final tumor measurements were obtained 4-5 weeks after the last dose of chemotherapy. Clinical tumor assessments by physical examination were recommended before each chemotherapy cycle. The criteria proposed by the Response Evaluation Criteria in Solid Tumors Committee(RECIST) were used to define clinical response status. CR was defined as the disappearance of all lesions with no evidence of PD. PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions, using as reference the baseline sum longest diameter and/or the persistence of greater than or equal to 1 nontarget lesion without worsening of any other clinical manifestations of disease. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions, or unequivocal progression of existing lesions. (NCT00365417)
Timeframe: Approximately 6 months
| Intervention | percentage of patients (Number) |
|---|
| Chemo Plus Bevacizumab | 77.27 |
Cardiac Events
Events: Congestive Heart Failure; Cardiac Death (NCT00365417)
Timeframe: Assessments throughout; up to 18 months following study entry
| Intervention | cardiac events (Number) |
|---|
| Chemo Plus Bevacizumab | 0 |
Severe GVHD Rate
Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD. (NCT00368355)
Timeframe: 100 Days
| Intervention | percentage of participants (Number) |
|---|
| CLINIMACS Device | 0 |
| ISOLEX Device | 4.3 |
Early Post BMT Toxicities
Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0) (NCT00368355)
Timeframe: 100 Days
| Intervention | Participants (Count of Participants) |
|---|
| CLINIMACS Device | 14 |
| ISOLEX Device | 14 |
Engraftment Rate After Transplant
Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10^9/ml. (NCT00368355)
Timeframe: 28 days
| Intervention | percentage of participants (Number) |
|---|
| CLINIMACS Device | 100 |
| ISOLEX Device | 100 |
Number of Patients Who Died While on Study
Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation. (NCT00376805)
Timeframe: Within 100 days, After 100 days
| Intervention | Participants (Number) |
|---|
| Died within 100 days | Died after 100 days |
|---|
| NK Cells With or Without Total Body Irradiation | 1 | 5 |
Number of Patients Who Had Expansion of Natural Killer Cells
Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of >100 cells/ul of whole blood 14 days after infusion with <5% donor T and B cells in mononuclear population (in metastatic breast cancer patients). (NCT00376805)
Timeframe: Day 14
| Intervention | Participants (Number) |
|---|
| NK Cells With or Without Total Body Irradiation | 0 |
Number of Patients by Disease Response
"Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:~Complete Response (CR: Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions~of clinical benefit (CB; stable disease for greater than 6 months." (NCT00376805)
Timeframe: 6 Months, 1 Year
| Intervention | Participants (Number) |
|---|
| Stable Disease | Progressive Disease |
|---|
| NK Cells With or Without Total Body Irradiation | 4 | 2 |
2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
Measured from date of registration to date of death due to any cause or last contact (NCT00376961)
Timeframe: 0-2 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP-V Followed by VM | 85 |
2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause. (NCT00376961)
Timeframe: 0-2 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP-V Followed by VM | 62 |
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00376961)
Timeframe: At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Unconfirmed Complete Response | Unconfirmed Partial Response | No Response | Assessment Inadequate |
|---|
| R-CHOP-V Followed by VM | 17 | 16 | 13 | 1 | 4 | 14 |
Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval
Treatment Failure was adjudicated by a clinical endpoints committee and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to treatment failure for each patient. The data presented are the percentage of participants who were treatment-failure free at each time interval as estimated by Kaplan-Meier. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36
| Intervention | Percentage of participants (Number) |
|---|
| Start of Maintenance Phase to Month 3 | Month 3 to Month 6 | Month 6 to Month 9 | Month 9 to Month 12 | Month 12 to Month 15 | Month 15 to Month 18 | Month 18 to Month 21 | Month 21 to Month 24 | Month 24 to Month 27 | Month 27 to Month 30 | Month 30 to Month 33 | Month 33 to Month 36 |
|---|
| Azathioprine | 97.2 | 89.3 | 86.2 | 83.0 | 77.5 | 74.1 | 70.7 | 68.3 | 67.1 | 65.9 | 63.4 | 58.6 |
,| Mycophenolate Mofetil | 98.2 | 93.7 | 89.9 | 86.0 | 86.0 | 84.9 | 84.9 | 83.9 | 82.8 | 82.8 | 81.7 | 81.7 |
Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein
24-hour urine protein was measured at Baseline and Week 24. (NCT00377637)
Timeframe: Baseline, Week 24
| Intervention | mg/day (Mean) |
|---|
| Baseline [n=180, 180] | Week 24 [n= 150, 144] | Change from Baseline to Week 24 [n= 146, 142] |
|---|
| Intravenous Cyclophosphamide | 4451.4 | 1831.6 | -2513.7 |
,| Mycophenolate Mofetil | 4208.9 | 1599.0 | -2510.6 |
Induction Phase: Change From Baseline to Week 24 in Serum Albumin
(NCT00377637)
Timeframe: Baseline, Week 24
| Intervention | g/L (Mean) |
|---|
| Baseline [n=184, 185] | Week 24 [n=155, 151] | Change from Baseline to Week 24 [n=154, 151] |
|---|
| Intravenous Cyclophosphamide | 28.6 | 38.3 | 9.0 |
,| Mycophenolate Mofetil | 30.5 | 38.4 | 7.5 |
Induction Phase: Change From Baseline to Week 24 in Serum Creatinine
(NCT00377637)
Timeframe: Baseline, Week 24
| Intervention | µmol/L (Mean) |
|---|
| Baseline [n= 184, 185] | Week 24 [n= 155, 151] | Change from Baseline to Week 24 [n= 154, 151] |
|---|
| Intravenous Cyclophosphamide | 92.7 | 83.5 | -5.1 |
,| Mycophenolate Mofetil | 108.6 | 77.6 | -18.9 |
Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score
"BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. The BILAG individual system summaries were calculated by a program supplied by ADS-Limathon (Sheffield, UK).~The score at baseline was compared to the score at the 24 week endpoint for each treatment group, reported here for the renal system." (NCT00377637)
Timeframe: Baseline, 24 weeks
| Intervention | Percentage of participants (Number) |
|---|
| Shift from Baseline=A to 24 Week Endpoint=A | Shift from Baseline=A to 24 Week Endpoint=B | Shift from Baseline=A to 24 Week Endpoint=C | Shift from Baseline=A to 24 Week Endpoint=D | Shift from Baseline=B to 24 Week Endpoint=A | Shift from Baseline=B to 24 Week Endpoint=B | Shift from Baseline=B to 24 Week Endpoint=C | Shift from Baseline=B to 24 Week Endpoint=D | Shift from Baseline=C to 24 Week Endpoint=A | Shift from Baseline=C to 24 Week Endpoint=B | Shift from Baseline=C to 24 Week Endpoint=C | Shift from Baseline=C to 24 Week Endpoint=D | Shift from Baseline=D to 24 Week Endpoint=A | Shift from Baseline=D to 24 Week Endpoint=B | Shift from Baseline=D to 24 Week Endpoint=C | Shift from Baseline=D to 24 Week Endpoint=D |
|---|
| Intravenous Cyclophosphamide | 27.1 | 34.8 | 24.9 | 9.4 | 0.0 | 1.1 | 1.7 | 0.0 | 0.0 | 0.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.6 | 0.0 |
,| Mycophenolate Mofetil | 17.1 | 39.2 | 33.1 | 5.5 | 0.0 | 1.7 | 2.2 | 1.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Induction Phase: Number of Participants Achieving Complete Remission
Number of participants achieving complete remission as defined by return to normal serum creatinine, proteinuria ≤500 mg/24 hours and an inactive urinary sediment (absence of red blood cells, white blood cells or cellular or granular casts) after 24 weeks. (NCT00377637)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Complete Remission - Yes | Complete Remission - No |
|---|
| Intravenous Cyclophosphamide | 15 | 170 |
,| Mycophenolate Mofetil | 16 | 169 |
Induction Phase: Number of Patients Showing Treatment Response
Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to <3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria <3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week 24 or who withdrew earlier than Week 24 were considered non-responders. (NCT00377637)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| Responder | Non-responder |
|---|
| Intravenous Cyclophosphamide | 98 | 87 |
,| Mycophenolate Mofetil | 104 | 81 |
Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy
The primary efficacy parameter was the time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), defined as any of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to rescue treatment for each patient. The data presented are the percentage of participants who were rescue treatment free at each time interval as estimated by Kaplan-Meier. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36
| Intervention | Percentage of participants (Number) |
|---|
| Start of Maintenance Phase to Month 3 | Month 3 to Month 6 | Month 6 to Month 9 | Month 9 to Month 12 | Month 12 to Month 15 | Month 15 to Month 18 | Month 18 to Month 21 | Month 21 to Month 24 | Month 24 to Month 27 | Month 27 to Month 30 | Month 30 to Month 33 | Month 33 to Month 36 |
|---|
| Azathioprine | 99.1 | 95.1 | 93.0 | 91.9 | 88.4 | 87.1 | 83.1 | 83.1 | 81.7 | 80.3 | 78.8 | 75.9 |
,| Mycophenolate Mofetil | 100 | 98.2 | 97.2 | 94.2 | 94.2 | 94.2 | 93.1 | 91.9 | 90.8 | 90.8 | 90.8 | 90.8 |
Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)
Time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), was defined as any 1 the following: death, ESRD, sustained doubling of serum creatinine, renal flare (proteinuric or nephritic), or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. ESRD is defined as progression to chronic hemodialysis or renal transplant. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36
| Intervention | participants (Number) |
|---|
| Mycophenolate Mofetil (MMF) | 0 |
| Azathioprine (AZA) | 3 |
Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine
Sustained doubling of serum creatinine concentration is defined as the first serum creatinine value that is twice the mean of the lowest 2 values from screening to end of induction, as confirmed by a second serum creatinine value obtained at least 4 weeks after the initial doubling. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36
| Intervention | participants (Number) |
|---|
| Mycophenolate Mofetil | 1 |
| Azathioprine | 5 |
Maintenance Phase: Participants With Major Extra-renal Flare
A major extra-renal flare is defined as a British Isles Lupus Assessment Group (BILAG) Score category A in one extrarenal organ or three organs with concurrent category B scores. BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36
| Intervention | participants (Number) |
|---|
| Mycophenolate Mofetil | 7 |
| Azathioprine | 6 |
Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores
The SF-36 is a 36 item quality of life questionnaire. The short-form version has eleven questions that permit the participant to rate how they feel that particular day. The SF-36 consists of eight scaled scores and two component scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score with the higher scores indicating better quality of life. (NCT00377637)
Timeframe: Baseline and 24 weeks
| Intervention | Scores on a scale (Mean) |
|---|
| Physical Component Summary [n=139, 137] | Mental Component Summary [n=139, 137] | Bodily Pain Score [n=141, 137] | General Health Score [n=139, 137] | Mental Health Score [n=141, 137] | Physical functioning Score [n=141, 137] | Role-Emotional Score [n=141, 137] | Role-Physical Score [n=141, 137] | Social Function Score [n=141, 137] | Vitality Score [n=141, 137] |
|---|
| Intravenous Cyclophosphamide | 6.4 | 5.7 | 16.8 | 11.5 | 9.8 | 9.3 | 18.4 | 34.0 | 18.2 | 11.6 |
,| Mycophenolate Mofetil | 5.2 | 6.7 | 13.4 | 9.1 | 9.3 | 11.6 | 23.4 | 28.6 | 17.7 | 14.2 |
Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval
A proteinuric flare is defined as a doubling of the urine protein:creatinine ratio, and proteinuria ≥1 g/24 h in patients with urine protein ≤0.5 g/24 h at the end of the induction phase, or proteinuria ≥2 g/24 h if urine protein was >0.5 g/24 h at the end of the induction phase. A nephritic flare is defined as a 25% increase in serum creatinine accompanied by 1 or more of the following: (a) simultaneous doubling of the proteinuria reaching a minimum of 2 g/24 h (b) new/increased hematuria or (c) the appearance of cellular casts. All flares were adjudicated by a clinical endpoints committee. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36
| Intervention | Percentage of participants (Number) |
|---|
| Start of Maintenance Phase to Month 3 | Month 3 to Month 6 | Month 6 to Month 9 | Month 9 to Month 12 | Month 12 to Month 15 | Month 15 to Month 18 | Month 18 to Month 21 | Month 21 to Month 24 | Month 24 to Month 27 | Month 27 to Month 30 | Month 30 to Month 33 | Month 33 to Month 36 |
|---|
| Azathioprine | 97.2 | 90.3 | 87.2 | 85.0 | 82.8 | 79.2 | 78.0 | 75.5 | 74.2 | 74.2 | 72.9 | 70.1 |
,| Mycophenolate Mofetil | 98.2 | 94.6 | 90.8 | 87.8 | 87.8 | 86.8 | 86.8 | 86.8 | 86.8 | 86.8 | 85.6 | 85.6 |
Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths
Treatment Failure was adjudicated by a clinical endpoints committee (CEC) and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis (LN). (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36
| Intervention | Deaths (Number) |
|---|
| Mycophenolate Mofetil (MMF) | 0 |
| Azathioprine (AZA) | 1 |
Number of Participants Who Developed Limited Chronic GVHD
"Number of incidences of participants who developed Limited Chronic Graft vs Host Disease (GVHD).~Limited disease is characterized by localized skin involvement and/or evidence of hepatic dysfunction.~Limited disease is associated with a favorable outcome without systemic therapy, while extensive disease patients have an unfavorable outcome." (NCT00378534)
Timeframe: 36 months
| Intervention | Participants (Count of Participants) |
|---|
| T Cell Depletion Transplant Participants | 8 |
Number of Participants Who Developed Acute GVHD Grades I, II, III, IV
"Number of participants who developed Acute Graft vs Host Disease (GVHD) Grades I, II, III, IV as defined by CIMBTR criteria for Organ Stages of Acute GVHD.~Grades are defined as:~Grade I: Skin = Maculopapular rash< 25% of body surface area (BSA); Liver = Total Bilirubin 2-3 mg/dL; Lower GI = stool output/day is 500-999 mL/day.~Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day.~Grade III: Skin = Rash on >50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea > 1500 mL/day.~Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin >15 mg/dL; Lower GI = Severe abdominal pain with or without ileus.~Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening." (NCT00378534)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Acute GVHD, Grade I | Acute GVHD, Grade II | Acute GVHD, Grade III | Acute GVHD, Grade IV |
|---|
| T Cell Depletion Transplant Participants | 14 | 16 | 9 | 1 |
Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System
Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion at day 90. The subjects receiving allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200. (NCT00378534)
Timeframe: Day 200
| Intervention | participants (Number) |
|---|
| Survival at day 200 | Non-relapse mortality |
|---|
| T Cell Depletion Transplant Participants | 43 | 4 |
Number of Participants With Relapse of Disease
Number of participants with relapse of disease by day 200 (NCT00378534)
Timeframe: Day 200
| Intervention | Participants (Count of Participants) |
|---|
| T Cell Depletion Transplant Participants | 17 |
Number of Participants Who Develop Extensive GVHD
"Number of participants with extensive, Chronic Graft vs Host Disease (GVHD). Extensive chronic GVHD is defined as GVHD occurring after day 100 that did not meet the definition of limited chronic GVHD.~Extensive disease presents either with generalized skin involvement, or with localized skin involvement or hepatic dysfunction plus at least one of the following:~Liver histology showing chronic progressive hepatitis, bridging necrosis, or cirrhosis~Involvement of the eye (Schirmer's test with less than 5 mm wetting) (see Diagnosis and classification of Sjögren's syndrome)~Involvement of minor salivary glands or oral mucosa (as demonstrated on labial or mucosal biopsy specimen)~Involvement of any other target organ" (NCT00378534)
Timeframe: 36 months
| Intervention | Participants (Count of Participants) |
|---|
| T Cell Depletion Transplant Participants | 18 |
Event Free Survival Probability
Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: 4 years
| Intervention | Probability (Number) |
|---|
| Stage IV and Rapid Complete Response (RCR) of Lung Metastases | 0.79 |
Event Free Survival Probability
Probability of no relapse, secondary malignancy, or death after 4 year in the study (NCT00379340)
Timeframe: At 4 years
| Intervention | Probability of EFS at 4 years (Number) |
|---|
| Stage III/IV With LOH 1p and 16q Treated With Regimen M | 0.90 |
| Stage IV With Non-lung Disease Treated With Regimen M | 0.73 |
Event Free Survival (EFS) Probability
Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: At 4 years
| Intervention | Probability of EFS at 4 years (Number) |
|---|
| Stage IV and Slow Incomplete Response (SIR) of Lung Metastases | 0.89 |
Number of Patients Who Experienced Adverse Events
(NCT00379574)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Bortezomib + CHOP Every 2 Weeks | 49 |
Number of Patients Who Achieved Complete Response
All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms. (NCT00379574)
Timeframe: 14 weeks
| Intervention | participants (Number) |
|---|
| Bortezomib + CHOP Every 2 Weeks | 32 |
Number of Participants Progression-free
Participants progression free as measured at six months following start of treatment. Criteria for Progressive Disease (PD): Peripheral blood: 50% increase in ALC with a level > 10 x 109/L on at least 2 occasions 2 weeks apart. Tumor: An increase of a lesion by 50% over the size present at entry on study or for patients who respond, the size at the time of maximum regression and/or the appearance of new areas of malignant disease. Reappearance of bone marrow disease. A deterioration in performance status or increasing symptoms do not constitute disease progression. (NCT00381004)
Timeframe: 6 months or until disease progression if earlier
| Intervention | participants (Number) |
|---|
| FCR + Sargramostim | 60 |
Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.
Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease. (NCT00381004)
Timeframe: Baseline to 6 Months
| Intervention | Percentage of Participants (Number) |
|---|
| FCR + Sargramostim | 100 |
Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.
Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease. (NCT00381004)
Timeframe: Baseline to 6 Months
| Intervention | Participants (Number) |
|---|
| Complete Response (CR) | Nodular Partial Response (nPR) | Partial Response (PD) |
|---|
| FCR + Sargramostim | 45 | 6 | 9 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1 (NCT00381680)
Timeframe: End of Block 1 (35 days) of Induction therapy
| Intervention | percentage of participants (Number) |
|---|
| Regimen A | 50.8 |
| Regimen B | 41.5 |
Event Free Survival. EFS
Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT). (NCT00381680)
Timeframe: 3 years after enrollment
| Intervention | percentage of participants EFS at 3 yrs3 (Number) |
|---|
| Regimen A: Standard Vincristine Dosing | 66.0 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3. (NCT00381680)
Timeframe: End of Block 3 (105 days) of Induction therapy
| Intervention | percentage of participants (Number) |
|---|
| Regimen A | 81.4 |
| Regimen B | 88.9 |
Adjusted Event Free Survival
Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT). (NCT00381680)
Timeframe: 3 years
| Intervention | adjusted percentage of participants (Number) |
|---|
| Received SCT | Did not receive SCT |
|---|
| Regimen A: Standard Vincristine Dosing | 82.2 | 64.2 |
Event Free Survival (EFS)
Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. (NCT00381680)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| MRD < 0.01% BL1 | MRD >= 0.01% BL1 | MRD < 0.01% BL3 | MRD >= 0.01% BL3 |
|---|
| Regimen A | 88.5 | 60.0 | 83.8 | 61.5 |
,| Regimen B | 77.3 | 46.2 | 83.3 | 33.3 |
Frequency and Severity of Adverse Effects
Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy. (NCT00381680)
Timeframe: Up to 107 weeks
| Intervention | percentage of participants (Number) |
|---|
| CC or CT genotype | High-risk CEP72 genotype (TT at rs924607) |
|---|
| All Patients | 17.3 | 44.4 |
Estimated Percentage of Participants With Event Free Survival
An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol. (NCT00382109)
Timeframe: at 2 years
| Intervention | percentage of participants (Number) |
|---|
| Experimental | 45 |
| Control | 54 |
Estimated Rate of Acute Graft VS Host Disease (GVHD)
Any grade acute graft vs host disease (defined in APPENDIX II study protocol). (NCT00382109)
Timeframe: At 200 days
| Intervention | percentage of participants (Number) |
|---|
| Experiemental | 32 |
| Control | 49 |
Rate of Relapses
An event is defined as relapse. (NCT00382109)
Timeframe: At 2 years
| Intervention | percentage of participants (Number) |
|---|
| Experimental | 41 |
| Control | 33 |
Estimated Rate of Overall Chronic Graft VS Host Disease
Chronic graft vs host disease is defined in APPENDIX III of study protocol. (NCT00382109)
Timeframe: At 2 years
| Intervention | percentage of participants (Number) |
|---|
| Experimental | 22 |
| Control | 27 |
Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Post Transplantation (Correlating Development of aGVHD With Relapse)
An event is defined as relapse; estimated probability of relapse. (NCT00382109)
Timeframe: At 1 year
| Intervention | percentage of participants (Number) |
|---|
| Experienced aGVHD, later relapsed | No aGVHD occurence, relapsed |
|---|
| All Patients | 5 | 24 |
Survival at 1 Year After Transplantation
The number of patients survival status 1 year after transplantation (NCT00387959)
Timeframe: 1 Year after transplant
| Intervention | participants (Number) |
|---|
| Alive at 1 Year Post Transplant | Died Prior to 1 Year Post Transplant |
|---|
| Unrelated Donor Umbilical Cord Transplant | 10 | 6 |
Relapse Post-transplant
Reports the percentage of participants that experienced relapse post-transplant. (NCT00388349)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Gemcitabine + High-dose Chemotherapy + PBSC Rescue | 29 |
Pulmonary Toxicity (BCNU Pneumonitis)
Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU). (NCT00388349)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Gemcitabine + High-dose Chemotherapy + PBSC Rescue | 26 |
Survival Measures
"Reports the survival measures:~Freedom from progression (FFP)~Event-free survival (EFS)~Overall survival (OS)~EFS and OS were estimated by Kaplan-Meier method~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" (NCT00388349)
Timeframe: 2 years
| Intervention | percentage of patients (Number) |
|---|
| Freedom from Progression (FFP) | Event-Free Survival (EFS) | Overall Survival (OS) |
|---|
| 1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue | 71 | 67 | 83 |
Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events. (NCT00388349)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| 1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue | 0 |
| 1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue | 3 |
Overall Survival (OS)
Reports the percentage of participants surviving 6 months after PBSC infusion (transplant). (NCT00388349)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Gemcitabine + High-dose Chemotherapy + PBSC Rescue | 87 |
Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
(NCT00389818)
Timeframe: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
| Intervention | proportion of patients (Number) |
|---|
| DR-COP | 0.475 |
The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis
| Intervention | Score on a scale (Mean) |
|---|
| Regimen A (SPNET Patients) | 84.6 |
| Regimen B (SPNET Patients) | 80.3 |
| Regimen C (SPNET Patients) | 99.3 |
| Regimen D (SPNET Patients) | 90.6 |
Tumor Response to Radiation Therapy for Patients With Medulloblastoma
Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses. (NCT00392327)
Timeframe: 12 weeks after treatment initiation
| Intervention | percentage of patients (Number) |
|---|
| Regimen A (Medulloblastoma Patients) | 75.9 |
| Regimen B (Medulloblastoma Patients) | 78.8 |
| Regimen C (Medulloblastoma Patients) | 72.9 |
| Regimen D (Medulloblastoma Patients) | 81.8 |
Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses. SPNET is no longer recognized by WHO (World Health Organization) as a disease entity. Additional trial information can be found under PubMed® # 30332335. (NCT00392327)
Timeframe: 12 weeks after treatment initiation
| Intervention | percentage of patients (Number) |
|---|
| Regimen A (SPNET Patients) | 69.9 |
| Regimen B (SPNET Patients) | 83.3 |
| Regimen C (SPNET Patients) | 66.7 |
| Regimen D (SPNET Patients) | 73.7 |
The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for SPNET Patients
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 30+/-6 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 24 - 36 months post diagnosis
| Intervention | Score on a scale (Mean) |
|---|
| Regimen A (SPNET Patients) | 83.3 |
| Regimen B (SPNET Patients) | 57.5 |
| Regimen C (SPNET Patients) | 83.7 |
| Regimen D (SPNET Patients) | 88.5 |
Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for SPNET Patients
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 24 - 36 months post diagnosis
| Intervention | T-Score (Mean) |
|---|
| Regimen A (SPNET Patients) | 53.5 |
| Regimen B (SPNET Patients) | 75.5 |
| Regimen C (SPNET Patients) | 64.5 |
| Regimen D (SPNET Patients) | 53.5 |
Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 48 - 72 months post diagnosis
| Intervention | T-Score (Mean) |
|---|
| Regimen A (SPNET Patients) | 56.0 |
| Regimen B (SPNET Patients) | 64.0 |
| Regimen C (SPNET Patients) | 71.5 |
| Regimen D (SPNET Patients) | 53.7 |
Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis
| Intervention | T-Score (Mean) |
|---|
| Regimen A (Medulloblastoma Patients) | 50.9 |
| Regimen B (Medulloblastoma Patients) | 50.2 |
| Regimen C (Medulloblastoma Patients) | 50.8 |
| Regimen D (Medulloblastoma Patients) | 47.5 |
Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for SPNET Patients
Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis
| Intervention | T-Score (Mean) |
|---|
| Regimen A (SPNET Patients) | 53.8 |
| Regimen B (SPNET Patients) | 66.7 |
| Regimen C (SPNET Patients) | 46.1 |
| Regimen D (SPNET Patients) | 64.3 |
Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma
The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined. (NCT00392327)
Timeframe: Up to 5 years
| Intervention | Percent Probability (Number) |
|---|
| Regimen A (Medulloblastoma Patients) | 57.5 |
| Regimen B (Medulloblastoma Patients) | 65.3 |
| Regimen C (Medulloblastoma Patients) | 60.3 |
| Regimen D (Medulloblastoma Patients) | 70.9 |
Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. (NCT00392327)
Timeframe: Up to 5 years
| Intervention | Percent Probability (Number) |
|---|
| Regimen A (SPNET Patients) | 52.2 |
| Regimen B (SPNET Patients) | 52.6 |
| Regimen C (SPNET Patients) | 19 |
| Regimen D (SPNET Patients) | 63 |
Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma
The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined. (NCT00392327)
Timeframe: Up to 5 years
| Intervention | Percent Probability (Number) |
|---|
| Regimen A (Medulloblastoma Patients) | 66.0 |
| Regimen B (Medulloblastoma Patients) | 75.9 |
| Regimen C (Medulloblastoma Patients) | 69.9 |
| Regimen D (Medulloblastoma Patients) | 81.6 |
Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact. (NCT00392327)
Timeframe: Up to 5 years
| Intervention | Percent Probability (Number) |
|---|
| Regimen A (SPNET Patients) | 60.9 |
| Regimen B (SPNET Patients) | 57.9 |
| Regimen C (SPNET Patients) | 35.3 |
| Regimen D (SPNET Patients) | 77.0 |
The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for SPNET Patients
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 60+/-12 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 48 - 72 months post diagnosis
| Intervention | score on a scale (Mean) |
|---|
| Regimen A (SPNET Patients) | 94.8 |
| Regimen B (SPNET Patients) | 48.0 |
| Regimen C (SPNET Patients) | 87.0 |
| Regimen D (SPNET Patients) | 79.7 |
The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported. (NCT00392327)
Timeframe: 6 - 12 months post diagnosis
| Intervention | Score on a scale (Mean) |
|---|
| Regimen A (Medulloblastoma Patients) | 96.6 |
| Regimen B (Medulloblastoma Patients) | 89.1 |
| Regimen C (Medulloblastoma Patients) | 83.5 |
| Regimen D (Medulloblastoma Patients) | 94.8 |
Overall Survival (OS) at 1 Year
(NCT00392834)
Timeframe: 1 year post treatment
| Intervention | Cumulative proportion surviving at 1 yr (Number) |
|---|
| Regimen A (R-CODOX-M Chemotherapy) | 1.0 |
| Regimen B (Rituximab and IVAC Chemotherapy) | 0.82 |
Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen
Progression Free Survival (PFS) will be defined from the first dose of study drug to the first documentation of progressive disease or death for any reason. Patients that are lost to follow-up before progression will be censored at the point of last documentation of not experiencing the event. (NCT00392990)
Timeframe: At 2 years from treatment initiation. Median follow up 34 months (range 15-45)
| Intervention | percentage of patients progression free (Number) |
|---|
| High Risk - Treated With Alternating R-CODOX-M/R-IVAC | 76 |
| Low Risk - Treatment With 3 Cycles of R-CODOX-M | 100 |
Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen
"Response Rate is defined as combined number of patients with Complete Remission (CR) Complete Remission undetermined (Cru) and Partial Remission (PR) for patients with Burkitt's and Burkitt-like Lymphoma/Leukemia. Response will be measured by CT scans following treatment completion and assessed using Response Criteria for Non-Hodgkin's Lymphoma where:~CR=complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.~CRu=same as above but allowing for 75% decrease in lymph node masses and indeterminate or normal bone marrow.~PR=50% decrease in SPD of the six largest dominant nodes or nodal masses with no increase in size or other nodes, liver, spleen and no new sites of disease." (NCT00392990)
Timeframe: After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks.
| Intervention | percentage of patients (Number) |
|---|
| ORR after two cycles of treatment | ORR at completion of treatment |
|---|
| High Risk - Treated With Alternating R-CODOX-M/R-IVAC | 100 | 100 |
,| Low Risk - Treatment With 3 Cycles of R-CODOX-M | 100 | 100 |
Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate)
"Adverse events (AE) graded as either 3 or 4 and determined to be at least possibly related to study treatment will be collected in patients Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen to assess the safety and toxicity profile of the addition of rituximab, subsitution of adriamycin for doxil and lower dose of methotrexate. AEs will be assessed as follows at the following time points: At the end of each cycle or monthly whichever is less frequent and 30 days post last dose of study treatment for a maximum of 3 cycles for regimen A and 4 cycles for regimen B and up to 12 months.~In general AEs will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v 3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE" (NCT00392990)
Timeframe: After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients.
| Intervention | participants (Number) |
|---|
| Anemia : Grade 3 | Anemia : Grade 4 | Neutropenia : Grade 3 | Neutropenia : Grade 4 | Thrombocytopenia : Grade 3 | Thrombocytopenia : Grade 4 | Mucositis : Grade 3 | Mucositis : Grade 4 | Infection : Grade 3 | Infection : Grade 4 | Elevated Transaminases : Grade 3 | Elevated Transaminases : Grade 4 | Fever (Neutropenic) : Grade 3 | Fever (Neutropenic) : Grade 4 | Low Phosphate : Grade 3 | Low Phosphate : Grade 4 | Sodium Abnormalities : Grade 3 | Sodium Abnormalities : Grade 4 | Hyperglycemia : Grade 3 | Hyperglycemia : Grade 4 | Hypoalbuminemia : Grade 3 | Hypoalbuminemia : Grade 4 | Hypokalemia : Grade 3 | Hypokalemia : Grade 4 | Cardiac : Grade 3 | Cardiac : Grade 4 | Diarrhea : Grade 3 | Diarrhea : Grade 4 | Elevated Creatinine : Grade 3 | Elevated Creatinine : Grade 4 | Nausea/Vomiting : Grade 3 | Nausea/Vomiting : Grade 4 | Low Blood Pressure : Grade 3 | Low Blood Pressure : Grade 4 | Rash : Grade 3 | Rash : Grade 4 | Edema : Grade 3 | Edema : Grade 4 | Low Magnesium : Grade 3 | Low Magnesium : Grade 4 |
|---|
| High Risk - Treated With Alternating R-CODOX-M/R-IVAC | 13 | 1 | 5 | 6 | 1 | 13 | 7 | 3 | 8 | 0 | 6 | 0 | 4 | 0 | 5 | 0 | 4 | 0 | 1 | 5 | 4 | 0 | 1 | 0 | 3 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
,| Low Risk - Treatment With 3 Cycles of R-CODOX-M | 3 | 0 | 2 | 2 | 1 | 2 | 2 | 0 | 1 | 0 | 2 | 0 | 3 | 0 | 1 | 0 | 2 | 0 | 3 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen
Overall Survival (OS) of patients with Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen. OS is defined from the first dose of study drug to the time of death for any reason. (NCT00392990)
Timeframe: At 2 years from treatment initiation Median follow up 34 months (range 15-45)
| Intervention | percentage of patients alive (Number) |
|---|
| High Risk - Treated With Alternating R-CODOX-M/R-IVAC | 81 |
| Low Risk - Treatment With 3 Cycles of R-CODOX-M | 100 |
In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants
Survival of TCR gene-engineered cells is defined as >10% murine TCR positive cells. (NCT00393029)
Timeframe: 3-12 months
| Intervention | participants (Number) |
|---|
| Metastatic Melanoma | 2 |
| Other Metastatic Cancers | 9 |
Clinical Tumor Regression
"Response Evaluation Criteria In Solid Tumors (RECIST).~See the protocol Link module for full criteria if desired." (NCT00393029)
Timeframe: 1-11 months
| Intervention | Participants (Number) |
|---|
| Metastatic Melanoma & Other Metastatic Cancers | 1 |
The Number of Participants With Adverse Events
Here are the total number of participants with adverse events. Adverse events were described using the Common Terminology Criteria for Adverse Events (CTCAE) version 3. For the detailed list of adverse events see the adverse event module. (NCT00393029)
Timeframe: events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.
| Intervention | participants (Number) |
|---|
| Metastatic Melanoma | 2 |
| Other Metastatic Cancers | 9 |
Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays
"Counts of participants who~completed the protocol-defined treatment cycles,~had a dose interruption~had a dose reduction~had a dose delay. A dose delay refers to the delay of all interventions in the cycle.~Dose modifications are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.~Use of pegfilgrastim is included in the summary." (NCT00394251)
Timeframe: up to Week 46
| Intervention | participants (Number) |
|---|
| Completed 4 cycles of Adriamycin/Cytoxan (AC) | Received pegfilgrastim for 4 cycles during AC | Completed 4 cycles of taxane | Completed 18 cycles of bevacizumab | One or more dose reduction: Adriamycin | One or more dose reduction: Cytoxan | One or more dose reduction: Taxane | One or more dose interruption: Adriamycin | One or more dose interruption: Cytoxan | One or more dose interruption: Taxane | One or more dose interruption: Bevacizumab | One or more delay in study regimen | Discontinued pegfilgrastim during AC cycles | Administered pegfilgrastim during taxane cycles |
|---|
| AC --> ABI-007 | 95 | 95 | 82 | 61 | 10 | 9 | 12 | 1 | 3 | 0 | 0 | 50 | 0 | 23 |
,| AC --> Taxol | 95 | 94 | 84 | 61 | 6 | 5 | 16 | 0 | 1 | 3 | 2 | 48 | 0 | 13 |
Percent of Protocol Taxane Dose
Percent of the protocol-defined taxane (ABI-007 or Taxol) dose that was actually taken by study participants. (NCT00394251)
Timeframe: approximately week 9-16
| Intervention | percentage of protocol-defined taxane (Mean) |
|---|
| AC --> ABI-007 | 91.40 |
| AC --> Taxol | 94.40 |
Summary of Participants' Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles)
"Summary of the most severe grades using the National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (CTCAE) for the following liver and renal function tests.~Grade 0 = within normal range for all measurements.~Alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST):~Grade 1 = > upper limit of normal (ULN) - 2.5*ULN~Grade 2= >2.5-5.0*ULN~Grade 3= >5.0-20.0*ULN~Grade 4= >20.0*ULN~Bilirubin:~Grade 1= >ULN - 1.5*ULN~Grade 3= >3.0 - 10.0*ULN~Creatinine:~- Grade 1= >ULN - 1.5*ULN" (NCT00394251)
Timeframe: Week 1 up to week 50
| Intervention | participants (Number) |
|---|
| Alkaline phosphatase, Grade 0 | Alkaline phosphatase, Grade 1 | Alkaline phosphatase, Grade 2 | ALT, Grade 0 | ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 4 | AST, grade 0 | AST, grade 1 | AST, grade 2 | AST, grade 3 | Bilirubin, grade 0 | Bilirubin, grade 1 | Bilirubin, grade 3 | Creatinine, grade 0 | Creatinine, grade 1 |
|---|
| AC --> ABI-007 | 69 | 26 | 1 | 66 | 24 | 5 | 1 | 74 | 20 | 1 | 1 | 95 | 0 | 1 | 94 | 2 |
,| AC --> Taxol | 70 | 29 | 0 | 75 | 23 | 1 | 0 | 81 | 17 | 1 | 0 | 98 | 1 | 0 | 97 | 2 |
Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation
Decreased left ventricular ejection fraction (LVEF) is an indication of cardiotoxicity. Change from baseline measurements to the final evaluation are summarized. (NCT00394251)
Timeframe: up to week 46
| Intervention | percentage of healthy LVEF (Median) |
|---|
| AC --> ABI-007 | -1.0 |
| AC --> Taxol | -1.0 |
Mean Taxane Dose Intensity Per Week
Cumulative taxane (ABI-007 or Taxol) dose divided by the number of weeks on taxane treatment. (NCT00394251)
Timeframe: approximately week 9-16
| Intervention | mg/m^2/week (Mean) |
|---|
| AC --> ABI-007 | 118.82 |
| AC --> Taxol | 82.60 |
The Cumulative Dose of Taxane Delivered During Study
The cumulative dose of taxane (Taxol or ABI-007) taken during the study (cycles 4-8 which is approximately weeks 9-16). (NCT00394251)
Timeframe: approximately week 9-16
| Intervention | mg/m^2 (Mean) |
|---|
| AC --> ABI-007 | 950.5 |
| AC --> Taxol | 660.8 |
Myelosuppression During Taxane Dosing Cycles
"Myelosuppression represented by neutropenia (low absolute neutrophil counts (ANC)) with severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).~Grade 1 = NCT00394251)
Timeframe: Weeks 9-16
| Intervention | participants (Number) |
|---|
| ANC (grades 1-4) | Taxane-related, grades 1-4 | Taxane-related, grades 3-4 |
|---|
| AC --> ABI-007 | 58 | 11 | 6 |
,| AC --> Taxol | 43 | 8 | 5 |
Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy
"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7)." (NCT00394251)
Timeframe: Month 7
| Intervention | participants (Number) |
|---|
| At least 1 AE at 3 Months | Neurology: Neuropathy: Sensory | Constitutional Symptoms: Fatigue | Dermatology/Skin: Hair Loss/Alopecia (Scalp+Body) | Endocrine: Hot Flashes/Flushes | Cardiac General: Hypertension | Pain: Arthralgia | Hemorrhage/Bleeding: Nasal | Pain: Other - Extremity | Pain: Myalgia | Dermatology/Skin: Nail Changes | Constitutional Symptoms: Insomnia |
|---|
| ABI-007 Subset | 65 | 36 | 16 | 2 | 12 | 4 | 7 | 11 | 4 | 10 | 14 | 3 |
,| AC --> ABI-007 | 74 | 50 | 46 | 33 | 28 | 18 | 22 | 19 | 15 | 20 | 22 | 16 |
,| AC --> Taxol | 77 | 35 | 32 | 17 | 22 | 25 | 19 | 18 | 22 | 16 | 10 | 11 |
,| Taxol Subset | 65 | 28 | 10 | 1 | 5 | 7 | 8 | 10 | 7 | 9 | 5 | 5 |
Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy
"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10)." (NCT00394251)
Timeframe: Month 10
| Intervention | participants (Number) |
|---|
| At least 1 AE at 6 Months | Neurology: Neuropathy: Sensory | Constitutional Symptoms: Fatigue | Endocrine: Hot Flashes/Flushes | Cardiac General: Hypertension | Pain: Arthralgia | Pain: Myalgia | Pain: Other - Extremity | Dermatology/Skin: Nail Changes |
|---|
| ABI-007 Subset | 49 | 25 | 11 | 7 | 4 | 4 | 8 | 1 | 8 |
,| AC --> ABI-007 | 62 | 42 | 32 | 23 | 12 | 17 | 17 | 6 | 13 |
,| AC --> Taxol | 65 | 19 | 18 | 17 | 18 | 13 | 8 | 14 | 6 |
,| Taxol Subset | 46 | 15 | 4 | 3 | 7 | 3 | 4 | 5 | 3 |
Number of Participants With Clinical Benefit
Clinical benefit is defined as the proportion of patients achieving complete response, partial response, or stable disease by RECIST. Complete response (CR) is defined as total disappearance of all clinical evidence of reversible disease. A partial response (PR) is defined as a >=30% reduction in tumor target lesions. Stable disease (SD) is defined as disease status that fails to qualify as as a response (CR or PR) or progressive disease (increase of at least 20% in tumor target lesions). (NCT00399529)
Timeframe: At 6 and 12 months from start of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Clinical Benefit at 6 months | Clinical Benefit at 12 months |
|---|
| Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 11 | 8 |
Number of Participants With Delayed Type Hypersensitivity (Immunological Response)
The number of participants with a Delayed Type Hypersensitivity (DTH) response was measured as an indicator of immune response. Participants were considered to have a DTH response if they had increased induration (>5mm from baseline) at the site of injection 2-3 days after intradermal injection with human epidermal growth factor receptor 2 (HER-2) peptides. This peptide injection was given 28 days after each dose of vaccine. (NCT00399529)
Timeframe: 30 days after each vaccine, up to 9 months
| Intervention | Participants (Count of Participants) |
|---|
| Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 7 |
Number of Participants With Adverse Events
Safety is measured as the number of patients that experienced adverse events related to study drug. (NCT00399529)
Timeframe: From first dose through 30 days after last dose of study drug, up to 9 months
| Intervention | Participants (Count of Participants) |
|---|
| Fatigue | Urticaria | Pruritus | Fever | Flu-like symptoms | Lymphadenopathy | Abdominal pain | Rash | Malaise | Chills | Dizziness | Anorexia | Erythema | Headache | Nausea | Arm pain | Cancer site pain | Leg pain | Groin tightness | Erythema at vaccine sites | Pruritus at vaccine sites | Induration at vaccine sites | Pain at vaccine sties | Rash at vaccine sites | Blister at vaccine sites | Hyperpigmentation at vaccine sites | Bruising at vaccine sites | Edema at vaccine sites | Vaccine site flare |
|---|
| Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide | 8 | 7 | 6 | 5 | 4 | 4 | 3 | 3 | 3 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 20 | 20 | 20 | 17 | 7 | 5 | 4 | 3 | 2 | 2 |
5-Year Disease-Free Survival by MRD Day 32 Status
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| Low Day 32 MRD Level | .79 |
| High Day 32 MRD Level | .90 |
Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate
Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.
| Intervention | percentage of participants (Number) |
|---|
| Intramuscular Native E Coli L-asparaginase (IM-EC) | 71 |
| Intravenous PEG-asparaginase (IV-PEG) | 99 |
5-Year Disease-Free Survival
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| Intramuscular Native E Coli L-asparaginase (IM-EC) | .89 |
| Intravenous PEG-asparaginase (IV-PEG) | .90 |
Post-Induction Nadir Serum Asparaginase Activity Level
Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.
| Intervention | IU/mL (Mean) |
|---|
| Week 5 NSAA Level | Week 11 NSAA Level | Week 17 NSAA Level | Week 23 NSAA Level | Week 29 NSAA Level |
|---|
| Intramuscular Native E Coli L-asparaginase (IM-EC) | 0.129 | 0.143 | 0.159 | 0.180 | 0.123 |
,| Intravenous PEG-asparaginase (IV-PEG) | 0.726 | 0.773 | 0.787 | 0.757 | 0.806 |
Induction Infection Toxicity Rate
Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy. (NCT00400946)
Timeframe: Assessed daily during remission induction days 4-32.
| Intervention | percentage of participants (Number) |
|---|
| Overall | 26 |
5-Year Disease-Free Survival by Bone Marrow Day 18 Status
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| M1 Day 18 Bone Marrow Status | .89 |
| M2/M3 Day 18 Bone Marrow Status | .78 |
| Hypocellular Day 18 Bone Marrow Status | .88 |
5-year Disease-Free Survival by CNS Directed Treatment Group
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| CNS-1 | .89 |
| CNS-2 | .89 |
| CNS-3 | 1.00 |
| Traumatic Tap With Blasts | .84 |
| Traumatic Tap Without Blasts | .87 |
Induction Therapeutic Nadir Serum Asparaginase Activity Rate
Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.
| Intervention | percentage of participants (Number) |
|---|
| Day 4 NSAA Rate | Day 11 NSAA Rate | Day 18 NSAA Rate | Day 25 NSAA Rate |
|---|
| Overall | 97 | 96 | 87 | 12 |
Induction Serum Asparaginase Activity Level
Serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.
| Intervention | IU/mL (Median) |
|---|
| Day 4 NSAA Level | Day 11 NSAA Level | Day 18 NSAA Level | Day 25 NSAA Level |
|---|
| Overall | .694 | .505 | .211 | .048 |
Disease-free Survival (DFS)
Disease-free survival (DFS) is expressed as the percentage of participants who were disease-free and alive at the time of analysis. (NCT00404066)
Timeframe: 42 months (median follow-up)
| Intervention | Participants (Count of Participants) |
|---|
| Neoadjuvant Chemotherapy | 16 |
Percentage of Participants With Pathologic Complete Response (pCR)
Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation. (NCT00404066)
Timeframe: 12 weeks
| Intervention | percentage of participants (Number) |
|---|
| Neoadjuvant Chemotherapy | 38.9 |
Overall Survival
Count of surviving patients at two years and six years (NCT00407888)
Timeframe: Up to 6 years.
| Intervention | Participants (Count of Participants) |
|---|
| Two years | Six years |
|---|
| Arm I | 59 | 53 |
Delivered Dose Intensity of the Regimen
(NCT00407888)
Timeframe: After at least one course of Adriamycin, up to 12 weeks.
| Intervention | percentage of mean administered dose (Number) |
|---|
| Doxorubicin | Cyclophosphamide | nP (intent-to-treat) |
|---|
| Arm I | 92.6 | 92.1 | 88.0 |
Time to Treatment Failure
Median time from date of start of therapy to date of removal from therapy for reason other than completion, date of first observation of recurrent disease or date of death due to any cause whichever comes first. (NCT00407888)
Timeframe: Up to 6 years
| Intervention | years (Median) |
|---|
| Arm I | 2.7 |
Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin
(NCT00407888)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 56 |
Toxicity Associated With This Regimen
(NCT00407888)
Timeframe: After at least one course of Adriamycin, up to 12 weeks.
| Intervention | Participants (Count of Participants) |
|---|
| Filgrastim used | Dose holds/reductions | Hospitalization/ER evaluation | Trastuzumab patients with decease in LVEF to <50% | Trastuzumab patients with decease in LVEF to <10% |
|---|
| Arm I | 37 | 43 | 5 | 2 | 3 |
Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction
| Intervention | percent probability (Number) |
|---|
| High Risk | Induction Failure |
|---|
| ARM II (Combination Chemotherapy) | 85.0 | 100 |
Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction
| Intervention | percent probability (Number) |
|---|
| Standard Risk | High Risk |
|---|
| ARM I (Combination Chemotherapy) | 87.4 | 85.1 |
Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| Low Risk | Intermediate Risk | High Risk |
|---|
| ARM I (Combination Chemotherapy) | 1.85 | 1.16 | 3.64 |
,| ARM III (Combination Chemotherapy) | 1.92 | 9.1 | 6.52 |
Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| Intermediate Risk | High Risk |
|---|
| ARM II (Combination Chemotherapy) | 1.08 | 0 |
,| ARM IV (Combination Chemotherapy) | 0.85 | 3.45 |
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I (Combination Chemotherapy) | 89.01 |
| ARM II (Combination Chemotherapy) | 90.53 |
| ARM III (Combination Chemotherapy) | 78.07 |
| ARM IV (Combination Chemotherapy) | 86.46 |
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I and ARM II (Combination Chemotherapy) | 91.45 |
| ARM III and ARM IV (Combination Chemotherapy) | 85.78 |
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I (Combination Chemotherapy) | 91.76 |
| ARM II (Combination Chemotherapy) | 90.53 |
| ARM III (Combination Chemotherapy) | 86.06 |
| ARM IV (Combination Chemotherapy) | 84.89 |
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I and ARM III (Combination Chemotherapy) | 82.96 |
| ARM II and ARM IV (Combination Chemotherapy) | 88.30 |
Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy
Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks
| Intervention | percentage of patients (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 77 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 87.6 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 73.7 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 84 |
| Arm 3A: Docetaxel + Gem Then AC | 82.6 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 88 |
Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone
The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics. (NCT00408408)
Timeframe: 24 months after study entry
| Intervention | participants (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 180 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 157 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 172 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 185 |
| Arm 3A: Docetaxel + Gem Then AC | 158 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 185 |
Surgical Complication
Number of patients with Grade 4 or above surgery-related toxicities (NCT00408408)
Timeframe: 24 months after study entry
| Intervention | participants (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 1 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 1 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 0 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 1 |
| Arm 3A: Docetaxel + Gem Then AC | 0 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 1 |
pCR in the Breast and Nodes
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes. (NCT00408408)
Timeframe: Time of surgery, on average 6 or 13 months
| Intervention | percentage of patients (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 27.3 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 24.4 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 18.7 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 27.4 |
| Arm 3A: Docetaxel + Gem Then AC | 22.9 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 30.3 |
Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens
The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST. (NCT00408408)
Timeframe: Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months
| Intervention | percentage of patients (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 52.3 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 64.6 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 51.3 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 59.1 |
| Arm 3A: Docetaxel + Gem Then AC | 52.6 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 60 |
Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy
Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Assessed at cycle 5 of chemotherapy, on average at 15 weeks
| Intervention | percentage of patients (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 30 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 43.3 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 29.8 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 34.5 |
| Arm 3A: Docetaxel + Gem Then AC | 37.9 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 42 |
Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen. (NCT00408408)
Timeframe: Time of surgery, on average 6 or 13 months
| Intervention | percentage of patients (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 33.7 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 31.6 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 23.5 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 36.1 |
| Arm 3A: Docetaxel + Gem Then AC | 27.6 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 35.8 |
Disease-free Survival (DFS)
Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years. (NCT00408408)
Timeframe: Measured through 5 years after study enrollment
| Intervention | percentage of patients (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 73.4 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 72.2 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 68.5 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 77.1 |
| Arm 3A: Docetaxel + Gem Then AC | 72.9 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 74.8 |
Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens
The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST. (NCT00408408)
Timeframe: Three to four weeks after the last chemotherapy dose on average 6 or 13 months
| Intervention | percentage of patients (Number) |
|---|
| Arm 1A: Docetaxel Then AC | 79.9 |
| Arm 1B Docetaxel + Bev Then AC + Bev | 87.7 |
| Arm 2A: Docetaxel + Capecitabine Then AC | 75.4 |
| Arm 2B: Docetaxel + Cape + Bev Then AC + Bev | 90.7 |
| Arm 3A: Docetaxel + Gem Then AC | 83.3 |
| Arm 3B: Docetaxel + Gem + Bev Then AC + Bev | 80.5 |
Time To Progression (TTP)
Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions. (NCT00409188)
Timeframe: Up to 66 months
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 10.0 |
| Saline + Placebo | 8.4 |
Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)
Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment. (NCT00409188)
Timeframe: Up to 66 months
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 14.2 |
| Saline + Placebo | 11.4 |
Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions
Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator. (NCT00409188)
Timeframe: From first dose up to 42 days after the last dose of the trial treatment
| Intervention | participants (Number) |
|---|
| Treatment Emergent Adverse events | Injection site reaction |
|---|
| Saline + Placebo | 432 | 56 |
,| Tecemotide (L-BLP25) + Cyclophosphamide | 938 | 176 |
One-, Two- and Three-year Survival Rate
The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach. (NCT00409188)
Timeframe: Years 1, 2, and 3
| Intervention | percentage of participants (Number) |
|---|
| Year 1 | Year 2 | Year 3 |
|---|
| Saline + Placebo | 74.7 | 45.9 | 37.0 |
,| Tecemotide (L-BLP25) + Cyclophosphamide | 77.0 | 50.8 | 40.2 |
Overall Survival
Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier. (NCT00409188)
Timeframe: Up to 66 months
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 25.6 |
| Saline + Placebo | 22.3 |
Number of Participants With Progression or Death
Disease progression is characterized by at least one of the following, per the Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia: a >=50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations 2 weeks apart (at least one node must be >=2 centimeters); or the appearance of new palpable lymph nodes; or a >=50% increase in liver and/or spleen size (measurement below the costal margin); or the appearance of palpable hepatomegaly or splenomegaly not previously present; or a >=50% increase in the numbers of circulating lymphocytes to at least 5.0 * 10^9/Liter; or transformation to a more aggressive histology (e.g., Richter's syndrome or prolymphocytic leukemia with >55% prolymphocytes). For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS. (NCT00410163)
Timeframe: From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years
| Intervention | Participants (Number) |
|---|
| Ofatumumab 500 mg + FC | 3 |
| Ofatumumab 1000 mg + FC | 7 |
Duration of Response
The duration of response was defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed. (NCT00410163)
Timeframe: From time of initial response to disease progression or death, whichever came first, assessed over 2 years
| Intervention | months (Median) |
|---|
| Ofatumumab 500 mg + FC | NA |
| Ofatumumab 1000 mg + FC | NA |
Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion
"Par. were evaluated for response by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute-sponsored Working Group (NCI-WG) 1996 guideline. Par. with Complete Remission (CR) were classified as complete responders. As per NCI-WG, CR requires all of the following criteria for a period of >=2 months: absence of lymphadenopathy (all lymph nodes <1.0 centimeters), no hepatomegaly/splenomegaly, absence of constitutional symptoms, lymphocytes <=4.0*10^9/liter (L), neutrophil leukocytes >=1.5*10^9/L, platelets >100*10^9/L, and hemoglobin >11 grams/deciliter." (NCT00410163)
Timeframe: Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)
| Intervention | participants (Number) |
|---|
| Ofatumumab 500 mg + FC | 10 |
| Ofatumumab 1000 mg + FC | 15 |
Progression-Free Survival
Progression-free survival (PFS) was defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS. (NCT00410163)
Timeframe: From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years
| Intervention | months (Median) |
|---|
| Ofatumumab 500 mg + FC | NA |
| Ofatumumab 1000 mg + FC | 23.5 |
Number of Participants With Positive Human Anti-human Anti Bodies (HAHA) at Visits 1, 21, 35, and 39
HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 21, 35, and 39 for analysis of HAHA. Analysis of HAHA was done in batches. (NCT00410163)
Timeframe: Visits 1 (Screening, Visit -2), 21 (Week 12), 35 (Month 6), and 39 (Month 18)
| Intervention | participants (Number) |
|---|
| Visit 1 (Week -2), n=31, 30 | Visit 21 (Week 12), n=24, 24 | Visit 35 (Month 6), n=19, 22 | Visit 39 (Month 18), n=14, 13 |
|---|
| Ofatumumab 1000 mg + FC | 0 | 0 | 0 | 0 |
,| Ofatumumab 500 mg + FC | 0 | 0 | 0 | 0 |
Number of Participants Classified as Responders Having CR Who Tested Negative for Minimal Residual Disease (MRD)
MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells (CD5+CD19+) to determine if there was any MRD. (NCT00410163)
Timeframe: From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to course 6 or Week 32)
| Intervention | participants (Number) |
|---|
| Ofatumumab 500 mg + FC | 2 |
| Ofatumumab 1000 mg + FC | 6 |
Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia)
Myelosuppression is one of the expected AEs for FC treatment and is defined as the decrease in the ability of the bone marrow to produce blood cells. The number of participants with myelosuppression was assessed from laboratory measurements with Grades 3(severe)-4 (life-threatening/disabling) (1, mild; 2, moderate; 5, death) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The CTCAE is issued by the National Cancer Institute (NCI) and is the standard classification used for the severity grading scale for AEs in cancer therapy clinical studies. (NCT00410163)
Timeframe: From first treatment (Visit 2) up to Visit 43 (Month 60)
| Intervention | participants (Number) |
|---|
| Anemia | Leukopenia | Neutropenia | Thrombocytopenia |
|---|
| Ofatumumab 1000 mg + FC | 8 | 22 | 26 | 8 |
,| Ofatumumab 500 mg + FC | 6 | 23 | 29 | 4 |
Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4)
Blood samples were drawn from participants at Visits 1 and 9 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 9 minus value at Visit 1 divided by value at Visit 1) * 100. (NCT00410163)
Timeframe: Visit 1 (Week -2) and Visit 9 (Week 4)
| Intervention | Percent change in complement levels (Median) |
|---|
| Ofatumumab 500 mg + FC | 0 |
| Ofatumumab 1000 mg + FC | 0 |
Number of Participants (Par.) Who Were Classified as Responders and Non-responders
Par. were evaluated by an IRC in accordance with NCI-WG 1996 guideline. Responders: CR, Nodular Partial Remission (nPR, same as CR, but persistent bone marrow nodules), and Partial Remission (PR, >=50% decrease in lymphocytes from pretreatment baseline (BL) value, >=50% reduction in lymphadenopathy, >=50% reduction of liver/spleen and neutrophils >= 1.5*10^9/L or platelets >100*10^9/L or hemoglobin >11 g/dL (or 50% improvement over BL for neutrophils, platelets, hemoglobin); non-responders: Stable Disease (SD, did not achieve CR/PR, and no PD), Progressive Disease (PD), or Not Evaluable (NE). (NCT00410163)
Timeframe: From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)
| Intervention | participants (Number) |
|---|
| All responders | Responders, CR | Responders, nPR | Responders, PR | All Non-responders | Non-responders, SD | Non-responders, PD | Non-responders, NE |
|---|
| Ofatumumab 1000 mg + FC | 22 | 15 | 1 | 6 | 8 | 2 | 5 | 1 |
,| Ofatumumab 500 mg + FC | 24 | 10 | 1 | 13 | 7 | 3 | 2 | 2 |
Ctrough and Cmax at the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)
Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). No drug is present before the first infusion; therefore, there are no Ctrough results for the first infusion. (NCT00410163)
Timeframe: Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)
| Intervention | Milligrams per liter (mg/L) (Geometric Mean) |
|---|
| First infusion, Cmax, n=31, 29 | Sixth infusion, Cmax, n=22, 19 | Sixth infusion, Ctrough, n=22, 19 |
|---|
| Ofatumumab 1000 mg + FC | 57.2 | 427 | 62.2 |
,| Ofatumumab 500 mg + FC | 67.5 | 201 | 19.9 |
CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)
CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time. (NCT00410163)
Timeframe: Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)
| Intervention | Milliliters per hour (mL/h) (Geometric Mean) |
|---|
| First infusion, CL, n=24, 26 | Sixth infusion, CL, n=20, 19 |
|---|
| Ofatumumab 1000 mg + FC | 157 | 6.7 |
,| Ofatumumab 500 mg + FC | 122 | 6.7 |
Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section. (NCT00410163)
Timeframe: From first treatment (Visit 2) up to Visit 43 (Month 60)
| Intervention | participants (Number) |
|---|
| Ofatumumab 500 mg + FC | 31 |
| Ofatumumab 1000 mg + FC | 30 |
AUC(0-inf) and AUC(0-672) After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)
AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-672) is AUC from start of infusion to 672 hours after start of infusion; AUC(0-inf) is AUC from start of infusion extrapolated to infinity. (NCT00410163)
Timeframe: Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)
| Intervention | Milligrams * hour per liter (mg.h/L) (Geometric Mean) |
|---|
| First infusion, AUC(0-inf), n=24, 26 | First infusion, AUC(0-672), n=24, 26 | Sixth infusion, AUC(0-inf), n=16, 16 | Sixth infusion, AUC(0-672), n=20, 19 |
|---|
| Ofatumumab 1000 mg + FC | 1915 | 1915 | 397577 | 149019 |
,| Ofatumumab 500 mg + FC | 2453 | 2452 | 145236 | 74728 |
Vss After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)
Vss is defined as the volume of distribution at steady state of ofatumumab. (NCT00410163)
Timeframe: Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)
| Intervention | liters (Geometric Mean) |
|---|
| First infusion, Vss, n=24, 26 | Sixth infusion, Vss, n=16, 16 |
|---|
| Ofatumumab 1000 mg + FC | 4.57 | 5.77 |
,| Ofatumumab 500 mg + FC | 3.88 | 5.15 |
t1/2 After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)
t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half. (NCT00410163)
Timeframe: Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)
| Intervention | hours (Geometric Mean) |
|---|
| First infusion, t1/2, n=24, 26 | Sixth infusion, t1/2, n=16, 16 |
|---|
| Ofatumumab 1000 mg + FC | 18.8 | 746 |
,| Ofatumumab 500 mg + FC | 19.4 | 551 |
Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death
Time to next anti-CLL (anti-lymphoma) therapy was defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab or death. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed. (NCT00410163)
Timeframe: From time of randomization to first administration of next anti-CLL therapy other than ofatumumab or death, assessed over 5 years
| Intervention | months (Median) |
|---|
| Ofatumumab 500 mg + FC | 33.4 |
| Ofatumumab 1000 mg + FC | 33.3 |
Maximum Tolerated Dose for Cyclophosphamide (MTD)
MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle (NCT00412243)
Timeframe: First 14 days of each cycle
| Intervention | mg/m^2 (Number) |
|---|
| Clofarabine + Cyclophosphamide | 200 |
Percentage of Participants With Chronic GVHD
Incidences of chronic GVHD will be graded per Shulman et al. 1980. This reference categorizes chronic GVHD as either limited or extensive. For this outcome, participants developing either type are considered to have a chronic GVHD event. (NCT00412360)
Timeframe: 1 year post-randomization
| Intervention | percentage of participants (Number) |
|---|
| Chronic GVHD | Extensive Chronic GVHD |
|---|
| Double UCB Transplant | 32 | 15 |
,| Single UCB Transplant | 30 | 9 |
Percentage of Participants With Acute Graft-versus-host Disease (GVHD)
"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4" (NCT00412360)
Timeframe: Day 100 post-randomization
| Intervention | percentage of participants (Number) |
|---|
| Acute GVHD Grade II-IV | Acute GVHD Grade III-IV |
|---|
| Double UCB Transplant | 56 | 23 |
,| Single UCB Transplant | 57 | 13 |
Percentage of Participants With Overall Survival
Overall survival is defined as survival of death from any cause. (NCT00412360)
Timeframe: 1 year post-randomization
| Intervention | percentage of participants (Number) |
|---|
| Single UCB Transplant | 73 |
| Double UCB Transplant | 65 |
Percentage of Participants With Disease-free Survival
Disease-free survival is defined as survival without relapse of the primary disease. (NCT00412360)
Timeframe: 1 year post-randomization
| Intervention | percentage of participants (Number) |
|---|
| Single UCB Transplant | 70 |
| Double UCB Transplant | 64 |
Percentage of Participants With Relapse
Relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features. Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. (NCT00412360)
Timeframe: 1 year post-randomization
| Intervention | percentage of participants (Number) |
|---|
| Single UCB Transplant | 12 |
| Double UCB Transplant | 14 |
Percentage of Participants With Neutrophil and Platelet Engraftment
Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days. (NCT00412360)
Timeframe: Days 42 and 100
| Intervention | percentage of participants (Number) |
|---|
| Neutrophil Engraftment at Day 42 | Platelet Engraftment at Day 100 |
|---|
| Double UCB Transplant | 88 | 65 |
,| Single UCB Transplant | 89 | 76 |
Number of Participants With Engraftment Syndrome
(NCT00412360)
Timeframe: Day 100 post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Single UCB Transplant | 11 |
| Double UCB Transplant | 7 |
Time to Neutrophil and Platelet Engraftment
Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days. (NCT00412360)
Timeframe: 2 years post-transplant
| Intervention | days (Median) |
|---|
| Neutrophil Engraftment | Platelet Engraftment |
|---|
| Double UCB Transplant | 23 | 84 |
,| Single UCB Transplant | 21 | 58 |
Overall Survival
The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%. (NCT00413959)
Timeframe: 4 years
| Intervention | percentage of participants (Number) |
|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron | 83 |
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
Percentage of complete responders plus percentage of partial responders equals overall response rate. (NCT00413959)
Timeframe: 4 years
| Intervention | percentage of patients (Number) |
|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron | 90 |
Survival
Survival (NCT00424489)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Hematopoietic Stem Cell Transplantation | 6 |
Time to Platelet Engraftment
(NCT00425802)
Timeframe: 1 year
| Intervention | days (Median) |
|---|
| Treatment | 12 |
Time to Neutrophil Engraftment
(NCT00425802)
Timeframe: 2 years
| Intervention | days (Median) |
|---|
| Treatment | 15 |
Overall Survival at 1 Year
(NCT00425802)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Treatment | 90 |
Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days
(NCT00425802)
Timeframe: 100 days
| Intervention | percentage of patients (Number) |
|---|
| Treatment | 18 |
Immune Reconstruction/CD4+ Count at 6 Months
(NCT00425802)
Timeframe: 6 months
| Intervention | cells/microliter (Median) |
|---|
| Treatment | 312 |
Immune Reconstruction/CD4+ Count at 3 Months
(NCT00425802)
Timeframe: 3 months
| Intervention | cells/microliters (Median) |
|---|
| Treatment | 253 |
Immune Reconstruction/CD4+ Count at 1 Year
(NCT00425802)
Timeframe: 1 year
| Intervention | cells/microliter (Median) |
|---|
| Treatment | 333 |
Incidence of Chronic GVHD at 1 Year
(NCT00425802)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Treatment | 14 |
Number of Patients With Engraftment Response
Engraftment defined as (1) the first of three consecutive days of an Absolute neutrophil count (ANC) >500/mL (b) the first of seven consecutive days of an unsupported platelet count 20,000. Patient needs to survive at least 28 days to be evaluable for engraftment. Chimerism studies need to demonstrate donor-derived hematopoiesis (>90%) (NCT00427336)
Timeframe: First 100 days post transplant.
| Intervention | Participants (Number) |
|---|
| Fludarabine + Cyclophosphamide + ATG | 9 |
Lymphoid Recovery
To assess the pace of lymphoid recovery in this patient population. (NCT00429143)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Haploidentical Allogeneic Transplantation | 23 |
Incidence of Grades III-IV GVHD
"To determine the incidence and severity of GVHD in these patients using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.'~Severity was graded using CTCAE 3.0 (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death)" (NCT00429143)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Haploidentical Allogeneic Transplantation | 2 |
Engraftment Rates
To assess hematopoietic engraftment rates. (NCT00429143)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Haploidentical Allogeneic Transplantation | 23 |
Overall Survival of Participants
To determine overall survival at 6 months post-transplant. (NCT00429143)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Haploidentical Allogeneic Transplantation | 13 |
Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD
"To determine the optimal dose of CD3+ donor lymphocytes required for consistent engraftment without the development of grade III/IV GVHD.~Measured as CD3+ donor lymphocytes given as n x 10^8/kg.~n was found to be 2 and was found to be the optimal dose and was the only dose given." (NCT00429143)
Timeframe: 6 months
| Intervention | lymphocytes x 10^8/kg (Number) |
|---|
| Haploidentical Allogeneic Transplantation | 2 |
Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products
Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs. (NCT00429182)
Timeframe: Baseline to 1 month post AHST
| Intervention | participants (Number) |
|---|
| High-dose Chemotherapy | 9 |
Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography
The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value. (NCT00429299)
Timeframe: At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27)
| Intervention | Percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease | Progressive Disease | Not Evaluable |
|---|
| CT Plus Lapatinib 1500 mg | 15.8 | 44.7 | 13.1 | 2.6 | 23.7 |
,| CT Plus Trastuzumab | 30.5 | 41.7 | 5.5 | 2.8 | 19.4 |
,| CT Plus Trastuzumab and Lapatinib 1000 mg | 42.2 | 28.9 | 0 | 0 | 28.9 |
Number of Variations/Somatic Mutation in PI3KCA at Baseline
Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots). (NCT00429299)
Timeframe: Baseline
| Intervention | Variations/Somatic mutations (Number) |
|---|
| PIK3CA Exon 9 Wild-Type | PIK3CA Exon 9 Mutation | PIK3CA Exon 20 Wild-type | PIK3CA Exon 20 Mutation |
|---|
| CT Plus Lapatinib 1500 mg | 35 | 2 | 31 | 6 |
,| CT Plus Trastuzumab | 29 | 1 | 25 | 5 |
,| CT Plus Trastuzumab and Lapatinib 1000 mg | 39 | 3 | 37 | 5 |
Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment had been exercised in deciding whether reporting was appropriate in other situations. (NCT00429299)
Timeframe: From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29)
| Intervention | Participants (Number) |
|---|
| CT Plus Trastuzumab | 35 |
| CT Plus Lapatinib 1500 mg | 38 |
| CT Plus Trastuzumab and Lapatinib 1000 mg | 46 |
Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes
Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery. (NCT00429299)
Timeframe: At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29)
| Intervention | Percentage of participants (Number) |
|---|
| CT Plus Trastuzumab | 25 |
| CT Plus Lapatinib 1500 mg | 26.3 |
| CT Plus Trastuzumab and Lapatinib 1000 mg | 46.7 |
Number of Participants With Treatment Failure
Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause. (NCT00429299)
Timeframe: From randomization up to 29 weeks
| Intervention | Participants (Number) |
|---|
| CT Plus Trastuzumab | 7 |
| CT Plus Lapatinib 1500 mg | 9 |
| CT Plus Trastuzumab and Lapatinib 1000 mg | 7 |
Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment
The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal). (NCT00429299)
Timeframe: At Baseline and Withdrawal (assessed up to Study Week 29)
| Intervention | Percentage of inhibition (Median) |
|---|
| Ki67, Baseline, n=34, 37, 42 | Ki67, Post-treatment, n=22, 21, 18 | pAKT, Baseline, n=34, 37, 42 | pAKT, Post-treatment, 18, 20, 17 | pMAPK, Baseline, n=9, 5, 7 | pMAPK, Post-treatment, n=0, 1, 2 | Tunel test, Baseline, n=25, 27, 31 | Tunel test, Post-treatment, n=7, 12, 11 | PTEN, Baseline, n=27, 35, 37 | PTEN, Post-treatment, n=14, 17, 15 | pEGFR, Baseline, n=21, 24, 28 | pEGFR, Post-treatment, n=5, 10, 11 |
|---|
| CT Plus Lapatinib 1500 mg | 25 | 15 | 10 | 0 | 10 | 70 | 0.58 | 0.1 | 80 | 80 | 0 | 0 |
,| CT Plus Trastuzumab | 25 | 19 | 2.5 | 0 | 0 | NA | 0.4 | 0.1 | 80 | 100 | 0 | 0 |
,| CT Plus Trastuzumab and Lapatinib 1000 mg | 30 | 10 | 0 | 0 | 0 | 5 | 0.8 | 0.05 | 90 | 80 | 0 | 0 |
Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS
The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported. (NCT00429299)
Timeframe: At Baseline and at surgery (up to Study Week 29)
| Intervention | Percentage of participants (Number) |
|---|
| BCS | Mastectomy | Conversion from mastectomy to BCS |
|---|
| CT Plus Lapatinib 1500 mg | 57.9 | 39.5 | 42.8 |
,| CT Plus Trastuzumab | 66.7 | 33.3 | 61.9 |
,| CT Plus Trastuzumab and Lapatinib 1000 mg | 68.9 | 31.1 | 60 |
Time to Treatment Failure From the Start of Primary Therapy
Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments. (NCT00429299)
Timeframe: From randomization up to Study Week 307
| Intervention | Months (Median) |
|---|
| CT Plus Trastuzumab | 28.2 |
| CT Plus Lapatinib 1500 mg | 39.6 |
| CT Plus Trastuzumab and Lapatinib 1000 mg | 39.6 |
Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)
Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit. (NCT00429416)
Timeframe: Through 24 months post-treatment
| Intervention | participants (Number) |
|---|
| Developed grade II-IV GVHD | Developed cGVHD (Chronic GVHD) |
|---|
| LLME to Decrease GVHD Following HSC T | 3 | 1 |
Rate of Serious Infectious Complications
"Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy.~CD4 counts will be measured monthly for the first 3 months after transplant." (NCT00429416)
Timeframe: Through 3 months post-transplant
| Intervention | participants (Number) |
|---|
| LLME to Decrease GVHD Following HSC T | 2 |
Rate of Engraftment of Non-Myeloablative Transplants
Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products. (NCT00429416)
Timeframe: Through 30 days post-transplant
| Intervention | participants (Number) |
|---|
| LLME to Decrease GVHD Following HSC T | 13 |
Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality
"Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events.~This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included." (NCT00429416)
Timeframe: Through 100 days post-transplant or death
| Intervention | participants (Number) |
|---|
| LLME to Decrease GVHD Following HSC T | 1 |
Number of Patients Who Achieve a CD4 Count > 200/Micro-liters
Determine the number of patients who achieve a CD4 count > 200/micro-liters by 60 days after transplant. (NCT00429416)
Timeframe: Through 60 Days Post Transplant
| Intervention | participants (Number) |
|---|
| LLME to Decrease GVHD Following HSC T | 13 |
Clinical Response Rate
Clinical Response Rate was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for target lesions before surgery: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00432172)
Timeframe: Up to week 24
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 (Luminal A) Standard Treatment | 31 |
| Group 1 (Luminal A) Selective Treatment | 23 |
| Group 2 (Basal) Standard Treatment | 32 |
| Group 2 (Basal) Selective Treatment | 36 |
5-year Overall Survival (OS)
Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive. (NCT00433511)
Timeframe: Assessed at 5 years
| Intervention | proportion of participants (Number) |
|---|
| Arm A (Chemo + Placebo) | 0.90 |
| Arm B (Chemo + Bevacizumab) | 0.86 |
| Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 0.90 |
Invasive Disease-free Survival (IDFS) Rate at 5 Years
Invasive disease-free survival (IDFS) was defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation. (NCT00433511)
Timeframe: Assessed at 5 years
| Intervention | proportion of participants (Number) |
|---|
| Arm A (Chemo + Placebo) | 0.77 |
| Arm B (Chemo + Bevacizumab) | 0.76 |
| Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) | 0.80 |
The Association Between IDFS and Genotype
Invasive disease-free survival (IDFS) is defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation. Three-year IDFS rate was reported by genetic ancestry and IDFS was compared between patients with European ancestry and patients with African ancestry. (NCT00433511)
Timeframe: Assessed at 3 years
| Intervention | proportion of participants (Number) |
|---|
| European Ancestry | 0.887 |
| African Ancestry | 0.832 |
3-year Overall Survival (OS)
OS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to death. Patients alive at last follow-up were censored. (NCT00433537)
Timeframe: Assessed every 6 months for 5 years, and then yearly thereafter.
| Intervention | probability (Number) |
|---|
| VcR-CVAD Induction Followed by Maintenance Rituximab | 0.91 |
| VcR-CVAD Induction Followed by ASCT | 0.96 |
2-year Progression-free Survival (PFS)
PFS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. (NCT00433537)
Timeframe: Assessed every 6 months for 5 years, and then yearly thereafter.
| Intervention | probability (Number) |
|---|
| VcR-CVAD Induction Followed by Maintenance Rituximab | 0.79 |
| VcR-CVAD Induction Followed by ASCT | 0.76 |
Complete Response (CR) Rate
Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. (NCT00433537)
Timeframe: Assessed after VcR-CVAD cycles 2, 4, and 6.
| Intervention | proportion (Number) |
|---|
| VcR-CVAD Induction | 0.68 |
Adverse Event Profile as Measured by NCI CTCAE v 3.0
Measured by number of patients with at least one with grade 3+, Grade 4+, Hem, and Non-Hem AEs. (NCT00436566)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3+ Adverse Event | Grade 4+ Adverse Event | Grade 3+ Hem Adverse Event | Grade 4+ Hem Adverse Event | Grade 3+ Non-Hem Adverse Event | Grade 4+ Non-Hem Adverse Event |
|---|
| AC/PTL | 84 | 27 | 33 | 23 | 80 | 12 |
Percentage of Participants With Disease-Free Survival (DFS)
DFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method. (NCT00436566)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| AC/PTL | 91.9 |
Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements
Overall Symptom Distress Scale (SDS) QOL Measurement and Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) QOL Measurement (NCT00436566)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| SDS Time from Cycle 5 Baseline (Months 2-3) | SDS Time from Cycle 5 Baseline (Months 5-6) | SDS Time from Cycle 5 Baseline (Month 18-Year 3) | SDS Time from Cycle 5 Baseline (Year 4-5) | LASA Time from Cycle 5 Baseline (Months 2-3) | LASA Time from Cycle 5 Baseline (Months 5-6) | LASA Time from Cycle 5 Baseline (Month 18-3 Year) | LASA Time from Cycle 5 Baseline (Year 4-5) |
|---|
| AC/PTL | 32 | 33 | 12 | 7 | 67 | 45 | 40 | 19 |
Percentage of Participants With Overall Survival (OS)
OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method. (NCT00436566)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| AC/PTL | 95.0 |
Cumulative Incidence (CI) of Cardiac Events
"Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy.~Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3)" (NCT00436566)
Timeframe: 5 years
| Intervention | Post AC Cardiac Adverse Event (Number) |
|---|
| AC/PTL | 5 |
Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL
LASA score is from 0-90 with 0 being the worst and 90 being the best. SDS score is from 13-65 with 65 being the worst and 13 being the best. (NCT00436566)
Timeframe: 5 years
| Intervention | units on a scale (Mean) |
|---|
| LASA Time from Cycle 5 Baseline (Months 2-3) | LASA Time from Cycle 5 Baseline (Months 5-6) | LASA Time from Cycle 5 Baseline (Month 18-Year 3) | LASA Time from Cycle 5 Baseline (Year 4-5) | SDS Time from Cycle 5 Baseline (Months 2-3) | SDS Time from Cycle 5 Baseline (Months 5-6) | SDS Time from Cycle 5 Baseline (Month 18-Year 3) | SDS Time from Cycle 5 Baseline (Year 4-5) |
|---|
| AC/PTL | -11.1 | -13.2 | -3.6 | -0.5 | -6.7 | -9.5 | -1.4 | 0.3 |
Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment
(NCT00436566)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| AC/PTL | 0 |
Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF)
Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) from baseline to any post-baseline time point. (NCT00436566)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Drop ≤ 10 between any 2 time points | Drop ≥ 10 between any 2 time points |
|---|
| AC/PTL | 41 | 63 |
Incidence of Pulmonary Events
Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment. (NCT00436566)
Timeframe: 5 years
| Intervention | pulmonary adverse events (Number) |
|---|
| AC/PTL | 0 |
Number of Patients That Achieved Complete Response to ABT-751
Complete response (CR) is the occurrence of all of the following on approximately Day 29: less than 5% leukemic blasts in the bone marrow aspirate with no evidence of leukemic blasts in the CSF or peripheral blood and recovery of peripheral blood counts of an Absolute neutrophil count (ANC) > 750/μL and Platelet count > 75,000 μL. (NCT00439296)
Timeframe: Day 29 of Course 1
| Intervention | Participants (Count of Participants) |
|---|
| # of patients not achieving complete response | # of patients who achieved complete response |
|---|
| Dose Level 0 | 1 | 3 |
,| Dose Level 1 | 4 | 1 |
Number of Patients That Experienced Dose Limiting Toxicity From ABT-751
"ABT-751 was given daily for 21 days for a period of 28 day course in combination with dexamethasone, PEG-asparaginase, and doxorubicin. The occurrence of a dose limiting toxicity (DLT) was evaluated at the end of the 28 day course.~DLT will be defined as any of the following events that are deemed by the investigator as probably or definitely attributable to ABT-751. Toxicity grade follows the CTCAE criteria, version 3.0. A copy of the CTCAE can be downloaded from the CTEP home page (http://ctep.cancer.gov).~Grade 3 or 4 Ileus~Grade 3 or 4 Constipation~Grade 3 or 4 Gastrointestinal obstruction, any location~Grade 3 or 4 Sensory Neuropathy~Grade 3 or 4 Motor Neuropathy~Grade 3 or 4 Neuropathic pain lasting longer than 24 hours despite medical intervention~Grade 3 or 4 Hypoxia in the absence of anemia or infection~Grade 4 Alanine aminotransferase (ALT) which does not return to" (NCT00439296)
Timeframe: Each dose level is evaluated
| Intervention | Participants (Count of Participants) |
|---|
| # of patients with DLT | # of patients without DLT |
|---|
| Dose Level 0 | 0 | 4 |
,| Dose Level 1 | 2 | 3 |
Number of Patients With Occurrence of Toxic Death
The occurrence of toxic death at anytime that is definitely, probably or possibly related to the treatment. (NCT00439296)
Timeframe: From the first dose of study therapy until 30 days after last therapy dose. Last dose protocol therapy is on day 21.
| Intervention | Participants (Count of Participants) |
|---|
| # of patients that experienced toxic death | # of patients that did not experience toxic death |
|---|
| Dose Level 0 | 0 | 4 |
,| Dose Level 1 | 0 | 5 |
Non-relapse Mortality (NRM) (Patients With AML/MDS)
Cumulative incidence rate with death as a competing risk, assessed at day 100. (NCT00445744)
Timeframe: Up to day 200
| Intervention | percent (Number) |
|---|
| Treatment (Cyclophosphamide, Busulfan, Transplant) | 17 |
Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)
The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF. (NCT00446030)
Timeframe: up to 2 years
| Intervention | Percentage of Participants (Mean) |
|---|
| Stratum 1: TAC + Bevacizumab | 4.3 |
| Stratum 2: TCH + Bevacizumab | 0 |
Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)
Response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR). (NCT00448019)
Timeframe: Response assessed after three 4-week courses and after six courses, up to 24 weeks
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Nodular Partial Response (NPR) |
|---|
| FCR + Bevacizumab | 13 | 24 | 8 |
Progression Free Survival (PFS) Rate
Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00448019)
Timeframe: Baseline up to 5 years
| Intervention | Months (Median) |
|---|
| FCR + Bevacizumab | 13.5 |
Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL
ORR defined as CR and PR response where response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR). (NCT00448019)
Timeframe: Response assessed after three 4-week courses and after six courses, up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|
| FCR + Bevacizumab | 79 |
Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.
Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies. (NCT00450385)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) |
|---|
| R-CHOP | 57 |
Response Rate
Percentage of participants achieving complete response (CR) to protocol therapy according to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) using the CT imaging method. Patients were classified by best tumor response; CR was defined as normalization of the lactate dehydrogenase (LDH), complete disappearance of disease-related symptoms and lymph nodes, and clearance of lymphoma from involved organs; complete response unconfirmed (CRu) as a residual lymph node greater than 1.5 cm in greatest transverse diameter that had regressed by more than 75% or an indeterminate bone marrow examination; partial response (PR) as greater than 50% reduction in the involved lymph nodes, or disappearance of the involved lymph nodes but persistent bone marrow involvement; relapse/progression as new or increased lymph nodes, organomegaly, or reappearance of bone marrow involvement. (NCT00450801)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| R-MACLO-IVAM-T | 100 |
Progression-free Survival Rate
Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion. (NCT00450801)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| 1 year progression-free survival | 3 year progression-free survival | 5-year progression-free survival |
|---|
| R-MACLO-IVAM-T | 91 | 78 | 69 |
Overall Survival Rate
Percentage of participants who are alive up to five years after receipt of protocol therapy. (NCT00450801)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| 1-year rate overall survival Rate | 2-year overall survival Rate | 3-year overall survival rate | 4-year overall survival rate | 5-year overall survival rate |
|---|
| R-MACLO-IVAM-T | 96 | 96 | 96 | 87 | 87 |
Number of Patients Experiencing Adverse Events.
Number of patients experiencing adverse events during the course of protocol therapy. (NCT00450801)
Timeframe: Up to 5 years
| Intervention | participants (Number) |
|---|
| R-MACLO Cycles | 22 |
| R-IVAM Cycles | 22 |
| Thalidomide Therapy | 19 |
Progression-free Survival (Phase II)
1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00450814)
Timeframe: At 1 year
| Intervention | percentage of patients (Number) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 6.7 |
Progression-free Survival (Phase II)
2-year progression-free survival (PFS2). Evidence of local recurrence, distant metastasis, or death from any cause within 2 years counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00450814)
Timeframe: At 2 years
| Intervention | percentage of patients (Number) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 6.7 |
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported. (NCT00450814)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 | 0 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 | 0 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 | 0 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 | 0 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 | 0 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 | 1 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 | 0 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 | 0 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 | 0 |
Time to Progression (TTP) (Phase II)
Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year. The distribution of time to progression will be estimated using the method of Kaplan-Meier. (NCT00450814)
Timeframe: Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year
| Intervention | months (Median) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 1.48 |
Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better (Phase II)
Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00450814)
Timeframe: Up to 1 year
| Intervention | proportion of patients (Number) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 0 |
Progression-free Survival (Phase II)
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00450814)
Timeframe: Up to 5 years
| Intervention | months (Median) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 1.48 |
Maximum Tolerated Dose (MTD) (Phase I)
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The MTD is reported below. (NCT00450814)
Timeframe: 6 weeks
| Intervention | Dose Level (Number) |
|---|
| Phase I (Stage 1) | 6 |
Failure-free Survival (Phase II)
Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year. The distribution of failure-free survival will be estimated using the method of Kaplan-Meier. (NCT00450814)
Timeframe: Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year
| Intervention | months (Median) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 1.4783 |
Number of Patients With Clinical Responses (Phase I)
The number of patients with clinical responses (CR, VGPR, PR, or minimal response [MR]) will be summarized by stage. (NCT00450814)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Phase I: Stage 1 (MV-NIS Alone) | 1 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) | 0 |
Overall Survival (Phase II)
Time from registration to death due to any cause, assessed up to 1 year. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT00450814)
Timeframe: Time from registration to death due to any cause, assessed up to 1 year
| Intervention | months (Median) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 12.0 |
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I)
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients. (NCT00450814)
Timeframe: Up to 1 year
| Intervention | percentage of patients (Number) |
|---|
| Phase I: Stage 1 (MV-NIS Alone) | 38 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) | 25 |
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II)
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below for Phase II patients. (NCT00450814)
Timeframe: Up to 1 year
| Intervention | percentage of patients (Number) |
|---|
| Phase II (Acetaminophen + Benadryl + MV-NIS) | 73.3 |
Overall Survival (OS)
OS is the elapsed time from the date of study enrollment (baseline) to the date of death from any cause. For participants not known to have died as of the data cutoff date, OS was censored at the last contact date or last date known to be alive, whichever was later. (NCT00451178)
Timeframe: Baseline to death from any cause (up to 55 months)
| Intervention | months (Median) |
|---|
| R-CHOP and Enzastaurin | NA |
| R-CHOP | NA |
Event-Free Survival (EFS)
EFS is the elapsed time from the date of randomization to the first date of objectively-determined PD, institution of a new anticancer treatment (other than maintenance therapy), or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date, who did not have objectively determined disease progression, and who were not treated with a new anticancer treatment, EFS was censored at the date of the last objectively determined disease-free assessment. (NCT00451178)
Timeframe: Randomization to measured PD, start of new therapy, or death from any cause (up to 55 months)
| Intervention | months (Median) |
|---|
| R-CHOP and Enzastaurin | 36.2 |
| R-CHOP | 22.6 |
Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate)
CR, CRu, and PR were defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. PR is a 50% decrease in the sum of the products of diameters for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. The percentage of participants with complete response (CR/CRu) and objective response (Cr/CRu/PR)=(Number of participants whose best overall response was CR/CRu or Cr/CRu/PR)/(Number of participants treated)*100. (NCT00451178)
Timeframe: Baseline through long-term follow-up (up to 2 years post last dose)
| Intervention | percentage of participants (Number) |
|---|
| Complete Response | Objective Response |
|---|
| R-CHOP | 42.9 | 85.7 |
,| R-CHOP and Enzastaurin | 51.8 | 83.9 |
Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan)
Lesion response was assessed according to International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. Percentage of participants with CR/CRu and/or PET-negative scan=(Number of participants with complete response and/or PET-negative scan at Cycle 6)/(Number of participants with a PET-positive scan at baseline)*100. (NCT00451178)
Timeframe: Cycle 6 (21 days/cycle)
| Intervention | percentage of participants (Number) |
|---|
| CR/CRu and PET-Negative Post-Baseline | CR/CRu or PET-Negative Post-Baseline |
|---|
| R-CHOP | 25.6 | 43.6 |
,| R-CHOP and Enzastaurin | 26.8 | 53.6 |
PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS
Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)]
| Intervention | months (Median) |
|---|
| Marker: EIF4EBP1 Cytoplasm | Marker: EIF4EBP1 Nucleus | Marker: EIF4E Cytoplasm | Marker: EIF4E Nucleus | Marker: HDAC2 Nucleus | Marker: PCREB Nucleus | Marker: PEIF3746 Cytoplasm | Marker: PEIF3746 Nucleus | Marker: PEIFS209 Cytoplasm | Marker: PEIFS65 Nucleus | Marker: PEIFT70 Cytoplasm | Marker: PEIFT70 Nucleus | Marker: P GSK3B Cytoplasm | Marker: PKCb2 Cytoplasm | Marker: PS6 Cytoplasm | Marker: PTEN Cytoplasm | Marker: PTEN Nucleus |
|---|
| High Biomarker Expression (R-CHOP) | 9.49 | NA | 21.42 | 4.50 | 10.55 | 10.55 | 20.90 | NA | 9.20 | NA | NA | 32.30 | 21.42 | 10.55 | 10.02 | 21.42 | 6.34 |
,| Low Biomarker Expression (R-CHOP and Enzastaurin) | 27.96 | NA | 27.96 | NA | NA | NA | NA | NA | 27.96 | 27.96 | 27.96 | 27.96 | NA | NA | 16.57 | NA | NA |
,| Low Biomarker Expression (R-CHOP) | 32.30 | 10.55 | NA | 32.30 | NA | NA | NA | 32.30 | NA | 32.30 | 10.55 | NA | 9.49 | 20.90 | NA | 9.49 | 32.30 |
PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS
Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)]
| Intervention | months (Median) |
|---|
| Marker: EIF4EBP1 Cytoplasm | Marker: EIF4E Cytoplasm | Marker: HDAC2 Nucleus | Marker: PCREB Nucleus | Marker: PEIF3746 Cytoplasm | Marker: PEIF3746 Nucleus | Marker: PEIFS209 Cytoplasm | Marker: PEIFS65 Nucleus | Marker: PEIFT70 Cytoplasm | Marker: PEIFT70 Nucleus | Marker: P GSK3B Cytoplasm | Marker: PKCb2 Cytoplasm | Marker: PS6 Cytoplasm | Marker: PTEN Cytoplasm | Marker: PTEN Nucleus |
|---|
| High Biomarker Expression (R-CHOP and Enzastaurin) | NA | NA | 27.96 | 24.10 | 27.96 | NA | NA | NA | NA | NA | 27.96 | 27.96 | NA | 27.96 | 27.96 |
Percentage of Participants With a PET-Negative Scan (PET-Negative Rate)
The percentage of participants with a PET-negative scan=(Number of participants who had a PET-negative scan at Cycle 6)/(Number of participants who had a PET-positive scan at baseline)*100. (NCT00451178)
Timeframe: Cycle 6 (21 days/cycle)
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP and Enzastaurin | 44.6 |
| R-CHOP | 41.0 |
Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin)
Data presented are the number of participants who experienced at least 1 TEAE, Grade 3 or 4 Common Terminology Criteria for Adverse Events (CTCAE), serious adverse event (SAE), as well as the number of participants who discontinued due to an adverse event (AE) or SAE, who died on therapy, died within 30 days post treatment or within 60 days of first dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT00451178)
Timeframe: First dose through 30 days post study treatment discontinuation (up to 56 months)
| Intervention | Participants (Count of Participants) |
|---|
| At Least 1 TEAE | At Least 1 Grade 3/4 CTCAE | At Least 1 SAE | Discontinued due to AE | Discontinued due to SAE | Died on Therapy (all causes) | Died within 30 days post treatment discontinuation | Died within 60 days of first dose |
|---|
| R-CHOP | 43 | 30 | 18 | 6 | 3 | 3 | 3 | 2 |
,| R-CHOP and Enzastaurin | 56 | 50 | 35 | 10 | 4 | 5 | 6 | 3 |
Progression-Free Survival (PFS) Time
PFS time is the elapsed time from the date of randomization to the first date of objectively-determined PD or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (other than enzastaurin maintenance therapy) prior to objectively determined disease progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of subsequent therapy. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)
| Intervention | months (Median) |
|---|
| R-CHOP and Enzastaurin | 36.2 |
| R-CHOP | 22.6 |
Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate)
PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. Percentage of participants alive progression-free at Year 2=(Number of participants alive progression free at Year 2)/(Number of participants assessed)*100. (NCT00451178)
Timeframe: Randomization to measured PD (up to Year 2)
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP and Enzastaurin | 59 |
| R-CHOP | 49 |
Duration of Complete Response (CR or CRu)
Duration of response (DOR) either CR or CRu: Elapsed time from date CR or CRu criteria met to first objectively-determined PD. For responding participants (pts) who died without PD and pts not known to have died as of data cut-off date, who did not have PD, DOR censored at date of last objective progression-free disease assessment. For responding pts who received subsequent systemic anticancer therapy (other than enzastaurin maintenance therapy) prior to PD, DOR was censored at date of last objective progression-free disease assessment prior to subsequent therapy. CR and CRu defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. (NCT00451178)
Timeframe: Time of response to PD (up to 55 months)
| Intervention | days (Median) |
|---|
| R-CHOP and Enzastaurin | NA |
| R-CHOP | NA |
Number of Patients Who Engraft at Each Dose of TBI Used
Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism. (NCT00453388)
Timeframe: Up to Day 200
| Intervention | Participants (Count of Participants) |
|---|
| Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | 5 |
| Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | 1 |
Incidence of Grades III-IV Acute GVHD
"Number of subjects who developed maximum grade acute graft-vs-host disease~aGVHD Stages~Skin:~- a maculopapular eruption involving < 25% BSA~- a maculopapular eruption involving 25 - 50% BSA~- generalized erythroderma~- generalized erythroderma with bullous formation and often with desquamation~Liver:~- bilirubin 2.0 - 3.0 mg/100 mL~- bilirubin 3 - 5.9 mg/100 mL~- bilirubin 6 - 14.9 mg/100 mL~- bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00453388)
Timeframe: Up to Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | 1 |
| Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | 0 |
Incidence of Adverse Events
Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria (NCT00453388)
Timeframe: Up to Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | 3 |
| Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | 0 |
Incidence of Pulmonary Complications
Defined as patients who exhibit a pulmonary (lung) adverse event. (NCT00455312)
Timeframe: 6 Months
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 3 |
| Patients With SAA | 3 |
Incidence of Chronic GVHD
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 0 |
| Patients With SAA | 0 |
Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 1 |
| Patients With SAA | 0 |
Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD)
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 0 |
| Patients With SAA | 0 |
Incidence of Late Secondary Malignancies
Defined as patients who have a secondary malignancy (cancer) occurring. (NCT00455312)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 0 |
| Patients With SAA | 4 |
Incidence of Chronic GVHD
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00455312)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 1 |
| Patients With SAA | 2 |
Neutrophil Engraftment
Defined as an absolute neutrophil count (ANC) >5 x 10^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation. (NCT00455312)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 15 |
| Patients With SAA | 20 |
Overall Survival
Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. (NCT00455312)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 12 |
| Patients With SAA | 19 |
Overall Survival
Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. (NCT00455312)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Patients With DC | 14 |
| Patients With SAA | 19 |
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations
Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 [log2 normalized intensity units], respectively (corresponding to prevalence rates of 43.3% and 44.3%). (NCT00455533)
Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.
| Intervention | Percentage of Participants (Number) |
|---|
| Beta-III positive subgroup (cross-validation) | Beta-III negative subgroup (cross-validation) | Beta-III positive subgroup (n=43, 42) | Beta-III negative subgroup (n=71, 75) | TACC3 positive subgroup (cross-validation) | TACC3 negative subgroup (cross-validation) | CAPG positive subgroup (cross-validation) | CAPG negative subgroup (cross-validation) |
|---|
| Ixabepilone | 35.9 | 17.4 | 34.9 | 18.3 | 30.1 | 19.8 | 30.7 | 20.4 |
,| Paclitaxel | 36.1 | 22.4 | 35.7 | 22.7 | 29.4 | 27.0 | 35.3 | 20.7 |
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants
Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score. (NCT00455533)
Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.
| Intervention | percentage of participants (Number) |
|---|
| Mem+Cyto Threshold/Negative Biomarker Status | Mem+Cyto Threshold/Positive Biomarker Status | Mem Threshold/Negative Biomarker Status |
|---|
| Ixabepilone | 0.192 | 0.447 | 0.327 | 0.417 |
,| Paclitaxel | 0.483 | 0.341 | 0.417 | 0.3 |
Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds
Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score . (NCT00455533)
Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.
| Intervention | percentage of participants (Number) |
|---|
| Mem+Cyto Threshold/Negative Biomarker Status | Mem+Cyto Threshold/Positive Biomarker Status | Mem Threshold/Negative Biomarker Status |
|---|
| Ixabepilone | 0.224 | 0.371 | 0.304 | 0.316 |
,| Paclitaxel | 0.339 | 0.362 | 0.363 | 0.267 |
Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)
Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive [with 90% confidence interval by Bootstrap method]): Beta 3 Tubulin IHC (45.866 [5, 83.9]); TACC3 mRNA (6.714 [6.312, 7.192]); CAPG mRNA (6.739 [5.728, 7.298]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm. (NCT00455533)
Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment
| Intervention | Percentage of Participants (Number) |
|---|
| Beta 3 Tubulin IHC (n=231) | Beta 3 Tubulin IHC H-Score (n=231) | Beta 3 Tubulin mRNA (n=245) | TACC3 mRNA (n=245) | CAPG mRNA (n=245) |
|---|
| Randomized Participants | 0.394 | 0.299 | 0.392 | 0.514 | 0.486 |
Reason for First Dose Reduction of AC
(NCT00455533)
Timeframe: 12 weeks (4 3-week cycles)
| Intervention | participants (Number) |
|---|
| Participants with at least 1 dose reduction of AC | Adverse Event | Hematologic Toxicity | Non-Hematologic Toxicity | Not Reported |
|---|
| Ixabepilone | 5 | 1 | 3 | 0 | 1 |
,| Paclitaxel | 7 | 3 | 3 | 1 | 0 |
Reason for First Dose Reduction of Ixabepilone/Paclitaxel
(NCT00455533)
Timeframe: 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)
| Intervention | participants (Number) |
|---|
| Participants with at least 1 dose reduction | Adverse Event | Hematologic Toxicity | Non-Hematologic Toxicity | Not Reported | Peripheral Neuropathy |
|---|
| Ixabepilone | 18 | 10 | 2 | 0 | 1 | 5 |
,| Paclitaxel | 18 | 3 | 0 | 4 | 2 | 9 |
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds
Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score. (NCT00455533)
Timeframe: : pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.
| Intervention | percentage of participants (Number) |
|---|
| Mem+Cyto Threshold/Negative Biomarker Status | Mem+Cyto Threshold/Positive Biomarker Status | Mem Threshold/Negative Biomarker Status |
|---|
| Ixabepilone | 0.143 | 0.323 | 0.228 | 0.316 |
,| Paclitaxel | 0.288 | 0.259 | 0.284 | 0.2 |
Percentage of Participants Achieving Clinical Objective Response
Clinical response was defined as the number of participants who achieved modified World Health Organization's tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of >= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm. (NCT00455533)
Timeframe: after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)
| Intervention | Percentage of Participants (Number) |
|---|
| Ixabepilone | 81.1 |
| Paclitaxel | 77.6 |
Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1
Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm. (NCT00455533)
Timeframe: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)
| Intervention | Percentage of Participants (Number) |
|---|
| Ixabepilone | 30.4 |
| Paclitaxel | 33.3 |
Percentage of Participants Achieving Pathologic Complete Response (pCR)
The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast. (NCT00455533)
Timeframe: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)
| Intervention | Percentage of Participants (Number) |
|---|
| Ixabepilone | 24.3 |
| Paclitaxel | 25.2 |
Percentage of Participants Requiring Breast Conservation Surgery
Number of randomized participants requiring breast conservation surgery following study treatment. (NCT00455533)
Timeframe: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)
| Intervention | Percentage of Participants (Number) |
|---|
| Ixabepilone | 41.9 |
| Paclitaxel | 32.7 |
Number of Participants by Dose for AC
(NCT00455533)
Timeframe: 12 weeks (4 3-week cycles)
| Intervention | participants (Number) |
|---|
| Dose 1 (Week 3) | Dose 2 (Week 6) | Dose 3 (Week 9) | Dose 4 (Week 12) |
|---|
| Ixabepilone | 145 | 145 | 145 | 143 |
,| Paclitaxel | 144 | 144 | 142 | 141 |
Number of Participants by Dose for Ixabepilone/Paclitaxel
(NCT00455533)
Timeframe: 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)
| Intervention | participants (Number) |
|---|
| Dose 1 (Week 3, ixabepilone; Week 1 paclitaxel) | Dose 2 (Week 6, ixabepilone; Week 2 paclitaxel) | Dose 3 (Week 9, ixabepilone; Week 3 paclitaxel) | Dose 4 (Week 12, ixabepilone; Week 4 paclitaxel) | Dose 5 (Week 5 paclitaxel) | Dose 6 (Week 6 paclitaxel) | Dose 7 (Week 7 paclitaxel) | Dose 8 (Week 8 paclitaxel) | Dose 9 (Week 9 paclitaxel) | Dose 10 (Week 10 paclitaxel) | Dose 11 (Week 11 paclitaxel) | Dose 12 (Week 12 paclitaxel) |
|---|
| Ixabepilone | 145 | 139 | 130 | 124 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Paclitaxel | 144 | 142 | 139 | 139 | 135 | 135 | 132 | 131 | 129 | 128 | 123 | 118 |
Number of Participants With Course Delay and Reason for Delay for AC
(NCT00455533)
Timeframe: 12 weeks (4 3-week cycles)
| Intervention | participants (Number) |
|---|
| Participants with at least 1 dose delay | Administrative Reason | Adverse Event | Hematologic Toxicity | Non-Hematologic Toxicity | Not Reported | Other | Subject Request |
|---|
| Ixabepilone | 41 | 5 | 6 | 17 | 3 | 14 | 3 | 2 |
,| Paclitaxel | 43 | 6 | 10 | 10 | 2 | 16 | 1 | 0 |
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel
(NCT00455533)
Timeframe: 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)
| Intervention | participants (Number) |
|---|
| Participants with at least 1 dose delay | Administrative Reason | Adverse Event | Hematologic Toxicity | Non-Hematologic Toxicity | Not Reported | Other | Peripheral Neuropathy | Subject Request |
|---|
| Ixabepilone | 31 | 3 | 6 | 10 | 0 | 13 | 3 | 0 | 0 |
,| Paclitaxel | 51 | 5 | 15 | 15 | 7 | 8 | 8 | 1 | 3 |
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death) (NCT00455533)
Timeframe: prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase
| Intervention | Participants (Number) |
|---|
| White Blood Cells (WBC), Grade 0 | WBC, Grade 1 | WBC, Grade 2 | WBC, Grade 3 | WBC, Grade 4 | WBC, Grade 1-4 | WBC, Grade 3-4 | Absolute Neutrophil Count (ANC), Grade 0 | ANC, Grade 1 | ANC, Grade 2 | ANC, Grade 3 | ANC, Grade 4 | ANC, Grade 1-4 | ANC, Grade 3-4 | Platelets, Grade 0 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 | Platelets, Grade 1-4 | Platelets, Grade 3-4 | Hemoglobin, Grade 0 | Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Hemoglobin, Grade 1-4 | Hemoglobin, Grade 3-4 |
|---|
| Ixabepilone | 32 | 27 | 32 | 44 | 8 | 111 | 52 | 33 | 23 | 28 | 36 | 23 | 110 | 59 | 109 | 33 | 0 | 1 | 0 | 34 | 1 | 13 | 77 | 51 | 2 | 0 | 130 | 2 |
,| Paclitaxel | 32 | 63 | 41 | 7 | 0 | 111 | 7 | 66 | 41 | 24 | 12 | 0 | 77 | 12 | 134 | 6 | 2 | 1 | 0 | 9 | 1 | 8 | 91 | 37 | 6 | 1 | 135 | 7 |
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death) (NCT00455533)
Timeframe: prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase
| Intervention | Participants (Number) |
|---|
| ALT, Grade 0 (n=142, 140) | ALT, Grade 1 (n=142, 140) | ALT, Grade 2 (n=142, 140) | ALT, Grade 3 (n=142, 140) | ALT, Grade 4 (n=142, 140) | ALT, Grade 1-4 (n=142, 140) | ALT, Grade 3-4 (n=142, 140) | AST, Grade 0 (n=141, 140) | AST, Grade 1 (n=141, 140) | AST, Grade 2 (n=141, 140) | AST, Grade 3 (n=141, 140) | AST, Grade 4 (n=141, 140) | AST, Grade 1-4 (n=141, 140) | AST, Grade 3-4 (n=141, 140) | Alkaline Phosphatase, Grade 0 (n=141, 140) | Alkaline Phosphatase, Grade 1 (n=141, 140) | Alkaline Phosphatase, Grade 2 (n=141, 140) | Alkaline Phosphatase, Grade 3 (n=141, 140) | Alkaline Phosphatase, Grade 4 (n=141, 140) | Alkaline Phosphatase, Grade 1-4 (n=141, 140) | Alkaline Phosphatase, Grade 3-4 (n=141, 140) | Total Bilirubin, Grade 0 (n=142, 140) | Total Bilirubin, Grade 1 (n=142, 140) | Total Bilirubin, Grade 2 (n=142, 140) | Total Bilirubin, Grade 3 (n=142, 140) | Total Bilirubin, Grade 4 (n=142, 140) | Total Bilirubin, Grade 1-4 (n=142, 140) | Total Bilirubin, Grade 3-4 (n=142, 140) |
|---|
| Ixabepilone | 72 | 54 | 13 | 3 | 0 | 70 | 3 | 85 | 51 | 4 | 1 | 0 | 56 | 1 | 114 | 27 | 0 | 0 | 0 | 27 | 0 | 137 | 4 | 0 | 1 | 0 | 5 | 1 |
,| Paclitaxel | 52 | 59 | 22 | 7 | 0 | 88 | 7 | 64 | 64 | 9 | 3 | 0 | 76 | 3 | 117 | 23 | 0 | 0 | 0 | 23 | 0 | 131 | 8 | 0 | 0 | 1 | 9 | 1 |
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death) (NCT00455533)
Timeframe: prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase
| Intervention | Participants (Number) |
|---|
| Creatinine, Grade 0 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Creatinine, Grade 1-4 | Creatinine, Grade 3-4 |
|---|
| Ixabepilone | 136 | 6 | 0 | 0 | 0 | 6 | 0 |
,| Paclitaxel | 135 | 3 | 1 | 0 | 0 | 4 | 0 |
Recurrence-free Survival
To determine the five-year RFS. (NCT00464646)
Timeframe: From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry
| Intervention | percentage of patients (Number) |
|---|
| Cohort A | 75.97 |
| Cohort B | 89.66 |
Percentage of Participants With Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)
The percentage of patients with surgical complications (from mastectomy, lumpectomy, and axillary staging procedures). (NCT00464646)
Timeframe: 2-4 weeks after surgery and at 9 and 12 months from study entry
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A | 37 |
Overall Survival
Death from any cause during the 5 years from study entry. (NCT00464646)
Timeframe: From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A | 12 |
| Cohort B | 0 |
Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)
The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy. (NCT00464646)
Timeframe: Assessed at time of surgery on average at 8 months
| Intervention | participants (Number) |
|---|
| Cohort A | 34 |
Number of Participants With no Histologic Evidence of Invasive Tumor Cells in the Surgical Breast Specimen.
The determination of pCR will be performed by the local pathologist following examination of tissue (breast and nodes) removed at the time of surgery. (NCT00464646)
Timeframe: Assessed at the time of surgery
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A | 36 |
| Cohort B | 0 |
Number of Participants With Cardiac Events
The number of cardiac events defined as NYHA Class III/IV CHF and cardiac death.To determine the rate of cardiac events (NYHA Class III/IV CHF and cardiac death) of a regimen of EC followed by THA when administered to: Cohort A as neoadjuvant therapy for HER-2 positive locally advanced (clinical stage IIIA, IIIB or IIIC breast cancer or Cohort B as adjuvant therapy for resected HER2-positive pN2 or pN3 (pathologic stage III) breast cancer. The number of participants with one or more cardiac events are being reported. (NCT00464646)
Timeframe: Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A | 4 |
| Cohort B | 0 |
Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)
(NCT00464646)
Timeframe: Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A | 55 |
| Cohort B | 22 |
Clinical Complete Response (cCR)
cCR following the last dose of docetaxel (Cohort A). cCR is detemined by tumor measurement by physical exam at baseline: target lesions greater than or equal to 2.0 cm; non-target lesions greater than or equal to 2.0 cm. cCR assessment at other timepoints: resolution of all target and non-target lesions identified at baseline, and no new lesions or other signs of disease progression. (NCT00464646)
Timeframe: Determined at baseline, 2-3 weeks after the last EC dose, 2-4 weeks after last Docetaxel dose-before surgery.
| Intervention | percentage of patients (Number) |
|---|
| Cohort A | 61.43 |
Number of Participants Analyzed for Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I)
The recommended phase II dose of tipifarnib (100 or 200 mg PO BID on days 1-3 each paclitaxel dose) in combination with paclitaxel (80 mg/m2/week x 12 consecutive weeks) (NCT00470301)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Number of participants with DLT (100 mg PO BID tipifarnib) | Number of participants with DLT (200 mg PO BID tifiparnib) |
|---|
| Arm I | 0 | 0 |
Pathologic Complete Response Rate (pCR)
An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising. (NCT00470301)
Timeframe: Up to 5 years
| Intervention | participants (Number) |
|---|
| Arm I | 33 |
Time to Failure (Phase II)
Failure will be defined as recurrence/progression of disease or death from either disease or toxicity. Bayesian toxicity monitoring schema will be used to monitor severe toxicity profile in combined therapy. Severe toxicity is defined as at least two episodes of neutropenic fever during treatment courses. (NCT00477412)
Timeframe: First date of diagnosis up to 5 years
| Intervention | months (Median) |
|---|
| Phase II- Treatment (Combination Chemotherapy) | 55 |
Overall Survival
Overall survival is the time in number of months from start of study treatment to date of death due to any cause. (NCT00477412)
Timeframe: Date of diagnosis to last known date of survival, up to 5 years
| Intervention | months (Median) |
|---|
| Phase II- Treatment (Combination Chemotherapy) | 44 |
Number of Participants With Overall Response Rate
Response rate is determined by CT scans of the chest, abdomen, and pelvis, unilateral BM biopsy and aspirate with lymphoma markers (if initially positive) and colonoscopy/endoscopy if applicable. (NCT00477412)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Phase II- Treatment (Combination Chemotherapy) | 87 |
Maximum Tolerated Dose of Bortezomib (Phase I)
Determine the safety and the maximum tolerated dose (MTD) of bortezomib when added to the combination of rituximab, methotrexate, and cytarabine alternating with bortezomib, rituximab-hyperCVAD in patients with untreated aggressive mantle cell lymphoma. (NCT00477412)
Timeframe: Cycle 1 Day 1 - End of Cycle 2 up to 60 days.
| Intervention | mg/m^2 (Number) |
|---|
| Phase 1 Maximum Tolerated Dose (MTD) | 1.3 |
Progression-free Survival (PFS)
"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.> Progression was defined as any one or more of the following:> An increase of 25% from lowest confirmed response in:>~Serum M-component (absolute increase >= 0.5g/dl)>~Urine M-component (absolute increase >= 200mg/24hour>~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl>~Bone marrow plasma cell percentage (absolute increase of >=10%)" (NCT00478218)
Timeframe: up to 5 years
| Intervention | months (Median) |
|---|
| LCD (Cyclophosphamide 300 mg/m^2) | 27 |
| LCD (Cyclophosphamide 300 mg) | NA |
Overall Survival (OS)
OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method. (NCT00478218)
Timeframe: up to 5 years
| Intervention | months (Median) |
|---|
| LCD (Cyclophosphamide 300 mg/m^2) | NA |
| LCD (Cyclophosphamide 300 mg) | NA |
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels" (NCT00478218)
Timeframe: Duration of Treatment (up to 5 years)
| Intervention | participants (Number) |
|---|
| LCD (Cyclophosphamide 300 mg/m^2) | 28 |
| LCD (Cyclophosphamide 300 mg) | 16 |
Duration of Response (DOR)
Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method. (NCT00478218)
Timeframe: up to 5 years
| Intervention | months (Median) |
|---|
| LCD (Cyclophosphamide 300 mg/m^2) | 26.1 |
| LCD (Cyclophosphamide 300 mg) | NA |
Number of Patients With Donor Derived Cells in Skin
Number of patients who had donor skin chimerism - donor cells in the patient's epidermis (a state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease). (NCT00478244)
Timeframe: Day 90 Post Transplant
| Intervention | participants (Number) |
|---|
| Evaluable Patients | 6 |
Number of Patients With Platelet Engraftment
Number of patients with a platelet count >5 x 10^10 cells/liter for 3 consecutive measurements. (NCT00478244)
Timeframe: Day 180 Post Transplant
| Intervention | participants (Number) |
|---|
| Evaluable Patients | 5 |
Overall Survival
Survival is defined as the number of patients that were alive post transplant. (NCT00478244)
Timeframe: 1 year and 2 years Post Transplant
| Intervention | participants (Number) |
|---|
| 1 Year Post Transplant | 2 Years Post Transplant |
|---|
| Evaluable Patients | 5 | 5 |
Number of Patients With >70% Donor Chimerism
Number of patients with donor chimerism - percentage of donor cells in the patient via the peripheral blood or bone marrow. (NCT00478244)
Timeframe: Days 21, 100, 180, 365 and 730 Post Transplant
| Intervention | participants (Number) |
|---|
| Day 21 | Day 100 | Day 180 | Day 365 | Day 730 |
|---|
| Evaluable Patients | 6 | 5 | 5 | 5 | 5 |
Number of Patients With Acute Graft-Versus-Host Disease (GVHD)
Number of patients with GVHD. Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00478244)
Timeframe: Day 100 Post Transplant
| Intervention | participants (Number) |
|---|
| Evaluable Patients | 1 |
Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD)
Number of patients with cGVHD; a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00478244)
Timeframe: Day 365 Post Transplant
| Intervention | participants (Number) |
|---|
| Evaluable Patients | 0 |
Number of Patients With Detectable Collagen Type VII
Number of patients with epidermolysis bullosa who had collagen type VII. Type VII collagen defects cause recessive dystrophic epidermolysis bullosa (RDEB), a blistering skin disorder often accompanied by epidermal cancers. (NCT00478244)
Timeframe: Day 100 Post Transplant
| Intervention | participants (Number) |
|---|
| Evaluable Patients | 5 |
Number of Patients With Neutrophil Engraftment
Number of patients with an absolute neutrophil count >5 x 10^8 cells/liter for 3 consecutive days. (NCT00478244)
Timeframe: Day 42 Post Transplant
| Intervention | participants (Number) |
|---|
| Evaluable Patients | 6 |
Overall Mortality Rate
Overall mortality is determined by Kaplan-Meier estimation. The overall morality rate is expressed as the percentage of patients who died for any reason, including disease-related death. (NCT00481832)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 56 |
Event-free Survival (EFS)
"Event-free survival (EFS) as determined for participants who receive both planned transplants, for a minimum of 3 years.~Events are defined as disease progression/relapse and death of all causes." (NCT00481832)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 35 |
Achieving Full Donor Chimerism
Achieving full donor chimerism (donor T cells >95%): Blood was sent for donor cell percentage measured by short tandem repeat (STR) at post-transplant Day 30; Day 60; Day 90; Day 120; Day 180; Day 270; and Day 360. Full donor chimerism is defined as donor CD3+ cells > 95%. (NCT00481832)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 10 |
Relapse Rate
Relapse rate (disease recurrence) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 27 |
Overall Survival (OS)
Overall Survival (OS) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 57 |
Incidence of Chemotherapy-associated Pneumonitis
Interstitial pneumonitis (IP) is a risk associated with high-dose carmustine (BCNU) or other chemotherapy drugs used for transplantation. IP is diagnosed by 1) a decrease of >25% in DLCO compared with pre-transplant PFT DLCO values or 2) a drop of 7% or more in oxygen saturation after exertion. (NCT00481832)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 16 |
Incidence of Chronic Graft Versus Host Disease (GvHD)
The development of GvHD in vaccinated patients of any grade at 6 months. (NCT00481832)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 3 |
Incidence of Acute Graft Versus Host Disease (GvHD)
The development of GvHD in vaccinated patients of any grade and at 6 months. (NCT00481832)
Timeframe: 6 Months
| Intervention | Participants (Count of Participants) |
|---|
| T & B Cell Mobilization Auto & Allo HCT | 3 |
Incidence of Chronic Graft vs Host Disease (GvHD)
The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD. (NCT00482053)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL | 0 |
Overall Survival (OS)
To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant. (NCT00482053)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL | 2 |
Event-free Survival (EFS) Per Protocol
Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death. (NCT00482053)
Timeframe: 48 months
| Intervention | months (Median) |
|---|
| Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL | 48 |
Number of Patients Who Completed All Planned Therapy
The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients. (NCT00482391)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB | 45 |
Number of Patients Who Were Evaluated for Toxicity
Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0. (NCT00482391)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Dose-dense Adjuvant/ Neoadjuvant Chemotherapy Regimen | 95 |
Response Rate (Complete and Partial Response)
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT00482911)
Timeframe: 2 years
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| Cohort 1-lenalidomide & Cyclophosphamide | 0 | 0 |
,| Cohort 2-sunitinib & Cyclophosphamide | 0 | 0 |
Toxicity
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00482911)
Timeframe: 16 months
| Intervention | Participants (Number) |
|---|
| Cohort 1-lenalidomide & Cyclophosphamide | 3 |
| Cohort 2-sunitinib & Cyclophosphamide | 8 |
Donor Chimerism at 30 Days
Number of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells. (NCT00489281)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Whole blood72092236 | Whole blood72092237 | T cells72092236 | T cells72092237 |
|---|
| 95-100% | 5-94% | 0-4% | Unknown or not measured |
|---|
| Transplant - 200 cGy | 12 |
| Transplant - 400 cGy | 8 |
| Transplant - 200 cGy | 15 |
| Transplant - 400 cGy | 3 |
| Transplant - 200 cGy | 1 |
| Transplant - 400 cGy | 1 |
| Transplant - 200 cGy | 4 |
| Transplant - 400 cGy | 4 |
| Transplant - 200 cGy | 18 |
| Transplant - 200 cGy | 5 |
| Transplant - 400 cGy | 0 |
| Transplant - 200 cGy | 2 |
Donor Chimerism at 1 Year
Number of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells. (NCT00489281)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Whole blood72092237 | Whole blood72092236 | T cells72092237 | T cells72092236 |
|---|
| 95-100% | Unknown or not measured | 5-94% | 0-4% |
|---|
| Transplant - 200 cGy | 6 |
| Transplant - 400 cGy | 9 |
| Transplant - 200 cGy | 9 |
| Transplant - 400 cGy | 3 |
| Transplant - 200 cGy | 1 |
| Transplant - 400 cGy | 1 |
| Transplant - 200 cGy | 7 |
| Transplant - 400 cGy | 10 |
| Transplant - 400 cGy | 2 |
| Transplant - 200 cGy | 0 |
| Transplant - 400 cGy | 0 |
| Transplant - 200 cGy | 13 |
Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT)
Molecular residual disease (MRD) is defined as detection in blood samples by the ClonoSEQ test of the (11;14) (q13;q32) gene translocation. It is considered positive if a tumor-specific VDJ sequence is detected in the peripheral blood cells by Ig-HTS at a frequency of greater or equal to 1 molecule per 10,000 input leukocyte equivalents of DNA within 1 year post-autologous stem cell transplant (ASCT). The outcome will be reported as number and percent of participants that maintain MRD-negative status (ie, 1-year freedom from MRD). This outcome is reported as a number without dispersion. (NCT00490529)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| CpG-MCL Vaccine | 41 |
Detection of Tumor-specific CD8-positve Memory T-cells Before and After Vaccination
Anti-tumor T-cell immune responses were evaluated by an in vitro evocative test on their peripheral blood mononuclear cell (PBMCs) before and after vaccination, as assessed by measurement of intracellular cytokines and/or intracellular perforin/granzyme in CD8+ T-cells, and/or CD137 induction on CD4+ T-cells. PBMCs were co-cultured with CpG-activated autologous MCL tumor cells and evaluated for tumor-specific immune responses as measured by CD137 expression on their T cells. The outcome is reported as the number of participants for whom tumor-specific memory CD8 cells were detected at baseline and after vaccination and transplant (numbers without dispersion). (NCT00490529)
Timeframe: Baseline and after vaccination and transplant, approximately 5 years
| Intervention | Participants (Count of Participants) |
|---|
| At Baseline | After Transplant |
|---|
| CpG-MCL Vaccine | 31 | 14 |
Overall Survival (OS)
Overall survival (OS) rate is reported as number and percentage of participants remaining alive the date of transplant through each year, up to 5 years (reported as a number without dispersion). (NCT00490529)
Timeframe: After 1, 2, 3, 4, and 5 years
| Intervention | Participants (Count of Participants) |
|---|
| OS after 1 year | OS after 2 year | OS after 3 year | OS after 4 year | OS after 5 year |
|---|
| CpG-MCL Vaccine | 42 | 33 | 27 | 19 | 13 |
Detection of Tumor-specific CD4-positve T-cells Before and After Vaccination
Anti-tumor T-cell immune responses were evaluated by an in vitro evocative test on their peripheral blood mononuclear cell (PBMCs) before and after vaccination, as assessed by measurement of intracellular cytokines and/or intracellular perforin/granzyme in CD8+ T-cells, and/or CD137 induction on CD4+ T-cells. PBMCs were co-cultured with CpG-activated autologous MCL tumor cells and evaluated for tumor-specific immune responses as measured by CD137 expression on their T cells. The outcome is reported as the number of participants for whom tumor-specific memory CD4 cells were detected at baseline and after transplant (numbers without dispersion). (NCT00490529)
Timeframe: Baseline and after vaccination and transplant, approximately 5 years
| Intervention | Participants (Count of Participants) |
|---|
| At Baseline | After Transplant |
|---|
| CpG-MCL Vaccine | 20 | 14 |
Time-to-progression (TTP)
Time-to-progression (TTP) is measured from the time of autologous stem cell transplantation (ASCT) until the cancer progresses or relapses. Progression is assessed based on CT imaging per the Cheson Criteria (2008). Progression per the Cheson Criteria is defined as having occurred when the sum of tumor lesion dimensions is ≥ 150% of the baseline value. The outcome is reported as the median with 95% confidence interval, as determined by Kaplan-Meier analysis and log-rank test. (NCT00490529)
Timeframe: 7.7 years
| Intervention | years (Median) |
|---|
| CpG-MCL Vaccine | 6.9 |
Maximum Tolerated Dose of High-dose Cyclophosphamide as Determined by Number of Participants Who Tolerated Each Dose of Cyclophosphamide
(NCT00492921)
Timeframe: Day 28
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide 50 mg/kg | 4 |
| Cyclophosphamide 100 mg/kg | 4 |
| Cyclophosphamide 150 mg/kg | 2 |
GVHD Response Rate
Percentage of patients whose GVHD (as defined by Przepiorka criteria) responded to cyclophosphamide (complete response). Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). (NCT00492921)
Timeframe: Day 28
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide 50 mg/kg | 1 |
| Cyclophosphamide 100 mg/kg | 0 |
| Cyclophosphamide 150 mg/kg | 1 |
Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.
OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. (NCT00493649)
Timeframe: 2 years
| Intervention | probability of overall survival (Number) |
|---|
| TOP2A-amplified Group | 0.995 |
| TOP2A-nonamplified Group | 0.988 |
DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.
DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up. (NCT00493649)
Timeframe: 2 years
| Intervention | probability of disease-free survival (Number) |
|---|
| cMYC-amplified Group | 0.968 |
| cMYC-nonamplified Group | 0.981 |
Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.
DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up. (NCT00493649)
Timeframe: 2 years
| Intervention | probability of disease-free survival (Number) |
|---|
| TOP2A-amplified Group | 0.978 |
| TOP2A-nonamplified Group | 0.979 |
OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. (NCT00493649)
Timeframe: 2 years
| Intervention | probability of overall survival (Number) |
|---|
| cMYC-amplified Group | 0.990 |
| cMYC-nonamplified Group | 0.991 |
Number and Frequency of Participants by TOP2A Status by Study Treatment
To evaluate the effectiveness of TC and TAC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer (NCT00493870)
Timeframe: 10 years (from baseline to end of study participation)
| Intervention | Participants (Count of Participants) |
|---|
| Amplification | Deletion | Normal |
|---|
| TAC Arm | 14 | 128 | 489 |
,| TC Arm | 14 | 131 | 479 |
3-year DFS-DCIS, OS and RFI Among Per-protocol Patients.
To compare disease-free survival-ductal carcinoma in situ (DFS-DCIS),overall survival (OS) and recurrence free interval (RFI) of TC with TAC among per protocol patients. (NCT00493870)
Timeframe: 3 years from randomization into study
| Intervention | percentage of participants (Number) |
|---|
| 3-year DFS-DCIS | 3-year OS | 3-year RFI |
|---|
| TAC Arm | 93.0 | 96.8 | 94.5 |
,| TC Arm | 91.1 | 96.8 | 92.1 |
3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients
The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among per-protocol patients. Per-protocol only includes those patients who were randomized and received treatment as outlined in the protocol. (NCT00493870)
Timeframe: 3 years from randomization into study
| Intervention | percentage of participants (Number) |
|---|
| TC Arm | 91.3 |
| TAC Arm | 93.2 |
3-year DFS Stratified by TOP2A Among TAC Arm
To evaluate DFS among TAC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer. (NCT00493870)
Timeframe: 3 years from randomization into study
| Intervention | percentage of participants (Number) |
|---|
| Amplification | 100 |
| Deletion | 90.9 |
| Normal | 93.2 |
3-year DFS Stratified by TOP2A Among TC Arm
To evaluate DFS among TC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer. (NCT00493870)
Timeframe: 3 years from randomization into study
| Intervention | percentage of participants (Number) |
|---|
| Amplification | 85.1 |
| Deletion | 82.8 |
| Normal | 93.8 |
3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients
The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among analyzed ITT patients. ITT patients are all patients who were randomized, whether or not they followed protocol. IDFS, defined as the time from the date of randomization to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free. (NCT00493870)
Timeframe: 3 years from randomization into study
| Intervention | percentage of participants (Number) |
|---|
| TC Arm | 91.1 |
| TAC Arm | 93.2 |
3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients
To compare disease-free survival-ductal carcinoma in situ (DFS-DCIS),overall survival (OS) and recurrence free interval (RFI) of TC with TAC. DFS-DCIS, defined as the time from the date of randomization to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant recurrence, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free. (NCT00493870)
Timeframe: 3 years from randomization into study
| Intervention | percentage of participants (Number) |
|---|
| 3-year DFS-DCIS | 3-year OS | 3-year RFI |
|---|
| TAC Arm | 93.0 | 96.8 | 94.5 |
,| TC Arm | 90.9 | 96.8 | 91.9 |
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33
HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA. (NCT00494780)
Timeframe: Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)
| Intervention | participants (Number) |
|---|
| Visit 1, n=29, 29 | Visit 28, n=18, 21 | Visit 33, n=16, 16 |
|---|
| 1000 mg Ofatumumab + CHOP | 0 | 0 | 0 |
,| 500 mg Ofatumumab + CHOP | 0 | 0 | 0 |
Progression-Free Survival (PFS)
PFS is defined as the time from randomization until progression or death. (NCT00494780)
Timeframe: Followed up to 5 years
| Intervention | months (Median) |
|---|
| 500 mg Ofatumumab + CHOP | 27.6 |
| 1000 mg Ofatumumab + CHOP | NA |
Time to New Anti-follicular Lymphoma (FL) Therapy
Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed. (NCT00494780)
Timeframe: Followed up to 5 years
| Intervention | months (Median) |
|---|
| 500 mg Ofatumumab + CHOP | 47.2 |
| 1000 mg Ofatumumab + CHOP | NA |
Vss at the Sixth Infusion (Week 15, Visit 22)
Vss is defined as the volume of distribution at steady state of ofatumumab. (NCT00494780)
Timeframe: Week 15 (Visit 22)
| Intervention | Liters (Geometric Mean) |
|---|
| 500 mg Ofatumumab + CHOP | 5.15 |
| 1000 mg Ofatumumab + CHOP | 5.32 |
AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)
AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. (NCT00494780)
Timeframe: Week 15 (Visit 22)
| Intervention | Milligrams * hours/liter (mg.h/L) (Geometric Mean) |
|---|
| AUC(0-inf), n=20, 28 | AUC(0-504), n=24, 28 |
|---|
| 1000 mg Ofatumumab + CHOP | 399676 | 168866 |
,| 500 mg Ofatumumab + CHOP | 177133 | 79500 |
Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)
Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). (NCT00494780)
Timeframe: Week 15 (Visit 22)
| Intervention | milligrams per liter (mg/L) (Geometric Mean) |
|---|
| Cmax | Ctrough |
|---|
| 1000 mg Ofatumumab + CHOP | 497 | 188 |
,| 500 mg Ofatumumab + CHOP | 232 | 78.5 |
Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)
Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. (NCT00494780)
Timeframe: Week 15 (Visit 22)
| Intervention | hours (Geometric Mean) |
|---|
| 500 mg Ofatumumab + CHOP | 652 |
| 1000 mg Ofatumumab + CHOP | 644 |
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)
Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions). (NCT00494780)
Timeframe: Maximum of 23 months after the start of treatment
| Intervention | participants (Number) |
|---|
| Responder, CR | Responder, CRu | Responder, PR | Non-Responder, SD | Non-Responder, PD |
|---|
| 1000 mg Ofatumumab + CHOP | 9 | 7 | 13 | 0 | 0 |
,| 500 mg Ofatumumab + CHOP | 6 | 10 | 10 | 2 | 1 |
Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)
The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment. (NCT00494780)
Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)
| Intervention | Percent change in cell counts (Median) |
|---|
| CD19+ | CD20+ |
|---|
| 1000 mg Ofatumumab + CHOP | 307.9 | 307.9 |
,| 500 mg Ofatumumab + CHOP | 154.1 | 154.1 |
Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section. (NCT00494780)
Timeframe: Up to 22 months after study start
| Intervention | participants (Number) |
|---|
| 500 mg Ofatumumab + CHOP | 29 |
| 1000 mg Ofatumumab + CHOP | 29 |
Duration of Response
The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. (NCT00494780)
Timeframe: Followed up to 5 years
| Intervention | months (Median) |
|---|
| 500 mg Ofatumumab + CHOP | 21.0 |
| 1000 mg Ofatumumab + CHOP | 25.0 |
CL After the Sixth Infusion (Week 15, Visit 22)
CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time. (NCT00494780)
Timeframe: Week 15 (Visit 22)
| Intervention | Milliliters per hour (mL/h) (Geometric Mean) |
|---|
| 500 mg Ofatumumab + CHOP | 6.29 |
| 1000 mg Ofatumumab + CHOP | 5.92 |
Number of Participants With Complete Remission (CR) at Visit 26
Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease. (NCT00494780)
Timeframe: Maximum of 23 months after the start of treatment
| Intervention | participants (Number) |
|---|
| 500 mg Ofatumumab + CHOP | 6 |
| 1000 mg Ofatumumab + CHOP | 9 |
3-Year Progression-Free Survival
Progression-free survival (PFS) was defined as time from initiation of therapy to progression of disease or death, whichever occurred first. The Kaplan-Meier method was used to estimate PFS. (NCT00496873)
Timeframe: PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year
| Intervention | percentage of participants (Number) |
|---|
| Cytoxan + Rituxan + Nipent | 73 |
Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy
Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy. (NCT00496873)
Timeframe: 9 cycles of 21 days, up to 7 months
| Intervention | participants (Number) |
|---|
| Cytoxan + Rituxan + Nipent | 72 |
Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999
Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease. (NCT00496873)
Timeframe: Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months
| Intervention | Percentage of Participants (Number) |
|---|
| CR/CRu | Overall response |
|---|
| Cytoxan + Rituxan + Nipent | 86.8 | 91.6 |
Number of Patients With Pathological Complete Response
"Assessed by the institutional pathologist.~Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs~Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs~Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis~Grade 4: no or few modifications of the tumor appearance" (NCT00499083)
Timeframe: At definitive surgery.
| Intervention | participants (Number) |
|---|
| Vaccine | 2 |
Correlation Between Myeloid Derived Suppressor Cell (MDSC) Levels and Pathologic Complete Response (pCR) and Non-Responders
The investigators hypothesized that patients with favorable responses, i.e. pCR, are more likely to have significantly lower levels of MDSCs than non-responders. MDSC levels will be measured at baseline and on day 1 of each treatment cycle, cycles 1 through 8. (NCT00499122)
Timeframe: Baseline, Day 1 of Cycles 1 through 8, about 7 months
| Intervention | MDSC/uL (Mean) |
|---|
| Baseline, non-pCR | Baseline, pCR | Cycles 2-4 Day 1, non-pCR | Cycles 2-4 Day 1, pCR | Cycles 5-8 Day 1, non-pCR | Cycles 5-8 Day 1, pCR |
|---|
| NOV-002 and Chemotherapy | 257.4 | 124.3 | 534.2 | 207.8 | 363.7 | 171.5 |
Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy
The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer. Pathologic complete response (pCR) is defined according to Hankoop et al [41] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery. (NCT00499122)
Timeframe: About 7 months
| Intervention | percentage of tumors (Median) |
|---|
| NOV-002 and Chemotherapy | 39 |
Definition of the Safety Profiles of Protocol Therapy
Definition of the safety profiles of protocol therapy in study participants as shown by the number of study participants experiencing adverse events or other toxicity. (NCT00499122)
Timeframe: Up to 30 days Post-Last Dose of Protocol Therapy, About 7 months
| Intervention | participants (Number) |
|---|
| NOV-002 and Chemotherapy | 41 |
Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours
Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present. (NCT00499603)
Timeframe: 48 hours after start of treatment
| Intervention | participants (Number) |
|---|
| Paclitaxel + FEC | 27 |
| Paclitaxel + RAD001 + FEC | 22 |
Participant Responses Per Treatment Arm at 12 Weeks
Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound. (NCT00499603)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| CR | PR | SD | PD |
|---|
| Paclitaxel + FEC | 3 | 5 | 16 | 3 |
,| Paclitaxel + RAD001 + FEC | 0 | 11 | 11 | 1 |
Participant Responses Per Treatment Arm at 24 Weeks
Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound. (NCT00499603)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|
| CR | PR | SD | PD |
|---|
| Paclitaxel + FEC | 4 | 16 | 7 | 0 |
,| Paclitaxel + RAD001 + FEC | 2 | 11 | 7 | 3 |
Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma
Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event. (NCT00499616)
Timeframe: Up to 3 years
| Intervention | Proportion (Number) |
|---|
| Group 2 (Chemotherapy, Surgery) | 0.18 |
| Group 3 (Chemotherapy, Surgery) | 0.11 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 0 |
Second-event-free Survival (E2FS)
E2FS (from time of first event) will be calculated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy. (NCT00499616)
Timeframe: From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death; up to 3 years
| Intervention | Percentage (Number) |
|---|
| All Patients | 57.14 |
Neurologic Symptoms
Percentage of patients with neurologic symptoms will be calculated. Includes patients with paraspinal or intraspinal tumors, including epidural tumors with or without spinal cord compression. Neurologic symptoms include back or extremities neurologic symptoms, motor deficit, abnormal sensation, abnormal bladder/bowel sphincteric function, chronic pain in back or extremities, scoliosis, kyphosis, or clinically relevant/functional abnormality in size or contour of leg or foot. (NCT00499616)
Timeframe: At baseline
| Intervention | percentage of patients (Number) |
|---|
| Group 2 (Chemotherapy, Surgery) | 36.57 |
| Group 3 (Chemotherapy, Surgery) | 35.46 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 27.27 |
Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates
To test the predictive ability of the extent of surgical resection for OS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection. (NCT00499616)
Timeframe: Up to 10 years
| Intervention | percentage of OS rate (Number) |
|---|
| OS w/complete surgical resection | OS w/o complete surgical resection |
|---|
| Group 2 (Chemotherapy, Surgery) | 100.0 | 99.1 |
,| Group 3 (Chemotherapy, Surgery) | 95.4 | 93.5 |
,| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 96.4 | 86.5 |
Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate
To test for the association of the extent of surgical resection (CR vs NCT00499616)
Timeframe: Up to 10 years
| Intervention | Proportion with surgical complications (Number) |
|---|
| CR with complications | CR with no complications |
|---|
| Group 2 (Chemotherapy, Surgery) | .32 | .14 |
,| Group 3 (Chemotherapy, Surgery) | .19 | .13 |
,| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | .18 | .09 |
Definitive Determination of the Prognostic Ability of 1p and 11q
Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q. (NCT00499616)
Timeframe: At baseline
| Intervention | percentage of 3 yr EFS/OS rate (Number) |
|---|
| EFS Eligible & evaluable patients without 1p loss | OS Eligible & evaluable patients without 1p loss | EFS Eligible & evaluable patients with normal 11q | OS Eligible & evaluable patients with normal 11q |
|---|
| Group 2 (Chemotherapy, Surgery) | 87.2 | 99.4 | 87.2 | 99.4 |
Definitive Determination of the Prognostic Ability of 1p and 11q
Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q. (NCT00499616)
Timeframe: At baseline
| Intervention | percentage of 3 yr EFS/OS rate (Number) |
|---|
| EFS Eligible & evaluable patients without 1p loss | OS Eligible & evaluable patients without 1p loss | EFS Eligible & evaluable patients with 1p loss | OS Eligible & evaluable patients with 1p loss | EFS Eligible & evaluable patients with normal 11q | OS Eligible & evaluable patients with normal 11q | EFS Eligible & evaluable patients w/unbalanced 11q | OS Eligible & evaluable patients w/unbalanced 11q |
|---|
| Group 3 (Chemotherapy, Surgery) | 84.6 | 92.8 | 94.7 | 94.7 | 87.5 | 93.7 | 75.0 | 87.5 |
,| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 65.4 | 83.7 | 81.8 | 95.5 | 73.3 | 87.7 | 65.5 | 88.2 |
Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment
Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy. (NCT00499616)
Timeframe: From baseline to up to 10 years
| Intervention | percentage survival (Number) |
|---|
| OS | EFS |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 50.0 | 25.0 |
Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961
Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age (NCT00499616)
Timeframe: Up to 3 years
| Intervention | percentage of 3 yr EFS rate (Number) |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 100.0 |
Image Defined Risk Factor (IDRF)
Percentage of patients with presence of one or more IDRFs will be calculated. IDRFs describe anatomic features which may make surgical resection more difficult. (NCT00499616)
Timeframe: At baseline
| Intervention | percentage of patients (Number) |
|---|
| Group 2 (Chemotherapy, Surgery) | 54.86 |
| Group 3 (Chemotherapy, Surgery) | 60.28 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 56.82 |
Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS)
To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection. (NCT00499616)
Timeframe: Up to 10 years
| Intervention | percentage of 3 yr EFS survival (Number) |
|---|
| EFS w/complete surgical resection | EFS w/o complete surgical resection |
|---|
| Group 2 (Chemotherapy, Surgery) | 95.4 | 82.2 |
,| Group 3 (Chemotherapy, Surgery) | 88.4 | 85.1 |
,| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 78.6 | 69.2 |
Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961
Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age. (NCT00499616)
Timeframe: Up to 3 years
| Intervention | percentage of 3 yr EFS rate (Number) |
|---|
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 66.7 |
Second-Overall Survival
OS (from the time of first event) will be calculated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy. (NCT00499616)
Timeframe: From the time of the first progressive, non-metastatic event; up to 3 years
| Intervention | Percentage (Number) |
|---|
| All Patients | 85.71 |
Overall Survival (OS) Rates
OS time is calculated from date of enrollment until death, or until last contact if the patient is alive. (NCT00499616)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| Group 2 (Chemotherapy, Surgery) | 99.4 |
| Group 3 (Chemotherapy, Surgery) | 93.5 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 88.4 |
Improvement in the Modified Rodnan Skin Score.
The modified Rodnan skin score is the accepted clinical measure of scleroderma skin activity. The investigator will assess the thickening of the skin using the modified Rodnan skin score through simple palpation on 17 different body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness is assessed on a scale of 0-3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0-51; 0 (normal) to 51 (severe thickening in all 17 areas) A 25% improvement in the modified Rodnan Skin score will be considered significant at any time point in the study. Modified Rodnan Skin Score was evaluated at months 0,1,3,6,12 and 24 months. (NCT00501995)
Timeframe: 0 to 24 months
| Intervention | percent improvement from baseline (Mean) |
|---|
| IV Cyclophosphamide (50 mg/kg) | 46.75 |
Change in the HAQ-DI, PGA, FVC and DLCO
The Health Assessment Questionnaire-Disability Index (HAQ-DI) a 48 item questionnaire assessing ability to perform activities of daily living, use of assistive devises and a 6 item analog scale of pain severity from 0 cm (no pain) to 14.3 cm (very severe pain). The lower the HAQ-DI score the less the disability. The physician global assessment (PGA) which is a visual analogue scale from 0 to 100 on which the physician rates the patient's disease severity based on their observations. A score of 0 is no disease activity and 100 is the worst possible disease activity. The Forced Vital Capacity (FVC) measure of lung capacity and Diffusing Capacity (DLCO) measures of oxygen exchange in the alveoli ( pulmonary function testing). The predicted lung volumes were referenced from NHANES/Hanikson et al and for DLCO predicts were from Knudson. Pre and post study percent predicted values were compared. (NCT00501995)
Timeframe: 0-24 months
| Intervention | percentage change (Mean) |
|---|
| HAQ-DI score | PGA | FVC | DLCO |
|---|
| IV Cyclophosphamide (50 mg/kg) | 79 | 71 | 0 | 14 |
Participant Progression Free Survival at 2 Years
Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant. (NCT00505921)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Campath-1H | 15 |
Number of Patients With Combined Complete Response and Very Good Partial Response
"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h" (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|
| V-DR | 21 |
| VDCR | 23 |
| V-DC | 13 |
| VDC-mod | 9 |
Number of Patients With Complete Response Rate + Near Complete Response Rate
"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|
| V-DR | 17 |
| VDCR | 14 |
| V-DC | 10 |
| VDC-mod | 8 |
Number of Patients With Overall Response
"Overall Response includes complete response and partial response.~Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|
| V-DR | 35 |
| VDCR | 35 |
| V-DC | 24 |
| VDC-mod | 17 |
Duration of Response
"Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | days (Median) |
|---|
| V-DR | NA |
| VDCR | NA |
| V-DC | NA |
| VDC-mod | NA |
Time to Disease Progression
"Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | days (Median) |
|---|
| V-DR | NA |
| VDCR | NA |
| V-DC | NA |
| VDC-mod | NA |
Progression-free Survival
"Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas." (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression/death
| Intervention | days (Median) |
|---|
| V-DR | NA |
| VDCR | 631 |
| V-DC | NA |
| VDC-mod | NA |
Probability of 1-year Survival
(NCT00507442)
Timeframe: survival probability at 1 year after randomization
| Intervention | percentage of patients (Number) |
|---|
| V-DR | 100 |
| VDCR | 91.6 |
| V-DC | 100 |
| VDC-mod | 100 |
Overall Survival
Overall survival is defined as time from the date of randomization to the date of death (NCT00507442)
Timeframe: Up to 48 weeks or until death
| Intervention | days (Median) |
|---|
| V-DR | NA |
| VDCR | NA |
| V-DC | NA |
| VDC-mod | NA |
Number of Patients With Adverse Events (AEs)
Evaluate the safety and tolerability of the combination therapy (NCT00507442)
Timeframe: From first dose of study drug through the 30 day post-treatment AE assessment visit
| Intervention | participants (Number) |
|---|
| V-DR | 42 |
| VDCR | 65 |
| V-DC | 33 |
| VDC-mod | 17 |
Time to Response
Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments. (NCT00507442)
Timeframe: Up to 48 weeks or until disease response
| Intervention | days (Median) |
|---|
| V-DR | 49 |
| VDCR | 50 |
| V-DC | 55 |
| VDC-mod | 49 |
Number of Patients With Stringent Complete Response Rate
Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. (NCT00507442)
Timeframe: Up to 48 weeks or until disease progression
| Intervention | participants (Number) |
|---|
| V-DR | 7 |
| VDCR | 6 |
| V-DC | 3 |
| VDC-mod | 5 |
Toxicity
Here is the number of participants with adverse events. For a detailed listing of adverse events, see the adverse event module. (NCT00509288)
Timeframe: 57 months
| Intervention | Participants (Number) |
|---|
| Anti-MART-1 F5 TCR PBL + HD IL-2 | 21 |
| Anti-MART-1 F5 TCR TIL + HD IL-2 | 3 |
Clinical Tumor Regression.
Tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT00509288)
Timeframe: 7/5/07-4/23/09
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response | Progressive Disease | Stable Disease |
|---|
| Anti-MART-1 F5 TCR PBL + HD IL-2 | 0 | 6 | 15 | 0 |
,| Anti-MART-1 F5 TCR TIL + HD IL-2 | 0 | 0 | 2 | 0 |
Clinical Tumor Regression.
Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT00509496)
Timeframe: 20 months
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response | Progressive Disease | Stable Disease |
|---|
| Anti-gp100:154-162 TCR PBL + HD IL-2 | 1 | 2 | 16 | 0 |
,| Anti-gp100:154-162 TCR TIL + HD IL-2 | 0 | 1 | 1 | 0 |
Toxicity
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00509496)
Timeframe: 6 years
| Intervention | Participants (Number) |
|---|
| Anti-gp100:154-162 TCR PBL + HD IL-2 | 19 |
| Anti-gp100:154-162 TCR TIL + HD IL-2 | 2 |
Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy
pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease). (NCT00513292)
Timeframe: Up to 5 years
| Intervention | Percentage (95% confidence Interval) (Number) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | 48.3 |
| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | 46.7 |
Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week
Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)]. (NCT00513292)
Timeframe: Baseline, at 24 week
| Intervention | percent (Median) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | -3 |
| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | -4 |
Breast Conservation
"Surgery was categorized as breast conserving surgery (Partial Mastectomy) or non-conserving surgery (Total Mastectomy or Modified Radical Mastectomy). Reported below is the percentage of patients receiving Partial Mastectomy. This was calculated by dividing the number of patients receiving Partial Mastectomy by the total number of patients undergoing surgery multiplied by 100 (to obtain the percentage)." (NCT00513292)
Timeframe: From time surgery to up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | 37.7 |
| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | 39.1 |
LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week
All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)]. (NCT00513292)
Timeframe: At 12 week
| Intervention | percent (Median) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | 2 |
| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | -3 |
Asymptomatic Decreases From Baseline in LVEF at Week 24
The summary of asymptomatic changed in LVEF. (NCT00513292)
Timeframe: Baseline, at 24 week
| Intervention | Percentage of Participants (Number) |
|---|
| no decrease or decrease < 10%, still above LLN | decrease < 10%, below lower limit of normal (LLN) | decrease 10-15%, still above lower limit of normal | decrease 10-15%, below lower limit of normal (LLN) | decrease > 15%, still above lower limit of normal | decrease > 15%, below lower limit of normal (LLN) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | 83.3 | 0.8 | 7.9 | 2.4 | 1.6 | 4.0 |
,| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | 73.1 | 3.1 | 15.4 | 0.8 | 6.9 | 0.8 |
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
The summary of asymptomatic decrease in LVEF. (NCT00513292)
Timeframe: Baseline, at 12 week
| Intervention | Percentage of participants (Number) |
|---|
| no decrease or decrease < 10%, still above LLN | decrease < 10%, below lower limit of normal (LLN) | decrease 10-15%, still above lower limit of normal | decrease 10-15%, below lower limit of normal (LLN) | decrease > 15%, still above lower limit of norm | decrease > 15%, below lower limit of normal |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | 92.3 | 0.8 | 6.2 | 0 | 0.8 | 0 |
,| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | 82.5 | 0 | 11.7 | 0 | 2.9 | 2.9 |
pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy
Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates. (NCT00513292)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | 56.5 |
| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | 54.2 |
Overall Survival (OS)
OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. (NCT00513292)
Timeframe: From time to registration to death, assessed up to 5 years
| Intervention | months (Median) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | NA |
| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | NA |
Disease-free Survival (DFS)
DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. (NCT00513292)
Timeframe: From time to registration to time of event, assessed up to 5 years
| Intervention | months (Median) |
|---|
| FEC-75 Then Paclitaxel/Trastuzumab | NA |
| Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 | NA |
Uric Acid Levels
Blood was collected and analyzed at a laboratory for serum uric acid levels reported in milligrams(mg)/deciliter(dL). Data is presented for those participants who experienced Grade II to IV aGVHD and those participants who did not experience Grade II to IV aGVHD at pre-transplant and post-transplant. (NCT00513474)
Timeframe: Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6
| Intervention | mg/dL (Mean) |
|---|
| Day -7 | Day -6 | Day -5 | Day -4 | Day -3 | Day -2 | Day -1 | Day 0 | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 |
|---|
| Control Group | 4.157 | 3.419 | 2.967 | 2.579 | 2.358 | 1.867 | 1.71 | 2.163 | 2.671 | 2.778 | 2.805 | 2.758 | 2.579 | 2.653 |
,| Rasburicase Group | 0.1 | 0.075 | 0.086 | 0.1 | 0.067 | 0.081 | 0.438 | 0.938 | 1.624 | 2.076 | 2.271 | 2.548 | 2.595 | 2.705 |
Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD)
"aGVHD severity was determined using International Bone Marrow Transplant Registry (IBMTR) scale stage and grade of the skin, liver and gut. Stage 1: Skin=maculopapular rash <25% of body surface; Liver=Bilirubin 2-3 mg/dL and Gut=500-999 mL diarrhea/day or peristent nausea with histologic evidence of GvHD. Stage 2: Skin=maculopapular rash 25-50% of body surface; Liver=Bilirubin 3.1-6 mg/dL and Gut=1000-1499 mL diarrhea/day. Stage 3: Skin=maculopapular rash >50% of body surface; Liver=Bilirubin 6.1-15 mg/dL and Gut=≥1500 mL diarrhea/day. Stage 4: Skin=generalized erythroderma with bulla formation; Liver=Bilirubin >15 mg/dL and Gut=severe abdominal pain.~Grade 1: Stage 1-2 rash; no liver or gut involvement. Grade II: Stage 3 rash, or stage 1 liver involvement, or stage 1 gut involvement. Grade III: None to stage 3 skin rash with stage 2-3 liver, or stage 2-4 gut involvement. Grade IV: Stage 4 skin rash, or stage 4 liver involvement." (NCT00513474)
Timeframe: Up to 71 months
| Intervention | percentage of participants (Number) |
|---|
| Rasburicase Group | 24 |
| Control Group | 57 |
Number of Participant With Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. (NCT00513474)
Timeframe: Up to 71 months
| Intervention | Participants (Count of Participants) |
|---|
| Rasburicase Group | 21 |
| Control Group | 21 |
Clinical Response
Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT00513604)
Timeframe: every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response | Progression | Stable Disease | Not evaluable - cell product did not grow | Not evaluable-toxicities re:disease/death | Not evaluable - Patient died of sepsis |
|---|
| Cohort 1 - NMA, TIL, Aldesleukin | 1 | 3 | 20 | 0 | 2 | 0 | 0 |
,| Cohort 2 - NMA, CD4+ TIL, Aldesleukin | 3 | 18 | 16 | 0 | 0 | 2 | 0 |
,| Cohort 3 - NMA, Total Body Irradiation | 3 | 7 | 12 | 0 | 1 | 0 | 1 |
,| Cohort 4 - NMA, Young TIL, Aldesleukin | 2 | 10 | 21 | 1 | 0 | 0 | 0 |
,| Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | 3 | 4 | 24 | 4 | 0 | 0 | 0 |
Toxicity
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00513604)
Timeframe: 5 years
| Intervention | Participants (Number) |
|---|
| Cohort 1 - NMA, TIL, Aldesleukin | 24 |
| Cohort 2 - NMA, CD4+ TIL, Aldesleukin | 39 |
| Cohort 3 - NMA, Total Body Irradiation | 23 |
| Cohort 4 - NMA, Young TIL, Aldesleukin | 34 |
| Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | 35 |
Time to Disease Progression
Median time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites. (NCT00513695)
Timeframe: Up to 2 years
| Intervention | days (Median) |
|---|
| Treatment (Neoadjuvant Chemotherapy Before Surgery) | NA |
Relapse Rate
Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk. (NCT00513695)
Timeframe: Up to two years
| Intervention | probability of relapse (Number) |
|---|
| Treatment (Neoadjuvant Chemotherapy Before Surgery) | 0.215 |
Overall Survival
Kaplan-Meier estimate from the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive, assessed at two years. (NCT00513695)
Timeframe: Up to 2 years
| Intervention | survival probability (Number) |
|---|
| Treatment (Neoadjuvant Chemotherapy Before Surgery) | 0.875 |
Number and Percent of Subjects Reporting Adverse Events
See Adverse Events section for more details. (NCT00513695)
Timeframe: 28 days after the last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Chemotherapy Before Surgery) | 67 |
Microscopic Pathologic CR (pCR) Rate
Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval. (NCT00513695)
Timeframe: At the time of surgery
| Intervention | percent of evaluable participants (Number) |
|---|
| Treatment (Neoadjuvant Chemotherapy Before Surgery) | 27 |
Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab
Time from enrollment to disease progression, death, second malignant neoplasm, or last patient follow-up whichever occurs first. Patients who experience disease progression, death or second malignant neoplasm will be considered to have experienced an event; otherwise the patient will be considered censored at last follow-up. (NCT00516295)
Timeframe: Maximum of 5 years after enrollment
| Intervention | days of event free survival (Median) |
|---|
| Arm I (Feasibility Assessment of VTCB) | 442 |
The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient.
Limiting toxicity defined as Any Grade IV hematological toxicities lasting longer than 7 days, myelosuppression causing delays > 14 days in delivery of therapy, > Grade 3 thromboembolic events, > Grade 3 bleeding events, > Grade 2 hypertension, > Grade 2 proteinuria. (NCT00516295)
Timeframe: First 2 courses (42 days) of therapy
| Intervention | number of toxicities (Number) |
|---|
| Arm I (Feasibility Assessment of VTCB) | 0 |
Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine
Blood samples were drawn to measure cellular response at pretreatment and weeks 3, 7, 11, between weeks 23 and 25, week 33, and every 12 weeks thereafter. Cellular immunity included an assay for gamma interferon-producing T cells and enumeration of NY-ESO-1b-specific T cells, detected by fluorescent labeled human leukocyte antigen (HLA)-A2 tetramers carrying the NY-ESO-1b peptide, expressed as percent positive staining of CD4+ and CD8+ T cells. Data are presented for CD4+ and CD8+ T-cell responses (not mutually exclusive) that were pre-existing at baseline (BL) or presented at any time post-BL. (NCT00518206)
Timeframe: Up to 22 months
| Intervention | participants (Number) |
|---|
| CD4+ T-cell Response at BL and Post-BL | New CD4+ T-cell Response Post-BL | CD8+ T-cell Response at BL and Post-BL | New CD8+ T-cell Response Post-BL | No CD4+ or CD8+ T-cell Response |
|---|
| Cohort 1: NY-ESO-1 ISCOM | 4 | 6 | 12 | 5 | 6 |
,| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | 3 | 7 | 3 | 1 | 3 |
Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine
Blood samples were drawn to measure humoral immunologic response at pretreatment and weeks 3, 7, 11, 33, and every 12 weeks thereafter. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 by enzyme-linked immunosorbent assay (ELISA). Data are presented according to baseline (BL) NY-ESO-1 antibody positivity and the time to seroconversion, if applicable. (NCT00518206)
Timeframe: Up to 22 months
| Intervention | Participants (Count of Participants) |
|---|
| NY-ESO-1 (+) at BL and Post-BL | NY-ESO-1 (-) at BL, converted to (+) Post-BL | NY-ESO-1 (-) at BL and Post-BL |
|---|
| Cohort 1: NY-ESO-1 ISCOM | 7 | 19 | 1 |
,| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | 2 | 8 | 5 |
Number of Subjects With Treatment-emergent Adverse Events
Toxicity was graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity was defined as any treatment-related grade 4 toxicity or any grade 3 toxicity, excluding grade 3 skin necrosis at the site of the delayed-type hypersensitivity reaction, fever, or asymptomatic hyperglycemia that improved to baseline within 3 weeks of onset. (NCT00518206)
Timeframe: Up to 22 months
| Intervention | participants (Number) |
|---|
| Any TEAE | Maximum Grade 3 TEAE | Maximum Grade 4 TEAE | Treatment-related TEAE | Serious TEAE | Death | TEAE Leading to Discontinuation | Dose-limiting Toxicity |
|---|
| Cohort 1: NY-ESO-1 ISCOM | 27 | 4 | 1 | 26 | 5 | 0 | 2 | 0 |
,| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | 19 | 9 | 1 | 19 | 7 | 0 | 1 | 0 |
Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions
NY-ESO-1-specific DTH was measured by intradermal injection with the full-length NY-ESO-1 protein, NY-ESO-1b peptide, and NY-ESO-1 DP4 peptide at pretreatment, week 11, and between week 23 and 25. DTH reactions (eg, local skin irritation) were evaluated 2 days after DTH injections. Data presented are based on injections with the full-length peptide, as these data are considered to be representative of the comprehensive DTH results. (NCT00518206)
Timeframe: Up to 22 months
| Intervention | Participants (Count of Participants) |
|---|
| Reaction at Pretreatment and Week 11 | Reaction at Pretreatment and Week 23 | Reaction at Pretreatment, No Reaction On Study | Reaction at Pretreatment, No On Study DTH Results | No Reaction Pretreatment , Reaction at Week 11 | No Reaction Pretreatment , Reaction at Week 23 | No Reaction Pretreatment or on Study | No Reaction Pretreatment, No On Study DTH Results |
|---|
| Cohort 1: NY-ESO-1 ISCOM | 2 | 1 | 0 | 0 | 6 | 0 | 16 | 0 |
,| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | 3 | 0 | 1 | 1 | 4 | 3 | 6 | 3 |
Overall Participant Response
Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy. (NCT00525603)
Timeframe: Evaluated after 3 courses of 4 week therapy (12 weeks)
| Intervention | Participants (Number) |
|---|
| Complete remission (CR) | Nodular partial remission (nPR) | Partial remission (PR) |
|---|
| CFAR | 44 | 1 | 10 |
Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)
Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma. (NCT00525876)
Timeframe: 100 days post transplant
| Intervention | participants (Number) |
|---|
| Matched Sibling Transplant | 16 |
| Allo MUD & MM | 19 |
Treatment Efficacy as Defined by Complete or Partial Remission
(NCT00526292)
Timeframe: 3 Months following treatment
| Intervention | participants (Number) |
|---|
| Complete Remission | Progression of Disease (POD) |
|---|
| HLA Haploidentical Natural Killer Cell Infusion | 1 | 5 |
Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)
"Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow." (NCT00531453)
Timeframe: all data included in clinical database as of 10 April 2009
| Intervention | percentage of participants (Number) |
|---|
| Three Drug Regimen (VDT) | 76 |
| Four Drug Regimen (VDTC) | 78 |
Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction
"Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow." (NCT00531453)
Timeframe: all data included in clinical database as of 10 April 2009
| Intervention | percentage of participants (Number) |
|---|
| Three Drug Regimen (VDT) | 51 |
| Four Drug Regimen (VDTC) | 44 |
Response Rate (Complete Remission)
Response rates will be reported using descriptive statistics. (NCT00536601)
Timeframe: At 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Acute Leukemia | 5 |
| Hodgkin Lymphoma | 17 |
| Non-Hodgkin Lymphoma | 54 |
| MM/Amyloid | 17 |
| Solid Tumors | 7 |
Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00538031)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Cyclophosphamide Alone) | 1 |
| Arm II (Cyclophosphamide + Celecoxib) | 1 |
Time to Treatment Failure
"Estimated using the product-limit method of Kaplan and Meier. Time to treatment failure is defined as the time from initial treatment to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT00538031)
Timeframe: Up to 3 years
| Intervention | Months (Median) |
|---|
| Arm I (Cyclophosphamide Alone) | 1.84 |
| Arm II (Cyclophosphamide + Celecoxib) | 1.92 |
Overall Survival
Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment to death from any cause. (NCT00538031)
Timeframe: Up to 5 years
| Intervention | Months (Median) |
|---|
| Arm I (Cyclophosphamide Alone) | 9.69 |
| Arm II (Cyclophosphamide + Celecoxib) | 12.55 |
Quality of Life Using the FACT-G Data
"Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.~Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome" (NCT00540644)
Timeframe: baseline and after last cycle (up to 6 cycles)
| Intervention | scores on a scale (Mean) |
|---|
| Physical Well-Being Change from Baseline | Social/Family Well-Being Change from Baseline | Emotional Well-Beling Change from Baseline | Functional Well-Being Change from Baseline | FACT-G Change from Baseline |
|---|
| Extension - Revlimid, Cyclophosphamide, Prednisone | -2.81 | -0.23 | 0.60 | -1.17 | -3.61 |
,| Original Study - Revlimid, Cyclophosphamide, Prednisone | 1.57 | -0.03 | 2.52 | 3.38 | 7.44 |
1) Pathologic Response
Pathologic measurement post-surgery viable primary tumor mass (NCT00542191)
Timeframe: Upon completion therapy after surgery
| Intervention | Participants (Count of Participants) |
|---|
| Single Arm Study; Taxol, XRT, Gemzar and Carbo | 15 |
Two-year Overall Survival
Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented. (NCT00544115)
Timeframe: Up to 2 years post transplant
| Intervention | percentage of survival probability (Number) |
|---|
| Regimen I | 58 |
| Regimen II | 50 |
| Regimen III | 54 |
| Regimen IV | 50 |
| Regimen V | 38 |
| Regimen VI | 50 |
Neutrophil Engraftment - The Days Till ANC Recovery
The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is > 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment. (NCT00544115)
Timeframe: Up to 180 days post transplant
| Intervention | days (Median) |
|---|
| Regimen I | 17 |
| Regimen II | 16 |
| Regimen III | 15 |
| Regimen IV | 14 |
| Regimen V | 18 |
| Regimen VI | 16 |
The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.
(NCT00544167)
Timeframe: 18 Months
| Intervention | percentage of patients (Number) |
|---|
| Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib | 40 |
Percentage of Participants With Positive and Negative Zeta-Chain-Associated Protein Kinase 70 (ZAP-70) Expression
Percentages of participants with positive and negative ZAP-70 expression during the Induction Phase, Maintenance Phase, and Follow-Up were reported. Positive ZAP-70 was defined as ZAP-70 expression by >/=20% of CLL cells. Negative ZAP-70 was defined as ZAP-70 expression by <20% of CLL cells. (NCT00545714)
Timeframe: Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 30, 36
| Intervention | Percentage of Participants (Number) |
|---|
| Post-IP: Positive | Post-IP: Negative | MP (9 Cycles): Positive | MP (9 Cycles): Negative | MP (12 Cycles): Positive | MP (12 Cycles): Negative | MP (15 Cycles): Positive | MP (15 Cycles): Negative | MP (18 Cycles): Positive | MP (18 Cycles): Negative | 6 Months FU: Positive | 6 Months FU: Negative | 12 Months FU: Positive | 12 Months FU: Negative | 18 Months FU: Positive | 18 Months FU: Negative | 24 Months FU: Positive | 24 Months FU: Negative | 30 Months FU: Positive | 30 Months FU: Negative | 36 Months FU: Positive | 36 Months FU: Negative |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 57.3 | 42.7 | 57.5 | 42.5 | 62.1 | 37.9 | 57.1 | 42.9 | 54.9 | 45.1 | 63.6 | 36.4 | 60.0 | 40.0 | 100.0 | 0.0 | 59.3 | 40.7 | 100.0 | 0.0 | 57.1 | 42.9 |
Percentage of Participants With Immunoglobulin Heavy Locus (IgH) Rearrangement
Percentages of participants with IgH rearrangement during the Induction Phase, Maintenance Phase, and Follow-Up were reported. (NCT00545714)
Timeframe: Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 30, 36
| Intervention | Percentage of Participants (Number) |
|---|
| Post-IP | MP (9 Cycles) | MP (12 Cycles) | MP (15 Cycles) | MP (18 Cycles) | 6 Months FU | 12 Months FU | 18 Months FU | 24 Months FU | 30 Months FU | 36 Months FU |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 36.2 | 37.1 | 20.0 | 29.4 | 33.3 | 100.0 | 37.9 | 50.0 | 33.3 | 0.0 | 45.8 |
Percentage of Participants With Genetic Abnormalities
Percentages of participants with genetic abnormalities (deletion 6q, deletion 11q22-q23, deletion p53, trisomy 12, and deletion 13q14) in the course of the disease during the Induction Phase and Maintenance Phase were reported. (NCT00545714)
Timeframe: Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Post-IP: Deletion 6q | Post-IP: Deletion 11q22-q23 | Post-IP: Deletion p53 | Post-IP: Trisomy 12 | Post-IP: Deletion 13q14 | MP (9C): Deletion 6q | MP (9C): Deletion 11q22-q23 | MP (9C): Deletion p53 | MP (9C): Trisomy 12 | MP (9C): Deletion 13q14 | MP (12C): Deletion 6q | MP (12C): Deletion 11q22-q23 | MP (12C): Deletion p53 | MP (12C): Trisomy 12 (n= 33) | MP (12C): Deletion 13q14 | MP (15C): Deletion 6q | MP (15C): Deletion 11q22-q23 | MP (15C): Deletion p53 | MP (15C): Trisomy 12 | MP (15C): Deletion 13q14 | MP (18C): Deletion 6q | MP (18C): Deletion 11q22-q23 | MP (18C): Deletion p53 | MP (18C): Trisomy 12 | MP (18C): Deletion 13q14 |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 3.6 | 26.2 | 4.8 | 15.5 | 50.0 | 4.3 | 25.5 | 0.0 | 17.0 | 55.3 | 3.0 | 21.2 | 0.0 | 21.2 | 51.5 | 4.5 | 31.8 | 0.0 | 18.2 | 59.1 | 3.4 | 23.7 | 0.0 | 18.6 | 49.2 |
Percentage of Participants With Cluster of Differentiation (CD) 38 Cells >/=30% in Peripheral Blood
Percentages of participants with CD38 expression by >/=30% of CLL cells during the Induction Phase, Maintenance Phase, and Follow-Up were reported. (NCT00545714)
Timeframe: Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 30, 36
| Intervention | Percentage of Participants (Number) |
|---|
| Post-IP | MP (9 Cycles) | MP (12 Cycles) | MP (15 Cycles) | MP (18 Cycles) | 6 Months FU | 12 Months FU | 18 Months FU | 24 Months FU | 30 Months FU | 36 Months FU |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 47.6 | 44.4 | 45.5 | 47.6 | 47.4 | 66.7 | 45.7 | 100.0 | 41.4 | 50.0 | 35.5 |
Percentage of Participants With Clinical Response of CR or PR as Assessed by Multiparameter Flow Cytometry
CR was defined as no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood <4000/mm^3; normalization of peripheral blood parameters: Neut >1500/mm^3, Plt >100,000/mm^3, Hb >11 g/dL without transfusion; normocellular BM with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. PR was defined as decrease >50% in Lymph in peripheral blood; reduction in ADPs >50% in total sum of up to 6 ADPs or in the baseline ADP of largest diameter (LD), no new ADP or enlargement of a prior ADP; >50% decrease in VSM; Neut >1500/mm^3 or >50% increase from Baseline; Plt >100,000/mm^3 or >50% increase from Baseline; Hb >11.0 g/dL or >50% increase from Baseline value without transfusion. Participants who met all CR criteria but had persistent anemia or thrombocytopenia were considered as PR. (NCT00545714)
Timeframe: Post-Induction Phase (IP): at 6 months; during Maintenance Phase (MP): at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up (FU): at Follow-Up Months 6, 12, 18, 24, 30, 36
| Intervention | Percentage of Participants (Number) |
|---|
| Post-IP: CR | Post-IP: PR | MP (9 Cycles): CR | MP (9 Cycles): PR | MP (12 Cycles): CR | MP (12 Cycles): PR | MP (15 Cycles): CR | MP (15 Cycles): PR | MP (18 Cycles): CR | MP (18 Cycles): PR | 6 Months FU: CR | 6 Months FU: PR | 12 Months FU: CR | 12 Months FU: PR | 18 Months FU: CR | 18 Months FU: PR | 24 Months FU: CR | 24 Months FU: PR | 30 Months FU: CR | 30 Months FU: PR | 36 Months FU: CR | 36 Months FU: PR |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 75.0 | 13.1 | 89.4 | 6.4 | 87.9 | 6.1 | 90.9 | 4.5 | 88.1 | 8.5 | 83.3 | 0.0 | 94.4 | 0.0 | 100.0 | 0.0 | 93.1 | 0.0 | 100.0 | 0.0 | 100.0 | 0.0 |
Percentage of Participants With Clinical Response of CR or PR Among Participants With Negative Minimal Residual Disease (MRD) as Assessed by Multiparameter Flow Cytometry
CR: no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood <4000/mm^3; normalization of peripheral blood parameters: Neut >1500/mm^3, Plt >100,000/mm^3, Hb >11 g/dL without transfusion; normocellular BM with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. PR: decrease >50% in Lymph in peripheral blood; reduction in ADPs >50% in total sum of up to 6 ADPs or in the baseline ADP of largest diameter (LD), no new ADP or enlargement of a prior ADP; >50% decrease in VSM; Neut >1500/mm^3 or >50% increase from Baseline; Plt >100,000/mm^3 or >50% increase from Baseline; Hb >11.0 g/dL or >50% increase from Baseline value without transfusion. Participants who met all CR criteria but had persistent anemia or thrombocytopenia were considered as PR. Negative MRD: Lymph <0.01% of all white blood cells (WBCs) in blood or BM after two consecutive measurements. Analysis performed only in blood during the Maintenance Phase and Follow-Up. (NCT00545714)
Timeframe: Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 36
| Intervention | Percentage of Participants (Number) |
|---|
| Post-IP: Blood MRD Negative | Post-IP: BM MRD Negative | MP (9 Cycles): Blood MRD Negative | MP (12 Cycles): Blood MRD Negative | MP (15 Cycles): Blood MRD Negative | MP (18 Cycles): Blood MRD Negative | 6 Months FU: Blood MRD Negative | 12 Months FU: Blood MRD Negative | 18 Months FU: Blood MRD Negative | 24 Months FU: Blood MRD Negative | 36 Months FU: Blood MRD Negative |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
Progression-Free Survival (PFS)
PFS was defined as time from start of study treatment to PD or death, whichever occurred first. For other participants, last follow-up available was taken as last control. If participant did not complete study, date of last visit available was considered. PFS was estimated using KM methodology. PD was defined as new ADPs (1.5 cm), HSM, RS, or other infiltrated organs; >/=50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase >/=50% in peripheral blood with B Lymph >/=5000/mm^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb <10 g/dL, >/=50% decrease in basal Plt count, or count <100,000/mm^3 at >/=3 months post-treatment was defined as PD if BM biopsy confirmed infiltration of clonal CLL cells. (NCT00545714)
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)
| Intervention | Years (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 6.96 |
Percentage of Participants With PD or Death
PD was defined as new ADPs (1.5 centimeters [cm]), hepato-/splenomegaly (HSM), Richter syndrome (RS), or other infiltrated organs; greater than or equal to (>/=) 50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase >/=50% in peripheral blood with B Lymph >/=5000/mm^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb <10 g/dL, >/=50% decrease in basal Plt count, or count <100,000/mm^3 at >/=3 months post-treatment was defined as PD if BM biopsy confirmed infiltration of clonal CLL cells. (NCT00545714)
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 39.29 |
Percentage of Participants With CR With Incomplete Bone Marrow Recovery (CRi)
Participants with CRi were those who met all CR criteria (including BM examinations) but had persistent anemia, thrombocytopenia, or neutropenia apparently unrelated to chronic lymphocytic leukemia (CLL) but related to drug toxicity. CR: no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood <4000/mm^3; normalization of peripheral blood parameters: Neut >1500/mm^3, Plt >100,000/mm^3, Hb >11 g/dL without transfusion; normocellular BM with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. (NCT00545714)
Timeframe: Baseline up to progressive disease (PD) or death due to any cause, whichever occurred first (up to 92 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 7.1 |
Percentage of Participants Who Died
(NCT00545714)
Timeframe: Baseline up to death due to any cause (up to 92 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 23.2 |
Overall Survival (OS)
OS was defined as time from treatment start to death of the participant. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered. OS was estimated using Kaplan-Meier (KM) methodology. (NCT00545714)
Timeframe: Baseline up to death due to any cause (up to 92 months)
| Intervention | Years (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 7.51 |
Duration of Response (DOR)
DOR: time from CR/PR to MRD/PD. PD: new ADP (1.5 cm), HSM, RS, other infiltrated organs or >/=50% increase size in those with PR; blood Lymph increase >/=50% with B Lymph >/=5000/mm^3; cytopenia due to CLL. Progression of (nonautoimmune) cytopenia: 2-g/dL decrease basal Hb, Hb <10 g/dL, >/=50% decrease basal Plt or <100,000/mm^3 at >/=3 months post-treatment was PD if clonal CLL cell infiltration on BM biopsy. CR: no ADP/VSM in PE; no general Sx; blood Lymph <4000/mm^3; Neut >1500/mm^3; Plt >100,000/mm^3; Hb >11 g/dL (no transfusion); normocellular BM with <30% Lymph; BM aspirate/biopsy with no lymphoid nodule infiltration. PR: >50% decrease blood Lymph; >50% decrease in total sum up to 6 ADPs or baseline ADP of LD, no new/enlargement of prior ADP; >50% decrease VSM; Neut >1500/mm^3 or >50% increase; Plt >100,000/mm^3 or >50% increase; Hb >11.0 g/dL or >50% increase (no transfusion). All CR criteria but persistent anemia or thrombocytopenia was PR. MRD: Lymph >0.01% of blood/BM WBCs. (NCT00545714)
Timeframe: From first CR or PR up to detectable MRD or disease occurrence/PD, whichever occurred first (up to 92 months)
| Intervention | Years (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | NA |
Treatment-Free Survival (TFS)
TFS was defined time from start of study treatment until participant received new chemotherapy/immunotherapy because of PD and to reduce the disease with palliative or curative intent. PD was defined as new ADPs (1.5 cm), HSM, RS, or other infiltrated organs; >/=50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase >/=50% in peripheral blood with B Lymph >/=5000/mm^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb <10 g/dL, >/=50% decrease in basal Plt count, or count <100,000/mm^3 at >/=3 months post-treatment was defined as PD if BM biopsy confirmed infiltration of clonal CLL cells. (NCT00545714)
Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)
| Intervention | Years (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 4.13 |
Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen
CR was defined as no adenopathies (ADPs) and visceromegalies (VSMs) in physical examination (PE); no general symptoms (Sx); lymphocytes (Lymph) in peripheral blood less than (<) 4000 per cubic millimeter (mm^3); normalization of peripheral blood parameters: neutrophils (Neut) greater than (>) 1500/mm^3, platelets (Plt) >100,000/mm^3, hemoglobin (Hb) >11 grams per deciliter (g/dL) without transfusion; normocellular bone marrow (BM) with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. (NCT00545714)
Timeframe: Month 9
| Intervention | Percentage of Participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 95.2 |
Decrease in Interstitial Fluid Pressure.
To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure (NCT00546156)
Timeframe: 3 years
| Intervention | mm Hg (Median) |
|---|
| HR+, HER2- | 0.70 |
| Triple Negative Breast Cancer Cohort | 1.04 |
Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.
Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery (NCT00546156)
Timeframe: 3 Years
| Intervention | percentage of participants (Number) |
|---|
| HR+, HER2- | 8 |
| Triple Negative Breast Cancer Cohort | 44 |
Maximum Tolerated Dose (MTD) of Mitoxantrone
The MTD is defined as the highest dose studied for which the incidence of DLT is less than 33%. In the phase I portion of the trial, cohorts of 3-6 pts will receive pentostatin, cyclophosphamide and rituximab along with one of three potential dose levels of mitoxantrone. The following dose escalation scheme will be followed: If none of the initial three pts in a cohort experience a dose-limiting toxicity (grade 4 infection, or grade ≥ 3 non-hematologic toxicity that persists for 7 days or more) then a new cohort of three pts will be treated at the next higher dose level. If one of the three pts in a cohort experiences DLT, then up to three additional pts will be treated at the same dose level. If two or more pts in a cohort experience DLT, then the maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. The previous dose level will be considered as the MTD. (NCT00546377)
Timeframe: 2 years
| Intervention | mg/m2 (Number) |
|---|
| Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone | 10 |
Overall Response
Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but at a minimum of prior to cycle four and following completion of all therapy. Patients who are removed from study early will have response status determined at time of removal from study. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response. (NCT00546377)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Stable Disease | Progression of Disease |
|---|
| Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone | 11 | 23 | 4 | 5 |
Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Number of surviving patients at Day 180 post-transplant divided by number of patients undergone transplantation. (NCT00547196)
Timeframe: From transplant up to Day 180 post-transplant
| Intervention | percentage of surviving patients (Number) |
|---|
| Regimen I (FTBI, Cyclophosphamide, Fludarabine) | 60 |
| Regimen III (TBI, Cyclophosphamide, Fludarabine) | 100 |
| Regimen IV (Fludarabine, Melphalan) | 50 |
Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Number of surviving patients at Day 100 post-transplant divided by number of patients undergone transplantation. (NCT00547196)
Timeframe: From transplant to Day 100 post-transplant
| Intervention | percentage of surviving patients (Number) |
|---|
| Regimen I (FTBI, Cyclophosphamide, Fludarabine) | 100 |
| Regimen III (TBI, Cyclophosphamide, Fludarabine) | 100 |
| Regimen IV (Fludarabine, Melphalan) | 100 |
Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
"The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2).~The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (<0.01%). Past experience indicate that few patients will fall into these unknown categories." (NCT00549848)
Timeframe: 3.5 years after the last enrollment up to 12.5 years
| Intervention | Percentage of participants (Number) |
|---|
| PEG 3500 Units/m^2 | 91.6 |
| PEG 2500 Units/m^2 | 90.7 |
Probability of CNS Relapse
To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
| Intervention | Percentage of participants (Number) |
|---|
| TOTXVI PEG 3500 | 0.8 |
| TOTXVI PEG 2500 | 1.8 |
| TOTXVI Not Randomized | 2.7 |
| All Eligible Patients in TOTXV | 5.7 |
Probability of Event-free Survival
"To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111).~EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission." (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
| Intervention | Percentage of participants (Number) |
|---|
| TOTXVI PEG 3500 | 92.4 |
| TOTXVI PEG 2500 | 91.1 |
| TOTXVI Not Randomized | 86.3 |
| All Eligible Patients in TOTXV | 87.1 |
Probability of Overall Survival
To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
| Intervention | Percentage of participants (Number) |
|---|
| TOTXVI PEG 3500 | 97.5 |
| TOTXVI PEG 2500 | 95.6 |
| TOTVI Not Randomized | 90.8 |
| All Eligible Patients in TOTXV | 93.5 |
Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XV
| Intervention | Participants (Count of Participants) |
|---|
| TOTXVI PEG 3500 | 22 |
| TOTXVI PEG 2500 | 26 |
| TOTXVI Not Randomized | 31 |
| All Eligible Patients in TOTXV | 55 |
Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: End of remission induction; day 42 in Total XVI and day 46 in Total XV
| Intervention | Participants (Count of Participants) |
|---|
| TOTXVI PEG 3500 | 7 |
| TOTXVI PEG 2500 | 12 |
| TOTXVI Not Randomized | 20 |
| All Eligible Patients in TOTXV | 44 |
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy
"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks." (NCT00550771)
Timeframe: During the 8 courses of chemotherapy
| Intervention | Participants (Number) |
|---|
| Level 1 Cardiotoxicity | Level 2 Cardiotoxicity | Inability to Administer Trastuzumab |
|---|
| Doxorubicin Based Regimen | 0 | 3 | 0 |
,| Pegylated Liposomal Doxorubicin (PLD) Based Regimen | 1 | 1 | 0 |
Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy
"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks." (NCT00550771)
Timeframe: During 1 year of trastuzumab therapy
| Intervention | Participants (Number) |
|---|
| Level 1 Cardiotoxicity | Level 2 Cardiotoxicity | Inability to Administer Trastuzumab |
|---|
| Doxorubicin Based Regimen | 0 | 10 | 8 |
,| Pegylated Liposomal Doxorubicin (PLD) Based Regimen | 1 | 4 | 4 |
Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year
"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks." (NCT00550771)
Timeframe: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment
| Intervention | Participants (Number) |
|---|
| Pegylated Liposomal Doxorubicin (PLD) Based Regimen | 5 |
| Doxorubicin Based Regimen | 11 |
Cumulative Incidence of NK Cell Reconstitution
Cumulative incidence of successful reconstitution to donor level is calculated. (NCT00553202)
Timeframe: At 5 years from HSCT date
| Intervention | Percentage of participants (Number) |
|---|
| Treatment (Chemotherapy and Allogeneic SCT) | 48.1 |
Overall Survival (OS)
OS - Time from HSCT until death (NCT00553202)
Timeframe: At 5 years from HSCT date
| Intervention | Percentage of participants (Number) |
|---|
| Treatment (Chemotherapy and Allogeneic SCT) | 45.9 |
Event-free Survival (EFS)
The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause. (NCT00554788)
Timeframe: At 1 year
| Intervention | Probability (Number) |
|---|
| Stage 2/3 Patients | 88 |
| Stage 4a Patients | 83 |
| Stage 4b Patients | 28 |
Response Rate to the Induction Phase of the Regimen
This study used a modified version of the international criteria for neuroblastoma response. The response rate to the induction phase of the regimen and a corresponding 95% confidence interval will be calculated for all strata combined. (NCT00554788)
Timeframe: 12 weeks after participant received the first dose
| Intervention | percentage of participants (Number) |
|---|
| All Eligible Patients | 68 |
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Grade 3 and higher toxicities will be descriptively summarized. (NCT00554788)
Timeframe: Up to 30 days after completion of study treatment
| Intervention | percentage of participants (Number) |
|---|
| Abdominal pain | Acute kidney injury | Alanine aminotransferase increased | Anemia | Anorexia | Apnea | Aspartate aminotransferase increased | Catheter related infection | Dehydration | Depressed level of consciousness | Diarrhea | Encephalopathy | Enterocolitis | Enterocolitis infectious | Esophagitis | Febrile neutropenia | Fever | GGT increased | Gastric hemorrhage | Hearing impaired | Hypermagnesemia | Hypertension | Hypoalbuminemia | Hypocalcemia | Hypoglycemia | Hypokalemia | Hypomagnesemia | Hyponatremia | Hypophosphatemia | Hypotension | Hypoxia | Infections and infestations - Other, specify | Lower gastrointestinal hemorrhage | Lung infection | Lymphocyte count decreased | Mucositis oral | Nausea | Nervous system disorders - Other, specify | Neutrophil count decreased | Oral pain | Pain | Peripheral motor neuropathy | Pharyngeal mucositis | Platelet count decreased | Pneumonitis | Rectal pain | Seizure | Sepsis | Sinus tachycardia | Sinusitis | Skin infection | Upper respiratory infection | Vomiting | White blood cell decreased |
|---|
| Stage 2/3 Patients | 0 | 0 | 0 | 0 | 11.1 | 0 | 0 | 11.1 | 0 | 0 | 5.6 | 0 | 0 | 5.6 | 0 | 55.6 | 11.1 | 0 | 0 | 11.1 | 5.6 | 0 | 0 | 5.6 | 0 | 27.8 | 5.6 | 11.1 | 22.2 | 0 | 0 | 27.8 | 0 | 16.7 | 0 | 5.6 | 16.7 | 0 | 5.6 | 0 | 0 | 5.6 | 0 | 5.6 | 5.6 | 0 | 0 | 0 | 0 | 11.1 | 0 | 11.1 | 11.1 | 5.6 |
,| Stage 4a Patients | 5.6 | 5.6 | 16.7 | 0 | 33.3 | 0 | 11.1 | 0 | 11.1 | 0 | 16.7 | 0 | 5.6 | 11.1 | 5.6 | 55.6 | 0 | 5.6 | 5.6 | 5.6 | 0 | 5.6 | 0 | 5.6 | 0 | 16.7 | 5.6 | 0 | 0 | 11.1 | 2.6 | 33.3 | 5.6 | 0 | 0 | 27.8 | 11.1 | 0 | 0 | 5.6 | 5.6 | 0 | 5.6 | 0 | 0 | 5.6 | 0 | 11.1 | 5.6 | 0 | 5.6 | 5.6 | 22.2 | 0 |
,| Stage 4b Patients | 0 | 0 | 5.3 | 5.3 | 15.8 | 5.3 | 5.3 | 0 | 10.5 | 5.3 | 0 | 5.3 | 0 | 5.3 | 0 | 36.8 | 5.3 | 0 | 0 | 5.3 | 0 | 0 | 5.3 | 10.5 | 5.3 | 21.1 | 10.5 | 15.8 | 10.5 | 0 | 0 | 21.1 | 0 | 0 | 5.3 | 5.3 | 5.3 | 10.5 | 5.3 | 0 | 0 | 0 | 0 | 5.3 | 0 | 0 | 5.3 | 0 | 0 | 0 | 5.3 | 0 | 5.3 | 5.3 |
Overall Survival
Count of surviving participants at 1 year (NCT00555048)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Alemtuzumab | 1 |
Disease Relapse
Count of participants with disease relapse at 1 year (NCT00555048)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Alemtuzumab | 0 |
Extensive Chronic GVHD
Count of participants with extensive chronic GVHD at 1 year (NCT00555048)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Alemtuzumab | 1 |
Grades III-IV Acute Graft-vs-host Disease (GVHD)
(NCT00555048)
Timeframe: Up to 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Alemtuzumab | 0 |
Graft Failure
Count of participants with graft failure at day 100 (NCT00555048)
Timeframe: Up to day 100
| Intervention | Participants (Count of Participants) |
|---|
| Alemtuzumab | 0 |
Life-threatening Infection
(NCT00555048)
Timeframe: Up to 180 days
| Intervention | Participants (Count of Participants) |
|---|
| Alemtuzumab | 0 |
Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction
| Intervention | Activity percentage (Mean) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 69.00 |
Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction
| Intervention | qPCR fold expression ratio (Mean) |
|---|
| Arm A (Standard Risk MLL-G) | 1.25 |
| Arm B (IR/HR MLL-R Chemotherapy) | 7.85 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 5.83 |
Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)
| Intervention | Proportion of cells that are viable (Mean) |
|---|
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.69 |
Percent Probability for Event-free Survival (EFS) for Patients on Arm A
EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
| Intervention | percentage probability (Number) |
|---|
| Arm A (Standard Risk MLL-G) | 86.67 |
Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)
| Intervention | qPCR fold expression ratio (Mean) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 5.73 |
Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
| Intervention | percentage probability (Number) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 35.82 |
Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.
| Intervention | percent probability (Number) |
|---|
| Arm B (IR/HR MLL-R Chemotherapy) | 38.89 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 35.82 |
Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)
| Intervention | percent probability (Number) |
|---|
| Arm A (MRD Negative) | 86.05 |
| Arm A (MRD Positive) | 87.5 |
| Arm B (MRD Negative) | 47.37 |
| Arm B (MRD Positive) | 22.73 |
| Arm C (MRD Negative) | 51.85 |
| Arm C (MRD Positive) | 27.03 |
Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction
| Intervention | Proportion of cells that are viable (Median) |
|---|
| Arm A (Standard Risk MLL-G) | 0.75 |
| Arm B (IR/HR MLL-R Chemotherapy) | 0.48 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.47 |
Complete Response Rate
Complete response rate is defined as the percentage of patients who achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) at the end of induction therapy. (NCT00558519)
Timeframe: Up to 8 years post-registration
| Intervention | percentage of patients (Number) |
|---|
| Treatment (Pediatric Regimen) | 89 |
Overall Survival
OS was defined from registration to death resulting from any cause. (NCT00558519)
Timeframe: Up to 8 years post-registration
| Intervention | months (Median) |
|---|
| Treatment (Pediatric Regimen) | NA |
Event-free Survival
EFS was defined as time from registration in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease. (NCT00558519)
Timeframe: Up to 8 years post-registration
| Intervention | months (Median) |
|---|
| Treatment (Pediatric Regimen) | 78.1 |
Disease-free Survival
DFS was defined as time from bone marrow response in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease. (NCT00558519)
Timeframe: Up to 8 years post-registration
| Intervention | months (Median) |
|---|
| Treatment (Pediatric Regimen) | 81.7 |
Progression
"Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first.~Below is reported Progression-free Survival: event is relapse or progression, or death." (NCT00559104)
Timeframe: Assessed at date of progression post-transplant
| Intervention | participants (Number) |
|---|
| Irradiation in Conditioning | 22 |
| Carmustine in Conditioning | 1 |
Mortality
Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first. (NCT00559104)
Timeframe: Assessed at date of death post-transplant
| Intervention | participants (Number) |
|---|
| Irradiation in Conditioning | 19 |
| Carmustine in Conditioning | 1 |
Percentage of Participants With Disease-Free Interval
Disease-free interval was defined as the time from enrollment until recurrence of tumor or death from any cause, and was estimated using the Kaplan-Meier method. The percentage of participants without events at Months 12, 24, 36, 48, and 60 is presented. (NCT00559845)
Timeframe: Months 12, 24, 36, 48, and 60
| Intervention | percentage of participants (Number) |
|---|
| 12 Months | 24 Months | 36 Months | 48 Months | 60 Months |
|---|
| Bevacizumab | 92.2 | 84.3 | 80.4 | 76.5 | 76.5 |
Percentage of Participants With Breast-Conserving Surgery
Rate of breast conversing surgery is defined as percentage of participants who achieved breast conversing surgery out of the ITT population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant treatment. (NCT00559845)
Timeframe: Up to 7.5 years
| Intervention | percentage of participants (Number) |
|---|
| Breast-conserving | Breast-conserving Plus Axillary Dissection |
|---|
| Bevacizumab | 17.0 | 13.2 |
Objective Response Rate
Objective response rate was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions. (NCT00559845)
Timeframe: Up to 7.5 years
| Intervention | percentage of participants (Number) |
|---|
| Bevacizumab | 59.0 |
Percentage of Participants Experiencing Any Adverse Event
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT00559845)
Timeframe: Up to 7.5 years
| Intervention | percentage of participants (Number) |
|---|
| Bevacizumab | 100.0 |
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. (NCT00559845)
Timeframe: Up to 7.5 years
| Intervention | percentage of participants (Number) |
|---|
| Bevacizumab | 23.2 |
Number of Participants Assessed for Safety and Tolerability as Assessed by NCI CTCAE v3.0
Participant toxicity will be evaluated by using NCI CTCAE v3.0 (NCT00562640)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 3 |
| WT1 Specific T Cells 2 x 10^7/m2 | 3 |
| WT1 Specific T Cells 5 x 10^7/m2 | 4 |
| WT1 Specific T Cells 1 x 10^8/m2 | 2 |
Mean Overall Survival
(NCT00562640)
Timeframe: Up to 3 years
| Intervention | months (Mean) |
|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 11.7 |
| WT1 Specific T Cells 2 x 10^7/m2 | 5.7 |
| WT1 Specific T Cells 5 x 10^7/m2 | 22.5 |
| WT1 Specific T Cells 1 x 10^8/m2 | 21.4 |
Best Response
(NCT00562640)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Stable Disease | Progressive Disease | Not Evaluable |
|---|
| WT1 Specific T Cells 1 x 10^8/m2 | 0 | 2 | 0 |
,| WT1 Specific T Cells 2 x 10^7/m2 | 0 | 3 | 0 |
,| WT1 Specific T Cells 5 x 10^6/m2 | 0 | 3 | 0 |
,| WT1 Specific T Cells 5 x 10^7/m2 | 1 | 3 | 0 |
Total Number of Dose Limiting Toxicities/DLT's
(NCT00562640)
Timeframe: 2 years
| Intervention | Dose Limiting Toxicities/DLTs (Number) |
|---|
| WT1 Specific T Cells 5 x 10^6/m2 | 0 |
| WT1 Specific T Cells 2 x 10^7/m2 | 0 |
| WT1 Specific T Cells 5 x 10^7/m2 | 0 |
| WT1 Specific T Cells 1 x 10^8/m2 | 0 |
Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings
Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment. (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment
| Intervention | participants (Number) |
|---|
| QTcB: BL normal, post-BL normal | QTcB: BL normal, post-BL Grade 1 | QTcB: BL normal, post-BL Grade 2 | QTcF: BL normal, post-BL normal | QTcF: BL normal, post-BL Grade 1 |
|---|
| Rituximab + Inotuzumab Ozogamicin | 4 | 2 | 3 | 6 | 3 |
Percentage of Participants With Objective Response (OR)
OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia). (NCT00562965)
Timeframe: Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Inotuzumab Ozogamicin | 93.3 |
| Control Regimens R-CVP + R-FND | 64.3 |
Overall Survival Probability at Months 6, 12 and 24
Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function. (NCT00562965)
Timeframe: Baseline up to Month 6, 12, 24
| Intervention | percent chance of survival (Number) |
|---|
| Overall Survival: Baseline up to Month 6 | Overall Survival: Baseline up to Month 12 | Overall Survival: Baseline up to Month 24 |
|---|
| Control Regimens R-CVP + R-FND | 92.3 | 83.9 | 67.1 |
,| Rituximab + Inotuzumab Ozogamicin | 100.0 | 86.7 | 86.7 |
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, and body weight>=10% increase or decrease of body weight in kilogram (kg). (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
| Intervention | participants (Number) |
|---|
| Baseline up to 42 days post-treatment | Disease follow up |
|---|
| Control Regimens R-CVP + R-FND | 1 | 2 |
,| Rituximab + Inotuzumab Ozogamicin | 0 | 3 |
Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings
Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase [greater than{>}5*upper limit of normal {ULN}, calcium [less than {<}1.75 millimole per liter {mmol/L}, creatinine [>3*ULN], glucose [>13.9 mmol/L], phosphorous [<0.6 mmol/L], potassium [<3 mmol/L], aspartate transaminase [>5.0*ULN], total bilirubin [>3*ULN]), Coagulation (international normalized ratio [>2*ULN]), Hematology (hemoglobin [<80 grams/Liter], lymphocytes [<0.5*10^9/L], absolute neutrophil count [<1*10^9/L], platelet count [<50*10^9/L], WBC [<2.0*10^9/L]). (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
| Intervention | participants (Number) |
|---|
| Baseline up to 42 days post-treatment | Disease follow up |
|---|
| Control Regimens R-CVP + R-FND | 12 | 7 |
,| Rituximab + Inotuzumab Ozogamicin | 11 | 8 |
Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)
AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment
| Intervention | participants (Number) |
|---|
| Rituximab + Inotuzumab Ozogamicin | 12 |
| Control Regimens R-CVP + R-FND | 13 |
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44. (NCT00562965)
Timeframe: Baseline until disease progression or death or up to 1 year after last dose of study drug
| Intervention | months (Median) |
|---|
| Rituximab + Inotuzumab Ozogamicin | NA |
| Control Regimens R-CVP + R-FND | 16.4 |
Number of Patients With Grade 3 or Greater Toxicity
The NCI Common Toxicity Criteria (CTC Version 2.0) are used. The patients, whose toxicities are grade 3 or greater and at possibly related to the study treatment, are reported. (NCT00562978)
Timeframe: From initial of study treatment to Day 100 post-ASCT
| Intervention | Participants (Count of Participants) |
|---|
| Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg | 5 |
| Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg | 37 |
Number of Patients Achieving Complete Response (CR)
Complete response is defined as complete disappearance of all measureable evidence of non-evaluable disease. No new lesions. No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. All measureable, evaluable and non-evaluable lesions and sites must be assessed using the same techniques as baseline. (NCT00562978)
Timeframe: Assessed up to 5 years post-ASCT
| Intervention | Participants (Count of Participants) |
|---|
| Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg | 4 |
| Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg | 32 |
5-Year Disease-free Survival (Phase II)
Disease-free survival (DFS) was defined as time from peripheral stem cell infusion to relapse or death. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Disease-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.] (NCT00562978)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to first observation of relapse or death due to any cause, whichever comes first, assessed up to 5 years
| Intervention | percentage of probability (Number) |
|---|
| Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg | 60 |
| Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg | 62 |
5-Year Overall Survival (Phase II)
Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.] (NCT00562978)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years
| Intervention | percentage of probability (Number) |
|---|
| Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg | 60 |
| Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg | 86 |
Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels." (NCT00564889)
Timeframe: Duration on study (up to 3 years)
| Intervention | participants (Number) |
|---|
| Len/Cyc/Dex | 21 |
Number of Participants With Severe Adverse Events
Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. (NCT00564889)
Timeframe: Duration of study (up to 3 years)
| Intervention | participants (Number) |
|---|
| Len/Cyc/Dex | 26 |
Number of Patients With Organ Response
"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%." (NCT00564889)
Timeframe: Duration of study (up to 3 years)
| Intervention | participants (Number) |
|---|
| Len/Cyc/Dex | 11 |
Overall Survival (OS)
Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. (NCT00564889)
Timeframe: Duration of study (up to 3 years)
| Intervention | months (Median) |
|---|
| Len/Cyc/Dex | 37.8 |
Progression Free Survival (PFS)
Progression free survival (PFS) was defined as the time from registration to hematologic progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. (NCT00564889)
Timeframe: Duration of study (up to 3 years)
| Intervention | months (Median) |
|---|
| Len/Cyc/Dex | 28.3 |
Event-free Survival (EFS)
To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis. (NCT00566696)
Timeframe: one year post-transplant
| Intervention | Percentage of participants (Number) |
|---|
| High-Risk Hematologic Malignancies | 54.8 |
Disease-Free Survival (DFS)
Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis. (NCT00566696)
Timeframe: One year post-transplant
| Intervention | Percentage of participants (Number) |
|---|
| High-Risk Hematologic Malignancies | 70.1 |
To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants.
The rate of Overall Grade III-IV Acute AVHD will be report as the proportion of patients who have Grade III-IV Acute GVHD to the total patients with transplant. The rate of Chronic GVHD will be report as the proportion of patients who have Chronic GVHD to the total patients with transplant. The Severity of Chronic GVHD will be reported using CTCAE grading system, as a number. (NCT00566696)
Timeframe: five years post-transplant
| Intervention | Percentage of participants (Number) |
|---|
| Rate of Overall Grade III-IV Acute AVHD | Rate of limited grade Chronic GVHD |
|---|
| High-Risk Hematologic Malignancies | 22.58 | 9.68 |
Overall Survival (OS)
Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis. (NCT00566696)
Timeframe: one year post-transplant
| Intervention | Percentage of participants (Number) |
|---|
| High-Risk Hematologic Malignancies | 71.0 |
To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment.
The Cumulative Incidence of Relapse will be reported as the proportion of number of relapses since transplant to the total number of patients at risk at five years post-transplant. (NCT00566696)
Timeframe: five years post-transplant
| Intervention | Percentage of participants (Number) |
|---|
| The Cumulative Incidence of Relapse at five year p | Estimate±SE |
|---|
| High-Risk Hematologic Malignancies | 30.0 | 8.6 |
Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532 (NCT00567567)
Timeframe: Day 1 of each course
| Intervention | Micromolar (Median) |
|---|
| Single HST (CEM) | 1.00 |
| Tandem HST (CEM), Randomly Assigned | 1.36 |
| Not Assigned | 1.26 |
Duration of Greater Than or Equal to Grade 3 Neutropenia
A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism. (NCT00567567)
Timeframe: Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days
| Intervention | Days (Median) |
|---|
| Single HST (CEM) | 7 |
| Tandem HST (CEM), Randomly Assigned | 7 |
| Not Assigned | 7 |
Incidence Rate of Local Recurrence
Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation. (NCT00567567)
Timeframe: Up to 3 years
| Intervention | Percentage 3-year cumulative incidence (Number) |
|---|
| Single HST (CEM) | 15.7 |
OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology
Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated. (NCT00567567)
Timeframe: Up to 3 years
| Intervention | percent probability (Number) |
|---|
| Single HST (CEM) | 81.0 |
Intraspinal Extension
Percentage of patients with primary tumors with intraspinal extension. (NCT00567567)
Timeframe: Up to 5 years
| Intervention | Percentage of patients (Number) |
|---|
| Single HST (CEM) | 8.25 |
| Tandem HST (CEM), Randomly Assigned | 9.66 |
| Not Assigned | 7.78 |
Event-free Survival Rate
Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM) (NCT00567567)
Timeframe: Three years, from time of randomization
| Intervention | percent probability (Number) |
|---|
| Single HST (CEM) | 48.8 |
| Tandem HST (CEM), Randomly Assigned | 61.8 |
Proportion of Patients With a Polymorphism
A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population. (NCT00567567)
Timeframe: Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days
| Intervention | Proportion of patients (Number) |
|---|
| Single HST (CEM) | 0.96 |
| Tandem HST (CEM), Randomly Assigned | 0.96 |
| Not Assigned | 0.97 |
Topotecan Systemic Clearance
Median topotecan systemic clearance for courses 1 and 2. (NCT00567567)
Timeframe: Day 1 of courses 1-2
| Intervention | L/h/m2 (Median) |
|---|
| Single HST (CEM) | 28.1 |
| Tandem HST (CEM), Randomly Assigned | 28.1 |
| Not Assigned | 28.5 |
EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).
Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated. (NCT00567567)
Timeframe: Up to 3 years
| Intervention | percent probability (Number) |
|---|
| Single HST (CEM) | 73.1 |
Duration of Greater Than or Equal to Grade 3 Thrombocytopenia
A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism. (NCT00567567)
Timeframe: Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days
| Intervention | Days (Median) |
|---|
| Single HST (CEM) | 4 |
| Tandem HST (CEM), Randomly Assigned | 4 |
| Not Assigned | 4 |
Surgical Response
Percentage of patients who achieved a surgical complete resection (NCT00567567)
Timeframe: Up to 3 years
| Intervention | Percentage of patients (Number) |
|---|
| Single HST (CEM) | 83.98 |
| Tandem HST (CEM), Randomly Assigned | 84.09 |
| Not Assigned | 58.89 |
Response After Induction Therapy
Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion (primary or metastases) with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive. (NCT00567567)
Timeframe: Study enrollment to the end of induction therapy
| Intervention | Proportion participants that responded (Number) |
|---|
| Single HST (CEM) | 0.54 |
| Tandem HST (CEM), Randomly Assigned | 0.48 |
| Not Assigned | 0.35 |
Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells
A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed. (NCT00567567)
Timeframe: Up to 6 months after completion of assigned myeloablation therapy
| Intervention | cells/mm^3 (Median) |
|---|
| CD3 | CD4 | CD8 |
|---|
| Single HST (CEM) | 200 | 73 | 104 |
,| Tandem HST (CEM), Randomly Assigned | 255.5 | 81 | 151 |
Type of Surgical or Radiotherapy Complication
The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea. (NCT00567567)
Timeframe: Up to 3 years
| Intervention | Percentage of patients (Number) |
|---|
| Single HST (CEM) | 13.11 |
| Tandem HST (CEM), Randomly Assigned | 12.50 |
| Not Assigned | 11.85 |
Progression-free Survival at 1 Year
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00574496)
Timeframe: 1 year
| Intervention | proportion of progression-free pts (Number) |
|---|
| High-Risk or Relapsed Hodgkin Lymphoma | 33.3 |
Disease Relapse or Progression as Measured by CT Scan or PET
(NCT00574496)
Timeframe: 3 years
| Intervention | months (Median) |
|---|
| High-Risk or Relapsed Hodgkin Lymphoma | 34.3 |
Overall Survival
(NCT00574496)
Timeframe: up to 8 years
| Intervention | months (Median) |
|---|
| High-Risk or Relapsed Hodgkin Lymphoma | 70.3 |
Pathological Complete Response (CR) Rate in Patients With Her2/Neu Positive Locally Advanced Breast Cancer.
Pathological Complete Response (CR) defined as absence of invasive cancer at surgery (NCT00574587)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Stratum A (HER2-positive) | 13 |
| Stratum B: Triple Negative | 4 |
| Stratum C: ER-Positive, HER2-negative | 0 |
Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab
Dose limiting toxicity in cycle 1 (NCT00574587)
Timeframe: 3 weeks
| Intervention | mg (Number) |
|---|
| Stratum A: VR-Paclitaxel-Trastuzumab | 300 |
| Stratum B: VR-Paclitaxel-Trastuzumab | 300 |
Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)
Toxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale. (NCT00576979)
Timeframe: 30 days post transplant
| Intervention | cGy (Number) |
|---|
| All Levels: 1200 cGy to 2000cGy | 2000 |
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
| Intervention | Platelet transfusions (Mean) |
|---|
| Usual Care | 3.1 |
| Exercise | 2.3 |
Total Number of Days of Stem Cell Collection (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
| Intervention | Days (Mean) |
|---|
| Usual Care | 5.3 |
| Exercise | 4.0 |
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 30 weeks
| Intervention | g/dl (Mean) |
|---|
| Baseline | Before Transplantation | During Transplanation | At Discharge |
|---|
| Exercise | 11.7 | 12.0 | 10.8 | 11.0 |
,| Usual Care | 11.5 | 12.0 | 10.8 | 10.9 |
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
| Intervention | Platelet Transfusions (Mean) |
|---|
| Usual Care | 3.6 |
| Exercise | 2.0 |
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 15 weeks
| Intervention | g/dl (Mean) |
|---|
| Baseline | Before transplantation | During transplantation | At discharge |
|---|
| Exercise | 11.6 | 11.0 | 10.4 | 10.6 |
,| Usual Care | 12.1 | 10.8 | 10.1 | 10.6 |
Total Number of Days of Stem Cell Collection (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
| Intervention | Days (Mean) |
|---|
| Usual Care | 4.9 |
| Exercise | 4.5 |
Number of Stem Cell Collection Attempts (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
| Intervention | Stem Cell Collection Attempts (Mean) |
|---|
| Usual Care | 1.4 |
| Exercise | 1.1 |
Number of Stem Cell Collection Attempts (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
| Intervention | Stem Cell Collection Attempts (Mean) |
|---|
| Usual Care | 1.3 |
| Exercise | 1.1 |
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 15 weeks
| Intervention | RBC Transfusions (Mean) |
|---|
| Usual Care | 2.3 |
| Exercise | 1.8 |
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 30 weeks
| Intervention | RBC Transfusions (Mean) |
|---|
| Usual Care | 1.8 |
| Exercise | 1.0 |
MPA Trough Concentration
To explore genetic determinants of MPA bioavailability and trough concentration by showing average MPA levels at cycle 1 (Day 10-14) and cycle 2 (Day 1). (NCT00577122)
Timeframe: Cycle 1 (Day 10-14) and Cycle 2 (Day 1)
| Intervention | ng/mL (Mean) |
|---|
| Cycle 1, Day 10-14 | Cycle 2, Day 1 |
|---|
| Cohort I: MPA-Alone | 14.5 | 52.6 |
,| Cohort II: MPA+IdoCM | 42.1 | 66.4 |
MPA Trough Level > 50 ng/mL When Have Clinical Benefit
To explore the relationship between MPA trough level and clinical benefit. This is done by seeing if the MPA concentrations remained > 50 ng/mL after initial dose escalation for those patients who showed clinical benefit. The number shows how many of the patients who showed clinical benefit had MPA concentrations > 50 ng/mL. (NCT00577122)
Timeframe: baseline through end of treatment
| Intervention | participants (Number) |
|---|
| Cohort I: MPA-Alone | 1 |
| Cohort II: MPA+IdoCM | 1 |
Clinical Benefit Rate (CR + PR + SD > 6 Months).
To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval. (NCT00577122)
Timeframe: baseline through end of study, up to 3 years
| Intervention | Percent of Participants (Number) |
|---|
| Cohort I: MPA-Alone | 7.1 |
| Cohort 2: MPA+IdoCM | 6.3 |
Overall Survival
Overall Survival is measured from the first day of chemotherapy until death from any cause. (NCT00577629)
Timeframe: 10 years
| Intervention | percentage of participants (Number) |
|---|
| Experimental: Induction + Consolidation + Bexxar | 82 |
1 Year Progression-free Survival Rate
Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy. (NCT00577629)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Experimental: Induction + Consolidation + Bexxar | 0.74 |
Disease-free Survival
Disease-free survival is measured from the date of CR or CRu to date of relapse or death (NCT00577629)
Timeframe: 10 years
| Intervention | months (Mean) |
|---|
| Experimental: Induction + Consolidation + Bexxar | 54.10 |
Overall Response
"Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.~CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PR =~>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.~No increase should be observed in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.~Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.~No new sites of disease should be observed." (NCT00577629)
Timeframe: up to 1 year
| Intervention | percentage of participants (Number) |
|---|
| Experimental: Induction + Consolidation + Bexxar | 92 |
Secondary Malignancies
The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes. (NCT00577629)
Timeframe: 10 years
| Intervention | Participants (Count of Participants) |
|---|
| Myelodysplastic Syndrome (MDS) | Acute Myeloid Leukemia (AML) | Pancreatic Cancer | Hodgkins Lymphoma | Melanoma | Renal Cell Carcinoma |
|---|
| Experimental: Induction + Consolidation + Bexxar | 3 | 1 | 1 | 1 | 1 | 1 |
Number of Participants With Overall Survival (10 Years) by Treatment
Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. (NCT00577993)
Timeframe: 10 Years
| Intervention | Participants (Count of Participants) |
|---|
| Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 59 |
| Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 58 |
Number of Participants With Progression Free Survival (10 Years) by Treatment
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00577993)
Timeframe: 10 years
| Intervention | Participants (Count of Participants) |
|---|
| Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | 59 |
| Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 58 |
Number of Participants With Stable Mixed Hematopoietic Chimerism (HC)
Stable hematopoietic chimerism is defined as having 50-99 percent of donor cells. (NCT00578292)
Timeframe: 1 year post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow or Stem Cell Infusion | 3 |
Number of Participants With Infectious Complications
All AEs and SAEs (including infections) will be collected for evaluation of infectious complications. (NCT00578292)
Timeframe: up to day 100
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow or Stem Cell Infusion | 7 |
Number of Participants With CHRONIC GVHD
Chronic GVHD is graded by NIH guidelines for chronic GVHD, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3 where 0 means no chronic GVHD, and 3 is the highest stage of chronic GVHD. (NCT00578292)
Timeframe: Assessed monthly from month 3 to month 12
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow or Stem Cell Infusion | 1 |
Immune Reconstitution
Immune reconstitution: defined as absolute lymphocyte count (ALC) >1000x10e3/microL (NCT00578292)
Timeframe: 1 year post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow or Stem Cell Infusion | 8 |
Hematopoietic Reconstitution
Hematopoietic: defined as transfusion independence. (NCT00578292)
Timeframe: 1 year post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow or Stem Cell Infusion | 7 |
Event-free Survival
Event-free survival is calculated from the date of transplant to the date of graft failure, disease recurrence or death from any cause. (NCT00578292)
Timeframe: up to 2 years post transplant
| Intervention | probability of event-free survival (Number) |
|---|
| Bone Marrow or Stem Cell Infusion | 0.7 |
Engraftment Rate After Transplant
Engraftment is defined as an absolute neutrophil count (ANC) >500/microL x 3 days. (NCT00578292)
Timeframe: up to 30 days
| Intervention | proportion of participants (Number) |
|---|
| Bone Marrow or Stem Cell Infusion | 1 |
Number of Participants With Transient Mixed Hematopoietic Chimerism (HC)
Transient mixed hematopoietic chimerism is defined as any mixed chimerism return to 100 percent donor. (NCT00578292)
Timeframe: 1 year post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow or Stem Cell Infusion | 0 |
Number of Participants With Immune Response to Immunization After BMT in Participants With SCD, Hemoglobin SC, or Hemoglobin Sb0/+.
Vaccine response will be measured via a humoral immunity panel evaluating streptococcus pneumonia IgG antibodies (microgram/mL). Panels are obtained pre and 1+ month post vaccination. Standard recommendations define a normal responder as having >4 fold increase in antibody level in 50-70% of the serotypes found in the vaccine. (NCT00578344)
Timeframe: up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic BMT/SCT Transplant | 0 |
Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan.
Assess Number of participants that recovered organ function diagnosed with sickle cell disease (SCD) or sickle hemoglobin variants after undergoing allogeneic SCT/BMT from HLA genotype identical donors. (NCT00578344)
Timeframe: One year
| Intervention | Participants (Count of Participants) |
|---|
| Stable | Progressive |
|---|
| Allogeneic BMT/SCT Transplant | 4 | 2 |
Median Percentage of Treg Cells at 1 Year Post Transplant
The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up. (NCT00578461)
Timeframe: 1 Year
| Intervention | percentage of total CD4+ cells (Median) |
|---|
| Stem Cell Transplant | 4.1 |
Median Percentage of Treg Cells at 1 Year Post Transplant
To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol (NCT00578539)
Timeframe: 1 year
| Intervention | percentage of total CD4+ cells (Median) |
|---|
| Stem Cell Transplant | 6.9 |
Percentage of Participants With Engraftment
To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. (NCT00578643)
Timeframe: 28 days post transplant
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Unrelated Transplant | 100 |
Number of Patients That Have Complete Donor Chimerism After Transplant.
To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. (NCT00578643)
Timeframe: 120 days post transplant
| Intervention | participants (Number) |
|---|
| Allogeneic Unrelated Transplant | 13 |
Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.
Partial response or better (NCT00578864)
Timeframe: 2 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase II Window With Protracted Etoposide | 1 |
| Phase II Window With Bolus Etoposide | 2 |
Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
(NCT00578864)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Phase II Window With Protracted Etoposide | 3 |
| Phase II Window With Bolus Etoposide | 2 |
Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy
the measure is the number of patients who have surgery after two cycles of induction (NCT00578864)
Timeframe: 2 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase II Window With Protracted Etoposide | 4 |
| Phase II Window With Bolus Etoposide | 2 |
Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
The first of the two events (relapse or death) was chosen to represent disease free survival (NCT00578864)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Phase II Window With Protracted Etoposide | 2 |
| Phase II Window With Bolus Etoposide | 1 |
Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.
If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC > 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia (NCT00578864)
Timeframe: 2 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase II Window With Protracted Etoposide | 0 |
| Phase II Window With Bolus Etoposide | 0 |
Number of Patients With Chronic GVHD at 2 Years Post Transplant
(NCT00578903)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Patients | 1 |
Number of Patients With Engraftment Rate at 100 Days Post Transplant
Absolute neutrophil count greater than 0.5 X 10^9/ml for at least 3 days (NCT00578903)
Timeframe: 100 days post transplant
| Intervention | participants (Number) |
|---|
| Patients | 19 |
Number of Subjects Alive at 1 Year Post Transplant
(NCT00578903)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Patients | 20 |
Number of Subjects Alive at 100 Days Post Transplant
(NCT00578903)
Timeframe: 100 days
| Intervention | participants (Number) |
|---|
| Patients | 21 |
Number of Subjects Alive at 2 Years Post Transplant
(NCT00578903)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Patients | 20 |
Number of Patients With Acute GVHD at 100 Days Post Transplant
(NCT00578903)
Timeframe: 100 days
| Intervention | participants (Number) |
|---|
| Patients | 4 |
Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.
The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer. (NCT00580333)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Cisplatin/Avastin | 16 |
Patients With Miller-Payne (MP) Score 3, 4, or 5 Response
To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response). (NCT00580333)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Cisplatin/Avastin | 45 |
Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.
Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons. (NCT00580333)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Cisplatin/Avastin | 8 |
Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00580333)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| CR | OR = CR+PR |
|---|
| Cisplatin/Avastin | 12 | 39 |
Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy
"Relapse is defined by the unequivocal objective evidence of recurrent disease such as:~myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis >10% or >5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for >2 months." (NCT00580372)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Study Treatment | 28 |
3 Year Overall Survival (OS)
This is the percent of participants who were still alive at 3 years after study entry. (NCT00581776)
Timeframe: 36 months
| Intervention | Percent of participants (Number) |
|---|
| VCR-CVAD With Rituximab Maintenance | 86 |
Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).
"Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy.~1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses." (NCT00581776)
Timeframe: At completion of induction therapy (21 weeks)
| Intervention | Percent of participants (Number) |
|---|
| VCR-CVAD With Rituximab Maintenance | 90 |
Complete Response Rate (CR) at the End of Induction Chemotherapy
Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable. (NCT00581776)
Timeframe: at 21 weeks
| Intervention | percent of participants (Number) |
|---|
| VCR-CVAD With Rituximab Maintenance | 77 |
3 Year Progression Free Survival
This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study. (NCT00581776)
Timeframe: 36 months
| Intervention | percent of participants (Number) |
|---|
| VCR-CVAD With Rituximab Maintenance | 63 |
Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen
"Survival and complete resolution of all signs of leukemia 2 years after transplant with all of the following:~1, Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis.~2. Normalization of blood counts (no basts, platelets >100,000/mm3, granulocytes >1,500/mm3) 3. No extramedullary disease." (NCT00589316)
Timeframe: 2 years post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody | 0 |
| Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody | 1 |
| Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody | 1 |
| Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody | 1 |
| Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody | 1 |
| Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | 0 |
| Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | 0 |
| Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | 1 |
Time to Absolute Neutrophil Count Recovery (Engraftment)
Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10^9/L (500/mm3) for three consecutive laboratory values obtained on different days (NCT00589563)
Timeframe: Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT
| Intervention | Days (Median) |
|---|
| All Patients | 14.5 |
Time to Platelet Count Recovery (Engraftment)
Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10^9 L obtained on different days. (NCT00589563)
Timeframe: Patients were evaluated until platelet recovery, a median of 14 days
| Intervention | Days (Median) |
|---|
| All Patients | 14 |
Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
Participants were monitored throughout the trial (median of 28 months) for various infections/complications. (NCT00589563)
Timeframe: Median Follow Up: 28 months (Range: 1-49 months)
| Intervention | participants (Number) |
|---|
| Neither CMV or EBV | CMV reactivation only | EBV only | Both CMV and EBV |
|---|
| All Patients | 16 | 9 | 3 | 4 |
Severity of Acute GVHD
All patients were considered for the evaluation of the severity of acute GVHD. (NCT00589563)
Timeframe: 100 Days Post HSCT
| Intervention | participants (Number) |
|---|
| No Acute GVHD | Yes - Grade I | Yes- Grade II | Yes- Grade III | Yes - Grade IV | No- Inevaluable (graft failures) |
|---|
| All Patients | 9 | 9 | 9 | 1 | 0 | 4 |
Overall Survival at Two Years Post HSCT
Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date. (NCT00589563)
Timeframe: 2 year point estimate was provided.
| Intervention | Percentage of patients who died (Number) |
|---|
| All Patients | 65.6 |
Occurrence of Thrombotic Microangiopathy
Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA. (NCT00589563)
Timeframe: Median Follow Up: 28 Months (Range: 1-49 months)
| Intervention | participants (Number) |
|---|
| All Patients | 7 |
Severity of Chronic GVHD
All Patients were considered for the evaluation of chronic GVHD severity. (NCT00589563)
Timeframe: Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT
| Intervention | participants (Number) |
|---|
| No Chronic GVHD | Yes- Limited | Yes - Extensive | No- Inevaluable (graft failure/died |
|---|
| All Patients | 4 | 4 | 17 | 7 |
Occurence of Sinusoidal Obstructive Syndrome (SOS)
Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS. (NCT00589563)
Timeframe: Median Follow Up: 28 Months (Range: 1-49 Months)
| Intervention | participants (Number) |
|---|
| All Patients | 1 |
Non-relapse Mortality at Two Years Post HSCT
Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment. (NCT00589563)
Timeframe: 2 year point estimate was provided.
| Intervention | Percentage of patients with a NRM (Number) |
|---|
| All Patients | 15.6 |
Non-relapse Mortality at 100 Days Post HSCT
Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment. (NCT00589563)
Timeframe: 100 day point estimate was provided
| Intervention | Percentage of patients with a NRM (Number) |
|---|
| All Patients | 9.4 |
Incidence of Disease Relapse/Progression at 2 Years Post HSCT
Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment. (NCT00589563)
Timeframe: 2 year point estimate was provided.
| Intervention | Percentage of patients who relapsed (Number) |
|---|
| All Patients | 12.5 |
Event Free Survival at Two Years Post HSCT
Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event. (NCT00589563)
Timeframe: 2 year point estimate was provided.
| Intervention | Percentage of patients with an event (Number) |
|---|
| All Patients | 61.3 |
Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment. (NCT00589563)
Timeframe: 100 Days Post Hematopoietic Stem Cell Transplant (HSCT)
| Intervention | Percentage of patients developing aGVHD (Number) |
|---|
| All Patients | 37.3 |
Cumulative Incidence of Chronic GVHD
Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment. (NCT00589563)
Timeframe: 2 year point estimate was provided.
| Intervention | Percentage of patients developing cGVHD (Number) |
|---|
| All Patients | 62.5 |
Cardiac Saftey
LVEF by Muga scan (NCT00591851)
Timeframe: Baseline-18 months
| Intervention | percentage of LVEF (Median) |
|---|
| LVEF at Baseline | LVEF at Month 2 | LVEF at Month 6 (67/70 pts) | LVEF at Month 9 (68/70 pts) | LVEF at Month 18 (48/70 pts) |
|---|
| AC Followed by Paclitaxel + Trastuzumab | 68 | 67 | 66 | 65 | 66 |
Number of Days for Absolute Neutrophil Count to Recover
Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days). (NCT00594308)
Timeframe: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
| Intervention | days per patient (Mean) |
|---|
| Basiliximab 20 mg | 14.00 |
Number of Patients With Acute Grade II-IV GVHD
Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities. (NCT00594308)
Timeframe: until 30 days after stem cell transplant
| Intervention | participants (Number) |
|---|
| Basiliximab 20 mg | 10 |
Time to Resolution of Cytopenias: Platelet Transfusion Independence
Average number of days per patient for resolution of cytopenias. (NCT00594308)
Timeframe: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)
| Intervention | days per patient (Mean) |
|---|
| Basiliximab 20 mg | 15.33 |
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
(NCT00594308)
Timeframe: until 30 days after stem cell transplant
| Intervention | participants (Number) |
|---|
| Basiliximab 20 mg | 10 |
Incidence & Quality of Engraftment & Hematopoietic Reconstitution
Number of patients who engrafted (NCT00595127)
Timeframe: 8 years
| Intervention | participants (Number) |
|---|
| Cyclophosphamide and Fludarabine | 19 |
Overall Response
To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response. (NCT00597519)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Complete Remission | Relapse |
|---|
| Treatment | 24 | 3 |
Number of Evaluable Participants With Tumor Response
Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival. (NCT00601796)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Combination Immunotherapy | 5 |
Number of Participants With Serious Adverse Events (SAEs)
Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena. (NCT00601796)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| Combination Immunotherapy | 11 |
Time-to-progression in Patients With Del(11q22.3)
Time to progression (TTP) in del(11q22.3) participants was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. (NCT00602459)
Timeframe: Up to 15 years
| Intervention | months (Median) |
|---|
| Arm C2, FCR in Del(11q22.3) | 35.5 |
| Arm D, FCR+L in Del(11q22.3) | 44.6 |
2-Year Progression Free Survival (PFS) Rate
Proportion of participants who were alive and progression free at 2 years. (NCT00602459)
Timeframe: 2 years
| Intervention | proportion of participants (Number) |
|---|
| Arm A, FR in Non-del(11q22.3) | 0.64 |
| Arm B, FR+L in Non-del(11q22.3) | 0.71 |
| Arm C1, FCR in Non-del(11q22.3) | 0.74 |
Overall Response Rate in Patients Without Del(11q22.3)
Percentage of non-del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. (NCT00602459)
Timeframe: Up to 15 years
| Intervention | percentage of participants (Number) |
|---|
| Arm A (Rituximab, Fludarabine Phosphate) | 75 |
| Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide) | 69 |
| Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 71 |
Overall Response Rates in Patients With Del(11q22.3)
Percentage of del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. (NCT00602459)
Timeframe: Up to 15 years
| Intervention | percentage of participants (Number) |
|---|
| Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 59 |
| Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide) | 74 |
PFS Rate of Patients With Del(11q22.3)
Proportion of del (11q22.3) participants who were alive and progression free at 2 years. (NCT00602459)
Timeframe: 2 years
| Intervention | proportion of participants (Number) |
|---|
| Arm C2, FCR in Del(11q22.3) | 0.56 |
| Arm D, FCR+L in Del(11q22.3) | 0.65 |
Time-to-progression in Patients Without Del(11q22.3)
Time to progression (TTP) was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progressive disease (PD) required at least one of the following: >= 50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes, >= 50% increase in the product of at least two lymphnodes, >= 50% increase in the enlargement of the liver and/or spleen. (NCT00602459)
Timeframe: Up to 15 years
| Intervention | months (Median) |
|---|
| Arm A, FR in Non-del(11q22.3) | 43.5 |
| Arm B, FR+L in Non-del(11q22.3) | 66.0 |
| Arm C1, FCR in Non-del(11q22.3) | 78.0 |
Topotecan Apparent Oral Clearance in Maintenance Chemotherapy
Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.25, 1.5 and 6 hours post-dose
| Intervention | L/h (Median) |
|---|
| Low-Risk Group | 41.4 |
| Intermediate-Risk Group | 41.0 |
| High-Risk Group | 44.6 |
Erlotinib Apparent Volume of Central Compartment
Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
| Intervention | L/m^2 (Median) |
|---|
| Low-Risk Group | 72.9 |
| Intermediate-Risk Group | 61.7 |
| High-Risk Group | 104.8 |
Rate of Local Disease Progression
Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval. (NCT00602667)
Timeframe: 1 year after completion of radiation therapy for last patient
| Intervention | Percentage of participants (Number) |
|---|
| Intermediate-risk Patients Who Received Focal Radiation | 13.2 |
Numbers of Patients With Gene Alterations
Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
| Intervention | Participants (Count of Participants) |
|---|
| PTCH1 alteration | SUFU alteration | KMT2D alteration | SMO alteration | BCOR alteration | PTEN alteration | BRCA2 alteration | GLI2 alteration | SMARCA4 alteration | TP53 alteration | MYCN alteration |
|---|
| High-Risk Group | 3 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,| Intermediate-Risk Group | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
,| Low-Risk Group | 7 | 6 | 5 | 2 | 1 | 1 | 0 | 0 | 2 | 0 | 0 |
Rate of Distant Disease Progression
Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval. (NCT00602667)
Timeframe: 1 year after completion of radiation therapy for last patient
| Intervention | percentage of participants (Number) |
|---|
| Intermediate-risk Patients Who Received Focal Radiation | 25.6 |
Percentage of Patients With Objective Responses Rate to Induction Chemotherapy
For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response [ PR]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks. (NCT00602667)
Timeframe: From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)
| Intervention | Percentage of patients (Number) |
|---|
| Intermediate-Risk Group | 58.3 |
| High-Risk Group | 21.1 |
Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup
Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile. (NCT00602667)
Timeframe: From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment
| Intervention | Percent Probability (Number) |
|---|
| Low-risk SHH Patients | 73.9 |
| Intermediate-risk SHH Patients | 50.0 |
| High-risk SHH Patients | 54.5 |
| Intermediate-risk Group 3 Patients | 30.8 |
| High-risk Group 3 Patients | 9.1 |
| Intermediate-risk Group 4 Patients | 62.5 |
| High-risk Group 4 Patients | 50.0 |
Erlotinib AUC0-24h
Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 31.0 |
| Intermediate-Risk Group | 23.5 |
| High-Risk Group | 22.0 |
Event-free Survival (EFS) Compared to Historical Controls
EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. (NCT00602667)
Timeframe: From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years
| Intervention | Percent probability (Number) |
|---|
| SJYC07 Low-risk Medulloblastoma Patients | 73.9 |
| SJYC07 Intermediate-risk Medulloblastoma Patients | 46.9 |
| SJYC07 High-risk Medulloblastoma Patients | 30.8 |
Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients
Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. (NCT00602667)
Timeframe: From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment
| Intervention | Percent Probability (Number) |
|---|
| Low-Risk Group | 73.9 |
| Intermediate-Risk Group | 46.9 |
| High-Risk Group | 30.8 |
Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients
Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. (NCT00602667)
Timeframe: From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after
| Intervention | Percent Probability (Number) |
|---|
| Low-Risk Group | 73.9 |
| Intermediate-Risk Group | 46.9 |
| High-Risk Group | 30.8 |
Percent of PET Scans With Loss of Signal Intensity
Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay. (NCT00602667)
Timeframe: Up to 3 times during RT consolidation
| Intervention | mean activation value (MAV) (Mean) |
|---|
| Intermediate Risk Group | 60 |
Percent of Patients With Sustained Objective Responses Rate After Consolidation
For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response. (NCT00602667)
Timeframe: 8 weeks after completion of consolidation therapy (up to 8 months after on-study date)
| Intervention | percentage of participants (Number) |
|---|
| High-Risk Group | 13.2 |
Numbers of Patients With Molecular Abnormalities by Tumor Type
Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
| Intervention | Participants (Count of Participants) |
|---|
| PTCH1 alteration | SUFU alteration | KMT2D alteration | SMO alteration | BCOR alteration | PTEN alteration | BRCA2 alteration | GLI2 alteration | SMARCA4 alteration | TP53 alteration | MYCN amplification | chr2p gain/amplification | chr2p loss/deletion | chr2q gain/amplification | chr2q loss/deletion | chr6p gain/amplification | chr6p loss/deletion | chr6q gain/amplification | chr6q loss/deletion | chr8p gain/amplification | chr8p loss/deletion | chr8q gain/amplification | chr8q loss/deletion | chr9p gain/amplification | chr9p loss/deletion | chr9q gain/amplification | chr9q loss/deletion | chr10p gain/amplification | chr10p loss/deletion | chr10q gain/amplification | chr10q loss/deletion | chr20p gain/amplification | chr20p loss/deletion | chr20q gain/amplification | chr20q loss/deletion |
|---|
| High-risk Group 3 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 3 | 2 | 3 | 2 | 0 | 7 | 0 | 6 | 0 | 3 | 0 | 3 | 0 | 7 | 0 | 8 | 0 | 4 | 0 | 4 |
,| High-risk Group 4 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| High-risk SHH Patients | 3 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 |
,| Intermediate-risk Group 3 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 2 | 0 | 1 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 5 | 0 | 5 | 0 | 3 | 0 | 3 |
,| Intermediate-risk Group 4 Patients | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 4 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Intermediate-risk SHH Patients | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 5 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 |
,| Low-risk SHH Patients | 7 | 6 | 5 | 2 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 5 | 0 | 5 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 4 | 4 | 2 | 6 | 0 | 0 | 0 | 3 | 0 | 2 | 0 | 1 |
Pharmacogenetic Variation on Central Nervous System Transmitters
Frequencies of genetic polymorphisms were reported. (NCT00602667)
Timeframe: At study enrollment (Day 0)
| Intervention | Participants (Count of Participants) |
|---|
| Genetic Polymorphisms for monoamine oxidase A (MAOA) rs632372067969 | Genetic Polymorphisms for catecholamine-O-methyltransferase (COMT) rs468072067969 | Genetic Polymorphisms for dopamine receptor D (DRD3) rs628072067969 |
|---|
| AG | CC | TC | TT | GG | AA | TG |
|---|
| Patients With Neurotransmitter Studies | 2 |
| Patients With Neurotransmitter Studies | 13 |
| Patients With Neurotransmitter Studies | 7 |
| Patients With Neurotransmitter Studies | 5 |
| Patients With Neurotransmitter Studies | 0 |
| Patients With Neurotransmitter Studies | 6 |
| Patients With Neurotransmitter Studies | 4 |
Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan
Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion
| Intervention | participants (Number) |
|---|
| Intermediate-Risk Group | 1 |
| High-Risk Group | 20 |
Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan
Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion
| Intervention | participants (Number) |
|---|
| Intermediate-Risk Group | 0 |
| High-Risk Group | 8 |
Overall Survival (OS) Compared to Historical Controls
OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. (NCT00602667)
Timeframe: 1 year after treatment initiation of last patient
| Intervention | Percent probability (Number) |
|---|
| SJYC07 Low-risk Medulloblastoma Patients | 100 |
| SJYC07 Intermediate-risk Medulloblastoma Patients | 84.4 |
| SJYC07 High-risk Medulloblastoma Patients | 61.5 |
OSI-420 AUC0-24h
Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 2.17 |
| Intermediate-Risk Group | 1.81 |
| High-Risk Group | 1.62 |
Methotrexate Volume of Central Compartment in Induction Cycle 4
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | L/m^2 (Median) |
|---|
| Low-Risk Group | 12.64 |
| Intermediate-Risk Group | 13.31 |
| High-Risk Group | 13.68 |
Methotrexate Volume of Central Compartment in Induction Cycle 2
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | L/m^2 (Median) |
|---|
| Low-Risk Group | 13.77 |
| Intermediate-Risk Group | 13.73 |
| High-Risk Group | 13.62 |
Methotrexate Volume of Central Compartment in Induction Cycle 1
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | L/m^2 (Median) |
|---|
| Low-Risk Group | 11.63 |
| Intermediate-Risk Group | 13.70 |
| High-Risk Group | 13.25 |
Methotrexate Volume of Central Compartment in Induction Cycle 3
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | L/m^2 (Median) |
|---|
| Low-Risk Group | 12.70 |
| Intermediate-Risk Group | 13.55 |
| High-Risk Group | 13.87 |
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX
| Intervention | µmol/L (Median) |
|---|
| Low-Risk Group | 0.64 |
| Intermediate-Risk Group | 0.64 |
| High-Risk Group | 0.55 |
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX
| Intervention | µmol/L (Median) |
|---|
| Low-Risk Group | 0.65 |
| Intermediate-Risk Group | 0.70 |
| High-Risk Group | 0.58 |
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX
| Intervention | µmol/L (Median) |
|---|
| Low-Risk Group | 0.75 |
| Intermediate-Risk Group | 0.72 |
| High-Risk Group | 0.69 |
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX
| Intervention | µmol/L (Median) |
|---|
| Low-Risk Group | 0.49 |
| Intermediate-Risk Group | 0.57 |
| High-Risk Group | 0.61 |
4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 95.9 |
| Intermediate-Risk Group | 49.5 |
| High-Risk Group | 43.5 |
4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 96.8 |
| Intermediate-Risk Group | 48.7 |
| High-Risk Group | 39.8 |
Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1
Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 2.39 |
| Intermediate-Risk Group | 2.08 |
| High-Risk Group | 2.43 |
4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 116.4 |
| Intermediate-Risk Group | 111.3 |
| High-Risk Group | 109.1 |
Number and Type of Genetic Polymorphisms
Types of genetic polymorphisms of neurotransmitters were examined. We studied 3 genetic polymorphisms; these were types of genetic polymorphisms involved in dopamine metabolism. They were as follows: rs6323, rs4680, and rs6280. (NCT00602667)
Timeframe: At study enrollment (Day 0)
| Intervention | Participants (Count of Participants) |
|---|
| rs6323 | rs4680 | rs6280 |
|---|
| Number of Patients With Neurotransmitter Studies | 17 | 17 | 17 |
Number of Participants With Chromosomal Abnormalities
Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
| Intervention | Participants (Count of Participants) |
|---|
| chr2p gain/amplification | chr2p loss/deletion | chr2q gain/amplification | chr2q loss/deletion | chr6p gain/amplification | chr6p loss/deletion | chr6q gain/amplification | chr6q loss/deletion | chr8p gain/amplification | chr8p loss/deletion | chr8q gain/amplification | chr8q loss/deletion | chr9p gain/amplification | chr9p loss/deletion | chr9q gain/amplification | chr9q loss/deletion | chr10p gain/amplification | chr10p loss/deletion | chr10q gain/amplification | chr10q loss/deletion | chr20p gain/amplification | chr20p loss/deletion | chr20q gain/amplification | chr20q loss/deletion |
|---|
| High-Risk Group | 6 | 0 | 6 | 0 | 3 | 2 | 3 | 2 | 0 | 8 | 0 | 7 | 3 | 3 | 1 | 5 | 0 | 7 | 0 | 9 | 0 | 5 | 0 | 5 |
,| Intermediate-Risk Group | 1 | 2 | 1 | 2 | 3 | 0 | 3 | 0 | 2 | 6 | 3 | 5 | 6 | 0 | 1 | 5 | 0 | 5 | 0 | 7 | 0 | 4 | 0 | 3 |
,| Low-Risk Group | 5 | 0 | 5 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 4 | 4 | 2 | 6 | 0 | 0 | 0 | 3 | 0 | 2 | 0 | 1 |
Methotrexate Clearance in Induction Cycle 4
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 5.75 |
| Intermediate-Risk Group | 5.89 |
| High-Risk Group | 5.79 |
Methotrexate Clearance in Induction Cycle 3
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 5.68 |
| Intermediate-Risk Group | 5.78 |
| High-Risk Group | 5.81 |
Methotrexate Clearance in Induction Cycle 2
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 5.47 |
| Intermediate-Risk Group | 5.70 |
| High-Risk Group | 5.70 |
Methotrexate Clearance in Induction Cycle 1
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 5.69 |
| Intermediate-Risk Group | 6.06 |
| High-Risk Group | 5.65 |
4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1.98 |
| Intermediate-Risk Group | 1.96 |
| High-Risk Group | 1.82 |
CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 128.9 |
| Intermediate-Risk Group | 62.2 |
| High-Risk Group | 51.8 |
CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 132.7 |
| Intermediate-Risk Group | 46.8 |
| High-Risk Group | 44.0 |
CEPM AUC0-24h in Induction Chemotherapy
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 140.2 |
| Intermediate-Risk Group | 137.8 |
| High-Risk Group | 135.3 |
Methotrexate AUC0-66h in Induction Cycle 4
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1804 |
| Intermediate-Risk Group | 1841 |
| High-Risk Group | 1886 |
Methotrexate AUC0-66h in Induction Cycle 3
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1872 |
| Intermediate-Risk Group | 1879 |
| High-Risk Group | 1831 |
Number of Successful Collections for Frozen and Fixed Tumor Samples
Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
| Intervention | Participants (Count of Participants) |
|---|
| Number with frozen tumor tissue | Number with fixed tumor tissue |
|---|
| High-Risk Group | 32 | 71 |
,| Intermediate-Risk Group | 73 | 153 |
,| Low-Risk Group | 27 | 54 |
Concentration of Cerebrospinal Fluid Neurotransmitters
Concentrations of various neurotransmitters in cerebrospinal fluid were measured at 5 timepoints. The median concentration of each neurotransmitter at each time point was calculated and provided with a full range. (NCT00602667)
Timeframe: Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date
| Intervention | ng/ml (Median) |
|---|
| Dopamine concentration at baseline | Dopamine concentration at completion of treatment | Dopamine concentration at 12 months off treatment | Dopamine concentration at 24 months off treatment | Dopamine concentration at 36 months off treatment | 3,4-dihydroxyphenylacetic acid concentration at baseline | 3,4-dihydroxyphenylacetic acid concentration at completion of treatment | 3,4-dihydroxyphenylacetic acid concentration at 12 months off treatment | 3,4-dihydroxyphenylacetic acid concentration at 24 months off treatment | 3,4-dihydroxyphenylacetic acid concentration at 36 months off treatment | Hydroxytryptamine concentration at baseline | Hydroxytryptamine concentration at completion of treatment | Hydroxytryptamine concentration at 12 months off treatment | Hydroxytryptamine concentration at 24 months off treatment | Hydroxytryptamine concentration at 36 months off treatment | Hydroxyindoleacetic acid concentration at baseline | Hydroxyindoleacetic acid concentration at completion of treatment | Hydroxyindoleacetic acid concentration at 12 months off treatment | Hydroxyindoleacetic acid concentration at 24 months off treatment | Hydroxyindoleacetic acid concentration at 36 months off treatment | Homovanillic acid concentration at baseline | Homovanillic acid concentration at completion of treatment | Homovanillic acid concentration at 12 months off treatment | Homovanillic acid concentration at 24 months off treatment | Homovanillic acid concentration at 36 months off treatment |
|---|
| Patients With Neurotransmitter Studies | 3.16 | 3.70 | 6.43 | 4.46 | 4.05 | 2.56 | 1.62 | 1.04 | 1.52 | 1.00 | 2.38 | 2.01 | 2.00 | 2.44 | 1.62 | 52.03 | 52.72 | 35.72 | 33.98 | 31.56 | 82.44 | 114.13 | 68.28 | 88.27 | 79.78 |
CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1
Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1.59 |
| Intermediate-Risk Group | 1.65 |
| High-Risk Group | 1.41 |
Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1
Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 2.95 |
| Intermediate-Risk Group | 2.83 |
| High-Risk Group | 2.74 |
Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1968 |
| Intermediate-Risk Group | 1504 |
| High-Risk Group | 868 |
Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1966 |
| Intermediate-Risk Group | 799 |
| High-Risk Group | 899 |
Cyclophosphamide AUC0-24h in Induction Chemotherapy
Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 2070 |
| Intermediate-Risk Group | 2150 |
| High-Risk Group | 2105 |
Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 39.9 |
| Intermediate-Risk Group | 38.7 |
| High-Risk Group | 42.2 |
Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2
Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 2.48 |
| Intermediate-Risk Group | 2.55 |
| High-Risk Group | 2.37 |
Cyclophosphamide Clearance in Induction Chemotherapy
Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 2.40 |
| Intermediate-Risk Group | 2.23 |
| High-Risk Group | 2.25 |
Erlotinib Apparent Oral Clearance
Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
| Intervention | L/h/m^2 (Median) |
|---|
| Low-Risk Group | 6.53 |
| Intermediate-Risk Group | 7.79 |
| High-Risk Group | 8.40 |
Topotecan Clearance in Consolidation Chemotherapy
Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion
| Intervention | L/h/m^2 (Median) |
|---|
| Intermediate-Risk Group | 30.3 |
| High-Risk Group | 26.40 |
Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
These data are based on patient diaries. For children <3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question. (NCT00602667)
Timeframe: From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)
| Intervention | Percentage of scheduled doses received (Mean) |
|---|
| Low-Risk Group | 96 |
| Intermediate-Risk Group | 91 |
| High-Risk Group | 98 |
Methotrexate AUC0-66h in Induction Cycle 1
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1797 |
| Intermediate-Risk Group | 1813 |
| High-Risk Group | 1821 |
Methotrexate AUC0-66h in Induction Cycle 2
Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX
| Intervention | µmol·h/L (Median) |
|---|
| Low-Risk Group | 1900 |
| Intermediate-Risk Group | 1902 |
| High-Risk Group | 1879 |
Topotecan AUC0-24h in Maintenance Chemotherapy
Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose
| Intervention | µg·h/L (Median) |
|---|
| Low-Risk Group | 10.90 |
| Intermediate-Risk Group | 11.60 |
| High-Risk Group | 10.33 |
Topotecan AUC0-24h in Consolidation Chemotherapy
Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion
| Intervention | µg·h/L (Median) |
|---|
| Intermediate-Risk Group | 117 |
| High-Risk Group | 116 |
Treatment Free Survival (TFS)
Treatment Free Survival (TFS) was defined as the time from registration to the earliest date documentation of subsequent treatment or death, whichever came first. Participants were followed for a maximum of 5 years from registration. The median TFS with 95% CI was estimated using the Kaplan Meier method. (NCT00602836)
Timeframe: time from registration to progression (up to 5 years)
| Intervention | months (Median) |
|---|
| PCR-Lenalidomide | NA |
Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide
MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells to determine if there was any MRD. (NCT00602836)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| PCR-Lenalidomide | 4 |
Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide
"According to the NCIWG criteria, response is defined as follows:~nPR: Meets all criteria for CR, as described above, except the presence of residual clonal nodules in the bone marrow PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions SD: participant who does not meet any of the criteria described above" (NCT00602836)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| PCR-Lenalidomide | 5 |
Number of Participants With a Response (CR, nPR, PR)
Response criteria described in above outcomes. (NCT00602836)
Timeframe: During treatment (up to 5 years)
| Intervention | Participants (Count of Participants) |
|---|
| PCR-Lenalidomide | 38 |
Overall Survival (OS)
Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method. (NCT00602836)
Timeframe: time from registration to death (up to 5 years)
| Intervention | months (Median) |
|---|
| PCR-Lenalidomide | NA |
Number of Participants With Complete Response (CR)
"A complete response, as defined by the National Cancer Institute Working Group (NCIWG), requires all of the following for a period of at least 2 months:~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy" (NCT00602836)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| PCR-Lenalidomide | 14 |
Progression-free Survival (PFS)
Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of measured lesions. (NCT00605566)
Timeframe: Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years
| Intervention | months (Median) |
|---|
| Sorafenib and Cyclophosphamide | 3 |
1-year Survival Rate
Survival rate at 1 year. (NCT00605566)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Sorafenib and Cyclophosphamide | 45 |
Efficacy of Combination Sorafenib Plus Metronomic Cyclophosphamide in Advanced, Progressive NET, as Measured by the Objective Response Rate (ORR).
"Objective response (complete and partial) evaluated using RECIST criteria. Complete response (CR): disappearance of all clinical and radiological evidence of tumour (both target and non-target).~Partial response (PR): at least a 30% decrease in the sum of longest diameter of target lesions." (NCT00605566)
Timeframe: Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years
| Intervention | Participants (Count of Participants) |
|---|
| Sorafenib and Cyclophosphamide | 1 |
Overall Survival (OS)
(NCT00605566)
Timeframe: Assessed from start of study treatment until death, assessed up to 7 years.
| Intervention | months (Median) |
|---|
| Sorafenib and Cyclophosphamide | 11.7 |
Association Between p-Shift Changes and Treatment Efficacy of Individual Dose Adjustment of Sorafenib
"A phosphoshift (pShift) flow cytometry-based test that measures RAF signal transduction capacity in peripheral blood cells was used in order to predict clinical course and/or guide individual dose-titration. Positive pShift values denote stimulation of RAF signal transduction, whereas negative pShift values denote inhibition of RAF signal transduction as measured by flow-cytometry.~Associations between pShift changes and treatment efficacy were measured using progression-free survival (PFS) and overall survival (OS)." (NCT00605566)
Timeframe: Assessed from start of study treatment until death, assessed up to 7 years.
| Intervention | months (Median) |
|---|
| PFS in patients with a negative pShift result | PFS in patients with a positive pShift result | OS for patients with a negative pShift | OS for patients with a positive pShift |
|---|
| Sorafenib and Cyclophosphamide | 2.8 | 14.9 | 6.4 | 21.3 |
Number of Participants Who Relapsed at 1 Year
(NCT00608517)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Pediatric Myeloablative Conditioning | 0 |
| Adult Myeloablative Conditioning | 0 |
| Reduced-intensity Conditioning | 0 |
Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells
Recovery of the neutrophil portion of white blood cells and showing complete donor cells. (NCT00608517)
Timeframe: 42 days
| Intervention | participants (Number) |
|---|
| Pediatric Myeloablative Conditioning | 1 |
| Adult Myeloablative Conditioning | 1 |
Number of Participants With Chronic Graft Versus Host Disease (GVHD)
As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement (NCT00608517)
Timeframe: 100 days
| Intervention | participants (Number) |
|---|
| Pediatric Myeloablative Conditioning | 0 |
| Adult Myeloablative Conditioning | 0 |
| Reduced-intensity Conditioning | 0 |
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Participants who exhibit acute GVHD. (NCT00608517)
Timeframe: 100 days
| Intervention | participants (Number) |
|---|
| Pediatric Myeloablative Conditioning | 0 |
| Adult Myeloablative Conditioning | 1 |
| Reduced-intensity Conditioning | 0 |
Number of Participants With 100-day Non-relapse Mortality
Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF). (NCT00608517)
Timeframe: 100 days
| Intervention | participants (Number) |
|---|
| Pediatric Myeloablative Conditioning | 1 |
| Adult Myeloablative Conditioning | 0 |
| Reduced-intensity Conditioning | 0 |
Overall Survival
Overall survival at 1 year (NCT00608517)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Pediatric Myeloablative Conditioning | 1 |
| Adult Myeloablative Conditioning | 3 |
| Reduced-intensity Conditioning | 1 |
Number of Subjects With All-cause Mortality
Death from any cause at 100 days (NCT00608517)
Timeframe: at 100 days
| Intervention | participants (Number) |
|---|
| Pediatric Myeloablative Conditioning | 1 |
| Adult Myeloablative Conditioning | 0 |
| Reduced-intensity Conditioning | 0 |
Duration of Response
Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. (NCT00609167)
Timeframe: Duration of study (up to 12 cycles)
| Intervention | months (Median) |
|---|
| CyBorD (Bortezomib 1.3mg/m^2) | NA |
| CyBorD (Bortezomib 1.5mg/m^2) | NA |
Progression Free Survival (PFS)
"PFS was defined as the time from registration to progression or death due to any cause.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~Bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas" (NCT00609167)
Timeframe: up to 5 years
| Intervention | months (Median) |
|---|
| CyBorD (Bortezomib 1.3mg/m^2) | NA |
| CyBorD (Bortezomib 1.5mg/m^2) | NA |
Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant
Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy. (NCT00609167)
Timeframe: After 4 cycles of treatment
| Intervention | participants (Number) |
|---|
| CyBorD (Bortezomib 1.3mg/m^2) | 33 |
| CyBorD (Bortezomib 1.5mg/m^2) | 17 |
Overall Survival (OS)
OS was defined as the time from registration to death of any cause. (NCT00609167)
Timeframe: From date of registration until death (up to 5 years)
| Intervention | months (Median) |
|---|
| CyBorD (Bortezomib 1.3mg/m^2) | NA |
| CyBorD (Bortezomib 1.5mg/m^2) | NA |
Number of Participants With Severe Adverse Events
Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. (NCT00609167)
Timeframe: Every cycle during treatment (up to 12 cycles)
| Intervention | participants (Number) |
|---|
| CyBorD (Bortezomib 1.3mg/m^2) | 16 |
| CyBorD (Bortezomib 1.5mg/m^2) | 11 |
Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles
"Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment.~Criteria for CR, nCR, VGPR and PR are defined in prior outcomes." (NCT00609167)
Timeframe: After 8 cycles of treatment
| Intervention | participants (Number) |
|---|
| CyBorD (Bortezomib 1.5mg/m^2) | 1 |
Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles
"Response that was confirmed on 2 consecutive evaluations after 8 months of treatment.~CR, nCR and VGPR as defined in the primary outcome.~Partial Response(PR): >=50% reduction in serum M-component and/or~Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels." (NCT00609167)
Timeframe: 4 cycles
| Intervention | participants (Number) |
|---|
| CyBorD (Bortezomib 1.3mg/m^2) | 29 |
| CyBorD (Bortezomib 1.5mg/m^2) | 28 |
Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment
"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow." (NCT00609167)
Timeframe: After 4 months of treatment
| Intervention | participants (Number) |
|---|
| CyBorD (Bortezomib 1.3mg/m^2) | 20 |
| CyBorD (Bortezomib 1.5mg/m^2) | 18 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00610311)
Timeframe: 18.5 months
| Intervention | Participants (Number) |
|---|
| ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2 | 3 |
Complete Remission
The number of patients who achieved a complete remission as a result of treatment (NCT00610883)
Timeframe: 330 Days
| Intervention | participants (Number) |
|---|
| All Patients | 10 |
Transplantation-related Mortality at 100 Days Post-transplantation
(NCT00611351)
Timeframe: at the 100 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated Donor Allogeneic | 2 |
Overall Survival
(NCT00611351)
Timeframe: 2 years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated Donor Allogeneic | 2 |
Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
(NCT00611351)
Timeframe: at day 100 post transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated Donor Allogeneic | 4 |
Event-free Survival
(NCT00611351)
Timeframe: 2 years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Unrelated Donor Allogeneic | 2 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00612222)
Timeframe: 15 months
| Intervention | Participants (Number) |
|---|
| ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2 | 4 |
Number of Participants With 1 Year Overall Survival
"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.~Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive." (NCT00612716)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 2 |
Number of Participants With Engraftment Failure
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets. (NCT00612716)
Timeframe: 3 Months
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 1 |
Number of Participants With Relapse of Malignancy
the return of disease after its apparent recovery/cessation. (NCT00612716)
Timeframe: 3 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 1 |
Number of Participants With Platelet Engraftment
Time to platelets > 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment >50,000 by day 100. (NCT00612716)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 2 |
Number of Participants With Persistence Disease
the return of disease after its apparent recovery/cessation. (NCT00612716)
Timeframe: 3 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 1 |
Number of Participants With of Chronic GVHD.
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00612716)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 0 |
Number of Participants With Neutrophil Engraftment
Time to 1st 3 consecutive days with absolute neutrophil count (ANC) > 5 x 10^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence). (NCT00612716)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 5 |
Number of Participants With Grade 3-4 Acute Graft-versus-host Disease
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00612716)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 3 |
Number of Participants With 2 Year Overall Survival
"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.~Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive." (NCT00612716)
Timeframe: 2 year
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Transplantation | 1 |
The Number of Patients Who Completed 8 Cycles.
the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles. (NCT00615901)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Cohort A (CMF at 14 Day Intervals) | 29 |
Duration of Response
"Duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST):~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable: Does not qualify for complete response, partial response or progression.~Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)." (NCT00616122)
Timeframe: until disease progression up to 13 months post treatment
| Intervention | weeks (Number) |
|---|
| Sunitinib, Cyclophosphamide, and Methotrexate | 10.6 |
Maximum Tolerated Dose of Sunitinib (Phase I)
"Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 degrees Celsius or 3 readings of oral temperature > 38.0 degrees Celsius in a 24 hour period) 3) ≥ grade 3 thrombocytopenia 4) ≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment.~5) Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity." (NCT00616122)
Timeframe: 8 weeks
| Intervention | mg (Number) |
|---|
| Sunitinib, Cyclophosphamide, and Methotrexate | 37.5 |
Patients With Progression-free Survival (PFS) Greater Than or Equal to 12 Weeks (Phase II)
Progression defined as: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), or appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). (NCT00616122)
Timeframe: up to 12 weeks after treatment start date
| Intervention | participants (Number) |
|---|
| Sunitinib, Cyclophosphamide, and Methotrexate | 7 |
Overall Response Rate
"Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable: Does not qualify for complete response, partial response or progression." (NCT00616122)
Timeframe: until disease progression, up to 13 months post treatment
| Intervention | participants (Number) |
|---|
| Sunitinib, Cyclophosphamide, and Methotrexate | 1 |
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Week 29 to week 37
| Intervention | participants (Number) |
|---|
| Treatment (Combination Chemotherapy) | 14 |
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Week 23 to week 28
| Intervention | participants (Number) |
|---|
| Treatment (Combination Chemotherapy) | 9 |
Incidence of Death
Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy (NCT00618813)
Timeframe: Length of protocol therapy (up to 37 weeks) plus 30 days
| Intervention | participants (Number) |
|---|
| Treatment (Combination Chemotherapy) | 0 |
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Enrollment to week 12
| Intervention | participants (Number) |
|---|
| Treatment (Combination Chemotherapy) | 12 |
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22
The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Week 13 to week 22
| Intervention | participants (Number) |
|---|
| Treatment (Combination Chemotherapy) | 9 |
Number of Patients Whose Disease Progressed After Treatment
Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment. (NCT00625729)
Timeframe: 6 Months
| Intervention | Participants (Number) |
|---|
| Responder Patients | 2 |
Number of Patients With Adequate Natural Killer Cells Infused
Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg). (NCT00625729)
Timeframe: Day 0
| Intervention | Participants (Number) |
|---|
| Patients Treated With Natural Killer Cells | 6 |
Number of Patients With Interleukin-15 Production and NK Cell Expansion
Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion (NCT00625729)
Timeframe: Day 0
| Intervention | Participants (Number) |
|---|
| Patients Treated With Natural Killer Cells | 0 |
Number of Patients With Overall Survival
Number of patients alive at 6 months after treatment. (NCT00625729)
Timeframe: 6 Months
| Intervention | Participants (Number) |
|---|
| Patients Treated With Natural Killer Cells | 3 |
Number of Patients Exhibiting Natural Killer Cell Expansion
Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population. (NCT00625729)
Timeframe: Day 14
| Intervention | Participants (Number) |
|---|
| Patients Treated With Natural Killer Cells | 0 |
Number of Patients With Overall Response
Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia (NCT00625729)
Timeframe: 3 Months
| Intervention | Participants (Number) |
|---|
| Patients Treated With Natural Killer Cells | 4 |
Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. NCT00626197)
Timeframe: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
| Intervention | Percentage of Participants (Number) |
|---|
| Baseline | Day 15 | Week 4 | Week 16 | Week 32 | Week 48 | Day 1 Pre-infusion | Day 1 Post-infusion | Day 15 Pre-infusion | Day 15 Post-infusion | Week 16 Pre-infusion | Week 16 Post-infusion | Week 32 Pre-infusion | Week 32 Post-infusion |
|---|
| OCR + SOC | 35 | 100 | 100 | 100 | 98.6 | 98.5 | 34.8 | 98.5 | 100 | 100 | 100 | 100 | 99.2 | 100 |
,| OCR 1000 mg + SOC | 33.3 | 100 | 100 | 100 | 100 | 100 | 32.8 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
,| OCR 400 mg + SOC | 36.6 | 100 | 100 | 100 | 97.3 | 97.2 | 36.6 | 97.1 | 100 | 100 | 100 | 100 | 98.4 | 100 |
,| Placebo + SOC | 27.1 | 28.8 | 39.7 | 57.1 | 52.9 | 51.5 | 27.1 | 55.7 | 30.0 | 58.2 | 56.7 | 80.3 | 50 | 88.3 |
,| Placebo-Euro Lupus (EL) | 23.1 | 26.9 | 40.7 | 72 | 87 | 78.3 | 23.1 | 59.3 | 28 | 68 | 70.8 | 95.2 | 85.7 | 95.5 |
,| Placebo-Mycophenolate Mofetil (MMF) | 29.5 | 30 | 39 | 48.9 | 35.6 | 37.8 | 29.5 | .5 | 32.6 | 52.4 | 48.8 | 72.5 | 30.8 | 84.2 |
Number of Participants Who Achieved Complete Renal Response (CRR)
CRR was defined as: 1. Normal serum creatinine (and with no more than a 25 percent [%] increase from Baseline); 2. Improvement in urinary protein:urinary creatinine ratio to less than or equal to (≤) 0.5. PRR was defined as at least 50 percent (%) reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was greater than (>) 3, a urine protein:urine creatinine ratio of less than (<) 3 needed to be achieved. (NCT00626197)
Timeframe: Week 48
| Intervention | Percentage of Participants (Number) |
|---|
| CRR | PRR |
|---|
| OCR 1000 mg + SOC | 31.5 | 35.6 |
,| OCR 400 mg + SOC | 42.7 | 24 |
,| Placebo + SOC | 34.7 | 20 |
Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. CD19+ cells were measured as cells per microliter (cells/uL). (NCT00626197)
Timeframe: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
| Intervention | Cells/uL (Mean) |
|---|
| Baseline | Day 15 | Week 4 | Week 16 | Week 32 | Week 48 | Day 1 Pre-infusion | Day 1 Post-infusion | Day 15 Pre-infusion | Day 15 Post-infusion | Week 16 Pre-infusion | Week 16 Post-infusion | Week 32 Pre-infusion | Week 32 Post-infusion |
|---|
| OCR + SOC | 240.8 | 2 | 1.4 | 2.3 | 5.1 | 7.3 | 240 | 8.4 | 2 | 0.9 | 2.3 | 1 | 3.6 | 0.9 |
,| OCR 1000 mg + SOC | 224.1 | 2.2 | 1.3 | 2 | 2.1 | 2.6 | 222.8 | 5.7 | 2.1 | 0.9 | 2.1 | 0.8 | 2 | 0.7 |
,| OCR 400 mg + SOC | 256.3 | 1.9 | 1.4 | 2.6 | 7.8 | 11.7 | 256.3 | 11.1 | 1.9 | 1 | 2.5 | 1.2 | 5.1 | 1 |
,| Placebo + SOC | 203.5 | 262.7 | 209.7 | 125.9 | 116.6 | 110 | 203.5 | 103.1 | 264.4 | 91.2 | 127.8 | 52.7 | 125 | 46.2 |
,| Placebo-Euro Lupus (EL) | 186.3 | 163.3 | 143.3 | 74.7 | 68.5 | 61.3 | 186.3 | 104.3 | 164.5 | 65.8 | 76.3 | 30.9 | 72.2 | 27.6 |
,| Placebo-Mycophenolate Mofetil (MMF) | 213.7 | 327.4 | 253.4 | 154.3 | 141.2 | 134.9 | 213.7 | 102.4 | 322.5 | 106.3 | 156.5 | 64.2 | 153.4 | 56.9 |
Percentage of Participants Who Achieved Overall Response
Overall response rate (ORR) equals (=) CRR + PRR. CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from baseline) 2. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50 % reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio is >3, a urine protein:urine creatinine ratio of <3 needs to be achieved. (NCT00626197)
Timeframe: Week 48
| Intervention | Percentage of Participants (Number) |
|---|
| OCR 400 mg + SOC | 66.7 |
| OCR 1000 mg + SOC | 67.1 |
| Placebo + SOC | 54.7 |
Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. n = number of participants analyzed at the specified visit. 0 represents 0% of participants. (NCT00626197)
Timeframe: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
| Intervention | Percentage of Participants (Number) |
|---|
| Baseline | Day 15 | Week 4 | Week 16 | Week 32 | Week 48 | Day 1 Pre-infusion | Day 1 Post-infusion | Day 15 Pre-infusion | Day 15 Post-infusion | Week 16 Pre-infusion | Week 16 Post-infusion | Week 32 Pre-infusion | Week 32 Post-infusion |
|---|
| OCR + SOC | 7.3 | 99.3 | 100 | 98.6 | 96.5 | 94.9 | 7.2 | 89.1 | 99.3 | 100 | 98.5 | 100 | 97.6 | 100 |
,| OCR 1000 mg + SOC | 3 | 98.5 | 100 | 98.6 | 100 | 98.5 | 3 | 91.2 | 98.6 | 100 | 98.5 | 100 | 100 | 100 |
,| OCR 400 mg + SOC | 11.3 | 100 | 100 | 98.6 | 93.2 | 91.5 | 11.3 | 87 | 100 | 100 | 98.5 | 100 | 95.2 | 100 |
,| Placebo + SOC | 7.1 | 7.6 | 10.3 | 11.4 | 13.2 | 17.6 | 7.1 | 22.9 | 7.4 | 17.9 | 10.4 | 41 | 8.3 | 35 |
,| Placebo-Euro Lupus (EL) | 0 | 3.8 | 7.4 | 8 | 8.7 | 26.1 | 0 | 25.9 | 4 | 12 | 8.3 | 57.1 | 4.8 | 50 |
,| Placebo-Mycophenolate Mofetil (MMF) | 11.4 | 10 | 12.2 | 13.3 | 15.6 | 13.3 | 11.4 | 20.9 | 9.3 | 21.4 | 11.6 | 32.5 | 10.3 | 26.3 |
Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL)
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. 0 represents 0% of participants. (NCT00626197)
Timeframe: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
| Intervention | Percentage of Participants (Number) |
|---|
| Baseline | Day 15 | Week 4 | Week 16 | Week 32 | Week 48 | Day 1 Pre-infusion | Day 1 Post-infusion | Day 15 Pre-infusion | Day 15 Post-infusion | Week 16 Pre-infusion | Week 16 Post-infusion | Week 32 Pre-infusion | Week 32 Post-infusion |
|---|
| OCR + SOC | 2.9 | 98.6 | 99.3 | 96.5 | 93.6 | 93.4 | 2.9 | 82.5 | 98.6 | 100 | 97 | 100 | 94.4 | 100 |
,| OCR 1000 mg + SOC | 1.5 | 97.1 | 100 | 97.1 | 95.6 | 98.5 | 1.5 | 83.8 | 97.1 | 100 | 97 | 100 | 95.2 | 100 |
,| OCR 400 mg + SOC | 4.2 | 100 | 98.5 | 95.8 | 91.8 | 88.7 | 4.2 | 81.2 | 100 | 100 | 97 | 100 | 93.7 | 100 |
,| Placebo + SOC | 4.3 | 4.5 | 4.4 | 4.3 | 7.4 | 5.9 | 4.3 | 10 | 4.4 | 7.5 | 4.5 | 11.5 | 3.3 | 15 |
,| Placebo-Euro Lupus (EL) | 0 | 0 | 0 | 0 | 4.3 | 8.7 | 0 | 3.7 | 0 | 0 | 0 | 9.5 | 0 | 22.7 |
,| Placebo-Mycophenolate Mofetil (MMF) | 6.8 | 7.5 | 7.3 | 6.7 | 8.9 | 4.4 | 6.8 | 14 | 7 | 11.9 | 7 | 12.5 | 5.1 | 10.5 |
Engraftment of Allogeneic Blood Cells.
"Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment.~Adequacy of engraftment will be assessed via assessment of chimerism (percent donor engraftment). Less than 20% engraftment by day 30 is then failure of engraftment.~Safety is defined per common toxicity criteria - Non-Hematological and non renal toxicities of ≥grade 3 or ≥grade 4 up to day 30 are scored as toxicity." (NCT00626626)
Timeframe: two years
| Intervention | Participants (Count of Participants) |
|---|
| Adequate Engraftment | Safety |
|---|
| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I ) | 2 | 5 |
,| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II) | 1 | 3 |
Overall Survival
Number of participants that are alive at 18th month (NCT00629499)
Timeframe: 18 Months
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 63 |
Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel
(NCT00629499)
Timeframe: 18 Months
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 63 |
Disease-free Survival
Number of participants that are disease free at 18th month (NCT00629499)
Timeframe: 18 Months
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 63 |
Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with ER+/PR-/HER2- breast cancer only. (NCT00630032)
Timeframe: At 5 years
| Intervention | Events (Number) |
|---|
| Docetaxel | 21 |
| Ixabepilone | 17 |
Number of Event-free Survival
The Event-free Survival is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first. (NCT00630032)
Timeframe: At 5 years
| Intervention | Events (Number) |
|---|
| Docetaxel | 77.46 |
| Ixabepilone | 81.53 |
Overall Survival
The overall survival is the length of time from randomization that patients enrolled in the study are still alive. (NCT00630032)
Timeframe: At 5 years
| Intervention | percentage of participants (Number) |
|---|
| Docetaxel | 87.00 |
| Ixabepilone | 87.60 |
Percentage of Participants With Disease-free Survival (DFS)
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first (NCT00630032)
Timeframe: At 5 years
| Intervention | Percentage of participants (Number) |
|---|
| Docetaxel | 78.97 |
| Ixabepilone | 83.37 |
Number of Disease-free Survival Events for Triple-negative Subgroup
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with triple negative breast cancer only. (NCT00630032)
Timeframe: At 5 years
| Intervention | Events (Number) |
|---|
| Docetaxel | 69 |
| Ixabepilone | 50 |
Number of Participants With Chronic Graft-Versus-Host Disease (GVHD)
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00630253)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 2 |
| UCB Arm | 0 |
| Marrow Clinimax | 0 |
Number of Participants With Acute Graft-Versus-Host Disease (GVHD)
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00630253)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 0 |
| UCB Arm | 0 |
| Marrow Clinimax | 0 |
Number of Participants Experiencing Overall Survival
"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.~Overall survival will be defined as time from enrollment to date of death or censored at the date of last documented contact for patients still alive." (NCT00630253)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 15 |
| UCB Arm | 8 |
| Marrow Clinimax | 5 |
Number of Participants Experiencing Graft Failure
graft failure = absolute neutrophil count (ANC) <5 x 10^8/L and an acellular bone marrow aspirate/biopsy (NCT00630253)
Timeframe: From Day 1 to event, assessed up to100 days
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Isolex | 0 |
| UCB Arm | 0 |
| Marrow Clinimax | 0 |
Progression Free Survival
Progression-Free Survival will be defined the percentage of participants alive and progression-free at median follow up of 25 months. Patients will be routinely followed for disease progression and those who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress or die will be censored at the day of their last treatment assessment. Patients who have not received study regimen or did not have on-study treatment assessments will be censored on the day they entered the trial. Patients who receive chemotherapy for reasons other than documented progression of disease or clinical progression without documented progression will be censored on the earliest date of subsequent therapy (NCT00632827)
Timeframe: Up to 3 years
| Intervention | percentage of partcipants (Number) |
|---|
| Treatment Plan | 65 |
Complete Response Rate
The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients. (NCT00632827)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment Plan | 14 |
Overall Survival Rate
Overall Survival will be defined the percentage of participants alive at median follow up of 25 months. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. The analysis is expected to occur up to 60 months after the first patient is entered the trial. (NCT00632827)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment Plan | 75 |
Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)
INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression. (NCT00634179)
Timeframe: Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks
| Intervention | mg/m^2 (Number) |
|---|
| MTD of Bortezomib With Vincristine Capped at 1.5 mg | 1.62 |
An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria
Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response. (NCT00634179)
Timeframe: Following completion of therapy, up to 2 years
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Overall Response Rate (ORR) |
|---|
| Phase I: Induction | 13 | 6 | 19 |
,| Phase II: Maintenance | 19 | 10 | 29 |
Number of Participant With Clinical or Subclinical Cardiotoxicity
Left ventricular ejection fraction (LVEF) measurements and clinical examination at baseline and at end of therapy will be used. (NCT00635050)
Timeframe: Prior to treatment and at completion of chemotherapy
| Intervention | participants (Number) |
|---|
| Doxil, Paclitaxel, Cyclophosphamide + Avastin | 0 |
Rate of Achievement of Pathological Complete Response (pCR)
Results of the pathologic evaluation of the surgical specimen(s) from operation (segmental or total mastectomy) will be used to report the overall complete pathological response rate. Criteria used were those described by Kaufmann et al, Journal of Clinical Oncology 2003; 21(13):2600-2608. The definition of pCR used from this source was absence of invasive cancer in both resected breast tissue and in resected axillary nodes. (NCT00635050)
Timeframe: After completion of at least 8 of the 9 chemotherapy doses and operation.
| Intervention | pathology specimens from participants (Number) |
|---|
| Doxil, Paclitaxel, Cyclophosphamide + Avastin | 9 |
Calculate Progression Free Survival
Progression free survival (PFS) will be defined as survival without local recurrence of breast cancer and without the development of distant metastasis. Death from any cause will be included as an event. The Kaplan-Meier nonparametric method will be used to estimate progression free survival. (NCT00635050)
Timeframe: 5 years
| Intervention | participants (Number) |
|---|
| Doxil, Paclitaxel, Cyclophosphamide + Avastin | 22 |
Overall Survival
(NCT00636155)
Timeframe: 5 years
| Intervention | months (Median) |
|---|
| All Patients | 10.6 |
Number of Patients With an Overall Response (Complete Response + Partial Response)
Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months. (NCT00636155)
Timeframe: every 3 cycles
| Intervention | participants (Number) |
|---|
| All Patients | 9 |
Progression Free Survival
Progression is defined as at least one of the following: 1) ≥ 50% increase in the sum of the products of at least two lymph nodes one two consecutive determinations (at least one node must be ≥ 2 cm); appearance of new palpable lymph nodes, 2) ≥ 50% increase in the size of the liver and/or spleen; appearance of palpable hepatomegaly or splenomegaly, which was not previously present, 3) ≥ 50% increase in the absolute number of circulating lymphocytes to at least 5,000/µl or 4)Transformation to a more aggressive histology. (NCT00636155)
Timeframe: 5 years
| Intervention | months (Median) |
|---|
| All Patients | 5.3 |
Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer
Pathological complete response (pCR) was defined as the disappearance of all invasive disease in the breast or if only residual in situ or lymph node disease is found. The pCR rate is presented with its 95% confidence interval for the Guided and Non-guided arms. (NCT00636441)
Timeframe: 4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks
| Intervention | percentage of participants (Number) |
|---|
| Guided Arm | 16.7 |
| Non-Guided Arm | 9.1 |
Overall Survival
Overall survival is defined as the time from enrollment to death due to any cause. The 2-year overall survival rate is estimated with the Kaplan-Meier method. (NCT00636441)
Timeframe: 2 years
| Intervention | Estimated % of participants surviving (Number) |
|---|
| Guided Arm | 96 |
| Non-Guided Arm | 100 |
Sites of Recurrence
Sites of Recurrence is a categorical outcome whose possible values are the organ-specific sites at which disease recurrence was observed. A patient may recur at more than one site. (NCT00636441)
Timeframe: 10 years
| Intervention | participants (Number) |
|---|
| Bone | Brain | Chest Wall | Liver | Lung |
|---|
| Guided Arm | 3 | 1 | 1 | 2 | 1 |
,| Non-Guided Arm | 1 | 0 | 0 | 0 | 0 |
Disease-free Survival
Disease-free survival is defined as the length of time from enrollment to local or distant disease recurrence, whichever comes first; disease-free deaths are censored. The 2-year disease-free survival rate is estimated with its 95% confidence interval. (NCT00636441)
Timeframe: 2 years
| Intervention | estimated % of participants disease-free (Number) |
|---|
| Guided Arm | 92 |
| Non-Guided Arm | 89 |
Clinical Response Using WHO Criteria
"WHO criteria are based on the sum of the products of the longest axis and the longest perpendicular axis. Bi-dimensional measurements were taken of all breast lesions and axillary nodes using the best imaging modality performed after completion of assigned therapy.~Clinical Complete Response (cCR): Disappearance of all target lesions by physical exam and best imaging modality.~Clinical Partial Response (cPR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum LD at treatment initiation. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.~Progression (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesion." (NCT00636441)
Timeframe: 12 weeks, 2-3 weeks after the fourth cycle of chemotherapy
| Intervention | participants (Number) |
|---|
| Complete Response (cCR) | Partial Response (cPR) | Stable Disease | Progressive Disease | Not Evaluable/Not Assessed |
|---|
| Guided Arm | 2 | 15 | 6 | 1 | 1 |
,| Non-Guided Arm | 2 | 7 | 2 | 0 | 2 |
To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.
The percentage of patients who had breast-conserving surgery at first attempt, measured only in patients with T2 tumors classified as potential candidates for breast conservation. (NCT00636441)
Timeframe: 6 months
| Intervention | percentage of T2 tumor patients (Number) |
|---|
| Guided Arm | 67 |
| Non-Guided Arm | 100 |
Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
| Intervention | ng/mL*hr (Geometric Mean) |
|---|
| Aprepitant | 4416 |
| Control | 3817 |
Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
| Intervention | ng/mL*hr (Geometric Mean) |
|---|
| Aprepitant | 41 |
| Control | 39 |
Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)
| Intervention | ng/mL*hr (Geometric Mean) |
|---|
| Aprepitant | 287 |
| Control | 265 |
Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
| Intervention | ug/mL*hr (Geometric Mean) |
|---|
| Aprepitant | 4.5 |
| Control | 6.0 |
Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
| Intervention | ug/mL*hr (Geometric Mean) |
|---|
| Aprepitant | 3.9 |
| Control | 4.0 |
Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)
| Intervention | ug/mL*hr (Geometric Mean) |
|---|
| Aprepitant | 300 |
| Control Group | 250 |
Number of Patients Per Disease Response
Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- < or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of < or = 1 new lesion. (NCT00652899)
Timeframe: 1 Month After Natural Killer Cell Infusion (Day 30)
| Intervention | Patients (Number) |
|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease |
|---|
| No Total Body Irradiation | 0 | 2 | 4 | 1 |
,| Total Body Irradiation | 0 | 1 | 4 | 0 |
Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion. (NCT00652899)
Timeframe: Day 12-14
| Intervention | Patients (Number) |
|---|
| Ovarian/Fallopian Tube/Peritoneal Cancer Patients | 0 |
Toxic Death
The number of patients who experience death that is considered to be primarily attributable to complications of treatment. (NCT00653068)
Timeframe: During and after completion of study treatment up to 1 year after enrollment.
| Intervention | Participants (Count of Participants) |
|---|
| Stratum I | 3 |
| Stratum III | 1 |
Overall Survival (OS)
Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored. (NCT00653068)
Timeframe: Up to 4 years after study enrollment
| Intervention | Estimated Probability (Number) |
|---|
| Stratum I | 0.3888 |
| Stratum III | 0.5486 |
Event-free Survival
Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT00653068)
Timeframe: Up to 4 years after study enrollment
| Intervention | Estimated probability (Number) |
|---|
| Stratum I | 0.3401 |
| Stratum III | 0.4500 |
Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy
Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy. (NCT00653068)
Timeframe: During protocol therapy up to 1 year after enrollment.
| Intervention | Participants (Count of Participants) |
|---|
| Acidosis | Acute kidney injury | Apnea | Adult respiratory distress syndrome | Aspiration | Atelectasis | Catheter related infection | Central nervous system necrosis | Dehydration | Diarrhea | Dissmeminated intravascular coagulation (DIC) | Enterocolitis | Febrile neutropenia | Hearing impairment | Hematuria | Hydrocephalus | Hypernatremia | Hypoalbuminemia | Hypocalcemia | Hypoglycemia | Hypokalemia | Hyponatremia | Hypophosphatemia | Hypotension | Hypoxia | Increased Alanine aminotransferase | Increased Aspartate aminotransferase | Increased Lipase | Intracranial hemorrhage | ntraoperative venous injury | Laryngospasm | Left ventricular systolic dysfunction | Lung infection | Multi-organ failure | Mucositis oral | Poisoning and procedural complications | Other gastrointestinal disorders | Other infection | Pneumonitis | Productive cough | Pulmonary edema | Recurrent laryngeal nerve palsy | Renal calculi | Respiratory failure | Seizure | Sepsis | Sinus tachycardia | Stridor | Upper respiratory infection | Vascular access complication | Voice alteration | Vomiting | Weight loss |
|---|
| All Patients | 1 | 1 | 2 | 1 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 6 | 1 | 1 | 1 | 1 | 1 | 3 | 2 | 9 | 2 | 2 | 4 | 6 | 5 | 4 | 1 | 2 | 1 | 1 | 1 | 3 | 1 | 3 | 1 | 1 | 7 | 2 | 1 | 1 | 1 | 1 | 3 | 2 | 6 | 2 | 2 | 1 | 1 | 1 | 1 | 1 |
Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy
Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value. (NCT00656669)
Timeframe: baseline through end of segment 1 (2 weeks)
| Intervention | mm Hg (Mean) |
|---|
| Sunitinib Monotherapy | 14.0 |
Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy
Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value. (NCT00656669)
Timeframe: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)
| Intervention | mm Hg (Mean) |
|---|
| Paclitaxel Plus Sunitinib | 1.7 |
To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy
This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib. (NCT00656669)
Timeframe: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)
| Intervention | participants (Number) |
|---|
| Paclitaxel Plus Sunitinib | 11 |
Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer
(NCT00656669)
Timeframe: screening through surgery
| Intervention | percentage of participants (Number) |
|---|
| AC Dosing | 53.3 |
Number of Participants With Grade 4 Adverse Events
Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE. (NCT00665457)
Timeframe: every 3 weeks X 4, then every 2 weeks X4
| Intervention | Participants (Count of Participants) |
|---|
| Celecoxib | 1 |
Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation.
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate." (NCT00667615)
Timeframe: through study completion, an average of 1 year
| Intervention | percentage of participants with CR (Number) |
|---|
| Relapsed or Refractory Diffuse Large B-cell Lymphoma | 32 |
Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
Maximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in >= 50% of participants (NCT00667615)
Timeframe: through study completion, an average of 1 year
| Intervention | mg/m2 (Number) |
|---|
| Relapsed or Refractory Diffuse Large B-cell Lymphoma | 300 |
Overall Survival
Number of patients alive at timepoints. (NCT00668564)
Timeframe: Day 100, 1 Year, 3 Years
| Intervention | Participants (Number) |
|---|
| Day 100 | 1 Year |
|---|
| Intent-to-Treat | 14 | 12 |
Number of Patients Achieving Engraftment
Rate of successful engraftment - patients who achieved and sustained donor engraftment; donor chimerism by day 100 of at least 90% after undergoing hematopoietic stem cell transplantation. (NCT00668564)
Timeframe: Day 100
| Intervention | Participants (Number) |
|---|
| Intent-to-Treat | 14 |
Complete Remission Rate: Percentage of Participants With Complete Remission (CR)
Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR. (NCT00669877)
Timeframe: After two 21-day courses, response to treatment checked for Complete Remission (CR)
| Intervention | percentage of participants (Number) |
|---|
| Hyper-CVAD | 85 |
Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR)
Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR. (NCT00669877)
Timeframe: After two 21-day courses, response to treatment checked for Complete Remission (CR)
| Intervention | percentage of participants (Number) |
|---|
| Hyper-CVAD | 89 |
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
(NCT00670358)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3+ Adverse Event | Grade 4+ Adverse Event | Grade 3+ Hem Adverse Event | Grade 4+ Hem Adverse Event | Grade 3+ Non-Hem Adverse Event |
|---|
| Ph 1, DL 1 | 3 | 2 | 3 | 2 | 1 |
,| Ph1, DL 2 | 3 | 1 | 3 | 1 | 1 |
,| Ph1, DL 3 | 5 | 4 | 5 | 4 | 2 |
Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3)
Other Phase II Cohorts were not evaluable for event-free survival analysis. (NCT00670358)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Ph II, DLBCL/Mixed | 44 |
Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT00670748)
Timeframe: Approximately 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response | Progressive Disease | Stable Disease | Not Evaluable |
|---|
| #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 3 | 6 | 7 | 0 | 1 |
,| #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 1 | 7 | 7 | 0 | 1 |
,| #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 1 | 1 | 4 | 0 | 1 |
,| #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 0 | 3 | 2 | 0 | 0 |
Number of Participants With Serious and Non-Serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00670748)
Timeframe: Date treatment consent signed to date off study, approximately, 66 months and 10 days
| Intervention | Participants (Count of Participants) |
|---|
| #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 17 |
| #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 16 |
| #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 7 |
| #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 5 |
Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells
Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells. (NCT00670748)
Timeframe: 1 month post treatment
| Intervention | Participants (Count of Participants) |
|---|
| #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 16 |
| #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 16 |
| #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 6 |
| #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 4 |
Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)
Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half. (NCT00671034)
Timeframe: Post Day 29 of Induction and Post Day 22 of Consolidation
| Intervention | hours (Mean) |
|---|
| Asparaginase half-life during Consolidation | Asparaginase half-life during Induction |
|---|
| Arm I (Calaspargase Pegol 2100) | 415.8 | 305.1 |
,| Arm II ( Calaspargase Pegol 2500) | 355.9 | 321.5 |
,| Arm III (Pegaspargase 2500) | 117.2 | 126.9 |
Plasma and CSF Concentrations of Asparagine in ug/ml
The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar. (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)
| Intervention | ug/mL (Mean) |
|---|
| CSF asparagine concentration (ug/mL) | Plasma asparagine concentration (ug/mL) |
|---|
| Arm I (Calaspargase Pegol 2100) | 0.2 | 0.2 |
,| Arm II (Calaspargase Pegol 2500) | 0.19 | 0.25 |
,| Arm III (Pegaspargase 2500) | 0.26 | 0.83 |
Toxicities During Post Induction Intensification Therapy (All Grades)
The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events. (NCT00671034)
Timeframe: Up to 5 years
| Intervention | Percentage of participants (Number) |
|---|
| Alergic Reaction - Consolidation | Alergic Reaction - Delayed Intensification I | Alergic Reaction - Interim Maintenance I | CNS - Consolidation | CNS - Delayed Intensification I | CNS - Interim Maintenance I | Hyperbilirubinemia - Consolidation | Hyperbilirubinemia - Delayed Intensification I | Hyperbilirubinemia - Interim Maintenance I | Hyperglycemia - Consolidation | Hyperglycemia - Delayed Intensification I | Hyperglycemia - Interim Maintenance I | Hyperlipidemia - Consolidation | Hyperlipidemia - Delayed Intensification I | Hyperlipidemia - Interim Maintenance I | % patients w/INR increase - Consolidation | % pts w/INR increase - Delayed Intensification I | % patients w/INR increase - Interim Maintenance I | Pancreatitis - Consolidation | Pancreatitis -Delayed Intensification I | Pancreatitis - Interim Maintenance I | % pts w/prolongation of APT time - Consolidation | % pts w/prolongation APT time -Delayed Intension I | %pts w/prolongation APT time-Interim maintenance I | Thrombosis - Consolidation | Thrombosis - Delayed Intensification I | Thrombosis - Interim Maintenance I |
|---|
| Arm I (Calaspargase Pegol 2100) | 20.4 | 4.4 | 0.0 | 0.0 | 0.0 | 0.0 | 53.1 | 28.9 | 41.3 | 44.9 | 44.4 | 34.8 | 2.0 | 2.2 | 2.2 | 6.1 | 6.7 | 2.2 | 10.2 | 2.2 | 2.2 | 8.2 | 8.9 | 6.5 | 0.0 | 2.2 | 0.0 |
,| Arm II (Calaspargase Pegol 2500) | 27.3 | 0.0 | 0.0 | 0.0 | 3.8 | 0.0 | 45.5 | 38.5 | 27.6 | 42.4 | 61.5 | 44.8 | 3.0 | 0.0 | 3.4 | 3.0 | 3.8 | 0.0 | 6.1 | 7.7 | 3.4 | 9.1 | 26.9 | 6.9 | 0.0 | 0.0 | 0.0 |
,| Arm III (Pegaspargase 2500) | 23.3 | 0.0 | 2.1 | 0.0 | 2.6 | 0.0 | 30.2 | 10.5 | 33.3 | 46.5 | 36.8 | 33.3 | 7.0 | 0.0 | 2.6 | 7.0 | 0.0 | 2.6 | 7.0 | 0.0 | 2.6 | 7.0 | 18.4 | 7.7 | 2.3 | 0.0 | 0.0 |
Pharmacodynamics (PD)
Plasma Asparaginase Concentration During consolidation and induction. (NCT00671034)
Timeframe: Day 29 of consolidation and induction
| Intervention | mIU/mL (Median) |
|---|
| Plasma Asparaginase Concentration- Consolidation | Plasma Asparaginase Concentration- Induction |
|---|
| Arm I (Calaspargase Pegol 2100) | 575.9 | 271.6 |
,| Arm II (Calaspargase Pegol 2500) | 617.2 | 339.6 |
,| Arm III (Pegaspargase 2500) | 562.1 | 72.8 |
Asparaginase Level
The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar (NCT00671034)
Timeframe: Days 4, 15, 22 and 29 of Induction
| Intervention | percentage of patients (Number) |
|---|
| Level at least 0.1 IU/mL day 4 | Level at least 0.1 IU/mL day 15 | Level at least 0.1 IU/mL day 22 | Level at least 0.1 IU/mL day 29 | Level at least 0.4 IU/mL day 4 | Level at least 0.4 IU/mL day 15 | Level at least 0.4 IU/mL day 22 | Level at least 0.4 IU/mL day 29 |
|---|
| Arm I (Calaspargase Pegol 2100) | 0 | 98.4 | 98.2 | 94.9 | 0 | 75.8 | 37.5 | 13.6 |
,| Arm II (Calaspargase Pegol 2500) | 0 | 100 | 100 | 95.0 | 0 | 95.0 | 62.5 | 27.5 |
,| Arm III (Pegaspargase 2500) | 0 | 100 | 95.1 | 28.6 | 0 | 93.0 | 14.6 | 0 |
Immunogenicity
Number of Patients with Positive Immunogenicity tests (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Calaspargase Pegol 2100) | 2 |
| Arm II (Calaspargase Pegol 2500) | 2 |
| Arm III (Pegaspargase 2500) | 4 |
Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction
Percentage of participants with Negative MRD (MRD<0.01%). (NCT00671034)
Timeframe: End of induction (Day 29)
| Intervention | Percentage of participants (Number) |
|---|
| Arm I (Calaspargase Pegol 2100) | 65.2 |
| Arm II (Calaspargase Pegol 2500) | 81 |
| Arm III (Pegaspargase 2500) | 72.5 |
Percentage of Participants With Event-free Survival (EFS)
Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free. (NCT00671034)
Timeframe: 5 Years
| Intervention | Percentage of participants (Number) |
|---|
| Arm I (Calaspargase Pegol 2100) | 72.35 |
| Arm II (Calaspargase Pegol 2500) | 80.8 |
| Arm III (Pegaspargase 2500) | 79.34 |
Percentage of Participants With Complete Remission at the End of Induction
Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow) (NCT00671034)
Timeframe: End of induction (Day 29)
| Intervention | Percentage of participants (Number) |
|---|
| Arm I (Calaspargase Pegol 2100) | 92.4 |
| Arm II (Calaspargase Pegol 2500) | 97.6 |
| Arm III (Pegaspargase 2500) | 94.1 |
Number of Participants With a Response
Response - Complete remission (CR): Normalization peripheral blood & bone marrow 5% or & platelet count >100x10^9/L; CR with incomplete platelet recovery (CRp): CR but platelet count <100x10^9/L. CR with incomplete recovery (CRi): CR but platelet count <100x10^9/L or absolute neutrophil count < 1x10^9/L. Partial response (PR): As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (& ALL subtypes with extramedullary disease): CR - disappearance all known disease. PR - >50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but <50% or lesions with slight enlargement <25% increase in size. Progressive Disease (PD): Appearance new lesions, 25% or > increase in size existing lesions (>50% if 1 lesion & <2). (NCT00671658)
Timeframe: Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days
| Intervention | Participants (Number) |
|---|
| Complete Response (CR) | Complete Response without Platelet Recovery | Partial Response (PR) |
|---|
| HYPER-CVAD | 198 | 3 | 4 |
Proportion of Subjects With Platelet Engraftment
Proportion of patients engrafting by days +45, +90, and +180. (NCT00676806)
Timeframe: +45, 90, and 180 days
| Intervention | participants (Number) |
|---|
| Platelet Engraftment +45 days | Platelet Engraftment +90 days | Platelet Engraftment +180 days |
|---|
| Myeloablative Conditioning | 0 | 0 | 1 |
,| Reduced Intensity Conditioning | 2 | 0 | 0 |
Infectious Complications in UCB Recipients.
(NCT00676806)
Timeframe: Day +100
| Intervention | participants (Number) |
|---|
| Myeloablative Conditioning | 3 |
| Reduced Intensity Conditioning | 3 |
Incidence of Chronic GVHD
(NCT00676806)
Timeframe: After Day +100
| Intervention | participants (Number) |
|---|
| Myeloablative Conditioning | 1 |
Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation
Composite endpoint of GVH or infection. Too few events to compare between arms. (NCT00676806)
Timeframe: +180 days
| Intervention | events (Number) |
|---|
| Myeloablative Conditioning | 5 |
| Reduced Intensity Conditioning | 3 |
Incidence of Acute GVHD
(NCT00676806)
Timeframe: Day +100
| Intervention | participants (Number) |
|---|
| Myeloablative Conditioning | 1 |
| Reduced Intensity Conditioning | 0 |
Number of Participants With Neutrophil Engraftment
Number of participants with neutrophil engraftment receiving umbilical cord blood for hematopoietic rescue following myeloablative or non-myeloablative conditioning (NCT00676806)
Timeframe: +45 and 90 days
| Intervention | participants (Number) |
|---|
| Myeloablative Conditioning | 2 |
| Reduced Intensity Conditioning | 1 |
Overall Survival as Assessed by the Kaplan and Meier Method
Overall survival as assessed by the Kaplan and Meier method at 5 years (NCT00679029)
Timeframe: Original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 69.1 |
Disease-free Survival
Disease-free survival as assessed by the Kaplan and Meier method (NCT00679029)
Timeframe: From the date of first treatment to the date of disease progression/recurrence, second cancer, or death, whichever came first: Original time frame up to 5 years from date of first treatment; study terminated at 2.5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 70 |
Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions
This outcome is to measure the feasibility of the of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting in women with stage II and III breast cancer that does not over-express human epidermal growth factor receptor 2 (HER 2)/neu (NCT00679029)
Timeframe: through study completion, an average of 10 months
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 20 |
Number of Participants With Disease-Free Survival Events
Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. (NCT00688740)
Timeframe: up to 10 year follow-up
| Intervention | Participants (Number) |
|---|
| TAC (Docetaxel) | 287 |
| FAC (5-fluorouracil) | 333 |
Number of Participants With Overall Survival Events
Overall Survival - time from the date of randomization up to the date of death of any cause. (NCT00688740)
Timeframe: up to 10 year follow-up
| Intervention | Participants (Number) |
|---|
| TAC (Docetaxel) | 188 |
| FAC (5-fluorouracil) | 241 |
Number of Participants With Second Primary Malignancies (Toxicity)
Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast. (NCT00688740)
Timeframe: up to 10 year follow-up
| Intervention | Participants (Number) |
|---|
| TAC (Docetaxel) | 67 |
| FAC (5-fluorouracil) | 66 |
Overall Survival.
(NCT00691015)
Timeframe: At 2 years after PBSCT
| Intervention | percentage of participants (Number) |
|---|
| All Participants | 57.4 |
Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )
(NCT00691015)
Timeframe: post transplant, up to 4 weeks
| Intervention | Days (Median) |
|---|
| All Participants | 11 |
Incidence of Acute Graft-versus-host Disease (GVHD)
(NCT00691015)
Timeframe: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
| Intervention | percentage of participants (Number) |
|---|
| All Participants | 44.7 |
Incidence of Chronic GVHD.
(NCT00691015)
Timeframe: Within 2 years after PBSCT
| Intervention | percentage of participants (Number) |
|---|
| All Participants | 44.68 |
Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)
(NCT00691015)
Timeframe: Within 6 months after PBSCT
| Intervention | percentage of participants (Number) |
|---|
| All Participants | 80.85 |
Severity of Acute Graft-versus-host Disease (GVHD)
(NCT00691015)
Timeframe: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
| Intervention | % of participants with severe aGVHD (Number) |
|---|
| All Participants | 33.3 |
Clinical Response (Complete Response + Partial Response)
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions. (NCT00704938)
Timeframe: 5 months
| Intervention | Participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 0 | 0 |
,| Anti-p53 TCR PBL + DC + IL-2: Other Histology | 0 | 0 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module. (NCT00704938)
Timeframe: 5 months
| Intervention | Participants (Number) |
|---|
| Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 |
| Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 |
Duration of Response
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed. (NCT00711828)
Timeframe: Up to 3 years from registration
| Intervention | months (Median) |
|---|
| Treatment | 25.9 |
Adverse Events
Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report. (NCT00711828)
Timeframe: up to 12 cycles (28 days per cycle) of treatment
| Intervention | participants (Number) |
|---|
| Grade 3 | Grade 4 | Grade 5 |
|---|
| Treatment | 19 | 8 | 0 |
Overall Survival
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT00711828)
Timeframe: Up to 3 years from registration
| Intervention | months (Median) |
|---|
| Treatment | 54.8 |
Progression-free Survival
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier. (NCT00711828)
Timeframe: Up to 3 years from registration
| Intervention | months (Median) |
|---|
| Treatment | 11.6 |
Time to Treatment Failure
Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier. (NCT00711828)
Timeframe: Up to 3 years from registration
| Intervention | months (Median) |
|---|
| Treatment | 6.6 |
Proportion of Responses (Complete Response or Partial Response)
A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution. (NCT00711828)
Timeframe: up to 12 cycles
| Intervention | percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) |
|---|
| Treatment | 19.0 | 42.9 |
2-year PFS From the Start of Induction Therapy Conditional
2-year PFS from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation. (NCT00712582)
Timeframe: 2 years
| Intervention | percentage of patients (Number) |
|---|
| Consolidation A | 86.6 |
| Consolidation B | 90.6 |
| Consolidation C | 0.4 |
Overall Survival at 1 Year
Overall survival from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation. (NCT00712582)
Timeframe: 1 year
| Intervention | Percent of patients (Number) |
|---|
| Consolidation A | 98.3 |
| Consolidation B | 96.9 |
| Consolidation C | 50.0 |
Percentage of Participants With Progression-free Survival (PFS) at 1 Year
PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better). (NCT00715208)
Timeframe: Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD
| Intervention | percentage of participants (Number) |
|---|
| VELCADE R-CAP | 67 |
| VELCADE R-CP | 63 |
Duration of Response
"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.~CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria." (NCT00715208)
Timeframe: 2 years
| Intervention | Months (Median) |
|---|
| VELCADE R-CP | 21.9 |
Number of Patients Who Experienced at Least One Serious Adverse Event
(NCT00715208)
Timeframe: From completion of informed consent through 30 days after the last dose of study drug
| Intervention | participants (Number) |
|---|
| VELCADE R-CAP | 2 |
| VELCADE R-CP | 12 |
Number of Patients With Complete Response (CR)
Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria. (NCT00715208)
Timeframe: 30 weeks
| Intervention | participants (Number) |
|---|
| VELCADE R-CAP | 1 |
| VELCADE R-CP | 13 |
Number of Participants With Overall Response (OR)
"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.~CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET." (NCT00715208)
Timeframe: 30 weeks
| Intervention | participants (Number) |
|---|
| VELCADE R-CAP | 6 |
| VELCADE R-CP | 37 |
Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 29
MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment. (NCT00718549)
Timeframe: 8 weeks after the last dose of rituximab during induction treatment (Week 29)
| Intervention | percentage of participants (Number) |
|---|
| Age <60 years | Age >/=60 years | Sex: Female | Sex: Male | Rai Stage: I or II | Rai Stage: III or IV | Beta-2-Microglobulin >/= Median Value | Beta-2-Microglobulin | ZAP-70 Expression: Negative | ZAP-70 Expression: Positive | CD38 Expression: Negative | CD38 Expression: Positive | Cytogenetic abnormality 17p: No | Cytogenetic abnormality 17p: Yes | Cytogenetic abnormality 13q: No | Cytogenetic abnormality 13q: Yes | Cytogenetic abnormality 11q: No | Cytogenetic abnormality 11q: Yes | Cytogenetic abnormality 12q: No | Cytogenetic abnormality 12q: Yes | |
|---|
| All Randomized Participants | 87.8 | 79.2 | 87.5 | 82.9 | 80.4 | 100.0 | 93.1 | 77.1 | 82.6 | 100.0 | 83.3 | 95.5 | 83.6 | 100.0 | 84.2 | 81.8 | 83.3 | 84.2 | 80.5 | 75.0 |
Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL
CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, platelets (PL) >100,000/mcL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), bone marrow (BM) sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly (decrease in lymph node size by >/=50% compared to pre-treatment state, no increase in any lymph node, no new enlarged lymph node); a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). (NCT00718549)
Timeframe: 8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)
| Intervention | percentage of participants (Number) |
|---|
| Week 129 |
|---|
| Maintenance Arm: Rituximab | 90.5 |
,| Observation Arm: No Intervention | 72.2 |
Percentage of Participants With Disease Progression (PD), Relapse, or Death Due to Any Cause Assessed According to the National Cancer Institute (NCI) Revised Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia (CLL)
PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (greater than [>]1.5 centimeters [cm]), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of greater than or equal to (>/=) 50 percent (%) in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000 per microliter (/mcL); transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. (NCT00718549)
Timeframe: From randomization to PD, Relapse, or death due to any cause (overall approximately 5 years)
| Intervention | percentage of participants (Number) |
|---|
| Maintenance Arm: Rituximab | 27.3 |
| Observation Arm: No Intervention | 54.5 |
| All Randomized Participants | 40.9 |
Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL
PFS was defined as the time from date of randomization to date of PD, relapse, or death due to any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. (NCT00718549)
Timeframe: From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)
| Intervention | years (Median) |
|---|
| Maintenance Arm: Rituximab | NA |
| Observation Arm: No Intervention | 2.1 |
| All Randomized Participants | 3.1 |
PFS Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors
PFS: time from date of randomization to date of PD, relapse, or death from any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in previously noted enlargement of liver or spleen by >/=50%; an increase in number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and clinical outcome (PFS) after study treatment. (NCT00718549)
Timeframe: From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)
| Intervention | years (Median) |
|---|
| Age <60 years | Age >/=60 years | Sex: Female | Sex: Male | Rai Stage: I or II | Rai Stage: III or IV | Beta-2-Microglobulin >/= Median Value | Beta-2-Microglobulin | Zeta-Associated Protein (ZAP)-70: Negative | ZAP-70 Expression: Positive | CD38 Expression: Negative | CD38 Expression: Positive | Cytogenetic abnormality 17p: No | Cytogenetic abnormality 17p: Yes | Cytogenetic abnormality 13q: No | Cytogenetic abnormality 13q: Yes | Cytogenetic abnormality 11q: No | Cytogenetic abnormality 11q: Yes | Cytogenetic abnormality 12q: No | Cytogenetic abnormality 12q: Yes | |
|---|
| All Randomized Participants | 3.0 | 4.0 | 4.0 | 3.0 | 3.1 | 3.0 | 1.9 | NA | 3.0 | NA | 2.1 | 2.8 | 3.1 | 1.9 | 3.5 | 3.0 | 3.5 | 2.8 | 2.2 | 3.1 |
Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 129
MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment. (NCT00718549)
Timeframe: 12 weeks after the end of maintenance treatment or observation phase (Week 129)
| Intervention | percentage of participants (Number) |
|---|
| Age <60 years | Age >/=60 years | Sex: Female | Sex: Male | Rai Stage: I or II | Rai Stage: III or IV | Beta-2-Microglobulin >/= Median Value | Beta-2-Microglobulin | ZAP-70 Expression: Negative | ZAP-70 Expression: Positive | CD38 Expression: Negative | CD38 Expression: Positive | Cytogenetic abnormality 17p: No | Cytogenetic abnormality 17p: Yes | Cytogenetic abnormality 13q: No | Cytogenetic abnormality 13q: Yes | Cytogenetic abnormality 11q: No | Cytogenetic abnormality 11q: Yes | Cytogenetic abnormality 12q: No | Cytogenetic abnormality 12q: Yes | |
|---|
| All Randomized Participants | 72.2 | 83.3 | 71.4 | 76.5 | 75.0 | 75.0 | 88.9 | 71.4 | 66.7 | 100.0 | 60.0 | 77.8 | 76.2 | 0.0 | 75.0 | 66.7 | 66.7 | 75.0 | 66.7 | 66.7 |
Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR
MRD was defined by the presence of tumor cells in bone marrow, using 4-color flow cytometry of cluster of differentiation (CD)19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR: if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). (NCT00718549)
Timeframe: 8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)
| Intervention | percentage of participants (Number) |
|---|
| Week 29 | Week 129 |
|---|
| All Randomized Participants | 15.4 | 25.0 |
Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR
MRD was defined by the presence of tumor cells in bone marrow, using 4-color flow cytometry of cluster of differentiation (CD)19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR: if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). (NCT00718549)
Timeframe: 8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)
| Intervention | percentage of participants (Number) |
|---|
| Week 129 |
|---|
| Maintenance Arm: Rituximab | 28.6 |
,| Observation Arm: No Intervention | 20.0 |
Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 29
CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment. (NCT00718549)
Timeframe: 8 weeks after the last dose of rituximab during induction treatment (Week 29)
| Intervention | percentage of participants (Number) |
|---|
| Age <60 years | Age >/=60 years | Sex: Female | Sex: Male | Rai Stage: I or II | Rai Stage: III or IV | Beta-2-Microglobulin >/= Median Value | Beta-2-Microglobulin | ZAP-70 Expression: Negative | ZAP-70 Expression: Positive | CD38 Expression: Negative | CD38 Expression: Positive | Cytogenetic abnormality 17p: No | Cytogenetic abnormality 17p: Yes | Cytogenetic abnormality 13q: No | Cytogenetic abnormality 13q: Yes | Cytogenetic abnormality 11q: No | Cytogenetic abnormality 11q: Yes | Cytogenetic abnormality 12q: No | Cytogenetic abnormality 12q: Yes | |
|---|
| Overall Population | 73.3 | 73.0 | 80.6 | 69.7 | 77.5 | 61.5 | 64.6 | 83.0 | 67.1 | 94.7 | 73.1 | 71.4 | 72.8 | 71.4 | 62.9 | 76.1 | 69.5 | 79.2 | 67.6 | 66.7 |
Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 129
CR was achieved if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment. (NCT00718549)
Timeframe: 12 weeks after the end of maintenance treatment or observation phase (Week 129)
| Intervention | percentage of participants (Number) |
|---|
| Age <60 years | Age >/=60 years | Sex: Female | Sex: Male | Rai Stage: I or II | Rai Stage: III or IV | Beta-2-Microglobulin >/= Median Value | Beta-2-Microglobulin | ZAP-70 Expression: Negative | ZAP-70 Expression: Positive | CD38 Expression: Negative | CD38 Expression: Positive | Cytogenetic abnormality 17p: No | Cytogenetic abnormality 17p: Yes | Cytogenetic abnormality 13q: No | Cytogenetic abnormality 13q: Yes | Cytogenetic abnormality 11q: No | Cytogenetic abnormality 11q: Yes | Cytogenetic abnormality 12q: No | Cytogenetic abnormality 12q: Yes | |
|---|
| All Randomized Participants | 80.8 | 84.6 | 85.7 | 80.0 | 80.6 | 87.5 | 76.9 | 84.0 | 83.3 | 83.3 | 77.8 | 75.0 | 86.7 | 50.0 | 90.0 | 76.5 | 84.2 | 80.0 | 76.2 | 100.0 |
Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL
CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, platelets (PL) >100,000/mcL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), bone marrow (BM) sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly (decrease in lymph node size by >/=50% compared to pre-treatment state, no increase in any lymph node, no new enlarged lymph node); a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). (NCT00718549)
Timeframe: 8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)
| Intervention | percentage of participants (Number) |
|---|
| Week 29 | Week 129 |
|---|
| Overall Population | 73.2 | 82.1 |
Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1
(NCT00719472)
Timeframe: Cycle 1
| Intervention | Percentage of participants (Number) |
|---|
| Rituximab 375 mg/m^2 | 91.8 |
Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)
(NCT00719472)
Timeframe: Cycle 2 through Cycle 6 or 8 (end of study)
| Intervention | Percentage of participants (Number) |
|---|
| Rituximab 375 mg/m^2 | 98.6 |
Duration of Rituximab Infusion Including Dose Interruption Times
The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported. (NCT00719472)
Timeframe: Day 1 of each of Cycles 1 to 6 or 8
| Intervention | Minutes (Median) |
|---|
| Cycle 1 (n=362) | Cycle 2 (n=363) | Cycle 3 (n=344) | Cycle 4 (n=329) | Cycle 5 (n=312) | Cycle 6 (n=303) | Cycle 7 (n=59) | Cycle 8 (n=59) |
|---|
| Rituximab 375 mg/m^2 | 245 | 91 | 91 | 91 | 91 | 91 | 91 | 91 |
Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)
Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples. (NCT00719472)
Timeframe: Day 1 of Cycles 2 and either 6 or 8 (last cycle)
| Intervention | µg/mL (Mean) |
|---|
| Cycle 2 (n=335) | Cycle 6 (n=238) | Cycle 8 (n=36) |
|---|
| Rituximab 375 mg/m^2 | 228.0 | 275.0 | 299.0 |
Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)
Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS). (NCT00719472)
Timeframe: Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)
| Intervention | Percentage of participants (Number) |
|---|
| Cycle 2 (n=338) | Cycle 6 (n=240) | Cycle 8 (n=32) |
|---|
| Rituximab 375 mg/m^2 | 50.5 | 68.3 | 87.5 |
Incidence of Clinically Significant Infections at 1 Year
Number of participants with clinically significant infections at 1 year (NCT00719849)
Timeframe: 1 year post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 3 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 3 |
Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year
"Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.~Clinical Limited cGVHD~Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.~Mild liver test abnormalities (alkaline phosphatase <2 x upper limit of normal, AST or ALT <3 x upper limit of normal and total bilirubin <1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.~Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving <20% of body surface area (BSA), dyspigmentation involving <20% BSA, or erythema involving <50% BSA, positive skin biopsy, and no other manifestations of cGVHD.~Ocular sicca (Schirmer's test <5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.~Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD." (NCT00719849)
Timeframe: 1 year post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 3 |
Chimerism
Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant. (NCT00719849)
Timeframe: 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Day 7 | Day 14 | Day 21 | Day 28 | Day 56 | Day 80 | 6 months | 1 year | 2 years |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 2 | 2 |
,| Cyclophosphamide/Fludarabine/TBI/ATG | 0 | 0 | 1 | 5 | 5 | 6 | 7 | 7 | 7 |
Probability of Survival at 2 Years
Kaplan-Meier estimate of the probability of survival at 2 years (NCT00719849)
Timeframe: 2 years post transplant
| Intervention | survival probability (Number) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0.25 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 0.38 |
Probability of Survival at 1 Year
Kaplan-Meier estimate of the probability of survival at 1 year (NCT00719849)
Timeframe: 1 year post transplant
| Intervention | survival probability (Number) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0.25 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 0.50 |
Probability of Progression-free Survival at 2 Years
Kaplan-Meier estimate of the probability of progression-free survival at 2 years (NCT00719849)
Timeframe: 2 years post transplant
| Intervention | progression free survival probability (Number) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0.25 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 0.25 |
Probability of Progression-free Survival at 1 Year
Kaplan-Meier estimate of the probability of progression-free survival at 1 year (NCT00719849)
Timeframe: 1 year post transplant
| Intervention | progression free survival probability (Number) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0.25 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 0.38 |
Incidence of Relapse at 2 Years
"Number of participants with relapse at 2 years.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated." (NCT00719849)
Timeframe: 2 years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 1 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 5 |
Incidence of Relapse at 1 Year
"Number of participants with relapse at 1 year.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated." (NCT00719849)
Timeframe: 1 year post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 1 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 4 |
Incidence of Platelet Engraftment at 6 Months
Number of participants with platelet engraftment at 6 months (NCT00719849)
Timeframe: 6 months post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 2 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 2 |
Incidence of Non-relapse Mortality at 6 Months
Number of Participants with Non-relapse Mortality at 6 Months (NCT00719849)
Timeframe: 6 months post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 2 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 2 |
Incidence of Neutrophil Engraftment at Day 42
Number of participants with neutrophil engraftment at day 42 (NCT00719849)
Timeframe: Day 42 post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 3 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 7 |
Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100
"Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)" (NCT00719849)
Timeframe: Day 100 post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 2 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 1 |
Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100
"Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)" (NCT00719849)
Timeframe: Day 100 post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 3 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 6 |
Incidence of Clinically Significant Infections at 6 Months
Number of participants with clinically significant infections at 6 months (NCT00719849)
Timeframe: 6 months post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 3 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 3 |
Incidence of Clinically Significant Infections at 2 Years
Number of participants with clinically significant infections at 2 years (NCT00719849)
Timeframe: 2 years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide/Fludarabine/TBI | 3 |
| Cyclophosphamide/Fludarabine/TBI/ATG | 3 |
Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years
| Intervention | Percent probability (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
| Standard-risk | 83.2 |
| High-risk | 66.7 |
Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 40.7 |
| Standard-risk | 29.2 |
| High-risk | 100.0 |
Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 10.5 |
| Standard-risk | 0 |
| High-risk | 66.7 |
Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years
| Intervention | percentage of patients (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
| Standard-risk | 83.2 |
| High-risk | 66.7 |
Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
| Intervention | Pts with DLTs (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 1 |
Time to Next Anti-lymphoma Treatment (TTNT)
The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive. (NCT00722137)
Timeframe: : Median duration of follow-up of 40 months
| Intervention | Days (Median) |
|---|
| R-CHOP | 756.0 |
| VcR-CAP | 1353.0 |
Treatment-free Interval (TFI)
The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
| Intervention | Days (Median) |
|---|
| R-CHOP | 624.0 |
| VcR-CAP | 1236.0 |
Time to Progression (TTP)
Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
| Intervention | Days (Median) |
|---|
| R-CHOP | 490.0 |
| VcR-CAP | 929.0 |
Duration of Response
The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH). (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
| Intervention | Days (Median) |
|---|
| Duration of response | Duration for Complete responders |
|---|
| R-CHOP | 459.0 | 563.0 |
,| VcR-CAP | 1110.0 | 1282.0 |
Overall Complete Response (CR + CRu)
Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
| Intervention | Participants (Number) |
|---|
| Overall complete response | CR | CRu |
|---|
| R-CHOP | 95 | 79 | 16 |
,| VcR-CAP | 122 | 106 | 16 |
Overall Survival (OS)
OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
| Intervention | Days (Median) |
|---|
| R-CHOP | 1714.0 |
| VcR-CAP | NA |
18-Month Survival
18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate). (NCT00722137)
Timeframe: Up to month 18 from the time of randomization
| Intervention | Percentage of Participants (Mean) |
|---|
| R-CHOP | 83.8 |
| VcR-CAP | 84.9 |
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug. (NCT00722137)
Timeframe: Up to 107.4 months
| Intervention | Participants (Number) |
|---|
| R-CHOP | 239 |
| VcR-CAP | 240 |
Overall Response Rate (ORR)
ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
| Intervention | Participants (Number) |
|---|
| R-CHOP | 204 |
| VcR-CAP | 211 |
Overall Survival (OS) in Long Term Follow-up Period
OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Up to 107.4 months
| Intervention | Days (Median) |
|---|
| R-CHOP | 1695.0 |
| VcR-CAP | 2760.0 |
Progression Free Survival (PFS)
PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months
| Intervention | Days (Median) |
|---|
| R-CHOP | 437.0 |
| VcR-CAP | 751.0 |
Time to Platelet Engraftment of > 20,000 Cells Per mm3
median and range (NCT00723099)
Timeframe: By 6 months
| Intervention | days (Median) |
|---|
| Treatment (Chemotherapy, Transplant) | 46 |
Percent of Patients With Non-relapse Mortality
Kaplan-Meier and cumulative incidence estimates (NCT00723099)
Timeframe: 6 months
| Intervention | percent of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 21 |
Percent of Patients With Non-relapse Mortality
Kaplan-Meier and cumulative incidence estimates (NCT00723099)
Timeframe: 1 year
| Intervention | percent of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 38 |
Percent of Patients With Grade II-IV Acute Graft Versus Host Disease
Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria (NCT00723099)
Timeframe: By day 100
| Intervention | percent of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 67 |
Percent of Patients With Chronic GVHD
Kaplan-Meier and cumulative incidence estimates will be used to measure percent of patients with chronic GVHD by NIH consensus criteria. (NCT00723099)
Timeframe: At 2 years
| Intervention | percent of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 19 |
Percent of Patients With Acute GVHD Grades III-IV
Fischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria (NCT00723099)
Timeframe: 100 days
| Intervention | percent of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 12 |
Overall Survival
Kaplan-Meier and cumulative incidence estimates will be used. (NCT00723099)
Timeframe: At 1 year
| Intervention | percent of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 35 |
Number of Participants With Graft Failure/Rejection
descriptive (NCT00723099)
Timeframe: By day 55
| Intervention | participants (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 3 |
Maximum Tolerated Dose of Lenalidomide (Phase I)
Maximum tolerated dose of lenalidomide given in combination with fludarabine. (NCT00727415)
Timeframe: The MTD of Lenalinomide will be evaluated during the two courses given with the escalated dose of Lenalinomide defined by the respective dose level.
| Intervention | number of patients without DLT (Number) |
|---|
| Dose level 1 - 5 mg | Dose level 2 - 10 mg |
|---|
| Phase I-II Lenalidomide | 6 | 1 |
Number of Patients With Severe Infections
Severe infection requiring more than 2 weeks of antibiotic therapy. (NCT00727415)
Timeframe: At 24 months from study entry (end of follow-up)
| Intervention | participants with severe infecitons (Number) |
|---|
| Phase I-II Lenalidomide | 2 |
Number of Patients Reaching Disease-free Survival (DSF) Overall
Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular. (NCT00727415)
Timeframe: After 6 months from study entry (end of treatment)
| Intervention | percentage of participants on DFS (Number) |
|---|
| Phase I-II Lenalidomide | 35.33 |
Toxicity as Assessed by NCI CTCAE v3.0
Data from all subjects who receive any study drug will be included in the safety analyses. (NCT00727415)
Timeframe: At 24 months from study entry (end of follow-up)
| Intervention | Participants who died during the study (Number) |
|---|
| Phase I-II Lenalidomide | 14 |
Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.).
(NCT00727415)
Timeframe: After 6 months from study entry (end of treatment).
| Intervention | percentage of participants (Number) |
|---|
| CR according to IgHV mutated | CR according to CD19+/CD38+, <30% | CR according to CD19+/CD38+, >30% | CR according to deletion 11q and 17p, absent |
|---|
| Phase I-II Lenalidomide | 28.00 | 33.33 | 16.67 | 31.82 |
Overall Complete Response (CR) Rate (Phase II)
Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular. (NCT00727415)
Timeframe: After 6 months from study entry (end of treatment).
| Intervention | percentage of patients in CR (Number) |
|---|
| Phase I-II Lenalidomide | 22.5 |
Disease Free Survival
Disease free survival is defined as the time interval from the date of randomization to the date of radiographic evidence of disease recurrence. Estimation based on the Kaplan-Meier curve. (NCT00727441)
Timeframe: 10 years and 7 months
| Intervention | months (Median) |
|---|
| Arm A - GVAX Vaccine Without Cyclophosphamide | 18.92 |
| Arm B - GVAX Vaccine With IV Cyclophosphamide | 8.54 |
| Arm C - GVAX Vaccine With PO Cyclophosphamide | 5.56 |
Overall Survival
OS will be measured from date of randomization until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (NCT00727441)
Timeframe: 10 years and 7 months
| Intervention | months (Median) |
|---|
| Arm A | 34.2 |
| Arm B | 15.4 |
| Arm C | 16.5 |
Number of Participants With Microarray Testing Results Are Completed Within 7 Days.
(NCT00736450)
Timeframe: Upto 7 days
| Intervention | Participants (Count of Participants) |
|---|
| results within 7 days or less | results in more than 7 days |
|---|
| Arm I | 11 | 2 |
Number of Participants With Neutrophil Recovery Post Allograft for Haplo-dCBT Recipients
Successful primary donor engraftment = neutrophill recovery within the first 45 days after transplant and partial/complete donor chimerism (>/= 10%) (NCT00739141)
Timeframe: up to 13 days from engraftment
| Intervention | participants (Number) |
|---|
| Haplo-dCBT with early haplo-derived myeloid bridge | Haplo-dCBT with transient haplo-derived bridge with second neutrophil nadir | Haplo-dCBT with no bridge | Remaining dCBT recipient |
|---|
| Participants With Hematologic Malignancies | 17 | 13 | 13 | 43 |
Progression Free Survival/PFS at 1 Year Post UCBT.
To obtain a preliminary estimate of progression free survival at 1 year post UCBT. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00739141)
Timeframe: 1 year post UCBT
| Intervention | percentage of participants (Number) |
|---|
| Participants With Hematologic Malignancies | 84 |
Percentage of Participants With Sustained CB-derived Neutrophil Engraftment
The day 100 cumulative incidence of sustained CB-derived neutrophil engraftment. (NCT00739141)
Timeframe: 100 days
| Intervention | Percentage of participants (Number) |
|---|
| Participants With Hematologic Malignancies | 99 |
Percentage of Participants With Sustained CB-derived Platelet Engraftment
The day 100 cumulative incidence of sustained CB-derived platelet engraftment to >/= 20 x 10^9/L (NCT00739141)
Timeframe: 100 days
| Intervention | Percentage of participants (Number) |
|---|
| Participants With Hematologic Malignancies | 93 |
Number of Participants With Successful Bone Marrow Engraftment
Rates of successful engraftment. (NCT00741455)
Timeframe: Within 30 days of bone marrow transplant
| Intervention | Participants (Count of Participants) |
|---|
| Engrafted | Engrafted 16-30 Days | Engrafted >30 Days |
|---|
| Study Treatment | 1 | 15 | 1 |
Overall Survival Measured in Participants
Mortality rates in subjects after successful completion of a bone marrow transplant (NCT00741455)
Timeframe: Up to 15 Years Post-Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Survival < 1 year post-transplant | Survival 1 to < 5 years post-transplant | Survival 5 to < 10 years post-transplant | Survival 10+ years post-transplant |
|---|
| Study Treatment | 2 | 8 | 0 | 7 |
Number of Participants Who Achieve Complete Donor Chimerism
Complete donor chimerism (NCT00741455)
Timeframe: Post-transplant days +30, +60, +100, +180 and +365
| Intervention | Participants (Count of Participants) |
|---|
| Complete Chimerism 30 Days Post Transplant | Complete Chimerism 60 Days Post Transplant | Complete Chimerism 100 Days Post Transplant | Complete Chimerism 180 Days Post Transplant | Complete Chimerism 365 Days Post Transplant | Chimerism Unknown | Did not achieve complete donor chimerism |
|---|
| Study Treatment | 2 | 2 | 3 | 3 | 4 | 1 | 2 |
Number of Patients Alive Without Disease Progression
Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria. Disease progression is defined as a greater than or equal to 25% increase in the sum of the product of target lesions, or unequivocal progression of non-target lesions or the appearance of new tumor lesions >10mm. (NCT00743509)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Oral Cyclophosphamide and Sirolimus (OCR) | 10 |
Phase II: Two Year Overall Survival (OS)
Overall survival by disease risk stratification after CVDD. OS: time from initiation of therapy until death from any cause. (NCT00750815)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| High-Risk Myeloma | 88.9 |
| Standard-Risk Myeloma | 91.1 |
Phase II: Progression-Free Survival (PFS)
"Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes.~Progressive Disease (PD): Progressive Disease requires any one or more of the following:~Increase of ≥ 25% from baseline in:~serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL)~urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)" (NCT00750815)
Timeframe: Up to 50.9 months
| Intervention | months (Median) |
|---|
| All Participants | 31.3 |
Phase I - Maximum Planned Dose (MPD) Level
"Maximum Phase II planned dose of cyclophosphamide when given in combination with bortezomib, pegylated liposomal doxorubicin and Dexamethasone (CVDD) in participants with newly diagnosed active multiple myeloma. Dose levels 1, 2, 3, 4 as outlined in Treatment Arm A.~If no dose limiting toxicity (DLT) was reported in the first 3 participants at a dose level, that dose level was to be considered safe and 3 participants would be enrolled at the next dose level. If 1/3 participants in a cohort at a dose level had dose limiting toxicity (DLT), the dose level would be expanded to obtain 6 evaluable participants. MPD reflects the highest dose of drug that did not cause a DLT in 33% of participants." (NCT00750815)
Timeframe: 9 months
| Intervention | Dosing Level (Number) |
|---|
| A. Phase I Dose Escalation | 4 |
Phase II: Overall Response Rate (ORR)
Best response to CVDD chemotherapy. Overall Response: Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR). PR: ≥ 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein with urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. (NCT00750815)
Timeframe: Up to 6 months
| Intervention | participants (Number) |
|---|
| Participants with Partial Response | Participants with Very Good Partial Response | Participants with Complete Response |
|---|
| All Participants | 16 | 23 | 15 |
Maximum Tolerated Dose (MTD)
"PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer.~ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD." (NCT00753220)
Timeframe: Up to 1 year
| Intervention | intratumorally delivered cells (Number) |
|---|
| VDC2008 | NA |
Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy. (NCT00756470)
Timeframe: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)
| Intervention | Percentage of Participants (Number) |
|---|
| Neoadjuvant Lapatinib Plus Chemotherapy | 6.6 |
Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery. (NCT00756470)
Timeframe: Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)
| Intervention | participants (Number) |
|---|
| RCB Class 0 (pCR) | RCB Class I | RCB Class II | RCB Class III |
|---|
| Neoadjuvant Lapatinib Plus Chemotherapy | 1 | 0 | 9 | 0 |
Number of Participants With Complete Remission (CR)
Complete Response defined by NCI Working Group / International Working Group for CLL criteria as no evidence of disease on physical examination (no adenopathy or organomegaly) or microscopic examination of blood (ALC <4,000/L) and bone marrow (<30% lymphocytes, no lymphoid nodules), and recovery of hemoglobin, neutrophil, and platelet counts. (NCT00759798)
Timeframe: After 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Fludarabine, Cyclophosphamide, Rituximab | 185 |
5-year Progression-free Survival
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. (NCT00770224)
Timeframe: 0-5 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 85 |
5-year Overall Survival
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00770224)
Timeframe: 0-5 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 94 |
Percentage of Participants With 3-year Progression-free Survival (PFS)
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. (NCT00770224)
Timeframe: 0-3 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 90 |
Rate of Toxicity in Study Participants
Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants (NCT00772668)
Timeframe: Up to 5 years
| Intervention | participants (Number) |
|---|
| RCVELP | 1 |
Overall Survival (OS)
Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact. (NCT00772668)
Timeframe: Up to 5 years
| Intervention | months (Number) |
|---|
| RCVELP | NA |
Progression-free Survival (PFS)
Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact. (NCT00772668)
Timeframe: Up to 5 years
| Intervention | months (Number) |
|---|
| RCVELP | NA |
Relative Efficacy of the 2 Groups
The goal is to see if there are major differences between the two arms for each group in term of efficacy and of toxicity both overall and in comparison to the previous responses to rituximab alone. The comparisons are for level of response eg CR (>100k) vs PR (230-100k) vs NR (<30k) and for duration of response-----duration of response is controlled by comparison to duration of response from initial rituximab infusions (NCT00774202)
Timeframe: 2 years
| Intervention | number of responders (Number) |
|---|
| CR | PR | response longer than previous response |
|---|
| High Dose Rituximab | 4 | 0 | 0 |
,| Rituximab, C, V, P | 4 | 1 | 0 |
Number of Participants With SAEs
How many participants had SAEs among those receiving R-CVP or among those receiving double dose rituximab and did participants in one arm have substantially more SAEs than those in the other arm (NCT00774202)
Timeframe: 2 years
| Intervention | number of patients with SAEs (Number) |
|---|
| Rituximab + CVP | 0 |
| Double Dose Rituximab | 1 |
Proportion of Vaccinated Participants With a Competent Immune Response
"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:~Pneumococcal vaccination response - absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.~Tetanus toxoid vaccination response - absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer~Competent immune response is indicative of low disease activity." (NCT00774852)
Timeframe: Week 52
| Intervention | percentage of participants (Number) |
|---|
| Pneumococcal Vaccines | Tetanus Toxoid Vaccines |
|---|
| Week 24 Complete Response: Abatacept | 67 | 50 |
,| Week 24 Complete Response: Placebo | 100 | 100 |
Lupus Disease Activity - SF-36 Scores Percent Change From Baseline
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life." (NCT00774852)
Timeframe: Week 104
| Intervention | percent change (Mean) |
|---|
| Percent Change From Baseline on Physical Component | Percent Change from Baseline Mental Component Scor |
|---|
| Abatacept | 32.1 | 39.6 |
,| Placebo | 28.2 | 37.1 |
Lupus Disease Activity - SF-36 Scores
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life." (NCT00774852)
Timeframe: Week 104
| Intervention | Score (Mean) |
|---|
| Week 104 Physical Component Score | Week 104 Mental Component Score |
|---|
| Abatacept | 49.3 | 50.9 |
,| Placebo | 45.3 | 49.2 |
Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease." (NCT00774852)
Timeframe: Week 104
| Intervention | percent change (Mean) |
|---|
| Abatacept | 26 |
| Placebo | -35.2 |
Lupus Disease Activity - Total BILAG-2004
BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity. (NCT00774852)
Timeframe: Week 52
| Intervention | units on a scale (Mean) |
|---|
| Week 24 Complete Response: Abatacept | 1.8 |
| Week 24 Complete Response: Placebo | 1.9 |
| Week 24 Partial Response: Abatacept | 3.2 |
| Week 24 Partial Response: Placebo | 3.5 |
Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response
A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
| Intervention | participants (Number) |
|---|
| Abatacept | 22 |
| Placebo | 21 |
Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response
A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
| Intervention | participants (Number) |
|---|
| Abatacept | 39 |
| Placebo | 42 |
Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52
Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 52
| Intervention | participants (Number) |
|---|
| Week 24 Complete Response: Abatacept | 11 |
| Week 24 Complete Response: Placebo | 13 |
Lupus Disease Activity - Presence of Hypocomplementemia
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus." (NCT00774852)
Timeframe: Week 104
| Intervention | participants (Number) |
|---|
| C3 Hypocomplementemia | C4 Hypocomplementemia |
|---|
| Abatacept | 12 | 11 |
,| Placebo | 11 | 8 |
Number of Participants With a Complete or Partial Response
"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.~Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.~Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis." (NCT00774852)
Timeframe: Week 52
| Intervention | participants (Number) |
|---|
| Week 24 Complete Response: Abatacept | 12 |
| Week 24 Complete Response: Placebo | 14 |
| Week 24 Partial Response: Abatacept | 13 |
| Week 24 Partial Response: Placebo | 13 |
Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study
A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe. (NCT00774852)
Timeframe: Week 104
| Intervention | participants (Number) |
|---|
| Week 24 Non-Responder: Abatacept | 0 |
| Week 24 Non-Responder: Placebo | 0 |
Lupus Disease Activity - Negative Anti-dsDNA
"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity." (NCT00774852)
Timeframe: Week 104
| Intervention | participants (Number) |
|---|
| Abatacept | 7 |
| Placebo | 10 |
Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104
"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity." (NCT00774852)
Timeframe: Week 104
| Intervention | participants (Number) |
|---|
| Abatacept | 3 |
| Placebo | 3 |
Lupus Disease Activity - Patient Global Assessment
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease." (NCT00774852)
Timeframe: Week 104
| Intervention | units on a scale (Mean) |
|---|
| Abatacept | 13.2 |
| Placebo | 18.7 |
Number of Participants With Complete Response
Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
| Intervention | participants (Number) |
|---|
| Abatacept | 22 |
| Placebo | 21 |
Lupus Disease Activity - Frequency of Flares
"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity." (NCT00774852)
Timeframe: Week 52
| Intervention | participants (Number) |
|---|
| Participants with a Renal Flare | Participants with at least 1 Non-renal Flare |
|---|
| Week 24 Complete Response: Abatacept | 0 | 1 |
,| Week 24 Complete Response: Placebo | 2 | 1 |
,| Week 24 No Response: Abatacept | 1 | 1 |
,| Week 24 No Response: Placebo | 0 | 0 |
,| Week 24 Partial Response: Abatacept | 1 | 0 |
,| Week 24 Partial Response: Placebo | 3 | 1 |
Number of Participants With Partial Response
Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24
| Intervention | participants (Number) |
|---|
| Abatacept | 39 |
| Placebo | 40 |
Incidence of Grade II - IV Acute Graft-versus-host Disease
(NCT00775931)
Timeframe: by Day 100 after transplant
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Graft Transplant Conditioning | 2 |
| Cord Blood Transplant Conditioning | 0 |
Number of Patients Who Achieved Donor Cell Engraftment
(NCT00775931)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Marrow Graft Transplant Conditioning | 5 |
| Cord Blood Transplant Conditioning | 0 |
Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease. (NCT00782379)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 2 |
Overall Survival at 12 Months
Overall survival, defined as a patient being alive after transplant, is without regard to disease status. (NCT00782379)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 14 |
Disease Free Survival at Day 100
Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point. (NCT00782379)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 16 |
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00782379)
Timeframe: Day 30
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 18 |
Disease Free Survival at 12 Months
Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point. (NCT00782379)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 7 |
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00782379)
Timeframe: Day 90
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 13 |
Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence (NCT00782379)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 2 |
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00782379)
Timeframe: Day 60
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 18 |
Incidence of Graft Rejection for Patients at Day 100
Number of patients who experienced graft rejection by Day 100 (NCT00782379)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 0 |
Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
(NCT00782379)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 2 |
Overall Survival at Day 100
Overall survival is assessed, without regard to disease status, post-transplant, at Day 100. (NCT00782379)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Haploidentical Transplant | 17 |
Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia).
"The proportion of responses in Waldenstrom's macroglobulinemia was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed." (NCT00784927)
Timeframe: Up to 1 year from registration.
| Intervention | percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) |
|---|
| Treatment | 6.7 | 66.7 |
Assessment of Tumor Response
"The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed." (NCT00784927)
Timeframe: Up to 1 year from registration.
| Intervention | percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) |
|---|
| Treatment | 30.3 | 54.5 |
Time to Treatment Failure
Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier. (NCT00784927)
Timeframe: Up to 1 year from registration.
| Intervention | months (Median) |
|---|
| Treatment | NA |
Survival Time
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT00784927)
Timeframe: Up to 1 year from registration.
| Intervention | months (Median) |
|---|
| Treatment | NA |
Progression-free Survival Time
"Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death.~Progressive disease is defined as having one of the following:~The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis." (NCT00784927)
Timeframe: Up to 1 year from registration.
| Intervention | months (Median) |
|---|
| Treatment | 38.3 |
Phase II MTD of Vorinostat
MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle). (NCT00787527)
Timeframe: 21 Days
| Intervention | mg/three times daily (Number) |
|---|
| Schedule B - Vorinostat Three Times Daily | 300 |
Phase I Maximum Tolerated Dose (MTD) of Vorinostat
MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle). (NCT00787527)
Timeframe: 21 Days
| Intervention | mg/day (Number) |
|---|
| Schedule A - Vorinostat Once or Twice Daily | 300 |
Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat
MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD. (NCT00787527)
Timeframe: 21 Days
| Intervention | participants (Number) |
|---|
| Schedule A - Vorinostat Once Daily | 1 |
| Schedule A - Vorinostat Twice Daily | 2 |
Survival
survival rate will be evaluated at 6 months,1 year, 2 year, 3 year, 4 year, 5 year after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant
| Intervention | Participants (Count of Participants) |
|---|
| 6 months survival | 1 year survival | 2 year survival | 3 year survival | 4 year survival | 5 year survival |
|---|
| Hematopoietic Stem Cell Transplantation | 13 | 12 | 12 | 11 | 11 | 11 |
NMO-IgG Aquaporin- 4 Autoantibody Titer
NMO-IgG aquaporin- 4 autoantibody titer will be tested pretransplant and post transplant. (NCT00787722)
Timeframe: Pretransplant and 5 year Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Pretransplant NMO ASSAY positive | 5 year post transplant NMO Assay positive |
|---|
| Hematopoietic Stem Cell Transplantation | 11 | 2 |
Disability Score: Expanded Disability Status Scale (EDSS)
"Disability scores (disease improvement defined by at least a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least three months apart.~The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability." (NCT00787722)
Timeframe: pretransplant 6 month, 5 year
| Intervention | score on a scale (Mean) |
|---|
| Pretransplant Disability Score (EDSS) | 1 Year Post Transplant Disability Score (EDSS) | 5 Year Post Transplant Disability Score (EDSS) |
|---|
| Hematopoietic Stem Cell Transplantation | 4.4 | 2.8 | 3.3 |
Number of Patients Who Require No Device Assistance for Ambulation
No Device Assistance Needed for Ambulation evaluated at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant
| Intervention | Participants (Count of Participants) |
|---|
| Pre HSCT- No Assistive Required | 6 Mos Post HSCT- No Assistive Device Required | 1 Year Post HSCT- No Assistive Device Required | 2 Year Post HSCT- No Assistive Device Required | 3 Year Post HSCT- No Assistive Device Required | 4 Year Post HSCT- No Assistive Device Required | 5 Year Post HSCT- No Assistive Device Required |
|---|
| Hematopoietic Stem Cell Transplantation | 6 | 9 | 10 | 9 | 8 | 8 | 9 |
Post HSCT Immune -Modulating Medication and Relapse
Number of immune - modulating medication and relapse evaluated 5 year - after the transplant (NCT00787722)
Timeframe: Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant
| Intervention | Participants (Count of Participants) |
|---|
| Pre HSCT - Immunosuppression/Relapse Rate | 6 Mos Post HSCT Immunosuppression/ Relapse Rate | 1 Year Post HSCT Immunosuppression/Relapse Rate | 2 Year Post HSCT Immunosuppression/Relapse Rate | 3 Year Post HSCT Immunosuppression/Relapse Rate | 4 Year Post HSCT Immunosuppression/Relapse Rate | 5 Year Post HSCT Immunosuppression Relapse Rate |
|---|
| Hematopoietic Stem Cell Transplantation (HSCT) | 12 | 1 | 1 | 3 | 0 | 1 | 1 |
Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease
number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. (NCT00787761)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Severe Graft Versus Host Disease | 2 |
T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00787761)
Timeframe: Day 90
| Intervention | participants (Number) |
|---|
| RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | 17 |
Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)
Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. (NCT00787761)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | 13 |
Overall Survival (OS) at 24 Months
Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease. (NCT00787761)
Timeframe: 24 months
| Intervention | participants (Number) |
|---|
| RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | 16 |
T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00787761)
Timeframe: 180 days
| Intervention | participants (Number) |
|---|
| RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | 19 |
Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00787761)
Timeframe: Day 30
| Intervention | participants (Number) |
|---|
| Transplant Recipients | 12 |
Disease-free Survival (DFS) at 24 Months
Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted. (NCT00787761)
Timeframe: 24 months
| Intervention | participants (Number) |
|---|
| RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | 13 |
Non-relapse Mortality (NRM) at Day 180 Post-transplantation
non-relapse mortality refers to the death of a patient for causes other than relapsed disease. (NCT00787761)
Timeframe: Day 180
| Intervention | participants (Number) |
|---|
| RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | 0 |
Overall Survival
The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause. (NCT00789581)
Timeframe: up to 5.25 years (63 months)
| Intervention | percentage of participants (Number) |
|---|
| 3-year OS | 5-year OS |
|---|
| Ixabepilone | 92.4 | 89.7 |
,| Paclitaxel | 93.8 | 89.6 |
Disease-free Survival
The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause. (NCT00789581)
Timeframe: up to 5.25 years (63 months)
| Intervention | percentage of participants (Number) |
|---|
| 3-year DFS | 5-year DFS |
|---|
| Ixabepilone | 88.6 | 87.1 |
,| Paclitaxel | 88.8 | 84.7 |
Number of Subjects Surviving Post-transplant.
Number of subjects surviving post-transplant. (NCT00789776)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Dose 1 (2.5 x 10^6/kg NK Cells) | 5 |
| Dose 2 (5.0 x 10^6/kg NK Cells) | 25 |
Number of Non-relapse Participant Mortalities
Defined as death in any patient for whom there has not been a diagnosis of relapse or disease progression. (NCT00789776)
Timeframe: Day 200
| Intervention | Participants (Count of Participants) |
|---|
| Dose 1 (2.5 x 10^6/kg NK Cells) | 0 |
| Dose 2 (5.0 x 10^6/kg NK Cells) | 0 |
Number of Participants Who Experienced Graft Failure
Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts >2 weeks and is refractory to growth factor support. (NCT00789776)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Dose 1 (2.5 x 10^6/kg NK Cells) | 0 |
| Dose 2 (5.0 x 10^6/kg NK Cells) | 4 |
Number of Participants With Dose Limiting Toxicities
Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality. (NCT00789776)
Timeframe: Day 35 (28 days after NK cell infusion)
| Intervention | Participants (Count of Participants) |
|---|
| Dose 1 (2.5 x 10^6/kg NK Cells) | 0 |
| Dose 2 (5.0 x 10^6/kg NK Cells) | 0 |
Number of Participants With Grades III-IV Acute GVHD
"Number of patients who developed acute GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00789776)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Dose 1 (2.5 x 10^6/kg NK Cells) | 1 |
| Dose 2 (5.0 x 10^6/kg NK Cells) | 0 |
Number of Participants Who Experienced Chronic Extensive GVHD
Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. (NCT00789776)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Dose 1 (2.5 x 10^6/kg NK Cells) | 2 |
| Dose 2 (5.0 x 10^6/kg NK Cells) | 3 |
Number of Participants With Relapsed Disease
"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions." (NCT00789776)
Timeframe: At 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Dose 1 (2.5 x 10^6/kg NK Cells) | 1 |
| Dose 2 (5.0 x 10^6/kg NK Cells) | 10 |
Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT
(NCT00791037)
Timeframe: Up to 2 year following the last infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Vaccine Therapy) | 15 |
Development of CD4+ and CD8+ Epitope Spreading
As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens. (NCT00791037)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Vaccine Therapy+ex Vivo Expanded T Cells) | 12 |
Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur. (NCT00791037)
Timeframe: Up to 4 months after first booster vaccine
| Intervention | participants (Number) |
|---|
| Treatment (Vaccine Therapy+ex Vivo-expanded T Cells) | 0 |
Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)
(NCT00791037)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Vaccine Therapy+ex Vivo Expanded T Cells) | 1 |
Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months
| Intervention | Probability of 12-month RFS (Number) |
|---|
| Treatment | 0.83 |
Overall Survival (OS)
OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years
| Intervention | Probability of surviving 12 months (Number) |
|---|
| Treatment | 0.88 |
Continuous Complete Remission (CCR) Rate
Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months
| Intervention | percentage of participants (Number) |
|---|
| Treatment | 57 |
Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months
CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD. (NCT00794820)
Timeframe: 6 months
| Intervention | Percentage of Participants (Number) |
|---|
| FCR-Multiple Dose Rituximab | 75 |
Overall Survival (OS) Rate
OS was defined as the time from the initiation of treatment to last follow-up date or death. OS were calculated using Kaplan-Meier estimates. (NCT00794820)
Timeframe: 6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.
| Intervention | Percentage of Participants (Number) |
|---|
| FCR-Multiple Dose Rituximab | 58 |
Remission Duration/Time to Progression (TTP)
TTP was defined as time from initiation of treatment to primary refractory disease or CLL progression. TTP was censored for therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) and death in remission. TTP calculated using Kaplan-Meier estimates. (NCT00794820)
Timeframe: 6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.
| Intervention | Months (Median) |
|---|
| FCR-Multiple Dose Rituximab | 81 |
Non-relapse Mortality
Number of participants deceased for reasons other than disease relapse or progression. (NCT00796562)
Timeframe: Day 100, 1 year
| Intervention | Participants (Count of Participants) |
|---|
| 100 days | 1 year |
|---|
| Myeloablative Haploidentical BMT | 10 | 10 |
Chronic GVHD
Percentage of participants who experience chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria. This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999) (NCT00796562)
Timeframe: 6 months, 12 months
| Intervention | percentage of participants (Number) |
|---|
| 6 months | 12 months |
|---|
| Myeloablative Haploidentical BMT | 4 | 15 |
Survival
Percentage of participants alive (overall survival) and alive without disease relapse, progression, or diagnosis of myeloid malignancy (event-free survival). Estimated using Kaplan-Meier method. (NCT00796562)
Timeframe: 1 year, 2 years, 3 years
| Intervention | percentage of participants (Number) |
|---|
| Overall survival, 1 year | Overall survival, 2 years | Overall survival, 3 years | Event-free survival, 1 year | Event-free survival, 2 years | Event-free survival, 3 years |
|---|
| Myeloablative Haploidentical BMT | 73 | 57 | 54 | 58 | 52 | 50 |
Acute GVHD
"Percentage of participants who experience grade II-IV or III-IV acute graft-versus-host-disease (GVHD) by Przepiorka criteria. The stages are defined as follows:~Stage II: Rash on >50% of skin, bilirubin 2-3 mg/dL, or diarrhea 500-1000 mL/day~Stage III: Bilirubin 3-15 mg/dL or diarrhea >1000 mL/day~Stage IV: Generalized erythroderma with bullae or bilirubin >15 mg/dL This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999)" (NCT00796562)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| Grade II-IV | Grade III-IV |
|---|
| Myeloablative Haploidentical BMT | 11 | 4 |
Relapse
Percentage of participants who experienced disease progression or relapse. This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999) (NCT00796562)
Timeframe: 1 year, 3 years
| Intervention | percentage of participants (Number) |
|---|
| 1 year | 3 years |
|---|
| Myeloablative Haploidentical BMT | 35 | 43 |
Engraftment as Measured by Donor Chimerism
Percentage of participants who achieved donor chimerism >=95%. (NCT00796562)
Timeframe: Day 60
| Intervention | percentage of participants (Number) |
|---|
| Myeloablative Haploidentical BMT | 91 |
Cumulative Incidence of Grade III to IV Acute GVHD
Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD. (NCT00800839)
Timeframe: 100 days post transplant
| Intervention | percentage of incidence (Number) |
|---|
| Busulfan + Fludarabine + Cyclophosphamide | 22 |
Cumulative Incidence of Grade II to IV Acute GVHD
Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD. (NCT00800839)
Timeframe: 100 days post transplant
| Intervention | percentage of incidence (Number) |
|---|
| Busulfan + Fludarabine + Cyclophosphamide | 53 |
2-year Progression-Free Survival
Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression. (NCT00800839)
Timeframe: First 25-35 days post transplant and then every 3 months for a maximum of 2 years
| Intervention | percentage of participants (Number) |
|---|
| Busulfan + Fludarabine + Cyclophosphamide | 26 |
2-year Overall Survival
Overall Survival (OS) is defined as the interval between day of transplant and day of death. (NCT00800839)
Timeframe: First 25-35 days post transplant and then every 3 months for a maximum of 2 years
| Intervention | percentage of participants (Number) |
|---|
| Busulfan + Fludarabine + Cyclophosphamide | 33 |
Rate of Engraftment
Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors. (NCT00800839)
Timeframe: From engraftment to 60 days post transplant
| Intervention | days (Median) |
|---|
| Busulfan + Fludarabine + Cyclophosphamide | 18 |
Percentage of Participants Surviving Through 156 Weeks
The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. (NCT00801632)
Timeframe: Transplantation until week 156
| Intervention | Percentage of Participants (Number) |
|---|
| MEDI-507 | 100 |
Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks
A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first. (NCT00801632)
Timeframe: 48 months post-transplant
| Intervention | participants (Number) |
|---|
| MEDI-507 | 3 |
Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection
Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)
| Intervention | Percentage of Participants (Number) |
|---|
| MEDI-507 | 0 |
Change in Renal Function
Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)
| Intervention | mg/dL (Mean) |
|---|
| Baseline Serum Creatinine | Study Termination/Completion | Change from Baseline |
|---|
| MEDI-507 | 1.9 | 3.2 | 1.2 |
Percentage of Participants Experiencing Acute Rejection
"The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation." (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)
| Intervention | Percentage of Participants (Number) |
|---|
| MEDI-507 | 40 |
Time to Platelet Recovery Following Transplant
Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)
| Intervention | days (Mean) |
|---|
| MEDI-507 | 1.0 |
Time to Neutrophil Recovery Following Transplant
Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)
| Intervention | days (Mean) |
|---|
| MEDI-507 | 14.0 |
Percentage of Participants With Graft Survival Through 156 Weeks
The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis. (NCT00801632)
Timeframe: Transplantation until week 156
| Intervention | Percentage of Participants (Number) |
|---|
| MEDI-507 | 80 |
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe. (NCT00809276)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| BuFlu Transplant | 15 |
Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria
Percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) is reported in the below table. IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescencec; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour. (NCT00813150)
Timeframe: Up to 46 days after last bortezomib dose, or as soon as possible after early discontinuation of study treatment or before start of alternative anti-myeloma therapy
| Intervention | Percentage of participants (Number) |
|---|
| Vd (Bortezomib + Dexamethasone) | 74.4 |
| Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide) | 70.2 |
Progression-Free Survival (PFS)
PFS is defined as time from randomization to myeloma progression according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of ≥25 percent from lowest response level in Serum M-component and/or (the absolute increase must be ≥0.5 g/dL) Urine M-component and/or (the absolute increase must be ≥200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be ≥10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65mmol/L) that can be attributed solely to the plasma cell proliferative disorder. PFS included disease progression as well as death. (NCT00813150)
Timeframe: From the date of randomization until the disease progression or participant's death from any cause whichever occured first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)
| Intervention | Months (Median) |
|---|
| Vd (Bortezomib + Dexamethasone) | 12.6 |
| Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide) | 9.9 |
Time to Progression of Disease
'Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date. (NCT00813150)
Timeframe: From the date of randomization until the disease progression or participant's death from any cause whichever occurred first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)
| Intervention | Months (Median) |
|---|
| Vd (Bortezomib + Dexamethasone) | 12.6 |
| Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide) | 9.9 |
Overall Survival (OS)
Time interval in months time from randomisation to death from any cause. (NCT00813150)
Timeframe: From the date of randomization until Month 49
| Intervention | Months (Median) |
|---|
| Vd (Bortezomib + Dexamethasone) | NA |
| Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide) | 41.50 |
Complete and Overall Response Rate
"A Complete Response (CR) requires all of the following for 2 months:~Absence of lymphadenopathy by physical examination (PE)~No hepato- or splenomegaly by PE~Neutrophils >1500/ul, Platelets >100,000/ul. Hemoglobin >11.0 gm/dl, Peripheral blood lymphocytes <4000/uL~Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples.~A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available.~A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin.~Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients." (NCT00816595)
Timeframe: Evaluated after 6 cycles (up to 196 days)
| Intervention | percentage of patients (Number) |
|---|
| Complete Response (CR) Rate | Overall Response Rate |
|---|
| Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | 50.0 | 93.8 |
,| Arm B: Pentostatin, Cyclophosphamide, and Rituximab | 33.3 | 96.7 |
Progression-free Survival
The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first. (NCT00816595)
Timeframe: Assessed up to 5 years from registration
| Intervention | months (Median) |
|---|
| Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | NA |
| Arm B: Pentostatin, Cyclophosphamide, and Rituximab | 34.1 |
Overall Survival
The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause. (NCT00816595)
Timeframe: Assessed up to 5 years from registration
| Intervention | months (Median) |
|---|
| Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | NA |
| Arm B: Pentostatin, Cyclophosphamide, and Rituximab | NA |
Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism
DLI is used for patients with mixed chimerism following transplant (NCT00818961)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 19 |
Survival at Day 100
Survival at Day 100 (NCT00818961)
Timeframe: 100 day
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 35 |
Platelet Engraftment
The number of patients experiencing platelet engraftment post-transplant (NCT00818961)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 35 |
Overall Survival at 1 Year
Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant) (NCT00818961)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 26 |
Non-relapse Mortality at 1 Year Post-transplant
Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive. (NCT00818961)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 4 |
Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant
Patients will be evaluated up to 4 years post transplant (NCT00818961)
Timeframe: 4 years
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 0 |
Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant
patients experiencing acute graft versus host disease post-transplant (NCT00818961)
Timeframe: patients were followed for 2 years
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 15 |
Number of Patients Experiencing Chronic Graft Versus Host Disease
(NCT00818961)
Timeframe: >100 days post-transplant
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 20 |
Non-relapse Mortality at Day 100
patients are evaluable for their cause of death at Day 100 (NCT00818961)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 1 |
Neutrophil Recovery
The number of patients experiencing neutrophil recovery post transplant (NCT00818961)
Timeframe: Day 100
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 35 |
Complete Donor Chimerism
Complete donor chimerism (defined as >/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured. (NCT00818961)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 26 |
Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap | 89 |
Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
| Intervention | percentage of patients (Number) |
|---|
| HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap | 83 |
Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy | 98 |
Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap | 79 |
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. (NCT00822120)
Timeframe: 7 months after registration
| Intervention | percentage of patients (Number) |
|---|
| PET-negative: Continued ABVD After 2 Cycles of ABVD | 100 |
| PET-positive: BEACOPP Escalated After 2 Cycles of ABVD | 93 |
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP | 64 |
Proportion of Patients With Target Adverse Events for the Step 2 Treatment
The study is to evaluate the safety of the combination of tecemotide immunotherapy with bevacizumab. The target adverse events for the combined treatment are as follows: grade 4-5 hemorrhage, esophagitis, fistula, platelet count decrease (thrombocytopenia), encephalitis infection, or hepatic failure episodes. (NCT00828009)
Timeframe: Assessed every 3 weeks while on treatment and up to 5 years
| Intervention | proportion of participants (Number) |
|---|
| Step 2 - Maintenance Therapy | 0.03 |
Overall Survival
Overall survival was defined as the time from the study registration until death from any cause. Patients who were alive or lost to follow-up at the time of analysis were censored at date last known alive. (NCT00828009)
Timeframe: Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 years
| Intervention | months (Median) |
|---|
| Step 2 - Maintenance Therapy | 42.7 |
Progression-free Survival
"Progression-free survival was defined as the time from study registration to disease progression or death from any cause, whichever came first. If date of death was greater than 3 months after date of last disease assessment that showed progression-free, the patient was censored at the time of last disease assessment. Patients alive and without documented progression were censored at the date last known progression-free.~Progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria (version 1.1), as at least 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, the appearance of new lesions, or unequivocal progression of existing non-target lesions." (NCT00828009)
Timeframe: Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 years
| Intervention | months (Median) |
|---|
| Step 2 - Maintenance Therapy | 14.9 |
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible (NCT00833560)
Timeframe: Up to Day 63
| Intervention | Percentage of participants (Number) |
|---|
| 13q- (n=112) | t (4;14) (n=38) | 17p- (n=31) | Other (n=104) | No changes (n=102) |
|---|
| Cyclophosphamide + Bortezomib + Dexamethasone | 90.2 | 89.5 | 74.2 | 87.5 | 84.3 |
Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)
CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. (NCT00833560)
Timeframe: Up to Day 63
| Intervention | Participants (Number) |
|---|
| Cyclophosphamide + Bortezomib + Dexamethasone | 334 |
Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)
CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. (NCT00833560)
Timeframe: Up to Day 63
| Intervention | Participants (Number) |
|---|
| Cyclophosphamide + Bortezomib + Dexamethasone | 284 |
Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible. (NCT00833560)
Timeframe: Up to Day 63
| Intervention | Percentage of participants (Number) |
|---|
| 13q- (n=92) | t (4;14) (n=34) | 17p- (n=24) | Other (n=87) | No changes (n=87) |
|---|
| Cyclophosphamide + Bortezomib + Dexamethasone | 92.4 | 91.2 | 87.5 | 88.5 | 85.1 |
Overall Clinical Response Rate (ORR)
"Overall clinical response was evaluated according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria (Therasse et al, 2000). Is defined as the sum of Complete responses plus Partial responses.~It was evaluated after the fourth EC cycle and before surgery using ultrasound, mammography, or MRI." (NCT00841828)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: EC -> D + Lapatinib | 62.7 |
| Arm 2: EC -> D + Trastuzumab | 77.1 |
Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).
Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D. (NCT00841828)
Timeframe: Up to 16 weeks
| Intervention | percentage of participants with pCR (Number) |
|---|
| Arm 1: EC -> D + Lapatinib | 23.5 |
| Arm 2: EC -> D + Trastuzumab | 47.9 |
Safety as Assessed by Number of Participants Experiencing Toxicity
Safety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy. (NCT00847171)
Timeframe: 4 years
| Intervention | Participants (Count of Participants) |
|---|
| Patients with drug-related toxicity | Patients with grade 3+ drug-related toxicity | Patients with serious drug-related toxicity |
|---|
| Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 20 | 0 | 0 |
Clinical Benefit as Assessed by Number of Participants With Progression-free Survival
Number of participants without evidence of disease progression. (NCT00847171)
Timeframe: 4 years
| Intervention | Participants (Count of Participants) |
|---|
| Patients with early stage disease | Patients with metastatic disease |
|---|
| Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 12 | 6 |
Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides
(NCT00847171)
Timeframe: 4 years
| Intervention | Participants (Count of Participants) |
|---|
| DTH-positive at baseline | Increased DTH from baseline | Converted from DTH-negative to DTH-positive |
|---|
| Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine | 12 | 11 | 5 |
Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1) [MTD Cyclophosphamide, MTD Bortezmib, MTD Docxorubicin]
If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure shows MTD for cyclophosphamide, bortezomib and doxorubicin. MTD for dexamethasone is include in a separate table due to the different Unit of Measure. (NCT00849251)
Timeframe: Up to 90 days after initiation of study treatment
| Intervention | mg/m2 (Number) |
|---|
| MTD cyclophosphamide | MTD bortezomib | MTD liposomal doxorubicin |
|---|
| Relapsed Disease | 300 | 1.6 | 30 |
Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1). [Dexamethasone MTD]
If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure will only describe the MTD for dexamethasone. Dexamethasone could not be reported with the MTD for the other three drugs due to a different Unit of Measure. (NCT00849251)
Timeframe: Up to 90 days after initiation of study treatment
| Intervention | mg (Number) |
|---|
| Relapsed Disease (Cohort I) | 40 |
Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods
cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion. (NCT00849472)
Timeframe: From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry)
| Intervention | Participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 39 |
Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated. (NCT00849472)
Timeframe: From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry)
| Intervention | Participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 0 |
Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated. (NCT00849472)
Timeframe: From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry).
| Intervention | Participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 0 |
Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period
cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion. (NCT00849472)
Timeframe: From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry
| Intervention | Participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 22 |
Number of Participants With Pathologic Complete Response (pCR) in the Breast
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen. (NCT00849472)
Timeframe: From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry)
| Intervention | Participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 18 |
Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy. (NCT00849472)
Timeframe: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)
| Intervention | Participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 16 |
Invasive Recurrence-free Interval (IRFI)
IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry. (NCT00849472)
Timeframe: up to 24 months after study entry
| Intervention | months (Median) |
|---|
| Overall Study Arm | NA |
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges. (NCT00849472)
Timeframe: up to 24 months after study entry
| Intervention | participants (Number) |
|---|
| Elevated TSH at Least Once during the Study, n=101 | AC Period, n=91 | (WP) + Pazopanib Preoperative Periods, n=89 | Surgery Period, n=78 | Postoperative Pazopanib Period, n=36 | Follow-up Period, n=33 |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 28 | 2 | 15 | 1 | 7 | 8 |
Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated. (NCT00849472)
Timeframe: From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry)
| Intervention | Participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 0 |
Number of Participants With Recurrence Events
The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry. (NCT00849472)
Timeframe: up to 24 months after study entry
| Intervention | participants (Number) |
|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | 15 |
Grade 3-5 Gastrointestinal Perforation
All grade 3-5 gastrointestinal perforation events based on CTCAEv3 as reported on case report forms. (NCT00856180)
Timeframe: Assessed each cycle/3 weeks throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).
| Intervention | proportion of participants (Number) |
|---|
| Bevacizumab Then Cyclophosphamide With Bevacizumab | 0.05 |
Clinical Benefit Response Rate
Clinical benefit response rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT00856180)
Timeframe: Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).
| Intervention | proportion of participants (Number) |
|---|
| Platinum Sensitive | 1.00 |
| Platinum Resistant | 0.64 |
Progression-Free Survival (PFS)
PFS estimated using Kaplan-Meier methods is defined as the duration of time from the start of bevacizumab alone to documented disease progression (PD) requiring removal from the study or death. If participant ultimately received both bevacizumab and cyclophosphamide then it was the time until PD on both agents. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA-125 that rises to >/=2xULN documented, both requiring 2nd confirmation. Participants who were event-free were censored at the date of their last disease evaluation. (NCT00856180)
Timeframe: Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment and every 3 months in follow-up until PD, death or lost to follow-up. Median treatment duration was 7.5 months (range 0.7-20.7) and survival follow-up 23 months..
| Intervention | months (Median) |
|---|
| Bevacizumab Then Cyclophosphamide With Bevacizumab | 8.41 |
Therapy Completion Rate
The therapy completion rate is defined as the proportion of participants who completed at least 3 months/4 cycles of therapy. Participants were treated until disease progression on the combination regimen or unacceptable toxicity. Clinical response was evaluated based on RECIST 1.0 criteria for measurable disease (MD) participants and Gynecologic Cancer Intergroup (GCIG) CA-125 (Rustin) criteria for non-MD participants. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA125 that rises to >/=2xULN documented, both requiring 2nd confirmation. (NCT00856180)
Timeframe: Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).
| Intervention | proportion of participants (Number) |
|---|
| Bevacizumab Then Cyclophosphamide With Bevacizumab | .75 |
Overall Survival (OS)
OS estimated using Kaplan-Meier methods is defined as the time from study entry to death or date last known alive. (NCT00856180)
Timeframe: Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median follow-up was 23 months in this study cohort.
| Intervention | months (Median) |
|---|
| Bevacizumab Then Cyclophosphamide With Bevacizumab | 22.72 |
Event-free Survival
Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause. (NCT00856492)
Timeframe: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence
| Intervention | participants (Number) |
|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 20 |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | 24 |
Number of Patients With Pathological Complete Response Rate
Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes. (NCT00856492)
Timeframe: pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 35 |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | 24 |
Overall Survival
Time from registration to death due to any cause (NCT00856492)
Timeframe: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.
| Intervention | deaths (Number) |
|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | 14 |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | 17 |
Overall Survival Rate
Overall Survival Rate will be estimated using the Kaplan-Meier method. (NCT00857389)
Timeframe: Up to 3 years post transplant
| Intervention | days (Median) |
|---|
| Conditioning Reg- Thiotepa, Busulfan, and Clofarabine | 320 |
Relapse Rate of Participants Treated With Thiotepa, Busulfan, and Clofarabine
Relapse Rate will be estimated using the Kaplan-Meier method. (NCT00857389)
Timeframe: Up to 2 years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Conditioning Reg- Thiotepa, Busulfan, and Clofarabine | 26 |
Engraftment
Engraftment is most commonly defined as the first of three consecutive days of achieving a sustained peripheral blood neutrophil count of >500 × 10^6/L . (NCT00857389)
Timeframe: up to 100 days post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Conditioning Reg- Thiotepa, Busulfan, and Clofarabine | 52 |
Graft vs Host Disease (GVHD)
Severity of toxicities graded according to the NCI Common Toxicity Criteria Adverse Effects (CTCAE) v3.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency. (NCT00857389)
Timeframe: Up to 30 days post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Conditioning Reg- Thiotepa, Busulfan, and Clofarabine | 34 |
Number of Participants With Disease Free Survival
Kaplan-Meier product limit method to estimate the disease free survival. (NCT00857389)
Timeframe: Up to 2 years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Conditioning Reg- Thiotepa, Busulfan, and Clofarabine | 32 |
Number of Participants With Serious Adverse Events
Severity of toxicities graded according to the NCI Common Toxicity Criteria Adverse Effects (CTCAE) v3.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency. (NCT00857389)
Timeframe: up to 30 days post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Conditioning Reg- Thiotepa, Busulfan, and Clofarabine | 52 |
Number of Participants With Survival Rate at 100 Days Post-transplant
The toxicities will be monitored and scored on a daily basis following the methods of Simon R. Practical Bayesian Guideline for Phase IIB Clinical Trials. A Bayesian stopping rule will be used to stop the trial if there is a 90% chance that the true toxicity rate exceeds the target toxicity rate of 0.25. (NCT00857389)
Timeframe: 100 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Conditioning Reg- Thiotepa, Busulfan, and Clofarabine | 45 |
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
Comparing regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3). (NCT00861705)
Timeframe: At the time of definitive surgical removal, up to 28 weeks
| Intervention | percentage of participants with pCR (Number) |
|---|
| Factor B: Bevacizumab | 52 |
| Factor B: No Bevacizumab | 44 |
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
Comparing regimens that contain carboplatin (arms 3&4) versus not (arms 1&2). (NCT00861705)
Timeframe: At the time of definitive surgical removal, up to 28 weeks
| Intervention | percentage of participants with pCR (Number) |
|---|
| Factor A: Carboplatin | 54 |
| Factor A: No Carboplatin | 41 |
Overall Survival
Number of Participants who Died Due to Any Cause (NCT00861705)
Timeframe: up to 10 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1 (Pac --> ddAC) | 22 |
| Arm 2 (Pac + Bev --> ddAC + Bev) | 26 |
| Arm 3 (Pac + Carboplatin --> ddAC) | 30 |
| Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev) | 24 |
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
Assessed by physician observation. (NCT00861705)
Timeframe: at definitive surgery, up to 28 weeks
| Intervention | percentage of participants with event (Number) |
|---|
| Excessive bleeding | Delayed healing | Wound dehiscence |
|---|
| Factor B: Bevacizumab | 0 | 1 | 1 |
,| Factor B: No Bevacizumab | 0 | 0 | 0 |
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3&4) versus not (arms 1&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods. (NCT00861705)
Timeframe: At the time of definitive surgical removal, up to 28 weeks
| Intervention | percentage of participants with pCR (Number) |
|---|
| Factor A: Carboplatin | 60 |
| Factor A: No Carboplatin | 46 |
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods. (NCT00861705)
Timeframe: At the time of definitive surgical removal, up to 28 weeks
| Intervention | percentage of participants with pCR (Number) |
|---|
| Factor B: Bevacizumab | 59 |
| Factor B: No Bevacizumab | 48 |
AALL08P1 Safety Outcome
Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification
| Intervention | percentage of participants (Number) |
|---|
| Group B (High Risk-High) | 50.0 |
AALL08P1 Feasibility Outcome
Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification
| Intervention | percentage of participants (Number) |
|---|
| Group B (High Risk-High) | 53.3 |
3-Year Event-Free Survival (EFS)
3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%. (NCT00866749)
Timeframe: 3 Years
| Intervention | Participants (Count of Participants) |
|---|
| Augmented BFM Therapy | 68 |
Participants Achieving Negative Minimal Residual Disease (MRD)
To evaluate the prognostic significance of minimal residual disease (MRD) in bone marrow samples of participants who achieved a complete response (CR) at the end of induction (day 29) and at the end of consolidation (day 84) in this group of patients. (NCT00866749)
Timeframe: up to 3 months
| Intervention | participants (Number) |
|---|
| Participants with CR and MRD negative on Day 29 | Participants with CR and MRD negative on day 84 |
|---|
| Augmented BFM Therapy | 60 | 87 |
Participants With a Complete Response (CR)
Complete Response defined as: Bone Marrow blasts /= 100 and an Absolute Neutrophil Count (ANC) >/= 1000 (NCT00866749)
Timeframe: Up to 1 year
| Intervention | participants (Number) |
|---|
| Augmented BFM Therapy | 108 |
Overall Survival
Overall Survival defined: Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT00866749)
Timeframe: Up to 12 years
| Intervention | Months (Median) |
|---|
| Augmented BFM Therapy | 121 |
Overall Survival
Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause. The percentage of patients who were alive at 3 years, estimated by Kaplan Meier method as the probability of being event free at 3 years is reported here. (NCT00866905)
Timeframe: 36 months
| Intervention | percentage of participants (Number) |
|---|
| Ixabepilone/Cyclophosphamide | 90 |
Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain
Non hematologic treatment-related grade 4 toxicities measured according to CTCAE 3.0 (NCT00866905)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|
| Fatigue | Peripheral neuropathy | Arthralgia/myalgia |
|---|
| Ixabepilone/Cyclophosphamide | 1 | 1 | 1 |
Pathologic Complete Response Rate (pCR)
Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples. (NCT00866905)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Ixabepilone/Cyclophosphamide | 27 |
Disease Free Survival
Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death. (NCT00866905)
Timeframe: 36 Months
| Intervention | months (Median) |
|---|
| Ixabepilone/Cyclophosphamide | NA |
Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease
"Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant." (NCT00871689)
Timeframe: Day 100 Post Transplant
| Intervention | participants (Number) |
|---|
| Patients Receiving Double Umbilical Cord Blood Transplant | 0 |
Number of Patients With Neutrophil Engraftment
Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant. (NCT00871689)
Timeframe: Day 42
| Intervention | Participants (Number) |
|---|
| Patients Receiving Double Umbilical Cord Blood Transplant | 1 |
Number of Patients With Successful Natural Killer Expansion
Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl. (NCT00871689)
Timeframe: Day 72 Post Transplant
| Intervention | participants (Number) |
|---|
| Patients Receiving Double Umbilical Cord Blood Transplant | 1 |
Incidence of Primary Graft Failure
Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42. (NCT00871689)
Timeframe: Day 42
| Intervention | Participants (Number) |
|---|
| Patients Receiving Double Umbilical Cord Blood Transplant | 1 |
Number of Patients With Acute Graft-Versus-Host (GVHD) Disease
"Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant." (NCT00871689)
Timeframe: Day 100 Post Transplant
| Intervention | participants (Number) |
|---|
| Patients Receiving Double Umbilical Cord Blood Transplant | 1 |
Number of Patients With Complete Remission of Disease
Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis). (NCT00871689)
Timeframe: Day 100
| Intervention | Participants (Number) |
|---|
| Patients Receiving Double Umbilical Cord Blood Transplant | 1 |
Toxic Death Rate
The proportion of toxic death rate among all eligible patients. (NCT00873093)
Timeframe: 4 months
| Intervention | percentage of participants (Number) |
|---|
| Overall | 2.1 |
Severe Adverse Events (SAE) Rate.
The proportion of SAE rate among all eligible patients (NCT00873093)
Timeframe: 4 months
| Intervention | percentage of participants (Number) |
|---|
| Overall | 8.2 |
Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy
The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. (NCT00873093)
Timeframe: The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.
| Intervention | Percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 72.2 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 63 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2. (NCT00873093)
Timeframe: End of Block 2 (Day 36 of Block 2) of re-induction therapy
| Intervention | percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 66.7 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 42.1 |
Event Free Survival
Percentage of patients who were event free at 4 months (NCT00873093)
Timeframe: 4 months after enrollment
| Intervention | Percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 68.5 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 37.8 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1. (NCT00873093)
Timeframe: End of Block 1 (Day 36 of Block 1) of re-induction therapy
| Intervention | percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 35.4 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 25 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3. (NCT00873093)
Timeframe: End of Block 3 (Day 36 of Block 3) of re-induction therapy
| Intervention | Percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 80 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 63.6 |
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period
AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event. (NCT00877006)
Timeframe: 32 weeks
| Intervention | participants (Number) |
|---|
| Any AE | Severe AEs (grades 3, 4, 5) | Treatment-related AEs | Deaths | SAEs | Withdrawn due to AEs |
|---|
| Bendamustine and Rituximab (BR) | 221 | 130 | 209 | 12 | 60 | 10 |
,| R-CHOP/R-CVP | 213 | 127 | NA | 9 | 49 | 3 |
Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period
Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications. (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period
| Intervention | Participants (Count of Participants) |
|---|
| All Deaths | Deaths within 30 days of study treatment | Deaths greater than 30 days of study treatment |
|---|
| Bendamustine and Rituximab (BR) | 40 | 2 | 38 |
,| R-CHOP/R-CVP | 32 | 1 | 31 |
Percentage of Participants With Complete Response (CR) at End of Treatment Period
CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Bendamustine and Rituximab (BR) | 31 |
| R-CHOP/R-CVP | 25 |
Therapeutic Classification of Concomitant Medications
(NCT00877006)
Timeframe: 32 weeks
| Intervention | participants (Number) |
|---|
| Psycholeptics | Sex Hormones and Modulators of the Genital System | Stomatological Preparations | Throat Preparations | Thyroid Therapy | Topical Preparations for Join and Muscular Pain | Unspecified Herbal | Urologicals | Vaccines | Vasoprotectives | Vitamins |
|---|
| Bendamustine and Rituximab (BR) | 69 | 6 | 23 | 3 | 3 | 1 | 3 | 5 | 11 | 1 | 16 |
,| R-CHOP/R-CVP | 74 | 4 | 29 | 2 | 1 | 2 | 5 | 4 | 11 | 8 | 21 |
Therapeutic Classification of Prior Medications
(NCT00877006)
Timeframe: prior to start of treatment
| Intervention | participants (Number) |
|---|
| Psycholeptics | Sex Hormones and Modulators of the Genital System | Stomatological Preparations | Throat Preparations | Thyroid Therapy | Topical Products for Join and Muscular Pain | Unspecified Herbal | Urologicals | Vaccines | Vasoprotectives | Vitamins |
|---|
| Bendamustine and Rituximab (BR) | 57 | 11 | 0 | 0 | 16 | 1 | 10 | 20 | 2 | 0 | 70 |
,| R-CHOP/R-CVP | 59 | 12 | 0 | 0 | 17 | 0 | 10 | 11 | 7 | 0 | 61 |
Percentage of Participants With Overall Response at End of Treatment Period
Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Bendamustine and Rituximab (BR) | 97 |
| R-CHOP/R-CVP | 91 |
Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results
Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
| Intervention | participants (Number) |
|---|
| Albumin: Grade 1 | Albumin: Grade 2 | Albumin: Grade 3 | Albumin: Grade 4 | Albumin: Grades 1-4 | Alkaline Phosphatase: Grade 1 | Alkaline Phosphatase: Grade 2 | Alkaline Phosphatase: Grade 3 | Alkaline Phosphatase: Grade 4 | Alkaline Phosphatase: Grades 1-4 | Creatinine: Grade 1 | Creatinine: Grade 2 | Creatinine: Grade 3 | Creatinine: Grade 4 | Creatinine: Grades 1-4 | Gamma-glutamyl transferase: Grade 1 | Gamma-glutamyl transferase: Grade 2 | Gamma-glutamyl transferase: Grade 3 | Gamma-glutamyl transferase: Grade 4 | Gamma-glutamyl transferase: Grades 1-4 | Hypercalcemia: Grade 1 | Hypercalcemia: Grade 2 | Hypercalcemia: Grade 3 | Hypercalcemia: Grade 4 | Hypercalcemia: Grades 1-4 | Hyperglycemia: Grade 1 | Hyperglycemia: Grade 2 | Hyperglycemia: Grade 3 | Hyperglycemia: Grade 4 | Hyperglycemia: Grades 1-4 | Hyperkalemia: Grade 1 | Hyperkalemia: Grade 2 | Hyperkalemia: Grade 3 | Hyperkalemia: Grade 4 | Hyperkalemia: Grades 1-4 | Hypernatremia: Grade 1 | Hypernatremia: Grade 2 | Hypernatremia: Grade 3 | Hypernatremia: Grade 4 | Hypernatremia: Grades 1-4 | Hypocalcemia: Grade 1 | Hypocalcemia: Grade 2 | Hypocalcemia: Grade 3 | Hypocalcemia: Grade 4 | Hypocalcemia: Grades 1-4 | Hypoglycemia: Grade 1 | Hypoglycemia: Grade 2 | Hypoglycemia: Grade 3 | Hypoglycemia: Grade 4 | Hypoglycemia: Grades 1-4 | Hypokalemia: Grade 1 | Hypokalemia: Grade 2 | Hypokalemia: Grade 3 | Hypokalemia: Grade 4 | Hypokalemia: Grades 1-4 | Hyponatremia: Grade 1 | Hyponatremia: Grade 2 | Hyponatremia: Grade 3 | Hyponatremia: Grade 4 | Hyponatremia: Grades 1-4 | Magnesium: Grade 1 | Magnesium: Grade 2 | Magnesium: Grade 3 | Magnesium: Grade 4 | Magnesium: Grades 1-4 | Phosphorus: Grade 1 | Phosphorus: Grade 2 | Phosphorus: Grade 3 | Phosphorus: Grade 4 | Phosphorus: Grades 1-4 | Aspartate Aminotransferase: Grade 1 | Aspartate Aminotransferase: Grade 2 | Aspartate Aminotransferase: Grade 3 | Aspartate Aminotransferase: Grade 4 | Aspartate Aminotransferase: Grades 1-4 | Alanine Aminotransferase: Grade 1 | Alanine Aminotransferase: Grade 2 | Alanine Aminotransferase: Grade 3 | Alanine Aminotransferase: Grade 4 | Alanine Aminotransferase: Grades 1-4 | Total Bilirubin: Grade 1 | Total Bilirubin: Grade 2 | Total Bilirubin: Grade 3 | Total Bilirubin: Grade 4 | Total Bilirubin: Grades 1-4 | Uric Acid: Grade 1 | Uric Acid: Grade 2 | Uric Acid: Grade 3 | Uric Acid: Grade 4 | Uric Acid: Grades 1-4 |
|---|
| Bendamustine and Rituximab (BR) | 33 | 14 | 3 | 0 | 50 | 41 | 1 | 0 | 0 | 42 | 19 | 3 | 1 | 0 | 23 | 31 | 18 | 3 | 0 | 52 | 6 | 0 | 1 | 0 | 7 | 94 | 20 | 15 | 0 | 129 | 7 | 3 | 1 | 0 | 11 | 8 | 0 | 0 | 0 | 8 | 36 | 8 | 1 | 3 | 48 | 15 | 1 | 0 | 0 | 16 | 18 | 0 | 0 | 0 | 18 | 40 | 0 | 0 | 0 | 40 | 46 | 0 | 0 | 0 | 46 | 7 | 25 | 3 | 0 | 35 | 42 | 2 | 1 | 0 | 45 | 46 | 6 | 2 | 0 | 54 | 14 | 1 | 0 | 0 | 15 | 41 | 0 | 0 | 1 | 42 |
,| R-CHOP/R-CVP | 44 | 13 | 0 | 0 | 57 | 25 | 3 | 0 | 0 | 28 | 25 | 1 | 0 | 0 | 26 | 37 | 10 | 6 | 0 | 53 | 6 | 0 | 0 | 0 | 6 | 74 | 34 | 15 | 1 | 124 | 8 | 1 | 0 | 0 | 9 | 10 | 0 | 0 | 0 | 10 | 28 | 6 | 0 | 0 | 34 | 10 | 0 | 0 | 0 | 10 | 16 | 0 | 1 | 0 | 17 | 28 | 0 | 5 | 0 | 33 | 44 | 1 | 1 | 0 | 46 | 5 | 22 | 3 | 1 | 31 | 32 | 2 | 1 | 0 | 35 | 38 | 3 | 1 | 0 | 42 | 7 | 0 | 0 | 0 | 7 | 42 | 0 | 0 | 0 | 42 |
Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period
"Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):~Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.~In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.~>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis~other conditions as specified in the protocol" (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period
| Intervention | Participants (Count of Participants) |
|---|
| Bendamustine and Rituximab (BR) | 36 |
| R-CHOP/R-CVP | 30 |
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
| Intervention | months (Median) |
|---|
| Bendamustine and Rituximab (BR) | 65.0 |
| R-CHOP/R-CVP | 64.1 |
Kaplan-Meier Estimate for Progression-free Survival (PFS)
PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
| Intervention | months (Median) |
|---|
| Bendamustine and Rituximab (BR) | 31.8 |
| R-CHOP/R-CVP | 33.4 |
Kaplan-Meier Estimate for Duration of Response (DOR)
DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
| Intervention | months (Median) |
|---|
| Bendamustine and Rituximab (BR) | 26.5 |
| R-CHOP/R-CVP | 32.1 |
Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life. (NCT00877006)
Timeframe: Day 1 (prior to treatment), 32 weeks
| Intervention | units on a scale (Mean) |
|---|
| Bendamustine and Rituximab (BR) | 3.6 |
| R-CHOP/R-CVP | -5.1 |
Worst Overall CTCAE Grade for Hematology Laboratory Test Results
Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)
| Intervention | participants (Number) |
|---|
| Absolute Neutrophil Count: Grade 1 | Absolute Neutrophil Count: Grade 2 | Absolute Neutrophil Count: Grade 3 | Absolute Neutrophil Count: Grade 4 | Absolute Neutrophil Count: Grades 1-4 | Hemoglobin: Grade 1 | Hemoglobin: Grade 2 | Hemoglobin: Grade 3 | Hemoglobin: Grade 4 | Hemoglobin: Grades 1-4 | Lymphocytes Absolute: Grade 1 | Lymphocytes Absolute: Grade 2 | Lymphocytes Absolute: Grade 3 | Lymphocytes Absolute: Grade 4 | Lymphocytes Absolute: Grades 1-4 | Platelets: Grade 1 | Platelets: Grade 2 | Platelets: Grade 3 | Platelets: Grade 4 | Platelets: Grades 1-4 | White Blood Cells: Grade 1 | White Blood Cells: Grade 2 | White Blood Cells: Grade 3 | White Blood Cells: Grade 4 | White Blood Cells: Grades 1-4 |
|---|
| Bendamustine and Rituximab (BR) | 22 | 51 | 48 | 50 | 171 | 129 | 42 | 5 | 1 | 177 | 1 | 5 | 54 | 83 | 143 | 106 | 14 | 9 | 7 | 136 | 41 | 79 | 65 | 19 | 204 |
,| R-CHOP/R-CVP | 14 | 20 | 47 | 104 | 185 | 129 | 51 | 7 | 2 | 189 | 6 | 55 | 55 | 9 | 125 | 72 | 14 | 7 | 8 | 101 | 22 | 49 | 89 | 27 | 187 |
Potentially Clinically Significant Abnormal Weight
Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant. (NCT00877006)
Timeframe: Baseline, Week 32
| Intervention | participants (Number) |
|---|
| Increase >=10% | Decrease >=10% |
|---|
| Bendamustine and Rituximab (BR) | 8 | 18 |
,| R-CHOP/R-CVP | 5 | 8 |
Kaplan-Meier Estimate for Event-free Survival (EFS)
"EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.~Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier." (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
| Intervention | months (Median) |
|---|
| Bendamustine and Rituximab (BR) | 31.8 |
| R-CHOP/R-CVP | 32.6 |
Clinically Significant Abnormal Vital Signs
(NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
| Intervention | participants (Number) |
|---|
| Heart Rate >=120 and ↑ >=15 bpm | Heart Rate <=50 and ↓ >=15 bpm | Systolic Blood Pressure(BP) >=180 and ↑ >=20 mm Hg | Systolic BP <=90 and ↓ >=20 mm Hg | Diastolic BP >=105 and ↑ from Baseline >=15 mm Hg | Diastolic BP <=50 and ↓ from Baseline >=15 mm Hg |
|---|
| Bendamustine and Rituximab (BR) | 0 | 2 | 2 | 6 | 1 | 2 |
,| R-CHOP/R-CVP | 1 | 2 | 2 | 2 | 2 | 2 |
Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity. (NCT00883129)
Timeframe: Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24
| Intervention | DLCO %-pred (Mean) |
|---|
| Baseline | Month 3 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Month 24 |
|---|
| Cyclophosphamide Arm | 54.05 | 51.92 | 50.87 | 51.55 | 53.12 | 53.62 | 55.9 | 54.26 | 52.90 |
,| Mycophenolate Arm | 53.99 | 53.38 | 54.86 | 54.13 | 55.32 | 57.77 | 56.62 | 55.47 | 55.31 |
Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.
The number of participants who remained in the study at the listed time points are reported (NCT00883129)
Timeframe: Continuous assessment from randomization to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | Month 3 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Month 24 |
|---|
| Cyclophosphamide Arm | 73 | 64 | 56 | 51 | 46 | 44 | 42 | 39 | 38 |
,| Mycophenolate Arm | 69 | 66 | 58 | 55 | 52 | 52 | 49 | 49 | 49 |
Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)
Imaging of the whole lung (WL) is performed using a volumetric high resolution computerized tomography (HRCT) scan, which is then analyzed using a computer algorithm to determine the percentage of overall pixels exhibiting features characteristic for quantitative lung fibrosis (QLF). Higher percentages for QLF-WL therefore represent greater involvement by lung fibrosis. (NCT00883129)
Timeframe: Measured at baseline and Month 24
| Intervention | % of lung exhibiting QLF (Mean) |
|---|
| Baseline | Month 24 |
|---|
| Cyclophosphamide Arm | 8.91 | 8.48 |
,| Mycophenolate Arm | 8.25 | 7.99 |
Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
The TLC represents the total volume of air within the lung after taking the deepest breath possible and the TLC %-predicted represents the TLC expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The TLC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity. (NCT00883129)
Timeframe: Measured at study entry and Months 6, 12, 18, and 24
| Intervention | TLC %-pred (Mean) |
|---|
| Baseline | Month 6 | Month 12 | Month 18 | Month 24 |
|---|
| Cyclophosphamide Arm | 65.49 | 67.39 | 68.25 | 69.63 | 66.97 |
,| Mycophenolate Arm | 66.16 | 67.84 | 67.31 | 68.50 | 68.24 |
Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)
Skin thickness is quantified using the modified Rodnan measurement method (mRSS), with a scale that ranges from 0 (no skin involvement) to a maximum of 51. The reported skin score is determined by a clinical assessment of skin thickness, which is performed by a trained reader, and represents the sum of individual assessments that are made in each of 17 body areas. Each area is given a score in the range of 0-3 (0 = normal; 1= mild thickness; 2 = moderate; 3 = severe thickness). A higher score represents more severe skin involvement. (NCT00883129)
Timeframe: Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24
| Intervention | mRSS score (Mean) |
|---|
| Baseline | Month 3 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Month 24 |
|---|
| Cyclophosphamide Arm | 14.04 | 12.85 | 11.95 | 10.61 | 9.47 | 9.80 | 9.87 | 8.50 | 7.87 |
,| Mycophenolate Arm | 15.32 | 16.03 | 14.37 | 14.33 | 12.45 | 12.43 | 11.98 | 11.22 | 11.40 |
Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death
(NCT00883129)
Timeframe: Measured throughout the 2-year study
| Intervention | Participants (Count of Participants) |
|---|
| Leukopenia (<2.5x10^3 WBC/microliter) | Neutropenia (<1.0x10^3 neutrophils/microliter) | Anemia (Hgb <10 g/dl) | Thrombocytopenia (<100x10^3 platelets/microliter) | Hematuria (>10 RBC/high power field) | Pneumonia | SAE-Total | SAE-related to treatment | Deaths |
|---|
| Cyclophosphamide Arm | 30 | 7 | 13 | 4 | 2 | 4 | 22 | 7 | 11 |
,| Mycophenolate Arm | 4 | 3 | 8 | 0 | 3 | 5 | 27 | 3 | 5 |
Transitional Dyspnea Index Score
Change in breathlessness was assessed using the Transitional Dyspnea Index, which compares current symptoms to those at baseline. Total score ranges from - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. (NCT00883129)
Timeframe: Measured at Months 6, 12, 18, and 24
| Intervention | Transitional Dyspnea Index Score (Mean) |
|---|
| Month 6 | Month 12 | Month 18 | Month 24 |
|---|
| Cyclophosphamide Arm | 0.31 | 1.23 | 1.78 | 2.09 |
,| Mycophenolate Arm | 0.74 | 1.17 | 0.91 | 1.86 |
Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
The primary outcome is the course over time from baseline to 24 months for the FVC %-predicted. The FVC %-predicted represents the adjusted volume of air (adjusted as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity) that can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of lung involvement and disease severity. (NCT00883129)
Timeframe: Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24
| Intervention | FVC %-pred (Mean) |
|---|
| Baseline | Month 3 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Month 24 |
|---|
| Cyclophosphamide Arm | 66.52 | 67.03 | 67.86 | 69.42 | 69.86 | 71.94 | 72.57 | 72.55 | 70.15 |
,| Mycophenolate Arm | 66.52 | 66.22 | 68.02 | 68.11 | 68.43 | 69.84 | 70.57 | 70.87 | 69.65 |
Number of Participants With Complete Remission
Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 * 10^9/L and a platelet count of ≥ 100 * 10^9/L with complete resolution of all sites of extramedullary disease required. (NCT00890656)
Timeframe: Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.
| Intervention | Participants (Number) |
|---|
| Augmented Hyper-CVAD | 41 |
Event-free Survival (EFS)
To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS) (NCT00899847)
Timeframe: 2 years after the last participant is enrolled
| Intervention | percentage of participants (Number) |
|---|
| Autologous-Allogeneic Hematopoietic Stem Cell Transplant | 44 |
Complete Response Rate (CRR)
"Complete response rate (CRR) was assessed as all of:~Negative immunoflixation on the serum and urine~Disappearance of any soft tissue plasmacytomas~< 5% plasma cells in bone marrow" (NCT00899847)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Autologous-Allogeneic Hematopoietic Stem Cell Transplant | 3 |
Overall Response Rate (ORR)
Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR) (NCT00899847)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Autologous-Allogeneic Peripheral Blood Stem Cell Transplant | 7 |
Partial Response Rate (PRR)
"Partial response rate (PRR) was assessed as~> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr~If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain~If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma." (NCT00899847)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Autologous-Allogeneic Peripheral Blood Stem Cell Transplant | 4 |
Incidence of Graft Versus Host Disease (GvHD)
To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting (NCT00899847)
Timeframe: 2 years after the last participant is enrolled.
| Intervention | Participants (Count of Participants) |
|---|
| Autologous-Allogeneic Hematopoietic Stem Cell Transplant | 1 |
Overall Survival (OS)
To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS) (NCT00899847)
Timeframe: 2 years after the last participant is enrolled
| Intervention | percentage of participants (Number) |
|---|
| Autologous-Allogeneic Hematopoietic Stem Cell Transplant | 67 |
Overall Best Confirmed Response
Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee. (NCT00908232)
Timeframe: Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 days
| Intervention | number of participants (Number) |
|---|
| Complete to Partial Response: Bortezomib + Dexamethasone | 101 |
| Stable Disease After 4 Cycles: VD, VDC, VDL | 6 |
One Year Survival
Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis. (NCT00908232)
Timeframe: At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 year
| Intervention | percent probability (Number) |
|---|
| Complete to Partial Response: Bortezomib + Dexamethasone | 80 |
| Stable Disease After 4 Cycles: VD, VDC, VDL | 89 |
Progression Free Survival
"Time from start of treatment to date of disease progression, relapse from CR or death. Estimated using the kaplan-meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate." (NCT00908232)
Timeframe: At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR). Median Follow-Up of 16.9 months
| Intervention | days (Median) |
|---|
| Complete to Partial Response: Bortezomib + Dexamethasone | 311.0 |
| Stable Disease After 4 Cycles: VD, VDC, VDL | 214.0 |
Overall Survival
Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive (NCT00908232)
Timeframe: At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy. Further follow up by monthly phone call until the last patient was treated and followed for 1 year
| Intervention | days (Median) |
|---|
| Complete to Partial Response: Bortezomib + Dexamethasone | NA |
| Stable Disease After 4 Cycles: VD, VDC, VDL | NA |
Time to Progression
Is calculated as the time from start of treatment to the date of the first observation of disease progression or relapse from CR. Deaths owing to causes other than progression not counted, but censored. Subjects who withdraw from the study or die will be censored at the time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). (NCT00908232)
Timeframe: At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), Median Follow-up of 16.9 months
| Intervention | days (Median) |
|---|
| Complete to Partial Response: Bortezomib + Dexamethasone | 366.0 |
| Stable Disease After 4 Cycles: VD, VDC, VDL | 214.0 |
Number of Participants in Complete Remission 6 Months After Randomization
"Complete remission [CR] is defined according to Cheson criteria. CR requires the following:~Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities.~All lymph nodes and nodal masses must have regressed to normal size. Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to ≤1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).~The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.~If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site." (NCT00911183)
Timeframe: 6 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (R-COP Regimen) | 14 |
| Arm II (R-COPY Regimen) | 9 |
Number of Participants With Severe Toxicity
"Severe toxicity, defined as febrile neutropenia or toxic death. Febrile neutropenia is defined in the International CTC toxicity scale as fever of unknown origin without clinically or microbiologically documented infection: neutrophils < 1.0 x 109/l and fever ≥ 38.5° C.~Toxic death is defined as any death which occur during treatment (from day 1 of the first cycle of chemotherapy up to day 30 of the last cycle) and is not related to lymphoma." (NCT00911183)
Timeframe: 6 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (R-COP Regimen) | 10 |
| Arm II (R-COPY Regimen) | 8 |
Overall Survival Time
OS is defined as the delay between the date of randomization and the date of death (NCT00911183)
Timeframe: from randomization, up to 5 years
| Intervention | months (Median) |
|---|
| Arm I (R-COP Regimen) | 20.1 |
| Arm II (R-COPY Regimen) | 25.4 |
Progression-free Survival Time
Delay between the date of randomization and the date of progression or death. Progression is defined according to the Cheson criteria. (NCT00911183)
Timeframe: from randomization, up to 5 years
| Intervention | months (Median) |
|---|
| Arm I (R-COP Regimen) | 10.4 |
| Arm II (R-COPY Regimen) | 18.0 |
To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat
Responses were measured after completion of FCR+ vorinostat induction therapy (within 21 days of starting maintenance) and again after completion of maintenance therapy (24 months after the start of maintenance therapy). Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat. Criteria for response are specified by the National Cancer Institute (NCI) working group guidelines; in addition, patients were required to meet computed tomography (CT) criteria as described in the protocol. Response categories include Complete Response (CR), Partial Response (PR), Nodular Partial Response (nPR), Stable Disease (SD) or Progressive Disease (PD). (NCT00918723)
Timeframe: After completion of maintenance therapy (24 months after start of maintenance)
| Intervention | percentage of participants (Number) |
|---|
| Conversion from PR to CR | Conversion from nPR (nodular PR) to CR |
|---|
| Treatment (Induction and Maintenance Chemotherapy) | 50 | 100 |
Percentage of Patients With Progression-free Survival at 2 Years
"Progression-free survival (PFS): The length of time during and after the treatment that a patient lives with the disease but it does not get worse.~Progressive disease is specified by the NCI (National Cancer Institute) working group guidelines and additional CT (computerized tomography) scan requirements:~Lymphadenopathy, > 50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations; one lymph node must be at least 2 cm.~An increase in the liver or spleen size by 50% or more by CT scan or the de novo appearance of hepatomegaly or splenomegaly.~An increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter.~Transformation to a more aggressive histology or occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL." (NCT00918723)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Induction and Maintenance Chemotherapy) | 87 |
Overall Survival
Overall survival (OS): The percentage of people in a study who are still alive at for a certain period of time after they started treatment. (NCT00918723)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Induction and Maintenance Chemotherapy) | 90 |
Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I)
"The MTD of vorinostat in combination with FCR will be defined as the dose level immediately below the dose level at which greater than or equal to 2 patients out of 6 of a cohort experience dose-limiting toxicity. Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Doses of vorinostat analyzed to reach the MTD were 200 mg, 300 mg and 400 mg." (NCT00918723)
Timeframe: 28 days
| Intervention | mg (Number) |
|---|
| MTD for Vorinostat During Induction Therapy | 400 |
| MTD for Vorinostat During Maintenance Therapy | 400 |
Toxicity Profile
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00923195)
Timeframe: 32 months
| Intervention | Participants (Number) |
|---|
| TBI 600cGy + PBL + HD IL-2+gp100:154-162 | 2 |
| TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L) | 2 |
Number of Participants With Disease Free Survival
Number of participants with documented evidence of disease progression following start of treatment. (NCT00923364)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Recipients Only | 8 |
Overall Survival
Overall survival is defined as date of on-study to date of death from any cause or last follow up. (NCT00923364)
Timeframe: 2 years
| Intervention | months (Median) |
|---|
| Recipients Only | 76 |
Days to Neutrophil Engraftment
Neutrophil engraftment is defined as a neutrophil count of >0.5 x 10(9) cells/L for 3 consecutive days. (NCT00923364)
Timeframe: 30 days
| Intervention | Days (Median) |
|---|
| Recipients Only | 12 |
Days to Platelet Engraftment
Platelet engraftment is defined as a platelet count of >20 x 10(9) cells/L for 7 consecutive days without requiring a platelet transfusion. (NCT00923364)
Timeframe: 30 days
| Intervention | Days (Median) |
|---|
| Recipients Only | 30 |
Number of Participants With Serious and Non-serious Adverse Events
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00923364)
Timeframe: Date treatment consent signed to date off study, approximately, 91 months
| Intervention | Participants (Count of Participants) |
|---|
| Recipients and Healthy Related Donors | 16 |
Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)
Engraftment of donor cells was assessed using polymorphisms in regions known to contain short tandem repeats. Peripheral blood cluster of differentiation 14 (CD14+), cluster of differentiation 3 (CD3-)/cluster of differentiation 56 (CD56+), cluster of differentiation 19 (CD19+), and CD3+ subsets were isolated by flow cytometry and chimerism was assessed. (NCT00923364)
Timeframe: 2 years
| Intervention | percentage of donor cells (Mean) |
|---|
| Donor CD14+ cells, % | Donor CD19+ cells, % | Donor CD3-/CD56+ cells, % | Donor CD3+ cells, % |
|---|
| Recipients Only | 99.8 | 100 | 99.8 | 97.6 |
Incidence of Acute and Chronic Graft-versus-host Disease (GVHD)
Acute GVHD is assessed according to the 1994 Consensus Conference Grading Criteria. Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. GVHD can affect performance status and attack multiple organ systems such as the skin, liver, gut, mouth, eyes, joints, lung, etc. that can lead to a rash, diarrhea, metabolic changes, infection and/or death. The clinical grading of acute GVHD is grade 0 (none) to 4 (severe). Chronic GVHD is a delayed form of GVHD that may occur after day 100 post transplant. (NCT00923364)
Timeframe: 2 years
| Intervention | participants (Number) |
|---|
| Acute | Chronic |
|---|
| Recipients Only | 2 | 3 |
Count of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00923845)
Timeframe: 50 months and 6 days
| Intervention | Participants (Count of Participants) |
|---|
| Donor | 0 |
| Recipient | 12 |
Count of Patients Having Neutropenia Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen
Absolute neutrophil count determination by complete blood count methodology (Absolute Neutrophil Count (ANC) < 500 Cells/µL). (NCT00923845)
Timeframe: During the 21-day PC regimen
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 0 |
Count of Patients Having an Infectious Complication Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen
Occurrence of infection by Common Terminology Criteria for Adverse Events (CTCAE). (NCT00923845)
Timeframe: During the 21-day PC regimen
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 0 |
Count of Patients With Grade II or Greater Acute Graft Versus Host Disease (GVHD) in First 100 Days Post-Transplant
Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)). (NCT00923845)
Timeframe: 100 days post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 0 |
Count of Patients With Late Acute Graft Versus Host Disease (GVHD) After Day 100 Post-Transplant
Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)). (NCT00923845)
Timeframe: 100 days post-transplant through 5 years post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 4 |
Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution
CD4 T Cells immune reconstitution is defined as distribution of CD4+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry. (NCT00923845)
Timeframe: Days 14, 60, and 100 post transplant
| Intervention | Percentage of total CD4 cell subsets (Median) |
|---|
| Day 14 | Day 60 | Day 100 |
|---|
| Recipient | 22 | 20 | 19 |
Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution
CD8+ T Cells immune reconstitution is defined as distribution of CD8+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry. (NCT00923845)
Timeframe: Days 14, 60, and 100 post transplant
| Intervention | Percent of total CD8 cell subsets (Median) |
|---|
| Day 14 | Day 60 | Day 100 |
|---|
| Recipient | 6 | 5 | 4 |
Engraftment Donor T Cell and Myeloid Cell Chimerism
Donor Genetic Elements by variable number tandem repeat-polymerase chain reaction (VNTR-PCR) Analysis. (NCT00923845)
Timeframe: Days 14, 28, 45, and 60 post transplant
| Intervention | Percent Donor by VNTR-PCR Analysis (Median) |
|---|
| Day 14 donor T cell chimerism | Day 28 donor T cell chimerism | Day 45 donor T cell chimerism | Day 60 donor T cell chimerism | Day 14 myeloid cell chimerism | Day 28 myeloid cell chimerism | Day 45 myeloid cell chimerism | Day 60 myeloid cell chimerism |
|---|
| Recipient | 61 | 72 | 74 | 77 | 0 | 13 | 18 | 26 |
Immune Depletion in Cluster of Differentiation 4 (CD4) Cells
Reduction in cluster of differentiation 4 (CD4)+ T cells [change in median values and (range of values)]. (NCT00923845)
Timeframe: Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)
| Intervention | Cells/µL (Median) |
|---|
| Baseline | Day 21 |
|---|
| Recipient | 503 | 54 |
Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells
Reduction in cluster of differentiation 8 (CD8)+ T cells [change in median values and (range of values)]. (NCT00923845)
Timeframe: Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)
| Intervention | cells/µL (Median) |
|---|
| Baseline | Day 21 |
|---|
| Recipient | 239 | 45 |
Immune Suppression
Immune suppression is defined by the frequency of elimination of a pre-transplant T cell cytokine value. (NCT00923845)
Timeframe: Cytokine analysis at baseline and within 24 hours of completion of the pentostatin/cyclophosphamide regimen
| Intervention | % of undetectable cytokine measurements (Number) |
|---|
| Positive at baseline | Negative at baseline | Positive 24 hours after regimen | Negative 24 hours after regimen |
|---|
| Recipient | 100 | 0 | 0 | 100 |
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))
CD4+ T cells were analyzed by flow cytometry for intracellular expression of FoxP3. (NCT00923845)
Timeframe: Days 14, 60, and 100 post transplant
| Intervention | Percentage of total CD4+ T cells (Median) |
|---|
| Day 14 | Day 60 | Day 100 |
|---|
| Recipient | 8 | 6 | 3 |
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet
CD4+ T cells were analyzed by flow cytometry for intracellular detection of Tbet transcription factor. (NCT00923845)
Timeframe: Days 14, 60, and 100 post transplant
| Intervention | Percentage of total CD4+T cells (Median) |
|---|
| Day 14 | Day 60 | Day 100 |
|---|
| Recipient | 8 | 8 | 6 |
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)
Intra-cellular flow cytometry detection of GATA3 transcription factor. (NCT00923845)
Timeframe: Days 14, 60 and 100 post transplant
| Intervention | Percentage of total CD4+ T cells (Median) |
|---|
| Day 14 | Day 60 | Day 100 |
|---|
| Recipient | 42 | 37 | 43 |
Count of Patients With Chronic Graft Versus Host Disease (GVHD)
Chronic GVHD was assessed by the 2005 Chronic GVHD Consensus Project. Chronic GVHS may include dryness of the mouth and eyes, weight loss, liver damage and lung damage leading to cough and shortness of breath (i.e. skin Grading: no symptoms = 0, <18% body surface area (BSA) = 1, 19-50% BSA = 2, and >50% BSA = 3); oral cavity Grading: no symptoms = 0, mild symptoms = 1, moderate symptoms =2 and severe symptoms =3)). (NCT00923845)
Timeframe: For the duration of post-transplant follow-up
| Intervention | Participants (Count of Participants) |
|---|
| Recipient | 1 |
Number of Participiants With In-vivo Survival of Infused Cells
In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS). (NCT00924001)
Timeframe: 44 days
| Intervention | Participants (Number) |
|---|
| Metastatic Melanoma | 1 |
Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria
Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progression (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00924001)
Timeframe: 44 days
| Intervention | Participants (Number) |
|---|
| Metastatic Melanoma | 0 |
Number of Participants With Adverse Events
Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00924001)
Timeframe: 44 days
| Intervention | Participants (Number) |
|---|
| Metastatic Melanoma | 1 |
Area Under the Plasma Concentration (AUC) - LMB2
AUC is a measure of the plasma concentration of drug over time. It is used to characterize drug absorption. Plasma levels were analyzed by cytotoxicity assay. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | µg/-min/mL (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 161 |
| All Other Patients | 144 |
Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders
Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | pg/ml (Median) |
|---|
| Soluble CD25, lowest post-treatment (nadir) value | Median sCD25 Nadir for responders | Median sCD25 Nadir for non-responders | Median sCD25 PRE-treatment for responders | Median sCD25 PRE-treatment for non-responders |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 1094 | 1082 | 70713 | 31893 | 66419 |
Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry
Peripheral blood was obtained and analyzed by flow cytometry. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | Cells/µL (Median) |
|---|
| Normal T-cells | Normal CD4+ cells | Normal CD8+ cells | Normal B-cells |
|---|
| All Other Patients | 23.5 | 186 | 23.5 | 0.5 |
,| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 28 | 99.5 | 28 | 8 |
Percentage of Participants With a Minimally Durable Clinical Response Rate
Response is based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma and must last >8 weeks to meet the primary endpoint of the study. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. Stable disease is neither a response nor progressive disease. Progressive disease is appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count. (NCT00924170)
Timeframe: 8 weeks
| Intervention | percentage of participants (Number) |
|---|
| Overall Response | Complete Response | Partial Response | Stable Disease | Progressive Disease | Not Evaluable |
|---|
| All Other Patients | 0 | 0 | 0 | 25 | 37.5 | 37.5 |
,| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 80 | 60 | 20 | 20 | 0 | 0 |
Count of Participants With Grades 3-5 Adverse Events of > 1 Adult T-Cell Leukemia (ATL) Patients Treated With 20+200, 25+250, and 30+300 mg/m^2 LMB-2/Fludarabine and Cyclophosphamide
Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 (mild), Grade 4 (life threatening) and Grade 5 (death). (NCT00924170)
Timeframe: 7 years and 12 days
| Intervention | Participants (Count of Participants) |
|---|
| Neutropenia | Nausea/vomiting/anorexia | Fever/chills | Leukopenia/lymphopenia | Transaminases | Hypotension/tachycardia | Thrombocytopenia | Anemia | Myalgia/headache | Hypoalbuminemia | Hematuria | Proteinuria | Fatigue/dizziness | Edema | Abdominal pain | Diarrhea | Creatine phosphokinase (CPK) | Mucositis | Hypomagnesemia | Bilirubin | Alkaline phosphatase/gamma-glutamyl transferase | Pneumonitis | Low cluster of differentiation 4 (CD4) count | Lipase | Bladder infection | Dyspnea | Prothrombin time | Pruritis |
|---|
| Fludarabine and Cyclophosphamide: 20 + 200mg/m^2 | 2 | 2 | 1 | 1 | 3 | 1 | 1 | 0 | 2 | 2 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
,| Fludarabine and Cyclophosphamide: 25 + 250mg/m^2 | 10 | 10 | 10 | 9 | 8 | 8 | 8 | 9 | 7 | 6 | 5 | 7 | 4 | 6 | 5 | 3 | 4 | 3 | 3 | 2 | 3 | 3 | 1 | 3 | 2 | 2 | 1 | 0 |
,| Fludarabine and Cyclophosphamide: 30 + 300mg/m^2 | 2 | 2 | 1 | 2 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
Count of Participants With Adverse Events Attributed At Least Possibly to Patients Treated With Fludarabine and Cyclophosphamide Dose Levels 20+200, 25+250, and 30+300 mg/m^2
Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00924170)
Timeframe: 7 years and 12 days
| Intervention | Participants (Count of Participants) |
|---|
| Neutropenia | Leukopenia/lymphopenia | Anemia | Transaminases | Thrombocytopenia | Fever/chills | Pneumonitis | Low cluster of differentiation 4 (CD4) count | Hypotension/tachycardia | Rectal hemorrhage | Bilirubin | Dysuria | Bladder infection | Hypoxia | Proteinuria | Sepsis* |
|---|
| 3Fludarabine and Cyclophosphamide: 0 + 300mg/m^2 | 2 | 2 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Fludarabine and Cyclophosphamide: 20 + 200mg/m^2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Fludarabine and Cyclophosphamide: 25 + 250mg/m^2 | 9 | 9 | 8 | 4 | 5 | 3 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Volume of Distribution of LMB-2
Dilutions of patient plasma were tested by cytotoxicity assays to determine volume of distribution of LMB-2. Volume distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. This was measured during the first 24 hours after administration of the dose on cycle 2 day 1. (NCT00924170)
Timeframe: 24 hours
| Intervention | Liters (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 49.6 |
| All Other Patients | 26.6 |
Progression Free Survival (PFS)
PFS was determined by the Kaplan Meier method beginning at the on study date and continuing until progression or last follow-up without progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count. (NCT00924170)
Timeframe: 70 months
| Intervention | Months (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 11.6 |
| All Other Patients | 1.05 |
Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders
Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | pg/ml (Median) |
|---|
| Soluble CD25, lowest post-treatment (nadir) value | Median sCD25 Nadir for non-responders | Median sCD25 PRE-treatment for non-responders |
|---|
| All Other Patients | 34591 | 34591 | 17079 |
Plasma Clearance (CL) of LMB-2
Dilutions of patient plasma was tested by cytotoxicity assays to determine plasma clearance of LMB-2.The CL is a quantitative measure of the rate at which a drug substance is removed from the body. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | mL/min (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 109 |
| All Other Patients | 101 |
Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2
Blood was drawn prior to each cycle of LMB-2 to determine if the level, >75% neutralization of 1000ng/ml of LMB-2 of neutralizing antibodies is too high to give additional LMB-2. Analysis was performed by cytotoxicity assay. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | percentage of participants (Number) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 40 |
| All Other Patients | 0 |
Peak Level of LMB-2 in Adult T-Cell Lymphoma
The maximum analyte concentration in serum was reported using a cytotoxicity assay measuring the level of LMB-2 in the plasma and using purified LMB-2 as a standard curve. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | ng/mL (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 602 |
| All Other Patients | 484 |
Overall Survival (OS)
OS is the time between the first day of treatment to the day of disease progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count. (NCT00924170)
Timeframe: 70 months
| Intervention | Months (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 18.6 |
| All Other Patients | 3.75 |
Number of Participants With Serious and Non-serious Adverse Events
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00924170)
Timeframe: 7 years and 12 days
| Intervention | Participants (Count of Participants) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 10 |
| All Other Patients | 8 |
Number of Participants With Dose Limiting Toxicity (DLT)
DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to NCT00924170)
Timeframe: 30 days after last dose of LMB2
| Intervention | Participants (Count of Participants) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 0 |
| All Other Patients | 0 |
Half Life (t1/2) of LMB-2
Dilutions of patient plasma was tested by cytotoxicity assays to determine half life. Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half. (NCT00924170)
Timeframe: First 24 hours after the dose given on Cycle 2, day 1
| Intervention | min (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 360 |
| All Other Patients | 251 |
Duration of Response (Complete Response + Partial Response)
Duration of response is defined as a response lasting for at least 4 weeks but >8 weeks and is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. (NCT00924170)
Timeframe: 69 months
| Intervention | Weeks (Median) |
|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 69.6 |
| All Other Patients | 0 |
Number of Participants With In Vivo Survival of Transfused Cells
In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS). (NCT00924287)
Timeframe: 12 days
| Intervention | Participants (Number) |
|---|
| Metastatic Cancer | 1 |
Number of Participants With Adverse Events
Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00924287)
Timeframe: 12 days
| Intervention | Participants (Number) |
|---|
| Metastatic Cancer | 1 |
Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00924326)
Timeframe: Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Complete Remission | Partial Remission | Stable Disease | Progressive Disease | Not Evaluable |
|---|
| 0.5x10^7 Cells/kg | 2 | 0 | 0 | 0 | 0 |
,| 1.0x10^6 Cells/kg | 3 | 2 | 0 | 0 | 1 |
,| 1.0x10^6 Cells/kg (Reduced Chemo) | 2 | 3 | 0 | 2 | 0 |
,| 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 | 2 | 4 | 1 | 0 | 1 |
,| 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat | 3 | 0 | 0 | 0 | 0 |
,| 2.0x10^6 Cells/kg (9-12 Days Culture) | 2 | 0 | 0 | 0 | 0 |
,| 2.0x10^6 Cells/kg (Moderate Chemo) | 2 | 0 | 0 | 0 | 0 |
,| 2.0x10^6 Cells/kg (Reduced Chemo) | 6 | 1 | 1 | 2 | 0 |
,| 2.5x10^6 Cells/kg | 3 | 0 | 0 | 1 | 1 |
,| 6.0x10^6 Cells/kg (Reduced Chemo) | 0 | 0 | 0 | 1 | 0 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00924326)
Timeframe: Date treatment consent signed to date off study, approximately 101 months and 17 days.
| Intervention | Participants (Count of Participants) |
|---|
| 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 | 8 |
| 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat | 1 |
| 0.5x10^7 Cells/kg | 2 |
| 2.5x10^6 Cells/kg | 5 |
| 1.0x10^6 Cells/kg | 6 |
| 1.0x10^6 Cells/kg (Reduced Chemo) | 7 |
| 2.0x10^6 Cells/kg (Reduced Chemo) | 10 |
| 6.0x10^6 Cells/kg (Reduced Chemo) | 1 |
| 2.0x10^6 Cells/kg (Moderate Chemo) | 2 |
| 2.0x10^6 Cells/kg (9-12 Days Culture) | 2 |
Number of Serious Adverse Event of Bevacizumab
Adverse event evaluations will occur at each study visit throughout the treatment period of 2 years and will continue every 6 months during the follow-up period. Only Grade 3/4 AE (CTCAE v4) was reported. (NCT00925652)
Timeframe: Followed every 6 months for 7.5 years after study entry, or completion of final analysis, whichever comes first.
| Intervention | cases (Number) |
|---|
| Lifestyle: Diet and Bevicizumab+CM | 12 |
| Lifestyle: Diet+Exericise and Bevicizumab+CM | 8 |
Number of Serious Adverse Event (AE) of Lifestyle
Exercise and/or dietary lifestyle interventions defined per protocol. The lifestyle intervention will be administered by telephone, supplemented with a participant workbook (Appendix 9 in protocol). Only Grade 3/4 AE (CTCAE v4) was reported. (NCT00925652)
Timeframe: Followed every 6 months for 7.5 years after study entry, or completion of final analysis, whichever comes first.
| Intervention | cases (Number) |
|---|
| Lifestyle: Diet | 2 |
| Lifestyle: Diet+Exericise | 4 |
| Lifestyle: Diet and Bevicizumab+CM | 14 |
| Lifestyle: Diet+Exericise and Bevicizumab+CM | 8 |
Number of Serious Adverse Event of Metronomic Chemotherapy
Adverse event evaluations will occur at each study visit throughout the treatment period of 2 years and will continue every 6 months during the follow-up period. Only Grade 3/4 AE (CTCAE v4) was reported. (NCT00925652)
Timeframe: Followed every 6 months for 7.5 years after study entry, or completion of final analysis, whichever comes first.
| Intervention | cases (Number) |
|---|
| Lifestyle: Diet and Bevicizumab+CM | 10 |
| Lifestyle: Diet+Exericise and Bevicizumab+CM | 5 |
Progression-Free Survival Rate
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years. (NCT00931918)
Timeframe: 2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)
| Intervention | percentage of participants (Number) |
|---|
| RCHOP | 78 |
| Vc-RCHOP | 82 |
Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
| Intervention | months (Median) |
|---|
| RCHOP | NA |
| Vc-RCHOP | NA |
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category
Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. (NCT00931918)
Timeframe: First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)
| Intervention | percentage of participants (Number) |
|---|
| At Least 1 TEAE | Drug-related, TEAEs | Grade 3 or higher TEAEs | Grade 3 or Higher Drug-related, TEAEs | TEAEs Resulting in Study Drug Discontinuation | Serious TEAEs |
|---|
| RCHOP | 100 | 88 | 71 | 55 | 4 | 31 |
,| Vc-RCHOP | 99 | 95 | 79 | 68 | 6 | 34 |
Duration of Response
Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
| Intervention | months (Median) |
|---|
| RCHOP | NA |
| Vc-RCHOP | NA |
Time to Progression (TTP)
TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
| Intervention | months (Median) |
|---|
| RCHOP | NA |
| Vc-RCHOP | NA |
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
| Intervention | months (Median) |
|---|
| RCHOP | NA |
| Vc-RCHOP | NA |
Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher
Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE. (NCT00931918)
Timeframe: Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)
| Intervention | percentage of participants (Number) |
|---|
| Lymphocytes | WBC Count | Neutrophils | Platelets | Hemoglobin | Hyperglycemia | Hypokalemia | Hypophosphatemia | Hyponatremia | Alanine aminotransferase (ALT) increased | Aspartate aminotransferase (AST) increased |
|---|
| RCHOP | 70 | 68 | 65 | 18 | 10 | 14 | 13 | 7 | 4 | 2 | 1 |
,| Vc-RCHOP | 86 | 69 | 70 | 39 | 15 | 9 | 14 | 10 | 3 | 1 | 2 |
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. (NCT00931918)
Timeframe: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
| Intervention | percentage of participants (Number) |
|---|
| End of Cycle 2 | End of Treatment (Cycle 6) | Best Overall Response Rate |
|---|
| RCHOP | 93 | 88 | 98 |
,| Vc-RCHOP | 90 | 84 | 96 |
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate
FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point. (NCT00931918)
Timeframe: End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
| Intervention | percentage of participants (Number) |
|---|
| End of Cycle 2 | End of Treatment (Cycle 6) |
|---|
| RCHOP | 42 | 53 |
,| Vc-RCHOP | 37 | 59 |
Complete Response Rate
Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease. (NCT00931918)
Timeframe: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
| Intervention | percentage of participants (Number) |
|---|
| End of Cycle 2 | End of Treatment (Cycle 6) | Best Complete Response Rate |
|---|
| RCHOP | 23 | 45 | 49 |
,| Vc-RCHOP | 16 | 56 | 56 |
Achievement of Complete Remission (CR) at Reinduction
Disease response assessed after chemotherapy from bone marrow aspirates/biopsies and complete blood count. (NCT00939653)
Timeframe: Between Days 22-36 or on Day 43 and weekly thereafter if peripheral counts haven't recovered
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled Patients | 1 |
Death
Number of participants who died. (NCT00939653)
Timeframe: From the first dose of study therapy until 30 days after last therapy dose
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled Patients | 4 |
Relapse-free Survival
Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group . (NCT00941720)
Timeframe: at 6 months
| Intervention | participants (Number) |
|---|
| Busulfan Treatment | 48 |
Pulmonary Toxicity
Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals. (NCT00941720)
Timeframe: At 6 months
| Intervention | percentage of participants (Number) |
|---|
| Busulfan Treatment | 3.5 |
Overall Survival
Number of patients alive at the end of the study period (NCT00941720)
Timeframe: at 6 months
| Intervention | participants (Number) |
|---|
| Busulfan Treatment | 53 |
Pathologic Complete Response
(NCT00944047)
Timeframe: 22 weeks
| Intervention | percentage of participants (Number) |
|---|
| Intervention Arm | 26 |
Graft Failure
Percentage of participants who failed to engraft. (NCT00946023)
Timeframe: Day 60
| Intervention | Participants (Count of Participants) |
|---|
| Transplant | 2 |
Incidence of Chronic GVHD
Percentage of participants who experienced chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria. (NCT00946023)
Timeframe: 1 year post intervention
| Intervention | percentage of participants (Number) |
|---|
| Transplant | 11 |
Incidence of Grades II-IV Acute Graft-versus-Host-Disease (GVHD)
Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria. (NCT00946023)
Timeframe: 1 year post intervention
| Intervention | percentage of participants (Number) |
|---|
| Transplant | 41 |
Incidence of Grades III-IV Acute GVHD
Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria. (NCT00946023)
Timeframe: 1 year post intervention
| Intervention | percentage of participants (Number) |
|---|
| Transplant | 5 |
Non-relapse Mortality
Percentage of participants who died due to BMT-related reasons. (NCT00946023)
Timeframe: 1 year post intervention
| Intervention | percentage of participants (Number) |
|---|
| Transplant | 8 |
Engraftment
Percentage of patients who engrafted neutrophils and platelets. (NCT00946023)
Timeframe: Day 60
| Intervention | percentage of participants (Number) |
|---|
| Neutrophil engraftment | Platelet engraftment |
|---|
| Transplant | 98 | 98 |
Relapse
Percentage of participants alive with relapse or disease progression. (NCT00946023)
Timeframe: 1 year post intervention
| Intervention | percentage of participants (Number) |
|---|
| All participants | Haploidentical recipients | VV donor | VF donor | FF donor |
|---|
| Transplant | 20 | 20 | 18 | 23 | 17 |
Progression-free Survival
Percentage of participants alive with and without relapse. (NCT00946023)
Timeframe: 2 years post-intervention
| Intervention | percentage of participants (Number) |
|---|
| All participants | Haploidentical recipients | VV donor | VF donor | FF donor |
|---|
| Transplant | 60 | 63 | 68 | 59 | 56 |
Progression-free Survival
Percentage of participants alive and without relapse or disease progression. (NCT00946023)
Timeframe: 1 year post-intervention
| Intervention | percentage of participants (Number) |
|---|
| All participants | Haploidentical recipients | VV donor | VF donor | FF donor |
|---|
| Transplant | 71 | 70 | 82 | 70 | 65 |
Overall Survival
Percentage of participants alive. (NCT00946023)
Timeframe: 2 years post intervention
| Intervention | percentage of participants (Number) |
|---|
| All participants | Haploidentical recipients | VV donor | VF donor | FF donor |
|---|
| Transplant | 76 | 73 | 87 | 76 | 69 |
Overall Survival
Percentage of participants alive. (NCT00946023)
Timeframe: 1 year post intervention
| Intervention | percentage of participants (Number) |
|---|
| All participants | Haploidentical recipients | VV donor | VF donor | FF donor |
|---|
| Transplant | 86 | 83 | 94 | 86 | 78 |
Relapse
Percentage of participants alive with relapse or disease progression. (NCT00946023)
Timeframe: 2 years post intervention
| Intervention | percentage of participants (Number) |
|---|
| All participants | Haploidentical recipients | VV donor | VF donor | FF donor |
|---|
| Transplant | 27 | 23 | 25 | 31 | 22 |
Overall Response Rate
The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points. (NCT00948090)
Timeframe: Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination)
| Intervention | Participants (Number) |
|---|
| Baseline-Complete Response (N=65, 0, 121, 16) | Baseline-Not Complete Response (N=65, 1, 121, 16) | Day 100-Complete Response (N=57, 0, 114, 12) | Day 100-Not Complete Response (N=57, 0, 114, 12) | Month 6-Complete Response (N=45, 0, 98, 11) | Month 6-Not Complete Response (N=45, 0, 98, 11) | Month 12-Complete Response (N=32, 0, 88, 8) | Month 12-Not Complete Response (N=32, 0, 88, 0) | Month 24-Complete Response (N=13, 0, 28, 6) | Month 24-Not Complete Response (N=13, 0, 28, 0) | Early Term-Complete Response (N=40, 0, 41, 0) | Early Term-Not Complete Response (N=40, 0, 41, 5) | End of Trial-Complete Response (N=22, 0, 71, 9) | End of Trial-Not Complete Response(N=22, 0, 71, 9) |
|---|
| Hodgkin's Lymphoma (> 65 Years) | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Hodgkin's Lymphoma (≤ 65 Years) | 35 | 30 | 35 | 22 | 30 | 15 | 22 | 10 | 11 | 2 | 2 | 38 | 20 | 2 |
,| Non-Hodgkin's Lymphoma (> 65 Years) | 12 | 4 | 8 | 4 | 9 | 2 | 8 | 0 | 6 | 0 | 0 | 5 | 8 | 1 |
,| Non-Hodgkin's Lymphoma (≤ 65 Years) | 72 | 49 | 85 | 29 | 84 | 14 | 71 | 17 | 26 | 2 | 4 | 37 | 65 | 6 |
Number of Progression Events in 2 Years.
The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease. (NCT00948090)
Timeframe: 2 years
| Intervention | Event (Number) |
|---|
| Hodgkin's Lymphoma (≤ 65 Years) | 41 |
| Hodgkin's Lymphoma (> 65 Years) | 1 |
| Non-Hodgkin's Lymphoma (≤ 65 Years) | 46 |
| Non-Hodgkin's Lymphoma (> 65 Years) | 8 |
Number of Death Events in 2 Years.
The time of overall survival was defined as the time from transplantation to death of all causes. (NCT00948090)
Timeframe: 2 years
| Intervention | Deaths (Number) |
|---|
| Hodgkin's Lymphoma (≤ 65 Years) | 13 |
| Hodgkin's Lymphoma (> 65 Years) | 1 |
| Non-Hodgkin's Lymphoma (≤ 65 Years) | 28 |
| Non-Hodgkin's Lymphoma (> 65 Years) | 6 |
Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab
"Participants provided PK samples for evaluation of anti-trastuzumab antibodies. The number of participants with Treatment-induced ADAs and Treatment-enhanced ADA against trastuzumab at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer)." (NCT00950300)
Timeframe: Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18
| Intervention | participants (Number) |
|---|
| Treatment-induced ADAs | Treatment-enhanced ADA |
|---|
| Herceptin IV + Chemotherapy | 28 | 2 |
,| Herceptin SC + Chemotherapy | 46 | 1 |
Tmax of Trastuzumab After Surgery
PK samples were obtained after surgery (Cycle 12). The Tmax during Cycle 12 was recorded, averaged among all participants, and expressed in days. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
| Intervention | days (Mean) |
|---|
| Herceptin IV + Chemotherapy | 0.06 |
| Herceptin SC + Chemotherapy | 4.08 |
AUC21d of Trastuzumab After Surgery
PK samples were obtained after surgery (Cycle 12). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 12 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in d*μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
| Intervention | d*μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 2179 |
| Herceptin SC + Chemotherapy | 2610 |
Cmax of Trastuzumab After Surgery
PK samples were obtained after surgery (Cycle 12). The Cmax during Cycle 12 was recorded, averaged among all participants, and expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
| Intervention | μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 230 |
| Herceptin SC + Chemotherapy | 166 |
Event-Free Survival (EFS)
Protocol-defined events included disease recurrence or progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. EFS was estimated by Kaplan-Meier analysis and defined as the time from randomization to the first protocol-defined event. (NCT00950300)
Timeframe: Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)
| Intervention | months (Median) |
|---|
| Herceptin IV + Chemotherapy | NA |
| Herceptin SC + Chemotherapy | NA |
Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery
PK samples were obtained prior to surgery (Cycle 7). The Cmax during Cycle 7 was recorded, averaged among all participants, and expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
| Intervention | μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 221 |
| Herceptin SC + Chemotherapy | 149 |
Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery
Pre-dose samples were obtained after surgery (Cycle 13). The number of participants who had an observed Ctrough >20 μg/mL was reported. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
| Intervention | participants (Number) |
|---|
| Herceptin IV + Chemotherapy | 216 |
| Herceptin SC + Chemotherapy | 227 |
Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery
Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough >20 μg/mL was reported. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
| Intervention | participants (Number) |
|---|
| Herceptin IV + Chemotherapy | 232 |
| Herceptin SC + Chemotherapy | 227 |
Observed Ctrough of Trastuzumab After Surgery
Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
| Intervention | μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 62.1 |
| Herceptin SC + Chemotherapy | 90.4 |
Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery
Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL). (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
| Intervention | μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 57.8 |
| Herceptin SC + Chemotherapy | 78.7 |
Overall Survival (OS)
OS was estimated by Kaplan-Meier analysis and defined as the time from randomization to death from any cause. (NCT00950300)
Timeframe: Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)
| Intervention | months (Median) |
|---|
| Herceptin IV + Chemotherapy | NA |
| Herceptin SC + Chemotherapy | NA |
Percentage of Participants Who Died
The percentage of participants who died at any time during the study was reported. (NCT00950300)
Timeframe: Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)
| Intervention | percentage of participants (Number) |
|---|
| Herceptin IV + Chemotherapy | 14.5 |
| Herceptin SC + Chemotherapy | 13.6 |
Percentage of Participants Who Experienced a Protocol-Defined Event
Protocol-defined events included disease recurrence/progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. The percentage of participants who experienced a protocol-defined event at any time during the study was reported. (NCT00950300)
Timeframe: Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)
| Intervention | percentage of participants (Number) |
|---|
| Herceptin IV + Chemotherapy | 33.3 |
| Herceptin SC + Chemotherapy | 32.7 |
Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline
Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm) with no prior assessment of progressive disease (PD). PR was defined as greater than or equal to (≥) 30% decrease from Baseline in sum diameter (SD) of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. The percentage of participants with overall response of CR or PR at the end of neoadjuvant treatment was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method. (NCT00950300)
Timeframe: Tumor assessments at Baseline; on Day 1 of Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months overall)
| Intervention | percentage of participants (Number) |
|---|
| Herceptin IV + Chemotherapy | 88.8 |
| Herceptin SC + Chemotherapy | 87.2 |
Percentage of Participants With Pathological Complete Response (pCR)
Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method. (NCT00950300)
Timeframe: After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)
| Intervention | percentage of participants (Number) |
|---|
| Herceptin IV + Chemotherapy | 40.7 |
| Herceptin SC + Chemotherapy | 45.4 |
Percentage of Participants With Total Pathological Complete Response (tpCR)
Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination. The percentage of participants with tpCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method. (NCT00950300)
Timeframe: After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)
| Intervention | percentage of participants (Number) |
|---|
| Herceptin IV + Chemotherapy | 34.2 |
| Herceptin SC + Chemotherapy | 39.2 |
Number of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)
"Participants in the Herceptin SC arm provided PK samples for evaluation of anti-rHuPH20 antibodies. The number of participants with Treatment-induced ADAs and Treatment-enhanced ADA against rHuPH20 (an excipient unique to the SC formulation) at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer)." (NCT00950300)
Timeframe: Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18
| Intervention | participants (Number) |
|---|
| Treatment-induced ADA | Treatment-enhanced ADA |
|---|
| Herceptin SC + Chemotherapy | 49 | 13 |
Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery
PK samples were obtained prior to surgery (Cycle 7). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 7 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in days multiplied by micrograms per milliliters (d*μg/mL). (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
| Intervention | d*μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 2056 |
| Herceptin SC + Chemotherapy | 2268 |
Predicted Ctrough of Trastuzumab After Surgery
Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
| Intervention | μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 51.7 |
| Herceptin SC + Chemotherapy | 80.6 |
Predicted Ctrough of Trastuzumab Prior to Surgery
Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
| Intervention | μg/mL (Mean) |
|---|
| Herceptin IV + Chemotherapy | 51.4 |
| Herceptin SC + Chemotherapy | 80.3 |
Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery
PK samples were obtained prior to surgery (Cycle 7). The Tmax during Cycle 7 was recorded, averaged among all participants, and expressed in days. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
| Intervention | days (Mean) |
|---|
| Herceptin IV + Chemotherapy | 0.05 |
| Herceptin SC + Chemotherapy | 4.12 |
Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline
Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm with no prior assessment of PD. PR was defined as ≥30% decrease from Baseline in SD of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. Time to response was defined as the time from first dose of study medication to the first assessment of CR or PR, which was the date the response was first documented by objective evidence, among participants with an overall response of CR or PR. (NCT00950300)
Timeframe: Tumor assessments at Baseline; on Day 1 Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of chemotherapy (approximately 6 months overall)
| Intervention | weeks (Median) |
|---|
| Herceptin IV + Chemotherapy | 6.14 |
| Herceptin SC + Chemotherapy | 6.14 |
Overall Survival at 1 Year After Umbilical Cord Blood Transplant in Pediatric Patients.
To determine the overall survival rate at 1 year after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies. (NCT00950846)
Timeframe: 1 year
| Intervention | probability of overall survival (Number) |
|---|
| Umbilical Cord Blood Transplant Treatment Plan | 0.868 |
Incidence of Severe Grade III-IV Acute GvHD at Day 100.
Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD. (NCT00950846)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Umbilical Cord Blood Transplant Treatment Plan | 1 |
Number of Participants With Chronic GvHD
Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3. (NCT00950846)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Umbilical Cord Blood Transplant Treatment Plan | 1 |
Overall Survival at 100 Days After Umbilical Cord Blood Transplant in Pediatric Patients.
To determine the overall survival rate at 100 days after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies. (NCT00950846)
Timeframe: 100 days
| Intervention | probability of overall survival (Number) |
|---|
| Umbilical Cord Blood Transplant Treatment Plan | 0.947 |
Overall Survival at 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients.
To determine the overall survival rate at 3 years after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies. (NCT00950846)
Timeframe: 3 years
| Intervention | probability of overall survival (Number) |
|---|
| Umbilical Cord Blood Transplant Treatment Plan | 0.868 |
Number of Participants With Donor Engraftment After Transplant.
To evaluate donor engraftment at 100 days, 6 and 12 months after transplant. (NCT00950846)
Timeframe: 100 days, 6 months and 12 months
| Intervention | Participants (Count of Participants) |
|---|
| 100 days | 6 months | 12 months |
|---|
| Umbilical Cord Blood Transplant Treatment Plan | 36 | 33 | 33 |
Response Rate
Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response. (NCT00958256)
Timeframe: Evaluation of disease after 2 cycles (approximately 6 weeks).
| Intervention | percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Progressive Disease (PD) | Stable Disease (SD) |
|---|
| Bortezomib With Cyclophosphamide and Rituximab | 52 | 0 | 19 | 5 |
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were to be identified as target lesions. Data were to be collected at Screening, every 6 weeks and at 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last). The best overall response was to be the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): >20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions; or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00960063)
Timeframe: Screening, every 6 weeks and at ~30 days after last dose of study drug (Up to ~10.3 months)
| Intervention | Participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) |
|---|
| Ifosfamide+Etoposide+Robatumumab | 0 | 2 | 0 | 1 |
,| Temozolomide+Irinotecan+Robatumumab | 0 | 1 | 0 | 0 |
Number of Participants With Dose Limiting Toxicities
Dose-limiting toxicity was defined by the following adverse events (AEs) that were considered possibly or probably related to either robatumumab or to its interaction with the chemotherapy regimen assigned: neutropenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 neutropenia with Grade ≥2 fever lasting 3 days; neutropenic infection; failure to recover to study entry/eligibility criteria laboratory requirement levels that resulted in a delay of 14 days between treatment cycles), thrombocytopenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 requiring a platelet transfusion on 2 separate days within a cycle) or all other AEs (Grade ≥3 [any duration] not ameliorable by supportive or symptomatic measures). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0) was to be used to grade AEs. (NCT00960063)
Timeframe: Up to ~30 days after last dose of study drug (Up to ~10.3 months)
| Intervention | Participants (Number) |
|---|
| Temozolomide+Irinotecan+Robatumumab | 1 |
| Ifosfamide+Etoposide+Robatumumab | 3 |
Number of Participants Who Developed Anti-robatumumab Antibodies
The incidence of anti-robatumumab antibodies was to be assessed. Only participants who had a negative pre-treatment sample and a post-treatment sample were considered to be evaluable. If a participant had a single sample considered positive in the anti-robatumumab antibody assay (with the exception of pre-treatment positive participants), then they would be counted as positive in the immunogenicity assessment. (NCT00960063)
Timeframe: Prior to 1st and 8th doses of robatumumab, ~30 days after last dose of study drug, and 4 months after last dose of study drug (Up to ~13.3 months)
| Intervention | Participants (Number) |
|---|
| Temozolomide+Irinotecan+Robatumumab | 0 |
| Ifosfamide+Etoposide+Robatumumab | 0 |
Overall Survival (OS) Time
OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier. (NCT00960115)
Timeframe: Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 32.4 |
| Placebo + Saline | 32.2 |
Time To Progression (TTP) - Investigator Read
TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration. (NCT00960115)
Timeframe: Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 11.3 |
| Placebo + Saline | 7.0 |
Time to Treatment Failure (TTF)
TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration. (NCT00960115)
Timeframe: Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 8.0 |
| Placebo + Saline | 6.2 |
Progression Free Survival (PFS) Time - Investigator Read
PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. (NCT00960115)
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 11.6 |
| Placebo + Saline | 8.0 |
Bone Marrow Chimerism
Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 21
| Intervention | percentage of donor DNA (Mean) |
|---|
| Complement Fragment 3A - Small Cell Dose | 84 |
| Complement Fragment A - Larger Cell Dose | 89 |
Neutrophil Engraftment
Achieving 500 neutrophils/uL by day 42. (NCT00963872)
Timeframe: Day 42
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 22 |
| Complement Fragment A - Larger Cell Dose | 5 |
Number of Patients With the Complement 3a (C3a) Unit Predominating
Efficacy of the pre-incubation of one of two umbilical cord blood (UCB) units with C3a as part of a unrelated donor double UCB nonmyeloablative transplantation in patients with high-risk hematological malignancies. (NCT00963872)
Timeframe: Day 180
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 9 |
| Complement Fragment A - Larger Cell Dose | 5 |
Overall Survival at Day 720
Survival (alive) from transplantation to last follow-up at day 720. (NCT00963872)
Timeframe: 720 days
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 13 |
| Complement Fragment A - Larger Cell Dose | 5 |
Overall Survival
Survival (alive) from transplantation to last follow-up. (NCT00963872)
Timeframe: Day 360
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 14 |
| Complement Fragment A - Larger Cell Dose | 5 |
Platelet Recovery
Number of patients with >20,000 platelets/uL by day 180 (NCT00963872)
Timeframe: Day 180
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 19 |
| Complement Fragment A - Larger Cell Dose | 5 |
Relapse of Disease
Patients who developed disease relapse after transplantation. (NCT00963872)
Timeframe: Day 360
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 10 |
| Complement Fragment A - Larger Cell Dose | 0 |
Relapse of Disease
Patients who developed disease relapse after transplantation. (NCT00963872)
Timeframe: Day 720
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 11 |
| Complement Fragment A - Larger Cell Dose | 1 |
Non-relapse Mortality
Deaths not due to relapse. (NCT00963872)
Timeframe: Day 360
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 3 |
| Complement Fragment A - Larger Cell Dose | 0 |
Non-Relapse Mortality
Deaths not due to relapse. (NCT00963872)
Timeframe: Day 180
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 3 |
| Complement Fragment A - Larger Cell Dose | 0 |
Incidence of Grades III-IV Graft-vs-host Disease
Development of graft-versus-host disease by day 100. (NCT00963872)
Timeframe: 0 to 100 days
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 2 |
| Complement Fragment A - Larger Cell Dose | 0 |
Incidence of Grades II-IV Graft-vs-host Disease
Development of graft-versus-host disease through day 100. (NCT00963872)
Timeframe: Day 0 through Day 100
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 8 |
| Complement Fragment A - Larger Cell Dose | 1 |
Donor Chimerism in Blood
Percentage of donor DNA present in the peripheral blood (NCT00963872)
Timeframe: Day 60
| Intervention | percentage of donor DNA (Mean) |
|---|
| Complement Fragment 3A - Small Cell Dose | 91 |
| Complement Fragment A - Larger Cell Dose | 97 |
Donor Chimerism in Blood
Percentage of donor DNA present in the peripheral blood (NCT00963872)
Timeframe: Day 28
| Intervention | percentage of donor DNA (Mean) |
|---|
| Complement Fragment 3A - Small Cell Dose | 92 |
| Complement Fragment A - Larger Cell Dose | 96 |
Donor Chimerism
Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 360
| Intervention | percentage of donor DNA (Mean) |
|---|
| Complement Fragment 3A - Small Cell Dose | 93 |
| Complement Fragment A - Larger Cell Dose | 100 |
Donor Chimerism
Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 180
| Intervention | percentage of donor DNA (Mean) |
|---|
| Complement Fragment 3A - Small Cell Dose | 99 |
| Complement Fragment A - Larger Cell Dose | 100 |
Donor Chimerism
Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 100
| Intervention | percentage of donor DNA (Mean) |
|---|
| Complement Fragment 3A - Small Cell Dose | 90 |
| Complement Fragment A - Larger Cell Dose | 94 |
Disease Progression
Patients who developed disease progression after transplantation. (NCT00963872)
Timeframe: Day 720
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 0 |
| Complement Fragment A - Larger Cell Dose | 0 |
Disease Progression
Patients who developed disease progression after transplantation. (NCT00963872)
Timeframe: Day 360
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 0 |
| Complement Fragment A - Larger Cell Dose | 0 |
Chronic Graft-Versus-Host Disease
Patients who developed chronic graft-versus-host disease. (NCT00963872)
Timeframe: Day 360
| Intervention | participants (Number) |
|---|
| Complement Fragment 3A - Small Cell Dose | 0 |
| Complement Fragment A - Larger Cell Dose | 0 |
Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)
Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures. (NCT00968253)
Timeframe: Up to 20 cycles of study drugs (21 day cycles) or till disease progression
| Intervention | participants (Number) |
|---|
| Complete Remission | Complete Remission without platelet recovery | CR with incomplete blood count recovery | Partial Remission | Nonresponder |
|---|
| Phase I: RAD001 10 mg + Combination Chemo | 2 | 0 | 1 | 1 | 5 |
,| Phase I: RAD001 5 mg + Combination Chemo | 1 | 0 | 0 | 1 | 1 |
,| Phase II: MTD RAD001 + Combination Chemo | 3 | 1 | 0 | 0 | 8 |
Overall Response Rate (OR) Where OR = CR + CRp + CRi
Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. (NCT00968253)
Timeframe: 8 courses of treatment, up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|
| Phase I: RAD001 5 mg + Combination Chemo | 33 |
| Phase I: RAD001 10 mg + Combination Chemo | 33 |
| Phase II: MTD RAD001 + Combination Chemo | 33 |
Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)
"The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.~A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs." (NCT00968253)
Timeframe: Following first two dose cycles (21 days/each), up to 42 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase I: RAD001 5 mg + Combination Chemo | 0 |
| Phase I: RAD001 10 mg + Combination Chemo | 1 |
Toxicity as Assessed by Number of Grade 3 or 4 Adverse Events
Number of grade 3 or 4 nonhematologic toxicity (except alopecia), or any grade 4 hematologic toxicity as defined by NCI CTCAE v3.0 (NCT00971737)
Timeframe: 3 years
| Intervention | adverse events (Number) |
|---|
| Cyclophosphamide and Vaccine Only | 0 |
| Cyclophosphamide, Vaccine and Trastuzumab | 2 |
HER-2/Neu-specific Immune Responses as Measured by Number of Participants With Positive for Delayed-type Hypersensitivity (DTH) Response
(NCT00971737)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide and Vaccine Only | 14 |
| Cyclophosphamide, Vaccine and Trastuzumab | 16 |
Clinical Benefit (CB) as Assessed by Progression Free Survival at Six Months
Progression-free survival is measured as percentage of participants with stable disease or complete response, as defined by RECIST criteria, six months after receiving last vaccination. Progressive disease (PD) will be defined by the appearance of a new lesion, or by an increase of at least 20% in the sum of the longest diameter of target lesions, taking as a reference that smallest sum longest diameter recorded since the study intervention began. In the case of bone lesions, progressive disease will be established after eight weeks of increasing or new lesions if there is subjective progressive disease as noted by increasing bone pain or decreasing performance status. These observations must be present for at least two measurement periods separated by at least four weeks. (NCT00971737)
Timeframe: 6 months post-intervention
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide and Vaccine Only | 33 |
| Cyclophosphamide, Vaccine and Trastuzumab | 37 |
Progression-free Survival (Phase II)
From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. (NCT00972478)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Ph II: R-CHOP+Vorinostat | 73 |
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL
Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. (NCT00972478)
Timeframe: Up to week 26
| Intervention | Participants (Number) |
|---|
| Abdominal pain | Acute kidney injury | Alanine aminotransferase increased | Anemia | Anorexia | Aspartate aminotransferase increased | Atrial fibrillation | Bladder spasm | Bronchial infection | CD4 lymphocytes decreased | CPK increased | Carbon monoxide diffusing capacity decreased | Colitis | Creatinine increased | Cystitis noninfective | Dehydration | Depression | Diarrhea | Disseminated intravascular coagulation | Dizziness | Duodenal perforation | Dysphagia | Dyspnea | Electrocardiogram QT corrected interval prolonged | Fatigue | Febrile neutropenia | Fecal incontinence | Gastrointestinal disorders - Other, specify | Generalized muscle weakness | Hematuria | Hiccups | Hyperglycemia | Hypoalbuminemia | Hypocalcemia | Hypokalemia | Hyponatremia | Hypophosphatemia | Hypotension | Infections and infestations - Other, specify | Jejunal perforation | Left ventricular systolic dysfunction | Leukocytosis | Lung infection | Lymphocyte count decreased | Mucosal infection | Mucositis oral | Multi-organ failure | Myalgia | Myocardial infarction | Nausea | Neutrophil count decreased | Obstruction gastric | Pain | Paronychia | Peripheral motor neuropathy | Platelet count decreased | Pneumonitis | Recurrent laryngeal nerve palsy | Respiratory failure | Sepsis | Sinus tachycardia | Sinusitis | Small intestinal obstruction | Stoma site infection | Syncope | Urinary tract infection | Urinary tract pain | Urine output decreased | Vasovagal reaction | Visceral arterial ischemia | Vomiting | Weight loss | White blood cell decreased |
|---|
| Ph I: R-CHOP+Vorinostat (400mg D1-9) | 1 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 1 | 3 | 3 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 1 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 1 | 1 | 0 | 1 | 8 | 0 | 0 | 0 | 1 | 4 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 7 |
,| Ph II: R-CHOP+Vorinostat | 3 | 1 | 1 | 22 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 4 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 9 | 24 | 1 | 1 | 2 | 0 | 1 | 4 | 3 | 0 | 8 | 6 | 2 | 3 | 3 | 1 | 1 | 1 | 4 | 20 | 1 | 3 | 0 | 2 | 2 | 3 | 37 | 1 | 1 | 1 | 0 | 22 | 1 | 1 | 1 | 11 | 1 | 1 | 1 | 1 | 4 | 3 | 2 | 0 | 1 | 0 | 2 | 3 | 32 |
Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)
Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00972478)
Timeframe: Up to week 26
| Intervention | percentage of participants (Number) |
|---|
| Ph II: R-CHOP+Vorinostat | 81 |
Overall Survival (Phase II)
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00972478)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Ph II: R-CHOP+Vorinostat | 86 |
Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)
Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite). (NCT00972478)
Timeframe: 21 days
| Intervention | mg PO Once daily Days 1-9 (Number) |
|---|
| Ph I: R-CHOP+Vorinostat (400mg D1-9) | 400 |
Number of Participants Who Develop Extensive GVHD
"Number of participants with extensive, Chronic Graft vs Host Disease (GVHD). Extensive chronic GVHD is defined as GVHD occurring after day 100 that did not meet the definition of limited chronic GVHD.~Extensive disease presents either with generalized skin involvement, or with localized skin involvement or hepatic dysfunction plus at least one of the following:~Liver histology showing chronic progressive hepatitis, bridging necrosis, or cirrhosis~Involvement of the eye (Schirmer's test with less than 5 mm wetting) (see Diagnosis and classification of Sjögren's syndrome)~Involvement of minor salivary glands or oral mucosa (as demonstrated on labial or mucosal biopsy specimen)~Involvement of any other target organ" (NCT00977691)
Timeframe: Year 5
| Intervention | Participants (Count of Participants) |
|---|
| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 0 |
| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 0 |
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 0 |
Number of Participants Who Developed Limited Chronic GVHD
"Number of incidences of participants who developed Limited Chronic Graft vs Host Disease (GVHD).~Limited disease is characterized by localized skin involvement and/or evidence of hepatic dysfunction.~Limited disease is associated with a favorable outcome without systemic therapy, while extensive disease patients have an unfavorable outcome." (NCT00977691)
Timeframe: Year 5
| Intervention | Participants (Count of Participants) |
|---|
| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 0 |
| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 0 |
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 1 |
Number of Participants With Disease-free Survival
Number of participants with disease-free survival, as defined by: alive and free acute complications related to sickle cell disease. (NCT00977691)
Timeframe: Year 5
| Intervention | Participants (Count of Participants) |
|---|
| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 0 |
| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 2 |
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 6 |
Number of Participants With Graft Failure
Number of participants with graft failure by year 5. Graft failure is defined by return of sickle cell disease. (NCT00977691)
Timeframe: Up to Year 5
| Intervention | Participants (Count of Participants) |
|---|
| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 3 |
| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 6 |
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 6 |
Participants Who Engrafted or Rejected and Type of Haploidentical Donors
Determine whether specific haploidentical donors (i.e. parent versus sibling versus child) will decrease the incidence of regimen failure (NCT00977691)
Timeframe: Up to Year 5
| Intervention | Participants (Count of Participants) |
|---|
| Father | Mother | Brother | Sister | Son |
|---|
| Participants Who Engrafted Following Stem Cell Transplant | 0 | 3 | 2 | 3 | 0 |
,| Participants Who Rejected Engraftment Following Stem Cell Transplant | 1 | 6 | 1 | 3 | 1 |
Number of Stem Cell Transplant Participants That Experienced Rejection at Each Dose of Post-transplant Cyclophosphamide
Number of stem cell transplant participants that experienced rejection at each dose of post-transplant cyclophosphamide. Determine whether post-transplant cyclophosphamide is required and will reduce the incidence and severity of regimen failure. (NCT00977691)
Timeframe: Year 5
| Intervention | Participants (Count of Participants) |
|---|
| No post-transplant cyclophosphamide | 50 mg/kg posttransplant cyclophosphamide | 100 mg/kg posttransplant cyclophosphamide |
|---|
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 0 | 0 | 6 |
,| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 0 | 6 | 0 |
,| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 3 | 0 | 0 |
Number of Participants Who Developed Acute GVHD Grades I, II, III, IV
"Number of participants who developed Acute Graft vs Host Disease (GVHD) Grades I, II, III, IV as defined by CIMBTR criteria for Organ Stages of Acute GVHD.~Grades are defined as:~Grade I: Skin = Maculopapular rash< 25% of body surface area (BSA); Liver = Total Bilirubin 2-3 mg/dL; Lower GI = stool output/day is 500-999 mL/day.~Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day.~Grade III: Skin = Rash on >50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea > 1500 mL/day.~Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin >15 mg/dL; Lower GI = Severe abdominal pain with or without ileus.~Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening." (NCT00977691)
Timeframe: Day100
| Intervention | Participants (Count of Participants) |
|---|
| Grade I acute GvHD | Grade II acute GvHD | Grade III acute GvHD | Grade IV acute GvHD |
|---|
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 1 | 0 | 0 | 0 |
,| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 1 | 0 | 0 | 0 |
,| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 0 | 0 | 0 | 0 |
Chimeric Value That is Required to Maintain Graft Survival and Hematologic Normalcy.
"Define the level of chimerism required to maintain graft survival and hematologic normalcy. Hematologic normalcy may be defined as: being free from sickle cell disease.~The chimeric status of patients will be measured on days +14 (or when subject starts to engraft), +30, +60 and +100, and periodically after day +100, by microsatellite analysis of the peripheral blood.~Engraftment of donor cells was assessed with the use of methods that detect informative polymorphisms in regions known to contain short tandem repeats. Peripheral-blood CD3+ T cells and CD14+CD15+ myeloid cells were selected for analysis with the use of immunomagnetic beads (Dynal)." (NCT00977691)
Timeframe: Up to Year 5
| Intervention | Participants (Count of Participants) |
|---|
| Greater than or Equal to 20% Chimerism with hematologic normalcy | Less than or Equal to 20% Chimerism with no hematologic normalcy |
|---|
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 6 | 6 |
,| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 2 | 6 |
,| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 0 | 3 |
Patients With Donor Type Hemoglobin
Percentage of patients post transplant with sustained donor type hemoglobin on hemoglobin electrophoresis (NCT00977691)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| PBSC Transplant With no Post-transplant Cyclophosphamide (PT-Cy) | 0 |
| PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 3 |
| PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy) | 6 |
To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL.
Patients will be evaluated at each dose level and for assessment of response to treatment. Not all patients enrolled at each dose level has been assessed to be evaluable for response. Only those that have met criteria for being evaluable for response will be counted in the Overall Number of Participants Analyzed. (NCT00981799)
Timeframe: 1-3 months
| Intervention | Participants (Count of Participants) |
|---|
| # of patients not with complete remission | # of patients with complete remission |
|---|
| Nelarabine Dose Level 0 | 0 | 0 |
,| Nelarabine Dose Level 1 | 3 | 2 |
,| Nelarabine Dose Level 2 | 4 | 2 |
,| Nelarabine Dose Level 3 | 9 | 1 |
To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL.
Patients will be evaluated based on Dose Level and total courses taken at each dose level and for presence of dose limiting toxicities. Not all patients enrolled at each dose level has been assessed to be evaluable for DLTs. Only those that have met criteria for being evaluable for DLT will be counted in the Overall Number of Participants Analyzed. (NCT00981799)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| # of patients with DLT | # of patients without DLT |
|---|
| Nelarabine Dose Level 0 | 0 | 0 |
,| Nelarabine Dose Level 1 | 0 | 5 |
,| Nelarabine Dose Level 2 | 1 | 5 |
,| Nelarabine Dose Level 3 | 2 | 8 |
The Incidence of Acute GvHD
(NCT00987480)
Timeframe: 100 days
| Intervention | percentage of participants (Number) |
|---|
| Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected | 6.7 |
Disease-free Survival at 3 Years
"Defined as time from date of transplant to relapse, graft rejection or graft failure, or death.~Primary non-engraftment is diagnosed when the participants fails to achieve an ANC >/= 500/ul at any time in the first 28 days post-transplant.~For participants with MDS or AML, relapse will be analyzed as to type and genetic origin of the MDS/leukemic cells. These will be defined by an increasing number of blasts in the marrow over 5% by the presence of circulating peripheral blasts, or by the presence of blasts in any extramedullary site. Cytogenetic analysis of the marrow and/or peripheral blood will also be obtained for the diagnosis of relapse." (NCT00987480)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected | 77.8 |
Overall Survival at 3 Years
Overall Survival is defined as time from date of transplant to event (death from any cause) or last follow-up. (NCT00987480)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected | 80 |
Time to Progression
-The progression definitions used for this study are from the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy
| Intervention | days (Median) |
|---|
| Best response of complete response | Best response of partial response | Best response of stable disease | All participants |
|---|
| EPOCH Chemotherapy & Bortezomib | 199 | 143 | 88 | 127 |
Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. (NCT01000285)
Timeframe: Up to 30 days after completion of treatment
| Intervention | participants (Number) |
|---|
| Fatigue | Vomiting | Spontaneous bacterial peritonitis | Abdominal distension | Hemoglobin | Leukocytes (WBC) | Lymphopenia | Neutrophils | Platelets | Infection without neutropenia | Infection with neutropenia | Omaya port infection | IV port infection | Sepsis | Neutropenic fever | Hypoglycemia | Hyperglycemia | Magnesium | Hypokalemia | Hypertriglyceridemia | Confusion | Headache | Encephalitis | Abdominal pain | Cough | Dyspnea |
|---|
| EPOCH Chemotherapy & Bortezomib | 1 | 1 | 1 | 2 | 6 | 7 | 1 | 6 | 6 | 1 | 1 | 1 | 1 | 2 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads
(NCT01000285)
Timeframe: 6 months
| Intervention | copies/peripheral blood mononuclear cell (Mean) |
|---|
| Baseline | Study completion |
|---|
| Non-responders | 0.417 | 0.033 |
,| Responders | 0.372 | 0.0128 |
Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence
(NCT01000285)
Timeframe: 6 months
| Intervention | percentage of nucleotide divergence (Mean) |
|---|
| Baseline | Study completion |
|---|
| EPOCH Chemotherapy & Bortezomib | 0.49 | 0.52 |
Effects of HTLV-1 Integration Sites After Treatment
(NCT01000285)
Timeframe: 6 months
| Intervention | number of integration sites (Mean) |
|---|
| Baseline | Study completion |
|---|
| EPOCH Chemotherapy & Bortezomib | 1.31 | 1.00 |
Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA
(NCT01000285)
Timeframe: 6 months
| Intervention | copies/peripheral blood mononuclear cell (Mean) |
|---|
| Baseline | Study completion |
|---|
| Non-responders | 41.9 | 35.7 |
,| Responders | 37.0 | 7.33 |
Efficacy of Treatment as Measured by Best Overall Response
-The response definitions used for this study are the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy
| Intervention | participants (Number) |
|---|
| Progressive Disease | Stable disease | Partial response | Complete response |
|---|
| EPOCH Chemotherapy & Bortezomib | 3 | 3 | 9 | 3 |
Relation of NFκB Gene Expression Profile on Response
Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated. (NCT01000285)
Timeframe: 6 months
| Intervention | fold expression (Mean) |
|---|
| BLK | CADMI | CD25 | CD4 | CD45 |
|---|
| Patient A (Responder) Post-Therapy | 0.178 | 0.011 | 0.035 | 1.380 | 1.718 |
,| Patient A (Responder) Pre-Therapy | 1.000 | 1.000 | 1.000 | 1.000 | 1.000 |
,| Patient B (Responder) Post-Therapy | 0.172 | 0.007 | 0.015 | 0.607 | 0.959 |
,| Patient B (Responder) Pre-Therapy | 0.889 | 0.623 | 0.303 | 1.437 | 2.049 |
,| Patient C (Non-responder) Post-Therapy | 77.590 | 1.816 | 0.691 | 1.923 | 1.640 |
,| Patient C (Non-responder) Pre-Therapy | 68.856 | 1.494 | 0.862 | 1.319 | 1.163 |
,| Patient D (Non-responder) Post-Therapy | 46.801 | 0.470 | 0.512 | 0.648 | 0.714 |
,| Patient D (Non-responder) Pre-Therapy | 233.179 | 2.013 | 2.897 | 3.057 | 0.594 |
Complete Response
Complete Response (NCT01004991)
Timeframe: 13 months
| Intervention | Participants (Count of Participants) |
|---|
| All Patients | 11 |
Pathologic Complete Response in Breast and Axillary Lymph Nodes.
Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy (NCT01008150)
Timeframe: At time of surgery, approximately 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Paclitaxel + Trastuzumab Then A C | 16 |
| Arm 2: Paclitaxel + Neratinib Then A C | 14 |
| Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C | 21 |
| Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC | 5 |
Clinical Complete Response, as Measured by Physical Exam
Upon physical exam the number of participants with resolution of all target and non-target lesions identified at baseline and no new lesions or other signs of disease progression. (NCT01008150)
Timeframe: At the completion of AC prior to surgery, approximately 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Paclitaxel + Trastuzumab Then A C | 25 |
| Arm 2: Paclitaxel + Neratinib Then A C | 25 |
| Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C | 28 |
| Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C | 6 |
Recurrence-free Interval (RFI)
Number of participants with no events of inoperable progressive disease and local, regional and distant recurrence. (NCT01008150)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Paclitaxel + Trastuzumab Then A C | 42 |
| Arm 2: Paclitaxel + Neratinib Then A C | 39 |
| Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C | 40 |
| Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C | 12 |
Adverse Events Experienced by Participants as a Measure of Toxicity
Number of patients with at least one adverse event. (NCT01008150)
Timeframe: Assessed through 2 years from randomization
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Paclitaxel + Trastuzumab Then A C | 41 |
| Arm 2: Paclitaxel + Neratinib Then A C | 42 |
| Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C | 42 |
| Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C | 12 |
Pathologic Complete Response in Breast.
Number of participants with by no histologic evidence of invasive tumor cells in the surgical breast specimen. (NCT01008150)
Timeframe: At time of surgery, approximately 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Paclitaxel + Trastuzumab Then A C | 21 |
| Arm 2: Paclitaxel + Neratinib Then A C | 16 |
| Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C | 22 |
| Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C | 6 |
Overall Survival
Number of participants alive at 24 months. (NCT01008150)
Timeframe: 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Paclitaxel + Trastuzumab Then A C | 42 |
| Arm 2: Paclitaxel + Neratinib Then A C | 42 |
| Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C | 42 |
| Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C | 12 |
Event-Free Survival (EFS)
Number of patients surviving without relapsed/progressive disease (NCT01008462)
Timeframe: 1 Year post-autograft
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Autologous HCT, Donor HCT) | 9 |
Number of Patients Who Engrafted
Number of patients with donor engraftment. (NCT01008462)
Timeframe: Day 84 post-allograft
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Autologous HCT, Donor HCT) | 13 |
Number of Patients Who Had Infections
Number of patients who had infections. (NCT01008462)
Timeframe: 1 Year post-autograft
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Autologous HCT, Donor HCT) | 16 |
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
"aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999).~GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death~CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD." (NCT01008462)
Timeframe: 1 year post-allograft,
| Intervention | Participants (Count of Participants) |
|---|
| Acute Graft-versus-Host-Disease | Chronic extensive Graft-versus-Host-Disease |
|---|
| Treatment (Autologous HCT, Donor HCT) | 8 | 1 |
Number of Patients With Relapsed/Progressive Disease
"Relapse/Progression defined as:~Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies.~Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy ." (NCT01008462)
Timeframe: 1 year post-autograft
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Autologous HCT, Donor HCT) | 6 |
Overall Survival
Number of patients surviving one year post-autograft (NCT01008462)
Timeframe: 1 year post-autograft
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Autologous HCT, Donor HCT) | 10 |
Non-relapse Mortality (NRM)
Number of patients with non-relapse mortalities. (NCT01008462)
Timeframe: 200 days and 1 Year post-allograft
| Intervention | Participants (Count of Participants) |
|---|
| 200 days | 1 Year |
|---|
| Treatment (Autologous HCT, Donor HCT) | 0 | 1 |
cGVHD
Chronic graft vs host disease (NCT01010217)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Haplo Arm | 11 |
| 1AgMM Related/Unrelated Donors | 7 |
| MUD Donor | 0 |
| Second Transplant | 0 |
| Myelofibrosis | 0 |
Disease Free Survival
Participants who have survived without their original disease. (NCT01010217)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Haplo Arm | 50 |
| 1AgMM Related/Unrelated Donors | 24 |
| MUD Donor | 12 |
| Second Transplant | 0 |
| Myelofibrosis | 0 |
Engraftments
(NCT01010217)
Timeframe: Day 28
| Intervention | Participants (Count of Participants) |
|---|
| Haplo Arm | 80 |
| 1AgMM Related/Unrelated Donors | 50 |
| MUD Donor | 21 |
| Second Transplant | 0 |
| Myelofibrosis | 0 |
Grade III-IV aGVHD
Acute Graft vs host disease (NCT01010217)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Haplo Arm | 11 |
| 1AgMM Related/Unrelated Donors | 7 |
| MUD Donor | 1 |
| Second Transplant | 0 |
| Myelofibrosis | 0 |
Number of Participants With Non-relapse Mortality (NRM)
Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease. Bayesian monitoring scheme described in Thall, Simon, and Estey (1996) employed to perform interim monitoring of the data during the course of the trial separately within each group. (NCT01010217)
Timeframe: At 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Haplo Arm | 8 |
| 1AgMM Related/Unrelated Donors | 7 |
| MUD Donor | 2 |
| Second Transplant | 0 |
| Myelofibrosis | 0 |
Progression Free Survival (PFS)
Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging. (NCT01015443)
Timeframe: From the date of randomization to PD, assessed up to 5.6 years
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+BSC | 7.0 |
| Saline + Placebo + BSC | 8.7 |
Time to Progression (TTP)
Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up. (NCT01015443)
Timeframe: From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+BSC | 6.4 |
| Saline + Placebo + BSC | 7.5 |
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented. (NCT01015443)
Timeframe: From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years
| Intervention | Subjects (Number) |
|---|
| TEAEs | Serious TEAE | TEAEs leading to discontinuation | TEAEs leading to death |
|---|
| Saline + Placebo + BSC | 73 | 21 | 11 | 2 |
,| Tecemotide (L-BLP25)+Cyclophosphamide+BSC | 156 | 34 | 22 | 4 |
Time to Treatment Failure (TTF)
TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment. (NCT01015443)
Timeframe: From the date of randomization to the date of first missed treatment, assessed up to 5.6 years
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+BSC | 4.6 |
| Saline + Placebo + BSC | 4.6 |
Overall Survival (OS) Time
OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis. (NCT01015443)
Timeframe: From the date of randomization until death, assessed up to 5.6 years
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+BSC | NA |
| Saline + Placebo + BSC | NA |
Time to Symptom Progression (TTSP)
TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation. (NCT01015443)
Timeframe: From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years
| Intervention | Months (Median) |
|---|
| Tecemotide (L-BLP25)+Cyclophosphamide+BSC | 19.3 |
| Saline + Placebo + BSC | 24.2 |
Overall Response Rate
Complete and partial responses; Responses will be evaluated using standard RECIST 1.1 criteria. (NCT01022138)
Timeframe: Following chemotherapy, up to 4 months
| Intervention | Participants (Count of Participants) |
|---|
| HER2Bi-armed Activated T Cells/Cyclophosphamide/Biomarker | 9 |
Number of Participant Who Were Alive Without Progression at 4 Months
26 evaluable patients will be accrued in this study. A single-arm, single-stage phase II design will be used. If ≥9 out of 26 patients have not progressed by the 4-month follow-up, we will declare that the treatment is effective on TTP. (NCT01022138)
Timeframe: At the 4-month follow-up
| Intervention | Participants (Count of Participants) |
|---|
| HER2Bi-armed Activated T Cells/Cyclophosphamide/Biomarker | 9 |
Overall Survival
Overall survival (OS) was defined as the time duration from the first infusion until death or last observation. (NCT01022138)
Timeframe: Followed until death or last observation (assessed up to 5 years), whichever occurs first
| Intervention | Months (Median) |
|---|
| HER2Bi-armed Activated T Cells/Cyclophosphamide/Biomarker | 13.1 |
Arm B: Treatment-free Survival at 18 Months
The primary endpoint Arm B: PCO+O is treatment-free survival rate at 18 months. An event for treatment-free survival will be defined as initiation of subsequent therapy for CLL or death due to any cause. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for event-free survival at 18 months. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. (NCT01024010)
Timeframe: 18 months
| Intervention | percentage of participants (Number) |
|---|
| Arm A: PCO | 87.5 |
| Arm B: PCO +O | 94.1 |
Treatment-free Survival
Treatment-free survial is defined as the time from registration to the date of initiation of subsequent treatment for CLL or death due to any cause. The distribution of treatment-free survival will be estimated using the method of Kaplan-Meier. (NCT01024010)
Timeframe: up to 5 years from registration
| Intervention | months (Median) |
|---|
| Arm A: PCO | 56.6 |
| Arm B: PCO +O | NA |
Arm A: Percentage of Complete Responses
"In Arm A: PCO, the primary endpoint of this trial is the percentage of complete responses. The NCI Working Group criteria was used to assess response to therapy:~A Complete Response (CR) is briefly defines as the absence of lymphadenopathy, no heptomegaly nor splenomegaly, neutrophils greater than 1500/ul, platelets > 100,000/ul, hemoglobin >11.0 gm/dl, and peripheral blood lymphocytes <4000uL." (NCT01024010)
Timeframe: 7 months
| Intervention | percentage of participants (Number) |
|---|
| Arm A: PCO | 46 |
Depth of Response After Ofatumumab Consolidation
The proportion of patients with an improvement in depth of response with the addition of ofatumumab consolidation after PCO induction will be estimated by the number of patients with improvement in response from the time of response evaluation at the completion of PCO to the time of response evaluation at the completion of ofatumumab consolidation divided by the total number of evaluable patients. The hierarchy for depth of response will be in the following increasing order: SD, PR, nPR, CR/CRi with MRD+, CR/CRi with MRD-. An improvement in depth of response will be defined as an improvement of at least one level in the hierarchy. Exact binomial 95% confidence intervals for the true overall improvement rate will be calculated. (NCT01024010)
Timeframe: 14 months
| Intervention | percentage of participants (Number) |
|---|
| Arm B: PCO +O | 25 |
Overall Response Rate
"The overall response rate will be estimated by the total number of complete or partial responses (CCR, CR, CRi, nPR, or PR) divided by the total number of evaluable patients. Responses will be evaluated using NCI Working Group criteria. Minimum requirements for a Partial Response (PR) requires:~50% decrease in peripheral blood lymphocyte count from the baseline~50% reduction in the sum of the products of the largest measured node or nodal masses on physical examination.~50% reduction in size of liver and/or spleen~50% improvement in neutrophils, platelets and hemoglobin" (NCT01024010)
Timeframe: 14 months
| Intervention | percentage of participants (Number) |
|---|
| Arm A: PCO | 96 |
| Arm B: PCO +O | 97 |
Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy. (NCT01026220)
Timeframe: During and after completion of study treatment.
| Intervention | participants (Number) |
|---|
| Group 1 | 72 |
Relapse-free Survival
A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy. (NCT01026220)
Timeframe: 3 years from enrollment
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.82 |
| Group 6 | 0.83 |
| Group 7 | 0.79 |
Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles. (NCT01026220)
Timeframe: 3 years from enrollment
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.84 |
| Group 4 | 0.82 |
| Group 5 | 0.90 |
Overall Survival
Survival from enrollment to death. (NCT01026220)
Timeframe: At 3 years from enrollment
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.97 |
| Group 2 | 0.97 |
| Group 3 | 0.97 |
Event Free Survival
Survival from enrollment to first event: relapse/progression, second malignancy, or death. (NCT01026220)
Timeframe: At 3 years from enrollment
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.81 |
| Group 2 | 0.83 |
| Group 3 | 0.78 |
Safety Analysis and Monitoring of Toxic Death
The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment. (NCT01026220)
Timeframe: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).
| Intervention | participants (Number) |
|---|
| Group 1 | 0 |
Second-event-free Survival
Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event. (NCT01026220)
Timeframe: At 4 years from enrollment
| Intervention | Probability of survival (Number) |
|---|
| Group 1 | 0.91 |
,| Group 2 | 0.94 |
| Group 3 | 0.88 |
2-year Progression-free Survival in Early Disease Participants
"Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.~A progression is defined as one of the following events:~>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= 2 cm); appearance of new palpable lymph nodes.~>= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present.~> 50% increase in peripheral blood lymphocytes with an absolute increase > 5000/μL.~Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with >= 56% prolymphocytes)." (NCT01027000)
Timeframe: 2 years post-registration
| Intervention | percentage of participants (Median) |
|---|
| Treatment (Combination of Chemotherapy and Transplant) | 79.5 |
Time to Platelet Recovery
The first day of a sustained platelet count > 20,000/mm^3 with no platelet transfusions in the preceding seven days. (NCT01028716)
Timeframe: Up to day 84 post-transplant
| Intervention | days (Median) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 23 |
Time to Neutrophil Recovery
Achievement of an absolute neutrophil count greater or equal to 500/mm^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery. (NCT01028716)
Timeframe: Up to day 84 post-transplant
| Intervention | days (Median) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 16 |
Relapse of Malignancy After Transplantation
Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy. (NCT01028716)
Timeframe: Up to 7 years
| Intervention | percent (Number) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 29 |
Point Estimate of Overall Survival at 3 Years
Kaplan Meier estimate of the percentage of participants with overall survival at 3 years (NCT01028716)
Timeframe: 3 years
| Intervention | percent (Number) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 45.3 |
Percentage of Participants With Chronic Graft Versus Host Disease
Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years. (NCT01028716)
Timeframe: Up to 2 years post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 26 |
Number of Red Blood Cell Transfusions
Number of units of RBCs given to the patient between day 0 and day 100 post transplant (NCT01028716)
Timeframe: Day 0-100
| Intervention | transfusions (Median) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 8 |
Non-relapse Mortality at 1 Year
Cumulative incidence of death without evidence of disease progression at 1 year (NCT01028716)
Timeframe: Up to 1 year
| Intervention | percent of participants (Number) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 22 |
Incidence of Primary Graft Failure
Defined as < 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions. (NCT01028716)
Timeframe: At day 84
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 0 |
Incidence of Grades III/IV Acute Graft Versus Host Disease
Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV. (NCT01028716)
Timeframe: At day 84
| Intervention | percent (Number) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 82 |
Disease-free Survival
Defined as being alive and in remission by < 5% blasts by bone marrow morphology for patients with myeloid malignancies and CT or PET imaging for patients with lymphoid malignancies at the time of the assessment (NCT01028716)
Timeframe: 3 years from the date of transplant
| Intervention | percent of participants (Number) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 40 |
Number of Platelet Transfusions
Number platelet transfusions given to the patient between day 0 and day 100 post transplant (NCT01028716)
Timeframe: Day 0-100
| Intervention | transfusions (Median) |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 6 |
Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System
Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 was determined. (NCT01028716)
Timeframe: Up to day 90
| Intervention | events (Number) |
|---|
| Cardiac | Fever | Rash | Gastrointestinal | Infections | CMV Reactivation | Febrile Neutropenia | Metabolic/laboratory | Musculoskeletal | Neurologic | Pain | Pulmonary | Renal/Genitourinary |
|---|
| Treatment (Nonmyeloablative HCT, TBI) | 13 | 9 | 4 | 17 | 55 | 26 | 25 | 24 | 3 | 5 | 6 | 10 | 10 |
Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC)
Clinical response was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas. Complete remission is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed is as per complete remission except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Relapsed disease is appearance of any new lesion or increase by ≥50% in the size of the previously involved sites. Stable disease is defined as less than a partial response but not progressive disease. Progression is ≥50% increase from nadir in the SPD of diameters of any previously identified abnormal node for partial response or non-responders; and an appearance of any new lesion during or at the end of therapy. (NCT01030900)
Timeframe: On study and at relapse after study treatment, approximately 10 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete remission | Complete response unconfirmed | Partial response | Stable disease | Relapsed disease | Progressive disease |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 17 | 0 | 13 | 2 | 0 | 14 |
Progression Free Survival (PFS)
PFS is the time interval from start of treatment to documented evidence of disease progression estimated using a Kaplan Meier curve. Progression was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as ≥50% increase from nadir in the sum of the products of diameters of any previously identified abnormal node for partial response or non-responders. And an appearance of any new lesion during or at the end of therapy. (NCT01030900)
Timeframe: Time of progression or death, approximately 10 months
| Intervention | months (Median) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 6.6 |
Overall Survival (OS)
OS is from enrollment to the day of death estimated using the Kaplan-Meier curve. (NCT01030900)
Timeframe: Median overall survival from enrollment to the day of death, approximately 17.9 months
| Intervention | months (Median) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 17.9 |
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01030900)
Timeframe: Date treatment consent signed to date off study, approximately 58 months and 18 days.
| Intervention | Participants (Count of Participants) |
|---|
| Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath | 48 |
Number of Participants That Achieved Pathologic Complete Response (CR)
Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field. (NCT01036087)
Timeframe: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
| Intervention | Participants (Count of Participants) |
|---|
| PNC + FEC | 11 |
Rate of Durable Complete Response
Proportion of subjects who achieved a CR with duration of at least 6 months (NCT01040871)
Timeframe: Median follow up approx 12 months
| Intervention | percentage of participants (Number) |
|---|
| VR-CAP | 44.7 |
| R-CHOP | 47.3 |
Progression-free Survival (PFS)Rate at 1-year
Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death. (NCT01040871)
Timeframe: 1 year
| Intervention | percentage of partipants (Number) |
|---|
| VR-CAP | 78.9 |
| R-CHOP | 83.9 |
Rate of Durable Response
Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. (NCT01040871)
Timeframe: Median follow up approx. 12 months
| Intervention | percentage of participants (Number) |
|---|
| VR-CAP | 53.9 |
| R-CHOP | 67.6 |
Overall Survival Rate at 1-year
Kaplan-meier estimate of overall survival at 1-year measured from date of randomization. (NCT01040871)
Timeframe: 1 year
| Intervention | percentage of partipants (Number) |
|---|
| VR-CAP | 94.1 |
| R-CHOP | 84.2 |
Subsequent Anti-lymphoma Therapy Rate at 1-year
Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive. (NCT01040871)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| VR-CAP | 71.1 |
| R-CHOP | 80.2 |
Complete Response (CR) Rate
"Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PET scan was negative.~The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.~If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.~No new sites of disease were detected." (NCT01040871)
Timeframe: 6 cycles
| Intervention | percentage of participants (Number) |
|---|
| VR-CAP | 64.5 |
| R-CHOP | 63.5 |
Overall Response Rate
"Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses." (NCT01040871)
Timeframe: 6 cycles
| Intervention | percentage of participants (Number) |
|---|
| VR-CAP | 93.4 |
| R-CHOP | 98.6 |
Donor Cell Chimerism Following Transplant
Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin. (NCT01043640)
Timeframe: Day 100
| Intervention | percentage of donor cells (Mean) |
|---|
| Transplant Patients | 90 |
Donor Cell Chimerism Following Transplant
Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin. (NCT01043640)
Timeframe: Day 28
| Intervention | percentage of donor cells (Mean) |
|---|
| Transplant Patients | 95 |
Donor Cell Chimerism Following Transplant
Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin. (NCT01043640)
Timeframe: Day 42
| Intervention | percentage of donor cells (Mean) |
|---|
| Transplant Patients | 93 |
Donor Cell Chimerism Following Transplant
Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin. (NCT01043640)
Timeframe: One year
| Intervention | percentage of donor cells (Mean) |
|---|
| Transplant Patients | 99 |
Number of Patients Who Died Peri-Transplant
Peri-transplant is defined as within 100 days of transplant. (NCT01043640)
Timeframe: By Day 100 Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Transplant Patients | 2 |
Number of Patients With Donor Derived Engraftment
Donor derived engraftment is defined as 80 percent or greater donor cells in the recipient's bone marrow and blood cells. (NCT01043640)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Transplant Patients | 42 |
Number of Patients With Grade 0 Graft-Versus-Host Disease (GVHD)
"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4" (NCT01043640)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Transplant Patients | 32 |
Number of Patients With Grade 1 Graft-Versus-Host Disease (GVHD)
"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4" (NCT01043640)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Transplant Patients | 2 |
Number of Patients With Grade 3 Graft-Versus-Host Disease (GVHD)
"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4" (NCT01043640)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Transplant Patients | 2 |
Number of Patients With Grade 4 Graft-Versus-Host Disease (GVHD)
"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4" (NCT01043640)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Transplant Patients | 5 |
Number of Patients With Grade 2 Graft-Versus-Host Disease (GVHD)
"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4" (NCT01043640)
Timeframe: Day 100 Post Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Transplant Patients | 5 |
Donor Cell Chimerism Following Transplant
Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin. (NCT01043640)
Timeframe: 6 months
| Intervention | percentage of donor cells (Mean) |
|---|
| Transplant Patients | 94 |
Event-free Survival
Estimated using Kaplan-Meier estimator. (NCT01044745)
Timeframe: From the date of transplant with relapse/progression or death as censored events, up to 2 years
| Intervention | months (Median) |
|---|
| Treatment (Rituximab and Allogeneic HCT Transplant) | 12 |
Number of Participants With Grades II-IV Acute GVHD
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria. (NCT01044745)
Timeframe: At day 100
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Rituximab and Allogeneic HCT Transplant) | 16 |
Overall Survival
Estimated using Kaplan-Meier estimator. (NCT01044745)
Timeframe: From the date of transplant with death from any cause as a censored event, up to 2 years
| Intervention | months (Median) |
|---|
| Treatment (Rituximab and Allogeneic HCT Transplant) | 12 |
Feasibility as Measured by Participant Withdrawal or Removal
Number of participants who withdrew or were removed from the study for reasons other than lack of efficacy prior to completion. (NCT01045460)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| ASCT + MILs | 3 |
| ASCT + MILs + Vaccine | 3 |
Overall Survival
Number of participants alive at 5 years (overall survival). (NCT01045460)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| ASCT + MILs | 7 |
| ASCT + MILs + Vaccine | 9 |
Progression-free Survival
Median number of months that participants were alive without disease relapse or progression (progression-free survival). (NCT01045460)
Timeframe: Up to 5 years
| Intervention | months (Median) |
|---|
| ASCT + MILs | 15.5 |
| ASCT + MILs + Vaccine | 18.6 |
Safety as Measured by Grade 3-5 Adverse Events
Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to MILs or the myeloma vaccine. (NCT01045460)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| ASCT + MILs | 0 |
| ASCT + MILs + Vaccine | 1 |
Response Rates by Blade Criteria
"Number of participants with each disease response category utilizing the Blade criteria:~Complete Response (CR): Defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.~Near Complete Response (nCR): Defined as negative serum and urine paraprotein, positive serum and/or urine immunofixation, and a bone marrow aspirate with < 5% plasma cells.~Very Good Partial Response (VGPR): Defined as negative serum and urine paraprotein with positive serum and/or urine immunofixation; or a 90% decrease in serum paraprotein with urine paraprotein < 100 mg/24 hours.~Partial Response (PR): Defined as a 50-89% decrease in serum paraprotein.~Minimal Response (MR): Defined as a 25-49% decrease in serum paraprotein.~Stable Disease (SD): Defined as not falling into any other response category.~Overall response rate (ORR): Total of CR, nCR, VGPR, and PR." (NCT01045460)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| CR | nCR | VGPR | PR | MR | SD | ORR |
|---|
| ASCT + MILs | 2 | 3 | 1 | 4 | 0 | 4 | 10 |
,| ASCT + MILs + Vaccine | 5 | 2 | 1 | 5 | 1 | 2 | 13 |
Response Rate (CR + PR)
Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR. (NCT01055314)
Timeframe: From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities
| Intervention | Proportion of Participants (Number) |
|---|
| IMC-A12 | 0.7667 |
| Temozolomide | 0.7846 |
Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment
Proportion of no Grade 4+ non-hematologic toxicity. (NCT01055314)
Timeframe: From start to week 26 of therapy
| Intervention | Proportion of Participants (Number) |
|---|
| Temozolomide | 0.7097 |
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE. (NCT01055314)
Timeframe: Up to 54 weeks
| Intervention | Participants (Number) |
|---|
| IMC-A12 | 89 |
| Temozolomide | 61 |
Event-Free Survival
Probability of no relapse, secondary malignancy, or death after 3 years in the study. (NCT01055314)
Timeframe: 3 years
| Intervention | Probability (Number) |
|---|
| IMC-A12 | 0.1627 |
| Temozolomide | 0.1919 |
Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment
Proportion of no Grade 3+ cardiac toxicity. (NCT01055314)
Timeframe: From start to week 26 of therapy
| Intervention | Proportion of Participants (Number) |
|---|
| IMC-A12 | 0.9390 |
Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2
DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1, Arm 2 | 0 |
| Cohort 2a, Arm 2 | 2 |
| Cohort 2b, Arm 2 | 1 |
| Cohort 3b, Arm 2 | 2 |
| Cohort 4, Arm 2 | 0 |
| MTD Confirmation Cohort, Arm 2 | 3 |
Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1
DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1, Arm 1 | 0 |
| Cohort 2, Arm 1 | 0 |
| Cohort 3, Arm 1 | 1 |
| Cohort 4, Arm 1 | 2 |
| MTD Confirmation Cohort, Arm 1 | 2 |
Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts
OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.
| Intervention | Percentage of participants (Number) |
|---|
| DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 81.3 |
| DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 51.9 |
Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy
"The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.
| Intervention | Percentage of Participants (Number) |
|---|
| Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 21.3 |
| Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 36.4 |
Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period
| Intervention | Months (Median) |
|---|
| MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA |
| MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA |
Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period
| Intervention | Months (Median) |
|---|
| DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA |
| DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA |
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts
Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12 and 24 months
| Intervention | Percent Probability (Number) |
|---|
| 6 months | 12 months | 24 months |
|---|
| DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 80.00 | 66.67 | 22.22 |
,| DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 60.98 | 47.92 | 33.54 |
Percentage of Participants With a Treatment Emergent AE
An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0). (NCT01055496)
Timeframe: SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.
| Intervention | Percentage of Participants (Number) |
|---|
| Subjects with AEs | Subjects with SAEs | Subjects with Grade 3 or 4 AEs | Subjects with Grade 5 AEs | Subjects discontinued due to AEs | Subjects with dose reduced due to AEs | Subjects with temporary discontinuation due to AEs |
|---|
| Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 100 | 31.3 | 89.6 | 4.2 | 27.1 | 16.7 | 54.2 |
,| Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 100 | 45.5 | 96.4 | 5.5 | 36.4 | 32.7 | 67.3 |
Mean Inotuzumab Ozogamicin Serum Concentrations
Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.
| Intervention | ng/mL (Mean) |
|---|
| Cycle 1 Day 2, 0h | Cycle 3 Day 2, 0h | Cycle 3 Day 2, 1h | Cycle 3 Day 2, 3h | Cycle 3 Day 3, 24h | Cycle 3 Day 8, 168h |
|---|
| Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | NA | 25.00 | 283.27 | 280.33 | 154.25 | NA |
,| Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | NA | NA | 189.74 | 213.95 | 110.39 | NA |
Mean Inotuzumab Ozogamicin Serum Concentrations
Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.
| Intervention | ng/mL (Mean) |
|---|
| Cycle 1 Day 2, 0h |
|---|
| Cohort 1, Arm 2 | NA |
,| Cohort 3b, Arm 2 | NA |
,| Cohort 4, Arm 1 | NA |
,| Cohort 4, Arm 2 | NA |
Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 Months
| Intervention | Percent Probability (Number) |
|---|
| 6 months | 12 months | 24 months |
|---|
| MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 84.38 | 78.13 | 71.61 |
,| MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 88.00 | 59.11 | 53.74 |
Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts
OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 months
| Intervention | Percent Probability (Number) |
|---|
| 6 months | 12 months | 24 months |
|---|
| DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 100.00 | 80.00 | 80.00 |
,| DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 74.07 | 62.96 | 55.09 |
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.
Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12, and 24 months
| Intervention | Percent Probability (Number) |
|---|
| 6 months | 12 months | 24 months |
|---|
| MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 61.85 | 51.54 | 44.67 |
,| MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 54.74 | 24.88 | NA |
Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts
OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.
| Intervention | Percentage of participants (Number) |
|---|
| MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 81.3 |
| MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 53.6 |
Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy
"The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.
| Intervention | Percentage of Participants (Number) |
|---|
| Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin | 91.7 |
| Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin | 96.4 |
Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts
PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks
| Intervention | Months (Median) |
|---|
| MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 14.36 |
| MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 6.14 |
Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts
PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks
| Intervention | Months (Median) |
|---|
| DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin | 16.36 |
| DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin | 10.12 |
Stem Cell Collection and Engraftment (Phase II)
For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported. (NCT01057225)
Timeframe: Following the first 4 courses of treatment
| Intervention | participants (Number) |
|---|
| All Treated Patients | 42 |
Progression-free Survival (Phase II)
"PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following:~• Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~• Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder" (NCT01057225)
Timeframe: From baseline to progression or death up to 3 years
| Intervention | months (Number) |
|---|
| Arm I | NA |
Survival Time (Phase II)
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (NCT01057225)
Timeframe: From baseline to death
| Intervention | months (Median) |
|---|
| All Treated Patients | NA |
Maximum Tolerated Dose (Phase I)
"To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone.~For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2.~We are reporting the number of DLTs" (NCT01057225)
Timeframe: From baseline to end of active treatment, up to 12 28-day cycles.
| Intervention | participants (Number) |
|---|
| Phase I: Dose Level -1 | 0 |
| Phase I: Dose Level 0 | 0 |
| Phase I: Dose Level 1 | 0 |
| Phase I: Dose Level 2 | 3 |
Overall Survival (12 Month)
12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months. (NCT01057225)
Timeframe: From baseline to death
| Intervention | percentage of patients (Number) |
|---|
| All Treated Patients | 96 |
Complete Response (Phase II)
In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy. (NCT01057225)
Timeframe: Following the first 4 courses of treatment
| Intervention | participants (Number) |
|---|
| Dose Level -1 | 0 |
| Dose Level 0 | 2 |
| Dose Level 1 | 3 |
| Dose Level 2 | 0 |
Time to Treatment Failure
The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (NCT01057225)
Timeframe: From baseline to end of active treatment
| Intervention | months (Number) |
|---|
| Arm I | NA |
Overall Survival (24 Month)
24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months. (NCT01057225)
Timeframe: From baseline to death
| Intervention | percentage of patients (Number) |
|---|
| All Treated Patients | 96 |
Progression Free Survival (12 Month)
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark. (NCT01057225)
Timeframe: 12 months
| Intervention | percentage of participants at 12 months (Number) |
|---|
| All Treated Patients | 85 |
Progession Free Survival (24 Month)
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark. (NCT01057225)
Timeframe: 24 months
| Intervention | percentage of participants at 24 months (Number) |
|---|
| All Treated Patients | 76 |
Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)
"The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients.~A complete response is defined as:~Negative immunofixation of the serum and urine~If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio~< 5% plasma cells in bone marrow~Disappearance of any soft tissue plasmacytomas~A very good partial response is defined as:~Serum and urine M-component detectable by immunofixation but not on electrophoresis or~If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent~Urine M-component <100 mg per 24 hour" (NCT01057225)
Timeframe: Following the first 4 cycles of treatment (28 day cycles)
| Intervention | percentage of participants (Number) |
|---|
| Arm I | 91 |
Overall Survival
Survival time is defined as the time from registration to death due to any cause. (NCT01072773)
Timeframe: Duration of Study (up to 5 years)
| Intervention | Months (Median) |
|---|
| Bortez/Cyc/Dex | 1.45 |
Time to Disease Progression
Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death (NCT01072773)
Timeframe: Duration of Study (up to 5 years)
| Intervention | Months (Median) |
|---|
| Bortez/Cyc/Dex | 1.45 |
Number of Participants With a Confirmed Hematologic Response
"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels." (NCT01072773)
Timeframe: Duration of treatment (up to 12 cycles/months)
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Very Good Partial Response (VGPR) | Partial Response (PR) |
|---|
| Bortez/Cyc/Dex | 0 | 0 | 0 |
Number of Participants With an Organ Response.
The number of patients that acheived a response in an affected organ. (NCT01072773)
Timeframe: Duration on treatment (up to 12 cycles/months)
| Intervention | participants (Number) |
|---|
| Bortez/Cyc/Dex | 0 |
One-year Survival in Patients Treated With This Regimen.
Proportion of patients who are still alive at 1 year after registration. (NCT01078441)
Timeframe: Assessed at 1 year
| Intervention | Proportion of patients (Number) |
|---|
| Treatment (Combination Chemotherapy) | 0.5 |
Number of Participants With an Overall Response
Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is > 50% decrease of clinical symptoms from baseline and recovery from blood counts. (NCT01082939)
Timeframe: 6 cycles of treatment (28 days per cycle)
| Intervention | Participants (Number) |
|---|
| Complete remission (CR) | Nodular partial remission (NPR) | Partial remission (PR) |
|---|
| CFAR | 23 | 3 | 26 |
Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years
| Intervention | percentage of participants (Number) |
|---|
| Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
| Group B - High-Risk Burkitt Lymphoma (BL) | 84.9 |
| Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 76.7 |
Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: After 2 cycles of therapy and prior to cycle 3
| Intervention | percentage of participants (Number) |
|---|
| Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
| Group B - High-Risk Burkitt Lymphoma (BL) | 90.0 |
| Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 78.7 |
Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: Time of progression or death at 4 years
| Intervention | percentage of participants (Number) |
|---|
| Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
| Group B - High-Risk Burkitt Lymphoma (BL) | 82.1 |
| Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 71.0 |
Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years
| Intervention | percentage of participants (Number) |
|---|
| Group A - Low-risk Burkitt Lymphoma (BL) | 100 |
| Group B - High-Risk Burkitt Lymphoma (BL) | 82.1 |
| Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 71.0 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01092182)
Timeframe: Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.
| Intervention | Participants (Count of Participants) |
|---|
| Group A - Low-risk Burkitt Lymphoma (BL) | 13 |
| Group B - High-Risk Burkitt Lymphoma (BL) | 87 |
| Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 72 |
Overall Survival
(NCT01093183)
Timeframe: Up to 4 years
| Intervention | months (Median) |
|---|
| Treatment (Lenalidomide and Cyclophosphamide) | 20 |
Proportion of Patients Achieving CR
(NCT01093183)
Timeframe: At 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Lenalidomide and Cyclophosphamide) | 0 |
Maximum Tolerated Dose of Lenalidomide Administered in Combination With Oral Cyclophosphamide (Phase I)
Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg. (NCT01093183)
Timeframe: 28 days
| Intervention | mg (Number) |
|---|
| Treatment (Lenalidomide and Cyclophosphamide) | 25 |
Number of Patients Achieving Objective PSA Response (50% Decrease in PSA Levels Sustained for at Least 4 Weeks) as Defined by PSA Working Group Criteria
(NCT01093183)
Timeframe: 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Lenalidomide and Cyclophosphamide) | 7 |
Overall Survival
Number of participants that were alive. (NCT01093586)
Timeframe: At 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 4 |
Overall Survival
Number of participants that were alive. (NCT01093586)
Timeframe: At 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 6 |
Overall Survival
Number of participants alive at 180 days post engraftment. (NCT01093586)
Timeframe: On day +180
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 8 |
Hematologic Engraftment
Number of participants that were able to complete engraftment by day 42. (NCT01093586)
Timeframe: On day +42
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 10 |
Disease Free
Number of participants that were disease free (NCT01093586)
Timeframe: At 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 4 |
Occurrence of Serious Infections
Number of participants that had infections (NCT01093586)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 13 |
Incidence of Chronic GVHD
Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR) (NCT01093586)
Timeframe: At 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 1 |
Recurrence or Relapse
Number of subjects that had disease recurrence (NCT01093586)
Timeframe: one year in patients post UCBT
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 2 |
Recurrence or Relapse
Number of subjects that had disease recurrence (NCT01093586)
Timeframe: two years post transplant
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 2 |
Disease Free
Number of participants that were disease free (NCT01093586)
Timeframe: At 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 4 |
Incidence of Acute Graft-versus-host Disease (GVHD)
Number of participants that had acute GVHD (NCT01093586)
Timeframe: At 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Arm I | 11 |
Time to Anti-tumor Therapy
Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy were treated as censored observations at time of death. (NCT01094548)
Timeframe: From the date of randomization up to Month 48
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 24.7 |
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 36.7 |
Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response
Baseline immune response towards MUC1 was defined as an immune response towards BP25, MUC-A2 or MUC-A11 peptide stimulation which was present in at least one of the two baseline assessments; the specific immune responses at baseline were based on the averaged baseline values across the two baseline visits. Initial increase of MUC1-specific immune response was defined as an increase of MUC1-specific immune response during the primary treatment period (up to Week 9). (NCT01094548)
Timeframe: Baseline and Week 9
| Intervention | participants (Number) |
|---|
| Baseline immune response | MUC1 specific immune response at Week 9 |
|---|
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 7 | 7 |
,| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 10 | 8 |
Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type
Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type. (NCT01094548)
Timeframe: From the date of randomization up to Week 104
| Intervention | participants (Number) |
|---|
| HLA A01 (n=3, 7) | HLA A01 not present (n=14, 8) | HLA A02 present (n=10, 10) | HLA A02 not present (n=7, 5) | HLA A03 present (n=4, 3) | HLA A03 not present (n=13, 12) | HLA A24 present (n=7, 1) | HLA A24 not present (n=10, 14) | HLA A68 present (n=2, 3) | HLA A68 not present (n=15, 12) | HLA B07 present (n=6, 5) | HLA B07 not present (n=11, 10) | HLA B08 present (n=3, 6) | HLA B08 not present (n=14, 9) | HLA B15 present (n=4, 1) | HLA B15 not present (n=13, 14) | HLA B27 present (n=3, 2) | HLA B27 not present (n=14, 13) | HLA B35 present (n=2, 4) | HLA B35 not present (n=15, 11) | HLA B44 present (n=4, 2) | HLA B44 not present (n=13, 13) | HLA C01 present (n=1, 4) | HLA C01 not present (n=16, 11) | HLA C02 present (n=3, 1) | HLA C02 not present (n=14, 14) | HLA C03 present (n=9, 2) | HLA C03 not present (n=8, 13) | HLA C04 present (n=1, 3) | HLA C04 not present (n=16, 12) | HLA C07 present (n=12, 10) | HLA C07 not present (n=5, 5) | HLA DQB02 present (n=2, 6) | HLA DQB02 not present (n=15, 9) | HLA DQB03 present (n=11, 9) | HLA DQB03 not present (n=6, 6) | HLA DQB05 present (n=6, 2) | HLA DQB05 not present (n=11, 13) | HLA DQB06 present (n=7, 5) | HLA DQB06 not present (n=10, 10) | HLA DRB01 present (n=3, 1) | HLA DRB01 not present (n=14, 14) | HLA DRB03 present (n=2, 6) | HLA DRB03 not present (n=15, 9) | HLA DRB04 present (n=11, 6) | HLA DRB04 not present (n=6, 9) | HLA DRB11 present (n=2, 5) | HLA DRB11 not present (n=15, 10) | HLA DRB13 present (n=5, 2) | HLA DRB13 not present (n=12, 13) | HLA DRB15 present (n=5, 3) | HLA DRB15 not present (n=12, 12) |
|---|
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 3 | 4 | 4 | 3 | 0 | 7 | 1 | 6 | 2 | 5 | 2 | 5 | 3 | 4 | 0 | 7 | 1 | 6 | 2 | 5 | 2 | 5 | 3 | 4 | 0 | 7 | 0 | 7 | 2 | 5 | 4 | 3 | 3 | 4 | 5 | 2 | 0 | 7 | 3 | 4 | 0 | 7 | 3 | 4 | 3 | 4 | 3 | 4 | 1 | 6 | 2 | 5 |
,| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 2 | 6 | 5 | 3 | 3 | 5 | 3 | 5 | 0 | 8 | 3 | 5 | 2 | 6 | 1 | 7 | 1 | 7 | 2 | 6 | 2 | 6 | 1 | 7 | 1 | 7 | 4 | 4 | 1 | 7 | 6 | 2 | 0 | 8 | 6 | 2 | 2 | 6 | 4 | 4 | 1 | 7 | 0 | 8 | 6 | 2 | 1 | 7 | 3 | 5 | 3 | 5 |
Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)
TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented. (NCT01094548)
Timeframe: From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)
| Intervention | participants (Number) |
|---|
| TEAEs | Serious TEAEs | NCI-CTC Grade 3 and 4 TEAEs | TEAEs leading to discontinuation of treatment | ISRs |
|---|
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 17 | 5 | 8 | 2 | 11 |
,| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 17 | 6 | 5 | 1 | 8 |
Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR]
OCR (CR, or PR, or MR or NC or PD or NE) was defined per Blade Criteria. OCR rate (CR, or PR, or MR) was defined as the number of participants having experienced at least once a CR, PR, or MR, divided by the number of all participants. CR: negative immunofixation on serum and urine monoclonal paraprotein (M-protein), disappearance of any soft tissue plasmacytomas (STP), <=5% plasma cells in bone marrow (BM); PR: >=50% reduction in serum M-protein, plasma cells in BM, size of STP; >=90% reduction of urinary M-protein in 24 hours, no increase in size/number of the lytic bone lesions (LBL). MR: 25%-49% reduction in serum M-protein, plasma cells in BM aspirate in non-secretory myeloma participants, size of STP; 50%-89% reduction in 24 h urinary light chain reaction (LCR), and no increase in size/number of LBL. PD: >25% increase in the serum M-protein level, 24 hour urinary LCR. Increase in size of existing BL or STP, development of new BL or STP, or development of hypercalcemia (NCT01094548)
Timeframe: From the date of randomization up to Month 48
| Intervention | Percentage of participants (Number) |
|---|
| CR+PR+MR | CR | PR | MR |
|---|
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 0.0 | 0.0 | 0.0 | 0.0 |
,| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 0.0 | 0.0 | 0.0 | 0.0 |
Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response
The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon [IFN] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell [PBMC]) with ratio to background >=2, and ratio of background-corrected value to baseline >=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS[t]=1), upon fulfilling the following criteria: Yt =>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t > AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only). (NCT01094548)
Timeframe: From the date of randomization up to Week 104
| Intervention | participants (Number) |
|---|
| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 8 |
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 7 |
Time to Progression (TTP)
Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: >25% increase in the level of serum monoclonal paraprotein (M-protein);>25% increase in the 24 h urinary light chain excretion; >25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death. (NCT01094548)
Timeframe: From the date of randomization up to Month 48
| Intervention | months (Median) |
|---|
| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 15.2 |
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 38.9 |
EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy
The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm IV: Nonrandomly Assigned to Arm II Treatment | 33.6 |
EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation
The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm I: Observation | 66.9 |
EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2 | 41.7 |
| Arm III: Randomized to Radiation Only in Stratum 2 | 67.5 |
Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented
| Intervention | percentage of participants (Number) |
|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy | 69.2 |
| Arm III: Randomized to Radiation Only | 63.7 |
OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only.
Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 1 | 90.7 |
| Arm III: Randomized to Radiation Only in Stratum 1 | 86.4 |
OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy
The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm IV: Nonrandomly Assigned to Arm II Treatment | 74.0 |
OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2 | 69.2 |
| Arm III: Randomized to Radiation Only in Stratum 2 | 89.5 |
OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation
The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm I: Observation | 100 |
EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 1 | 72.7 |
| Arm III: Randomized to Radiation Only in Stratum 1 | 62.9 |
Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.
| Intervention | percentage of participants (Number) |
|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy | 88.3 |
| Arm III: Randomized to Radiation Only | 86.9 |
Time to Maximum Plasma Concentration (Tmax)
Time to reach peak concentration after drug administration. (NCT01100944)
Timeframe: on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose
| Intervention | Hour (Mean) |
|---|
| Phase I Dose Level 1 + Phase 2 | 25.28 |
| Phase I Dose Level 2 | 50.0 |
Time to Response
Time to response is the time between the first day of treatment until first date of response (complete response (CR) + partial response (PR)) (whichever is first recorded). (NCT01100944)
Timeframe: From the first day of treatment until the date of first documented response, assessed up to 43 months
| Intervention | days (Median) |
|---|
| Phase I Dose Level 1 & Phase I Dose Level 2 | 44.5 |
Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat
A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours. (NCT01100944)
Timeframe: up to 122 months
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3 Nausea | Grade 3 Diarrhea | Grade 4 Neutropenia | Grade 4 Thrombocytopenia |
|---|
| Phase I Dose Level 2 | 2 | 2 | 2 | 2 |
Number of Participants With Serious and Non-serious Adverse Events
Here is the number of participants with serious and non-serious adverse events. For a detailed list of events, see the adverse event module. (NCT01100944)
Timeframe: up to 122 months
| Intervention | Participants (Count of Participants) |
|---|
| Serious | Non-serious |
|---|
| All Participants | 20 | 26 |
Relative Change Observed in Total Protein Hyperacetylation of Cluster of Differentiation 3 (CD3)+T Cells With Belinostat
Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline. (NCT01100944)
Timeframe: Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)
| Intervention | Relative fold change (Median) |
|---|
| C1D2 | C1D3 | C2D1 |
|---|
| All Participants | 3.45 | 2.49 | 1.15 |
Total Clearance (CL) of Belinostat
Clearance is the amount of time for the drug to be eliminated from the body. (NCT01100944)
Timeframe: on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose
| Intervention | L/hr (Mean) |
|---|
| Phase 1 Dose Level 1 + Phase 2 | 133.5 |
| Phase 1 Dose Level 2 | 132.1 |
Relative Changes in the Number of Tregs With Treatment
Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline. (NCT01100944)
Timeframe: Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)
| Intervention | relative fold change (Median) |
|---|
| C1D2 | C1D3 | C2D1 |
|---|
| All Participants | 0.58 | 0.47 | 1.12 |
Relative Changes in T Cell Immunoglobulin Domain and Mucin Domain-3 (TIM3)-Expressing Cluster of Differentiation 8 (CD8)+Tcells
Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline. (NCT01100944)
Timeframe: Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)
| Intervention | Relative fold change (Median) |
|---|
| C1D2 | C1D3 | C2D1 |
|---|
| All Participants | 0.81 | 0.66 | 1.01 |
Duration of Response
Duration of response is measured from the time measurement criteria (e.g. Response Evaluation Criteria in Solid Tumors (RECIST)) are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). (NCT01100944)
Timeframe: From the time of first response until date of progression, assessed up to 43 months
| Intervention | months (Median) |
|---|
| Thymic Participants | 7.4 |
| Thymoma Participants | NA |
| Thymic and Thymoma Participants | 7.4 |
Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF))
AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption. (NCT01100944)
Timeframe: on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose
| Intervention | hr*ng/ml (Mean) |
|---|
| Phase I Dose Level 1 + Phase 2 | 19756 |
| Phase I Dose Level 2 | 29686 |
Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)/Dose
AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption. (NCT01100944)
Timeframe: on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose
| Intervention | hr*ng/ml/mg (Mean) |
|---|
| Phase I Dose Level 1 + Phase 2 | 10.78 |
| Phase I Dose Level 2 | 7.57 |
Disease Control Rate (DCR)
DCR is defined as stable disease (SD) + partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST). (NCT01100944)
Timeframe: 43 months
| Intervention | percentage of participants (Number) |
|---|
| Thymic Participants | 93 |
| Thymoma Participants | 100 |
| Thymic and Thymoma Participants | 96 |
Maximum Observed Plasma Concentration (Cmax) of Belinostat
Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL. (NCT01100944)
Timeframe: on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose
| Intervention | ng/ml (Mean) |
|---|
| Phase I Dose Level 1 + Phase 2 | 650.6 |
| Phase I Dose Level 2 | 1202 |
Maximum Plasma Concentration (Cmax)/Dose
Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL. (NCT01100944)
Timeframe: on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose
| Intervention | ng/ml/mg (Mean) |
|---|
| Phase I Dose Level 1 + Phase 2 | 0.36 |
| Phase I Dose Level 2 | 0.31 |
Maximum Tolerated Dose (MTD) of Belinostat
The MTD is defined as the highest dose at which less than 2 out of 6 patients experienced a dose limiting toxicity (DLT). A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours. (NCT01100944)
Timeframe: 2 years
| Intervention | mg/m(2) (Number) |
|---|
| Phase I Dose Level 1 & Phase I Dose Level 2 | 1000 |
Clinical Response
Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT01100944)
Timeframe: 43 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) |
|---|
| Thymic and Thymoma Participants | 1 | 9 | 14 | 1 |
,| Thymic Particpants | 0 | 3 | 10 | 1 |
,| Thymoma Participants | 1 | 6 | 4 | 0 |
Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies
Objective response rate is the number of participants with a best objective response of partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST) divided by the number of participants who had treatment. (NCT01100944)
Timeframe: 43 months
| Intervention | percentage of participants (Number) |
|---|
| Thymic Participants | 21 |
| Thymoma Participants | 64 |
| Thymic and Thymoma Participants | 40 |
Overall Survival (OS)
Overall survival is defined as the on-study date until the date of death or progression as appropriate. (NCT01100944)
Timeframe: Start of treatment to time of death, assessed up to 43 months
| Intervention | months (Median) |
|---|
| Thymic Participants | 21.4 |
| Thymoma Participants | NA |
| Thymic and Thymoma Participants | 28.5 |
Progression Free Survival (PFS)
Duration of time from start of treatment to time of progression or death whichever occurs first. (NCT01100944)
Timeframe: Start of treatment to time of disease progression or death whichever occurs first, assessed up to 43 months
| Intervention | months (Median) |
|---|
| Thymic Participants | 7.2 |
| Thymoma Participants | NA |
| Thymic and Thymoma Participants | 9 |
Time to Half Life (t1/2) of Belinostat
Half life is the duration of time for the drug to be reduced to half the original amount. (NCT01100944)
Timeframe: on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose.
| Intervention | Hour (Mean) |
|---|
| Phase 1 Dose Level 1 + Phase 2 | 0.47 |
| Phase 1 Dose Level 2 | 0.40 |
Number of Participants With Progressive Disease at One Year
(NCT01105650)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: CsA | 2 |
| Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 | 1 |
| Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2 | 5 |
Time to Disease Progression
Time from study entry until progressive disease or data collection cutoff. (NCT01105650)
Timeframe: 1 Year
| Intervention | days (Median) |
|---|
| Arm 1: CsA | 52 |
| Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 | 98 |
| Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2 | 100 |
Response Rate
Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease. (NCT01105650)
Timeframe: Month 3
| Intervention | participants (Number) |
|---|
| Arm 1: CsA | 1 |
| Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 | 2 |
| Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2 | 4 |
Overall Survival
Number of participants alive at 1 year. (NCT01105650)
Timeframe: 1 Year
| Intervention | participants (Number) |
|---|
| Arm 1: CsA | 0 |
| Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 | 1 |
| Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2 | 3 |
Recurrence-free Survival
Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease. (NCT01106898)
Timeframe: Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years
| Intervention | percentage of subjects (Number) |
|---|
| Treatment (Chemotherapy With or Without Maintenance Therapy) | 98 |
Percent of Patients With Complete Remission of Disease
Disease response was defined as complete remission (disease response) by morphologic criteria including <5% blasts in a moderately cellular or cellular marrow. Complete remission was also correlated with NK cell expansion in vivo, IL-15 levels and donor/recipient KIR B genotyping, and Treg depletion. (NCT01106950)
Timeframe: At least 4 weeks after last dose (28 days)
| Intervention | Percentage of patients (Number) |
|---|
| Evaluable (Treated) Patients | 53 |
Percent of Patients With Disease Free Survival
Number of patients alive and disease free at 6 months. The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. (NCT01106950)
Timeframe: Month 6
| Intervention | Percentage of patients (Number) |
|---|
| Evaluable (Treated) Patients | 33 |
Percent of Patients With Incidence of Relapse
Number of patients who have had a relapse(the return of disease after its apparent recovery/cessation) after obtaining a complete remission of their disease. (NCT01106950)
Timeframe: Month 6
| Intervention | Percentage of patients (Number) |
|---|
| Evaluable (Treated) Patients | 53 |
Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion
Association between in vivo natural killer (NK) cell expansion and complete response without platelet recovery (CRp) with donor killer immunoglobulin-like (KIR) genotype and Treg depletion. In vivo donor NK cell expansion was correlated with regulatory T-cell (Treg) depletion as detected on flow cytometry. (NCT01106950)
Timeframe: Day 14
| Intervention | Percentage of patients (Number) |
|---|
| Evaluable (Treated) Patients (Expansion=No) | 43 |
| Evaluable (Treated) Patients (Expansion=Yes) | 13 |
Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion
The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/ul in the patient's peripheral blood 14 days after infusion. (NCT01106950)
Timeframe: Day 14
| Intervention | Percentage of patients (Number) |
|---|
| Evaluable (Treated) Patients | 27 |
The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.
(NCT01119066)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Engrafted | Primary Graft Failure | Late graft failure | Not Evaluable Engraftment |
|---|
| Busulfan, Melphalan and Fludarabine | 205 | 0 | 5 | 0 |
,| Clofarabine, Melphalan and Thiotepa | 45 | 0 | 2 | 0 |
,| Melphalan, Fludarabine and Thiotepa | 10 | 0 | 1 | 0 |
,| Total Body Irradiation, Thiotepa and Cyclophosphamide | 118 | 0 | 1 | 1 |
Survival and Disease-free Survival (DFS)
(NCT01119066)
Timeframe: at 6 months post transplant
| Intervention | percentage of participants (Number) |
|---|
| Survival | Disease Free Survival |
|---|
| Busulfan, Melphalan and Fludarabine | 92.4 | 89.0 |
,| Clofarabine, Melphalan and Thiotepa | 87.2 | 85.1 |
,| Melphalan, Fludarabine and Thiotepa | 90.9 | 90.9 |
,| Total Body Irradiation, Thiotepa and Cyclophosphamide | 93.3 | 82.5 |
Survival and Disease-free Survival (DFS)
(NCT01119066)
Timeframe: 2 years post transplant
| Intervention | % of pts at 2 years (Number) |
|---|
| Survival | Disease Free Survival |
|---|
| Busulfan, Melphalan and Fludarabine | 72.1 | 62.1 |
,| Clofarabine, Melphalan and Thiotepa | 63.8 | 59.6 |
,| Melphalan, Fludarabine and Thiotepa | 71.6 | 62.3 |
,| Total Body Irradiation, Thiotepa and Cyclophosphamide | 68.7 | 58.9 |
Survival and Disease-free Survival (DFS)
(NCT01119066)
Timeframe: 1 year post transplant
| Intervention | % of pts at 1 year post transplant (Number) |
|---|
| Survival | Disease free survival |
|---|
| Busulfan, Melphalan and Fludarabine | 83.8 | 73.7 |
,| Clofarabine, Melphalan and Thiotepa | 85.1 | 83.0 |
,| Melphalan, Fludarabine and Thiotepa | 81.8 | 72.7 |
,| Total Body Irradiation, Thiotepa and Cyclophosphamide | 80.8 | 68.3 |
Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System.
Standard BMT-CTN and IBMTR systems clinical criteria as defined by Rowlings, et al will be used to establish and grade acute GvHD. Chronic GvHD will be diagnosed and graded according to the criteria of Sullivan (CIBMTR). (NCT01119066)
Timeframe: 3 years
| Intervention | participants (Number) |
|---|
| aGVHD II-IV | cGVHD, Limited | cGVHD, Extensive |
|---|
| Busulfan, Melphalan and Fludarabine | 60 | 4 | 1 |
,| Clofarabine, Melphalan and Thiotepa | 10 | 1 | 1 |
,| Melphalan, Fludarabine and Thiotepa | 2 | 0 | 1 |
,| Total Body Irradiation, Thiotepa and Cyclophosphamide | 34 | 2 | 8 |
36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT. (NCT01132807)
Timeframe: at 36 months
| Intervention | proportion of participants (Number) |
|---|
| Treatment (ABVD:4 Cycles) | .91 |
| Escalated BEACOPP and Involved Field Radiation Therapy | .67 |
Complete Response Rate
A Complete Response (CR) was defined as having the following conditions: 1. A complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. In patients with a PET scan that was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET-negative. A Complete Response rate was defined as the number of patients who achieved a CR divided by the number of patients that were eligible for analysis in each group. The CR rate was calculated for patients that completed 4 cycles of ABVD and for patients that completed 2 cycles of ABVD and 2 cycles of BEACOPP and IFRT. (NCT01132807)
Timeframe: Up to 5 years
| Intervention | proportion of participants (Number) |
|---|
| Treatment (ABVD: 4 Cycles) | .97 |
| Escalated BEACOPP and Involved Field Radiation Therapy | .85 |
Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included. (NCT01132807)
Timeframe: 36 Months
| Intervention | proportion of patients (Number) |
|---|
| Treatment (ABVD: 4 Cycles) | .91 |
Graft Failure
Percentage of participants who failed to engraft. (NCT01135329)
Timeframe: Day 60
| Intervention | Participants (Count of Participants) |
|---|
| Transplant | 8 |
Overall Response Rate (ORR)
Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites. (NCT01144403)
Timeframe: Up to 50 months (approximately)
| Intervention | percentage of participants (Number) |
|---|
| Rituximab | 87.5 |
Overall Survival (OS)
Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death. (NCT01144403)
Timeframe: From the time of enrollment until death due to any cause (up to 50 months [approximately])
| Intervention | days (Median) |
|---|
| Rituximab | 927 |
Progression-free Survival (PFS)
PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. (NCT01144403)
Timeframe: From the time of enrollment until death due to any cause (up to 50 months [approximately])
| Intervention | days (Median) |
|---|
| Rituximab | 653 |
Number of Participant With Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment. (NCT01144403)
Timeframe: Up to 50 months (approximately)
| Intervention | participants (Number) |
|---|
| Rituximab | 8 |
Progression Free Survival Rate 2 Years After Initiation of Induction Therapy
"Death or disease progression defined by the 2008 IWCLL guideline as follows;~Greater than or equal to 50% increase in the SPD of at least 2 lymph nodes (at least one node must be greater than or equal to 2 cm); appearance of any new lymph nodes on physical examination or imaging~Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or CT scan or appearance of palpable hepatomegaly or splenomegaly, which was not previously present~Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5000/ul~Transformation to a more aggressive histology~Occurrence of any cytopenia attributable to CLL. After treatment: the progression of any cytopenia (unrelated to autoimmune cytopenia), as documented by a decrease of Hb levels by more than 20 g/L (2 g/dL) or to less than 100 g/L (10 g/dL), or by a decrease of platelet counts by more than 50% or to les" (NCT01145209)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| FO Arm | 14 |
| FCO Arm | 9 |
Participants With MRD Negativity at the Completion of Consolidation Immunotherapy Who Failed to Achieve MRD Negativity
Participants with MRD negativity at the completion of consolidation immunotherapy who failed to achieve MRD negativity following completion of induction chemoimmunotherapy (NCT01145209)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| FO Arm | 14 |
| FCO Arm | 4 |
Participants With Minimal Residual Disease (MRD) Negativity
Participants with minimal residual disease (MRD) negativity following the completion of induction chemoimmunotherapy. (NCT01145209)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| FO ARM | 4 |
| FCO ARM | 6 |
Participants With Complete Response Rates Following Induction Chemoimmunotherapy.
"Participants with complete response rates to induction chemoimmunotherapy.~Criteria for complete response (CR): CR requires all of the following:~Peripheral blood lymphocytes < 4000/uL~Absence of significant lymphadenopathy by physical examination and appropriate radiographic techniques (CT or MRI). All lymph nodes must have regressed to <=1.5cm in greatest diameter~Absence of hepatomegaly or splenomegaly by physical examination, or appropriate radiographic techniques. Spleen, if enlarged before therapy must have regressed in size and must not be palpable by physical exam.~Absence of constitutional symptoms~Normal CBC, defined as: - Polymorphonuclear cells ≥ 1,500/uL - Platelets > 100,000/uL (untransfused) - Hemoglobin > 11 g/dL (untransfused)~Bone marrow biopsy demonstrates normal cellularity for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent" (NCT01145209)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| FCO Arms | 6 |
| FO Arm | 2 |
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E. (NCT01146834)
Timeframe: 36 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF | 11 |
| Arm B: VELCADE & G-CSF | 0 |
| Arm C: CYCLOPHOSPHAMIDE & G-CSF | 14 |
Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
Number of patients who achieved neutrophil recovery after Melphalan 200 based transplant in 20 days or fewer. Neutrophil recovery is defined as an absolute neutrophil count of greater than 0.5 k/uL for three consecutive days. (NCT01146834)
Timeframe: 20 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF | 7 |
| Arm B: VELCADE & G-CSF | 4 |
| Arm C: CYCLOPHOSPHAMIDE & G-CSF | 11 |
| Arm D: PLERIXAFOR & G-CSF | 0 |
| Arm E: PLERIXAFOR, VELCADE, & G-CSF | 0 |
Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days. (NCT01146834)
Timeframe: 20 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF | 4 |
| Arm B: VELCADE & G-CSF | 1 |
| Arm C: CYCLOPHOSPHAMIDE & G-CSF | 9 |
| Arm D: PLERIXAFOR & G-CSF | 0 |
| Arm E: PLERIXAFOR, VELCADE, & G-CSF | 0 |
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion (NCT01147016)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..
| Intervention | months (Median) |
|---|
| Activated T Cells | 43 |
Overall Deaths
Total number of deaths (NCT01147016)
Timeframe: From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years
| Intervention | Participants (Count of Participants) |
|---|
| Treated | 1 |
Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG
Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory. (NCT01175356)
Timeframe: Up to 6 weeks after course 5 of induction
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (131I-MIBG, Chemotherapy) | 3 |
Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy
Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%. (NCT01175356)
Timeframe: Up to day -6 of conditioning
| Intervention | Percentage of participants (Number) |
|---|
| Treatment (131I-MIBG, Chemotherapy) | 82.2 |
Serious Adverse Events
Number of participants experiencing serious adverse events that occur during study. Adverse event collection for the purposes of this study will focus on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL2 injections. (NCT01181258)
Timeframe: Day 1 through Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Patients Receiving NK Cell Infusion | 15 |
Number of Patients With an Objective Response
The number of patients with a partial response (PR) or complete response (CR). For patients with non-hodgkin's lymphoma: CR - complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR - at least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. For patients with chronic lymphocytic leukemia: CR - disappearance of all palpable disease, normalization of the blood counts without transfusions, bone marrow aspirate lymphocyte percentage < 30%, and no evidence of disease on bone marrow biopsy. PR - 50% or more reduction in palpable disease as well as one or more of the remaining features: neutrophils >= 1.5 × 109/L or 50% improvement over baseline, platelets more than 100 × 109/L or 50% improvement over baseline, and hemoglobin more than 11.0 g/dL or 50% improvement over baseline without transfusions. (NCT01181258)
Timeframe: Month 2 Post Infusion
| Intervention | Participants (Count of Participants) |
|---|
| Patients Receiving NK Cell Infusion | 4 |
Patients With Expansion of NK Cells
Number of patients who experience in vivo expansion of allogeneic donor natural killer (NK) cells. (NCT01181258)
Timeframe: Day 14
| Intervention | Participants (Count of Participants) |
|---|
| Patients Receiving NK Cell Infusion | 0 |
Time to Disease Progression
Cumulative incidence will be used to determine time to disease progression. (NCT01181258)
Timeframe: Day 1 through Month 12
| Intervention | days (Median) |
|---|
| Patients Receiving NK Cell Infusion | 38 |
Cumulative Incidence of Disease Relapse
(NCT01181271)
Timeframe: 2-years after allogeneic transplant
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 17.2 |
Cumulative Incidence of Extensive Chronic Graft-versus-host-disease
Extensive chronic graft versus-host-disease (GVHD) was defined as GVHD that required systemic immunosuppression. (NCT01181271)
Timeframe: 1-year after allogeneic transplant
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 37.9 |
Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant
(NCT01181271)
Timeframe: Two Years
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 46 |
Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD)
Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT01181271)
Timeframe: within 200 days after allogeneic transplant
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 13.8 |
Cumulative Incidence of Non-relapse Mortality
Non-relapse mortality is defined as participants who die from causes other than their underlying disease relapse, such as infection or graft versus host disease (NCT01181271)
Timeframe: 2-years after allogeneic transplant
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 11.1 |
Estimated Two Year Overall Survival Rate for All Participants
(NCT01181271)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 83 |
Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants
(NCT01181271)
Timeframe: Two-years after Allogeneic Transplant
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 89 |
Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant
(NCT01181271)
Timeframe: two years
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 69 |
Estimated Two Year Progression Free Survival Rate for All Participants
(NCT01181271)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 64 |
Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants
(NCT01181271)
Timeframe: 2 years after allogeneic transplant
| Intervention | percentage of participants (Number) |
|---|
| Autologous Then Allogeneic Transplant | 72 |
Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL
(NCT01181271)
Timeframe: within 28 days after allogeneic transplant
| Intervention | days (Median) |
|---|
| Autologous Then Allogeneic Transplant | 12 |
Peripheral Blood All-cell Donor Chimerism
Successful donor stem cell engraftment is defined as when ≥ 80% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood at day 100 after non-myeloablative allogeneic stem cell transplantation. (NCT01181271)
Timeframe: 100 days post allogeneic transplant
| Intervention | percentage of donor-derived elements (Median) |
|---|
| Autologous Then Allogeneic Transplant | 95 |
Complete Response
"To describe response rates to hyper-CVAD and sirolimus in adults with ALL and other aggressive lymphoid malignancies.~Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)." (NCT01184885)
Timeframe: Every 21 days or as count recovery allows (at least 14 days apart) up to 24 weeks
| Intervention | participants (Number) |
|---|
| Hyper-CVAD and Sirolimus | 4 |
Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival
"This will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of > 0.5 x 10^9/L and platelet count > 50 x 10^9/L.~Hyper-CVAD/Rapamycin will be deemed acceptable if it is feasible to administer in 80% or more of subjects." (NCT01184885)
Timeframe: 18 months
| Intervention | participants (Number) |
|---|
| Hyper-CVAD and Sirolimus | 7 |
Number of Participants With Clonal Evolution
Number of participants with Severe Aplastic Anemia who received Fludarabine Plus Cyclophosphamide that experienced Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH), Myelodysplasia or Acute Leukemia. (NCT01187017)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Fludarabine/ Cyclophosphamide in Participants With Severe Aplastic Anemia | 0 |
Number of Patients Who Experienced Disease Relapse
Number of patients who relapsed who experienced disease relapse following Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic Anemia (NCT01187017)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Fludarabine/ Cyclophosphamide in Participants With Severe Aplastic Anemia | 0 |
Participant Survival Following Fludarabine/ Cyclophosphamide in Participants With Severe Aplastic Anemia
Participant survival at 6 months following Fludarabine/ Cyclophosphamide in participants with Severe Aplastic Anemia (NCT01187017)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Fludarabine/ Cyclophosphamide in Participants With Severe Aplastic Anemia | 1 |
Response Rate at 6 Months
The primary objective is to assess hematologic response of Refractory Severe aplastic anemia (SAA) subjects to who have received fludarabine and cyclophosphamide. Subjects blood counts will be evaluated at 6 months to assess a hematologic response. The hematologic response will be defined as complete, partial or no response. (NCT01187017)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| No Response | Partial Response | Complete Response |
|---|
| Fludarabine/Cyclophosphamide in Participants With Severe Aplastic Anemia | 1 | 0 | 0 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.5 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.74 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 4.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.12 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 4.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.19 |
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.40 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.20 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.63 |
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.67 |
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.62 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.84 |
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.46 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.33 |
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.85 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.47 |
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.71 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.51 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.19 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.66 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.86 |
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.42 |
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.44 |
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.21 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.27 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.34 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.64 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.67 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.16 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.25 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.62 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.64 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.30 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.59 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.80 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.89 |
Sample Collection of Central Path Review Slides in B-LLy Patients
Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported. (NCT01190930)
Timeframe: Up to 1 month
| Intervention | percentage of patients (Number) |
|---|
| B-LLy | 89.7 |
Overall Survival (OS) for B-LLy Patients
OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5 years
| Intervention | percent probability (Number) |
|---|
| B-LLy | 93.97 |
Event Free Survival (EFS) for B-LLy Patients
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5 years
| Intervention | percent probability (Number) |
|---|
| B-LLy | 94.54 |
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.7 years
| Intervention | percent probability (Number) |
|---|
| B-ALL Average Risk: MTX 20 mg/m^2/Week Starting Dose | 95.05 |
| B-ALL Average Risk: MTX 40 mg/m^2/Week Starting Dose | 94.17 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.84 |
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.1 years
| Intervention | percent probability (Number) |
|---|
| B-ALL Low Risk Arm I (LR-M) | 98.75 |
| B-ALL Low Risk Arm II (LR-C) | 98.50 |
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.7 years
| Intervention | percent probability (Number) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | 94.10 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | 95.13 |
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5.1 years
| Intervention | percent probability (Number) |
|---|
| Standard Risk With Down Syndrome | 89.77 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -1.12 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.02 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.72 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.77 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -1.19 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | 0.21 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.27 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.28 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.39 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.36 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.87 |
Blood Counts and Adverse Event Profile After 6 Months of Treatment.
The safety endpoint will be toxicity profile after 6 months of treatment. The efficacy endpoint is complete response rate at 6 months, with complete response defined as blood counts no longer meeting the standard criteria for severe pancytopenia in severe aplastic anemia. (NCT01193283)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Complete response | Partial Response | No Response |
|---|
| SAA Hematologic Response | 4 | 5 | 12 |
Overall Survival (OS) (Phase II)
The percentage of participants surviving one year after starting treatment. (NCT01193842)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Phase II: VR-DA-EPOCH | 77.6 |
| Phase II: DA-R-EPOCH | 86.7 |
Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
"Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.~In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH)." (NCT01193842)
Timeframe: Up to 6 months
| Intervention | percentage of participants (Number) |
|---|
| Phase II: VR-DA-EPOCH | 67.5 |
| Phase II: DA-R-EPOCH | 76.2 |
Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)
Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle. (NCT01193842)
Timeframe: 21 days
| Intervention | Mg per day of Vorinostat (Number) |
|---|
| Phase I: VR-DA-EPOCH | 300 |
Change in CD8 Cell Counts (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts. (NCT01193842)
Timeframe: Baseline up to 12 months
| Intervention | cells/mm^3 (Median) |
|---|
| End of cycle 2 | Treatment discontinuation | 6-month follow-up | 12-month follow-up |
|---|
| Phase I: VR-CHOP, Dose Level 1 | -172 | -81 | -16 | 128 |
,| Phase I: VR-DA-EPOCH, Dose Level 1 | 35.5 | -164.5 | -56 | 604 |
,| Phase I: VR-DA-EPOCH, Dose Level 2 | -115 | 211 | 275 | 154 |
Pharmacokinetic Clearance (Phase I)
Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points. (NCT01193842)
Timeframe: 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion
| Intervention | Liter/hour (Mean) |
|---|
| Doxorubicin | Etoposide | Vincristine |
|---|
| Phase I: VR-DA-EPOCH, Dose Level 1 | 78.6 | 3.0 | 22.4 |
,| Phase I: VR-DA-EPOCH, Dose Level 2 | 76.0 | 2.4 | 16.8 |
Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months
| Intervention | copies per milliliter (Median) |
|---|
| End of cycle 2 | Treatment discontinuation | 6-month follow-up | 12-month follow-up |
|---|
| Phase I: VR-CHOP, Dose Level 1 | 28 | 0 | 0 | 0 |
,| Phase I: VR-DA-EPOCH, Dose Level 1 | -14518 | -4517 | -55116 | 0 |
,| Phase I: VR-DA-EPOCH, Dose Level 2 | -12.5 | 0 | 0 | 0 |
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy. (NCT01193842)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Death | Life-threatening | Severe | Moderate | Mild |
|---|
| Phase II: DA-R-EPOCH | 20.0 | 28.9 | 31.1 | 17.8 | 0 |
,| Phase II: VR-DA-EPOCH | 28.9 | 37.8 | 20.0 | 8.9 | 2.2 |
Changes in Absolute CD4 Cell Counts (Phase I)
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts. (NCT01193842)
Timeframe: Baseline up to 12 months
| Intervention | cell/mm^3 (Median) |
|---|
| End of cycle 2 | Treatment discontinuation | 6-month follow-up | 12-month follow-up |
|---|
| Phase I: VR-CHOP, Dose Level 1 | -218 | -190 | -175 | -84 |
,| Phase I: VR-DA-EPOCH, Dose Level 1 | 92 | -39 | 76 | 169 |
,| Phase I: VR-DA-EPOCH, Dose Level 2 | -9 | -29 | 31 | 31 |
Changes in Human Herpes Virus (HHV)-8 Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months
| Intervention | copies per 100uL (Median) |
|---|
| At treatment discontinuation | 6-month follow-up | 12-month follow-up |
|---|
| Phase II: DA-R-EPOCH | 0 | 0 | 0 |
Changes in Human Immunodeficiency Virus (HIV) Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months
| Intervention | median change in copies per mL (Median) |
|---|
| End of Cycle 2 | At treatment discontinuation | 6-month follow-up | 12-month follow-up |
|---|
| Phase II: DA-R-EPOCH | -25 | -22.5 | -18 | -20 |
,| Phase II: VR-DA-EPOCH | -20 | -87 | -20 | 0 |
Event-free Survival (EFS) (Phase II)
The percentage of participants surviving without events (relapse or death) one year after starting treatment. (NCT01193842)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Phase II: VR-DA-EPOCH | 75.6 |
| Phase II: DA-R-EPOCH | 82.2 |
Tumor Response (Phase I)
The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease (NCT01193842)
Timeframe: Up to 2 years post treatment
| Intervention | percentage of participants (Number) |
|---|
| Complete response | Partial Response |
|---|
| Phase I: Arm C (VR-CHOP) Dose Level 1 | 100 | 0 |
,| Phase I: VR-DA-EPOCH, Dose Level 1 | 83.3 | 16.7 |
,| Phase I: VR-DA-EPOCH, Dose Level 2 | 83.3 | 16.7 |
Changes in Epstein-Barr Virus (EBV) Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load. (NCT01193842)
Timeframe: Baseline up to 12 months
| Intervention | IU/mL (Median) |
|---|
| End of Cycle 2 | At treatment discontinuation | 6-month follow-up | 12-month follow-up |
|---|
| Phase I: VR-DA-EPOCH, Dose Level 1 | 0 | 0 | 0 | 0 |
,| Phase I: VR-DA-EPOCH, Dose Level 2 | -2436.1 | -1.92 | -1.92 | -1.15 |
,| Phase II, DA-R-EPOCH | 0 | -0.28 | 0 | -2.7 |
,| Phase II, VR-DA-EPOCH | -0.61 | -2.9 | -1.55 | -0.56 |
Changes in Human Herpes Virus (HHV)-8 Viral Load
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months
| Intervention | copies per 100uL (Median) |
|---|
| 12-month follow-up |
|---|
| Phase II: VR-DA-EPOCH | 0 |
Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 78.1 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 77.9 |
Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
| Intervention | days (Median) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA |
Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 25.0 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 42.9 |
Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months]) (NCT01200758)
Timeframe: Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 250.63 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 236.82 |
Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months]) (NCT01200758)
Timeframe: Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
| Intervention | mcg*day/mL (Geometric Mean) |
|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 2734.21 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 3778.93 |
Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 57.9 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 50.6 |
Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 31.7 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 32.2 |
Percentage of Participants Who Died
(NCT01200758)
Timeframe: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
| Intervention | percentage of participants (Number) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 12.7 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 8.8 |
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive. (NCT01200758)
Timeframe: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
| Intervention | days (Median) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA |
Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
| Intervention | percentage of participants (Number) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 34.6 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 31.7 |
Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Cycle 8 (n = 174, 170) | Cycle 9 (n = 171, 168) | Cycle 10 (n = 164, 160) | Cycle 11 (n = 164, 157) | Cycle 12 (n = 160, 150) | Cycle 13 (n = 157, 150) | Cycle 14 (n = 153, 147) | Cycle 15 (n = 148, 143) | Cycle 16 (n = 150, 145) | Cycle 17 (n = 149, 143) | Cycle 18 (n = 143, 132) | Cycle 19 (n = 138, 131) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 37.69 | 30.35 | 28.44 | 28.77 | 28.80 | 28.84 | 28.09 | 28.19 | 28.05 | 28.24 | 28.59 | 27.75 |
,| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 61.31 | 49.47 | 47.27 | 46.70 | 44.72 | 44.32 | 43.32 | 44.11 | 42.96 | 42.82 | 44.79 | 43.69 |
Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months]) (NCT01200758)
Timeframe: Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Cycle 1 (n = 198, 193) | Cycle 2 (n = 197, 190) | Cycle 3 (n = 192, 190) | Cycle 4 (n = 186, 185) | Cycle 5 (n = 185, 185) | Cycle 6 (n = 187, 180) | Cycle 7 (n = 183, 172) | Cycle 8 (n = 52, 54) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 14.00 | 30.13 | 45.25 | 54.06 | 64.68 | 71.02 | 78.31 | 77.60 |
,| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 12.88 | 40.00 | 63.83 | 81.71 | 98.00 | 109.56 | 120.75 | 131.48 |
Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
| Intervention | days (Median) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA |
Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
Depletion is defined as a CD19 value <80 cells/mm^3. (NCT01200758)
Timeframe: Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])
| Intervention | percentage of participants (Number) |
|---|
| Cycle 9 Day 1 (n=170, 161) | Cycle 10 Day 1 (n=165, 164) | Cycle 11 Day 1 (n=158, 158) | Cycle 12 Day 1 (n=151, 146) | Cycle 13 Day 1 (n=149, 143) | Cycle 14 Day 1 (n=152, 143) | Cycle 15 Day 1 (n=149, 140) | Cycle 16 Day 1 (n=142, 141) | Cycle 17 Day 1 (n=145, 142) | Cycle 18 Day 1 (n=141, 140) | Cycle 19 Day 1 (n=140, 138) | Cycle 20 Day 1 (n=139, 134) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 99.4 | 99.4 | 99.4 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
,| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3). (NCT01200758)
Timeframe: Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2
| Intervention | percentage of participants (Number) |
|---|
| Cycle 1 Day 1 - Baseline (n=188, 168) | Cycle 2 Day 0 (n=183, 180) | Cycle 3 Day 1 (n=175, 175) | Cycle 4 Day 1 (n=178, 180) | Cycle 5 Day 1 (n=179, 176) | Cycle 6 Day 1 (n=173, 175) | Cycle 7 Day 1 (n=178, 173) | Cycle 8 Day 1 (n=175, 174) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 51.6 | 95.1 | 99.4 | 99.4 | 100.0 | 100.0 | 100.0 | 100.0 |
,| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 54.8 | 95.0 | 99.4 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)
Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 85.1 |
| Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 80.3 |
Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 34.8 |
| Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 28.2 |
Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
(NCT01200758)
Timeframe: Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)
| Intervention | micrograms per milliliter (mcg/mL) (Geometric Mean) |
|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 83.1 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 134.6 |
Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 82.8 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 90.5 |
Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
(NCT01200758)
Timeframe: 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])
| Intervention | mcg/mL (Median) |
|---|
| Week 12: Follow-up Visit 1 (n = 117, 118) | Week 24: Follow-up Visit 2 (n = 88, 96) | Week 36: Follow-up Visit 3 (n = 38, 53) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 15.60 | 2.89 | 1.08 |
,| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 22.35 | 5.19 | 2.02 |
Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20
All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV. (NCT01200758)
Timeframe: After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
| Intervention | percentage of responses (Number) |
|---|
| After Cy8: <1 hour (n=166) | After Cy8: ≥1 to <2 hours (n=166) | After Cy8: ≥2 to <3 hours (n=166) | After Cy8: ≥3 to <4 hours (n=166) | After Cy8: ≥4 hours (n=166) | After Cy15: <1 hour (n=130) | After Cy15: ≥1 to <2 hours (n=130) | After Cy15: ≥2 to <3 hours (n=126) | After Cy15: ≥3 to <4 hours (n=130) | After Cy15: ≥4 hours (n=130) | After Cy20: <1 hour (n=126) | After Cy20: ≥1 to <2 hours (n=126) | After Cy20: ≥2 to <3 hours (n=126) | After Cy20: ≥3 to <4 hours (n=126) | After Cy20: ≥4 hours (n=126) |
|---|
| All Participants | 11 | 20 | 35 | 18 | 16 | 13 | 17 | 34 | 14 | 22 | 14 | 32 | 21 | 13 | 19 |
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
| Intervention | percentage of participants (Number) |
|---|
| Baseline (n=68, 188) | Post-Baseline (n=66, 197) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 10.3 | 7.6 |
,| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 11.2 | 13.2 |
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
| Intervention | percentage of participants (Number) |
|---|
| Baseline (n=208, 191) | Post-Baseline (n=206, 197) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 5.8 | 1.5 |
,| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 2.6 | 2.0 |
Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
| Intervention | percentage of participants (Number) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 36.1 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 35.1 |
Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 84.9 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 84.4 |
Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure. (NCT01205503)
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2
| Intervention | Percent Change from Baseline (Geometric Mean) |
|---|
| Cycle 1 Post | Cycle 2 Pre | Cycle 2 Post |
|---|
| Cycle 1 Mesna; Cycle 2 Saline | 102.63 | 97.00 | 75.71 |
,| Cycle 1 Saline; Cycle 2 Mesna | 98.95 | 100.52 | 87.91 |
Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Continuous Measure of troponin at the 4 time points outlined in the protocol for each group. (NCT01205503)
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2
| Intervention | ng/ml (Geometric Mean) |
|---|
| Cycle 1 Pre | Cycle 1 Post | Cycle 2 Pre | Cycle 2 Post |
|---|
| Cycle 1 Mesna; Cycle 2 Saline | 0.017 | 0.012 | 0.016 | 0.019 |
,| Cycle 1 Saline; Cycle 2 Mesna | 0.015 | 0.014 | 0.020 | 0.021 |
Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure. (NCT01205503)
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2
| Intervention | Percent Change from Baseline (Geometric Mean) |
|---|
| Cycle 1 Post | Cycle 2 Pre | Cycle 2 Post |
|---|
| Cycle 1 Mesna; Cycle 2 Saline | 73.54 | 97.00 | 75.71 |
,| Cycle 1 Saline; Cycle 2 Mesna | 108.82 | 100.52 | 87.91 |
B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes. (NCT01205503)
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2
| Intervention | pg/ml (Geometric Mean) |
|---|
| Cycle 1 Pre | Cycle 1 Post | Cycle 2 Pre | Cycle 2 Post |
|---|
| Cycle 1 Mesna; Cycle 2 Saline | 49.24 | 47.17 | 46.30 | 46.66 |
,| Cycle 1 Saline; Cycle 2 Mesna | 46.36 | 50.73 | 45.85 | 54.33 |
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group. (NCT01205503)
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2
| Intervention | log(pg/ml) (Geometric Mean) |
|---|
| Cycle 1 Pre | Cycle 1 Post | Cycle 2 Pre | Cycle 2 Post |
|---|
| Cycle 1 Mesna; Cycle 2 Saline | 3.68 | 3.18 | 1.67 | 1.29 |
,| Cycle 1 Saline; Cycle 2 Mesna | 3.55 | 2.95 | 2.26 | 1.78 |
Number of Participants With a Response to Therapy
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT01218867)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Partial Response (PR) | Progressive Disease (PD) | Stable Disease (SD) |
|---|
| Cohort 1 - 1x10(6) Cells (High Dose IL-2) | 0 | 0 | 1 | 0 |
,| Cohort 10 - 1x10(10) Cells (Low Dose IL-2) | 0 | 1 | 3 | 0 |
,| Cohort 11 - 3x10(10) Cells (Low Dose IL-2) | 0 | 0 | 2 | 0 |
,| Cohort 2 - 3x10(6) Cells (High Dose IL-2) | 0 | 0 | 1 | 0 |
,| Cohort 3 - 1x10(7) Cells (High Dose IL-2) | 0 | 0 | 3 | 0 |
,| Cohort 4 - 3x10(7) Cells (High Dose IL-2) | 0 | 0 | 1 | 0 |
,| Cohort 5 - 1x10(8) Cells (High Dose IL-2) | 0 | 0 | 1 | 0 |
,| Cohort 6 - 3x10(8) Cells (High Dose IL-2) | 0 | 0 | 1 | 0 |
,| Cohort 7 - 1x10(9) Cells (High Dose IL-2) | 0 | 0 | 3 | 1 |
,| Cohort 8 - 1x10(9) Cells (Low Dose IL-2) | 0 | 0 | 3 | 0 |
,| Cohort 9 - 3x10(9) Cells (Low Dose IL-2) | 0 | 0 | 3 | 0 |
Number of Participants With Serious and Non-Serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01218867)
Timeframe: Date treatment consent signed to date off study, approximately, 33 months and 25 days
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) | 1 |
| Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) | 1 |
| Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) | 3 |
| Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) | 1 |
| Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) | 1 |
| Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) | 1 |
| Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) | 4 |
| Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) | 3 |
| Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) | 3 |
| Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) | 3 |
| Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2) | 2 |
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 13 | 1 | 1 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 6 | 0 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 9 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 5 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 9 | 2 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 3 | 1 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Breast Cancer Pathological Response
The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present. (NCT01220128)
Timeframe: During the treatment period, up to Week 26/32
| Intervention | Subjects (Number) |
|---|
| Partial respose | Complete response |
|---|
| Cohort A-GSK2302024A Group | 4 | 0 |
,| Cohort A-Placebo Group | 3 | 0 |
,| Cohort B-GSK2302024A Group | 5 | 0 |
,| Cohort B-Placebo Group | 3 | 2 |
,| Cohort C-GSK2302024A Group | 3 | 6 |
,| Cohort C-Placebo Group | 1 | 3 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 1 |
Number of Patients With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Cohort A-GSK2302024A Group | 15 |
| Cohort A-Placebo Group | 5 |
| Cohort B-GSK2302024A Group | 9 |
| Cohort B-Placebo Group | 6 |
| Cohort C-GSK2302024A Group | 11 |
| Cohort C-Placebo Group | 4 |
| Cohort D-GSK2302024A-D14 Group | 7 |
Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response
For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-administration antibody concentration. (NCT01220128)
Timeframe: At post-GSK2302024A/placebo Dose 4 (Week 13)
| Intervention | Subjects (Number) |
|---|
| Cohort A-GSK2302024A Group | 10 |
| Cohort A-Placebo Group | 0 |
| Cohort B-GSK2302024A Group | 0 |
| Cohort B-Placebo Group | 0 |
| Cohort C-GSK2302024A Group | 6 |
| Cohort C-Placebo Group | 0 |
| Cohort D-GSK2302024A-D14 Group | 2 |
Number of Subjects With Serious Adverse Events SAE(s)
A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE. (NCT01220128)
Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)
| Intervention | Subjects (Number) |
|---|
| Cohort A-GSK2302024A Group | 3 |
| Cohort A-Placebo Group | 0 |
| Cohort B-GSK2302024A Group | 4 |
| Cohort B-Placebo Group | 2 |
| Cohort C-GSK2302024A Group | 5 |
| Cohort C-Placebo Group | 1 |
| Cohort D-GSK2302024A-D14 Group | 5 |
Number of Subjects With Severe Toxicities
Severe toxicity was defined as follows: - A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo - A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at < 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks. - A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo. - A Grade 2 or higher allergic reaction occurring within 24 hours following the administration. - A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration. - A decrease in renal function at the time of administration that was considered as related or possibly related. (NCT01220128)
Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)
| Intervention | Subjects (Number) |
|---|
| Cohort A-GSK2302024A Group | 0 |
| Cohort A-Placebo Group | 0 |
| Cohort B-GSK2302024A Group | 1 |
| Cohort B-Placebo Group | 0 |
| Cohort C-GSK2302024A Group | 1 |
| Cohort C-Placebo Group | 0 |
| Cohort D-GSK2302024A-D14 Group | 0 |
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Any AE(s) Grade 1 | Any AE(s) Grade 2 | Any AE(s) Grade 3 | Any AE(s) Grade 4 | Any AE(s) Grade 5 | Any AE(s) |
|---|
| Cohort A-GSK2302024A Group | 6 | 6 | 3 | 0 | 0 | 15 |
,| Cohort A-Placebo Group | 1 | 4 | 0 | 0 | 0 | 5 |
,| Cohort B-GSK2302024A Group | 0 | 6 | 0 | 2 | 1 | 9 |
,| Cohort B-Placebo Group | 0 | 0 | 5 | 1 | 0 | 6 |
,| Cohort C-GSK2302024A Group | 0 | 4 | 3 | 4 | 0 | 11 |
,| Cohort C-Placebo Group | 0 | 3 | 0 | 1 | 0 | 4 |
,| Cohort D-GSK2302024A-D14 Group | 0 | 2 | 1 | 4 | 0 | 7 |
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 12 | 2 | 0 | 0 | 0 | 1 |
,| Cohort A-Placebo Group | 5 | 1 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 8 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 4 | 2 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 6 | 5 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 2 | 2 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 1 | 2 | 0 | 0 | 0 | 5 |
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 10 | 5 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 5 | 1 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 8 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 7 | 4 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 3 | 1 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 1 | 2 | 0 | 0 | 0 | 5 |
Number of Subjects With Anemia, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 12 | 2 | 1 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 7 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 1 | 7 | 0 | 1 | 0 | 0 |
,| Cohort B-Placebo Group | 0 | 4 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 0 | 7 | 4 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 0 | 3 | 1 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 2 | 2 | 0 | 0 | 0 | 4 |
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 12 | 3 | 1 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 4 | 2 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 8 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 7 | 4 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 1 | 3 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 2 | 1 | 0 | 0 | 0 | 5 |
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 15 | 0 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 5 | 1 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 9 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 11 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 2 | 0 | 1 | 1 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 11 | 4 | 0 | 0 | 0 | 4 |
,| Cohort A-Placebo Group | 4 | 2 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 8 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 5 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 10 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 3 | 1 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 15 | 0 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 6 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 9 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 11 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 4 | 0 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 4 | 0 | 0 | 0 | 0 | 4 |
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 14 | 1 | 0 | 0 | 0 | 3 |
,| Cohort A-Placebo Group | 3 | 3 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 8 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 11 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 4 | 0 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 15 | 0 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 5 | 1 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 7 | 1 | 1 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 10 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 4 | 0 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 14 | 1 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 4 | 2 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 9 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 10 | 0 | 1 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 4 | 0 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 12 | 3 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 6 | 0 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 5 | 3 | 1 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 4 | 1 | 1 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 10 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 3 | 1 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 15 | 0 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 6 | 0 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 9 | 0 | 1 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 10 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 4 | 0 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and post 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 15 | 0 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 6 | 0 | 0 | 0 | 0 | 1 |
,| Cohort B-GSK2302024A Group | 5 | 4 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 11 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 4 | 0 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 3 | 0 | 0 | 0 | 0 | 5 |
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 9 | 5 | 1 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 4 | 2 | 1 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 0 | 3 | 5 | 1 | 0 | 0 |
,| Cohort B-Placebo Group | 0 | 2 | 2 | 2 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 2 | 3 | 5 | 1 | 0 | 0 |
,| Cohort C-Placebo Group | 1 | 1 | 1 | 1 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 1 | 1 | 2 | 0 | 0 | 4 |
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 15 | 0 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 7 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 9 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 6 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 11 | 0 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 4 | 0 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 4 | 0 | 0 | 0 | 0 | 4 |
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 12 | 3 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 6 | 0 | 1 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 7 | 1 | 1 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 5 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 10 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 3 | 0 | 0 | 1 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 0 | 0 | 1 | 0 | 3 | 4 |
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 14 | 1 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 6 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 8 | 1 | 0 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 5 | 1 | 0 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 5 | 5 | 1 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 2 | 2 | 0 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 2 | 2 | 0 | 0 | 0 | 4 |
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Any SAE(s) Grade 1 | Any SAE(s) Grade 2 | Any SAE(s) Grade 3 | Any SAE(s) Grade 4 | Any SAE(s) Grade 5 | Any SAE(s) |
|---|
| Cohort A-GSK2302024A Group | 0 | 1 | 2 | 0 | 0 | 3 |
,| Cohort A-Placebo Group | 0 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 0 | 1 | 0 | 2 | 1 | 4 |
,| Cohort B-Placebo Group | 0 | 0 | 1 | 1 | 0 | 2 |
,| Cohort C-GSK2302024A Group | 0 | 0 | 1 | 4 | 0 | 5 |
,| Cohort C-Placebo Group | 0 | 0 | 0 | 1 | 0 | 1 |
,| Cohort D-GSK2302024A-D14 Group | 0 | 0 | 1 | 4 | 0 | 5 |
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade
Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration
| Intervention | Subjects (Number) |
|---|
| Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade Unknown |
|---|
| Cohort A-GSK2302024A Group | 13 | 2 | 0 | 0 | 0 | 0 |
,| Cohort A-Placebo Group | 7 | 0 | 0 | 0 | 0 | 0 |
,| Cohort B-GSK2302024A Group | 6 | 2 | 1 | 0 | 0 | 0 |
,| Cohort B-Placebo Group | 3 | 2 | 1 | 0 | 0 | 0 |
,| Cohort C-GSK2302024A Group | 7 | 4 | 0 | 0 | 0 | 0 |
,| Cohort C-Placebo Group | 2 | 1 | 1 | 0 | 0 | 0 |
,| Cohort D-GSK2302024A-D14 Group | 0 | 1 | 0 | 3 | 0 | 4 |
Veno-occlusive Disease (VoD)
Assessed as the incidence of veno-occlusive disease (VoD) at 100 days post-transplant. (NCT01220297)
Timeframe: 100 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo | 0 |
| GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo | 1 |
Overall Survival
Overall survival is defined as time from enrollment to time of death or last follow-up, within 2 years. (NCT01220297)
Timeframe: 2 years
| Intervention | Days (Median) |
|---|
| GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo | 405 |
Disease-free Survival (DFS)
Assessed as survival without recurrence of disease (NCT01220297)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo | 0 |
| GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo | 0 |
Acute GvHD (Grade 3 to 4)
"Assessed as the incidence of grade 3 to 4 acute GvHD at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage" (NCT01220297)
Timeframe: 100 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo | 0 |
| GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo | 1 |
Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)
"Assessed as the incidence of grade 2 to 4 acute graft-vs-host disease (GvHD) at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage" (NCT01220297)
Timeframe: 100 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo | 0 |
| GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo | 1 |
Response Rate (CR + PR)
Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. (NCT01222715)
Timeframe: From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.
| Intervention | Proportion of participants (Number) |
|---|
| Regimen A | 0.3250 |
| Regimen B | 0.4737 |
Rate of Dose-Limiting Toxicities
The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays > 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis > 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP). (NCT01222715)
Timeframe: From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.
| Intervention | Percentage of participants (Number) |
|---|
| Regimen A | 2 |
| Regimen B | 21 |
Event Free Survival Probability
Probability of no relapse, secondary malignancy, or death after 1 year in the study. (NCT01222715)
Timeframe: 1 year
| Intervention | Probability (Number) |
|---|
| Regimen A | 0.23 |
| Regimen B | 0.43 |
Event-Free Survival
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT01231906)
Timeframe: 5 years after enrollment
| Intervention | Percent Probability (Number) |
|---|
| Arm A (Combination Chemotherapy) | 77.64 |
| Arm B (Combination Chemotherapy, Topotecan Hydrochloride) | 78.79 |
Response (Complete Response (CR) + Partial Response (PR)) to Therapy
Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline um LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. (NCT01236573)
Timeframe: 4 years
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Progressive Disease (PD) | Not Assessed (NA) | Not Evaluable (NE) |
|---|
| Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) | 0 | 0 | 1 | 0 | 0 |
,| Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) | 1 | 3 | 0 | 0 | 0 |
,| Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2) | 0 | 1 | 3 | 1 | 1 |
,| Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) | 0 | 0 | 1 | 0 | 0 |
,| Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) | 0 | 0 | 6 | 0 | 0 |
,| Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) | 0 | 0 | 0 | 1 | 0 |
,| Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) | 0 | 0 | 1 | 0 | 0 |
,| Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) | 0 | 0 | 4 | 0 | 0 |
,| Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) | 0 | 0 | 2 | 1 | 0 |
,| Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) | 0 | 0 | 2 | 1 | 0 |
,| Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) | 0 | 1 | 2 | 1 | 0 |
Maximum Tolerated Dose (MTD)
The MTD was determined by evaluating dose limiting toxicities (DLT) of participants that received increasing doses of intravenous infusion of IL-12 gene transduced tumor infiltrating lymphocytes (TIL) (i.e., 1x10^6, 3x10^6, 3x10^7, 1x10^7, 3x10^7, 1x10^8, 3x10^8, 1x10^9, and 3x10^9) in cohorts 1-10. Maximum tolerated cell dose is the highest dose at which NCT01236573)
Timeframe: 4 years
| Intervention | Cells (Number) |
|---|
| All Phase I Participants | 1,000,000,000 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT01236573)
Timeframe: 49 months and 20 days
| Intervention | participants (Number) |
|---|
| Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1) | 1 |
| Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1) | 1 |
| Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1) | 6 |
| Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1) | 1 |
| Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1) | 1 |
| Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1) | 4 |
| Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1) | 3 |
| Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1) | 3 |
| Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1) | 4 |
| Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1) | 4 |
| Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2) | 6 |
Overall Survival at 100 Days, 1 Year, and 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients.
To determine the overall survival rate at 1 year after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies. (NCT01247701)
Timeframe: 100 days, 1 year, and 3 years
| Intervention | probability of overall survival (Number) |
|---|
| 100 days | 1-Year | 3-Year |
|---|
| Umbilical Cord Blood Transplant | 0.923 | 0.923 | 0.923 |
Number of Participants With Donor Engraftment After Transplant.
To evaluate donor engraftment at 100 days, 6, 9, 12, 24, and 36 months after transplant. (NCT01247701)
Timeframe: 100 days, 6, 9, 12, 24 and 36 months
| Intervention | Participants (Count of Participants) |
|---|
| 100 days | 6 months | 9 months | 12 months | 24 months | 36 months |
|---|
| Umbilical Cord Blood Transplant | 11 | 6 | 6 | 6 | 6 | 3 |
Number of Participants With Severe Acute GVHD Grade III-IV
Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD. (NCT01247701)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Umbilical Cord Blood Transplant | 2 |
Number of Participants With Platelet Engraftment
Achievement of untransfused platelet count > 20 x 10^9/L on three consecutive days (NCT01247701)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| Umbilical Cord Blood Transplant | 13 |
Number of Participants With Neutrophil Engraftment
Achievement of absolute neutrophil count > 0.5 x 10^9/L on three consecutive days (NCT01247701)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Umbilical Cord Blood Transplant | 15 |
Number of Participants With Chronic GvHD
Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3. (NCT01247701)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Umbilical Cord Blood Transplant | 1 |
Number of Participants With Relapse Rate After Transplant
To assess relapse rate at 1 and 3 years after transplant. Cumulative incidence of relapse was calculated from the date of umbilical cord blood transplant using the competing risk method as described in Gray(1988) with death prior to relapse as the competing risk. Participants still alive without a date of relapse were censored at the time of the last follow-up. (NCT01247701)
Timeframe: 1 and 3 years
| Intervention | percentage of participants (Number) |
|---|
| 1 year | 3 year |
|---|
| Umbilical Cord Blood Transplant | 53.3 | 53.3 |
Overall Response Rate (ORR)
Patients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia [IWCLL] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least 50% reduction in disease signs and symptoms, a 50% improvement in peripheral blood and greater than or equal to 50% reduction in lymph nodes. (NCT01253460)
Timeframe: 84 days
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide, Rituximab + Sapacitabine | 8 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT01253460)
Timeframe: Up to 8.5 years
| Intervention | Months (Median) |
|---|
| Cyclophosphamide, Rituximab + Sapacitabine | 31 |
Disease Free Survival (DFS)
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years
| Intervention | Months (Median) |
|---|
| Treatment (Chemotherapy, Transplant) | 29.7 |
Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: At 3 years after CR
| Intervention | percentage of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 52.6 |
Response
Proportion of patients reaching a CR. A CR requires the following: an absolute neutrophil count (segs and bands) >1000/μL, no circulating blasts, platelets >100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and <5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement). (NCT01256398)
Timeframe: 10 years
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | .9846 |
Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)
Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 0.667 |
Overall Survival (OS)
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years
| Intervention | Months (Median) |
|---|
| Treatment (Chemotherapy, Transplant) | 55.9 |
Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.
Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, Transplant) | 5 |
Quality of Life (QoL): Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire
The FACIT-F questionnaire consists of 13 questions with a total score range of 0 to 52 with 0 indicating a better outcome and 52 indicating a worse outcome. (NCT01263704)
Timeframe: [Visit 1 (Screening, Week 0), at Visits 11 (Week 45) and 14 (Week 80) and at the end of the study (Month 42)]
| Intervention | score on a scale (Mean) |
|---|
| Visit 1 (Screening, Week 0) | Visit 11 (Week 45) | Visit 14 (Week 80) | End of the Study (Month 42) |
|---|
| Rituximab Plus Fludarabine and Cyclophosphamide | 36.1 | 39.4 | 40.2 | 47.0 |
Progression-free Survival (PFS)
PFS was defined as the interval from the first study drug treatment day to the first sign of disease progression according to NCI-WG guidelines. Progressive disease (PD): Any new lesion, any disease symptoms, >/=50% increase in lymphadenopathy, splenomegaly, hepatomegaly, >/= 50% increase in the number of circulating clonal B lymphocytes, decrease of hemoglobin levels by > 2.0 g/dL, >/= 50% decrease of platelet counts, increase of lymphocytes in bone marrow to more than 30% from normal. (NCT01263704)
Timeframe: Up to 53 months
| Intervention | months (Median) |
|---|
| Rituximab Plus Fludarabine and Cyclophosphamide | 36.1 |
Overall Response Rate
Overall response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to National Cancer Institute - Working Group [NCI-WG] guidelines. CR: no clonal B lymphocytes in peripheral blood, no significant lymphadenopathy, liver and spleen normal size, no disease symptoms, blood counts: absolute neutrophil count (ANC) >1,500/microliter (mcL), platelets > 100,000/mcL, hemoglobin > 11.0 grams/deciliter (g/dL), normocellular bone marrow. PR: >/= 50% decrease in clonal B lymphocyte count, >/= 50% reduction in lymphadenopathy, >/= 50% reduction of liver or spleen enlargement and ANC >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 11.0 g/dL OR >/= 50% increase in ANC, platelets or hemoglobin. (NCT01263704)
Timeframe: Up to 42 months
| Intervention | percentage of participants (Number) |
|---|
| Rituximab Plus Fludarabine and Cyclophosphamide | 67.5 |
Hospitalization Days
(NCT01263704)
Timeframe: Up to 53 months
| Intervention | days (Median) |
|---|
| Rituximab Plus Fludarabine and Cyclophosphamide | 8 |
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as adverse events. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution, and fulfills any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. (NCT01263704)
Timeframe: Up to 53 months
| Intervention | percentage of participants (Number) |
|---|
| AEs | SAEs |
|---|
| Rituximab Plus Fludarabine and Cyclophosphamide | 97.6 | 45.2 |
PFS in Low Risk Subjects
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Low risk assessment and data analysis was not performed during the study and was performed only after database lock. (NCT01265849)
Timeframe: From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | months (Median) |
|---|
| LI + CIZ + SOC | 66.4 |
| LI + SOC | 68.2 |
| Standard of Care (SOC) | 51.5 |
Overall Survival (OS)
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Interim analyses were performed (by the iDMC) periodically throughout the study to assess safety, sample size and futility. (NCT01265849)
Timeframe: From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | months (Median) |
|---|
| LI + CIZ + SOC | 46.3 |
| LI + SOC | 58.1 |
| Standard of Care (SOC) | 52.9 |
OS in Low Risk Subjects
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Low-risk assessment and data analysis was never performed during the study and was done only after database lock. (NCT01265849)
Timeframe: From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | months (Median) |
|---|
| LI + CIZ + SOC | 101.7 |
| LI + SOC | 68.2 |
| Standard of Care (SOC) | 55.2 |
LRC in Low Risk Subjects
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression. Low risk assessment and data analysis was never performed during the study and was done only after database lock. (NCT01265849)
Timeframe: From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | months (Median) |
|---|
| LI + CIZ + SOC | NA |
| LI + SOC | NA |
| Standard of Care (SOC) | NA |
Local Regional Control (LRC)
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression. (NCT01265849)
Timeframe: From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | months (Median) |
|---|
| LI + CIZ + SOC | NA |
| LI + SOC | NA |
| Standard of Care (SOC) | NA |
Tumor Response by RECIST 1.0 in Low Risk Subjects
Tumor response was evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR. Response was assessed to LI treatment and compared to controls (SOC) from randomization to surgery in the lower risk ITT population for recurrence. (NCT01265849)
Timeframe: From treatment assignment to planned surgery, 29-38 days for LI treated groups and as soon as practicable with within 8 - 38 days for the SOC group (median 33 days).
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Partial Response (PR) | Objective Response (CR+PR) |
|---|
| LI + CIZ + SOC | 5 | 19 | 24 |
,| LI + SOC | 0 | 10 | 10 |
,| Standard of Care (SOC) | 0 | 0 | 0 |
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36
"The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head & neck cancer module (EORTC QLQ-C30 - QLQ H&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat? The 4 swallowing questions score problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100*[(RS-1)/3]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment." (NCT01265849)
Timeframe: Baseline [pre-randomization], Long Term Follow-up Month 36
| Intervention | units on a scale (0-100) (Least Squares Mean) |
|---|
| Change from Baseline in Head & Neck PAIN at Long Term Follow-up Month 36 | Change from Baseline in Head & Neck SWALLOWING at Long Term Follow-up Month 36 |
|---|
| LI + CIZ + SOC | -9.47 | 6.90 |
,| LI + SOC | -8.63 | 1.66 |
,| Standard of Care (SOC) | -8.42 | 8.94 |
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2
"The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head & neck cancer module (EORTC QLQ-C30 - QLQ H&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat? The 4 swallowing questions score problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100*[(RS-1)/3]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment." (NCT01265849)
Timeframe: Baseline [pre-randomization], Long Term Follow-up Month 2
| Intervention | units on a scale (0-100) (Least Squares Mean) |
|---|
| Change from Baseline in Head & Neck PAIN at Long Term Follow-up Month 2 | Change from Baseline in Head & Neck SWALLOWING at Long Term Follow-up Month 2 |
|---|
| LI + CIZ + SOC | -2.75 | 8.11 |
,| LI + SOC | -2.80 | 6.29 |
,| Standard of Care (SOC) | -3.81 | 7.31 |
Statistical Comparisons of Time-to-event Outcomes (OS, LRC, PFS) Were Repeated for Varying Levels of Histopathology (HP) Markers in Low Risk Subjects
HP analysis was performed in a blinded manner by a central pathology laboratory at the end of the study on available samples. To examine potential effects of HP markers on time-to-event efficacy outcomes (OS, LRC, PFS), participants were classified by HP marker levels: 20 HP markers were classified as (low, medium, high), 2 HP ratios as (low, medium, high) and 14 HP combinations as (low, high), resulting in 94 (20*3+2*3+2*14) possible treatment comparisons of LI + CIZ + SOC to SOC. A total of 282 (94 x 3 efficacy outcomes) statistical tests (Cox proportional hazards regressions to test for a significant treatment effect in the model) were made. Significance (two-sided p<0.05 favoring LI + CIZ + SOC) were reported under LI + CIZ + SOC. Significant test results favoring SOC were reported under SOC. The total number of statistical comparisons between LI + CIZ + SOC and SOC (282) is reported under both arms. (NCT01265849)
Timeframe: From the date of treatment assignment to event (LRC,PFS,OS) or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | N of Statistically Significant Results (Number) |
|---|
| LI + CIZ + SOC | 61 |
| Standard of Care (SOC) | 0 |
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36
"The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale [GHS] is a comprised of two Items: Item 29 How would you rate your overall health during the past week?, and item 30: How would you rate your overall quality of life during the past week?. Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100*[(RS-1)/6]. A higher score represents a higher (better) QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment." (NCT01265849)
Timeframe: Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 36
| Intervention | units on a scale (0-100) (Least Squares Mean) |
|---|
| LI + CIZ + SOC | 7.64 |
| LI + SOC | 10.79 |
| Standard of Care (SOC) | 6.33 |
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2
"The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale [GHS] is a comprised of two Items: Item 29 How would you rate your overall health during the past week?, and item 30: How would you rate your overall quality of life during the past week?. Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100*[(RS-1)/6]. A higher score represents a higher (better) QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment." (NCT01265849)
Timeframe: Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 2
| Intervention | units on a scale (0-100) (Least Squares Mean) |
|---|
| LI + CIZ + SOC | 0.28 |
| LI + SOC | 7.95 |
| Standard of Care (SOC) | 3.29 |
Progression Free Survival (PFS)
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01265849)
Timeframe: From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | months (Median) |
|---|
| LI + CIZ + SOC | 32.4 |
| LI + SOC | 37.0 |
| Standard of Care (SOC) | 45.5 |
Tumor Response by RECIST 1.0
Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and confirmed by pathology at surgery. For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR. Response was assessed to LI treatment and compared to controls (SOC) from randomization to surgery in the ITT population for recurrence. (NCT01265849)
Timeframe: From treatment assignment to planned surgery, 29-38 days for LI treated groups and as soon as practicable with within 8 - 38 days for the SOC group (median 33 days).
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Objective Response (CR+PR) |
|---|
| LI + CIZ + SOC | 5 | 27 | 32 |
,| LI + SOC | 0 | 13 | 13 |
,| Standard of Care (SOC) | 0 | 0 | 0 |
Survival by Objective Response (CR+PR)
Survival is assessed as dead or alive at last follow-up. Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR. (NCT01265849)
Timeframe: Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | Participants (Count of Participants) |
|---|
| Non-responder and Alive | Non-responder and Dead | Responder and Alive | Responder and Dead |
|---|
| LI + CIZ + SOC | 166 | 197 | 25 | 7 |
,| LI + SOC | 56 | 65 | 10 | 3 |
,| Standard of Care (SOC) | 204 | 190 | 0 | 0 |
Overall Survival by Objective Response (CR+PR) in Low Risk Subjects
"OS is assessed using Kaplan-Meier life-table using an unstratified log rank test and a stratified log rank test, stratified by tumor stage, tumor location, and geographic region. Alive at last follow-up was was censored.~Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR." (NCT01265849)
Timeframe: Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | participants (Number) |
|---|
| Non-responder and Alive | Non-responder and Dead | Responder and Alive | Responder and Dead |
|---|
| LI + CIZ + SOC | 79 | 55 | 21 | 3 |
,| LI + SOC | 23 | 21 | 7 | 3 |
,| Standard of Care (SOC) | 84 | 84 | 0 | 0 |
Survival by Objective Response (CR+PR) in Low Risk Subjects
OS is assessed as dead or alive at last follow-up. Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR. (NCT01265849)
Timeframe: Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
| Intervention | Participants (Count of Participants) |
|---|
| Non-responder and Alive | Non-responder and Dead | Responder and Alive | Responder and Dead |
|---|
| LI + CIZ + SOC | 79 | 55 | 21 | 3 |
,| LI + SOC | 23 | 21 | 7 | 3 |
,| Standard of Care (SOC) | 84 | 84 | 0 | 0 |
Percentage of Participants With Stable Disease
Stable disease was defined as not meeting the criteria for partial remission or disease progression (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 4.1 |
Overall Survival
Overall survival was defined as the time period from the first day of study treatment to participant death. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | NA |
Duration of Response
Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | NA |
Percentage of Participants With Complete Remission
Complete remission was defined as the disappearance of all signs of disease. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 49.3 |
Percentage of Participants With Disease Progression
Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 5.5 |
Event-free Survival
Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 1567 |
Percentage of Participants With Partial Remission
Partial remission was defined as a reduction in tumor size by >50%. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 41.1 |
Percentage of Participants With Phenotypic Remission
Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 66.7 |
Percentage of Participants With Adverse Events (AEs) and Serious AEs
An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| Non-serious AEs | Serious AEs |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 78.65 | 13.48 |
Progression-free Survival
Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. (NCT01271010)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | NA |
Clinical Response
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression disease (PD) is at least a 20 % increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT01271907)
Timeframe: 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response | Progressive Disease | Stable Disease |
|---|
| Cohort 0 | 0 | 1 | 2 | 0 |
Safety of Drosophila Generated PBL Administered in Combination With a Lymphodepleting Preparative Regimen and Supportive Systemic Aldesleukin
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT01271907)
Timeframe: 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 0 | 3 |
Toxicity Profile
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT01273181)
Timeframe: 2 years
| Intervention | Participants (Number) |
|---|
| Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 | 3 |
| Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 | 3 |
| Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC | 2 |
| Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer | 1 |
Percentage of Patients Alive and Recurrence-Free (RFI)
Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes). (NCT01275677)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Arm I (Chemotherapy) | 92.3 |
| Arm II (Chemotherapy, Trastuzumab) | 92.0 |
Percentage of Patients Alive and Free From Invasive Disease (IDFS)
Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause. (NCT01275677)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Arm I (Chemotherapy) | 89.2 |
| Arm II (Chemotherapy, Trastuzumab) | 89.8 |
Percentage of Patients Alive and Free From Distant Recurrence (DRFI)
Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer. (NCT01275677)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Arm I (Chemotherapy) | 93.6 |
| Arm II (Chemotherapy, Trastuzumab) | 92.7 |
Percentage of Patients Alive and Free From Breast Cancer (BCFS)
Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause. (NCT01275677)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Arm I (Chemotherapy) | 91.0 |
| Arm II (Chemotherapy, Trastuzumab) | 90.7 |
Percentage of Patients Alive and Disease-Free (DFS-DCIS)
Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause. (NCT01275677)
Timeframe: 5 years
| Intervention | percentage of patients (Number) |
|---|
| Arm I (Chemotherapy) | 89.1 |
| Arm II (Chemotherapy, Trastuzumab) | 89.6 |
Toxicity Assessed by Adverse Events
Percentage of patients who ever experienced grade 2 or higher toxicites. (NCT01275677)
Timeframe: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.
| Intervention | percentage of patients (Number) |
|---|
| Arm I (Chemotherapy) | 90.9 |
| Arm II (Chemotherapy, Trastuzumab) | 94.1 |
Percentage of Patients Alive (Overall Survival)
Percentage of patients alive. (NCT01275677)
Timeframe: 5 years
| Intervention | percentage of patients alive (Number) |
|---|
| Arm I (Chemotherapy) | 96.3 |
| Arm II (Chemotherapy, Trastuzumab) | 94.8 |
Event-free Survival
Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| FCR-lite | 679 |
| LR Therapy | NA |
Overall Survival
Overall survival was defined as the time period from the first day of study treatment to participant death. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| FCR-lite | NA |
| LR Therapy | NA |
Percentage of Participants With Complete Remission
Complete remission was defined as the disappearance of all signs of disease. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| FCR-lite | 42.9 |
| LR Therapy | 18.8 |
Percentage of Participants With Disease Progression
Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| FCR-lite | 0 |
| LR Therapy | 6.3 |
Percentage of Participants With Partial Remission
Partial remission was defined as a reduction in tumor size by >50%. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| FCR-lite | 42.9 |
| LR Therapy | 56.3 |
Percentage of Participants With Phenotypic Remission
Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| FCR-lite | 25.0 |
| LR Therapy | 30.0 |
Percentage of Participants With Stable Disease
Stable disease was defined as not meeting the criteria for partial remission or disease progression (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| FCR-lite | 14.3 |
| LR Therapy | 18.8 |
Progression-free Survival
Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| FCR-lite | NA |
| LR Therapy | NA |
Percentage of Participants With Adverse Events (AEs) and Serious AEs
An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | percentage of participants (Number) |
|---|
| Non-serious AEs | Serious AEs |
|---|
| FCR-lite | 80.00 | 20.00 |
,| LR Therapy | 56.25 | 18.75 |
Duration of Response
Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. (NCT01283386)
Timeframe: Up to approximately 5 years
| Intervention | days (Median) |
|---|
| FCR-lite | NA |
| LR Therapy | NA |
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Change Baseline, Cycle 3 Day 1 | Change Baseline, Study Completion | Change Baseline, Follow-Up Month 12 | Change Baseline, Follow-Up Month 24 | Change Baseline, Follow-Up Month 30 | Change Baseline, Follow-Up Month 36 | Change Baseline, Follow-Up Month 48 | Change Baseline, Follow-Up Completion |
|---|
| Obinutuzumab+Chemotherapy | 58.55 | 7.51 | 10.22 | 13.84 | 15.81 | 58.33 | 17.99 | 17.53 | 8.46 |
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Score Change, Cycle 3 Day 1 | Score Change, Study Compl./Discont. | Score Change, Follow-Up Month 12 | Score Change, Follow-Up Month 24 | Score Change, Follow-Up Month 30 | Score Change, Follow-Up Month 36 | Score Change, Follow-Up Month 48 | Score Change, Follow-Up Term./Compl. |
|---|
| Obinutuzumab+Chemotherapy | 45.18 | 3.70 | 4.35 | 6.18 | 6.66 | 25.00 | 7.31 | 7.37 | 5.55 |
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Score Change, Cycle 3 Day 1 | Score Change, Study Compl./Discont. | Score Change, Follow-Up Month 12 | Score Change, Follow-Up Month 24 | Score Change, Follow-Up Month 36 | Score Change, Follow-Up Month 48 | Score Change, Follow-Up Term./Compl. |
|---|
| Rituximab+Chemotherapy | 45.34 | 3.83 | 5.03 | 6.37 | 7.07 | 7.57 | 8.22 | 5.51 |
Overall Response Rate (ORR), IRC-Assessed
Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants. (NCT01287741)
Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
| Intervention | percentage of participants (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 82.3 | 82.1 |
,| Rituximab+Chemotherapy | 80.2 | 81.1 |
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Change Baseline, Cycle 3 Day 1 | Change Baseline, Study Completion | Change Baseline, Follow-Up Month 12 | Change Baseline, Follow-Up Month 24 | Change Baseline, Follow-Up Month 36 | Change Baseline, Follow-Up Month 48 | Change Baseline, Follow-Up Completion |
|---|
| Rituximab+Chemotherapy | 59.81 | 6.37 | 9.84 | 12.67 | 14.74 | 15.01 | 16.62 | 8.74 |
Time to Next Anti-Lymphoma Treatment (TTNALT)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. (NCT01287741)
Timeframe: Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
| Intervention | months (Median) |
|---|
| Rituximab+Chemotherapy | NA |
| Obinutuzumab+Chemotherapy | NA |
Percentage of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)
| Intervention | percentage of participants (Number) |
|---|
| Rituximab+Chemotherapy | 95.3 |
| Obinutuzumab+Chemotherapy | 98.1 |
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab. (NCT01287741)
Timeframe: C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)
| Intervention | micrograms per milliliter (μg/mL) (Geometric Mean) |
|---|
| Cycle 1, Day 8 pre-infusion | Cycle 1, Day 15 pre-infusion | Cycle 2, Day 1 pre-infusion | Cycle 4, Day 1 pre-infusion | Cycle 6, Day 1 pre-infusion | Cycle 8, Day 1 pre-infusion | Cycle 1, Day 1 post-infusion | Cycle 1, Day 1 20-28 hours after end of infusion | Cycle 1, Day 1 66-80 hours after end of infusion | Cycle 1, Day 8 post-infusion | Cycle 1, Day 15 post-infusion | Cycle 2, Day 1 post-infusion | Cycle 4, Day 1 post-infusion | Cycle 6, Day 1 post-infusion | Cycle 8, Day 1 post-infusion |
|---|
| Obinutuzumab+Chemotherapy | 174 | 320 | 431 | 352 | 378 | 478 | 435 | 259 | 219 | 578 | 718 | 938 | 817 | 813 | 881 |
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants. (NCT01287741)
Timeframe: Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
| Intervention | percentage of participants (Number) |
|---|
| Screening | Cycle 4 Day 1 | Study Completion / Early Discontinuation | Follow-Up Month 6 | Follow-Up Month 12 | Follow-Up Month 18 | Follow-Up Month 24 | Follow-Up Month 30 | Follow-Up Completion/ Early Discontinuation | Unscheduled |
|---|
| Obinutuzumab+Chemotherapy | 2.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Duration of Response (DOR), Investigator-Assessed
DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%. (NCT01287741)
Timeframe: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
| Intervention | months (Median) |
|---|
| Rituximab+Chemotherapy | 71.9 |
| Obinutuzumab+Chemotherapy | NA |
Overall Response Rate (ORR), Investigator-Assessed
Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)
| Intervention | percentage of participants (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 81.4 | 77.1 |
,| Rituximab+Chemotherapy | 80.1 | 77.6 |
Complete Response (CR) at the End of Treatment, IRC-Assessed
Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants. (NCT01287741)
Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
| Intervention | percentage of participants (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 39.1 | 66.7 |
,| Rituximab+Chemotherapy | 34.4 | 65.3 |
Complete Response (CR) at the End of Treatment, Investigator-Assessed
Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)
| Intervention | percentage of participants (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 35.4 | 56.5 |
,| Rituximab+Chemotherapy | 33.9 | 59.1 |
Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6
Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined. (NCT01292603)
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6
| Intervention | days (Geometric Mean) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 0.22 |
| Part 2: Rituximab SC 1600 mg | 3.14 |
Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC (NCT01292603)
Timeframe: Days 4 to 5 in Cycle 6
| Intervention | percentage of participants or nurses (Number) |
|---|
| Participants who preferred SC | Participants who preferred IV | Nurses who preferred SC | Nurses who preferred IV |
|---|
| Part 1: Rituximab SC 1400 mg | 88.0 | 13.0 | 88.0 | 13.0 |
,| Part 1: Rituximab SC 1600 mg | 100.0 | 0.0 | 100.0 | 0.0 |
,| Part 1: Rituximab SC 1870 mg | 91.0 | 9.0 | 91.0 | 9.0 |
Part 1: Percentage of Participants With Anti-Rituximab Antibodies
Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose. (NCT01292603)
Timeframe: Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose
| Intervention | percentage of participants (Number) |
|---|
| Pre-Dose Cycle 5: positive for HACAs (n=59) | Pre-Dose Cycle 5: negative for HACAs (n=59) | Post-Dose: positive for HACAs (n=61) | Post-Dose: negative for HACAs (n=61) |
|---|
| Part 1: Rituximab SC | 0.0 | 100.0 | 5.0 | 95.1 |
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL. (NCT01292603)
Timeframe: Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24
| Intervention | percentage of participants (Number) |
|---|
| Cycle 5 Day 1 (n=15,1319,1,2) | Cycle 6 Day 1(n= 15,14,18,1,0) | FU 28 Day Visit (n=15,11,19,1,0) | FU 56 Day Visit (n=15,9,15,1,0) | FU 3 Month Visit (n=16,8,18,0,0) | FU 6 Month Visit (n=15,13,17,1,0) | FU 9 Month Visit (n=15,13,15,1,0) | FU 12 Month Visit (n=14,14,20,0,0) | FU 15 Month Visit (n=14,11,15,0,0) | FU 18 Month Visit (n=13,14,15,0,0) | FU 21 Month Visit (n=13,12,16,0,0) | FU 24 Month Visit (n=12,14,16,0,0) |
|---|
| Part 1: No SC Dose Received | 100.0 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,| Part 1: Rituximab SC 1400 mg | 93.3 | 93.3 | 93.3 | 93.3 | 93.8 | 86.7 | 53.3 | 28.6 | 35.7 | 30.8 | 30.8 | 25.0 |
,| Part 1: Rituximab SC 1600 mg | 92.3 | 100.0 | 100.0 | 100.0 | 100.0 | 92.3 | 84.6 | 85.7 | 54.5 | 50.0 | 50.0 | 21.4 |
,| Part 1: Rituximab SC 1870 mg | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 94.1 | 60.0 | 45.0 | 40.0 | 26.7 | 18.8 | 18.8 |
,| Rituximab SC 1000 mg | 0.0 | 100.0 | 100.0 | 100.0 | NA | 100.0 | 100.0 | NA | NA | NA | NA | NA |
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
CD 19 is a surface antigen (protein) present on B-lymphocytes. (NCT01292603)
Timeframe: Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24
| Intervention | cells per microliter (cells/μL) (Median) |
|---|
| Cycle 5 Day 1 (n=15,13,19,1,2) | Cycle 6 Day 1 (n=15,14,18,1,0) | FU 28 Day Visit (n=15,11,19,1,0) | FU 56 Day Visit (n=15,9,15,1,0) | FU 3 Month Visit (n=16,8,18,0,0) | FU 6 Month Visit (n=15,13,17,1,0) | FU 9 Month Visit (n=15,13,15,1,0) | FU 12 Month Visit (n=14,14,20,0,0) | FU 15 Month Visit (n=14,11,15,0,0) | FU 18 Month Visit (n=13,14,15,0,0) | FU 21 Month Visit (n=13,12,16,0,0) | FU 24 Month Visit(n=12, 4,16,0,0) |
|---|
| Part 1: No SC Dose Received | 2 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,| Part 1: Rituximab SC 1000 mg | 84 | 27 | 7 | 14 | NA | 51 | 74 | NA | NA | NA | NA | NA |
,| Part 1: Rituximab SC 1400 Milligrams (mg) | 2 | 1 | 2 | 1 | 3 | 2 | 66 | 126 | 175 | 175 | 128 | 238 |
,| Part 1: Rituximab SC 1600 mg | 3 | 2 | 2 | 3 | 1 | 1 | 19 | 31 | 41 | 82 | 78 | 110 |
,| Part 1: Rituximab SC 1870 mg | 0 | 1 | 0 | 0 | 1 | 2 | 29 | 90 | 106 | 189 | 149 | 232 |
Part 2: Percentage of Participants With Anti-Rituximab Antibodies
In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab. (NCT01292603)
Timeframe: Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.
| Intervention | percentage of participants (Number) |
|---|
| Baseline pre Cycle 1: positive for HACAs (n=87,85) | Baseline pre Cycle 1: negative for HACAs (n=87,85) | Post-Baseline: positive for HACAs (n=89,85) | Post-Baseline: negative for HACAs (n=89,85) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 0.0 | 100.0 | 15.0 | 85.0 |
,| Part 2: Rituximab SC 1600 mg | 2.4 | 97.6 | 12.0 | 88.0 |
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL. (NCT01292603)
Timeframe: Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit
| Intervention | percentage of participants (Number) |
|---|
| Cycle 1 - Baseline (n=80,80)) | Cycle 2 - Pre-dose (n=71, 74) | Cycle 2 - Post-dose (n=65, 66) | Cycle 2 Day 2 (n=54, 59) | Cycle 2 Day 3 (n=48, 54) | Cycle 3 Day 1 (n=67,68) | Cycle 4 Day 1 (n=71,69) | Cycle 5 Day 1 (n=68,67) | Cycle 6 Day 1 (n=71,64) | FU 28 Day Visit (n=66,64) | FU 56 Day Visit (n=63,67) | FU 3 Month Visit (n=67,67) | FU 6 Month Visit (n=60,69) | FU 9 Month Visit (n=65,64) | FU 12 Month Visit (n=60,61) | FU 15 Month Visit (n=59,60) | FU 18 Month Visit (n=57,58) | FU 21 Month Visit (n=55,52) | FU 24 Month Visit (n=56,51) | Withdrawn/Termination (n=17,15) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 0.0 | 23.9 | 32.3 | 35.2 | 50.0 | 73.1 | 83.1 | 88.2 | 95.8 | 95.5 | 92.1 | 95.5 | 88.3 | 66.2 | 43.3 | 33.9 | 24.6 | 14.5 | 10.7 | 41.2 |
,| Part 2: Rituximab SC 1600 mg | 0.0 | 31.1 | 37.9 | 30.5 | 37.0 | 76.5 | 84.1 | 89.6 | 95.3 | 96.9 | 97.0 | 92.5 | 91.3 | 70.3 | 42.6 | 30.0 | 25.9 | 19.2 | 15.7 | 73.3 |
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
"Physicians and nurses who administered rituximab were asked to answer the following question: Which formulation of rituximab (SC or IV) do you think is more convenient? with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively." (NCT01292603)
Timeframe: Days 4-5 in Cycle 6
| Intervention | percentage of participants in the survey (Number) |
|---|
| Nurse: Rituximab SC is much more convenient | Nurse: Rituximab SC is a little more convenient | Nurse: Both formulations are equally convenient | Nurse: Rituximab IV is a little more convenient | Nurse: Rituximab IV is much more convenient | Physician: Rituximab SC is much more convenient | Physician: Rituximab SC a little more convenient | Physician: Both formulations equally convenient | Physician: Rituximab IV a little more convenient | Physician: Rituximab IV is much more convenient |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 81.0 | 7.0 | 9.0 | 3.0 | 0.0 | 78.0 | 15.0 | 6.0 | 0.0 | 0.0 |
,| Part 2: Rituximab SC 1600 mg | 77.0 | 9.0 | 4.0 | 10.0 | 0.0 | 80.0 | 14.0 | 6.0 | 0.0 | 0.0 |
Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6
Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings. (NCT01292603)
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6
| Intervention | μg/mL (Geometric Mean) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 279.78 |
| Part 2: Rituximab SC 1600 mg | 202.16 |
Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6
AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV). (NCT01292603)
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6
| Intervention | μg*day/mL (Geometric Mean) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 3630.43 |
| Part 2: Rituximab SC 1600 mg | 4088.78 |
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
"Physicians and nurses who administered rituximab were asked to answer the following question: If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones). The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively." (NCT01292603)
Timeframe: Days 4-5 in Cycle 6
| Intervention | percentage of participants in the survey (Number) |
|---|
| Nurse: 4 or more hours | Nurse: At least 3 hours but less than 4 hours | Nurse: At least 2 hours but less than 3 hours | Nurse: At least 1 hour but less than 2 hours | Nurse: Less than 1 hour | Physician: 4 or more hours | Physician: At least 3 hours but less than 4 hours | Physician: At least 2 hours but less than 3 hours | Physician: At least 1 hour but less than 2 hours | Physician: Less than 1 hour |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 21.0 | 23.0 | 26.0 | 17.0 | 13.0 | 21.0 | 18.0 | 24.0 | 22.0 | 10.0 |
,| Part 2: Rituximab SC 1600 mg | 21.0 | 29.0 | 23.0 | 11.0 | 16.0 | 22.0 | 21.0 | 26.0 | 19.0 | 7.0 |
Part 2: Total CD19+ B-Cell Counts by Visit
CD 19 is a surface antigen (protein) present on B-lymphocytes. (NCT01292603)
Timeframe: Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit
| Intervention | cells/μL (Median) |
|---|
| Cycle 1 - Baseline (n=80,80) | Cycle 2 - Pre-dose (n=71,74) | Cycle 2 - Post-dose (n=65, 66) | Cycle 2 Day 2 (n=54, 59) | Cycle 2 Day 3 (n=48, 54) | Cycle 3 Day 1 (n=67,68) | Cycle 4 Day 1 (n=71,69) | Cycle 5 Day 1 (n=68,67) | Cycle 6 Day 1 (n=71,64) | FU 28 Day Visit (n=66,64) | FU 56 Day Visit (n=63,67) | FU 3 Month Visit (n=67,67) | FU 6 Month Visit (n=60,69) | FU 9 Month Visit (n=65,64) | FU 12 Month Visit (n=60,61) | FU 15 Month Visit (n=59,60) | FU 18 Month Visit (n=57,58) | FU 21 Month Visit (n=55,52) | FU 24 Month Visit (n=56,51) | Withdrawn/Termination (n=17,15) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 68905 | 338 | 163 | 154 | 87 | 12 | 4 | 2 | 3 | 2 | 2 | 2 | 3 | 35 | 91 | 135 | 134 | 171 | 214 | 150 |
,| Part 2: Rituximab SC 1600 mg | 50565 | 253 | 168 | 266 | 125 | 8 | 4 | 2 | 3 | 2 | 2 | 2 | 3 | 30 | 104 | 171 | 223 | 277 | 256 | 6 |
Part 2: Terminal Half-Life of Rituximab at Cycle 6
The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration. (NCT01292603)
Timeframe: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6
| Intervention | days (Geometric Mean) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 30.09 |
| Part 2: Rituximab SC 1600 mg | 30.71 |
Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab
Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial. (NCT01292603)
Timeframe: Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose
| Intervention | mg (Number) |
|---|
| Part 1: Rituximab SC | 1600 |
Part 2: Rituximab C Trough Levels at Cycle 5
Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI. (NCT01292603)
Timeframe: +/- 25hours around the 28th day post the 5th Cycle of Rituximab administration
| Intervention | μg/mL (Geometric Mean) |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 61.50 |
| Part 2: Rituximab SC 1600 mg | 97.53 |
Percentage of Participants Who Had B-Cell Depletion
B-cell depletion was defined as cluster of differentiation 19 (CD19) <0.07×10^9/L and could occur only after at least one dose of study drug had been administered. (NCT01300247)
Timeframe: Up to the end of the treatment period, and follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)
| Intervention | percentage of participants (Number) |
|---|
| End of the treatment period | Follow-up at 6 months | Within 6-12 months of follow-up | After 12 months follow-up |
|---|
| Obinutuzumab + Bendamustine | 100.0 | 100.0 | 100.0 | 70.0 |
,| Obinutuzumab + Fludarabine + Cyclophosphamide | 90.5 | 85.7 | 81.0 | 47.6 |
Percentage of Participants Who Were Alive
(NCT01300247)
Timeframe: Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + Fludarabine + Cyclophosphamide | 95.2 |
| Obinutuzumab + Bendamustine | 95.0 |
Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines
DOR for participants with OR: time from first CR, CRi or PR to disease progression (DP), relapse, or death, assessed by the investigator. DP: >=50% increase in lymphocytes to at least 5x10^9/L;new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology. CR:peripheral blood lymphocytes (PBL) <4x10^9/L; no lymphadenopathy; no hepatomegaly or splenomegaly (below relevant costal margin); no symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR: >=50% decrease in PBL, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi: met CR criteria, lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery. (NCT01300247)
Timeframe: From first documented objective response up to disease progression or relapse or death, whichever occurred first (up to approximately 6 months)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + Fludarabine + Cyclophosphamide | NA |
| Obinutuzumab + Bendamustine | 100.00 |
Percentage of Participants Who Were Alive and Progression Free
Progressive disease assessed using IWCLL: >=50% increase in the absolute number of circulating lymphocytes to at least 5x10^9/L; Appearance of new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology. (NCT01300247)
Timeframe: Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + Fludarabine + Cyclophosphamide | 90.5 |
| Obinutuzumab + Bendamustine | 90.0 |
Number of Participants With Human Anti-Human Antibodies (HAHAs)
(NCT01300247)
Timeframe: Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)
| Intervention | participants (Number) |
|---|
| Obinutuzumab + Fludarabine + Cyclophosphamide | 0 |
| Obinutuzumab + Bendamustine | 0 |
Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines
Objective response was defined as a complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR), as determined by investigator. CR:required peripheral blood lymphocytes <4x10^9/L; absence of lymphadenopathy; no hepatomegaly or splenomegaly by physical examination as determined by measurement below relevant costal margin; absence of disease/constitutional symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR:Greater than equal to (>=) 50% decrease in peripheral blood lymphocyte count, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi:met all CR criteria including confirmed lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery. The 95% confidence interval (CI) was estimated by Clopper-Pearson method. The end of treatment response visit occurred 2-3 months after end of treatment. (NCT01300247)
Timeframe: Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to approximately 9 months)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + Fludarabine + Cyclophosphamide | 61.9 |
| Obinutuzumab + Bendamustine | 90.0 |
Percentage of Participants Who Had B-Cell Recovery
B-cell recovery was defined as CD19 >=0.07×10^9/L, where participants' CD19 were previously depleted. B-cell recovery was only considered possible when the participant had received the last dose of study treatment. (NCT01300247)
Timeframe: Follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)
| Intervention | percentage of participants (Number) |
|---|
| Follow-up at 6 months | Within 6-12 months of follow-up | After 12 months follow-up |
|---|
| Obinutuzumab + Bendamustine | 0 | 0 | 30.0 |
,| Obinutuzumab + Fludarabine + Cyclophosphamide | 0 | 9.5 | 42.9 |
Number of Participants With Deleterious Mutations in DNA Repair Genes
Gene expression profiling was performed in archival tumor tissue for a panel of 211 genes using deoxyribonucleic acid (DNA) array to determine deleterious mutations (i.e. nonsynonymous mutations at coding regions) of genes. Sequences were mapped to human genome reference hg19. Variants were identified with VarScan, annotated with AVIA, and masked to the exonic or exonic:splicing regions of the 211 interrogated DNA repair genes, with nonsynonymous/frameshift/stop-gain/stop-loss variants that have a population frequency of 1% or less in either 1000G (2014_04) or the ExomeSequencingProject (ESP6500si_all) with a minimum variant frequency of 10% and at least 20 reads. Lastly, variants were manually inspected for known platform and mapping errors. (NCT01306032)
Timeframe: Optional tumor biopsies were performed prior to start of treatment (baseline) and 6 months
| Intervention | Participants (Count of Participants) |
|---|
| BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide | 28 |
| BRCA-positive Ovarian Cancer: Crossover | 27 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT01306032)
Timeframe: up to 30 days following the last dose of study drug.
| Intervention | Participants (Count of Participants) |
|---|
| BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide | 28 |
| BRCA-positive Ovarian Cancer: Cyclophosphamide Alone | 24 |
| BRCA-positive Ovarian Cancer: Crossover | 29 |
| Triple-negative Breast Cancer: Cyclophosphamide & ABT-888 | 14 |
| Triple-negative Breast Cancer: Cyclophosphamide Alone | 4 |
| Triple-negative Breast Cancer: Crossover | 6 |
| Non-Hodgkin's: ABT-888 & Cyclophosphamide | 0 |
| Non-Hodgkin's: Cyclophosphamide Alone | 1 |
Change in ϓH2AX- Positive Circulating Tumor Cells (CTCs) in Whole Blood
Number of CTCs (evaluable defined as ≥ 6 CTCs) were measured in whole blood during the course of treatment to determine drug-induced deoxyribonucleic acid damage in tumor cells. (NCT01306032)
Timeframe: At baseline (t=0h) and 24h post drug administration (t=24h)
| Intervention | ϓH2AX- Positive CTCs (Mean) |
|---|
| BRCA-positive Ovarian Cancer: Crossover | 400 |
| Triple-negative Breast Cancer: Cyclophosphamide & ABT-888 | 200 |
| Triple-negative Breast Cancer: Crossover | 9.5 |
Change in Poly-ADP Ribose (PAR) Concentration Levels From Baseline
PAR levels (in pg/μg protein) were assessed in peripheral blood mononuclear cells (PBMCs) by immunoassay to assess poly (ADP-ribose) polymerase (PARP) activity. Significant inhibition of PARP activity is associated with 50% or greater reduction in PAR levels. (NCT01306032)
Timeframe: At baseline (t=0h) and 4h post drug administration (t=4h)
| Intervention | pg/μg protein (Mean) |
|---|
| BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide | -81 |
| BRCA-positive Ovarian Cancer: Crossover | -88 |
| Triple-negative Breast Cancer: Cyclophosphamide & ABT-888 | -74 |
| Triple-negative Breast Cancer: Crossover | -85 |
Progression Free Survival
Time to progression for each participant for the initial intervention. (NCT01306032)
Timeframe: Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.
| Intervention | Cycles of therapy (Median) |
|---|
| Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide | 3 |
| Triple-negative Breast Cancer: Cyclophosphamide Alone | 2 |
| BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide | 3 |
| BRCA-positive Ovarian Cancer: Cyclophosphamide Alone | 3 |
Percentage of Participants With an Overall Response Rate
Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (NCT01306032)
Timeframe: an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.
| Intervention | percentage of participants (Number) |
|---|
| Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide | 9.5 |
| Triple-negative Breast Cancer: Cyclophosphamide Alone | 5.6 |
| Triple-negative Breast Cancer: Crossover | 0 |
| BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide | 11.8 |
| BRCA-positive Ovarian Cancer: Cyclophosphamide Alone | 19.4 |
| BRCA-positive Ovarian Cancer: Crossover | 3.4 |
Number of Patients With Complete Remission at One Year
The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. (NCT01319981)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Hyper-CMAD + Rituximab | 12 |
| Hyper-CMAD | 13 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis. (NCT01319981)
Timeframe: Up to 7 years, 8 months
| Intervention | Months (Median) |
|---|
| Hyper-CMAD + Rituximab | NA |
| Hyper-CMAD | NA |
Complete Response Duration
The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.. (NCT01319981)
Timeframe: Up to 7 years, 8 months
| Intervention | Months (Median) |
|---|
| Hyper-CMAD + Rituximab | NA |
| Hyper-CMAD | NA |
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). (NCT01332968)
Timeframe: Baseline up to final analysis (up to 10 years)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 40.6 |
| Obinutuzumab+Chemotherapy | 34.3 |
Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 23.5 |
| Obinutuzumab+Chemotherapy | 18.0 |
Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 24.6 |
| Obinutuzumab+Chemotherapy | 18.4 |
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 4 years and 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 24.0 |
| Obinutuzumab+Chemotherapy | 16.8 |
Disease-Free Survival (Overall Study Population)
Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 14.9 |
| Obinutuzumab+Chemotherapy | 11.2 |
Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. (NCT01332968)
Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 25.5 |
| Obinutuzumab+Chemotherapy | 18.7 |
Overall Response (Overall Study Population), IRC-Assessed
Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 89.9 | 87.2 |
,| Rituximab+Chemotherapy | 86.7 | 83.3 |
Overall Response (Overall Study Population), Investigator-Assessed
Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 87.3 | 85.4 |
,| Rituximab+Chemotherapy | 85.7 | 81.8 |
Overall Response (Follicular Lymphoma Population), IRC-Assessed
Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 91.3 | 88.6 |
,| Rituximab+Chemotherapy | 88.0 | 85.2 |
Event-Free Survival (Follicular Lymphoma Population)
Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event. (NCT01332968)
Timeframe: Baseline up to 10 years
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 42.9 |
| Obinutuzumab+Chemotherapy | 35.8 |
Event-Free Survival (Overall Study Population)
Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 30.6 |
| Obinutuzumab+Chemotherapy | 22.6 |
Overall Survival (Follicular Lymphoma Population)
Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to 10 years
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 14.3 |
| Obinutuzumab+Chemotherapy | 12.6 |
Overall Survival (Overall Study Population)
Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 10.2 |
| Obinutuzumab+Chemotherapy | 8.4 |
Progression-Free Survival in the Overall Study Population, Investigator-Assessed
Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 41.5 |
| Obinutuzumab+Chemotherapy | 34.8 |
Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to 10 years
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 34.8 |
| Obinutuzumab+Chemotherapy | 26.6 |
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| Total Score, Baseline | Total Score Change, Cycle 3 Day 1 | Total Score Change, End Induction | Total Score Change, Maint Month 2 | Total Score Change, Maint Month 12 | Total Score Change, End Maint |
|---|
| Obinutuzumab+Chemotherapy | 128.42 | 3.21 | 5.10 | 8.13 | 7.90 | 8.80 |
,| Rituximab+Chemotherapy | 127.40 | 1.98 | 4.18 | 8.40 | 8.87 | 7.43 |
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01332968)
Timeframe: Baseline up to 10 years
| Intervention | percentage of participants (Number) |
|---|
| Rituximab+Chemotherapy | 99.6 |
| Obinutuzumab+Chemotherapy | 99.9 |
Time to Next Anti-Lymphoma Treatment (Overall Study Population)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 21.6 |
| Obinutuzumab+Chemotherapy | 15.7 |
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| Physical Well-being (PW), Baseline | PW Change, Cycle 3, Day 1 | PW Change, End Induction | PW Change, Maint Month 2 | PW Change, Maint Month 12 | PW Change, End Maint | Social/Family Well-being , Baseline | S/FW Change, Cycle 3 Day 1 | S/FW Change, End Induction | S/FW Change, Maint Month 2 | S/FW Change, Maint Month 12 | S/FW Change, End Maint | Emotional Well-being (EW), Baseline | EW Change, Cycle 3 Day 1 | EW Change, End Induction | EW Change, Maint Month 2 | EW Change, Maint Month 12 | EW Change, End Maint | Functional Well-being (FW), Baseline | FW Change, Cycle 3 Day 1 | FW Change, End Induction | FW Change, Maint Month 2 | FW Change, Maint Month 12 | FW Change, End Maint |
|---|
| Obinutuzumab+Chemotherapy | 23.14 | -0.21 | 0.56 | 1.42 | 1.34 | 1.33 | 23.28 | -0.67 | -0.56 | -0.67 | -0.97 | -0.71 | 17.87 | 1.35 | 1.14 | 1.49 | 1.46 | 1.49 | 18.76 | -0.07 | 0.93 | 1.25 | 1.65 | 1.72 |
,| Rituximab+Chemotherapy | 23.36 | -0.91 | -0.06 | 0.83 | 1.14 | 0.88 | 22.84 | -0.52 | -0.46 | -0.39 | -0.61 | -0.93 | 17.64 | 1.49 | 1.16 | 1.77 | 1.45 | 1.43 | 18.66 | -0.30 | 0.44 | 1.04 | 1.84 | 1.40 |
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| Change Baseline, Follow-Up Month 36 | Change Baseline, Follow-Up Month 48 |
|---|
| Obinutuzumab+Chemotherapy | 0.06 | 0.06 |
,| Rituximab+Chemotherapy | 0.05 | 0.05 |
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| Lymphoma, Baseline | Lymphoma Change, Cycle 3 Day 1 | Lymphoma Change, End Induction | Lymphoma Change, Maint Month 2 | Lymphoma Change, Maint Month 12 | Lymphoma Change, End Maint |
|---|
| Obinutuzumab+Chemotherapy | 45.54 | 2.71 | 3.01 | 4.52 | 4.27 | 4.57 |
,| Rituximab+Chemotherapy | 45.01 | 2.04 | 2.99 | 4.80 | 4.93 | 4.31 |
Overall Response (Follicular Lymphoma Population), Investigator-Assessed
Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 88.2 | 85.5 |
,| Rituximab+Chemotherapy | 86.4 | 81.2 |
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| Change Baseline, Maint/Obs Month 2 | Change Baseline, Maint/Obs Month 12 | Change Baseline, Maint/Obs Completion |
|---|
| Obinutuzumab+Chemotherapy | 0.04 | 0.06 | 0.05 |
,| Rituximab+Chemotherapy | 0.04 | 0.06 | 0.03 |
Complete Response (Overall Study Population), IRC-Assessed
Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)]
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 27.1 | 69.5 |
,| Rituximab+Chemotherapy | 26.3 | 59.4 |
Complete Response (Overall Study Population), Investigator-Assessed
Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 18.4 | 61.1 |
,| Rituximab+Chemotherapy | 23.3 | 57.0 |
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| Baseline Induction | Change Baseline, Cycle 3 Day 1 | Change Baseline, Induction Compl | Change Baseline, Maint/Obs Month 2 | Change from Baseline, Maint/Obs Month 12 |
|---|
| Rituximab+Chemotherapy | 0.80 | 0.03 | 0.04 | 0.05 | 0.00 |
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| Baseline Induction | Change Baseline, Cycle 3 Day 1 | Change Baseline, Induction Compl | Change Baseline, Maint/Obs Month 2 | Change from Baseline, Maint/Obs Month 12 | Change Baseline, Maint/Obs Completion |
|---|
| Obinutuzumab+Chemotherapy | 0.81 | 0.03 | 0.03 | 0.06 | -0.20 | -0.10 |
Complete Response (Follicular Lymphoma Population), IRC-Assessed
Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 28.5 | 71.4 |
,| Rituximab+Chemotherapy | 26.8 | 59.7 |
Complete Response (Follicular Lymphoma Population), Investigator-Assessed
Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Without PET | With PET |
|---|
| Obinutuzumab+Chemotherapy | 18.6 | 62.0 |
,| Rituximab+Chemotherapy | 24.1 | 56.7 |
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
| Intervention | units on a scale (Mean) |
|---|
| TOI Score, Baseline | TOI Score Change, Cycle 3 Day 1 | TOI Score Change, End Induction | TOI Score Change, Maint M2 | TOI Score Change, Maint M12 | TOI Score Change, End Maint |
|---|
| Obinutuzumab+Chemotherapy | 86.94 | 2.18 | 4.57 | 7.17 | 7.20 | 7.44 |
,| Rituximab+Chemotherapy | 86.61 | 0.46 | 2.91 | 6.22 | 7.61 | 6.23 |
Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. (NCT01332968)
Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 39.3 |
| Obinutuzumab+Chemotherapy | 33.3 |
Disease-Free Survival (Follicular Lymphoma Population)
Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
| Intervention | percentage of participants with event (Number) |
|---|
| Rituximab+Chemotherapy | 27.9 |
| Obinutuzumab+Chemotherapy | 26.3 |
Percent of Patients Who Proceeded With Transplant
Percentage of patients who received consolidation with high dose therapy and autologous stem cell rescue (HDT/SCR). (NCT01336933)
Timeframe: 168-252 days (4 courses up to 6 courses of treatment)
| Intervention | Participants (Count of Participants) |
|---|
| Treatment | 15 |
To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events
Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly. (NCT01336933)
Timeframe: 22 months
| Intervention | percentage of participants (Number) |
|---|
| Grade 3-4 anaemia | Grade 3-4 thrombocoytopenia | Grade 3-4 febrile neutropenia | Grade 3-4 mucositis | Grade 3-4 sepsis | Grade 3-4 increased creatinine | Grade 3-4 liver transaminases |
|---|
| Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 27 | 12 | 18 | 18 | 15 | 12 | 12 |
Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment
"Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used.~Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) [18F]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative" (NCT01336933)
Timeframe: 168 days - 252 days (4-6 courses; 42 days per course)
| Intervention | percentage of participants analyzed (Number) |
|---|
| Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 52 |
Overall Survival (OS)
Estimated 2-year Overall Survival (OS), as well as plots of OS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for OS. Overall survival is defined as time from the first chemotherapy administered on trial until death from any cause. (NCT01336933)
Timeframe: 2 years
| Intervention | percentage of participants analyzed (Number) |
|---|
| Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 60 |
Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))
"Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals.~Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: > 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT Spleen, Liver:> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified" (NCT01336933)
Timeframe: 2 years
| Intervention | percentage of participants analyzed (Number) |
|---|
| Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 70 |
Event Free Survival (EFS)
Estimated 2-year Event Free Survival (EFS), as well as plots of EFS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for EFS. Event-free survival is defined as time from therapy until relapse, progression, or death from any cause. (NCT01336933)
Timeframe: 2 years
| Intervention | percentage of participants analyzed (Number) |
|---|
| Treatment (Chemotherapy and Enzyme Inhibitor Therapy) | 39 |
Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)
B cell percentage is defined as the percentage of lymphocytes that are B cells. (NCT01338987)
Timeframe: after first Bone Marrow Transplant, approximately 12 months post-transplant
| Intervention | percentage of cells (Median) |
|---|
| Males that received leuprolide | Males that did not receive leuprolide | Females who all received leuprolide |
|---|
| Transplant Recipient | 22.1 | 21.9 | 14.3 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01338987)
Timeframe: Date treatment consent signed to date off study, approximately 79 months and 11 days.
| Intervention | Participants (Count of Participants) |
|---|
| Males That Did Not Receive Leuprolide for 1st Transplant | 10 |
| Males Randomized to Receive Leuprolide for 1st Transplant | 8 |
| Females That Received Leuprolide for 1st Transplant | 20 |
| Matched Related Donors for Transplant | 4 |
| Recipients of 2nd Transplant | 2 |
Percentage of Participants With Chronic GVHD
Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. (NCT01339910)
Timeframe: 18 months post-transplant
| Intervention | percentage (Number) |
|---|
| Myeloablative Conditioning Regimen (MAC) | 64.0 |
| Reduced Intensity Conditioning (RIC) | 47.6 |
Number of Participants With Donor Cell Engraftment
Donor cell engraftment will be assessed by donor-recipient chimerism assays. Full donor chimerism is defined as the presence of at least 95% donor cells as a proportion of the total population in the peripheral blood or bone marrow. Graft rejection is defined as the presence of no more than 5% donor cells as a proportion of the total population. Mixed chimerism is defined as the presence of between 5% and 95% donor cells. Mixed or full donor chimerism will be considered evidence of donor engraftment. (NCT01339910)
Timeframe: Days 28 and 100 and 18 months post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Day 2872548419 | Day 2872548420 | Day 10072548420 | Day 10072548419 | 18 Months72548420 | 18 Months72548419 |
|---|
| Mixed Chimerism | Full Donor Chimerism | Graft Rejection | Death Prior to Assessment | Unknown (relapsed or missing assay) |
|---|
| Myeloablative Conditioning Regimen (MAC) | 86 |
| Reduced Intensity Conditioning (RIC) | 80 |
| Myeloablative Conditioning Regimen (MAC) | 9 |
| Reduced Intensity Conditioning (RIC) | 30 |
| Myeloablative Conditioning Regimen (MAC) | 1 |
| Myeloablative Conditioning Regimen (MAC) | 0 |
| Reduced Intensity Conditioning (RIC) | 0 |
| Myeloablative Conditioning Regimen (MAC) | 36 |
| Reduced Intensity Conditioning (RIC) | 22 |
| Myeloablative Conditioning Regimen (MAC) | 106 |
| Reduced Intensity Conditioning (RIC) | 86 |
| Myeloablative Conditioning Regimen (MAC) | 12 |
| Myeloablative Conditioning Regimen (MAC) | 2 |
| Myeloablative Conditioning Regimen (MAC) | 6 |
| Reduced Intensity Conditioning (RIC) | 8 |
| Myeloablative Conditioning Regimen (MAC) | 71 |
| Reduced Intensity Conditioning (RIC) | 66 |
| Myeloablative Conditioning Regimen (MAC) | 4 |
| Reduced Intensity Conditioning (RIC) | 5 |
| Reduced Intensity Conditioning (RIC) | 1 |
| Myeloablative Conditioning Regimen (MAC) | 31 |
| Reduced Intensity Conditioning (RIC) | 42 |
| Myeloablative Conditioning Regimen (MAC) | 25 |
| Reduced Intensity Conditioning (RIC) | 19 |
Number of Participants With Primary Graft Failure
Primary graft failure is defined by lack of neutrophil engraftment. (NCT01339910)
Timeframe: 28 days post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Myeloablative Conditioning Regimen (MAC) | 1 |
| Reduced Intensity Conditioning (RIC) | 3 |
Percentage of Participants With Neutrophil and Platelet Engraftment
Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for 3 consecutive measurements on different days. The first of the 3 days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 20,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days. (NCT01339910)
Timeframe: Days 28 and 60 post-transplant
| Intervention | percentage (Number) |
|---|
| Neutrophil Engraftment at Day 28 | Platelet Engraftment at Day 60 |
|---|
| Myeloablative Conditioning Regimen (MAC) | 98.5 | 95.5 |
,| Reduced Intensity Conditioning (RIC) | 97.8 | 96.2 |
Percentage of Participants With Acute Graft Versus Host Disease (GVHD)
"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4" (NCT01339910)
Timeframe: Day 100 post-transplant
| Intervention | percentage (Number) |
|---|
| Grade II-IV Acute GVHD | Grade III-IV Acute GVHD |
|---|
| Myeloablative Conditioning Regimen (MAC) | 44.7 | 13.6 |
,| Reduced Intensity Conditioning (RIC) | 31.6 | 6.8 |
Percentage of Participants With Relapse-Free Survival (RFS)
Relapse-free survival is defined as survival without relapse of the primary disease. (NCT01339910)
Timeframe: 18 months post-randomization
| Intervention | percentage (Number) |
|---|
| Myeloablative Conditioning Regimen (MAC) | 67.8 |
| Reduced Intensity Conditioning (RIC) | 47.3 |
Percentage of Participants With Overall Survival (OS)
Overall survival is defined as survival of death from any cause. (NCT01339910)
Timeframe: 18 months post-randomization
| Intervention | percentage (Number) |
|---|
| Myeloablative Conditioning Regimen (MAC) | 77.5 |
| Reduced Intensity Conditioning (RIC) | 67.7 |
Percentage of Participants With Disease Relapse
Disease Relapse is defined as relapse of the primary disease. (NCT01339910)
Timeframe: 18 months post-randomization
| Intervention | percentage (Number) |
|---|
| Myeloablative Conditioning Regimen (MAC) | 13.5 |
| Reduced Intensity Conditioning (RIC) | 48.3 |
Number of Participants With Secondary Graft Failure
Secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in neutrophil counts to less than 500x10^6/liter that is unresponsive to growth factor therapy. (NCT01339910)
Timeframe: 18 months post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Myeloablative Conditioning Regimen (MAC) | 1 |
| Reduced Intensity Conditioning (RIC) | 4 |
Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT)
To assess relapse free survival in participants undergoing Hematopoietic Stem Cell Transplant (HSCT) using the Thomas Jefferson University 2 step approach with an extra day inserted between the donor lymphocyte infusion (DLI) and administration of cyclophosphamide. (NCT01341301)
Timeframe: 1 year after undergoing hematopoietic stem cell transplant
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic HSCT | 5 |
Objective Response Rate (ORR)
ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by the local investigators. (NCT01343043)
Timeframe: Up to 4.5 years
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 50 |
| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 30.8 |
| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 20 |
| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 26.7 |
Overall Survival
Overall survival is defined as the interval between the date of the first T-cell infusion and date of death from any cause. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented. (NCT01343043)
Timeframe: Up to 4.5 years
| Intervention | Weeks (Median) |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 80.7 |
| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 43.1 |
| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 86.4 |
| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 105.3 |
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had non-SAEs and SAEs are presented. (NCT01343043)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Non-SAE | SAE |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 15 | 9 |
,| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 13 | 7 |
,| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 5 | 4 |
,| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 15 | 6 |
Progression Free Survival
Progression free survival is defined as the interval between the date of first T cell infusion and the earliest documented evidence of disease progression or death due to any cause or surgical resection or start of prohibited medications. Progression free survival was evaluated per RECIST v1.1. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented. (NCT01343043)
Timeframe: Up to 4.5 years
| Intervention | Weeks (Median) |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 15.4 |
| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 13.1 |
| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 8.6 |
| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 22.4 |
Best Overall Response
Best overall response is the best response recorded from the start of treatment (first T cell infusion) until disease progression/recurrence. Response categories from best to worst are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD). Best overall response is a stable disease, if CR or PR are unconfirmed. Data for number of participants with CR, PR, SD and PD are presented. (NCT01343043)
Timeframe: Up to 4.5 years
| Intervention | Participants (Count of Participants) |
|---|
| Complete response | Partial response | Stable disease | Progressive disease | Not evaluable |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 1 | 5 | 5 | 1 | 0 |
,| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 0 | 4 | 7 | 1 | 1 |
,| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 0 | 1 | 3 | 0 | 1 |
,| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 0 | 4 | 10 | 1 | 0 |
Time to Maximum Persistence of NY-ESO-1 Genetically Engineered T Cells
Time to maximum persistence is defined as date of maximum persistence for infusion visit minus date of first T cell infusion visit plus 1. Median and full range of time to maximum persistence are presented. (NCT01343043)
Timeframe: Up to 4.5 years
| Intervention | Days (Median) |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 8.0 |
| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 8.0 |
| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 8.0 |
| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 9 |
Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-infused (NY-ESO-1 Genetically Engineered T) Cell Antibody Result
Serum samples were collected for the determination of anti-infused (NY-ESO-1 genetically engineered T) cell antibodies (ATA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. A participant was considered to have a confirmed positive ATA result if they have a positive screening assay result and a positive confirmation assay result. (NCT01343043)
Timeframe: Up to 4.5 years
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 0 |
| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 0 |
| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 0 |
| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 0 |
Duration of Overall Response
Duration of overall response (DOR) is defined as the time from first documented evidence of confirmed CR or confirmed PR until first documented date of disease progression or death due to any cause or surgical resection or start of prohibited medications. Duration of overall response was evaluated per RECIST v1.1. Median and full range of DOR are presented. (NCT01343043)
Timeframe: Up to 4.5 years
| Intervention | Weeks (Median) |
|---|
| Cohort 1: High NY-ESO-1 Expression Treated With Regimen A | 31.0 |
| Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A | 8.6 |
| Cohort 3: High NY-ESO-1 Expression Treated With Regimen B | 32.1 |
| Cohort 4: High NY-ESO-1 Expression Treated With Regimen C | 16.4 |
Disease-Free Survival (DFS)
1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant. (NCT01350245)
Timeframe: 1 year post-transplant
| Intervention | percentage of patients (Number) |
|---|
| TJU 2 Step Regimen | 78.6 |
Probability of Overall Survival at 15 Months Post-treatment
Probability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant. (NCT01350245)
Timeframe: 15 months
| Intervention | percentage of probability (Number) |
|---|
| TJU 2 Step Regimen | 85 |
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. (NCT01358877)
Timeframe: 3 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 97.65 |
| Placebo + Trastuzumab + Chemotherapy | 97.67 |
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 13 | Change at Week 25 | Change at EOT | Change at FU Month 18 | Change at FU Month 24 | Change at FU Month 36 |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 20.3 | 3.1 | 2.3 | -0.2 | -4.1 | -5.2 | -7.1 |
,| Placebo + Trastuzumab + Chemotherapy | 22.1 | 1.7 | -0.3 | -1.5 | -5.1 | -6.9 | -8.3 |
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | units on a scale (Mean) |
|---|
| Baseline:Systemic SE | Change at Week 13: Systemic SE | Change at Week 25: Systemic SE | Change at EOT: Systemic SE | Change at FU Month 18: Systemic SE | Change at FU Month 24: Systemic SE | Change at FU Month 36: Systemic SE | Baseline: Hair Loss | Change at Week 13: Hair Loss | Change at Week 25: Hair Loss | Change at EOT: Hair Loss | Change at FU Month 18: Hair Loss | Change at FU Month 24: Hair Loss | Change at FU Month 36: Hair Loss | Baseline: Arm Symptoms | Change at Week 13: Arm Symptoms | Change at Week 25: Arm Symptoms | Change at EOT: Arm Symptoms | Change at FU Month 18: Arm Symptoms | Change at FU Month 24: Arm Symptoms | Change at FU Month 36: Arm Symptoms | Baseline: Breast Symptoms | Change at Week 13: Breast Symptoms | Change at Week 25: Breast Symptoms | Change at EOT: Breast Symptoms | Change at FU Month 18: Breast Symptoms | Change at FU Month 24: Breast Symptoms | Change at FU Month 36: Breast Symptoms |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 9.5 | 21.1 | 9.2 | 8.3 | 4.4 | 4.1 | 4.5 | 26.4 | 17.3 | 8.3 | 10.9 | -7.0 | -4.1 | -5.6 | 21.6 | -4.7 | -2.9 | -3.5 | -4.0 | -5.1 | -5.9 | 19.5 | -5.0 | 1.9 | -0.6 | -3.0 | -6.4 | -7.3 |
,| Placebo + Trastuzumab + Chemotherapy | 10.2 | 21.7 | 8.2 | 7.5 | 5.5 | 4.9 | 5.2 | 22.1 | 21.2 | 14.5 | 17.9 | 3.2 | 0.7 | 2.4 | 21.7 | -2.1 | -2.3 | -3.4 | -3.9 | -5.0 | -4.7 | 20.4 | -5.2 | -0.4 | -3.8 | -5.9 | -7.3 | -7.9 |
Percentage of Participants With Secondary Cardiac Event
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB). (NCT01358877)
Timeframe: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 2.7 |
| Placebo + Trastuzumab + Chemotherapy | 2.8 |
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence. (NCT01358877)
Timeframe: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 5.8 |
| Placebo + Trastuzumab + Chemotherapy | 7.2 |
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. (NCT01358877)
Timeframe: 3 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 93.42 |
| Placebo + Trastuzumab + Chemotherapy | 92.29 |
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence. (NCT01358877)
Timeframe: 3 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 95.70 |
| Placebo + Trastuzumab + Chemotherapy | 95.13 |
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. (NCT01358877)
Timeframe: 3 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 94.06 |
| Placebo + Trastuzumab + Chemotherapy | 93.24 |
Trough Serum Concentration (Cmin) of Pertuzumab
(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)
| Intervention | micrograms per milliliter (mcg/mL) (Mean) |
|---|
| Cycle 1 | Cycle 10 | Cycle 15 |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 68.0 | 88.1 | 95.5 |
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No problems | Baseline: Some problems | Baseline: Confined to bed | Week 13: No problems | Week 13: Some problems | Week 13: Confined to bed | Week 25: No problems | Week 25: Some problems | Week 25: Confined to bed | EOT: No problems | EOT: Some problems | EOT: Confined to bed | FU Month 18: No problems | FU Month 18: Some problems | FU Month 18: Confined to bed | FU Month 24: No problems | FU Month 24: Some problems | FU Month 24: Confined to bed | FU Month 36: No problems | FU Month 36: Some problems | FU Month 36: Confined to bed |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 93.8 | 6.2 | 0.0 | 77.5 | 22.1 | 0.4 | 83.8 | 16.1 | 0.1 | 85.1 | 14.8 | 0.1 | 88.8 | 11.2 | 0.1 | 87.8 | 12.1 | 0.1 | 88.5 | 11.5 | 0.0 |
,| Placebo + Trastuzumab + Chemotherapy | 92.9 | 6.9 | 0.2 | 74.8 | 24.8 | 0.4 | 82.7 | 17.2 | 0.1 | 84.9 | 14.9 | 0.2 | 87.0 | 12.8 | 0.2 | 87.7 | 12.1 | 0.1 | 87.8 | 12.1 | 0.1 |
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No problems | Baseline: Some problems | Baseline: Unable | Week 13: No problems | Week 13: Some problems | Week 13: Unable | Week 25: No problems | Week 25: Some problems | Week 25: Unable | EOT: No problems | EOT: Some problems | EOT: Unable | FU Month 18: No problems | FU Month 18: Some problems | FU Month 18: Unable | FU Month 24: No problems | FU Month 24: Some problems | FU Month 24: Unable | FU Month 36: No problems | FU Month 36: Some problems | FU Month 36: Unable |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 67.4 | 30.4 | 2.2 | 56.8 | 40.1 | 3.1 | 66.5 | 32.2 | 1.2 | 72.4 | 26.3 | 1.3 | 78.5 | 20.6 | 0.9 | 78.7 | 20.4 | 0.9 | 80.9 | 18.3 | 0.7 |
,| Placebo + Trastuzumab + Chemotherapy | 66.1 | 32.2 | 1.7 | 54.1 | 43.0 | 2.9 | 65.8 | 32.7 | 1.4 | 72.5 | 26.6 | 0.9 | 76.3 | 23.0 | 0.7 | 79.1 | 19.7 | 1.1 | 79.8 | 19.4 | 0.8 |
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No pain/discomfort | Baseline: Moderate pain/discomfort | Baseline: Extreme pain/discomfort | Week 13: No pain/discomfort | Week 13: Moderate pain/discomfort | Week 13: Extreme pain/discomfort | Week 25: No pain/discomfort | Week 25: Moderate pain/discomfort | Week 25: Extreme pain/discomfort | EOT: No pain/discomfort | EOT: Moderate pain/discomfort | EOT: Extreme pain/discomfort | FU Month 18: No pain/discomfort | FU Month 18: Moderate pain/discomfort | FU Month 18: Extreme pain/discomfort | FU Month 24: No pain/discomfort | FU Month 24: Moderate pain/discomfort | FU Month 24: Extreme pain/discomfort | FU Month 36: No pain/discomfort | FU Month 36: Moderate pain/discomfort | FU Month 36: Extreme pain/discomfort |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 49.0 | 50.0 | 1.0 | 44.6 | 52.7 | 2.7 | 44.3 | 53.3 | 2.4 | 49.3 | 48.5 | 2.2 | 51.3 | 46.6 | 2.1 | 56.7 | 41.3 | 1.9 | 59.5 | 38.9 | 1.6 |
,| Placebo + Trastuzumab + Chemotherapy | 49.0 | 49.7 | 1.3 | 40.5 | 56.5 | 3.0 | 43.7 | 54.4 | 1.9 | 50.0 | 47.6 | 2.4 | 53.1 | 44.7 | 2.1 | 56.0 | 41.5 | 2.5 | 57.8 | 40.1 | 2.1 |
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | percentage of participants (Number) |
|---|
| Baseline: Not anxious/depress | Baseline: Moderate anxious/depress | Baseline: Extreme anxious/depress | Week 13: Not anxious/depress | Week 13: Moderate anxious/depress | Week 13: Extreme anxious/depress | Week 25: No anxious/depress | Week 25: Moderate anxious/depress | Week 25: Extreme anxious/depress | EOT: Not anxious/depress | EOT: Moderate anxious/depress | EOT: Extreme anxious/depress | FU Month 18: Not anxious/depress | FU Month 18: Moderate anxious/depress | FU Month 18: Extreme anxious/depress | FU Month 24: Not anxious/depress | FU Month 24: Moderate anxious/depress | FU Month 24: Extreme anxious/depress | FU Month 36: Not anxious/depress | FU Month 36: Moderate anxious/depress | FU Month 36: Extreme anxious/depress |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 47.1 | 49.4 | 3.5 | 53.6 | 43.4 | 3.0 | 55.5 | 41.9 | 2.5 | 58.5 | 38.9 | 2.6 | 61.4 | 36.2 | 2.4 | 63.8 | 33.8 | 2.4 | 64.0 | 33.3 | 2.6 |
,| Placebo + Trastuzumab + Chemotherapy | 44.7 | 50.1 | 5.2 | 52.4 | 44.0 | 3.7 | 55.5 | 41.8 | 2.7 | 58.3 | 39.1 | 2.6 | 59.9 | 37.0 | 3.1 | 61.0 | 36.2 | 2.8 | 61.6 | 35.4 | 3.0 |
Percentage of Participants With Primary Cardiac Event
Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. (NCT01358877)
Timeframe: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Primary Cardiac Event (Composite) | Heart Failure and LVEF Decline | Cardiac Death (Definite or Probable) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 0.7 | 0.6 | 0.1 |
,| Placebo + Trastuzumab + Chemotherapy | 0.3 | 0.2 | 0.1 |
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event. (NCT01358877)
Timeframe: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 7.1 |
| Placebo + Trastuzumab + Chemotherapy | 8.7 |
Peak Serum Concentration (Cmax) of Pertuzumab
(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1 | Cycle 10 | Cycle 15 |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 237 | 222 | 206 |
Cmin of Trastuzumab
(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1 | Cycle 10 | Cycle 15 |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 32.1 | 65.0 | 72.9 |
,| Placebo + Trastuzumab + Chemotherapy | 34.1 | 68.4 | 71.0 |
Cmax of Trastuzumab
(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1 | Cycle 10 | Cycle 15 |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 180 | 219 | 187 |
,| Placebo + Trastuzumab + Chemotherapy | 190 | 225 | 234 |
Change From Baseline in LVEF to Worst Post-Baseline Value
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan. (NCT01358877)
Timeframe: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
| Intervention | percentage of blood pumped out (Mean) |
|---|
| Baseline | Change to Worst Value |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 65.2 | -7.5 |
,| Placebo + Trastuzumab + Chemotherapy | 65.3 | -7.6 |
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No problems | Baseline: Some problems | Baseline: Unable | Week 13: No problems | Week 13: Some problems | Week 13: Unable | Week 25: No problems | Week 25: Some problems | Week 25: Unable | EOT: No problems | EOT: Some problems | EOT: Unable | FU Month 18: No problems | FU Month 18: Some problems | FU Month 18: Unable | FU Month 24: No problems | FU Month 24: Some problems | FU Month 24: Unable | FU Month 36: No problems | FU Month 36: Some problems | FU Month 36: Unable |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 89.7 | 10.0 | 0.3 | 94.3 | 5.3 | 0.4 | 95.5 | 4.3 | 0.1 | 95.4 | 4.4 | 0.2 | 97.2 | 2.6 | 0.2 | 96.9 | 2.8 | 0.3 | 97.3 | 2.5 | 0.2 |
,| Placebo + Trastuzumab + Chemotherapy | 90.7 | 9.1 | 0.2 | 93.2 | 6.4 | 0.4 | 95.0 | 4.7 | 0.3 | 95.8 | 4.0 | 0.2 | 96.0 | 3.6 | 0.3 | 96.3 | 3.5 | 0.3 | 96.5 | 3.2 | 0.3 |
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 13 | Change at Week 25 | Change at EOT | Change at FU Month 18 | Change at FU Month 24 | Change at FU Month 36 |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 72.9 | -11.2 | -4.4 | -3.1 | 1.9 | 2.2 | 2.8 |
,| Placebo + Trastuzumab + Chemotherapy | 72.5 | -10.2 | -2.9 | -1.1 | 1.3 | 2.4 | 1.8 |
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). (NCT01358877)
Timeframe: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 7.9 |
| Placebo + Trastuzumab + Chemotherapy | 9.6 |
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | units on a scale (Mean) |
|---|
| Baseline: Body Image | Change at Week 13: Body Image | Change at Week 25: Body Image | Change at EOT: Body Image | Change at FU Month 18: Body Image | Change at FU Month 24: Body Image | Change at FU Month 36: Body Image | Baseline: Sexual Enjoyment | Change at Week 13: Sexual Enjoyment | Change at Week 25: Sexual Enjoyment | Change at EOT: Sexual Enjoyment | Change at FU Month 18: Sexual Enjoyment | Change at FU Month 24: Sexual Enjoyment | Change at FU Month 36: Sexual Enjoyment | Baseline: Sexual Function | Change at Week 13: Sexual Function | Change at Week 25: Sexual Function | Change at EOT: Sexual Function | Change at FU Month 18: Sexual Function | Change at FU Month 24: Sexual Function | Change at FU Month 36: Sexual Function | Baseline: FP | Change at Week 13: FP | Change at Week 25: FP | Change at EOT: FP | Change at FU Month 18: FP | Change at FU Month 24 : FP | Change at FU Month 36: FP |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 79.7 | -12.9 | -7.6 | -4.9 | -0.1 | 0.5 | 1.7 | 54.0 | -16.5 | -11.9 | -10.7 | -4.2 | -6.0 | -5.3 | 19.6 | -5.6 | -2.6 | -1.0 | 2.5 | 2.8 | 2.6 | 51.3 | 3.1 | 6.3 | 7.7 | 12.9 | 13.7 | 14.7 |
,| Placebo + Trastuzumab + Chemotherapy | 78.9 | -13.9 | -7.3 | -6.0 | -1.3 | 0.1 | 0.7 | 55.0 | -13.1 | -7.9 | -8.0 | -6.7 | -5.0 | -6.0 | 20.8 | -6.6 | -2.3 | -1.4 | 1.4 | 1.8 | 1.6 | 50.5 | 1.8 | 5.4 | 6.9 | 10.5 | 12.9 | 13.6 |
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
| Intervention | units on a scale (Mean) |
|---|
| Baseline: Physical | Change at Week 13: Physical | Change at Week 25: Physical | Change at EOT: Physical | Change at FU Month 18: Physical | Change at FU Month 24: Physical | Change at FU Month 36: Physical | Baseline: Role | Change at Week 13: Role | Change at Week 25: Role | Change at EOT: Role | Change at FU Month 18: Role | Change at FU Month 24: Role | Change at FU Month 36: Role | Baseline: Social | Change at Week 13: Social | Change at Week 25: Social | Change at EOT: Social | Change at FU Month 18: Social | Change at FU Month 24: Social | Change at FU Month 36: Social | Baseline: Cognitive | Change at Week 13: Cognitive | Change at Week 25: Cognitive | Change at EOT: Cognitive | Change at FU Month 18: Cognitive | Change at FU Month 24: Cognitive | Change at FU Month 36: Cognitive | Baseline: Emotional | Change at Week 13: Emotional | Change at Week 25: Emotional | Change at EOT: Emotional | Change at FU Month 18: Emotional | Change at FU Month 24: Emotional | Change at FU Month 36: Emotional |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 89.6 | -10.7 | -4.6 | -4.1 | -0.9 | -0.4 | -0.3 | 79.8 | -8.0 | -0.7 | 0.4 | 6.1 | 7.3 | 7.9 | 81.9 | -8.7 | -2.2 | 0.0 | 5.0 | 5.5 | 6.6 | 88.8 | -9.1 | -7.6 | -7.7 | -6.1 | -6.2 | -5.4 | 72.8 | 3.3 | 5.1 | 5.6 | 7.7 | 7.8 | 7.8 |
,| Placebo + Trastuzumab + Chemotherapy | 89.1 | -10.6 | -4.3 | -3.2 | -0.9 | -0.3 | -0.1 | 79.4 | -8.5 | 0.4 | 2.3 | 5.7 | 6.9 | 7.6 | 80.6 | -7.8 | -0.7 | 1.2 | 4.8 | 6.5 | 7.1 | 87.9 | -9.0 | -7.0 | -7.2 | -5.8 | -5.5 | -4.9 | 71.3 | 2.9 | 5.9 | 6.2 | 7.6 | 8.5 | 8.4 |
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence. (NCT01358877)
Timeframe: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 5.0 |
| Placebo + Trastuzumab + Chemotherapy | 6.0 |
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. (NCT01358877)
Timeframe: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 8.0 |
| Placebo + Trastuzumab + Chemotherapy | 9.8 |
Percentage of Participants Who Died
Percentage of participants who died due to any cause is reported. (NCT01358877)
Timeframe: Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
| Intervention | percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 3.3 |
| Placebo + Trastuzumab + Chemotherapy | 3.7 |
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence. (NCT01358877)
Timeframe: 3 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 95.18 |
| Placebo + Trastuzumab + Chemotherapy | 94.27 |
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). (NCT01358877)
Timeframe: 3 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 93.50 |
| Placebo + Trastuzumab + Chemotherapy | 92.51 |
Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. (NCT01359592)
Timeframe: up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Interim PET-negative | 89 |
| Interim PET-positive | 86 |
Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT01359592)
Timeframe: up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP x 3 Followed by PET-directed Therapy | 89 |
Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
"Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.~Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion >1.5 cm in the longest axis." (NCT01359592)
Timeframe: up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| R-CHOP x 3 Followed by PET-directed Therapy | 87 |
Response Assessment
Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT01362790)
Timeframe: 52 months and 4 days
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease |
|---|
| Mesothelioma Pilot Phase Regimen | 0 | 0 | 6 | 1 |
,| Mesothelioma Pilot Phase Regimen A | 0 | 2 | 5 | 3 |
,| Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 0 | 0 | 1 | 2 |
,| Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 0 | 0 | 6 | 1 |
,| Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 0 | 0 | 6 | 3 |
Count of Participants SS1P Cycles Received Following Onstudy
Here are the number of participants who had SS1P cycles during cycle 1-6. (NCT01362790)
Timeframe: Cycles 1-6, up to 180 days
| Intervention | Participants (Count of Participants) |
|---|
| SS1P 1 Cycle | SS1P 2 Cycles | SS1P 3 Cycles | SS1P 4 Cycles | SS1P 5 Cycles | SS1P 6 Cycles |
|---|
| Mesothelioma Pilot Phase Regimen A | 1 | 8 | 0 | 1 | 0 | 1 |
,| Mesothelioma Pilot Phase Regimen B | 3 | 0 | 3 | 1 | 1 | 0 |
,| Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A | 0 | 0 | 0 | 0 | 0 | 0 |
,| Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 2 | 1 | 1 | 0 | 0 | 0 |
,| Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 0 | 4 | 0 | 3 | 0 | 0 |
,| Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 5 | 8 | 1 | 0 | 1 | 0 |
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01362790)
Timeframe: Date treatment consent signed to date off study, approximately 64 months and 26 days
| Intervention | Participants (Count of Participants) |
|---|
| Mesothelioma Pilot Phase Regimen A | 11 |
| Mesothelioma Pilot Phase Regimen B | 8 |
| Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 7 |
| Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 15 |
| Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 4 |
| Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A | 0 |
Count of Participants With SS1P Antibody Formation
Development of antibodies following treatment with SS1P. The goal was to delay development of antibodies to SS1P so a patient could get a second cycle of therapy with SS1P. (NCT01362790)
Timeframe: On last day of last dosing cycle, end of cycle 1 (day 30)
| Intervention | Participants (Count of Participants) |
|---|
| Mesothelioma Pilot Phase Regimen A | 6 |
| Mesothelioma Pilot Phase Regimen B | 2 |
| Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 3 |
| Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 7 |
| Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 0 |
| Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A | 0 |
Duration of Response
DOR is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is measured from the time measurement criteria is met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to<10mm. partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). (NCT01362790)
Timeframe: up to 2.5 years
| Intervention | Months (Median) |
|---|
| Mesothelioma Pilot Phase Regimen A | 16.3 |
Overall Survival
The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis). (NCT01362790)
Timeframe: 36 months
| Intervention | Months (Median) |
|---|
| Mesothelioma Pilot Phase Regimen A | 8.9 |
| Mesothelioma Pilot Phase Regimen B | 11.2 |
| Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 29.3 |
| Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 4.2 |
| Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 9.3 |
Progression-free Survival
Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression). (NCT01362790)
Timeframe: 36 months
| Intervention | Months (Median) |
|---|
| Meothelioma Pilot Phase Phase Regimen A | 11.8 |
| Meothelioma Pilot Phase Regimen B | 8.8 |
| Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 8.9 |
| Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 3.9 |
| Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 4.4 |
Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01
Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose. (NCT01362790)
Timeframe: Days 1, 3, and 5 of a 21 day cycle
| Intervention | mcg/kg/dose (Number) |
|---|
| Meso., Peritoneal, Pleural & Pancreatic Regimen A | 25 |
4-year Event Free Survival
Event Free Survival defined as the time from the start of therapy to time of primary refractory disease, relapse from CR, death from any cause or last follow-up. Kaplan-Meier method will be utilized to analyze event free survival for the 4 year percent alive and in CR. (NCT01363128)
Timeframe: Up to 4 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Ofatumumab) | 41 |
4-Year Overall Survival
Overall Survival is defined as time from date of treatment start until date of death due to any cause or last Follow-up. For continuous data, summary statistics including n, mean, standard deviation, median, minimum and maximum will be computed. The posterior median time to event and it 95% credible interval will be estimated. Kaplan-Meier method, Log rank test and Cox proportional hazards regression modeling will be utilized to analyze survival at 4 years. (NCT01363128)
Timeframe: Up to 4 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Ofatumumab) | 47 |
Number of Participants With Complete Remission (CR)
Complete Remission is Normalization of the peripheral blood and bone marrow with 5% or less blasts in marrow with a granulocyte count of 1 x 109/L or above and a platelet count of 100x 109/L or above. Complete resolution of all sites of extramedullary disease is required for CR. (NCT01363128)
Timeframe: Up to 8 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Ofatumumab) | 68 |
Number of Participants With Serious and Non-Serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01369875)
Timeframe: Date treatment consent signed to date off study, up to approximately 8 months.
| Intervention | Participants (Count of Participants) |
|---|
| Standard Young TIL | 1 |
| ECCE Young TIL | 1 |
Number of Participants With Clinical Tumor Regression.
Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD. (NCT01369875)
Timeframe: up to approximately 8 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response | Progression | Stable Disease |
|---|
| ECCE Young TIL | 0 | 0 | 1 | 0 |
,| Standard Young TIL | 0 | 0 | 1 | 0 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT01369888)
Timeframe: 8 months, 9 days
| Intervention | participants (Number) |
|---|
| IL-15 Following Young TIL (0.25 mcg) | 1 |
| IL-15 Following Young TIL (0.50 mcg) | 2 |
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT01370694)
Timeframe: From first dose of combination therapy up to 24 weeks
| Intervention | Participants (Number) |
|---|
| MK-8808 Combination Therapy | 6 |
Clinical Response of Tumor to MK-8808/CVP Combination Therapy
The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review. (NCT01370694)
Timeframe: Up to 2 years
| Intervention | Participants (Number) |
|---|
| PR | CR | CRu |
|---|
| MK-8808 Combination Therapy | 6 | 0 | 0 |
Proportion of Patients Who Are PET Negative After Induction Treatment
(NCT01390584)
Timeframe: Assessed at end of Cycle 2
| Intervention | proportion of participants (Number) |
|---|
| Step 1: Induction Tx | 0.8 |
Progression-free Survival Rate
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months
| Intervention | proportion of participants (Number) |
|---|
| ABVD + INRT | NA |
| ABVD + BEACOPP + INRT | NA |
Overall Survival
Overall survival is defined as the time from study entry to death or date last known alive. (NCT01390584)
Timeframe: Assessed at 36 months
| Intervention | months (Median) |
|---|
| ABVD + INRT | NA |
| ABVD + BEACOPP + INRT | NA |
Complete Response (CR) Rate After Induction Treatment
Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. (NCT01390584)
Timeframe: Assessed at end of Cycle 2
| Intervention | proportion of participants (Number) |
|---|
| Step 1: Induction Tx | 1.0 |
Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months
| Intervention | proportion of participants (Number) |
|---|
| ABVD + BEACOPP + INRT | NA |
Percentage of Participants With Non-Relapse Mortality
The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy. (NCT01410344)
Timeframe: Day 100, 1 Year, and 2 Years Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Day 100 | 1 Year | 2 Years |
|---|
| Allogeneic Transplant | 0.0 | 11.8 | 18.3 |
Percentage of Participants With Overall Survival
Overall survival is defined as the time from transplant to death from any cause. (NCT01410344)
Timeframe: Six months, 1 Year, and 2 Years Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| 6 Months | 1 Year | 2 Years |
|---|
| Allogeneic Transplant | 82.4 | 58.8 | 50.2 |
Chimerism
Donor T-cell and myeloid chimerism will be described separately by conditioning regimen intensity (myeloablative or reduced intensity) according to proportions with mixed chimerism (5-95% donor cells out of all), full chimerism (>95% donor cells), or graft rejection (<5% donor cells). (NCT01410344)
Timeframe: Week 4, Day 100, and 6 months Post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Week 472365409 | Week 472365410 | Day 10072365410 | Day 10072365409 | 6 Months72365409 | 6 Months72365410 |
|---|
| Graft Rejection | No Assay Reported | Full Chimerism | Mixed Chimerism | Dead at Assessment |
|---|
| Reduced Intensity Allogeneic Transplant | 4 |
| Myeloablative Allogeneic Transplant | 1 |
| Myeloablative Allogeneic Transplant | 3 |
| Myeloablative Allogeneic Transplant | 4 |
| Reduced Intensity Allogeneic Transplant | 5 |
| Myeloablative Allogeneic Transplant | 2 |
| Reduced Intensity Allogeneic Transplant | 2 |
| Myeloablative Allogeneic Transplant | 0 |
| Reduced Intensity Allogeneic Transplant | 0 |
Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD)
"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL 1.2-3 mg/dL 2.3.01-6 mg/dL 3.6.01-15.0 mg/dL 4.>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4" (NCT01410344)
Timeframe: Day 100 Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Grade II-IV Acute GVHD | Grade III-IV Acute GVHD |
|---|
| Allogeneic Transplant | 41.2 | 11.8 |
Percentage of Participants Recovering Hematologic Function
Recovery of hematologic function is described by the time to neutrophil and platelet recovery. Time to neutrophil recovery will be the first of three consecutive days of > 500 neutrophils/μL following the expected nadir. Time to platelet engraftment will be described by the date when platelet count is > 20,000/μL for the first of three consecutive labs with no platelet transfusions 7 days prior. (NCT01410344)
Timeframe: Days 28 and 100 Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Day 28 Neutrophil Recovery | Day 100 Platelet Recovery |
|---|
| Allogeneic Transplant | 100.0 | 94.1 |
Percentage of Participants With Relapse/Progression
Relapse/Progression is defined as relapse or progression of the primary malignancy. (NCT01410344)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Transplant | 29.4 |
Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD)
Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. (NCT01410344)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Transplant | 17.6 |
Progression-Free Survival (PFS) at 2 Years
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT01412879)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) | 82 |
| Arm 2: R-Bendamustine (Induction Therapy) | 81 |
Response Rate (Complete and Partial Response)
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. (NCT01412879)
Timeframe: Up to 9 months
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) | 94.1 |
| Arm 2: R-Bendamustine (Induction Therapy) | 82.9 |
5-year Overall Survival (OS)
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT01412879)
Timeframe: Up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) | 81 |
| Arm 2: R-Bendamustine (Induction Therapy) | 79 |
Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
| Intervention | mL (Mean) |
|---|
| Cycle 1 (n = 54) | Cycle 8 (n = 37) |
|---|
| Obinutuzumab + CHOP | 4580 | 9210 |
Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + CHOP | 75.0 |
Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + CHOP | 58.0 |
Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + CHOP | 55.0 |
Duration of Response (DOR)
DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the response assessment to relapse, progression, or death (up to 64 months)
| Intervention | months (Median) |
|---|
| Obinutuzumab + CHOP | 45.6 |
Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + CHOP | 82.0 |
Percentage of Participants With Adverse Events as a Measure of Safety
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events. (NCT01414855)
Timeframe: From the first dose of study treatment to end of study (up to 5 years 4 months)
| Intervention | percentage of participants (Number) |
|---|
| Obinutuzumab + CHOP | 100.0 |
Progression-Free Survival (PFS) as Assessed by the Investigator
PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause. (NCT01414855)
Timeframe: From the first dose of study treatment to PFS assessment (up to 64 months)
| Intervention | months (Median) |
|---|
| Obinutuzumab + CHOP | 48.3 |
Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
| Intervention | μg/mL (Mean) |
|---|
| Cycle 1 | Cycle 8 (n = 85) |
|---|
| Obinutuzumab + CHOP | 297 | 574 |
Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
| Intervention | day*μg/mL (Mean) |
|---|
| Cycle 1 (n = 59) | Cycle 8 (n = 74) |
|---|
| Obinutuzumab + CHOP | 1320 | 3300 |
Pharmacokinetics: Clearance (Cl) for Obinutuzumab
Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
| Intervention | mL/day (Mean) |
|---|
| Cycle 1 (n = 54) | Cycle 8 (n = 37) |
|---|
| Obinutuzumab + CHOP | 456 | 143 |
Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
| Intervention | days (Mean) |
|---|
| Cycle 1 (n = 37) | Cycle 8 (n = 21) |
|---|
| Obinutuzumab + CHOP | 6.04 | 23 |
Overall Survival (OS) in Subjects Receiving Test Treatments (FAS)
"For all treated subjects, OS was defined as the time between the date of randomization and the date of death or censoring, and was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects without documentation of death at the time of the final analysis were censored using the date the subject was last known to be alive. Per the study protocol, following an Interim Analysis (IA), subjects in the Cy/GVAX arm were offered rollover to Cy/GVAX + CRS-207 arm. 3 subjects rolled over to the Cy/GVAX + CRS-207 arm (rollover subjects). These rollover subjects were censored at the day prior to the first rollover treatment dose date, and were included for analysis in the Cy/GVAX arm. Additionally, 2 subjects originally treated per the Cy/GVAX + CRS-207 arm discontinued treatment and entered follow-up, but following IA were re-treated per the Cy/GVAX + CRS-207 arm regimen. Data from these re-treated subjects were included in the Cy/GVAX + CRS-207 arm analysis." (NCT01417000)
Timeframe: Subjects were followed from the date of randomization to the date of death or discontinuation, whichever came first, assessed up to 60 months.
| Intervention | months (Median) |
|---|
| Cy/GVAX + CRS-207 | 6.28 |
| Cy/GVAX | 4.07 |
To Assess Safety of the Cyclophosphamide, GVAX Pancreas Vaccine, and CRS-207 Treatment Regimen
Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs. AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date. (NCT01417000)
Timeframe: Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.
| Intervention | Participants (Count of Participants) |
|---|
| Serious AEs | Total AEs |
|---|
| Cy/GVAX | 10 | 29 |
,| Cy/GVAX + CRS-207 | 29 | 64 |
Local Skin Tumor Response Rates (Complete Response + Partial Response)
The response refers to the best overall response, based on European Organization for Research and Treatment of Cancer's definitions for chest wall tumors (Kouloulias, et al., 2002). (NCT01421017)
Timeframe: 9 weeks from the start of the treatment
| Intervention | proportion of tumors (Number) |
|---|
| Local Area A; irradiated area | Local Area B; non-irradiated area |
|---|
| CTX/IMQ/RT | 0.75 | .083 |
,| IMQ+RT | 0.83 | .33 |
Systemic Tumor Response Rates (Complete Response+Partial Response)
The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009). (NCT01421017)
Timeframe: 9 weeks from the start of the treatment of RT
| Intervention | proportion of tumors (Number) |
|---|
| IMQ+RT | .25 |
| CTX/IMQ/RT | .083 |
| CTX/RT | 0 |
Disease-free Survival
Disease-free survival will be evaluated as Kaplan-Meier estimates. (NCT01427881)
Timeframe: At 1 year post-transplant
| Intervention | percentage of patients (Number) |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 73.8 |
Hematologic Recovery
Descriptive statistics will be used to assess the median days of neutrophil and platelet recovery. The day of neutrophil recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the absolute neutrophil count is > 500/uL. The day of platelet recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the platelet count is >= 20,000/uL without platelet transfusion support in the seven days prior. (NCT01427881)
Timeframe: Up to day +100
| Intervention | days (Median) |
|---|
| Neutrophil Engraftment | Platelet Engraftment |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 19 | 14 |
Grades II-IV and III-IV Acute GVHD
Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots. (NCT01427881)
Timeframe: Through day +100 post-transplant
| Intervention | percentage of patients (Number) |
|---|
| Grades II-IV GVHD | Grades III-IV GVHD |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 77 | 0 |
Persistent or Recurrent Malignancy After HCT
Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation. (NCT01427881)
Timeframe: At 2 years
| Intervention | percentage of patients (Number) |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 17 |
Overall Survival
Overall survival will be evaluated as Kaplan-Meier estimates. (NCT01427881)
Timeframe: At 1 year post-transplant
| Intervention | percentage of patients (Number) |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 75.6 |
Non-relapse Mortality
Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence. (NCT01427881)
Timeframe: At 2 years
| Intervention | percentage of patients (Number) |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 14 |
Graft Failure
Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of >= 500/uL by >= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to < 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors. (NCT01427881)
Timeframe: By greater than or equal to 28 days post-transplant
| Intervention | percentage of patients (Number) |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 2 |
Donor Engraftment
Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood. (NCT01427881)
Timeframe: At day 28
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 6 |
Chronic GVHD Requiring Systemic Immunosuppressive Treatment
Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from ~35% to ~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error. (NCT01427881)
Timeframe: At 1 year after transplantation
| Intervention | percent of patients (Number) |
|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 16 |
Phase II - Overall Response Rate (ORR)
Overall response, Minimal Remission (MR) or better per treatment arm, using the uniform response criteria by the International Myeloma Working Group (IMWG) of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in participants with relapsed and refractory myeloma. In addition, Minimal response was incorporated in those response criteria as this is a valid endpoint in patients with relapsed or refractory myeloma. MR: 25-49% reduction in serum paraprotein and a 50-89% reduction in urine light chain excretion; A 25-49% reduction in the size of soft tissue plasmacytoma must be demonstrated is applicable. (NCT01432600)
Timeframe: 36 Months
| Intervention | percentage of participants (Number) |
|---|
| B: Pomalidomide and Dexamethasone | 38.9 |
| C: Pomalidomide, Dexamethasone, Cyclophosphamide | 64.7 |
Phase I - Maximum Tolerated Dose (MTD)
The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity related to treatment with pomalidomide or cyclophosphamide; Participants must have received optimal symptomatic treatment for Grade 3 or 4 nausea, vomiting, or diarrhea to be considered a DLT; Grade 4 transaminitis; Grade 3 transaminitis must be present for ≥ 7 days to be considered a DLT; Grade 4 thrombocytopenia for 7 or more days; Grade 4 neutropenia for 7 or more days. (NCT01432600)
Timeframe: 28 Days
| Intervention | mg (Number) |
|---|
| A: Dose Escalation of Cyclophosphamide | 400 |
Number of Participants With Adverse Events of Grade 3 or Higher
Adverse events reported here were at least possibly related to the protocol therapy. (NCT01438177)
Timeframe: Treatment period plus 30 days post-treatment
| Intervention | participants (Number) |
|---|
| Fatigue | Hemoglobin | Nasal cavity/paranasal reactions | ANC/AGC | Pain: pleural | Platelets |
|---|
| Velcade+Cyclophosphamide+Chloroquine | 2 | 1 | 1 | 4 | 1 | 5 |
Response Rate (CR + PR After 2 Cycles)
"Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:~CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h" (NCT01438177)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Velcade+Cyclophosphamide+Chloroquine | 30 |
Number of Participants With Serious and Non-serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01445535)
Timeframe: Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 - 3.4 mg/kg | 3 |
| Cohort 2 - 4.8 mg/kg | 3 |
| Cohort 3 - 8.5 mg/kg | 3 |
| Cohort 4 - 15 mg/kg | 5 |
Number of Dose-Limiting Toxicities (DLT)
DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an EBV-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) and grade 3 laboratory AEs were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.
| Intervention | Dose Limiting Toxicities (Number) |
|---|
| Cohort 1 - 3.4 mg/kg | 0 |
| Cohort 2 - 4.8 mg/kg | 0 |
| Cohort 3 - 8.5 mg/kg | 0 |
| Cohort 4 - 15 mg/kg | 0 |
Maximum Tolerated Dose (MTD) of Siplizumab
A classic 3+3 dose-escalation design was used to assess the MTD of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). If 2 of 6 patients experienced a dose-limiting toxicity (DLT) at a particular dose level, the MTD has been exceeded. The preceding dose level will be the MTD, provided 6 patients have been entered at this level and no more than one has experienced a DLT. DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an Epstein Barr Virus (EBV)-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted EPOCH-R and grade 3 laboratory adverse events (AEs) were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.
| Intervention | mg/kg (Number) |
|---|
| All Participants | 15 |
Number of Participants With a Response to Therapy
Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD. (NCT01445535)
Timeframe: Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years.
| Intervention | Participants (Count of Participants) |
|---|
| Complete Remission | Complete Response Unconfirmed | Partial Response | Relapsed Disease | Progressive Disease | Stable Disease | Not Evaluable |
|---|
| Cohort 1 - 3.4 mg/kg | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
,| Cohort 2 - 4.8 mg/kg | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,| Cohort 3 - 8.5 mg/kg | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
,| Cohort 4 - 15 mg/kg | 4 | 0 | 0 | 0 | 0 | 0 | 2 |
Overall Survival (OS)
Overall survival was determined from the on-study date until date of progression or last follow up. The probability of OS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On study date until date of death or last follow up, approximately 12 months.
| Intervention | Months (Median) |
|---|
| All Participants | 12.1 |
Overall Progression Free Survival (PFS)
Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On-study date until date of progression or last follow up, approximately 7 months.
| Intervention | Months (Median) |
|---|
| All Participants | 6.8 |
Number of Participants With Treatment Failure
"Treatment failure will not occur until a minimum of 12 months after treatment at which time failure is defined as:~Increase of skin score (if > 14 on enrollment) by > 25% above enrollment value and must be documented on 2 occasions at least 6 months apart~Deterioration in percent predicted FVC by 10% below enrollment level, due to systemic sclerosis, and documented on 2 occasion at least 6 months apart" (NCT01445821)
Timeframe: up to and post 12 months of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide rATG/HSCT | 2 |
| Cyclophosphamide rATG/Fludarabine/HSCT | 2 |
Survival of Treatment
Survival of Hematopoietic Stem Cell Transplant. (NCT01445821)
Timeframe: up to 12 months post treatment
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide rATG/HSCT | 22 |
| Cyclophosphamide rATG/Fludarabine/HSCT | 21 |
Minimal Disseminated Disease (MDD)
Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable) (NCT01451515)
Timeframe: At Diagnosis
| Intervention | participants (Number) |
|---|
| Negative | Positive |
|---|
| Stratum 1 | 4 | 1 |
,| Stratum 2 | 2 | 3 |
,| Stratum 3 | 0 | 4 |
Probability of Overall Survival (OS)
"For OS, only deaths are considered failures for OS. Kaplan-Meier estimates of the OS curves are computed along with estimates of standard errors by Peto's method.~Please note the unit of measurement of probabilities are percentages." (NCT01451515)
Timeframe: Two years post therapy.
| Intervention | percentage of patients alive (Number) |
|---|
| Stratum 1 | 91.7 |
| Stratum 2 | 71.4 |
| Stratum 3 | 100 |
| All Enrollments | 86.96 |
Probability of Event-free Survival (EFS)
"For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method.~Please note the unit of measurement of probabilities are percentages." (NCT01451515)
Timeframe: Two years post therapy.
| Intervention | percentage of event-free patients (Number) |
|---|
| Stratum 1 | 91.7 |
| Stratum 2 | 71.4 |
| Stratum 3 | 100 |
| All Enrollments | 86.96 |
Minimal Residual Disease (MRD)
Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable) (NCT01451515)
Timeframe: Day 8
| Intervention | participants (Number) |
|---|
| Negative | Positive |
|---|
| Stratum 1 | 8 | 0 |
,| Stratum 2 | 4 | 1 |
,| Stratum 3 | 0 | 4 |
Response Rate of Patients With Steroid-refractory Graft-versus-host Disease (GVHD) Using Cyclophospahmide and Sirolimus Combined With 3 Variations of Low-dose IL 2 and Low-dose Vidaza.
The primary objective of this study is to determine the response rate of patients treated steroid-refractory graft-versus-host disease (GVHD) using cyclophospahmide and sirolimus combined with 3 variations of low-dose IL 2 and low-dose Vidaza with an outcome goal of promoting CD4+CD25+FoxP3+ Tregs. (NCT01453140)
Timeframe: 28 days to 100 days post transplant
| Intervention | Participants (Number) |
|---|
| Cyclophosphamide and Sirolimus | 0 |
Number of Patients With an Objective Response
Objective response was assessed by comparison with baseline dynamic contrast enhanced magnetic resonance imaging with perfusion using Neuro-oncology Working Group proposed guidelines. Complete Response is disappearance of all measurable and non-measurable disease for at least 4 weeks. Partial Response is >/= 50% decrease in lesions for at least 4 weeks. Stable Disease does not meet the criteria for complete response, partial response or progression and requires stable lesions compared with baseline. Progression is >/= 25% increase in lesions. (NCT01454596)
Timeframe: 4 weeks after cell infusion and monthly as feasible up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Group A (Steroids) - Cohort 1: 1x10(7) | 0 |
| Group A (Steroids) - Cohort 2: 3x10(7) | 0 |
| Group A (Steroids) - Cohort 3: 1x10(8) | 0 |
| Group B (No Steroids) - Cohort 1: 1x10(7) | 0 |
| Group B (No Steroids) - Cohort 2: 3x10(7) | 0 |
| Group B (No Steroids) - Cohort 3: 1x10(8) | 0 |
| Group B (No Steroids) - Cohort 4: 3x10(8) | 0 |
| Group B (No Steroids) - Cohort 5: 1x10(9) | 0 |
| Combined Steroids/no Steroids) - Cohort 6: 3x10(9) | 0 |
| Combined Steroids/no Steroids) - Cohort 7: 1x10(10) | 0 |
| Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) | 0 |
| Combined Steroids/no Steroids) - Cohort 9: 3x10(10) | 0 |
Progression Free Survival
Progression was assessed by the Response Assessment in Neuro-Oncology (RANO) criteria and is defined as the circumstance when the magnetic resonance imaging (MRI) scan is ranked -2 (definitely worse) or -3 (development of a new lesion). (NCT01454596)
Timeframe: Time from the date of registration to the date of first observation of progressive disease up to 6 months after end of treatment
| Intervention | months (Median) |
|---|
| Group A (Steroids) - Cohort 1: 1x10(7) | 1.1 |
| Group A (Steroids) - Cohort 2: 3x10(7) | 1.1 |
| Group A (Steroids) - Cohort 3: 1x10(8) | 1.3 |
| Group B (No Steroids) - Cohort 1: 1x10(7) | 1.9 |
| Group B (No Steroids) - Cohort 2: 3x10(7) | 2.0 |
| Group B (No Steroids) - Cohort 3: 1x10(8) | 1.5 |
| Group B (No Steroids) - Cohort 4: 3x10(8) | 1.2 |
| Group B (No Steroids) - Cohort 5: 1x10(9) | 1.1 |
| Combined Steroids/no Steroids) - Cohort 6: 3x10(9) | 2.7 |
| Combined Steroids/no Steroids) - Cohort 7: 1x10(10) | 1.1 |
| Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) | 0 |
| Combined Steroids/no Steroids) - Cohort 9: 3x10(10) | 2.0 |
Circulating Chimeric Antigen Receptor (CAR+) Cells in Peripheral Blood at 1 Month Post Treatment
CAR and vector presence were quantitated in peripheral blood mononuclear cell (PBMC) samples using established polymerase chain reaction (PCR) techniques (NCT01454596)
Timeframe: 1 month post transplant
| Intervention | K/µL (Median) |
|---|
| Group A (Steroids) - Cohort 1: 1x10(7) | 23 |
| Group A (Steroids) - Cohort 2: 3x10(7) | 70 |
| Group A (Steroids) - Cohort 3: 1x10(8) | 36 |
| Group B (No Steroids) - Cohort 1: 1x10(7) | 67 |
| Group B (No Steroids) - Cohort 2: 3x10(7) | 7 |
| Group B (No Steroids) - Cohort 3: 1x10(8) | 43 |
| Group B (No Steroids) - Cohort 4: 3x10(8) | 28 |
| Group B (No Steroids) - Cohort 5: 1x10(9) | 25 |
| Combined Steroids/no Steroids) - Cohort 6: 3x10(9) | 12 |
| Combined Steroids/no Steroids) - Cohort 7: 1x10(10) | 67.5 |
| Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) | NA |
| Combined Steroids/no Steroids) - Cohort 9: 3x10(10) | 8 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01454596)
Timeframe: 51 dys Grp A, Cohort 1; Cohort 2:68 dys; Cohort 3:40 dys; Grp B, Cohort 1:67 dys; Cohort 2:48 dys; Cohort 3:55 dys; Cohort 4: 46 dys; Cohort 5:147 dys; C. Ster/No Ster Grp, Cohort 6:12 mos, 26 dys; Cohort 7:11 mos, 18 dys; Cohort 8:7 dys; Cohort 9:70 dys.
| Intervention | Participants (Count of Participants) |
|---|
| Group A (Steroids) - Cohort 1: 1x10(7) | 1 |
| Group A (Steroids) - Cohort 2: 3x10(7) | 1 |
| Group A (Steroids) - Cohort 3: 1x10(8) | 1 |
| Group B (No Steroids) - Cohort 1: 1x10(7) | 1 |
| Group B (No Steroids) - Cohort 2: 3x10(7) | 1 |
| Group B (No Steroids) - Cohort 3: 1x10(8) | 1 |
| Group B (No Steroids) - Cohort 4: 3x10(8) | 1 |
| Group B (No Steroids) - Cohort 5: 1x10(9) | 3 |
| Combined Steroids/no Steroids) - Cohort 6: 3x10(9) | 3 |
| Combined Steroids/no Steroids) - Cohort 7: 1x10(10) | 3 |
| Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) | 1 |
| Combined Steroids/no Steroids) - Cohort 9: 3x10(10) | 1 |
The Primary End-point is the Number of Patients in CR After Induction Therapy.
Disappearance of any clinical and laboratoristic sign of ALL. The patient must be transfusion-free with neutrophils >1.0 x109/L and platelets >100 x109/L. BM examination must show absence or reduction of blast cell content (< 5%, none of which obviously leukemic), with cellularity in the normal or slightly hypocellular range and with evidence of trilineage hemopoiesis. BM is examined on day 28 from start of chemotherapy cycle 1, or later as clinically indicated in ill/cytopenic patients, and after cycle 2 in patients with PR proceeding to this treatment. (NCT01462253)
Timeframe: At day +28 from start of chemotherapy cycle 1 and after cycle 2 in pts with PR
| Intervention | Participants (Count of Participants) |
|---|
| Clofarabine + Cyclophosphamide | 9 |
Overall Survival (OS)
Overall Survival (OS) at 1 year; defined as the time interval between inclusion and death for any cause; patients still alive will be censored at the time of the last follow-up. In this case, the OS curve will be truncated at 1 year. (NCT01462253)
Timeframe: At one year from therapy completion.
| Intervention | Percentage of patients (Number) |
|---|
| Clofarabine + Cyclophosphamide | 28.6 |
Number of Participants With Toxicity of Grade 2 or Greater
Referring to CTCAE (Common Toxicity Criteria Events), version 4.0 (NCT01462253)
Timeframe: At 13 months from study entry
| Intervention | Participants (Count of Participants) |
|---|
| Clofarabine + Cyclophosphamide | 10 |
Number of Participants With Minimal Residual Disease (MRD) Response in Remission.
(NCT01462253)
Timeframe: At week 10, 16 and 22 from start of treatment and the, every three months till study completion
| Intervention | Participants (Count of Participants) |
|---|
| Clofarabine + Cyclophosphamide | 1 |
Disease-free Survival (DFS)
Disease-free survival (DFS) at 1 year, defined as the time interval between the evaluation of CR and relapse of the disease or death in first CR; patients still alive, in first CR, will be censored at the time of the last follow-up. In this case, the DFS curve will be truncated at 1 year (NCT01462253)
Timeframe: At one year from completion of chemotherapy
| Intervention | Percentage of patients (Number) |
|---|
| Clofarabine + Cyclophosphamide | 31.25 |
Cumulative Incidence of Relapse (CIR)
Cumulative incidence of relapse (CIR) at 1 year, it will be calculated from the date of achievement of the first CR, using the cumulative incidence method, considering death in CR as a competing risk. Patients still alive, without a date of relapse, will be censored at the time of the last follow-up. In this case, the CIR curve will be truncated at 1 year. (NCT01462253)
Timeframe: At one year from therapy completion.
| Intervention | Percentage of patients (Number) |
|---|
| Clofarabine + Cyclophosphamide | 31.25 |
Clinical Disease Response
Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 2 years from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only untilthe resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care. (NCT01464359)
Timeframe: 2 Years from Transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Patients With Acute Myelogenous Leukemia | 2 |
Clinical Disease Response
Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 1 year from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only until the resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care. (NCT01464359)
Timeframe: 1 Year from Transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Patients With Acute Myelogenous Leukemia | 2 |
Disease Free Survival
The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo. (NCT01464359)
Timeframe: At 3 months
| Intervention | participants (Number) |
|---|
| Patients With Acute Myelogenous Leukemia | 1 |
Duration of Survival
(NCT01464359)
Timeframe: 1 year after Transplantation.
| Intervention | Participants (Count of Participants) |
|---|
| Patients With Acute Myelogenous Leukemia | 0 |
Duration of Survival
(NCT01464359)
Timeframe: 2 years after Transplantation.
| Intervention | Participants (Count of Participants) |
|---|
| Patients With Acute Myelogenous Leukemia | 0 |
Duration of Survival
(NCT01464359)
Timeframe: 6 months after Transplantation.
| Intervention | Participants (Count of Participants) |
|---|
| Patients With Acute Myelogenous Leukemia | 1 |
Incidence of Acute Graft-Versus-Host Disease
(NCT01464359)
Timeframe: Day 60
| Intervention | Participants (Count of Participants) |
|---|
| Patients With Acute Myelogenous Leukemia | 0 |
Incidence of Graft Failure
Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) (NCT01464359)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Patients With Acute Myelogenous Leukemia | 0 |
Number of Participants With Adverse Events
Safety will be assessed by physical examination, interim history, and laboratory assessments. Adverse events will be graded according to the NCI-CTCAE, version 4.0 (NCT01492673)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide, Topotecan, and Bevacizumab (CTB) | 9 |
Clinical Tumor Response
Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. (NCT01495572)
Timeframe: One year
| Intervention | participants (Number) |
|---|
| Complete Response | Partial Response | Progressive Disease | Stable Disease |
|---|
| Peripheral Blood Lymphocytes (PBL) | 0 | 0 | 5 | 0 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. (NCT01495572)
Timeframe: 10 months
| Intervention | participants (Number) |
|---|
| Peripheral Blood Lymphocytes (PBL) | 5 |
Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT)
Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1). (NCT01496131)
Timeframe: Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)
| Intervention | Participants (Count of Participants) |
|---|
| Pre-RT | Post-RT |
|---|
| Standard Therapy Plus Tecemotide (L-BLP25) | 1 | 1 |
Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT)
Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1). (NCT01496131)
Timeframe: Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)
| Intervention | Participants (Count of Participants) |
|---|
| Pre-RT |
|---|
| Standard Therapy | 1 |
Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels
"Progression/recurrence status was reported based on Prostate-specific Antigen (PSA) Levels. Recurrence of PSA after completion of therapy represents disease progression and was determined using the American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix criteria. These criteria define biochemical recurrence after radiation therapy as a PSA level equal to the lowest (nadir) PSA level achieved after therapy plus 2 nanogram per milliliter." (NCT01496131)
Timeframe: From randomization up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Standard Therapy | 2 |
| Standard Therapy Plus Tecemotide (L-BLP25) | 0 |
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)
MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1). (NCT01496131)
Timeframe: Baseline and Day 60 (Pre-Radiation)
| Intervention | Participants (Count of Participants) |
|---|
| Standard Therapy | 2 |
| Standard Therapy Plus Tecemotide (L-BLP25) | 3 |
Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)
MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1). (NCT01496131)
Timeframe: Baseline and Day 190 (Post-radiation)
| Intervention | Participants (Count of Participants) |
|---|
| Standard Therapy | 1 |
| Standard Therapy Plus Tecemotide (L-BLP25) | 1 |
Pathologic Complete Response Rate at the Time of Surgery
Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist's standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR. (NCT01498588)
Timeframe: Average of 24 weeks
| Intervention | participants (Number) |
|---|
| Pathologic Complete Response (pCR) | No pCR | Unknown |
|---|
| Eribulin+Doxorubicin+Cyclophosphamide | 1 | 5 | 1 |
Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events)
Toxicity of chemotherapy at each physician visit using Common Toxicity Criteria for Adverse Effects (CTCAE) criteria. (NCT01498588)
Timeframe: Through 20 weeks of chemotherapy
| Intervention | participants (Number) |
|---|
| Eribulin+Doxorubicin+Cyclophosphamide | 2 |
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)
Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale. (NCT01507103)
Timeframe: Baseline and Week 18 (follow-up / end-of trial)
| Intervention | log2 (percentage of T cells) (Mean) |
|---|
| CD3-CD56+CD16+GranzymeB+ (n=26,30,24) | CD3-CD56+CD16+Perforin+ (n=26,30,24) | CD3+CD4+CD27+ (n=26,30,24) | CD3-CD56+CD16+Granzyme B+/LY (n=26,30,24) | CD3-CD56+CD16+Perforin+/LY (n=26,30,24) | CD3-CD56+CD16-CD107a+ (n=26,30,24) | CD3+CD8+CD127-FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24) | CD3+CD56+CD16-Granzyme B+ (n=26,30,24) | CD3-CD56+CD16+/LY (n=26,30,24) | CD3-CD19+BTLA4+ (n=27,29,23) | Lymphs Tube 2 (n=27,30,25) | CD3+CD56+CD16+CD107a+ (n=26,30,24) | CD3+CD4+BTLA4+ (n=26,30,24) | Lymphs Tube 3 (n=27,30,25) | CD3+CD56+CD16+CCR7+ (n=26,30,24) | CD3+CD8+CD127+FoxP3-CD25-CD45RA+CTLA4-(n=27,29,24) | Background corrected CD3+CD4+IFNg+ (n=21,27,21) | CD3+CD56+CD16+Granzyme B+/LY (n=26,30,24) | CD3+CD56+CD16+Perforin+/LY (n=26,30,24) | CD3+CD4+CD127+FoxP3-CD45RA-CD25+CTLA4+(n=27,29,24) |
|---|
| Chemoradiotherapy | -0.081 | -0.088 | -0.099 | 0.415 | 0.411 | 0.037 | -0.012 | -0.024 | 0.497 | -0.017 | -0.952 | -2.752 | -0.035 | -0.936 | -3.390 | -0.940 | 0.359 | 0.131 | 0.101 | 1.035 |
,| Chemoradiotherapy+Tecemotide (L-BLP25) | -0.046 | -0.033 | -0.135 | 0.047 | 0.058 | -0.318 | 0.152 | -0.241 | 0.090 | -0.028 | -0.941 | 1.966 | 0.122 | -0.920 | 0.541 | -1.062 | 0.544 | -0.201 | -0.177 | 0.674 |
,| Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide | -0.013 | -0.050 | -0.181 | 0.264 | 0.226 | 0.216 | 0.050 | 0.479 | 0.277 | -0.030 | -1.024 | -1.216 | 0.063 | -0.994 | -1.341 | -0.604 | 0.058 | 0.243 | 0.240 | 0.711 |
Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category
A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27). (NCT01507103)
Timeframe: 18 weeks
| Intervention | subjects (Number) |
|---|
| No | Yes |
|---|
| Chemoradiotherapy | 30 | 0 |
,| Chemoradiotherapy+Tecemotide (L-BLP25) | 32 | 1 |
,| Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide | 25 | 2 |
Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)
Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells. (NCT01507103)
Timeframe: Baseline and Week 14 (post-surgery)
| Intervention | TILs per 100 tumor cells (Mean) |
|---|
| CD8+ (n=23, 27, 26) | CD8+/GrB+ (n=23, 27, 26) |
|---|
| Chemoradiotherapy | 1.538 | 0.936 |
,| Chemoradiotherapy+Tecemotide (L-BLP25) | 0.543 | 0.216 |
,| Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide | 0.609 | 0.565 |
Number of Participants With at Least One Serious Adverse Event
Evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (NCT01527149)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | 19 |
Percentage of Participants With Autologous Stem Cell Transplantation
Estimated using simple relative frequencies. The corresponding 95% confidence intervals will be computed using the method proposed in Clopper and Pearson. (NCT01527149)
Timeframe: Up to 6 weeks after the last dose of ofatumumab-chemotherapy, an average of 4 month
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | 73 |
Proportion of Patients Experiencing a Complete Response
"Evaluated according to the International Working Group Response criteria as reported by Cheson et al. and the revised Cheson criteria.~Complete response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Typically FDG-avid lymphoma: in patients with PET scan positive before therapy, a posttreatment residual mass of any size is permitted as long as it is PET negative. Variably FDG-avid lymphomas/FDG avidity unknown: in patients with a negative pretreatment PET scan, all lymph nodes and nodal masses must have regressed on CT to normal size (1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy). Previously involved nodes that were 1.1 cm to 1.5 cm in their long axis and more than 1)" (NCT01527149)
Timeframe: 22 weeks
| Intervention | Proportion of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | .62 |
Time-to-tumor Progression (TTP) at 3 Years
Estimated percentage of patients that progressed at 3 years. Time to Progression distributions obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed. (NCT01527149)
Timeframe: From baseline until objective tumor progression, as assessed up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | 76 |
Proportion of Patients Who Experience Complete Remission as Assessed by HSFCM
Established when all CR criteria are met and negative flow cytometry examination of peripheral blood and bone marrow biopsy/aspiration collected at baseline, before courses 3 and 5, within 3 weeks after course 6, on day 100 (if HDC-ASCT eligible), and then every 6 months for 3 years. (NCT01527149)
Timeframe: Up to 3 years
| Intervention | Proportion of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | .84 |
Change From Baseline in Percentage of Cells Positive for Ki67
Mean change from baseline in Percentage of Cells Positive for Ki67 by patient response. (NCT01527149)
Timeframe: Baseline and up to 3 years
| Intervention | percentage of cells positive for Ki-67 (Mean) |
|---|
| Not CR | CR |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | -2.5 | NA |
The Number of Adverse Events as a Measure of Safety and Tolerability.
Treatment-Related Adverse Events occurring in >= 15% of treated patients (NCT01527487)
Timeframe: 43 months
| Intervention | participants (Number) |
|---|
| Fatigue | Alopecia | Nausea | Peripheral Sensory Neuropathy | Neutrophil Count Decreased | Constipation | Diarrhea | Anemia | Headache | Dysgeusia | White Blood Cell Decreased | Myalgia | Hot Flashes | Mucositis | Arthralgia | Edema Limbs |
|---|
| Docetaxel+Cyclophosphamide (TC) | 14 | 14 | 8 | 10 | 6 | 6 | 10 | 8 | 4 | 5 | 5 | 6 | 3 | 5 | 8 | 8 |
,| Eribulin+Cyclophosphamide (ErC) | 32 | 25 | 26 | 18 | 21 | 15 | 11 | 12 | 9 | 8 | 8 | 7 | 7 | 5 | 2 | 2 |
Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery
One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist. (NCT01527487)
Timeframe: 18 weeks
| Intervention | percentage of surgical patients (Number) |
|---|
| Eribulin+Cyclophosphamide (ErC) | 18 |
| Docetaxel+Cyclophosphamide (TC) | 10 |
Disease-Free Survival (DFS) at 2 Years
Defined as the percent probability that participants had not experienced disease recurrence or died from any cause at 2 years post-surgery, analyzed by Kaplan-Meier methodology. (NCT01527487)
Timeframe: 24 months
| Intervention | percent probability of survival (Number) |
|---|
| Eribulin+Cyclophosphamide (ErC) | 82.35 |
| Docetaxel+Cyclophosphamide (TC) | 89.06 |
Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy
Defined as the number of patients with a best response of clinical complete or partial response (cCR or cPR) divided by the number of patients qualified for tumor response analysis per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI or CT. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; (NCT01527487)
Timeframe: 43 months
| Intervention | percentage of participants (Number) |
|---|
| Eribulin+Cyclophosphamide (ErC) | 67.6 |
| Docetaxel+Cyclophosphamide (TC) | 64.7 |
Clearance (Cl) for Doxorubicin and Cyclophosphamide
Cyclophosphamide analysis was not possible due to rapid drug degradation (NCT01537029)
Timeframe: 0-48 hours
| Intervention | L/hr (Median) |
|---|
| Doxorubicin and Cyclophosphamide | 1.85 |
Overall Survival (OS)
OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event. (NCT01539083)
Timeframe: Up to 5 years
| Intervention | months (Median) |
|---|
| Thalidomide + Prednisolone [TP Consolidation] | NA |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | NA |
Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. (NCT01539083)
Timeframe: Months 3, 6, 9 and 12
| Intervention | percentage of participants (Number) |
|---|
| Month 3 | Month 6 | Month 9 | Month 12 |
|---|
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 23.5 | 28.6 | 30.6 | 28.6 |
,| Thalidomide + Prednisolone [TP Consolidation] | 20.8 | 27.1 | 26.0 | 26.0 |
Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life. (NCT01539083)
Timeframe: Baseline, Month 12
| Intervention | units on a scale (Mean) |
|---|
| Thalidomide + Prednisolone [TP Consolidation] | 2.9 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 1.0 |
Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. (NCT01539083)
Timeframe: Months 3, 6, 9 and 12
| Intervention | percentage of participants (Number) |
|---|
| Month 3 | Month 6 | Month 9 | Month 12 |
|---|
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 36.7 | 44.9 | 52.0 | 53.1 |
,| Thalidomide + Prednisolone [TP Consolidation] | 36.5 | 44.8 | 49.0 | 51.0 |
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL). (NCT01539083)
Timeframe: Baseline, Month 12
| Intervention | units on a scale (Mean) |
|---|
| Independent Living | Relationships | Mental Health | Coping | Pain | Senses | AQoL-6D Utility score |
|---|
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.14 | 0.05 | 0.18 | 0.05 | 0.20 | 0.00 | 0.11 |
,| Thalidomide + Prednisolone [TP Consolidation] | 0.15 | 0.06 | 0.18 | 0.08 | 0.20 | 0.03 | 0.11 |
Progression Free Survival (PFS)
PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder. (NCT01539083)
Timeframe: Baseline until progressive disease (up to 5 years)
| Intervention | months (Median) |
|---|
| Thalidomide + Prednisolone [TP Consolidation] | 22.05 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 22.51 |
Disease-free Survival (DFS)
DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia). (NCT01539083)
Timeframe: Up to 5 years
| Intervention | months (Median) |
|---|
| Thalidomide + Prednisolone [TP Consolidation] | 18.53 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 13.37 |
Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12
CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours. (NCT01539083)
Timeframe: Month 12
| Intervention | percentage of participants (Number) |
|---|
| Thalidomide + Prednisolone [TP Consolidation] | 81.3 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 92.9 |
Progression Free Survival
Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria. (NCT01542255)
Timeframe: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
| Intervention | weeks (Median) |
|---|
| Single Arm | 3 |
Effect of SB-728-T on Plasma HIV-1 RNA Levels Following HAART Interruption
"Effect of SB-728-T on plasma HIV-1 RNA levels following HAART interruption. The unit is log copies/mL, except for the Cohort 1, the unit is copies/mL.~Cohort 1 mean and SD are 0. All 3 subjects had NO HIV-1 RNA DETECTED." (NCT01543152)
Timeframe: Up to 12 months after the last SB-728-T infusion
| Intervention | log copies/mL (Mean) |
|---|
| Cohort 1 - IV Cyclophosphamide 200 mg | 0 |
| Cohort 2 - IV Cyclophosphamide 0.5 g/m2 | 0.250 |
| Cohort 3 - IV Cyclophosphamide 1.0 g/m2 | 1.537 |
| Cohort 4 - IV Cyclophosphamide 2.0 g/m2 | 0.667 |
| Cohort 5 - IV Cyclophosphamide 1.5 g/m2 | 3.442 |
Treatment-emergent Adverse Events
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728-T infusion (NCT01543152)
Timeframe: 28 days after the SB-728-T infusion of the last subject in each Cohort and up to 12 months
| Intervention | participants (Number) |
|---|
| Cohort 1 - IV Cyclophosphamide 200 mg | 3 |
| Cohort 2 - IV Cyclophosphamide 0.5 g/m2 | 6 |
| Cohort 3 - IV Cyclophosphamide 1.0 g/m2 | 11 |
| Cohort 4 - IV Cyclophosphamide 2.0 g/m2 | 3 |
| Cohort 5 - IV Cyclophosphamide 1.5 g/m2 | 3 |
Change From Baseline to Month 12 in CD4+ T-cell Counts in Peripheral Blood After Repeat Treatments With SB-728-T. (i.e. Month 12 Value - Baseline Value)
Change from baseline to month 12 in CD4+ T-cell counts in peripheral blood after repeat treatments with SB-728-T. (i.e. month 12 value - baseline value) (NCT01543152)
Timeframe: Up to 12 months after the last SB-728-T infusion
| Intervention | cells 10^9/L (Mean) |
|---|
| Cohort 1 - IV Cyclophosphamide 200 mg | 0.064 |
| Cohort 2 - IV Cyclophosphamide 0.5 g/m2 | 0.149 |
| Cohort 3 - IV Cyclophosphamide 1.0 g/m2 | -0.043 |
| Cohort 4 - IV Cyclophosphamide 2.0 g/m2 | 0.153 |
| Cohort 5 - IV Cyclophosphamide 1.5 g/m2 | 0.099 |
Effect of Escalating Doses of Cyclophosphamide on SB-728-T Engraftment as Measured by CCR5 Modified CD4 Cells in Blood.
Effect of repeat doses of SB-728-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells in blood at Month 12. (NCT01543152)
Timeframe: Up to 12 months after the last SB-728-T infusion
| Intervention | cells 10^9/L (Mean) |
|---|
| Cohort 1 - IV Cyclophosphamide 200 mg | 0.038 |
| Cohort 2 - IV Cyclophosphamide 0.5 g/m2 | 0.061 |
| Cohort 3 - IV Cyclophosphamide 1.0 g/m2 | 0.143 |
| Cohort 4 - IV Cyclophosphamide 2.0 g/m2 | 0.085 |
| Cohort 5 - IV Cyclophosphamide 1.5 g/m2 | 0.079 |
Event-Free Survival (EFS)
To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis. (NCT01548573)
Timeframe: 8 years
| Intervention | () |
|---|
| Tandem Autologous Stem Cell Transplant | 0 |
Identification of Drug Resistant Genes
To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation. (NCT01548573)
Timeframe: 5 years
| Intervention | () |
|---|
| Tandem Transplant in MM <12 Mos of Prior Treatment | 0 |
Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.
To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches. (NCT01548573)
Timeframe: 2 years
| Intervention | () |
|---|
| Tandem Transplant in MM <12 Mos of Prior Treatment | 0 |
Overall Survival
To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy. (NCT01548573)
Timeframe: 10 years
| Intervention | () |
|---|
| Tandem Transplant in MM <12 Mos of Prior Treatment | 0 |
Number of Participants With Dose Limiting Toxicity (DLT) for Participants With Any Solid Tumor (Phase 1b)
For the purposes of Phase Ib dose escalation, DLTs will be defined as any treatment-related toxicity occurring within the first 21 days of combination therapy as grade 3 or 4 clinically evident non-hematologic toxicity; grade 4 neutropenia or thrombocytopenia lasting > 7 days or febrile neutropenia; or any clinically significant toxicity grade 2 or higher that requires more than 14 days to resolve. (NCT01554371)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort) | 0 |
| Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid | 0 |
Maximum Tolerated Dose (MTD) in Participants With Any Solid Tumor (Phase Ib)
Standard dose-confirmation design of 3 to 6 participants per cohort (3+3 design) was used to determine the MTD of eribulin in combination with cyclophosphamide for participants with any solid tumor. The highest dose level or MTD is reached when no more than one of six participants experience a Dose Limiting Toxicity (DLTs). A DLT is defined as any treatment-related toxicity in first 28 days of therapy with a grade 3 or 4 non-hematologic toxicity, a grade 4 neutropenia or thrombocytopenia lasting >7 days or febrile neutropenia, or any clinically significant toxicity grade 2 or higher that requires more than 14 days to resolve. The highest dose level at which no more than one of six participants experience DLT defines the MTD. (NCT01554371)
Timeframe: Up to 24 months
| Intervention | milligrams per square meter (mg/m2) (Number) |
|---|
| Eribulin | Cyclophosphamide |
|---|
| Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort) | 1.4 | 600 |
Time to Progression for Participants With Advanced Breast Cancer (Phase II)
Time to progression will be evaluated as time from first treatment to tumor progression in weeks. Disease progression will be measured using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST 1.1 criteria. (NCT01554371)
Timeframe: Up to 24 months
| Intervention | weeks (Median) |
|---|
| Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort) | 16.4 |
Overall Response Rate (ORR) for Participants With Advanced Breast Cancer (Phase II)
The ORR is defined as the proportion of participants displaying a CR or PR per RECIST criteria recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response will depend on the achievement of both measurement and confirmation criteria with CR defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter and PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (NCT01554371)
Timeframe: Up to 24 months
| Intervention | proportion of participants (Number) |
|---|
| Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort) | .131 |
Clinical Benefit Rate for Patients With Advanced Breast Cancer (ABC) (Phase II)
The clinical benefit rate is defined as the proportion of participants with confirmed complete response (CR), partial response (PR) and stable disease (SD) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Responses are determined by changes in the largest diameter of the tumor lesions and the shortest diameter in the case of malignant lymph nodes. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter, PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Only participants with measurable disease present at baseline, received at least 1 cycle of therapy, and had disease re-evaluated will be considered evaluable. (NCT01554371)
Timeframe: Up to 24 months
| Intervention | proportion of particpants (Number) |
|---|
| Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort) | .135 |
Development of Infectious Complications
The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient. (NCT01570348)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 1 |
Event-free Survival (EFS)
Defined as alive and free of active CD. Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals. (NCT01570348)
Timeframe: At 1 year post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 1 |
EFS
Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals. (NCT01570348)
Timeframe: Up to 5 years post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 1 |
Overall Survival
Characterized by the event rates as functions of all patients enrolled and at risk of the event, with exact confidence intervals. (NCT01570348)
Timeframe: Time of treatment assignment until death due to any cause, assessed up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 1 |
Incidence of Graft Rejection
Engraftment is defined as achieving > 5% donor peripheral blood CD3 T cell chimerism by day 84 after HCT. Primary graft failure is defined as a donor peripheral blood CD3 T cell chimerism peak of < 5% by Day 84 post-HCT. Secondary graft failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood CD3 T cell chimerism < 5% as demonstrated by a chimerism assay. (NCT01570348)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 0 |
Quality of Life Measured Using the Previously Validated Short Inflammatory Bowel Disease Questionnaire
(NCT01570348)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 0 |
Incidence of Disease-modifying Drugs for CD Initiated Post-transplant
Includes the administration of any therapy (drugs, biologics, or any other treatments) clearly given as immunomodulatory therapy for underlying CD. (NCT01570348)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 0 |
Disease Activity
Evaluated using a standardized tool for evaluating CD (CDAI). (NCT01570348)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 0 |
Incidence and Severity of GVHD
The grading of acute and chronic GVHD will follow previously published guidelines but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and CD involve the gastrointestinal tract, all diagnostic biopsies of these organs will be reviewed by pathologists experienced in the diagnosis of GVHD and IBD, respectively. (NCT01570348)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Allogeneic BMT) | 1 |
Overall Survival
Defined as the number of patients alive two years out from study enrollment. (NCT01581970)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Cetuximab/Low Dose Cyclophosphamide | 1 |
Aggregate Ratio of Tregs to Effector Cells for All Participants
The ratio of Tregs to effector cells (NK cells, CD 8+ lymphocytes, macrophages/monocytes) in tumor tissue as measured by immune-histochemistry (IHC) of tumor tissue for all Participants. Measure of central tendency was collected but the data is not accessible anymore because PI left institution and did not respond to requests for data. (NCT01581970)
Timeframe: 6 Weeks Post Treatment with Cyclophosphamide
| Intervention | ratio (Number) |
|---|
| Cetuximab/Low Dose Cyclophosphamide | 0.112 |
Aggregate Ratio of Tregs to Natural Killer (NK) Cells for All Participants
the Ratio of Tregs to NK cells in peripheral blood as measured by flow cytometry for all Participants. Measure of central tendency was collected but the data is not accessible anymore because the PI left institution and did not respond to requests for data. (NCT01581970)
Timeframe: 6 Weeks Post Treatment with Cyclophosphamide
| Intervention | ratio (Number) |
|---|
| Cetuximab/Low Dose Cyclophosphamide | 2.443 |
Progression
The number of patients without disease progression two years out from study enrollment. Progression of disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is as at least a 20% increase in size of the lesion(s) being followed and/or the appearance of one or more new lesions. (NCT01581970)
Timeframe: At 2 Years
| Intervention | Participants (Count of Participants) |
|---|
| Cetuximab/Low Dose Cyclophosphamide | 1 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01583686)
Timeframe: Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
| Intervention | Participants (Count of Participants) |
|---|
| Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2 | 3 |
| Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2 | 3 |
| Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2 | 3 |
| Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2 | 3 |
| Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2 | 3 |
Number of Patients With Serious and Non-serious Adverse Events
Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence. (NCT01585428)
Timeframe: 51 months and 18 days
| Intervention | Participants (Count of Participants) |
|---|
| Cervical | 18 |
| NonCervical | 11 |
Overall Survival (OS)
(NCT01593020)
Timeframe: from start of treatment, up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Paclitaxel Weekly for 12 Doses Followed by FAC/FEC | 100 |
| Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC | 84.4 |
Pathologic Complete Response (pCR)
Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response. (NCT01593020)
Timeframe: 4 -6 weeks from last dose of FAC/FEC-regimen.
| Intervention | Participants (Count of Participants) |
|---|
| Paclitaxel Weekly for 12 Doses Followed by FAC/FEC | 7 |
| Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC | 1 |
5 Year Event Free Survival (EFS)
Event free survival (EFS) the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay. (NCT01593020)
Timeframe: from start of treatment, up to 5 years
| Intervention | percentage of participants (Number) |
|---|
| Paclitaxel Weekly for 12 Doses Followed by FAC/FEC | 81.8 |
| Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC | 74 |
Minimum Residual Disease (MRD) Levels Present at End of Cycle 1 Therapy in Patients
"MRD positive is defined as > or = to 0.1% MRD MRD negative is define as < 0.1% MRD~All these analyses will be descriptive and exploratory and hypotheses generating in nature." (NCT01614197)
Timeframe: Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| MRD positive | MRD negative |
|---|
| Dose Level 1 | 3 | 0 |
,| Dose Level 2 | 2 | 1 |
,| Dose Level 3 | 5 | 1 |
,| Dose Level 4 | 2 | 1 |
Disease-Free Survival (DFS)
Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported. (NCT01621477)
Timeframe: one year post transplant
| Intervention | participants (Number) |
|---|
| Treatment | 7 |
Event-Free Survival (EFS)
Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported. (NCT01621477)
Timeframe: one year post transplant
| Intervention | participants (Number) |
|---|
| Treatment | 4 |
Incidence and Severity of Chronic Graft Versus Host Disease (GVHD)
The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity. (NCT01621477)
Timeframe: 100 days post transplant
| Intervention | participants (Number) |
|---|
| No Chronic GVHD | Mild | Moderate | Severe |
|---|
| Treatment | 15 | 0 | 2 | 0 |
Incidence of Malignant Relapse
Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease. (NCT01621477)
Timeframe: One year post transplantation.
| Intervention | participants (Number) |
|---|
| Treatment | 10 |
Incidence and Severity of Acute Graft Versus Host Disease (GVHD)
The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe. (NCT01621477)
Timeframe: 100 days post transplant
| Intervention | participants (Number) |
|---|
| No Acute GVHD | Grade I | Grade II | Grade III | Grade IV |
|---|
| Treatment | 9 | 3 | 1 | 3 | 1 |
One-year Survival (OS)
Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given. (NCT01621477)
Timeframe: One year post transplant
| Intervention | participants (Number) |
|---|
| Treatment | 7 |
Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT01632150)
Timeframe: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide | 62.5 |
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT01632150)
Timeframe: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone | 55.0 |
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. (NCT01632150)
Timeframe: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone | 57.5 |
Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity. (NCT01632150)
Timeframe: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide | 65.0 |
Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II)
(NCT01640301)
Timeframe: Up to 1 year following infusion per patient
| Intervention | Participants (Count of Participants) |
|---|
| Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) | 0 |
Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I)
(NCT01640301)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 (Avelumab and MHC Class I Up-regulation) | 6 |
Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II)
"Response is assessed throughout the 1 year post treatment timeframe. Morphologic criteria for response:~Complete Response (CR) = Bone Marrow blasts <5%; no blasts with Auer rods; no extramedullary disease. Transfusion independent.~Platelets ≥ 100,000/μl Absolute neutrophil count >1000/μl (CRi: incomplete hematologic recovery CRp: incomplete platelet recovery)~Partial Response (PR) = Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow and the normalization of blood counts as for CR. (PRi and PRp if incomplete hematologic or platelet recovery)~Stable Disease (SD) = Failure to achieve at least PR, but no evidence of progression for >4 weeks." (NCT01640301)
Timeframe: Up to 1 year
| Intervention | days (Median) |
|---|
| Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) | 28 |
Incidence of Relapse After T Cell Therapy (Arm II)
(NCT01640301)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) | 9 |
Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II)
(NCT01640301)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) | 8 |
Maintenance of Function of Transduced T Cells (Arm I)
(NCT01640301)
Timeframe: Up to 28 days post intervention per patient
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 (Avelumab and MHC Class I Up-regulation) | 9 |
Maintenance of T Cell Receptor (TCR) Expression of Transduced T Cells (Arm I) i.e. Persistence
(NCT01640301)
Timeframe: Up to 28 days post intervention per patient
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 (Avelumab and MHC Class I Up-regulation) | 12 |
Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I)
(NCT01640301)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 (Avelumab and MHC Class I Up-regulation) | 1 |
Disease-free Survival After T Cell Therapy
(NCT01640301)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (High-risk for Relapse After HCT) | 13 |
| Arm II (Relapsed After HCT) | 7 |
Percentage of Participants With Overall Response (OR)
Overall response (OR) is defined as the patient being alive at month 12, and tumor size evaluated at screening and at month 12 using the RECIST 1.1 criteria to be a complete response (CR) or partial response (PR). Evaluations will be made by CT scan approximately 12 months from the date of tumor harvest, and by clinical evaluation during the first 12 months (NCT01659151)
Timeframe: 12 Months
| Intervention | percentage of participants (Number) |
|---|
| Combination Therapy | 38 |
Number of Participants With Progression Free Survival (PFS)
Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Confidence intervals for the median and survival rates at different time points will be constructed if needed and appropriate. This secondary endpoint will be reported descriptively. (NCT01659151)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Combination Therapy | 7 |
Percentage of Participant Drop Out Rate
"The percentage of participants who drop out due to progression between the time of harvest and TIL transfer (i.e., the drop-out rate)." (NCT01659151)
Timeframe: Up to 12 months
| Intervention | percentage of participants (Number) |
|---|
| Combination Therapy | 6 |
Percentage of Participants With Overall Hematologic Response
Overall hematologic response was defined as the percentage of participants with complete response (CR), very good partial response (VGPR) and partial response (PR) based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as assessed by an adjudication committee. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of free light chain (FLC) ratio. VGPR: differential free light chain (difference between involved and uninvolved FLC levels; dFLC) < 40 mg/L. PR: ≥50% reduction in dFLC. Percentages were rounded off to the nearest decimal. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Ixazomib + Dexamethasone | 53 |
| Arm B: Dexamethasone + Melphalan | 58 |
| Arm B: Dexamethasone + Cyclophosphamide | 30 |
| Arm B: Dexamethasone + Thalidomide | 50 |
| Arm B: Dexamethasone + Lenalidomide | 51 |
Percentage of Participants With Complete Hematologic Response
Complete hematologic response was defined as the percentage of participants with CR based on central laboratory results and the 2010 ISA Consensus Criteria as assessed by the investigator. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of FLC ratio. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Ixazomib + Dexamethasone | 30 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 17 |
Percentage of Participants With Best Vital Organ (Cardiac and/or Kidney) Response
Vital organ (heart and kidney) response rate was defined as the percentage of participants who achieved vital organ response according to central laboratory results and ISA criteria as evaluated by an adjudication committee. A vital organ response was defined as response of 1 or 2 of the involved vital organs with no change from Baseline in the rest of involved vital organs. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Ixazomib + Dexamethasone | 19 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 12 |
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | 69.55 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 43.17 |
Number of Participants With Serious Adverse Events (SAEs)
A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or medically important event. (NCT01659658)
Timeframe: From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months)
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: Ixazomib + Dexamethasone | 44 |
| Arm B: Dexamethasone + Melphalan | 11 |
| Arm B: Dexamethasone + Cyclophosphamide | 2 |
| Arm B: Dexamethasone + Thalidomide | 0 |
| Arm B: Dexamethasone + Lenalidomide | 17 |
Number of Hospitalizations
A hospitalization was defined as at least one overnight stay in an intensive care unit and/or non-intensive care unit. If a single hospitalization included both an intensive care unit stay and a non-intensive care unit stay, the hospitalization was counted only once (as an intensive care unit stay). The mean number of hospitalizations is reported in this outcome measure. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | hospitalizations (Mean) |
|---|
| Arm A: Ixazomib + Dexamethasone | 1.8 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 1.4 |
Hematologic Disease Progression Free Survival
Hematologic disease PFS was defined as the time from the date of randomization to the date of first documentation of hematologic PD according to central laboratory results and ISA criteria as evaluated by an adjudication committee, or death due to any cause, whichever occurred first. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | 29.50 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 27.73 |
EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analogue Scale Score
The EQ visual analogue scale (VAS) records the participant's self-rated health on a 20 centimeter vertical VAS that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the value collected at the time closest to, but prior to, the start of study drug administration. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: At Week 28 of the OS follow-up
| Intervention | score on a scale (Mean) |
|---|
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 23.0 |
Duration of Hematologic Response
Duration of hematologic response (DOR) was defined as the time from the date of first documentation of a hematologic response to the date of first documented hematologic disease progression as determined by the investigator. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From time of first documented response to disease progression (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | NA |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 21.19 |
Change From Baseline in SF-36 Physical Component Summary Score at Week 28 of the PFS Follow-up
SF-36 Version 2 is a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100, where higher scores are associated with less disability and better quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: Baseline, Week 28 of the PFS Follow-up
| Intervention | score on a scale (Mean) |
|---|
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 10.3 |
Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Score at Week 28 of the PFS Follow-up
The FACT/GOG-Ntx is a participant completed questionnaire that comprises 11 individual items evaluating symptoms of neurotoxicity on a 5-point scale where: 0=not at all (best) to 4=very much for a total possible score of 0 to 44. Symptom scores are inverted so that higher scores of FACT/GOG-Ntx indicate higher quality of life or functioning. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: Baseline, Week 28 of the PFS Follow-up
| Intervention | score on a scale (Mean) |
|---|
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 0.0 |
Change From Baseline in Amyloidosis Symptom Scale Total Score at Week 28 of the PFS Follow-up
The amyloidosis symptom scale questionnaire is a participant completed questionnaire that evaluates symptom severity of 3 symptoms: Swelling, Shortness of Breath and Dizziness, each rated on an 11-point scale where: 0=no symptoms to 10=very severe symptoms. Higher scores indicate worsening of symptoms. Total Score is the sum of all responses from the amyloidosis symptom scale ranging from 0 to 30. Higher scores represent higher levels of symptomatology or problems and a negative change from baseline indicates improvement. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: Baseline, Week 28 of the PFS Follow-up
| Intervention | score on a scale (Mean) |
|---|
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | -16.0 |
2-Year Vital Organ (Heart or Kidney) Deterioration and Mortality Rate
Cardiac (Heart) deterioration was defined as the need for hospitalization for heart failure. Kidney deterioration was defined as progression to end-stage renal disease (ESRD) with the need for maintenance dialysis or renal transplantation. Vital organ deterioration was evaluated by an adjudication committee. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Ixazomib + Dexamethasone | 47 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 54 |
Vital Organ Progression Free Survival
Vital organ PFS is defined as the time from the date of randomization to the date of first documentation of progression of vital organ (heart or kidney) according to central laboratory results and ISA criteria as evaluated by an adjudication committee, or death due to any cause, whichever occurs first. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | 15.77 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 11.01 |
Plasma Concentration of Ixazomib
As prespecified in the protocol, data for this outcome measure was planned to be collected for ixazomib arm group only. (NCT01659658)
Timeframe: Cycle 1, Day 1: 1, 4 hours postdose, Day 14: 144 hours postdose; Cycle 2, Day 1: predose, Day 14: 144 hours postdose; Cycles 3 to 10, Day 1: predose (cycle length=28 days)
| Intervention | nanogram per milliliter (ng/mL) (Geometric Mean) |
|---|
| Cycle 1 Day 1: 1 Hour Post-dose | Cycle 1 Day 14: 4 Hours Post-dose | Cycle 1 Day 14: 144 Hours Post-dose | Cycle 2 Day 1: Pre-dose | Cycle 2 Day 14: 144 Hours Post-dose | Cycle 3 Day 1: Pre-dose | Cycle 4 Day 1 Pre-dose | Cycle 5 Day 1 Pre-dose | Cycle 6 Day 1: Pre-dose | Cycle 7 Day 1: Pre-dose | Cycle 8 Day 1: Pre-dose | Cycle 9 Day 1: Pre-dose | Cycle 10 Day 1: Pre-dose |
|---|
| Arm A: Ixazomib + Dexamethasone | 16.518 | 10.652 | 3.875 | 2.000 | 4.726 | 2.187 | 2.276 | 2.264 | 2.235 | 2.299 | 2.038 | 2.143 | 2.232 |
Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score
The European Quality of Life (EuroQOL) 5-Dimensional (EQ-5D) is a patient completed questionnaire consisting of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 3 possible choices: no problems to extreme problems. Higher scores=worsening of the quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: At Week 28 of the OS follow-up
| Intervention | Participants (Count of Participants) |
|---|
| Mobility: No Problems in Walking About | Mobility: Some Problem in Walking About | Mobility: Confined to Bed | Self-Care: No Problems With Self- Care | Self-Care: Some Problems Washing or Dressing | Self-Care: Unable to Wash or Dress | Usual Activities: No Problems With Performing Usual Activities | Usual Activities: Some Problem With Performing Usual Activities | Usual Activities: Unable to Performing Usual Activities | Pain/Discomfort: No Pain or Discomfort | Pain/Discomfort: Moderate Pain or Discomfort | Pain/Discomfort: Extreme Pain or Discomfort | Anxiety/Depression: Not Anxious or Depressed | Anxiety/Depression: Moderately Anxious or Depressed | Anxiety/Depression: Extremely Anxious or Depressed |
|---|
| Arm A: Ixazomib + Dexamethasone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
Time to Vital Organ (Heart or Kidney) Deterioration and Mortality Rate
Time to vital organ deterioration or death was assessed by the investigator and defined as the time from randomization to vital organ (heart or kidney) deterioration or death, whichever occurs first. Cardiac deterioration is defined as the need for hospitalization for heart failure. Kidney deterioration is defined as progression to ESRD with the need for maintenance dialysis or renal transplantation. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From randomization to time of vital organ deterioration or death (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | 38.67 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 26.09 |
Time To Treatment Failure (TTF)
TTF was defined as the time from randomization to the date of first documented treatment failure. Treatment failure was defined as: 1) death due to any cause; 2) hematologic progression or major organ progression according to central laboratory results and ISA criteria as evaluated by the investigator; 3) clinically morbid organ disease requiring additional therapy; or 4) withdrawn for any reason. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | 10.32 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 5.32 |
Time To Subsequent Anticancer Treatment
Time to subsequent anticancer therapy was defined as the time from randomization to the first date of subsequent anticancer therapy. Participants without subsequent anticancer therapy were censored at the date of death or last known to be alive. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until subsequent anticancer treatment (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | 26.48 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 12.45 |
Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of hematologic disease progression, or organ (cardiac or renal) progression, or death due to any cause, whichever occurred first according to central laboratory results and ISA criteria as evaluated by the investigator. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. (NCT01659658)
Timeframe: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months)
| Intervention | months (Median) |
|---|
| Arm A: Ixazomib + Dexamethasone | 11.86 |
| Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | 7.62 |
Rate of Pathologic Complete Response (pCR)
Pathologic complete response (pCR) rate (determined by the Miller-Payne method) in doxorubicin-cyclophosphamide vs cisplatin arms. (NCT01670500)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| Doxorubicin-Cyclophosphamide | 26 |
| Cisplatin | 18 |
Clinical Response Rate
"Clinical response rate, defined as the number of partial and complete responses, after preoperative therapy with either cisplatin or AC in participants with germline BRCA mutation and breast cancer.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or ultrasound: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT01670500)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Doxorubicin-Cyclophosphamide | 43 |
| Cisplatin | 45 |
Rate of Residual Cancer Burden (RCB) 0/1
Residual Cancer Burden (RCB) rate of RCB 0 or 1 in participants receiving Doxorubicin-Cyclophosphamide vs participants receiving Cisplatin. (NCT01670500)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Doxorubicin-Cyclophosphamide | 46 |
| Cisplatin | 33 |
Rate of Miller Payne 4 and 5
"Rates of Miller Payne 4 (near pCR) and 5 (near pCR) combined between those subjects who received neoadjuvant cisplatin and those who received neoadjuvant AC.~Definitions:~Miller Payne 4: a marked disappearance of tumor cells (more than 90%) such that only small clusters or widely dispersed individual cells remain (almost pCR);~Miller Payne 5: no malignant cells identifiable in sections from the site of the tumor (pCR)" (NCT01670500)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Doxorubicin-Cyclophosphamide | 30 |
| Cisplatin | 22 |
Number of Grade 3 and Grade 4 Adverse Events
Comparison of toxicities for cisplatin and AC preoperative chemotherapy in BRCA mutation carriers with newly diagnosed breast cancer, reported as number of all Grade 3 and 4 adverse events and number of non-hematologic Grade 3 and 4 adverse events. (NCT01670500)
Timeframe: 2 years
| Intervention | Adverse Events (Number) |
|---|
| All Grade 3 & 4 Adverse Events | Non-hematologic Grade 3 & 4 Adverse Events |
|---|
| Cisplatin | 16 | 11 |
,| Doxorubicin-Cyclophosphamide | 15 | 4 |
Incidence of Febrile Neutropenia
Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy. (NCT01671319)
Timeframe: Up to 10 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Dose Dense TC + Pegfilgrastim | 1 |
Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy
Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks. (NCT01671319)
Timeframe: 4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks
| Intervention | participants (Number) |
|---|
| Dose Dense TC + Pegfilgrastim | 37 |
Number of Subjects Reporting Adverse Events
Count of subjects with incidences of adverse events. (NCT01675765)
Timeframe: From first study dose until 28 days after the final dose (an average of 44 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Immunotherapy Plus Chemotherapy | 38 |
| Immunotherapy With Cyclophosphamide Plus Chemotherapy | 22 |
Objective Tumor Response
Objective tumor response was measured using modified Response Evaluation Criteria in Solid Tumors (mRECIST) for assessment of response in malignant pleural mesothelioma (MPM). Per mRECIST for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, those who fulfilled the criteria for neither PR nor PD; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions. (NCT01675765)
Timeframe: Baseline to measured disease progression or death (up to 12 months or longer)
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease | Not Assessable |
|---|
| Immunotherapy Plus Chemotherapy | 1 | 19 | 14 | 1 | 1 |
,| Immunotherapy With Cyclophosphamide Plus Chemotherapy | 0 | 11 | 8 | 2 | 0 |
Number of Participant Who Were Alive at 7 Years Post Transplant
Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive. (NCT01685411)
Timeframe: 7 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 1 |
Percentage of Participants With Chronic Graft-Versus-Host Disease
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT01685411)
Timeframe: 6 Months
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 0 |
Percentage of Participants With Chronic Graft-Versus-Host Disease
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT01685411)
Timeframe: 1 Year
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 0 |
Number of Participant Who Were Alive at 5 Years Post Transplant
Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive. (NCT01685411)
Timeframe: 5 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 3 |
Count of Participants Who Achieved Neutrophil Engraftment
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater. (NCT01685411)
Timeframe: By Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 5 |
Percentage of Participants With Relapse
The return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 1 Year
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 40 |
Count of Participants With Disease Free Survival
The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 5 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 1 |
Count of Participants With Disease Free Survival
The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 7 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 1 |
Percentage of Participants With Engraftment Failure
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets. (NCT01685411)
Timeframe: Day 42
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 0 |
Percentage of Participants With Relapse
The return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 2 Years
| Intervention | percentage of participants (Number) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 40 |
Number of Participant Who Were Alive at 2 Years Post Transplant
Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive. (NCT01685411)
Timeframe: 2 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 4 |
Counts of Participants With Disease Free Survival
The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 2 Years
| Intervention | Participants (Count of Participants) |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 3 |
Percentage of Participants With Acute Graft-Versus-Host Disease by Grade
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT01685411)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| Grade 2-4 | Grade 3-4 |
|---|
| Allogeneic Hematopoietic Stem Cell Transplant | 40 | 20 |
Proportion of Patients With Severe Acute Graft Versus Host Disease
(NCT01690520)
Timeframe: Up to 100 days post-transplant
| Intervention | proportion of participants (Number) |
|---|
| Arm I (Standard of Care) | 0.14 |
| Arm II (Experimental) | 0.16 |
Non-relapse Mortality
(NCT01690520)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Standard of Care) | 16 |
| Arm II (Experimental) | 16 |
Overall Survival
(NCT01690520)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Standard of Care) | 52 |
| Arm II (Experimental) | 57 |
Time to Platelet Engraftment (20k)
First day of seven consecutive days with platelet count equal to or greater than 20,000 cells/microliter without platelet transfusions measured from day of transplant. (NCT01690520)
Timeframe: Up to 100 days post-transplant
| Intervention | days (Median) |
|---|
| Arm I (Standard of Care) | 40.0 |
| Arm II (Experimental) | 38.0 |
Proportion of Participants With Chronic Graft Versus Host Disease
(NCT01690520)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Standard of Care) | 27 |
| Arm II (Experimental) | 23 |
Time to Neutrophil Engraftment
First of two consecutive days with absolute neutrophil count (ANC) equal to or greater than 500 cell/microliter measured from day of transplant. (NCT01690520)
Timeframe: Up to 55 days post-transplant
| Intervention | days (Median) |
|---|
| Arm I (Standard of Care) | 20.0 |
| Arm II (Experimental) | 22.0 |
Pathological Complete Responses
Number of participants with pathological complete response (pCR) (NCT01696877)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Degarelix | 0 |
| Cyclophosphamide, GVAX and Degarelix | 0 |
Intraprostatic CD8+ T Cell Infiltration
CD8+ T cell infiltration (quantified as log[CD8 density]) into the prostate from harvested prostate glands in men with localized prostate cancer receiving neoadjuvant Androgen deprivation therapy alone (2 weeks prior to surgery), or cyclophosphamide and GVAX followed by Androgen deprivation therapy, (with cyclophosphamide/GVAX administered 4 weeks prior to prostatectomy, and Androgen deprivation therapy administered 2 weeks prior to prostatectomy). (NCT01696877)
Timeframe: 2 years
| Intervention | log10 (cells/mm^2) (Mean) |
|---|
| Degarelix | 204.81 |
| Cyclophosphamide, GVAX and Degarelix | 263.33 |
Prostate-specific Antigen Response Rate
Number of participants with Prostate-specific antigen response (NCT01696877)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Degarelix | 13 |
| Cyclophosphamide, GVAX and Degarelix | 11 |
Percentage of Participants Without Prostate Specific Antigen Recurrence at 24 Months After Surgery
Percentage of participants in each arm who were free of prostate specific antigen recurrence (i.e. prostate specific antigen remained undetectable after prostatectomy) at 24 months after undergoing surgery. (NCT01696877)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Degarelix | 38 |
| Cyclophosphamide, GVAX and Degarelix | 66 |
3-year Overall Survival Rate of Patients With Relapsed ALL
Estimate the 3-year survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy. (NCT01700946)
Timeframe: 3 years of follow-up since the on-study date
| Intervention | percentage of participants (Number) |
|---|
| STANDARD RISK | 94.4 |
| HIGH RISK | 55.5 |
| All Patients Enrolled on the Study | 72.63 |
Mean of CD20 Expression Levels
To estimate mean levels of CD20 expression at baseline, during treatment with dexamethasone-containing chemotherapy and following rituximab treatment in Block I of remission induction therapy for relapsed precursor B-cell ALL. (NCT01700946)
Timeframe: Baseline and at the end of Block I (approximately 5 weeks after the on-study date)
| Intervention | percentage of CD20 Antigen (Mean) |
|---|
| At Baseline | At Block I |
|---|
| All Patients Enrolled on the Study | 36.23 | 19.43 |
,| HIGH RISK | 39.82 | 20.10 |
,| STANDARD RISK | 31.10 | 18.54 |
3-year Event-free Survival Rates in Patients With Relapsed ALL
Estimate the 3-year event-free survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy. (NCT01700946)
Timeframe: 3 years of follow-up since the on-study date
| Intervention | percentage of participants (Number) |
|---|
| STANDARD RISK | 83.3 |
| HIGH RISK | 55.7 |
| All Patients Enrolled on the Study | 67.83 |
Progression Free Survival (PFS)
Progression-free survival (PFS) per RECIST V1.1, defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions. (NCT01701674)
Timeframe: 42 months
| Intervention | months (Median) |
|---|
| Experimental: Combination Therapy | 7.4 |
Occurrence of Dose Limiting Toxicity (DLT) Events
Occurrence of adverse events with dose limiting toxicity, per adverse event category. (NCT01701674)
Timeframe: 3 months
| Intervention | DLT events (Number) |
|---|
| Eye-related: Uveitis | Gastrointestinal: Colitis |
|---|
| Experimental: Combination Therapy | 1 | 1 |
Rate of Meeting Feasibility Requirements
Number of participants who were successfully treated with at least 2 doses of ipilimumab and received TIL. Feasibility is defined as the ability to deliver at least 50% (i.e., two out of four) of the planned doses of ipilimumab and successfully treat at least 60% (i.e., ≥ 6/10) of the patients with TIL. (NCT01701674)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Experimental: Combination Therapy | 12 |
Overall Response Rate (ORR)
Overall Response: Complete Response (CR) + Partial Response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by computed tomography (CT) scan. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions.. (NCT01701674)
Timeframe: 12 weeks
| Intervention | percentage of participants (Number) |
|---|
| Experimental: Combination Therapy | 38.5 |
Clinical Overall Response (cOR)(Complete and Partial) Assessed by MRI at the Completion of WP or Eribulin (Before AC)
Percentage of patients with clinical complete response (no significant enhancement on MR images) or clinical partial response (at least 30% decrease in the maximal diameter of the tumor) (NCT01705691)
Timeframe: 12 weeks after initiation of study therapy
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Paclitaxel Then AC | 58 |
| Arm 2: Eribulin Then AC | 40 |
Clinical Complete Response (ycCR) Following Neoadjuvant Therapy Assessed by Physical Exam at the Completion of Neoadjuvant Chemotherapy
The number of patients with clinical complete response. (NCT01705691)
Timeframe: At approximately 24 to 28 weeks from initiation of study therapy
| Intervention | participants (Number) |
|---|
| Arm 1: Paclitaxel Then AC | 8 |
| Arm 2: Eribulin Then AC | 10 |
Adverse Events Experienced by Participants as a Measure of Toxicity.
Total patients with at least 1 AE. (NCT01705691)
Timeframe: Assessed through 24 months from randomization
| Intervention | participants (Number) |
|---|
| Arm 1: Paclitaxel Then AC | 19 |
| Arm 2: Eribulin Then AC | 30 |
2-year Overall Survival (OS): Death From Any Cause From Time of Randomization Through 2 Years After Randomization.
Percentage of patients alive at 24 months. (NCT01705691)
Timeframe: Assessed through 24 months from randomization
| Intervention | percentage of patients (Number) |
|---|
| Arm 1: Paclitaxel Then AC | 88.5 |
| Arm 2: Eribulin Then AC | 92.6 |
ypCR Nodes
Percentage of patients with no histologic evidence of cancer in axillary lymph nodes. (NCT01705691)
Timeframe: At the time of surgery approximately 24 to 28 weeks.
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Paclitaxel Then AC | 42.1 |
| Arm 2: Eribulin Then AC | 30.0 |
Recurrence Free Interval (RFI): The Time to Occurrence of Inoperable Progressive Disease and Local, Regional, and Distant Recurrence.
The percentage of patients free from recurrence at 24 months. (NCT01705691)
Timeframe: Assessed through 24 months from randomization
| Intervention | percentage of patients (Number) |
|---|
| Arm 1: Paclitaxel Then AC | 83.6 |
| Arm 2: Eribulin Then AC | 80.7 |
Pathologic Complete Response Rate (ypCR) Following Neoadjuvant Therapy in Breast and Axillary Lymph Nodes
Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes. (NCT01705691)
Timeframe: At the time of surgery approximately 24 to 28 weeks.
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Paclitaxel Then AC | 26.3 |
| Arm 2: Eribulin Then AC | 16.7 |
Survival Time
The distribution of survival time will be estimated by arm using the method of Kaplan-Meier. (NCT01706666)
Timeframe: From registration to death due to any cause, assessed up to 3 years
| Intervention | Months to death (Number) |
|---|
| Arm A | NA |
| Arm B | NA |
| Arm C | NA |
Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months
Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry. (NCT01706666)
Timeframe: 24 months
| Intervention | percentage of participants (Number) |
|---|
| Arm A | 100 |
| Arm B | 0 |
| Arm C | 100 |
Progression-free Survival
The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier. (NCT01706666)
Timeframe: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
| Intervention | Months to Progression (Number) |
|---|
| Arm A | NA |
| Arm B | 9.2 |
| Arm C | NA |
Cumulative Incidence of Grade III-IV Acute GVHD
Determined by the standard bone marrow transplant (BMT) Clinical Trials Network criteria (BMTCTN). Will be analyzed using KM method, a Graft versus Host Disease (GVHD) grade III-IV will be obtained from the KM estimates along with 95% confidence intervals. (NCT01707004)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| Decitabine + Bone Marrow Transplant | 27.8 |
Number of Participants With Complete Remission After Transplantation
(NCT01707004)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Decitabine + Bone Marrow Transplant | 14 |
Overall Survival (OS)
Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals. (NCT01707004)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| Decitabine + Bone Marrow Transplant | 64.7 |
Percentage of Participants With Platelet Recovery by Day 30
Platelet recovery is defined as the first day of a platelet count greater than 20,000/mm^3 with no platelet transfusions. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05. (NCT01707004)
Timeframe: Up to day 30
| Intervention | percentage with plt engraftment, day 30 (Number) |
|---|
| Decitabine + Bone Marrow Transplant | 58 |
Progression Free Survival
(NCT01707004)
Timeframe: Up to 1 year
| Intervention | days (Median) |
|---|
| Decitabine + Bone Marrow Transplant | 141 |
Number of Participants With Primary Graft Failure
Defined as less than 5% donor chimerism in the cluster of differentiation (CD)3 and CD33 selected cell populations at any time after transplantation. Will be analyzed using KM method. (NCT01707004)
Timeframe: Day 30
| Intervention | Participants (Count of Participants) |
|---|
| Decitabine + Bone Marrow Transplant | 0 |
Time to Neutrophil Recovery
Defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/ul for three consecutive measurements on different days. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05. (NCT01707004)
Timeframe: Up to 1 year
| Intervention | days (Mean) |
|---|
| Decitabine + Bone Marrow Transplant | 16 |
Cumulative Incidence of Chronic GVHD According to BMTCTN
Will be summarized with a proportion and a 95% confidence interval. (NCT01707004)
Timeframe: Up to 1 year
| Intervention | percentage (Number) |
|---|
| Decitabine + Bone Marrow Transplant | 40.7 |
Overall Response Rate
Analysis of the other Secondary Endpoints: The overall response rate will be estimated by the number of patients with complete and partial responses divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 6 cycles
| Intervention | Percentage of Participants (Number) |
|---|
| FCR With Lenalidomide | 95 |
Complete Response
Analysis of the Primary Endpoint: The complete responses will be estimated by the number of patients with CR divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 4 cycles
| Intervention | Percentage of Participants (Number) |
|---|
| FCR With Lenalidomide | 45 |
Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)
| Intervention | units on a scale (Mean) |
|---|
| Expectations of therapy domain | Feelings about side effects domain | Satisfaction with therapy domain |
|---|
| Rituximab Intravenous (IV) | 80.88 | 60.63 | 84.59 |
,| Rituximab Subcutaneous (SC) | 82.07 | 61.64 | 85.42 |
Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
| Intervention | percentage of participants (Number) |
|---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Interim staging | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Final staging | Follow-up, 6 months | Follow-up, 12 months | End of study/early treatment termination |
|---|
| Arm A | 11.4 | 7.0 | 7.1 | 7.0 | 9.0 | 12.5 | 16.0 | 23.8 | 13.3 | 10.0 | 6.5 | 7.7 | 3.5 |
,| Arm B | 15.6 | 18.2 | 23.5 | 14.7 | 9.7 | 10.2 | 11.6 | 10.9 | 11.0 | 12.6 | 13.4 | 8.7 | 6.3 |
Rituximab Administration Satisfaction Questionnaire (RASQ) Score
The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)
| Intervention | units on a scale (Mean) |
|---|
| Physical impact domain | Psychological Impact domain | Impact on activitiesf daily living | Convenience domain | Satisfaction domain |
|---|
| Rituximab Intravenous (IV) | 82.14 | 77.73 | 59.49 | 59.05 | 74.88 |
,| Rituximab Subcutaneous (SC) | 82.08 | 84.00 | 81.86 | 81.05 | 87.26 |
Progression-free Survival (PFS)
PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
| Intervention | months (Median) |
|---|
| Arm A | NA |
| Arm B | NA |
Summary of Observed Serum Rituximab Concentration
(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
| Intervention | microgram per milliter (Mean) |
|---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Interim staging | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Final staging | Follow-up, 6 months | Follow-up, 12 months | End of study/early treatment termination |
|---|
| Arm A | 3355.9 | 25053.1 | 62977.0 | 87956.6 | 117273.6 | 108030.9 | 100927.7 | 95614.0 | 104873.0 | 86806.6 | 7802.9 | 2380.1 | 9302.0 |
,| Arm B | 970.1 | 24541.1 | 46093.9 | 59485.5 | 77665.3 | 70387.3 | 98679.7 | 117172.0 | 137048.1 | 120995.7 | 8042.9 | 1685.3 | 9553.9 |
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
| Intervention | months (Median) |
|---|
| Arm A | NA |
| Arm B | NA |
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. (NCT01724021)
Timeframe: Cycle 8 (Up to 32 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Arm A | 77.1 |
| Arm B | 84.2 |
Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01724021)
Timeframe: Randomization of first participant to clinical cutoff date (Up to 4 years)
| Intervention | participants (Number) |
|---|
| Arm A | 352 |
| Arm B | 347 |
Event-free Survival (EFS)
EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
| Intervention | months (Median) |
|---|
| Arm A | NA |
| Arm B | NA |
Percentage of Participants With Anti-Rituximab Antibodies Over Time
(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
| Intervention | percentage of participants (Number) |
|---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Interim staging | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Final staging | Follow-up, 6 months | Follow-up, 12 months | End of study/early treatment termination |
|---|
| Arm A | 2.0 | 2.1 | 0.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 2.1 | 0.6 |
,| Arm B | 3.0 | 2.2 | 0.9 | 0.3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 0.6 |
Disease-free Survival (DFS)
DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
| Intervention | months (Median) |
|---|
| Arm A | NA |
| Arm B | NA |
Complete Response (CR) Rate
CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. (NCT01724021)
Timeframe: 28 days (± 3 days) after Day 1 of the last dose of induction treatment
| Intervention | percentage of participants (Number) |
|---|
| Arm A | 49.2 |
| Arm B | 52.7 |
Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion (NCT01724021)
Timeframe: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
| Intervention | minutes (Median) |
|---|
| Rituximab Intravenous (IV) | 840 |
| Rituximab Subcutaneous (SC) | 22 |
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. (NCT01724021)
Timeframe: Cycle 6 (Up to 24 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Arm A | 79.1 |
| Arm B | 80.6 |
Duration of DSN in Cycle 2
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 2. (NCT01724866)
Timeframe: Cycle 2 (each cycle was 21 days)
| Intervention | days (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 0.46 |
| Arm 2: SPI-2012 135 µg/kg and TC | 0.12 |
| Arm 3: SPI-2012 270 µg/kg and TC | 0.03 |
| Arm 4: Pegfilgrastim and TC | 0.08 |
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities
"An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Participants with SAE other than death were reported.AE and Laboratory Abnormalities (Hematology and Chemistry) were collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated and Grade 4 refers to life-threatening consequences; urgent intervention indicated." (NCT01724866)
Timeframe: From the first dose up to 30 days post last dose of study drug (up to 4 months)
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3-4 TEAEs | Death | SAEs Other Than Death | TEAEs Leading to Discontinuation From Study Therapy | Grade 3-4 Lab Abnormalities: Hematology | Grade 3-4 Lab Abnormalities: Chemistry |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 24 | 0 | 5 | 0 | 33 | 8 |
,| Arm 2: SPI-2012 135 µg/kg and TC | 12 | 0 | 4 | 2 | 19 | 4 |
,| Arm 3: SPI-2012 270 µg/kg and TC | 13 | 0 | 2 | 1 | 18 | 6 |
,| Arm 4: Pegfilgrastim and TC | 12 | 0 | 8 | 1 | 28 | 8 |
Depth of ANC Nadir in Cycle 4
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4. (NCT01724866)
Timeframe: Cycle 4 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 8.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 4.2 |
| Arm 3: SPI-2012 270 µg/kg and TC | 4.2 |
| Arm 4: Pegfilgrastim and TC | 2.4 |
Depth of ANC Nadir in Cycle 3
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3. (NCT01724866)
Timeframe: Cycle 3 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 1.9 |
| Arm 2: SPI-2012 135 µg/kg and TC | 3.4 |
| Arm 3: SPI-2012 270 µg/kg and TC | 4.1 |
| Arm 4: Pegfilgrastim and TC | 3.5 |
Depth of ANC Nadir in Cycle 2
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2. (NCT01724866)
Timeframe: Cycle 2 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 1.3 |
| Arm 2: SPI-2012 135 µg/kg and TC | 3.3 |
| Arm 3: SPI-2012 270 µg/kg and TC | 4.8 |
| Arm 4: Pegfilgrastim and TC | 2.9 |
Depth of ANC Nadir in Cycle 1
Depth of ANC nadir was defined as the lowest Median ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1. (NCT01724866)
Timeframe: Cycle 1 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 0.8 |
| Arm 2: SPI-2012 135 µg/kg and TC | 3.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 6.2 |
| Arm 4: Pegfilgrastim and TC | 3.0 |
Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)
AUC(0-312) is the area under the serum concentration-time curve from time zero to 312 hour post dose calculated by the linear trapezoidal rule. Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters. (NCT01724866)
Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
| Intervention | nanogram*hour per milliliter (ng*hr/mL) (Mean) |
|---|
| Arm 2: SPI-2012 135 µg/kg and TC | 16000 |
| Arm 3: SPI-2012 270 µg/kg and TC | 22900 |
Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1. (NCT01724866)
Timeframe: Cycle 1 (each cycle was 21 days)
| Intervention | 10^9 ANC per liter (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 1.5 |
| Arm 2: SPI-2012 135 µg/kg and TC | 4.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 7.2 |
| Arm 4: Pegfilgrastim and TC | 3.2 |
Absolute ANC Nadir Overtime in Cycle 4
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4. (NCT01724866)
Timeframe: Cycle 4 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 2.1 |
| Arm 2: SPI-2012 135 µg/kg and TC | 4.1 |
| Arm 3: SPI-2012 270 µg/kg and TC | 4.8 |
| Arm 4: Pegfilgrastim and TC | 2.7 |
Absolute ANC Nadir Overtime in Cycle 3
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3. (NCT01724866)
Timeframe: Cycle 3 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 2.3 |
| Arm 2: SPI-2012 135 µg/kg and TC | 4.4 |
| Arm 3: SPI-2012 270 µg/kg and TC | 6.1 |
| Arm 4: Pegfilgrastim and TC | 3.5 |
Absolute ANC Nadir Overtime in Cycle 2
Mean ANC nadir was defined as the mean of the lowest ANC value (*10^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2. (NCT01724866)
Timeframe: Cycle 2 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 2.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 3.9 |
| Arm 3: SPI-2012 270 µg/kg and TC | 6.8 |
| Arm 4: Pegfilgrastim and TC | 3.3 |
Time to Reach Maximum Concentration of SPI-2012 (Tmax)
Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive pharmacokinetic (PK) parameters. (NCT01724866)
Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
| Intervention | hours (hrs) (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 58.7 |
| Arm 2: SPI-2012 135 µg/kg and TC | 9.00 |
| Arm 3: SPI-2012 270 µg/kg and TC | 24.0 |
Time to ANC Recovery in Cycle 4
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 4. (NCT01724866)
Timeframe: Cycle 4 (each cycle was 21 days)
| Intervention | days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 11.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 10.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 10.0 |
| Arm 4: Pegfilgrastim and TC | 10.0 |
Maximum Concentration of SPI-2012 (Cmax)
Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters. (NCT01724866)
Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
| Intervention | nanograms per milliliter (ng/mL) (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 7.00 |
| Arm 2: SPI-2012 135 µg/kg and TC | 247 |
| Arm 3: SPI-2012 270 µg/kg and TC | 299 |
Time to ANC Recovery in Cycle 1
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 1. (NCT01724866)
Timeframe: Cycle 1 (each cycle was 21 days)
| Intervention | days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 10.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 8.5 |
| Arm 3: SPI-2012 270 µg/kg and TC | 8.0 |
| Arm 4: Pegfilgrastim and TC | 9.0 |
Time to ANC Nadir in Cycle 4
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. (NCT01724866)
Timeframe: Cycle 4 (each cycle was 21 days)
| Intervention | days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 8.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 8.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 8.0 |
| Arm 4: Pegfilgrastim and TC | 8.0 |
Time to ANC Nadir in Cycle 3
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. (NCT01724866)
Timeframe: Cycle 3 (each cycle was 21 days)
| Intervention | days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 8.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 7.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 8.0 |
| Arm 4: Pegfilgrastim and TC | 8.0 |
Time to ANC Nadir in Cycle 2
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. (NCT01724866)
Timeframe: Cycle 2 (each cycle was 21 days)
| Intervention | days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 8.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 7.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 8.0 |
| Arm 4: Pegfilgrastim and TC | 8.0 |
Time to ANC Nadir in Cycle 1
Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. (NCT01724866)
Timeframe: Cycle 1 (each cycle was 21 days)
| Intervention | Days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 8.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 7.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 7.0 |
| Arm 4: Pegfilgrastim and TC | 7.5 |
Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4
(NCT01724866)
Timeframe: All cycles from Cycle 1 to Cycle 4 (each cycle was 21 days)
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 7.7 |
| Arm 2: SPI-2012 135 µg/kg and TC | 8.3 |
| Arm 3: SPI-2012 270 µg/kg and TC | 2.8 |
| Arm 4: Pegfilgrastim and TC | 13.9 |
Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4
FN was defined as a temperature of more than 38.2 degree Celsius (°C) concurrent with an ANC greater than 0.5×10^9/L.. (NCT01724866)
Timeframe: Cycle 1 to Cycle 4 (each cycle was 21 days)
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 7.7 |
| Arm 2: SPI-2012 135 µg/kg and TC | 2.8 |
| Arm 3: SPI-2012 270 µg/kg and TC | 2.8 |
| Arm 4: Pegfilgrastim and TC | 5.6 |
Number of Participants With Positive Antibodies for SPI-2012
Serum samples were to be tested in a screening assay for antibodies binding to SPI-2012 using a validated enzyme-linked immunosorbent assay (ELISA). Any serum samples positive for the antibody were to be tested in a confirmatory competitive inhibition assay using two antigens, SPI-2012 or granulocyte colony-stimulating factor (G-CSF), to confirm the presence of antibodies binding to SPI-2012 and to identify samples that were positive for antibodies binding to G-CSF. (NCT01724866)
Timeframe: Up to the end of the study (Approximately 3.5 months)
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 2 |
Half-life of SPI-2012 (t1/2)
t1/2 data were calculated and reported as harmonic mean and pseudo standard deviation (SD). Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters. (NCT01724866)
Timeframe: Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)
| Intervention | hrs (Mean) |
|---|
| Arm 2: SPI-2012 135 µg/kg and TC | 81.0 |
| Arm 3: SPI-2012 270 µg/kg and TC | 31.5 |
Duration of Severe Neutropenia (DSN) in Cycle 1
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 1. (NCT01724866)
Timeframe: Cycle 1 (each cycle was 21 days)
| Intervention | days (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 1.03 |
| Arm 2: SPI-2012 135 µg/kg and TC | 0.44 |
| Arm 3: SPI-2012 270 µg/kg and TC | 0.03 |
| Arm 4: Pegfilgrastim and TC | 0.31 |
Duration of DSN in Cycle 4
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 4. (NCT01724866)
Timeframe: Cycle 4 (each cycle was 21 days)
| Intervention | days (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 1.05 |
| Arm 2: SPI-2012 135 µg/kg and TC | 0.19 |
| Arm 3: SPI-2012 270 µg/kg and TC | 0.09 |
| Arm 4: Pegfilgrastim and TC | 0.11 |
Duration of DSN in Cycle 3
DSN was defined as the interval from the day of first observation of severe neutropenia (ANC <0.5*10^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to => 2.0*10^9/L in Cycle 3. (NCT01724866)
Timeframe: Cycle 3 (each cycle was 21 days)
| Intervention | days (Mean) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 0.45 |
| Arm 2: SPI-2012 135 µg/kg and TC | 0.16 |
| Arm 3: SPI-2012 270 µg/kg and TC | 0.15 |
| Arm 4: Pegfilgrastim and TC | 0.14 |
Time to ANC Recovery in Cycle 2
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 2. (NCT01724866)
Timeframe: Cycle 2 (each cycle was 21 days)
| Intervention | days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 11.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 9.5 |
| Arm 3: SPI-2012 270 µg/kg and TC | 10.0 |
| Arm 4: Pegfilgrastim and TC | 10.0 |
Time to ANC Recovery in Cycle 3
Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10^9/L within Cycle 3. (NCT01724866)
Timeframe: Cycle 3 (each cycle was 21 days)
| Intervention | days (Median) |
|---|
| Arm 1: SPI-2012 45 µg/kg and TC | 10.0 |
| Arm 2: SPI-2012 135 µg/kg and TC | 9.5 |
| Arm 3: SPI-2012 270 µg/kg and TC | 9.0 |
| Arm 4: Pegfilgrastim and TC | 10.0 |
Severe Adverse Event Rate
Defined as number of patients experiencing any grade or severe (≥ grade 3 by common toxicity criteria for adverse events (CTCAE) v4.0 criteria) adverse events at any time during the study (NCT01729338)
Timeframe: Up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| Velcade, Cyclophosphamide, Revlimid | 64 |
Overall Response Rate (ORR) During Induction Therapy
"Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria:~IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour." (NCT01729338)
Timeframe: Up to 8 months
| Intervention | percentage of participants (Number) |
|---|
| Velcade, Cyclophosphamide, Revlimid | 64 |
Maximum Depth of Response During Maintenance Therapy
"Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy.~IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease." (NCT01729338)
Timeframe: Up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| Stable Disease | Partial Response | Very good partial response | Complete Response/Stringent complete response | Progressive Disease/no response |
|---|
| Velcade, Cyclophosphamide, Revlimid | 13 | 0 | 50 | 38 | 0 |
QLQ-C30 Question 30
"Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week?~7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality." (NCT01729338)
Timeframe: baseline, 3 months, 5 months
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 3 months | 5 months |
|---|
| Velcade, Cyclophosphamide, Revlimid | 51.7 | 66.7 | 66.7 |
QLQ-C30 Question 29
Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 29: how would you rate your overall health during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality. (NCT01729338)
Timeframe: baseline, 3 months, 5 months
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 3 months | 5 months |
|---|
| Velcade, Cyclophosphamide, Revlimid | 58.3 | 65 | 68.3 |
Maximum Depth of Response During Induction Therapy
Maximum depth of response is defined as: ranging from partial response to complete response by International Myeloma Working Group (IMWG). Described as number of patients achieving each level of response. IMWG: CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease. (NCT01729338)
Timeframe: Up to 8 months
| Intervention | percentage of participants (Number) |
|---|
| Stable Disease | Partial Response | Very good partial response (VGPR) | Complete Response/Stringent complete response | Progressive Disease/no response |
|---|
| Velcade, Cyclophosphamide, Revlimid | 21 | 7 | 29 | 29 | 14 |
Complete Response Rate
The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)). (NCT01731886)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: Low-dose Dexamethasone + Stem Cell Transplantation | 7 |
| Arm B: Low-dose Dexamethasone | 7 |
Overall Survival Rate (OS)
To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis. (NCT01731886)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Low-dose Dexamethasone + Stem Cell Transplantation | 100 |
| Arm B: Low-dose Dexamethasone | 94.7 |
Overall Survival Rate (OS)
To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis. (NCT01731886)
Timeframe: 4 years
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Low-dose Dexamethasone + Stem Cell Transplantation | 79.8 |
| Arm B: Low-dose Dexamethasone | 78.9 |
Progression Free Survival (PFS)
PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. (NCT01731886)
Timeframe: 4 years
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Low-dose Dexamethasone + Stem Cell Transplantation | 36.0 |
| Arm B: Low-dose Dexamethasone | 31.6 |
Progression Free Survival (PFS)
PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. (NCT01731886)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Low-dose Dexamethasone + Stem Cell Transplantation | 52.0 |
| Arm B: Low-dose Dexamethasone | 47.4 |
The Anti-tumor Activity of the Combination of Low Dose Cyclophosphamide and CTLA-4 Blockade Using Objective Response Rate (ORR)
Objective response rate (ORR) using mWHO RC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01740401)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Stable disease | Progression of disease |
|---|
| Cyclophosphamide, Ipilimumab | 4 | 6 |
24-month Progression-Free Survival Rate
24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.
| Intervention | proportion of patients (Number) |
|---|
| CHOEP + High Dose Therapy + Auto SCT | 0.0 |
Induction Response
Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks. (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).
| Intervention | proportion of patients (Number) |
|---|
| CHOEP + High Dose Therapy + Auto SCT | .60 |
Number of Participants That Engrafted and the Number of Participants That Had Full Donor Chimerism at Day 60
To estimate the number of participants that had engraftment rates and the number of participants that had full donor chimerism at Day 60 in patients undergoing an HLA haploidentical stem cell transplant with post transplant high dose cyclophosphamide. (NCT01749293)
Timeframe: Up to Day 60 post-transplant.
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical Transplant | 0 |
Number of Participants That Had an Event Free Survival Rate
To estimate the number of participants who had an event free survival rate (NCT01749293)
Timeframe: Up to 1 year post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical Transplant | 0 |
Number of Participants That Had an Overall Survival Rate
To estimate the number of participants that had an overall survival (OS) rate (NCT01749293)
Timeframe: Up to one year post-transplant.
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical Transplant | 1 |
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
Results reported as total events per grade for human epidermal growth factor receptor 2 (HER2)negative and HER2 positive (Overall severity of toxicities, graded according to the NCI CTCAE version 4.0). (NCT01750073)
Timeframe: Up to 30 days after completion of study treatment, maximum of 114 days
| Intervention | Events (Number) |
|---|
| SAE grade 1 | SAE grade 2 | SAE grade 3 | SAE grade 4 | SAE grade 5 | Non-SAE grade 1 | Non-SAE grade 2 | Non-SAE grade 3 | Non-SAE grade 4 |
|---|
| Her-2 Negative | 1 | 10 | 22 | 2 | 1 | 1286 | 390 | 93 | 11 |
,| Her-2 Positive | 9 | 4 | 8 | 2 | 1 | 302 | 143 | 23 | 4 |
Overall Incidence of Toxicities, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Number of participants in each subset (Her2 positive and Her2 negative) who experience at least one adverse event [overall incidence of toxicities, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0]. (NCT01750073)
Timeframe: Up to 30 days after completion of study treatment, maximum of 114 days
| Intervention | Participants (Count of Participants) |
|---|
| Her-2 Negative | 73 |
| Her-2 Positive | 19 |
Number of Participants in the Subgroups Who Had a Pathologic Complete Response (pCR)
The number of participants in the subgroups who had a pathologic complete response (pCR) determined from the surgical specimen and defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ. (NCT01750073)
Timeframe: Up to 12 weeks (after the first 6 courses of treatment), maximum of 168 days
| Intervention | participants (Number) |
|---|
| Her-2 Negative | 13 |
| Her-2 Positive | 2 |
Participants Who Experienced an Adverse Event
Number of participants who experienced an adverse event (NCT01775475)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (CHOP) | 4 |
| Arm II (Oral Chemotherapy) | 3 |
Overall Survival
Proportion of participants who survived 2 years (NCT01775475)
Timeframe: Up to 24 months
| Intervention | Proportion of participants (Number) |
|---|
| Arm I (CHOP) | 0 |
| Arm II (Oral Chemotherapy) | 0 |
Overall Response Rate
Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is >=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease. (NCT01775475)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (CHOP) | 3 |
| Arm II (Oral Chemotherapy) | 1 |
Number of Patients Who Complete Treatment
Number of patients who complete chemotherapy treatment. (NCT01775475)
Timeframe: Up to 18 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (CHOP) | 3 |
| Arm II (Oral Chemotherapy) | 1 |
Change in Absolute CD4 Count From Baseline to Post-treatment
Change in absolute CD4 count from baseline to post-treatment (visit 6) (NCT01775475)
Timeframe: From baseline to 18 weeks
| Intervention | cells per mm^3 (Mean) |
|---|
| Arm I (CHOP) | -41.3 |
| Arm II (Oral Chemotherapy) | 203.3 |
Proportion of Patients Who Are Adherent to Chemotherapy
Patients who did not miss any doses of chemotherapy (NCT01775475)
Timeframe: Up to 18 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (CHOP) | 4 |
| Arm II (Oral Chemotherapy) | 3 |
Proportion of Patients Who Are Adherent to Antiretroviral Therapy
Number of patients who did not miss any of their doses of antiretroviral therapy (NCT01775475)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (CHOP) | 3 |
| Arm II (Oral Chemotherapy) | 3 |
Progression-free Survival
Proportion of participants who survived without disease progression at 2 years (NCT01775475)
Timeframe: Up to 24 months
| Intervention | proportion (Number) |
|---|
| Arm I (CHOP) | 0 |
| Arm II (Oral Chemotherapy) | 0 |
Overall Survival (OS)
The time from randomization to death due to any cause. (NCT01777152)
Timeframe: Up to 90 months
| Intervention | Months (Median) |
|---|
| A+CHP | NA |
| CHOP | NA |
Incidence of Laboratory Abnormalities
Number of participants who experienced a Grade 3 or higher laboratory toxicity. (NCT01777152)
Timeframe: Up to 8.28 months
| Intervention | Participants (Count of Participants) |
|---|
| Any Chemistry Test | Alanine Aminotransferase High | Albumin Low | Alkaline Phosphatase High | Calcium Low | Glucose High | Phosphate Low | Potassium High | Potassium Low | Sodium High | Sodium Low | Urate High | Any Hematology Test | Absolute Neutrophil Count Low | Hemoglobin High | Hemoglobin Low | Leukocytes Low | Lymphocytes High | Lymphocytes Low | Neutrophils Low | Platelets Low |
|---|
| A+CHP | 25 | 3 | 2 | 1 | 1 | 8 | 4 | 0 | 3 | 1 | 4 | 5 | 68 | 17 | 1 | 9 | 12 | 0 | 52 | 17 | 1 |
,| CHOP | 23 | 1 | 3 | 0 | 1 | 6 | 3 | 2 | 2 | 0 | 6 | 2 | 78 | 19 | 0 | 13 | 21 | 1 | 61 | 19 | 1 |
Incidence of Adverse Events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. (NCT01777152)
Timeframe: Up to 8.28 months
| Intervention | Participants (Count of Participants) |
|---|
| Any treatment-emergent AE | Blinded study treatment-related AE | CHP treatment-related AE | Any serious adverse event (SAE) | Blinded study treatment-related SAE | CHP treatment-related SAE | Treatment discontinuations due to AE | Treatment discontinuations due to blinded study treatment-related AE | Treatment discontinuations due to CHP treatment-related AE |
|---|
| A+CHP | 221 | 201 | 198 | 87 | 58 | 62 | 14 | 10 | 8 |
,| CHOP | 221 | 193 | 205 | 87 | 45 | 53 | 15 | 10 | 7 |
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months
| Intervention | months (Median) |
|---|
| A+CHP | 55.66 |
| CHOP | 32.03 |
Progression-free Survival Per Independent Review Facility (IRF)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months
| Intervention | months (Median) |
|---|
| A+CHP | 48.20 |
| CHOP | 20.80 |
Objective Response Rate (ORR) Per IRF at End of Treatment
The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months
| Intervention | Participants (Count of Participants) |
|---|
| A+CHP | 188 |
| CHOP | 163 |
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months
| Intervention | Participants (Count of Participants) |
|---|
| A+CHP | 153 |
| CHOP | 126 |
Number of Participants With Disease Recurrence
-Disease recurrence is defined as the documented appearance of local (breast, chest wall, axillary, supraclavicular nodes) or distant disease. (NCT01779050)
Timeframe: Up to 3 years after completion of treatment (estimated to be 4 years)
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Definitive Therapy) | 1 |
| Arm II (Definitive Therapy, Trastuzumab) | 0 |
Death Rate
(NCT01779050)
Timeframe: Up to 3 years after completion of treatment (estimated to be 4 years)
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Definitive Therapy) | 1 |
| Arm II (Definitive Therapy, Trastuzumab) | 0 |
Number of Participants With Congestive Heart Failure
Number of participants with clinically significant congestive heart failure (CHF) as determined by established medical practices. (NCT01796197)
Timeframe: 1 year and 8 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment Arm | 0 |
Percentages of Participants With Pathologic Complete Response
Pathologic complete response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative treatment. Participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR. (NCT01796197)
Timeframe: 18 weeks
| Intervention | percentage of participants (Number) |
|---|
| Treatment Arm | 48 |
Residual Cancer Burden Rate
"Residual cancer burden is calculated an then categorized based on the methods described in the following: Symmans WF, Peintinger F, Hatzis C, et al. Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol 2007;25(28): 4414-22.~This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. These parameters are combined in a formula that outputs a RCB index. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III. The previous categories are in order of increasing severity of RCB." (NCT01796197)
Timeframe: 18 Weeks
| Intervention | percentage of participants (Number) |
|---|
| RCB-0 | RCB-I | RCB-II | RCB-III |
|---|
| Treatment Arm | 48 | 33 | 5 | 14 |
Predictive Accuracy Rate of Pre-Treatment Versus On-Treatment Tumor Biopsy RNA Sequencing Profiles
Tumor RNA expression from pre-treatment (Day 1) and on-treatment (Day 8) biopsies were evaluated to see if the expression profiles had predictive accuracy of pCR. pCR is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative treatment. Participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR. The biopsies were analyzed by differential expression analysis using standard procedures in R package, limma. A predictive Random Forest model was trained using leave-pair-out-cross-validation with the 80 genes most associated with pCR and/or non-pCR. This model gives an accuracy rate, which indicates the percentage of time that the gene profile predicts pCR or non-pCR for both the pre-treatment and on-treatment profiles. An increase in accuracy for the on-treatment profile would indicate an adaptive response within the tumor associated with resistance to HER2 directed therapies. (NCT01796197)
Timeframe: 18 Weeks
| Intervention | percent accuracy (Number) |
|---|
| Day 1 Biopsy | Day 8 Biopsy |
|---|
| Treatment Arm | 50 | 90 |
The Tolerability of BuMel Regimen
Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome [SOS] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria [CTC] v.4.0) during the Consolidation phase of therapy. (NCT01798004)
Timeframe: Up to 28 days post-consolidation therapy, up to 1 year
| Intervention | participants (Number) |
|---|
| All Patients | 9 |
Number of Participants Who Experienced in Vivo Persistence of Adoptively Transferred T Cells Following TIL Infusion
Whole exome and RNA sequencing of tumor cells and normal tissue was performed to identify non synonymous missense mutations, which was then used to generate peptide pools to identify neoantigen-reactive T cells. T-Cell Receptor (TCR) sequencing of T cell clonotypes in blood at time of treatment, 10 months and 24 months was performed and used to assess the persistence of a tumor antigen specific clonotype infused in the TIL product. (NCT01807182)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| At time of treatment | 10 months post infusion | 24 months post infusion |
|---|
| Treatment (TIL, Combination Chemotherapy, Aldesleukin) | 1 | 1 | 1 |
A Count of Participants With Biomarker Expression Above Threshold
Several biomarkers, CXCL13+ CD4 cells, CXCL13+ CD8+ cells, and regulatory cells were evaluated to assess correlation with clinical responses to TIL therapy. (NCT01807182)
Timeframe: Up to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| CXCL13+ as % of CD4 T Cell (40% Threshold) | Treg as % of CD4 T Cell (40% Threshold) | CXCL13+ as % of CD8 T Cell (40% Threshold) |
|---|
| Treatment (TIL, Combination Chemotherapy, Aldesleukin) | 2 | 3 | 6 |
Count of Participants Who Experienced Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
(NCT01807182)
Timeframe: Adverse events will be collected through 4 weeks after T cell infusion. Beginning 4 weeks after the T cell infusion, only study-related toxicities will be collected for up to 1 year following T cell infusion.
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (TIL, Combination Chemotherapy, Aldesleukin) | 10 |
Overall Survival
The one-year survival is defined by the patient who has not died within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients. (NCT01807611)
Timeframe: one year post-transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Experimental: Transplant Recipients | 59 |
Event-free Survival
The one-year event free survival is defined by the patient who has neither experienced relapse nor death within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year event free survival patients and the total number of patients. (NCT01807611)
Timeframe: One year post-transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Experimental: Transplant Recipients | 49 |
Number of Transplant Recipients With Acute and/or Chronic Graft Versus Host Disease (GVHD)
Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The estimate will be the number of recipients who experienced GVHD divided by the total number of patients considered in this group. (NCT01807611)
Timeframe: 100 days post-transplant for acute GVHD; one year post-transplant for chronic GVHD .
| Intervention | Participants (Count of Participants) |
|---|
| Number of Transplant Recipients With Acute Graft Versus Host Disease (aGVHD) | 24 |
| Number of Transplant Recipients With Chronic Graft Versus Host Disease (cGVHD) | 16 |
Number of Transplant Recipients With Malignant Relapse
Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease. (NCT01807611)
Timeframe: One-year post-transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Experimental: Transplant Recipients | 18 |
Number of Transplant Recipients With Successful Engraftment
Neutrophil engraftment will be determined using the parameters put forth by the Center for International Blood and Marrow Registry. Assessments will be made upon review of daily complete blood count and serial chimerism studies. Successful engraftment for the purposes of this objective will be patients who do not experience graft failure. (NCT01807611)
Timeframe: 42 days post engraftment
| Intervention | Participants (Count of Participants) |
|---|
| Experimental: Transplant Recipients | 70 |
Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR))
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT01814046)
Timeframe: approximately 3 years
| Intervention | percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) |
|---|
| Cells + High Dose Aldesleukin | 4.54 | 31.81 |
,| Cells and no High Dose Aldesleukin | 0 | 0 |
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01814046)
Timeframe: 46 months and 12 days
| Intervention | Participants (Count of Participants) |
|---|
| Cells + High Dose Aldesleukin | 22 |
| Cells and no High Dose Aldesleukin | 2 |
Count of Participants With Changes in Visual Symptoms
Visual symptoms (e.g., blurred) were evaluated and if changes had occurred from baseline, i.e. in visual acuity, an ophthalmologic consult was performed. (NCT01814046)
Timeframe: 6 weeks (+/- 2 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Cells + High Dose Aldesleukin | 1 |
| Cells and no High Dose Aldesleukin | 0 |
Count of Participants That Achieve Pathologic Complete Response (PCR)
PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes. (NCT01818063)
Timeframe: 36 months following surgery
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1 (Paclitaxel, Carboplatin) | 3 |
| Arm 2 (Veliparib, Paclitaxel, Carboplatin) | 3 |
Percentage of Participants Who Experience Primary Graft Failure Event Between Arms
Primary Graft failure is defined as the failure to achieve an ANC >= 500/uL after 42 days, determined by 3 consecutive measurements on different days; OR < 5% donor cells in blood or bone marrow by day +42 (as demonstrated by a chimerism assay), without evidence of Juvenile Myelomonocytic Leukemia (JMML). (NCT01824693)
Timeframe: Day 0 - day 540 (18 months) following completion of stem cell transplant
| Intervention | percentage of patients (Number) |
|---|
| Arm I (Busulfan, Cyclophosphamide, Melphalan) | 0 |
| Arm II (Busulfan, Fludarabine Phosphate) | 0 |
Percent Probability of Event-free Survival (EFS)
Probability of Event-free Survival (EFS) for Patients after 18 months. An event is either treatment related mortality (TRM), primary or secondary graft failure, or relapse/non-response (as defined in protocol section 10). Time to event is time from transplant with patients who die between the start of the conditioning regimen and transplant given a time to event of zero. (NCT01824693)
Timeframe: From transplant up to 18 months
| Intervention | percent probability (Number) |
|---|
| Arm I (Busulfan, Cyclophosphamide, Melphalan) | 83 |
| Arm II (Busulfan, Fludarabine Phosphate) | 22 |
Percent Probability of 18 Months-relapse Event Between Arms
Probability of patients relapsing at 18 months. A relapse event is defined in protocol section 10.2.3. Time to relapse/non-response is defined as time from transplant to when all criteria of section 10.2.3 are met. (NCT01824693)
Timeframe: From transplant up to 18 months
| Intervention | percent probability (Number) |
|---|
| Arm I (Busulfan, Cyclophosphamide, Melphalan) | 17 |
| Arm II (Busulfan, Fludarabine Phosphate) | 55 |
Total Number of Participants Who Reached The Target Propranolol Dosing
The target Propranolol dosing was 80mg ER daily. (NCT01847001)
Timeframe: Approximately 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Propranolol + Neoadjuvant Chemotherapy | 9 |
Mean Adherence to Propranolol
Propranolol adherence was documented biweekly by pill counts and drug diary checks. (NCT01847001)
Timeframe: Approximately 6 months
| Intervention | Percentage of propanolol adherence (Mean) |
|---|
| Propranolol + Neoadjuvant Chemotherapy | 96 |
Number of Patients With Pathologic Complete Response
Response was confirmed with pathology. (NCT01847001)
Timeframe: Approximately 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Propranolol + Neoadjuvant Chemotherapy | 1 |
Mean Change in Quality-Of-Life Indicators Post-Transplant
Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement. (NCT01849783)
Timeframe: Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.
| Intervention | score on a scale (Mean) |
|---|
| Change in Physical Functioning at Pre-Maintenance | Change in Physical Functioning at Maintenance Cycle 6 | Change in Physical Functioning at Maintenance Cycle 12 | Change in Physical Functioning at Maintenance Cycle 18 | Change in Physical Functioning at Maintenance Cycle 24 | Change in Role Functioning at Pre-Maintenance | Change in Role Functioning at Maintenance Cycle 6 | Change in Role Functioning at Maintenance Cycle 12 | Change in Role Functioning at Maintenance Cycle 18 | Change in Role Functioning at Maintenance Cycle 24 | Change in Emotional Functioning at Pre-Maintenance | Change in Emotional Functioning at Maintenance Cycle 6 | Change in Emotional Functioning at Maintenance Cycle 12 | Change in Emotional Functioning at Maintenance Cycle 18 | Change in Emotional Functioning at Maintenance Cycle 24 | Change in Cognitive Functioning at Pre-Maintenance | Change in Cognitive Functioning at Maintenance Cycle 6 | Change in Cognitive Functioning at Maintenance Cycle 12 | Change in Cognitive Functioning at Maintenance Cycle 18 | Change in Cognitive Functioning at Maintenance Cycle 24 | Change in Social Functioning at Pre-Maintenance | Change in Social Functioning at Maintenance Cycle 6 | Change in Social Functioning at Maintenance Cycle 12 | Change in Social Functioning at Maintenance Cycle 18 | Change in Social Functioning at Maintenance Cycle 24 | Change in Global Health Status at Pre-Maintenance | Change in Global Health Status at Maintenance Cycle 6 | Change in Global Health Status at Maintenance Cycle 12 | Change in Global Health Status at Maintenance Cycle 18 | Change in Global Health Status at Maintenance Cycle 24 | Change in Distress Symptoms at Pre-Maintenance | Change in Distress Symptoms at Maintenance Cycle 6 | Change in Distress Symptoms at Maintenance Cycle 12 | Change in Distress Symptoms at Maintenance Cycle 18 | Change in Distress Symptoms at Maintenance Cycle 24 | Change in Side Effects of Treatment at Pre-Maintenance | Change in Side Effects of Treatment at Maintenance Cycle 6 | Change in Side Effects of Treatment at Maintenance Cycle 12 | Change in Side Effects of Treatment at Maintenance Cycle 18 | Change in Side Effects of Treatment at Maintenance Cycle 24 |
|---|
| Autologous Stem Cell Transplant | 1.3 | -0.6 | 1.1 | 5.4 | 4.6 | 7.4 | 8.7 | 4.4 | 7.0 | 6.0 | 8.7 | 5.5 | 1.4 | 5.8 | 8.3 | 0.4 | -4.6 | -5.1 | -6.0 | -3.6 | -1.0 | 2.7 | -4.9 | 0.8 | -1.5 | 5.4 | 0.2 | -3.1 | -0.1 | 3.4 | 6.2 | 5.9 | 5.7 | 3.8 | 5.3 | -3.3 | -0.7 | -5.1 | -2.4 | -2.7 |
Percentage of Participants Able to Complete Full Course Therapy
Percentage of participants able to complete the full course of therapy. (NCT01849783)
Timeframe: Up to 6 years
| Intervention | Participants (Count of Participants) |
|---|
| Autologous Stem Cell Transplant | 24 |
Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years
| Intervention | Months (Median) |
|---|
| Treatment Arm B: Ibrutinib+R-CHOP | 48.56 |
| Treatment Arm A: Placebo+R-CHOP | 48.16 |
Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to 5.5 years
| Intervention | Months (Median) |
|---|
| Treatment Arm B: Ibrutinib+R-CHOP | 49.64 |
| Treatment Arm A: Placebo+R-CHOP | 54.77 |
Percentage of Participants Who Achieved Complete Response (CR)
Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to [<=]1.5 cm in greatest transverse diameter [GTD] for nodes greater than [>]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (>)1.0 cm in short axis before treatment decreased to <=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years
| Intervention | Percentage of participants (Number) |
|---|
| Treatment Arm B: Ibrutinib+R-CHOP | 67.3 |
| Treatment Arm A: Placebo+R-CHOP | 68.0 |
Progression-Free Survival (PFS)
PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (cm) in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years
| Intervention | Months (Median) |
|---|
| Treatment Arm B: Ibrutinib+R-CHOP | 48.56 |
| Treatment Arm A: Placebo+R-CHOP | NA |
Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01855750)
Timeframe: Up to approximately 4.5 years
| Intervention | Months (Median) |
|---|
| Treatment Arm B: Ibrutinib+R-CHOP | 11.7 |
| Treatment Arm A: Placebo+R-CHOP | 35.0 |
Overall Survival
Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT01855750)
Timeframe: Up to 5.5 years
| Intervention | Months (Median) |
|---|
| Treatment Arm B: Ibrutinib+R-CHOP | NA |
| Treatment Arm A: Placebo+R-CHOP | NA |
Proportion of Participants With a Pathologic Complete Response Rate
To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen. (NCT01855828)
Timeframe: 20 weeks
| Intervention | proportion of participants (Number) |
|---|
| HR Positive | HR Negative |
|---|
| Chemo Plus Pertuzumab,Trastuzumab | .26 | .80 |
Residual Cancer Burden Score
To assess cancer burben, the Residual Cancer Burden (RCB) score was used. This score has a range of 0 - III, where III (3) is the worst level of burden. (NCT01855828)
Timeframe: Up to 28 weeks
| Intervention | Participants (Count of Participants) |
|---|
| RCB = 0 | RCB = I (1) | RCB = II (2) | RCB = III (3) |
|---|
| Chemo Plus Pertuzumab,Trastuzumab | 28 | 5 | 4 | 4 |
Count of Patients With Clinical Response
To assess clinical response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, the number of patients are presented with a clinical response. (NCT01855828)
Timeframe: Up to 28 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Chemo Plus Pertuzumab,Trastuzumab HR-positive | 6 |
| Chemo Plus Pertuzumab,Trastuzumab HR-negative | 20 |
Cardiac Safety
To assess the safety of the regimen, cardiac safety was measured by rates of clinically symptomatic congestive heart failure, asymptomatic decrease in LVEF >10%, and decrease of LVEF below normal level. This was assessed up to 1 year following surgery. (NCT01855828)
Timeframe: Up to 1 year post surgery
| Intervention | Participants (Count of Participants) |
|---|
| Chemo Plus Pertuzumab,Trastuzumab-symptomatic Congestive Heart | 0 |
| Chemo Plus Pertuzumab,Trastuzumab-asympomatic Decrease in LVEF | 14 |
| Chemo Plus Pertuzumab,Trastuzumab-LVEF Below Normal Level | 1 |
Overall Survival Rate at 3 Years
Overall survival is defined as time from randomization to death or date last known alive. Overall survival rate at 3 years was calculated using the method of Kaplan Meier. (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
| Intervention | proportion of participants (Number) |
|---|
| Arm A (R2CHOP) | 0.826 |
| Arm B (RCHOP) | 0.751 |
Proportion of Patients With Response
"Response is defined as complete response (CR) or partial response (PR) CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms~PR:~>=50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses~No increase in the size of other nodes, liver or spleen~Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified~No new sites of disease~The post-treatment PET should be positive at any previously involved sites~For variably FDG-avid lymphomas/FDG-avidity unknown, without a pretreatment PET scan, or if a pretreatment PET scan was negative, CT scan criteria should be used~Patients with a CR and persistent morphologic bone marrow involvement~Patients with bone marrow involved before therapy and a clinical CR but no bone marrow assessment after treatment" (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
| Intervention | proportion of participants (Number) |
|---|
| Arm A (R2CHOP) | 0.97 |
| Arm B (RCHOP) | 0.92 |
3-year Progression-free Survival Rate
"Progression-free survival is defined as the time from randomization to disease progression, new primary of the same type or death, whichever occurs first. Progressive disease is defined as:~Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~>= 50% increase from nadir in the sum of the product of the diameters of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions.~>= 50% increase in the longest diameter of any single previously identified node or extranodal mass > 1 cm in its short axis.~Lesions should be PET positive unless the lesion is too small to be detected with current PET systems.~Measurable extranodal disease should be assessed in a manner similar to that for nodal disease.~3-year progression-free survival rate was calculated using Kaplan-Meier method." (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year PFS rate reported
| Intervention | proportion of participants (Number) |
|---|
| Arm A (R2CHOP) | 0.727 |
| Arm B (RCHOP) | 0.615 |
Proportion of Patients With Complete Response
Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
| Intervention | proportion of participants (Number) |
|---|
| Arm A (R2CHOP) | 0.73 |
| Arm B (RCHOP) | 0.68 |
Local Failure Rate and Pattern of Failure
Local failure is defined as relapse or progression of disease at the primary site. The cumulative incidence of local failure will be estimated; competing events will include distant failure or death prior to local failure. (NCT01857934)
Timeframe: Up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody Antibody (hu14.18K322A) | 1.56 |
Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]
Per the 1993 INRC: measurable tumor defined as product of the longest x widest perpendicular diameter, elevated catecholamine levels and tumor cels in bone marrow. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in an any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive. (NCT01857934)
Timeframe: After two initial courses of chemotherapy (approximately 6 weeks after enrollment)
| Intervention | Participants (Count of Participants) |
|---|
| NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) | 42 |
Event-free Survival (EFS)
EFS was estimated as time to relapse, progressive disease, secondary neoplasm, or death from any cause from enrollment. The EFS was estimated by Kaplan-Meier method (NCT01857934)
Timeframe: 3 years, from time of enrollment
| Intervention | percent of probability (Number) |
|---|
| NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 73.7 |
Dose Limiting Toxicity (DLT)
Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) Toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade 3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding. (NCT01857934)
Timeframe: During MRD treatment cycle (approximately 8-12 months after enrollment)
| Intervention | Participants (Count of Participants) |
|---|
| NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 1 |
Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation
Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding in any subject receiving the hu14.18K322A with NK cell combination; 4) Failure of recovery of ANC > 500/mm3 by day 35 after PBSC infusion. Number of patients who experience Grade 3 or Grade 4 (per Common Toxicity Criteria v 4.0) veno occlusive disease (VOD). (NCT01857934)
Timeframe: During the recovery phase after busulfan/melphalan and PBSC rescue (approximately 24-26 weeks after enrollment)
| Intervention | Participants (Count of Participants) |
|---|
| NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 0 |
Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy
"The study is designed to monitor the feasibility of delivering hu14.18K332A to 6 cycles of Induction chemotherapy. The feasibility of Induction therapy for this study will be to target no worse than 75%. A patient was considered as a failure for the 6 cycles of Induction therapy if the patient failed to complete Induction therapy within 155 days since treatment initiation due to toxicity or disease progression, unless the delay was a result of non-medical issues (e.g. not due to protocol toxicity). The proportion of patients who successfully received hu14.18K322A with 6 cycles of induction chemotherapy was estimated together with a 95% confidence interval. The response rate (CR + VGPR + PR) to 6 cycles of Induction chemoimmunotherapy was estimated together with the 95% confidence intervals" (NCT01857934)
Timeframe: After 6 cycles of induction therapy (approximately 24 weeks after enrollment)
| Intervention | percentage of participants (Number) |
|---|
| NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 96.8 |
GVHD
"aGVHD onset at a certain grade will be used to calculate the cumulative incidence for that grade (e.g., onset of grade 70 post-transplant , time to grade III is 70 days). This end point will be evaluated through day 150 post-transplant. The diagnosis of aGVHD is based on clinical and pathological evaluation by the treating physician.~The first day of cGVHD will be used to calculate the cumulative incidence of cGVHD. The diagnosis of cGVHD is based on clinical and pathological evaluation by the treating physician." (NCT01860170)
Timeframe: Assessed routinely by clinical and pathological evaluation. Acute GVHD will be assessed up to day 150 post-transplant. Chronic GVHD will be assess up to 2 years post-transplant.
| Intervention | participants (Number) |
|---|
| Acute GvHD Grade II-IV | Acute GvHD Grade III-IV | Chronic GvHD |
|---|
| Cohort 1-Bortezomib (Velcade®) | 0 | 0 | 1 |
,| Cohort 2-Bortezomib (Velcade®) | 0 | 0 | 1 |
,| Cohort 3-Bortezomib (Velcade®) | 10 | 3 | 5 |
Dose Limiting Toxicity
Grade 3 non-hematologic Common Toxicity Criteria toxicity directly related to bortezomib (such as peripheral neuropathy) or Grade 2 or > hepatic bilirubin Common Toxicity Criteria Graft failure (NCT01860170)
Timeframe: Assessed daily (while inpatient) through clinical and laboratory examination up to 90 days.
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1-Bortezomib (Velcade®) | 0 |
| Cohort 2-Bortezomib (Velcade®) | 0 |
| Cohort 3-Bortezomib (Velcade®) | 0 |
Engraftment
"Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) > 0.5 109/L for 3 consecutive measurements on different days. The first of the 3 days will be considered the day of neutrophil engraftment.~Platelet engraftment is defined as platelet count > 20 109/L for 3 consecutive measurements over at least 3 days. The first of the 3 days will be considered the day of platelet engraftment.~In this study, graft failure is defined as lack of achieving neutrophil engraftment by day 22 and donor chimerism > 50% by day 45." (NCT01860170)
Timeframe: Assessed daily by laboratory evaluation until engraftment or up to 90 days.
| Intervention | Participants (Count of Participants) |
|---|
| Neutrophil Engraftment | Platelet Engraftment | Graft Failure |
|---|
| Cohort 1-Bortezomib (Velcade®) | 3 | 3 | 0 |
,| Cohort 2-Bortezomib (Velcade®) | 3 | 1 | 0 |
,| Cohort 3-Bortezomib (Velcade®) | 22 | 22 | 0 |
Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. (NCT01864018)
Timeframe: At 28 days
| Intervention | mg weekly (Number) |
|---|
| MTD of ixazomib | MTD of dexamethasone |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 4 | 40 |
Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I)
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. (NCT01864018)
Timeframe: At 28 days
| Intervention | mg/m² weekly (Number) |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 400 |
Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)
The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. (NCT01864018)
Timeframe: Up to 48 weeks
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 35 |
Progression-free Survival (PFS)
The distribution of PFS will be estimated using the method of Kaplan Meier. (NCT01864018)
Timeframe: Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
| Intervention | months (Median) |
|---|
| Phase I/II, Cohort A | NA |
| Phase II, Cohort B | NA |
Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. (NCT01864018)
Timeframe: Up to 48 weeks
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 63 |
Survival Time
The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT01864018)
Timeframe: Time from registration to death due to any cause, assessed up to 5 years
| Intervention | months (Median) |
|---|
| Phase I/II, Cohort A | NA |
| Phase II, Cohort B | NA |
Pathological Response
Pathological response (pCR or microscopic only primary) in both primary and nodes using the Miller-Payne criteria for pathologic response. (NCT01869192)
Timeframe: Up to 8 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm A | 2 |
| Arm B | 8 |
Overall Response Rate
To describe the overall response rate as measured by physical exam and MRI if indicated using the following definition: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01869192)
Timeframe: Up to 8 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm A | 25 |
| Arm B | 21 |
Number of Participants With Disease-free Survival (DFS)
Disease free survival (DFS), defined as the time to death, relapse or disease progression. (NCT01871441)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Haploidentical Allogeneic HSCT) | 1 |
Number of Participants With Relapse of Disease
Relapse of Disease is defined as the return of a disease or the signs and symptoms of a disease after a period of improvement. Relapse is almost always associated with the immunological failure of the donor immune system to recognize and/or respond to reemergence of a tumor. The number of participants with relapse of disease will be collected. (NCT01871441)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Haploidentical Allogeneic HSCT) | 2 |
Overall Survival (OS)
OS is the duration from study entry to death. Participants last known to be alive are censored at date of last contact. (NCT01873833)
Timeframe: From study entry until death from any cause or date of last contact (up to 70 months)
| Intervention | Months (Median) |
|---|
| Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 29.6 |
Overall Response Rate (ORR)
Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT01873833)
Timeframe: From study entry until disease progression/recurrence (maximum duration: 351 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 4 |
Number of Participants With Any Adverse Events as a Measure of Safety and Tolerability
Assessment based on CTCAE version 4.0 toxicity criteria. For the detailed list of adverse events see the adverse event module. (NCT01873833)
Timeframe: ****Time Frame: Adverse events were collected from first dose of study treatment up to 30 days after last dose of treatment, up to 63 months (number or treatment given ranged from 2 cycles to 85 cycles).
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 10 |
Clinical Benefit Rate (CBR)
Participants with a best response of CR, PR, or stable disease (SD) sustained for ≥24 weeks, as assessed using RECIST v1.1. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. SD: Neither PR nor progression of disease (PD) criteria met. SD follow PR only when sum increases by less than 20% from the nadir, but previously seen 30% decrease from baseline no longer hold. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. (NCT01873833)
Timeframe: From study entry until the date of the first documented disease progression of date of death whichever came first, assessed for approximately 351 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 7 |
Progression Free Survival (PFS)
PFS was defined as duration of time from the first dose of study drug to the first documentation of Progressive Disease (PD) by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. (NCT01873833)
Timeframe: From study entry to the date of first documented disease progression (assessed every 6 weeks) or death due to any cause, whichever came first, approximately 63 months.
| Intervention | months (Median) |
|---|
| Treatment (Chemotherapy, Lapatinib Ditosylate, Trastuzumab) | 13.7 |
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment to disease progression or death (due to any cause), whichever occurred first. Median PFS was estimated using Kaplan-Meier methods. Participants who started a new anticancer therapy before documentation of disease progression or death, or who were alive without documentation of disease progression before the data cut-off date or who died or had disease progression immediately after more than 1 consecutively missed disease assessment visit were censored at the date of last disease assessment. (NCT01881789)
Timeframe: From first dose of study drug through the data cut-off date of 18 July 2016; median time on follow-up was 14.1, 3.5, 2.6, 16.0, 3.6, and 11.2 months in each group, respectively
| Intervention | months (Median) |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | NA |
Number of Participants With Dose-Limiting Toxicities (DLTs)
"DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. A DLT is defined as any of the following treatment-related events:~Any ≥ Grade 3 nonhematologic toxicity with the following conditions:~≥ Grade 3 nausea, vomiting, diarrhea, or constipation only if for > 7 days despite optimal supportive care~Asymptomatic Grade 3 hypophosphatemia, Grade 3 hyperglycemia or toxicity solely due to dexamethasone, ≥ Grade 3 rash attributed to lenalidomide, and Grade 3 fatigue for < 14 days were not considered DLTs~Grade 4 neutropenia: absolute neutrophil count (ANC) < 0.5 × 10^9/L lasting ≥ 7 days, despite myeloid growth factor support~Febrile neutropenia~Grade 4 thrombocytopenia for ≥ 7 days or < 7 days with ≥ Grade 2 clinically significant bleeding or < 10,000 platelets requiring platelet transfusion, or Grade ≥ 3 with clinically significant bleeding or requiring platelet transfusion." (NCT01881789)
Timeframe: Cycle 1, 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 2 |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 0 |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 1 |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 0 |
Duration of Response (DOR)
"Duration of response was defined as the time from first evidence of partial response (PR) or better to confirmation of disease progression or death due to any cause.~Median DOR was estimated using Kaplan-Meier methods. Participants who started a new anticancer therapy before documentation of disease progression or death, or who were alive without documentation of disease progression before the data cut-off date or who died or had disease progression immediately after more than 1 consecutively missed disease assessment visit were censored at the date of last disease assessment." (NCT01881789)
Timeframe: Disease response was assessed every 4 weeks for 24 cycles then every 8 weeks until end of treatment; median time on follow-up at the analysis cut-off date of 18 July 2016 was 14.1, 3.5, 2.6, 16.0, 3.6, and 11.2 months in each group, respectively.
| Intervention | months (Median) |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | NA |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | NA |
Plasma Oprozomib Concentration
"Plasma samples for oprozomib concentration assays were only collected for participants in the 5/14 dosing schedule groups.~Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry." (NCT01881789)
Timeframe: Cycle 1 day 1 at 1 to 2.5 hours and 2.75 to 5 hours after end of infusion (EOI) and cycle 3 day 1 at predose and 1 to 2.5 hours and 2.75 to 5 hours after EOI.
| Intervention | ng/mL (Mean) |
|---|
| Cycle 1 day 1, 1 - 2.5 hours post EOI | Cycle 1 day 1, 2.75 - 5 hours post EOI | Cycle 3 day 1, predose | Cycle 3 day 1, 1 - 2.5 hours post EOI | Cycle 3 day 1, 2.75 - 5 hours post EOI |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 497 | 299 | 0.0 | 111 | 2.00 |
,| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 632 | 15.8 | 142 | 175 | 255 |
,| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 697 | 78.0 | 0.0 | 178 | 69.1 |
Overall Response Rate (ORR)
"ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria.~PR: ≥ 50% reduction of serum M-protein and ≥ 90% reduction in urine M-protein or to < 200 mg/24 hrs, or a ≥ 50% decrease in dFLC. A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline.~VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein <100 mg/24 hrs. If disease measurable only by SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC).~CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC.~sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM). (NCT01881789)
Timeframe: Disease response was assessed every 4 weeks for 24 cycles then every 8 weeks until end of treatment; median duration of treatment at the analysis cutoff date of 18 July 2016 was 29.1, 12.4, 11.3, 66.6, 7.8 and 46.4 weeks in each group, respectively
| Intervention | percentage of participants (Number) |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 66.7 |
| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 57.1 |
| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 66.7 |
| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 100.0 |
| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 50.0 |
| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 100.0 |
Number of Participants With Treatment-emergent Adverse Events (AEs)
"Adverse events (AEs) were graded using NCI-CTCAE (version 4.03) and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE.~A serious AE is an event that met 1 or more of the following criteria:~Death~Life-threatening experience~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~A congenital anomaly birth defect in the offspring of an exposed female subject or offspring of a female partner of a male subject~Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent an outcome listed above.~Treatment-related AEs are those considered related to at least 1 study drug by the investigator." (NCT01881789)
Timeframe: From first dose of any study treatment to 30 days after last dose; median duration of treatment was 29.1, 12.4, 11.3, 66.6, 7.8, and 46.4 weeks in each treatment group, respectively.
| Intervention | Participants (Count of Participants) |
|---|
| Any treatment-emergent adverse event (TEAE) | TEAE ≥ grade 3 | Serious adverse events | TEAEs leading to discontinuation of study drug | Fatal adverse events | Treatment-related adverse events (TRAE) | TRAE ≥ grade 3 | Treatment-related serious adverse events | TRAEs leading to discontinuation of study drug |
|---|
| Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone | 3 | 3 | 2 | 1 | 0 | 3 | 3 | 2 | 1 |
,| Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone | 7 | 6 | 4 | 1 | 0 | 7 | 6 | 4 | 1 |
,| Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone | 3 | 2 | 1 | 0 | 0 | 3 | 2 | 1 | 0 |
,| Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone | 3 | 3 | 2 | 1 | 0 | 3 | 2 | 1 | 1 |
,| Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone | 3 | 3 | 3 | 2 | 0 | 3 | 2 | 2 | 2 |
,| Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone | 2 | 2 | 1 | 1 | 0 | 2 | 2 | 1 | 1 |
Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores
Patient-assessed satisfaction was evaluated using RASQ. Participants were asked questions regarding convenience and satisfaction for rituximab SC. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. DLBCL participants could be enrolled at cycle 2, cycle 3, or cycle 4. FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must be able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Each Cycle is 21 days for DLBCL. Each Cycle 21 days during the Induction phase and 2 months during Maintenance phase for FL. (NCT01889069)
Timeframe: DLBCL: Cycle (C) 2, C3, C4, C5, C6, End of C8; FL: Induction: C3, C4, C5, C6, C8, Maintenance: C2, C3, C4, C5, C6, C7, C8, C10, C12, End of treatment (4-8 weeks after last dose)
| Intervention | Units on a Scale (Mean) |
|---|
| Convenience domain Cycle 3 Induction | Convenience domain Cycle 4 Induction | Convenience domain Cycle 5 Induction | Convenience domain Cycle 6 Induction | Convenience domain Cycle 8 Induction | Convenience domain Cycle 2 Maintenance | Convenience domain Cycle 3 Maintenance | Convenience domain Cycle 4 Maintenance | Convenience domain Cycle 5 Maintenance | Convenience domain Cycle 6 Maintenance | Convenience domain Cycle 7 Maintenance | Convenience domain Cycle 8 Maintenance | Convenience domain Cycle 10 Maintenance | Convenience domain Cycle 12 Maintenance | Convenience domain End of Treatment | Satisfaction domain Cycle 3 Induction | Satisfaction domain Cycle 4 Induction | Satisfaction domain Cycle 5 Induction | Satisfaction domain Cycle 6 Induction | Satisfaction domain Cycle 8 Induction | Satisfaction domain Cycle 2 Maintenance | Satisfaction domain Cycle 3 Maintenance | Satisfaction domain Cycle 4 Maintenance | Satisfaction domain Cycle 5 Maintenance | Satisfaction domain Cycle 6 Maintenance | Satisfaction domain Cycle 7 Maintenance | Satisfaction domain Cycle 8 Maintenance | Satisfaction domain Cycle 10 Maintenance | Satisfaction domain Cycle 12 Maintenance | Satisfaction domain End of Treatment |
|---|
| Follicular Lymphoma (FL) | 81.8 | 76.5 | 79.6 | 95.8 | 83.1 | 83.6 | 87.5 | 100.0 | 80.2 | 83.3 | 82.7 | 93.8 | 91.7 | 86.3 | 75.0 | 89.4 | 84.1 | 91.7 | 93.8 | 91.3 | 92.0 | 79.2 | 100.0 | 79.7 | 87.5 | 94.2 | 93.8 | 50.0 | 91.0 | 75.0 |
Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores
Patient-assessed satisfaction was evaluated using RASQ. Participants were asked questions regarding convenience and satisfaction for rituximab SC. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. DLBCL participants could be enrolled at cycle 2, cycle 3, or cycle 4. FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must be able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Each Cycle is 21 days for DLBCL. Each Cycle 21 days during the Induction phase and 2 months during Maintenance phase for FL. (NCT01889069)
Timeframe: DLBCL: Cycle (C) 2, C3, C4, C5, C6, End of C8; FL: Induction: C3, C4, C5, C6, C8, Maintenance: C2, C3, C4, C5, C6, C7, C8, C10, C12, End of treatment (4-8 weeks after last dose)
| Intervention | Units on a Scale (Mean) |
|---|
| Convenience domain Cycle 2 Treatment | Convenience domain Cycle 3 Treatment | Convenience domain Cycle 4 Treatment | Convenience domain Cycle 5 Treatment | Convenience domain Cycle 6 Treatment | Convenience domain Cycle 8 Treatment | Satisfaction domain Cycle 2 Treatment | Satisfaction domain Cycle 3 Treatment | Satisfaction domain Cycle 4 Treatment | Satisfaction domain Cycle 5 Treatment | Satisfaction domain Cycle 6 Treatment | Satisfaction domain Cycle 8 Treatment |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 75.0 | 81.9 | 82.1 | 83.3 | 80.8 | 83.8 | 87.5 | 83.3 | 85.6 | 83.3 | 84.6 | 91.2 |
Percentage of Participants With Administration-Associated Reactions (AAR)
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01889069)
Timeframe: Baseline up to 54 months
| Intervention | Percentage of Participants (Number) |
|---|
| At least One AAR | At Least One AAR Grade ≥3 | Cutaneous and Soft Tissue AARs (Localized) | Cutaneous and Soft Tissue AARs (Non-Localized) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 4.2 | 0 | 1.4 | 2.8 |
,| Follicular Lymphoma (FL) | 8.1 | 0 | 8.1 | 0 |
,| Subcutaneous (SC) Rituximab | 6.3 | 0 | 5.1 | 1.3 |
DLBCL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Geometric Least Squares Mean) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 70.50 |
DLBCL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 8 Predose |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 53.97 | 101.79 | 110.50 | 121.67 | 109.40 | 157.93 | 132.57 |
DLBCL: Apparent Total Clearance (CL/F) of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | liter per hour (L/h) (Mean) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | NA |
DLBCL: Area Under the Plasma Concentration-Time Curve (AUC) of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | mcg*hr/mL (Mean) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | NA |
DLBCL: Maximum Plasma Concentration (Cmax) of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | NA |
FL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab
FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. PK data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Geometric Least Squares Mean) |
|---|
| Follicular Lymphoma (FL) | 61.01 |
Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the CTCAE, version 4.0. (NCT01889069)
Timeframe: Baseline up to 54 months
| Intervention | Percentage of Participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 51.4 |
| Follicular Lymphoma (FL) | 43.0 |
| Subcutaneous (SC) Rituximab | 46.8 |
Percentage of Participants With Overall Survival (OS)
OS was defined as the time from first dose of rituximab to death from any cause. (NCT01889069)
Timeframe: Day 1 until death (up to maximum 54 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 19.4 |
| Follicular Lymphoma (FL) | 4.7 |
| Subcutaneous (SC) Rituximab | 11.4 |
Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events
SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. (NCT01889069)
Timeframe: Baseline up to 54 months
| Intervention | Percentage of Participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 36.1 |
| Follicular Lymphoma (FL) | 26.7 |
| Subcutaneous (SC) Rituximab | 31.0 |
Percentage of Participants With Complete Response (CR) According to IWG Response Criteria
Complete response required: 1) the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities, 2) all lymph nodes and nodal masses had regressed to normal size, 3) the spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and not be palpable on physical examination and 4) if the bone marrow was involved by lymphoma before treatment, the infiltrate was cleared on repeat bone marrow aspirate and biopsy of the same site. CR/unconfirmed (CRu) included those patients who fulfilled criteria 1 and 3 above as well as 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that regressed by more than 75% in the SPD and 2) indeterminate bone marrow. Response was assessed according to the IWG response criteria. (NCT01889069)
Timeframe: At 4 to 8 weeks after end of Induction period (end of Induction period = up to 8 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 65.2 |
| Follicular Lymphoma (FL) | 67.9 |
| Subcutaneous (SC) Rituximab | 66.4 |
Percentage of Participants With Disease-Free Survival (DFS) According to IWG Response Criteria
DFS assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from 4 to 8 weeks after end of Induction period up to relapse or death from any cause, whichever occured first. (NCT01889069)
Timeframe: From 4 to 8 weeks after end of Induction period up to relapse or death from any cause, whichever occurs first (up to maximum 54 months) (end of Induction period = up to 8 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 21.7 |
| Follicular Lymphoma (FL) | 25.6 |
| Subcutaneous (SC) Rituximab | 23.5 |
Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria
EFS was defined as the time from first dose of rituximab to first occurrence of progression or relapse, according to the International Working Group (IWG) response criteria or other country standards, or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurred first. (NCT01889069)
Timeframe: Day 1 up to first occurrence of progression or relapse, or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first (up to maximum 54 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 29.2 |
| Follicular Lymphoma (FL) | 22.1 |
| Subcutaneous (SC) Rituximab | 25.3 |
DLBCL: Plasma Trough Concentrations of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 pre-dose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 8 Predose |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 42.53 | 88.92 | 110.50 | 100.20 | 92.92 | 141.44 | 117.61 |
DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21
Plasma concentrations of rituximab in participants with DLBCL by chemotherapy regimen cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 14 days (R-CHOP-14) or cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 21 days (R-CHOP-21) in the PK) population.DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 7 Day 7 | Cycle 7 Day 14 | Cycle 8 Predose |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-21 | 28.37 | 88.92 | 110.50 | 94.00 | 74.25 | 150.13 | 398.76 | 272.50 | 123.76 |
DLBCL: Plasma Concentrations of Rituximab
DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 7 Day 7 | Cycle 7 Day 14 | Cycle 8 Predose |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 42.53 | 88.92 | 110.50 | 100.20 | 92.92 | 141.44 | 348.81 | 226.40 | 117.61 |
Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria
PFS was defined as the time from first dose of rituximab to the first occurrence of disease progression or relapse, according to the International Working Group (IWG) response criteria or other country standards, or death from any cause, whichever occurred first. (NCT01889069)
Timeframe: Day 1 up to first occurrence of progression or relapse, or death, whichever occurs first (up to maximum 54 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | 29.2 |
| Follicular Lymphoma (FL) | 22.1 |
| Subcutaneous (SC) Rituximab | 25.3 |
DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21
Plasma concentrations of rituximab in participants with DLBCL by chemotherapy regimen cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 14 days (R-CHOP-14) or cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 21 days (R-CHOP-21) in the PK) population.DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Cycle 2 Predose | Cycle 5 Predose | Baseline | Cycle 7 Predose | Cycle 7 Day 7 | Cycle 7 Day 14 | Cycle 8 Predose |
|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-14 | 170.00 | 125.00 | 214.25 | 93.50 | 71.55 | 42.00 | 78.50 |
FL: Plasma Trough Concentrations of Rituximab
FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Pharmacokinetic (PK) data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 8 Predose |
|---|
| Follicular Lymphoma (FL) | 55.49 | 119.50 | 157.25 | 7.60 | 90.88 | 201.56 |
FL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)
FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. PK data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1
| Intervention | micrograms per millilitre (ug/mL) (Mean) |
|---|
| Cycle 2 Predose | Cycle 3 Predose | Cycle 4 Predose | Cycle 5 Predose | Baseline | Cycle 8 Predose |
|---|
| Follicular Lymphoma (FL) | 48.86 | 156.33 | 200.33 | 7.60 | 97.90 | 284.08 |
Time to Progression (Phase I, Phase II, and Pediatric)
TTP is defined as the time from date of first dose of fludarabine until evidence of disease progression. (NCT01898793)
Timeframe: Up to 3 years
| Intervention | days (Median) |
|---|
| Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells | 20.0 |
| Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells | 36.0 |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | 46.0 |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | 33.0 |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | 34.0 |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | 28.0 |
Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)
DOR is defined only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR), and is measured from the first date of attaining CR or PR until the date of disease progression or death. (NCT01898793)
Timeframe: Up to 3 years
| Intervention | days (Median) |
|---|
| Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells | 126.0 |
| Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells | 22.0 |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | 76.5 |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | 30.0 |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | 80.0 |
Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)
"Complete remission rate (CR): Morphologically leukemia free state (i.e. bone marrow with <5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions~Complete Remission with Incomplete Blood Count Recovery (CRi): All of the above criteria for CR must be met, except that absolute neutrophils <1000 /μL or platelets <100,000 /μL in the blood." (NCT01898793)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | 3 |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | 0 |
Overall Survival (OS) (Phase I, Phase II, and Pediatric)
OS is defined from the date of first dose of fludarabine on this study until death. (NCT01898793)
Timeframe: Up to 3 years
| Intervention | days (Median) |
|---|
| Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells | 39.00 |
| Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells | 142.50 |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | 49.00 |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | 38.00 |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | 92.00 |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | 147.00 |
Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric)
DFS is defined as the time from the day CR, mCR, or CRi is documented until disease progression or death. (NCT01898793)
Timeframe: Up to 3 years
| Intervention | days (Median) |
|---|
| Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells | 126.00 |
| Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells | 73.00 |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | 56.00 |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | 30.00 |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | 60.00 |
Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)
Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) or the maximum dose if less than or equal to 1 patient suffers a DLT at the maximum dose. (NCT01898793)
Timeframe: 35 days
| Intervention | x 10^7 cells/kg (Number) |
|---|
| Phase I | 1.0 |
Number of Participants With Adverse Events of Particular Interest (AEPIs)
"The following AEs were defined as AEPIs: AEs with the preferred term Progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation defined as AEs with preferred term containing Hepatitis B or hepatitis acute, thrombocytopenia defined via Roche MedDRA basket subgroup haematopoietic thrombocytopenia, second malignancies defined as AEs from the SOC Neoplasms benign, malignant and unspecified starting 6 months after the first study drug intake, second malignancies based on standardised MedDRA queries (SMQ) starting 6 months after the first study drug intake based on the MedDRA SMQ Malignant or unspecified tumours, in which benign neoplasms are not included, Cardiac events including AEs from the SOC Cardiac disorders, and hemorrhagic events defined via Roche MedDRA basket subgroup Haemorrhagic events. Reported are number of participants with total AEPIs and each of the AEPI categories." (NCT01905943)
Timeframe: Baseline up to time of primary completion (3 years)
| Intervention | Participants (Count of Participants) |
|---|
| Total AEPIs | Thrombocytopenia | Cardiac events | Second malignancies | Second malignancies (SMQ) | Hemorrhagic events | Hepatitis B reactivation | PML |
|---|
| Obinutuzumab | 467 | 314 | 109 | 82 | 75 | 69 | 3 | 1 |
Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry
MRD-negativity was defined as the presence of less than 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes in blood and bone marrow as assessed by flow cytometry 3 months after last dose of study treatment (i.e. at final response assessment [FRA] visit). (NCT01905943)
Timeframe: 3 months after the last dose of study treatment (up to approximately 5 years)
| Intervention | percentage of participants (Number) |
|---|
| Blood | Bone Marrow |
|---|
| G Mono: Previously Untreated Fit | 8.3 | 4.2 |
,| G Mono: Previously Untreated Unfit | 23.1 | 3.8 |
,| G Mono: Relapsed/Refractory | 4.1 | 2.0 |
,| G-Benda: Previously Untreated Fit | 63.1 | 31.5 |
,| G-Benda: Previously Untreated Unfit | 65.3 | 27.2 |
,| G-Benda: Relapsed/Refractory | 39.8 | 14.9 |
,| G-Clb: Previously Untreated Unfit | 9.4 | 5.7 |
,| G-Clb: Relapsed/Refractory | 6.3 | 3.1 |
,| G-FC: Previously Untreated Fit | 72.0 | 40.0 |
,| G-FC: Previously Untreated Unfit | 58.3 | 41.7 |
,| G-FC: Relapsed/Refractory | 51.5 | 24.2 |
Number of Participants With Adverse Events of Special Interest (AESIs)
"The following AEs were defined as AESIs: AEs with the preferred term Tumour Lysis Syndrome (TLS), Infusion-Related Reactions (IRRs) defined as AEs that occurred during or within 24 hours of the completion of obinutuzumab infusion and were assessed as related to obinutuzumab by the Investigator, Infections defined as AEs from System Organ Class (SOC) Infections and infestations and AEs with the preferred term Neutropenia. Reported are number of participants with total AESIs, IRRs, Infections, Neutropenia and TLS." (NCT01905943)
Timeframe: Baseline up to time of primary completion (3 years)
| Intervention | Participants (Count of Participants) |
|---|
| Total AESIs | IRRs | Neutropenia | Infections | TLS |
|---|
| Obinutuzumab | 905 | 635 | 599 | 521 | 62 |
Number of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). (NCT01905943)
Timeframe: Baseline up to time of primary completion (3 years)
| Intervention | Participants (Count of Participants) |
|---|
| AEs | Grade 3-5 AEs | SAEs |
|---|
| Obinutuzumab | 950 | 780 | 516 |
Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA)
OR: percentage of participants with complete response (CR) or CR with incomplete marrow recovery (CRi), or partial response (PR), as determined by the investigator based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin. (NCT01905943)
Timeframe: 3 months after the last dose of study treatment (up to approximately 5 years)
| Intervention | percentage of participants (Number) |
|---|
| G Mono: Previously Untreated Fit | 71.0 |
| G Mono: Previously Untreated Unfit | 59.4 |
| G Mono: Relapsed/Refractory | 41.5 |
| G-Benda: Previously Untreated Fit | 83.9 |
| G-Benda: Previously Untreated Unfit | 81.6 |
| G-Benda: Relapsed/Refractory | 73.2 |
| G-FC: Previously Untreated Fit | 90.0 |
| G-FC: Previously Untreated Unfit | 84.6 |
| G-FC: Relapsed/Refractory | 85.0 |
| G-Clb: Previously Untreated Fit | 100 |
| G-Clb: Previously Untreated Unfit | 82.1 |
| G-Clb: Relapsed/Refractory | 56.5 |
Percentage of Participants With Best Overall Response (BOR)
BOR was defined as the percentage of participants with the best response obtained throughout the trial with CR, CRi, or PR, as determined by the investigator based on IWCLL tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin. (NCT01905943)
Timeframe: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)
| Intervention | percentage of participants (Number) |
|---|
| G Mono: Previously Untreated Fit | 83.9 |
| G Mono: Previously Untreated Unfit | 71.9 |
| G Mono: Relapsed/Refractory | 60.0 |
| G-Benda: Previously Untreated Fit | 91.7 |
| G-Benda: Previously Untreated Unfit | 93.9 |
| G-Benda: Relapsed/Refractory | 86.8 |
| G-FC: Previously Untreated Fit | 97.1 |
| G-FC: Previously Untreated Unfit | 84.6 |
| G-FC: Relapsed/Refractory | 97.5 |
| G-Clb: Previously Untreated Fit | 100 |
| G-Clb: Previously Untreated Unfit | 94.0 |
| G-Clb: Relapsed/Refractory | 84.8 |
Descriptive of Neuropathic Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)
| Intervention | Participants (Count of Participants) |
|---|
| Peripheral sensory neuropathy | Pain in extremity | Neuralgia | Pain NOS |
|---|
| Cycle 1 - Grade 2 | 0 | 3 | 1 | 1 |
,| Cycle 1 - Grade 3-4 | 0 | 1 | 0 | 0 |
,| Cycle 2 - Grade 2 | 1 | 4 | 0 | 1 |
,| Cycle 2 - Grade 3-4 | 0 | 0 | 0 | 0 |
,| Cycle 3 - Grade 2 | 2 | 1 | 0 | 0 |
,| Cycle 3 - Grade 3-4 | 0 | 0 | 0 | 0 |
,| Cycle 4 - Grade 2 | 3 | 1 | 0 | 0 |
,| Cycle 4 - Grade 3-4 | 0 | 0 | 0 | 0 |
,| Cycle 5 - Grade 2 | 1 | 2 | 1 | 0 |
,| Cycle 5 - Grade 3-4 | 0 | 0 | 0 | 0 |
,| Cycle 6 - Grade 2 | 1 | 0 | 0 | 1 |
,| Cycle 6 - Grade 3-4 | 0 | 0 | 0 | 1 |
Descriptive of Infectious Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)
| Intervention | Participants (Count of Participants) |
|---|
| Febrile neutropenia | Mucositis | Upper respiratory infection | Genitourinary infection |
|---|
| Cycle 1 - Grade 2 | 0 | 10 | 5 | 1 |
,| Cycle 1 - Grade 3-4 | 6 | 2 | 2 | 0 |
,| Cycle 2 - Grade 2 | 0 | 6 | 3 | 1 |
,| Cycle 2 - Grade 3-4 | 3 | 4 | 0 | 0 |
,| Cycle 3 - Grade 2 | 0 | 0 | 0 | 2 |
,| Cycle 3 - Grade 3-4 | 0 | 0 | 0 | 0 |
,| Cycle 4 - Grade 2 | 0 | 1 | 0 | 1 |
,| Cycle 4 - Grade 3-4 | 2 | 0 | 2 | 0 |
,| Cycle 5 - Grade 2 | 0 | 1 | 0 | 2 |
,| Cycle 5 - Grade 3-4 | 1 | 0 | 0 | 0 |
,| Cycle 6 - Grade 2 | 0 | 1 | 0 | 0 |
,| Cycle 6 - Grade 3-4 | 0 | 0 | 0 | 0 |
Descriptive of Hematological Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)
| Intervention | Participants (Count of Participants) |
|---|
| Leukopenia | Neutropenia | Lymphopenia | Anemia | Thrombocytopenia |
|---|
| Cycle 1 - Grade 2 | 15 | 5 | 15 | 23 | 3 |
,| Cycle 1 - Grade 3-4 | 49 | 62 | 36 | 12 | 3 |
,| Cycle 2 - Grade 2 | 28 | 13 | 18 | 28 | 2 |
,| Cycle 2 - Grade 3-4 | 23 | 51 | 15 | 5 | 1 |
,| Cycle 3 - Grade 2 | 8 | 7 | 9 | 6 | 0 |
,| Cycle 3 - Grade 3-4 | 4 | 10 | 7 | 1 | 2 |
,| Cycle 4 - Grade 2 | 5 | 5 | 16 | 6 | 0 |
,| Cycle 4 - Grade 3-4 | 5 | 3 | 15 | 0 | 1 |
,| Cycle 5 - Grade 2 | 7 | 4 | 13 | 4 | 0 |
,| Cycle 5 - Grade 3-4 | 2 | 3 | 22 | 1 | 1 |
,| Cycle 6 - Grade 2 | 14 | 8 | 20 | 2 | 1 |
,| Cycle 6 - Grade 3-4 | 5 | 6 | 31 | 1 | 2 |
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients. (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
| Intervention | percentage of participants (Number) |
|---|
| AEPA Chemotherapy | 31.25 |
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients. (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
| Intervention | percentage of participants (Number) |
|---|
| AEPA Chemotherapy | 31.25 |
Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.
The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT01920932)
Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
| Intervention | Probability (Number) |
|---|
| AEPA/CAPDac | 0.013 |
Complete Response Rate Estimate for All Evaluable Participants
To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL). (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
| Intervention | percentage of participants (Number) |
|---|
| AEPA/CAPDac | 35 |
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2). (NCT01920932)
Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
| Intervention | probability (Number) |
|---|
| AEPA/CAPDac | 0.974 |
MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia
To determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia [B-ALL], mixed phenotype, and Burkitt's). The MTD is defined as the highest dose studied in which the incidence of dose-limiting toxicities is < 33% using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. (NCT01925131)
Timeframe: 28 days
| Intervention | mg/m^2 (Number) |
|---|
| Day 1 Dose | Day 8 Dose | Day 15 Dose |
|---|
| CVP + Inotuzumab | 0.8 | 0.5 | 0.5 |
Frequency and Severity of Toxicities
Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported by given type of adverse event. (NCT01925131)
Timeframe: Up to 3 years
| Intervention | Participants (Number) |
|---|
| Anemia | Ascites | Dysphagia | Encephalopathy | Enterocolitis | Fatigue | Febrile neutropenia | Fever | Gastric hemorrhage | Gastrointestinal disorders - Other, specify | Headache | Hyperglycemia | Hypertension | Hypoalbuminemia | Hypocalcemia | Hypokalemia | Infections and infestations - Other, specify | Intracranial hemorrhage | Lipase increased | Lung infection | Lymphocyte count decreased | Mucositis oral | Neutrophil count decreased | Platelet count decreased | Renal and urinary disorders - Other, specify | Sepsis | Skin infection | White blood cell decreased |
|---|
| CVP + Inotuzumab Dose Level 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 3 | 2 | 0 | 0 | 0 | 3 |
,| CVP + Inotuzumab Dose Level 2 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 2 | 0 | 0 | 0 | 4 |
,| CVP + Inotuzumab Dose Level 3 | 7 | 0 | 1 | 1 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 9 | 7 | 0 | 0 | 1 | 10 |
,| CVP + Inotuzumab Dose Level 4 | 3 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 3 | 0 | 4 | 4 | 0 | 0 | 0 | 5 |
,| CVP + Inotuzumab Dose Level 5 | 5 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 0 | 8 | 5 | 0 | 0 | 0 | 7 |
,| CVP + Inotuzumab MTD | 5 | 1 | 0 | 0 | 0 | 1 | 7 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 1 | 0 | 6 | 1 | 8 | 10 | 1 | 2 | 0 | 9 |
Response Rate (CR+CRi) Among Expansion Cohort
The response rate (CR + CRi) is defined as the rate of complete remission (CR) + complete remission with incomplete count recovery (CRi). Complete remission (CR) is defined as < 5% marrow aspirate blasts, neutrophils ≥ 1000/uL, platelets > 100,000/uL, no blasts in peripheral blood, and C1 Extramedullary disease status. C1 Extramedullary disease status is characterized by complete disappearance of all measurable and non-measurable extramedullary disease with the exception of lesions for which the following must be true: for participants with at least one measurable lesion, all lesions must have reduced by 75% in sum of products of greatest diameters (SPD), have no new lesions, and the spleen and other previously enlarged organs must have regressed in size. Complete remission with incomplete platelet recovery (CRi) is defined the same as CR, except absolute neutrophil count may be <1000/uL and/or platelet count may be ≤ 100,000/uL. (NCT01925131)
Timeframe: Up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| CVP + Inotuzumab MTD | 83.33 |
Complete Remission Rate
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). (NCT01925612)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | 20 |
| Part 1: BV(1.8 mg/kg) + RCHOP | 16 |
| Part 2: BV(1.8 mg/kg) + RCHP | 9 |
| Part 3: BV(1.8 mg/kg) + RCHP | 6 |
| Part 3: RCHOP | 8 |
Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. (NCT01925612)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Any Hematology Test | Lymphocytes (x10^3/uL) | Absolute Neutrophil Count (x10^3/uL) | Neutrophils (x10^3/uL) | Leukocytes (x10^3/uL) | Hemoglobin (x10^3/uL) | Platelets (x10^3/uL) | Any Chemistry Test | Glucose (mg/dL) | Potassium (mEq)/L | Calcium (mg/dL) | Sodium (mEq/L) | Alanine Aminotransferase (IU/L) |
|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | 10 | 8 | 4 | 4 | 3 | 0 | 1 | 4 | 3 | 0 | 1 | 0 | 0 |
,| Part 1: BV(1.8 mg/kg) + RCHOP | 16 | 15 | 4 | 4 | 2 | 1 | 1 | 7 | 5 | 2 | 1 | 2 | 0 |
,| Part 2: BV(1.8 mg/kg) + RCHP | 4 | 3 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 1 |
,| Part 3: BV(1.8 mg/kg) + RCHP | 6 | 4 | 2 | 2 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
,| Part 3: RCHOP | 4 | 4 | 0 | 0 | 1 | 0 | 0 | 3 | 1 | 2 | 0 | 0 | 0 |
Overall Survival
Median overall survival (in months) and observed minimum-maximum range. (NCT01925612)
Timeframe: Up to approximately 4 years
| Intervention | Months (Median) |
|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | NA |
| Part 1: BV(1.8 mg/kg) + RCHOP | NA |
| Part 2: BV(1.8 mg/kg) + RCHP | NA |
| Part 3: BV(1.8 mg/kg) + RCHP | NA |
| Part 3: RCHOP | NA |
Incidence of Adverse Events
Number (count) of participants that experienced at least 1 adverse event. (NCT01925612)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | 29 |
| Part 1: BV(1.8 mg/kg) + RCHOP | 22 |
| Part 2: BV(1.8 mg/kg) + RCHP | 11 |
| Part 3: BV(1.8 mg/kg) + RCHP | 11 |
| Part 3: RCHOP | 12 |
Objective Response Rate
Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) (NCT01925612)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | 23 |
| Part 1: BV(1.8 mg/kg) + RCHOP | 19 |
| Part 2: BV(1.8 mg/kg) + RCHP | 10 |
| Part 3: BV(1.8 mg/kg) + RCHP | 10 |
| Part 3: RCHOP | 9 |
Progression-free Survival
Median progression-free survival (in months) and observed minimum-maximum range. (NCT01925612)
Timeframe: Up to approximately 4 years
| Intervention | Months (Median) |
|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | NA |
| Part 1: BV(1.8 mg/kg) + RCHOP | NA |
| Part 2: BV(1.8 mg/kg) + RCHP | NA |
| Part 3: BV(1.8 mg/kg) + RCHP | NA |
| Part 3: RCHOP | NA |
Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants
Response rate will be defined as the proportion of patients who achieved complete response or partial response (CR+PR) using the World Health Organization (WHO) criteria evaluated after two initial courses of temsirolimus, temozolomide and irinotecan in previously untreated patients with high risk Ewing Sarcoma Family of Tumor (ESFT). Participants who are treated in Group B with Desmoplastic Small Round Cell Tumor (DSRCT) or those who do not receive window therapy will not be included in this analysis. (NCT01946529)
Timeframe: at 6 weeks after start of therapy (after 2 initial courses)
| Intervention | participants (Number) |
|---|
| Partial Response (PR) | Stable disease (no response) (NR) | Progressive Disease (PD) |
|---|
| Group B (High Risk) - ESFT | 3 | 8 | 1 |
Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event are reported below. (NCT01955434)
Timeframe: Up to 30 days after the last day of study drug treatment
| Intervention | percentage of patients (Number) |
|---|
| Anemia | Fatigue | Nausea | Platelet count decreased | Neutrophil count decreased | Lymphocyte count decreased | Vomiting | White blood cell decreased | Diarrhea | Rash maculo-papular | Hyperglycemia | Lymphocyte count increased | Syncope | Hyperuricemia | Hypotension | Lung infection | Pain in extremity | Sepsis | Uriticaria |
|---|
| Treatment (SMAC Mimetic LCL161 and Cyclophosphamide) | 24 | 16 | 4.0 | 12.0 | 36.0 | 52.0 | 4.0 | 20.0 | 4.0 | 4.0 | 12.0 | 8 | 12.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 |
Overall Survival
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT01955434)
Timeframe: From registration to death due to any cause, assessed up to 1 year
| Intervention | months (Median) |
|---|
| Treatment (SMAC Mimetic LCL161 and Cyclophosphamide) | NA |
Event-free Survival
The event-free survival time is defined as the time from registration to disease progression while receiving LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma. Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of cyclophosphamide. If a patient goes off study treatment and never received cyclophosphamide, they will be censored on the date they went off study treatment. If a patient initiates cyclophosphamide but later discontinues cyclophosphamide due to toxicity and continues LCL161 alone, disease progression on LCL161 alone will be considered an event in this case. The distribution of event-free survival will be estimated using the method of Kaplan-Meier. (NCT01955434)
Timeframe: From registration to disease progression while receiving SMAC mimetic LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 1 year
| Intervention | months (Median) |
|---|
| Treatment (SMAC Mimetic LCL161 and Cyclophosphamide) | 10.0 |
Confirmed Overall Response Rate (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) With Single Agent SMAC Mimetic LCL161
The primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), or PR (If present at baseline, ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to <200 mg/24hrs) noted as the objective status on two consecutive evaluations while receiving single agent LCL161.The rate (percentage) of successes will be estimated by the number of successes divided by the total number of evaluable patients times 100. 95% confidence intervals for the true success percentage will be calculated by the exact binomial method. (NCT01955434)
Timeframe: Up to 1 year
| Intervention | percentage of patients (Number) |
|---|
| Treatment (SMAC Mimetic LCL161 and Cyclophosphamide) | 0 |
Combination Agent Response Rate
The overall response rate (percentage) with the addition of cyclophosphamide will be estimated by the number of patients who achieve a confirmed overall response at any time (with SMAC mimetic LCL161 plus cyclophosphamide) divided by the number of evaluable patients times 100. 95% confidence intervals for the true confirmed overall response rate will be calculated by the exact binomial method. (NCT01955434)
Timeframe: Up to 1 year
| Intervention | percentage of patients (Number) |
|---|
| Treatment (SMAC Mimetic LCL161 and Cyclophosphamide) | 17.4 |
Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.
Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy. (NCT01959490)
Timeframe: Up to 30 days after last cycle of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1P (HER2 Positive) | 4 |
| Cohort 1T (HER2 Positive) | 6 |
| Cohort II (HER2 Negative) | 3 |
Progression-free Survival (PFS) Rate at 3 Months
PFS is defined as the time from first treatment day until objective disease progression or death from any cause. Assessment of disease progression based on Response Evaluation Criteria in Solid Tumor (RESIST) guideline version 1.1 is performed every 12 weeks on study. The percent of participants with PFS at 3 months will be reported. (NCT01963481)
Timeframe: 3 months
| Intervention | percent of participants (Number) |
|---|
| Exemestane and Cyclophosphamide | 50.1 |
Response Rate (RR) - Complete Response and Partial Response
Complete response (CR) is defined as the disappearance of all target lesions, while partial response (PR) is when at least a 30% decrease in the sum of the diameters of target lesions. Evaluation of response is based on RESIST guideline version 1.1. RR is reported as percentage of participants with a CR and/or PR at 2 years. (NCT01963481)
Timeframe: 2 years
| Intervention | percent of participants (Number) |
|---|
| Exemestane and Cyclophosphamide | 26.1 |
Clinical Benefit Rate Score
Clinical benefit rate is defined as the percentage of patients who have achieved objective response or stable disease for at least 24 weeks. Evaluation of response and disease progression is based on RESIST guideline version 1.1. Response and progression are assessed every 12 weeks. (NCT01963481)
Timeframe: 3 years
| Intervention | percent of participants (Number) |
|---|
| Exemestane and Cyclophosphamide | 47.8 |
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). (NCT01966471)
Timeframe: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
| Intervention | Units on a Scale (Mean) |
|---|
| Baseline: Appetite Loss | Change at Cycle 1: Appetite Loss | Change at Cycle 2: Appetite Loss | Change at Cycle 3: Appetite Loss | Change at Cycle 4: Appetite Loss | Change at Cycle 5: Appetite Loss | Change at Cycle 9: Appetite Loss | Change at Cycle 14: Appetite Loss | Change at EoT: Appetite Loss | Change at FU Month 6: Appetite Loss | Change at FU Month 12: Appetite Loss | Baseline: Constipation | Change at Cycle 1: Constipation | Change at Cycle 2: Constipation | Change at Cycle 3: Constipation | Change at Cycle 4: Constipation | Change at Cycle 5: Constipation | Change at Cycle 9: Constipation | Change at Cycle 14: Constipation | Change at EoT: Constipation | Change at FU Month 6: Constipation | Change at FU Month 12: Constipation | Baseline: Diarrhea | Change at Cycle 1: Diarrhea | Change at Cycle 2: Diarrhea | Change at Cycle 3: Diarrhea | Change at Cycle 4: Diarrhea | Change at Cycle 5: Diarrhea | Change at Cycle 9: Diarrhea | Change at Cycle 14: Diarrhea | Change at EoT: Diarrhea | Change at FU Month 6: Diarrhea | Change at FU Month 12: Diarrhea | Baseline: Dyspnea | Change at Cycle 1: Dyspnea | Change at Cycle 2: Dyspnea | Change at Cycle 3: Dyspnea | Change at Cycle 4: Dyspnea | Change at Cycle 5: Dyspnea | Change at Cycle 9: Dyspnea | Change at Cycle 14: Dyspnea | Change at EoT: Dyspnea | Change at FU Month 6: Dyspnea | Change at FU Month 12: Dyspnea | Baseline: Fatigue | Change at Cycle 1: Fatigue | Change at Cycle 2: Fatigue | Change at Cycle 3: Fatigue | Change at Cycle 4: Fatigue | Change at Cycle 5: Fatigue | Change at Cycle 9: Fatigue | Change at Cycle 14: Fatigue | Change at EoT: Fatigue | Change at FU Month 6: Fatigue | Change at FU Month 12: Fatigue | Baseline: Financial Difficulties | Change at Cycle 1: Financial Difficulties | Change at Cycle 2: Financial Difficulties | Change at Cycle 3: Financial Difficulties | Change at Cycle 4: Financial Difficulties | Change at Cycle 5: Financial Difficulties | Change at Cycle 9: Financial Difficulties | Change at Cycle 14: Financial Difficulties | Change at EoT: Financial Difficulties | Change at FU Month 6: Financial Difficulties | Change at FU Month 12: Financial Difficulties | Baseline: Insomnia | Change at Cycle 1: Insomnia | Change at Cycle 2: Insomnia | Change at Cycle 3: Insomnia | Change at Cycle 4: Insomnia | Change at Cycle 5: Insomnia | Change at Cycle 9: Insomnia | Change at Cycle 14: Insomnia | Change at EoT: Insomnia | Change at FU Month 6: Insomnia | Change at FU Month 12: Insomnia | Baseline: Nausea/Vomiting | Change at Cycle 1: Nausea/Vomiting | Change at Cycle 2: Nausea/Vomiting | Change at Cycle 3: Nausea/Vomiting | Change at Cycle 4: Nausea/Vomiting | Change at Cycle 5: Nausea/Vomiting | Change at Cycle 9: Nausea/Vomiting | Change at Cycle 14: Nausea/Vomiting | Change at EoT: Nausea/Vomiting | Change at FU Month 6: Nausea/Vomiting | Change at FU Month 12: Nausea/Vomiting | Baseline: Pain | Change at Cycle 1: Pain | Change at Cycle 2: Pain | Change at Cycle 3: Pain | Change at Cycle 4: Pain | Change at Cycle 5: Pain | Change at Cycle 9: Pain | Change at Cycle 14: Pain | Change at EoT: Pain | Change at FU Month 6: Pain | Change at FU Month 12: Pain | Baseline: Cognitive Functioning | Change at Cycle 1: Cognitive Functioning | Change at Cycle 2: Cognitive Functioning | Change at Cycle 3: Cognitive Functioning | Change at Cycle 4: Cognitive Functioning | Change at Cycle 5: Cognitive Functioning | Change at Cycle 9: Cognitive Functioning | Change at Cycle 14: Cognitive Functioning | Change at EoT: Cognitive Functioning | Change at FU Month 6: Cognitive Functioning | Change at FU Month 12: Cognitive Functioning | Baseline: Emotional Functioning | Change at Cycle 1: Emotional Functioning | Change at Cycle 2: Emotional Functioning | Change at Cycle 3: Emotional Functioning | Change at Cycle 4: Emotional Functioning | Change at Cycle 5: Emotional Functioning | Change at Cycle 9: Emotional Functioning | Change at Cycle 14: Emotional Functioning | Change at EoT: Emotional Functioning | Change at FU Month 6: Emotional Functioning | Change at FU Month 12: Emotional Functioning | Baseline: Physical Functioning | Change at Cycle 1: Physical Functioning | Change at Cycle 2: Physical Functioning | Change at Cycle 3: Physical Functioning | Change at Cycle 4: Physical Functioning | Change at Cycle 5: Physical Functioning | Change at Cycle 9: Physical Functioning | Change at Cycle 14: Physical Functioning | Change at EoT: Physical Functioning | Change at FU Month 6: Physical Functioning | Change at FU Month 12: Physical Functioning | Baseline: Role Functioning | Change at Cycle 1: Role Functioning | Change at Cycle 2: Role Functioning | Change at Cycle 3: Role Functioning | Change at Cycle 4: Role Functioning | Change at Cycle 5: Role Functioning | Change at Cycle 9: Role Functioning | Change at Cycle 14: Role Functioning | Change at EoT: Role Functioning | Change at FU Month 6: Role Functioning | Change at FU Month 12: Role Functioning | Baseline: Social Functioning | Change at Cycle 1: Social Functioning | Change at Cycle 2: Social Functioning | Change at Cycle 3: Social Functioning | Change at Cycle 4: Social Functioning | Change at Cycle 5: Social Functioning | Change at Cycle 9: Social Functioning | Change at Cycle 14: Social Functioning | Change at EoT: Social Functioning | Change at FU Month 6: Social Functioning | Change at FU Month 12: Social Functioning | Baseline: Global Health Status | Change at Cycle 1: Global Health Status | Change at Cycle 2: Global Health Status | Change at Cycle 3: Global Health Status | Change at Cycle 4: Global Health Status | Change at Cycle 5: Global Health Status | Change at Cycle 9: Global Health Status | Change at Cycle 14: Global Health Status | Change at EoT: Global Health Status | Change at FU Month 6: Global Health Status | Change at FU Month 12: Global Health Status |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 8.2 | 12.2 | 15.2 | 14.3 | 16.2 | 12.0 | 5.7 | 2.2 | 0.5 | -1.3 | -2.2 | 9.6 | 8.4 | 1.1 | 2.0 | 2.5 | 0.5 | -0.7 | 0.6 | 0.2 | 3.4 | 2.8 | 5.2 | 4.7 | 32.5 | 28.4 | 26.5 | 23.9 | 12.6 | 12.5 | 10.3 | -0.3 | -0.3 | 5.8 | 10.4 | 11.6 | 13.4 | 14.3 | 13.7 | 7.8 | 6.8 | 7.6 | 7.0 | 6.2 | 21.5 | 13.2 | 15.4 | 15.3 | 16.0 | 14.9 | 8.4 | 6.7 | 5.5 | 2.8 | 1.9 | 20.1 | 2.2 | 2.0 | 3.9 | 3.7 | 3.4 | 0.9 | -1.4 | -1.1 | -3.8 | -5.1 | 23.9 | 3.6 | 6.0 | 6.2 | 8.6 | 5.2 | 4.3 | 2.7 | 2.5 | 0.9 | 0.0 | 2.6 | 10.4 | 6.0 | 5.0 | 4.7 | 4.0 | 1.1 | 1.1 | 0.9 | 0.2 | 0.5 | 17.4 | 1.8 | 5.0 | 3.5 | 5.4 | 5.2 | 3.4 | 2.0 | 1.9 | 0.8 | 0.0 | 88.6 | -9.7 | -9.4 | -10.1 | -11.8 | -10.8 | -8.3 | -8.1 | -8.7 | -8.0 | -7.1 | 76.0 | -1.1 | -1.0 | -0.9 | -2.5 | -1.2 | 3.1 | 4.1 | 3.0 | 4.7 | 5.8 | 88.4 | -6.0 | -7.8 | -7.1 | -8.4 | -8.3 | -4.0 | -2.7 | -2.2 | -0.6 | -0.1 | 83.1 | -5.1 | -9.7 | -8.9 | -10.7 | -9.4 | -3.3 | -0.5 | -0.2 | 2.2 | 2.6 | 83.0 | -8.0 | -10.1 | -9.5 | -10.3 | -8.7 | -1.7 | -0.1 | 0.3 | 3.3 | 4.6 | 74.3 | -7.5 | -12.4 | -11.7 | -12.7 | -12.1 | -5.9 | -3.9 | -3.5 | -0.6 | -0.2 |
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. (NCT01966471)
Timeframe: First participant randomized up to approximately 7.5 years
| Intervention | Percent Probability (Number) |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 96.03 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 94.86 |
Invasive Disease-Free Survival (IDFS) in the Overall Population
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization. (NCT01966471)
Timeframe: First participant randomized up to approximately 7.5 years
| Intervention | Percent Probability (Number) |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 94.22 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 93.06 |
Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization. (NCT01966471)
Timeframe: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.
| Intervention | Percent Probability (Number) |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 94.10 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 92.75 |
IDFS Plus Second Primary Non-Breast Cancer
IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). (NCT01966471)
Timeframe: Baseline up to approximately 70 months
| Intervention | Percent Probability (Number) |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 93.43 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 92.26 |
Distant Recurrence-Free Interval (DRFI)
DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence. (NCT01966471)
Timeframe: Baseline up to approximately 70 months
| Intervention | Percent Probability (Number) |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 95.23 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 94.91 |
Disease-Free Survival (DFS)
DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS). (NCT01966471)
Timeframe: Baseline up to approximately 70 months
| Intervention | Percent Probability (Number) |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 93.32 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 92.04 |
Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans. (NCT01966471)
Timeframe: First participant randomized up to approximately 7.5 years.
| Intervention | Participants (Count of Participants) |
|---|
| Decrease from baseline <10 Ejection Fraction (EF) points | Absolute value >= 50% and decrease from baseline >= 10 EF points | Absolute value < 50% and decrease from baseline >= 10 EF points | Absolute value < 50% and decrease from baseline >= 15 EF points |
|---|
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 522 | 245 | 35 | 28 |
,| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 506 | 254 | 71 | 61 |
Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment
The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning. (NCT01966471)
Timeframe: From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above.
| Intervention | months (Median) |
|---|
| GHS/QoL Score | Physical Function | Role Function | Cognitive Function |
|---|
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 13.57 | NA | 9.92 | 9.46 |
,| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 2.73 | 25.53 | 2.23 | 5.49 |
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). (NCT01966471)
Timeframe: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
| Intervention | Units on a Scale (Mean) |
|---|
| Baseline: Appetite Loss | Change at Cycle 1: Appetite Loss | Change at Cycle 2: Appetite Loss | Change at Cycle 3: Appetite Loss | Change at Cycle 4: Appetite Loss | Change at Cycle 5: Appetite Loss | Change at Cycle 9: Appetite Loss | Change at Cycle 14: Appetite Loss | Change at EoT: Appetite Loss | Change at FU Month 6: Appetite Loss | Change at FU Month 12: Appetite Loss | Change at FU Month 18: Appetite Loss | Baseline: Constipation | Change at Cycle 1: Constipation | Change at Cycle 2: Constipation | Change at Cycle 3: Constipation | Change at Cycle 4: Constipation | Change at Cycle 5: Constipation | Change at Cycle 9: Constipation | Change at Cycle 14: Constipation | Change at EoT: Constipation | Change at FU Month 6: Constipation | Change at FU Month 12: Constipation | Change at FU Month 18: Constipation | Baseline: Diarrhea | Change at Cycle 1: Diarrhea | Change at Cycle 2: Diarrhea | Change at Cycle 3: Diarrhea | Change at Cycle 4: Diarrhea | Change at Cycle 5: Diarrhea | Change at Cycle 9: Diarrhea | Change at Cycle 14: Diarrhea | Change at EoT: Diarrhea | Change at FU Month 6: Diarrhea | Change at FU Month 12: Diarrhea | Change at FU Month 18: Diarrhea | Baseline: Dyspnea | Change at Cycle 1: Dyspnea | Change at Cycle 2: Dyspnea | Change at Cycle 3: Dyspnea | Change at Cycle 4: Dyspnea | Change at Cycle 5: Dyspnea | Change at Cycle 9: Dyspnea | Change at Cycle 14: Dyspnea | Change at EoT: Dyspnea | Change at FU Month 6: Dyspnea | Change at FU Month 12: Dyspnea | Change at FU Month 18: Dyspnea | Baseline: Fatigue | Change at Cycle 1: Fatigue | Change at Cycle 2: Fatigue | Change at Cycle 3: Fatigue | Change at Cycle 4: Fatigue | Change at Cycle 5: Fatigue | Change at Cycle 9: Fatigue | Change at Cycle 14: Fatigue | Change at EoT: Fatigue | Change at FU Month 6: Fatigue | Change at FU Month 12: Fatigue | Change at FU Month 18: Fatigue | Baseline: Financial Difficulties | Change at Cycle 1: Financial Difficulties | Change at Cycle 2: Financial Difficulties | Change at Cycle 3: Financial Difficulties | Change at Cycle 4: Financial Difficulties | Change at Cycle 5: Financial Difficulties | Change at Cycle 9: Financial Difficulties | Change at Cycle 14: Financial Difficulties | Change at EoT: Financial Difficulties | Change at FU Month 6: Financial Difficulties | Change at FU Month 12: Financial Difficulties | Change at FU Month 18: Financial Difficulties | Baseline: Insomnia | Change at Cycle 1: Insomnia | Change at Cycle 2: Insomnia | Change at Cycle 3: Insomnia | Change at Cycle 4: Insomnia | Change at Cycle 5: Insomnia | Change at Cycle 9: Insomnia | Change at Cycle 14: Insomnia | Change at EoT: Insomnia | Change at FU Month 6: Insomnia | Change at FU Month 12: Insomnia | Change at FU Month 18: Insomnia | Baseline: Nausea/Vomiting | Change at Cycle 1: Nausea/Vomiting | Change at Cycle 2: Nausea/Vomiting | Change at Cycle 3: Nausea/Vomiting | Change at Cycle 4: Nausea/Vomiting | Change at Cycle 5: Nausea/Vomiting | Change at Cycle 9: Nausea/Vomiting | Change at Cycle 14: Nausea/Vomiting | Change at EoT: Nausea/Vomiting | Change at FU Month 6: Nausea/Vomiting | Change at FU Month 12: Nausea/Vomiting | Change at FU Month 18: Nausea/Vomiting | Baseline: Pain | Change at Cycle 1: Pain | Change at Cycle 2: Pain | Change at Cycle 3: Pain | Change at Cycle 4: Pain | Change at Cycle 5: Pain | Change at Cycle 9: Pain | Change at Cycle 14: Pain | Change at EoT: Pain | Change at FU Month 6: Pain | Change at FU Month 12: Pain | Change at FU Month 18: Pain | Baseline: Cognitive Functioning | Change at Cycle 1: Cognitive Functioning | Change at Cycle 2: Cognitive Functioning | Change at Cycle 3: Cognitive Functioning | Change at Cycle 4: Cognitive Functioning | Change at Cycle 5: Cognitive Functioning | Change at Cycle 9: Cognitive Functioning | Change at Cycle 14: Cognitive Functioning | Change at EoT: Cognitive Functioning | Change at FU Month 6: Cognitive Functioning | Change at FU Month 12: Cognitive Functioning | Change at FU Month 18: Cognitive Functioning | Baseline: Emotional Functioning | Change at Cycle 1: Emotional Functioning | Change at Cycle 2: Emotional Functioning | Change at Cycle 3: Emotional Functioning | Change at Cycle 4: Emotional Functioning | Change at Cycle 5: Emotional Functioning | Change at Cycle 9: Emotional Functioning | Change at Cycle 14: Emotional Functioning | Change at EoT: Emotional Functioning | Change at FU Month 6: Emotional Functioning | Change at FU Month 12: Emotional Functioning | Change at FU Month 18: Emotional Functioning | Baseline: Physical Functioning | Change at Cycle 1: Physical Functioning | Change at Cycle 2: Physical Functioning | Change at Cycle 3: Physical Functioning | Change at Cycle 4: Physical Functioning | Change at Cycle 5: Physical Functioning | Change at Cycle 9: Physical Functioning | Change at Cycle 14: Physical Functioning | Change at EoT: Physical Functioning | Change at FU Month 6: Physical Functioning | Change at FU Month 12: Physical Functioning | Change at FU Month 18: Physical Functioning | Baseline: Role Functioning | Change at Cycle 1: Role Functioning | Change at Cycle 2: Role Functioning | Change at Cycle 3: Role Functioning | Change at Cycle 4: Role Functioning | Change at Cycle 5: Role Functioning | Change at Cycle 9: Role Functioning | Change at Cycle 14: Role Functioning | Change at EoT: Role Functioning | Change at FU Month 6: Role Functioning | Change at FU Month 12: Role Functioning | Change at FU Month 18: Role Functioning | Baseline: Social Functioning | Change at Cycle 1: Social Functioning | Change at Cycle 2: Social Functioning | Change at Cycle 3: Social Functioning | Change at Cycle 4: Social Functioning | Change at Cycle 5: Social Functioning | Change at Cycle 9: Social Functioning | Change at Cycle 14: Social Functioning | Change at EoT: Social Functioning | Change at FU Month 6: Social Functioning | Change at FU Month 12: Social Functioning | Change at FU Month 18: Social Functioning | Baseline: Global Health Status | Change at Cycle 1: Global Health Status | Change at Cycle 2: Global Health Status | Change at Cycle 3: Global Health Status | Change at Cycle 4: Global Health Status | Change at Cycle 5: Global Health Status | Change at Cycle 9: Global Health Status | Change at Cycle 14: Global Health Status | Change at EoT: Global Health Status | Change at FU Month 6: Global Health Status | Change at FU Month 12: Global Health Status | Change at FU Month 18: Global Health Status |
|---|
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 7.6 | 10.8 | 13.1 | 10.3 | 9.4 | 9.0 | 8.2 | 6.4 | 5.6 | -2.4 | -2.3 | -16.7 | 9.0 | 8.0 | 0.9 | 0.2 | -0.6 | -0.4 | 3.3 | 4.2 | 4.7 | 1.5 | 2.0 | 0.0 | 4.7 | 4.2 | 16.0 | 11.3 | 10.3 | 8.8 | 4.7 | 5.1 | 3.0 | -1.1 | 0.0 | -16.7 | 6.2 | 9.2 | 7.4 | 6.5 | 5.9 | 5.6 | 7.5 | 8.1 | 8.8 | 5.3 | 5.8 | -16.7 | 20.6 | 14.4 | 11.2 | 8.7 | 8.2 | 8.4 | 9.8 | 10.6 | 9.3 | 3.1 | 1.8 | -5.6 | 19.9 | 0.3 | -0.6 | -0.4 | -0.2 | 0.7 | -0.5 | -1.0 | -1.7 | -5.2 | -6.8 | 0.0 | 24.9 | 1.8 | 0.4 | -0.1 | 1.1 | 1.1 | 1.1 | 2.7 | 0.9 | -2.3 | -2.9 | -16.7 | 2.3 | 10.5 | 7.5 | 5.2 | 3.7 | 3.2 | 2.8 | 3.0 | 1.7 | 0.1 | 0.6 | -8.3 | 16.4 | 1.1 | 2.8 | 2.5 | 3.1 | 3.8 | 3.9 | 5.7 | 5.1 | 1.4 | 0.5 | -25.0 | 88.7 | -6.9 | -6.8 | -6.4 | -6.9 | -7.3 | -7.6 | -8.1 | -8.4 | -6.1 | -6.0 | 16.7 | 75.7 | 0.0 | 1.6 | 2.2 | 2.8 | 2.6 | 2.9 | 2.5 | 3.1 | 6.1 | 6.5 | 12.5 | 89.1 | -5.9 | -4.8 | -4.1 | -3.5 | -3.5 | -3.8 | -4.2 | -4.9 | -1.6 | -0.8 | 13.3 | 83.4 | -5.7 | -5.5 | -2.7 | -3.2 | -3.5 | -3.2 | -4.3 | -3.5 | 2.4 | 3.7 | 8.3 | 83.2 | -5.3 | -4.1 | -3.3 | -3.2 | -2.6 | -3.4 | -2.4 | -1.6 | 4.0 | 6.4 | 33.3 | 73.9 | -7.2 | -7.1 | -5.2 | -5.5 | -5.8 | -6.4 | -6.3 | -4.9 | 0.3 | 1.2 | 16.7 |
EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement. (NCT01966471)
Timeframe: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
| Intervention | Units on a Scale (Mean) |
|---|
| Baseline: Arm Symptoms | Change at Cycle 1: Arm Symptoms | Change at Cycle 2: Arm Symptoms | Change at Cycle 3: Arm Symptoms | Change at Cycle 4: Arm Symptoms | Change at Cycle 5: Arm Symptoms | Change at Cycle 9: Arm Symptoms | Change at Cycle 14: Arm Symptoms | Change at EoT: Arm Symptoms | Change at FU Month 6: Arm Symptoms | Change at FU Month 12: Arm Symptoms | Baseline: Breast Symptoms | Change at Cycle 1: Breast Symptoms | Change at Cycle 2: Breast Symptoms | Change at Cycle 3: Breast Symptoms | Change at Cycle 4: Breast Symptoms | Change at Cycle 5: Breast Symptoms | Change at Cycle 9: Breast Symptoms | Change at Cycle 14: Breast Symptoms | Change at EoT: Breast Symptoms | Change at FU Month 6: Breast Symptoms | Change at FU Month 12: Breast Symptoms | Baseline: Systemic Therapy Side Effects (SE) | Change at Cycle 1: Systemic Therapy SE | Change at Cycle 2: Systemic Therapy SE | Change at Cycle 3: Systemic Therapy SE | Change at Cycle 4: Systemic Therapy SE | Change at Cycle 5: Systemic Therapy SE | Change at Cycle 9: Systemic Therapy SE | Change at Cycle 14: Systemic Therapy SE | Change at EoT: Systemic Therapy SE | Change at FU Month 6: Systemic Therapy SE | Change at FU Month 12: Systemic Therapy SE | Baseline: Upset by Hair Loss Item | Change at Cycle 1: Upset by Hair Loss Item | Change at Cycle 2: Upset by Hair Loss Item | Change at Cycle 3: Upset by Hair Loss Item | Change at Cycle 4: Upset by Hair Loss Item | Change at Cycle 5: Upset by Hair Loss Item | Change at Cycle 9: Upset by Hair Loss Item | Change at Cycle 14: Upset by Hair Loss Item | Change at EoT: Upset by Hair Loss Item | Change at FU Month 6: Upset by Hair Loss Item | Change at FU Month 12: Upset by Hair Loss Item | Baseline: Body Image | Change at Cycle 1: Body Image | Change at Cycle 2: Body Image | Change at Cycle 3: Body Image | Change at Cycle 4: Body Image | Change at Cycle 5: Body Image | Change at Cycle 9: Body Image | Change at Cycle 14: Body Image | Change at EoT: Body Image | Change at FU Month 6: Body Image | Change at FU Month 12: Body Image | Baseline: Future Perspectives (FP) | Change at Cycle 1: FP | Change at Cycle 2: FP | Change at Cycle 3: FP | Change at Cycle 4: FP | Change at Cycle 5: FP | Change at Cycle 9: FP | Change at Cycle 14: FP | Change at EoT: FP | Change at FU Month 6: FP | Change at FU Month 12: FP | Baseline: Sexual Enjoyment | Change at Cycle 1: Sexual Enjoyment | Change at Cycle 2: Sexual Enjoyment | Change at Cycle 3: Sexual Enjoyment | Change at Cycle 4: Sexual Enjoyment | Change at Cycle 5: Sexual Enjoyment | Change at Cycle 9: Sexual Enjoyment | Change at Cycle 14: Sexual Enjoyment | Change at EoT: Sexual Enjoyment | Change at FU Month 6: Sexual Enjoyment | Change at FU Month 12: Sexual Enjoyment | Baseline: Sexual Function | Change at Cycle 1: Sexual Function | Change at Cycle 2: Sexual Function | Change at Cycle 3: Sexual Function | Change at Cycle 4: Sexual Function | Change at Cycle 5: Sexual Function | Change at Cycle 9: Sexual Function | Change at Cycle 14: Sexual Function | Change at EoT: Sexual Function | Change at FU Month 6: Sexual Function | Change at FU Month 12: Sexual Function |
|---|
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 19.5 | -3.1 | -3.0 | -3.5 | -2.9 | -2.6 | -1.1 | 1.3 | 0.4 | -1.3 | -2.8 | 16.8 | -2.5 | -2.9 | -3.1 | -3.3 | -2.6 | 0.3 | 0.5 | 0.3 | -1.5 | -3.7 | 8.7 | 23.3 | 18.3 | 15.1 | 13.2 | 11.8 | 10.4 | 9.8 | 8.5 | 4.2 | 4.2 | 14.2 | 25.2 | 21.8 | 21.4 | 19.7 | 10.0 | 6.0 | 2.5 | 0.0 | -3.5 | -2.8 | 78.9 | -13.3 | -10.1 | -6.6 | -5.9 | -5.0 | -4.2 | -2.4 | -2.9 | 0.3 | 0.7 | 49.8 | -0.3 | 3.7 | 6.5 | 7.8 | 9.7 | 8.4 | 7.9 | 7.6 | 12.6 | 13.1 | 46.7 | -8.2 | -10.7 | -8.9 | -9.2 | -8.8 | -7.4 | -9.7 | -9.7 | -3.0 | -2.3 | 18.3 | -3.5 | -4.4 | -3.3 | -3.4 | -3.0 | -1.8 | -2.8 | -1.7 | 0.6 | 0.9 |
,| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 19.9 | -1.3 | -2.8 | -3.5 | -2.0 | -0.5 | -0.2 | 0.3 | 0.1 | -0.1 | -0.8 | 17.5 | -2.3 | -3.3 | -4.0 | -3.9 | -3.1 | 1.7 | -0.2 | -1.0 | -2.5 | -4.2 | 8.5 | 24.9 | 24.1 | 23.4 | 23.1 | 20.0 | 9.5 | 7.5 | 7.2 | 5.8 | 5.4 | 13.2 | 35.1 | 28.7 | 28.8 | 28.4 | 26.4 | 11.8 | 9.3 | 17.3 | 6.2 | 2.4 | 78.5 | -13.7 | -12.7 | -11.5 | -11.4 | -10.5 | -5.9 | -4.5 | -3.3 | -1.3 | 0.0 | 49.3 | -1.3 | 1.4 | 3.2 | 4.2 | 5.9 | 8.2 | 9.5 | 8.5 | 10.5 | 15.0 | 43.4 | -5.9 | -9.5 | -11.4 | -11.9 | -14.2 | -9.4 | -3.9 | -6.5 | -4.6 | -5.7 | 16.7 | -2.3 | -4.8 | -5.6 | -6.8 | -5.9 | -3.4 | -1.8 | -1.5 | 1.6 | 0.9 |
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). (NCT01966471)
Timeframe: From randomization to approximately 7.5 years
| Intervention | Percentage of participants (Number) |
|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 98.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 99.1 |
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
T Cell Receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. (NCT01967823)
Timeframe: 3 and 6 months, and 1 year post cell administration
| Intervention | Percentage of Tcells (Number) |
|---|
| 1010003 | 1010006 | 1010008 | 1010009 | 1010010 | 1010011 |
|---|
| T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 6 (± 2) Months | 7.15 | 7.15 | 0.28 | 18.4 | 0.32 | 46.2 |
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
T Cell Receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. (NCT01967823)
Timeframe: 3 and 6 months, and 1 year post cell administration
| Intervention | Percentage of Tcells (Number) |
|---|
| 1010001 | 1010002 | 1010003 | 1010006 | 1010007 | 1010008 | 1010009 | 1010010 |
|---|
| T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 3 (± 1) Months | 1.93 | 40.9 | 16.1 | 16.1 | 44 | 16.9 | 31.8 | 0.37 |
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
T Cell Receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. (NCT01967823)
Timeframe: 3 and 6 months, and 1 year post cell administration
| Intervention | Percentage of Tcells (Number) |
|---|
| 1010001 | 1010002 | 1010003 | 1010006 | 1010007 | 1010008 | 1010009 | 1010010 | 1010011 |
|---|
| T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells on Day of Infusion. | 81 | 83 | 76.4 | 87.3 | 80 | 86.7 | 82 | 68.4 | 78.2 |
Percentage of Participants With a Response
Percentage of patients who have a clinical response (complete response or partial response) to treatment (objective tumor regression). Response was determined entirely by radiographic imaging using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 to compare target lesions in centimeters. Complete Response is defined as disappearance of all target lesions. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT01967823)
Timeframe: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2, then per principal investigator (PI) discretion, up to five years or disease progression.
| Intervention | percentage of participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes | 10 | 50 |
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
T Cell Receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. (NCT01967823)
Timeframe: 3 and 6 months, and 1 year post cell administration
| Intervention | Percentage of Tcells (Number) |
|---|
| 1010003 | 1010006 |
|---|
| T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at ≥ 1 Year | 0.87 | 0.87 |
Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 23.75 |
| Ibrutinib + CIT | 40.51 |
Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL
DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 89.17 |
| Ibrutinib + CIT | NA |
Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire
Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 37.03 |
| Ibrutinib + CIT | 24.84 |
Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | percentage of participants (Number) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 60.7 |
| Ibrutinib + CIT | 64.3 |
Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL
Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | Participants (Count of Participants) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 28 |
| Ibrutinib + CIT | 28 |
Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL
ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | percentage of participants (Number) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 82.1 |
| Ibrutinib + CIT | 89.3 |
Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | NA |
| Ibrutinib + CIT | NA |
Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 91.63 |
| Ibrutinib + CIT | NA |
Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL
TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 36.83 |
| Ibrutinib + CIT | 58.91 |
Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | percentage of participants (Number) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 90.5 |
| Ibrutinib + CIT | 91.6 |
Primary Analysis: Overall Survival (OS): Stratified Analysis
OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | NA |
| Ibrutinib + CIT | NA |
Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | Participants (Count of Participants) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 197 |
| Ibrutinib + CIT | 199 |
Primary Analysis: Duration of Response (DOR): Stratified Analysis
DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | months (Median) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 21.68 |
| Ibrutinib + CIT | 44.32 |
Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years
| Intervention | percentage of participants (Number) |
|---|
| Placebo + Chemoimmunotherapy (CIT) | 50.2 |
| Ibrutinib + CIT | 55 |
Event Free Survival (EFS)
The Kaplan-Meier method will be used to estimate the 2-year EFS for each of the treatment regimens. (NCT01979536)
Timeframe: Time from study entry until progressive disease, relapse, or death, assessed up to 2 years
| Intervention | Percentage of patients (Number) |
|---|
| Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 78.8 |
| Arm CZ (Crizotinib, Combination Chemotherapy) | 76.8 |
Prognostic Significance of Minimal Residual Disease
Analyzed by estimating the 2-year EFS of negative MRD and positive MRD by arm. Minimal disease was performed using serial assessments of the t(2;5)(p23;q35) NPM-ALK fusion transcript using quantitative RT-PCR. Quantitative RT-PCR was performed by extracting total RNA from peripheral blood specimens. Peripheral blood samples were obtained at baseline, on day 1 of cycle 1, and on day 1 of cycle 2. The normalized copy numbers (NCN) were expressed as copy numbers of NPM-ALK per 104 copies of ABL. Minimal disease (MDD) was defined as >10 NCN at baseline. (NCT01979536)
Timeframe: Baseline up to progressive disease, relapse, or death, assessed up to 2 years
| Intervention | Percentage of patients (Number) |
|---|
| MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 89 |
| MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 52.6 |
| MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) | 85.6 |
| MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) | 58.1 |
Occurrence of Grade 3+ Non-hematologic Adverse Events
Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm. (NCT01979536)
Timeframe: Up to 60 months
| Intervention | Percentage of patients (Number) |
|---|
| Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 80.6 |
| Arm CZ (Crizotinib, Combination Chemotherapy) | 87.9 |
Number of Participants With Dose-limiting Toxicities (DLTs)
"The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.~Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:~Nonhematologic:~≥ Grade 3 non-hematological toxicity~≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours~Hematologic:~Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days~Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration~Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment~Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding" (NCT01980589)
Timeframe: First cycle treatment over 28-days
| Intervention | participants (Number) |
|---|
| Carfilzomib 36 mg/m² | 0 |
| Carfilzomib 45 mg/m² | 0 |
| Carfilzomib 56 mg/m² | 0 |
Overall Response Rate (ORR)
Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response. (NCT01980589)
Timeframe: Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
| Intervention | percentage of participants (Number) |
|---|
| Carfilzomib 36 mg/m² | 66.7 |
| Carfilzomib 45 mg/m² | 100.0 |
| Carfilzomib 56 mg/m² | 87.5 |
Time To Response (TTR)
Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only. (NCT01980589)
Timeframe: Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
| Intervention | months (Median) |
|---|
| Carfilzomib 36 mg/m² | 1.3 |
| Carfilzomib 45 mg/m² | 0.8 |
| Carfilzomib 56 mg/m² | 1.0 |
Number of Participants With Adverse Events
"Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:~Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal." (NCT01980589)
Timeframe: From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.
| Intervention | participants (Number) |
|---|
| Any adverse event | Adverse event ≥ Grade 3 | Serious adverse events | AE leading to discontinuation of study drug | Fatal adverse events |
|---|
| Carfilzomib 36 mg/m² | 3 | 3 | 0 | 0 | 0 |
,| Carfilzomib 45 mg/m² | 3 | 3 | 1 | 1 | 1 |
,| Carfilzomib 56 mg/m² | 16 | 10 | 5 | 4 | 0 |
Median Pace of T Cell Immune Recovery at 90 Days Post Hematopoietic Stem Cell Transplantation (HSCT)
An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 90 days will be monitored by collecting cluster of differentiation (CD24) and (CD38). (NCT01982682)
Timeframe: 90 days post HSCT
| Intervention | cells/ul (Median) |
|---|
| Median CD3/4 count at d+90 | Median CD3/8 count at d+90 |
|---|
| Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT) | 141 | 384 |
Count of Participants That Experienced Death as a Result of Graft-versus-host Disease (GVHD)
"Graft versus host disease was clinically characterized based on 4 stages of progression for three major body areas, skin, liver, gut. Subjects who experienced life threatening reactions in their skin, liver and gut ultimately experienced functional impairment and expired.~Life threatening reactions in the Skin were characterized by desquamation (the shedding of the outer layers of skin) and bullae (a bubblelike cavity filled with air or fluid, in particular).~Life threatening reactions in the Liver were characterized by Bilirubin, > 15 mg/dl Life threatening reactions in the Gut were characterized by Pain +/- ileus (a painful obstruction of the ileum or other part of the intestine.)" (NCT01982682)
Timeframe: Up to 1 year after HSCT
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT) | 2 |
Count of Participants That Experience 1 Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplantation (HSCT) Using the Thomas Jefferson University 2 Step Approach
(NCT01982682)
Timeframe: Up to 1 year after HSCT
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT) | 27 |
Number of Participants With Successful Engraftment
Will be reported descriptively. Successful engraftment is defined as ANC (absolute neutrophil count, the number of white blood cells (WBCs) that are neutrophils) ≥ 0.5x109/L for at least 30 days and Platelet engraftment > 20,000 with no transfusion x 7 days. (NCT01982682)
Timeframe: Up to 1 year after HSCT
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT) | 37 |
Median Pace of T Cell Immune Recovery at 28 Days Post Hematopoietic Stem Cell Transplantation (HSCT)
An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 28 days will be monitored by collecting cluster of differentiation (CD24) and (CD38). (NCT01982682)
Timeframe: At 28 days post HSCT
| Intervention | cells/ul (Median) |
|---|
| Median CD3/4 count at d+28 | Median cluster of diff. 38 (CD3/8) count at d+28 |
|---|
| Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT) | 41.3 | 48 |
Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. (NCT01992653)
Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 1 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 1 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Overall Survival for DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive. (NCT01992653)
Timeframe: Screening up to death due to any cause (up to approximately 6 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Overall Survival for Non-DLBCL Population
The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive. (NCT01992653)
Timeframe: Screening up to death due to any cause (up to approximately 6 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 15.24 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. (NCT01992653)
Timeframe: At the end of treatment (Month 6)
| Intervention | Percentage of Participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) |
|---|
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 76.5 | 11.8 |
,| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 75.0 | 15.0 |
,| Polatuzumab Vedotin (1.0mg) + R-CHP | 50.0 | 50.0 |
,| Polatuzumab Vedotin (1.4mg) + G-CHP | 75.0 | 0 |
,| Polatuzumab Vedotin (1.4mg) + R-CHP | 100.0 | 0 |
,| Polatuzumab Vedotin (1.8mg) + G-CHP | 100.0 | 0 |
,| Polatuzumab Vedotin (1.8mg) + R-CHP | 100.0 | 0 |
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. (NCT01992653)
Timeframe: At the end of treatment (Month 6)
| Intervention | Percentage of Participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 100.0 | 0 |
,| Polatuzumab Vedotin (1.4mg) + G-CHP | 100.0 | 0 |
,| Polatuzumab Vedotin (1.8mg) + G-CHP | 100.0 | 0 |
,| Polatuzumab Vedotin (1.8mg) + R-CHP | 100.0 | 0 |
,| Polatuzumab Vedotin (2.4mg) + R-CHP | 100.0 | 0 |
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
| Intervention | Score of a Questionnaire (Mean) |
|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 |
|---|
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 | 0 | 0.25 | 0.33 | 0.40 | 0.40 | 0.40 | 0.29 | 0.33 | 0.40 | 0.86 | 0.86 | 1.14 | 0.86 | 1.12 | 1.12 | 1.56 | 0.40 |
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
| Intervention | Score of a Questionnaire (Mean) |
|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 22 |
|---|
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 | 1 | 0 | 0.40 | 0.50 | 0.17 | 0.40 | 0.60 | 0.25 | 0.50 | 1.14 | 0.57 | 0.71 | 1.12 | 0.88 | 0.75 | 1.50 | 1.14 | 2 | 2 | 1 |
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
| Intervention | Score of a Questionnaire (Mean) |
|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 |
|---|
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 | 0 | 0.02 | 0.06 | 0.18 | 0.16 | 0.16 | 0.14 | 0.17 | 0.25 | 0.30 | 0.26 | 0.30 | 0.25 | 0.49 | 0.48 | 0.66 | 0.25 |
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score
The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
| Intervention | Score of a Questionnaire (Mean) |
|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 22 |
|---|
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0.32 | 0.91 | 0.07 | 0.22 | 0.26 | 0.17 | 0.25 | 0.35 | 0.31 | 0.38 | 0.53 | 0.39 | 0.65 | 0.78 | 0.62 | 0.70 | 1.12 | 0.91 | 0.64 | 0.45 | 0.09 |
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage. (NCT01992653)
Timeframe: 6 months
| Intervention | Percentage (Mean) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 100.70 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 99.97 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 96.04 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 99.35 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 99.95 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 96.71 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 98.92 |
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 6.87 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin
AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
| Intervention | ng day/mL (Mean) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 1300 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 1510 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 2600 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 4090 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 1940 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 1850 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 1870 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 1940 |
Clearance (CL) of Polatuzumab Vedotin
CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
| Intervention | mL/day/kg (Mean) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 14.0 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 17.3 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 12.8 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 10.5 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 13.2 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 18.7 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 18.9 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 17.7 |
Plasma Levels of Cyclophosphamide
Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin. (NCT01992653)
Timeframe: End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)
| Intervention | ug/mL (Mean) |
|---|
| C1D1 0.5hr POSTDOSE | C1D1 3.5hr POSTDOSE | C1D1 23.5hr POSTDOSE | C3D1 0.5hr POSTDOSE | C3D1 3.5hr POSTDOSE | C3D1 23.5hr POSTDOSE |
|---|
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 32.3 | 22.5 | 3.32 | 35.2 | 22.5 | 3.16 |
,| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 37.5 | 23.2 | 2.98 | 34.8 | 24.2 | 3.17 |
Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin
Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
| Intervention | mL/kg (Mean) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 58.2 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 80.0 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 57.7 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 41.9 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 67.9 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 87.5 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 96.5 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 99.3 |
Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 4.11 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Plasma Levels of Doxorubicin
Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin. (NCT01992653)
Timeframe: 2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)
| Intervention | ug/mL (Mean) |
|---|
| C1D1 2hr POSTDOSE | C1D1 24hr POSTDOSE | C3D1 2hr POSTDOSE | C3D1 24hr POSTDOSE |
|---|
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 30.2 | 11.7 | 29.6 | 9.14 |
,| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 35.4 | 9.13 | 29.3 | 8.68 |
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population
Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage. (NCT01992653)
Timeframe: 6 months
| Intervention | Percentage (Mean) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 100.00 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 100.94 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 132.22 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 99.72 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 100.17 |
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 35.45 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
| Intervention | Months (Median) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 6.87 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 6.70 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | NA |
| Polatuzumab Vedotin (1.8mg) + G-CHP | NA |
Terminal Half-Life (t1/2) of Polatuzumab Vedotin
t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
| Intervention | days (Mean) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 5.03 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 4.85 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 4.79 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 4.42 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 5.19 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 4.89 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 5.03 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 5.50 |
Maximum Concentration (Cmax) of Polatuzumab Vedotin
Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
| Intervention | ng/mL (Mean) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 373 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 537 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 781 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 1400 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 537 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 557 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 532 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 530 |
Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). (NCT01992653)
Timeframe: Baseline up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 2 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 3 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 5 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 4 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 4 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 40 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 17 |
Number of Participants With Anti-Obinutuzumab Antibodies
The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA. (NCT01992653)
Timeframe: Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Number of Participants With Anti-Polatuzumab Vedotin Antibodies
The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from <0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL. (NCT01992653)
Timeframe: Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Number of Participants With DLTs in Non-DLBCL Population
All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. (NCT01992653)
Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Number of Participants With Adverse Events in Non-DLBCL Population
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). (NCT01992653)
Timeframe: Baseline up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Polatuzumab Vedotin (1.0mg) + R-CHP | 1 |
| Polatuzumab Vedotin (1.4mg) + R-CHP | 0 |
| Polatuzumab Vedotin (1.8mg) + R-CHP | 1 |
| Polatuzumab Vedotin (2.4mg) + R-CHP | 1 |
| Polatuzumab Vedotin (1.4mg) + G-CHP | 2 |
| Polatuzumab Vedotin (1.8mg) + G-CHP | 2 |
| Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 0 |
| Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 0 |
Progression-free Survival (PFS)
PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression up to approximately 67.2 months.
| Intervention | Months (Median) |
|---|
| Retreat |
|---|
| Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 32.5 |
Progression-free Survival (PFS)
PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression up to approximately 67.2 months.
| Intervention | Months (Median) |
|---|
| Initial Treatment | Retreat |
|---|
| Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 3.1 | 1.6 |
Overall Response Rate (ORR)
Overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.0). Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression, up to approximately 67.2 months.
| Intervention | percentage of participants (Number) |
|---|
| Initial Treatment | Retreat |
|---|
| Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 23.10 | 33.30 |
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01993719)
Timeframe: Date treatment consent signed to date off study, approximately 102 months and 9 days, 92 months and 19 days, 86 months and 9 days, 99 months and 16 days, and 86 months and 26 days for each group respectively.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 7 |
| Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 9 |
| Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 3 |
| Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 9 |
| Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2 |
Overall Progression Free Survival (PFS)
PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Time to progression and time to death, approximately up to 67.2 months.
| Intervention | Months (Median) |
|---|
| All Participants in Arms 1N, 1P, Arm 2/Foll By Arm 1P, Arm 2, and Arm 1P/Foll By Arm 1P/R | 3 |
Overall Survival
Overall survival is defined as the time from treatment start date until date of death, or date last known alive. (NCT01993719)
Timeframe: An average of 25.6 months.
| Intervention | Months (Median) |
|---|
| All Participants in Arms 1N, 1P, Arm 2/Foll By Arm 1P, Arm 2, and Arm 1P/Foll By Arm 1P/R | 17.5 |
Overall Survival
Overall survival is defined as the time from treatment start date until date of death, or date last known alive. (NCT01993719)
Timeframe: Date of cells until time to death, up until 90.1 months.
| Intervention | Months (Median) |
|---|
| Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 14.3 |
| Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | NA |
| Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 15.1 |
Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Clinical response to treatment was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST v1.0). Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT01993719)
Timeframe: 4 weeks after cell infusion, then every 3 months x 3 and then every 6 months for 5 years, then per Principal Investigator (PI) discretion up to 5 years or disease progression
| Intervention | Participants (Count of Participants) |
|---|
| First Treatment - Complete Response | First Treatment - Partial Response | First Treatment - Progressive Disease | First Treatment - Stable Disease | Second Treatment - Complete Response | Second Treatment - Partial Response | Second Treatment - Progressive Disease | Second Treatment - Stable Disease |
|---|
| Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2 | 2 | 2 | 1 | NA | NA | NA | NA |
,| Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 2 | 8 | 3 | 0 | 1 | 1 | 1 |
,| Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | NA | NA | NA | NA | 0 | 1 | 1 | 0 |
,| Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 2 | 0 | 1 | NA | NA | NA | NA |
Overall Response Rate (ORR)
Overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.0). Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression, up to approximately 67.2 months.
| Intervention | percentage of participants (Number) |
|---|
| Initial Treatment |
|---|
| Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 57.10 |
,| Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 16.70 |
Overall Response Rate (ORR)
Overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.0). Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression, up to approximately 67.2 months.
| Intervention | percentage of participants (Number) |
|---|
| Retreat |
|---|
| Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 50 |
Progression-free Survival (PFS)
PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression up to approximately 67.2 months.
| Intervention | Months (Median) |
|---|
| Initial Treatment |
|---|
| Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 7.9 |
,| Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2.1 |
Primary Cohort: OS (All Data, FAS)
For all treated subjects, OS was calculated using KM methods with 95% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis data cut. (NCT02004262)
Timeframe: Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.
| Intervention | months (Median) |
|---|
| Primary Cohort: Cy/GVAX + CRS-207 | 4.2 |
| Primary Cohort: CRS-207 | 5.2 |
| Primary Cohort: Chemotherapy | 4.7 |
Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set)
OS was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs), with censoring at the date when 138 deaths were reached in the Primary Cohort in the FAS. Subjects without documentation of death at the time of final analysis were censored as of the date the subject was last known to be alive on/prior to the primary analysis data cut. (NCT02004262)
Timeframe: Subjects were followed from date of randomization to the date of death by any cause, whichever came first, assessed up to 32 months. Analysis conducted when 138 deaths reached in the Primary Cohort in the FAS.
| Intervention | months (Median) |
|---|
| Primary Cohort: Cy/GVAX + CRS-207 | 3.8 |
| Primary Cohort: CRS-207 | 5.4 |
| Primary Cohort: Chemotherapy | 4.6 |
2nd-line Cohort: OS (All Data, FAS)
For all treated subjects, OS was calculated using KM methods with 70% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis cut. 70% CIs were selected to provide an 80% probability to rule out differences in median survival less than -2.4 months between the 2nd-line Cohort: Chemotherapy arm and the 2nd-line Cohort: Cy/GVAX + CRS-207 and 2nd-line Cohort: CRS-207 arms, based upon the assumptions made in the statistical analysis plan (SAP). (NCT02004262)
Timeframe: Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.
| Intervention | months (Median) |
|---|
| 2nd-line Cohort: Cy/GVAX + CRS-207 | 4.6 |
| 2nd-line Cohort: CRS-207 | 4.0 |
| 2nd-line Cohort: Chemotherapy | 6.9 |
Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen
Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs. (NCT02004262)
Timeframe: From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.
| Intervention | Participants (Count of Participants) |
|---|
| Serious AEs | Total AEs |
|---|
| Pooled Cohort: Chemotherapy | 15 | 52 |
,| Pooled Cohort: CRS-207 | 32 | 87 |
,| Pooled Cohort: Cy/GVAX + CRS-207 | 44 | 94 |
Engraftment Rate
To determine the engraftment at Day +60 following HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents and low-dose total body irradiation (TBI) for conditioning and post-transplant cyclophosphamide in patients with sickle cell disease. (NCT02013375)
Timeframe: Up to Day 60 post-transplant.
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical Transplant | 0 |
Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)
Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC. (NCT02013817)
Timeframe: Weeks 1, 5, 9, 12, 13, 17, 21 and 24
| Intervention | percentage of participants (Number) |
|---|
| NCI Clinical | NCI Clinical (including CRu, CRi) | NCI Clinical + Radiological | NCI Clinical + Radiological (including CRu, CRi) |
|---|
| Rituximab, Fludarabine, Cyclophosphamide | 73.7 | 94.7 | 63.2 | 78.9 |
Percentage of Participants With Adverse Events (AEs)
AEs were recorded from the date of first medication administration until 28 days after the last trial medication. (NCT02013817)
Timeframe: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.
| Intervention | percentage of participants (Number) |
|---|
| Any AE | Related AE | Severe AE | SAE | Pregnancy |
|---|
| Rituximab, Fludarabine, Cyclophosphamide | 100 | 93.0 | 76.7 | 62.8 | 0.0 |
Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)
Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum. (NCT02013817)
Timeframe: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)
| Intervention | percentage of participants (Number) |
|---|
| CR, Week 12 | CRu, Week 12 | CRi, Week 12 | PR, Week 12 | PRTox, Week 12 | SD, Week 124 | PD, Week 12 | Not evaluable, Week 12 | CR, Week 24 | CRu, Week 24 | CRi, Week 24 | PR, Week 24 | PRTox, Week 24 | SD, Week 24 | PD, Week 24 | Not evaluable, Week 24 | CR, Final staging | CRu, Final staging | CRi, Final staging | PR, Final staging | PRTox, Final staging | SD, Final staging | PD, Final staging | Not evaluable, Final staging |
|---|
| Rituximab, Fludarabine, Cyclophosphamide | 30.2 | 4.7 | 7.0 | 30.2 | 9.3 | 7.0 | 0.0 | 11.6 | 23.3 | 7.0 | 30.2 | 14.0 | 7.0 | 7.0 | 0.0 | 11.6 | 48.8 | 7.0 | 7.0 | 11.6 | 2.3 | 2.3 | 9.3 | 11.6 |
Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)
Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum. (NCT02013817)
Timeframe: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)
| Intervention | percentage of participants (Number) |
|---|
| CR, Week 12 | CRu, Week 12 | CRi, Week 12 | PR, Week 12 | PRTox, Week 12 | SD, Week 12 | PD, Week 12 | Not evaluable, Week 12 | CR, Week 24 | CRu, Week 24 | CRi, Week 24 | PR, Week 24 | PRTox, Week 24 | SD, Week 24 | PD, Week 24 | Not evaluable, Week 24 | CR, Final staging | CRu, Final staging | CRi, Final staging | PR, Final staging | PRTox, Final staging | SD, Final staging | PD, Final staging | Not evaluable, Final staging |
|---|
| Rituximab, Fludarabine, Cyclophosphamide | 41.9 | 16.3 | 16.3 | 11.6 | 2.3 | 0.0 | 0.0 | 11.6 | 30.2 | 11.6 | 37.2 | 9.3 | 0.0 | 0.0 | 0.0 | 11.6 | 60.5 | 7.0 | 11.6 | 7.0 | 0.0 | 0.0 | 2.3 | 11.6 |
Time to Next Treatment - Time to Event
Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment. (NCT02013817)
Timeframe: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months
| Intervention | days (Mean) |
|---|
| Rituximab, Fludarabine, Cyclophosphamide | 423.3 |
Time to Next Treatment - Percentage of Participants With an Event
Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment. (NCT02013817)
Timeframe: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months
| Intervention | percentage of participants (Number) |
|---|
| Rituximab, Fludarabine, Cyclophosphamide | 37.2 |
Percentage of Patients With Responses at 273 Days
The percentage of patients with complete response (CR) at the end of therapy (~273 days) was reported and presented with the associated exact 95% confidence interval. (NCT02017964)
Timeframe: 273 days from start of treatment
| Intervention | Percentage of patients (Number) |
|---|
| All Eligible Patients (Combination Chemotherapy) | 88.0 |
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time interval from diagnosis to the earliest of disease progression/recurrence or death from any cause, or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's. (NCT02017964)
Timeframe: 2 years from diagnosis
| Intervention | percent probability (Number) |
|---|
| All Eligible Patients (Combination Chemotherapy) | 52.0 |
Event-free Survival (EFS)
Event-free survival (EFS) is defined as the time from diagnosis to the earliest of disease progression/recurrence, second malignancy or death from any cause, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's. (NCT02017964)
Timeframe: 2 years from diagnosis
| Intervention | percent probability (Number) |
|---|
| All Eligible Patients (Combination Chemotherapy) | 52.0 |
Overall Survival (OS)
Overall Survival (OS) is defined as the time from diagnosis to death from any cause, or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's, as the data are not mature to 72 months. (NCT02017964)
Timeframe: Assessed up to 72 months, reported at 2 years from diagnosis
| Intervention | percent probability (Number) |
|---|
| All Eligible Patients (Combination Chemotherapy) | 92.0 |
Percentage of Patients With Responses at 189 Days
The percentage of patients with complete response (CR) at the end of induction (~189 days) was reported and presented with the associated exact 95% confidence interval. (NCT02017964)
Timeframe: 189 days from start of treatment
| Intervention | Percentage of patients (Number) |
|---|
| All Eligible Patients (Combination Chemotherapy) | 92.0 |
Safety of DC Vaccine Combined With Chemotherapy
Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 . This will include all patients (eligible and ineligible) who receive at least 1 inoculation of DC vaccine therapy. This safety population will also be used for the summaries and analysis of all safety parameters (drug exposure, tables of adverse events information, including serious adverse events, etc.). (NCT02018458)
Timeframe: 4 years
| Intervention | Participants (Count of Participants) |
|---|
| LA TNBC: DC Vaccine+Preop Chemo | 10 |
Disease-free Survival
"Results are only reported for Arm 1, LA TNBC: DC vaccine+preop chemo patients. Arm 2, ER+/HER2- BC: DC vaccine+preop chemo patients did not enroll any patients with these hormone receptor criteria.~Analysis of disease-free survival (DFS, reported in months) was calculated from the first day of treatment up to 36 months." (NCT02018458)
Timeframe: 36 months
| Intervention | months (Mean) |
|---|
| LA TNBC: DC Vaccine+Preop Chemo | 15.6 |
Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed
Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal. (NCT02029638)
Timeframe: Transplant to 52 Weeks after Discontinuation of All Immunosuppression
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 0 |
Number of Transplanted Participants With Acute Renal Allograft Rejection
Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 1 |
Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery
Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher. (NCT02029638)
Timeframe: Post-Transplant Neutrophil Nadir to Neutrophil Recover
| Intervention | Days (Mean) |
|---|
| Enrolled, Transplanted | 15 |
Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection
Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 1 |
Number of Days From Transplant to Platelet Count Recovery
Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood. (NCT02029638)
Timeframe: Transplant to Platelet Count Recovery
| Intervention | Days (Mean) |
|---|
| Enrolled, Transplanted | 36 |
Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment
Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
| Intervention | Days (Mean) |
|---|
| Enrolled, Transplanted | 23 |
Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 1 |
Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Initiation of Immunosuppression Withdrawal to End of Study (to 25 months)
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 0 |
Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
| Intervention | Events (Number) |
|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
|---|
| Enrolled, Not Transplanted | 0 | 0 | 0 | 0 | 0 |
,| Enrolled, Transplanted | 0 | 0 | 2 | 0 | 0 |
Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months)
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 0 |
Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
| Intervention | Events (Number) |
|---|
| Infection | Wound complications | Post-transplant diabetes | Hemorrhagic cystitis | Malignancy |
|---|
| Enrolled, Not Transplanted | 0 | 0 | 0 | 0 | 0 |
,| Enrolled, Transplanted | 2 | 0 | 0 | 0 | 0 |
Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
| Intervention | Days (Mean) |
|---|
| Enrolled, Transplanted | 9.5 |
Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology
This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
| Intervention | participants (Number) |
|---|
| Acute Cellular Rejection Banff Grade IA | Acute Cellular Rejection Banff Grade IB | Acute Cellular Rejection Banff Grade IIA | Acute Cellular Rejection Banff Grade IIB | Acute Cellular Rejection Banff Grade III | Acute Antibody Mediated Rejection |
|---|
| Enrolled, Transplanted | 0 | 0 | 0 | 0 | 0 | 0 |
Percent of Participants Who Achieved Operational Tolerance
Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval. (NCT02029638)
Timeframe: Transplantation through 52 Weeks after Discontinuation of All Immunosuppression
| Intervention | Percent of participants (Number) |
|---|
| Enrolled, Transplanted | 0 |
Number of Transplanted Participants With Engraftment Syndrome
Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 0 |
Number of Participants Free From Return to Immunosuppression for the Duration of the Study
Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 Months)
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 0 |
Duration in Days of Graft-versus-Host Disease in Transplanted Participants
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant
| Intervention | Days (Mean) |
|---|
| Enrolled, Transplanted | 7 |
Number of Transplanted Participants Who Died
Number of participant deaths after receiving a transplant per protocol. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)
| Intervention | Participants (Count of Participants) |
|---|
| Enrolled, Transplanted | 1 |
AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in RRMM Participants
(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
| Intervention | hr*ng/mL (Mean) |
|---|
| Cycle 1 Day 1 | Cycle 1 Day 15 |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 518.167 | 1241.000 |
Number of Participants With AEs, SAEs, AEs Resulting in Discontinuation and AEs Resulting in Dose Reduction in NDMM Participants Remaining on Treatment After 13 Cycles
"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator." (NCT02046070)
Timeframe: First dose of study drug through 30 days after the last dose of drug (Up to 45 months)
| Intervention | Participants (Count of Participants) |
|---|
| Any AE | SAE | AEs Resulting in Treatment Discontinuation | AEs Resulting in Dose Reduction |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 22 | 6 | 1 | 5 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 20 | 4 | 2 | 4 |
Tmax: Time to First Occurrence of Cmax for Ixazomib in RRMM Participants
(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168) hours postdose
| Intervention | hr (Median) |
|---|
| Cycle 1 Day 1 | Cycle 1 Day 15 |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 1.225 | 2.000 |
Tmax: Time to First Occurrence of Cmax for Ixazomib in NDMM Participants
(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
| Intervention | hour (hr) (Median) |
|---|
| Cycle 1 Day 1 | Cycle 1 Day 15 |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 1.250 | 1.000 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 1.040 | 1.000 |
Percentage of Participants With CR + VGR + PR (ORR), CR, VGPR, and PR in NDMM Participants Remaining on Treatment After 13 Cycles
Percentage of participants with Overall Response (CR + VGPR + PR), CR, VGPR and PR according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28-day Cycle (Up to 45 months)
| Intervention | percentage of participants (Number) |
|---|
| CR + VGPR + PR | CR | VGPR | PR |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 75.0 | 16.7 | 20.8 | 37.5 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 85.7 | 19.0 | 28.6 | 38.1 |
Percentage of Participants With CR + VGPR + PR (ORR), CR, VGPR, PR and Stable Disease (SD), Progressive Disease (PD) During the Induction Phase
Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)
| Intervention | percentage of participants (Number) |
|---|
| CR + VGPR + PR | CR | VGPR | PR | SD | PD |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 79 | 12 | 15 | 67 | 12 | 0 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 71 | 9 | 15 | 62 | 18 | 3 |
Percentage of Participants With CR + VGPR + PR (ORR), CR + VGPR, CR, VGPR, PR, SD and PD Throughout the Entire Treatment Period in NDMM Participants
Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28-day Cycle (Up to 45 months)
| Intervention | percentage of participants (Number) |
|---|
| CR + VGPR + PR | CR + VGPR | CR | VGPR | PR | SD | PD |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 82 | 36 | 15 | 21 | 67 | 18 | 0 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 71 | 32 | 12 | 21 | 59 | 18 | 6 |
Percentage of Participants With (CR + VGPR), CR, VGPR, PR, SD and PD in RRMM Participants
Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28-day Cycle (Up to 45 months)
| Intervention | percentage of participants (Number) |
|---|
| CR + VGPR | CR | VGPR | PR | SD | PD |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 19 | 5 | 14 | 44 | 37 | 10 |
Number of Participants With AEs, Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction, SAEs in RRMM Participants
"An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator." (NCT02046070)
Timeframe: First dose of study drug through 30 days after last dose of drug (Up to 45 months)
| Intervention | Participants (Count of Participants) |
|---|
| Any AE | Grade 3 or Higher AE | AEs Resulting in Treatment Discontinuation | AEs Resulting in Dose Reduction | SAEs |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 72 | 49 | 19 | 30 | 30 |
Number of Participants With Adverse Events (AEs), Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction and Serious Adverse Events (SAEs) in NDMM Participants
"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator." (NCT02046070)
Timeframe: First dose of study drug through 30 days after last dose of drug (Up to 45 months)
| Intervention | Participants (Count of Participants) |
|---|
| Any AE | Grade 3 or Higher AEs | AEs Resulting in Treatment Discontinuation | AEs Resulting in Dose Reduction | SAEs |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 35 | 27 | 9 | 11 | 17 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 34 | 27 | 11 | 10 | 20 |
Cmax: Maximum Observed Plasma Concentration for Ixazomib in RRMM Participants
(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
| Intervention | ng/mL (Mean) |
|---|
| Cycle 1 Day 1 | Cycle 1 Day 15 |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 47.400 | 52.229 |
Cmax: Maximum Observed Plasma Concentration for Ixazomib in NDMM Participants
(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
| Intervention | nanogram/mL (ng/mL) (Mean) |
|---|
| Cycle 1 Day 1 | Cycle 1 Day 15 |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 64.283 | 53.145 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 46.600 | 62.280 |
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) During the Induction Phase in NDMM Participants
EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). (NCT02046070)
Timeframe: Baseline (BL) (Day 1 of Cycle 1), Day 1 of Cycle 13 (Up to 1 year)
| Intervention | score on a scale (Mean) |
|---|
| Global Health Status/QoL, Change from BL; Cycle 13 | Physical functioning, Change from BL at Cycle 13 | Role functioning, Change from BL at Cycle 13 | Emotional functioning, Change from BL at Cycle 13 | Cognitive functioning, Change from BL at Cycle 13 | Social functioning, Change from BL at Cycle 13 | Fatigue, Change from BL at Cycle 13 | Nausea/Vomiting, Change from BL at Cycle 13 | Pain, Change from BL at Cycle 13 | Dyspnea, Change from BL at Cycle 13 | Insomnia, Change from BL at Cycle 13 | Appetite Loss, Change from BL at Cycle 13 | Constipation, Change from BL at Cycle 13 | Diarrhea, Change from BL at Cycle 13 | Financial Difficulties, Change from BL at Cycle 13 |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 3.47 | 14.17 | 8.33 | 11.34 | 2.78 | 9.03 | -10.88 | -4.86 | -13.89 | -11.11 | -16.67 | -18.06 | -13.89 | -2.78 | 4.17 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | -5.43 | 17.97 | 6.52 | 2.54 | -7.25 | -11.59 | -6.76 | -4.35 | -10.87 | -7.25 | -10.14 | -7.25 | -5.80 | 5.80 | 1.45 |
Change From Baseline in EORTC Quality of Life Questionnaire (QLQ-C30) in RRMM Participants
EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). (NCT02046070)
Timeframe: Baseline (Day 1 of Cycle 1), Day 1 of End of Treatment (EOT) (Up to 45 months)
| Intervention | score on a scale (Mean) |
|---|
| Global Health Status/QoL, Change from BL at EOT | Physical functioning, Change from BL at EOT | Role functioning, Change from BL at EOT | Emotional functioning, Change from BL at EOT | Cognitive functioning, Change from BL at EOT | Social functioning, Change from BL at EOT | Fatigue, Change from BL at EOT | Nausea/Vomiting, Change from BL at EOT | Pain, Change from BL at EOT | Dyspnea, Change from BL at EOT | Insomnia, Change from BL at EOT | Appetite Loss, Change from BL at EOT | Constipation, Change from BL at EOT | Diarrhea, Change from BL at EOT | Financial Difficulties, Change from BL at EOT |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | -5.50 | -6.00 | -7.67 | -5.00 | -5.33 | -11.33 | 5.11 | 3.33 | 5.00 | 10.00 | -6.00 | 4.67 | 2.00 | 6.00 | 4.00 |
AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in NDMM Participants
(NCT02046070)
Timeframe: Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
| Intervention | hr*ng/mL (Mean) |
|---|
| Cycle 1 Day 1 | Cycle 1 Day 15 |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 885.167 | 1338.333 |
,| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 792.600 | 1226.600 |
Time to Response (TTR) in RRMM Participants
TTR is defined as the time interval from the date of the first dose of study treatment to the date of the first documented confirmed response of PR or better up to the alternative therapy in a participant who responded. (NCT02046070)
Timeframe: Up to 45 months
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 2.1 |
Time to Response (TTR) in NDMM Participants During the Induction Phase
TTR is defined as the time interval from the date of the first dose of study treatment to the date of the first documented confirmed response of PR or better up to the initiation of alternative therapy in a participant who responded. (NCT02046070)
Timeframe: Up to 1 year
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 2.2 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 1.9 |
Time to Progression (TTP) in RRMM Participants
TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression. (NCT02046070)
Timeframe: Up to 45 months
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 16.8 |
Time to Progression (TTP) in NDMM Participants
TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression. (NCT02046070)
Timeframe: Up to 45 months
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 30.9 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 32.2 |
Progression Free Survival (PFS) in RRMM Participants
PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression or death. (NCT02046070)
Timeframe: Up to 45 months
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 14.2 |
Progression Free Survival (PFS) in NDMM Participants
PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression or death. (NCT02046070)
Timeframe: Up to 45 months
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 23.5 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 23.0 |
Overall Response Rate (ORR) in Relapsed and/or Refractory Multiple Myeloma (RRMM) Participants
ORR is the percentage of participants with CR, VGPR or PR according to IMWG criteria. CR=negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PC) in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved free light chain (FLC) levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. (NCT02046070)
Timeframe: Day 1 of each 28 day cycle (Up to 45 months)
| Intervention | percentage of participants (Mean) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 49 |
Duration of Response (DOR) in RRMM Participants
DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documented PD up to the alternative therapy. (NCT02046070)
Timeframe: Up to 45 months
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM) | 26.3 |
Duration of Response (DOR) in NDMM Participants
DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documented PD up to the initiation of alternative therapy. (NCT02046070)
Timeframe: Up to 45 Months
| Intervention | months (Median) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 32.2 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 36.6 |
Combined Response Rate During the Induction Phase in Newly Diagnosed Multiple Myeloma (NDMM) Participants
Combined Response Rate is the percentage of participants with Complete Response (CR), including stringent Complete Response (sCR), and Very Good Partial Response (VGPR) according to the International Myeloma Working Group (IMWG) criteria during the Induction Phase (Cycles 1-13, 28-day cycles). CR=negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. (NCT02046070)
Timeframe: Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)
| Intervention | percentage of participants (Number) |
|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 27 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 24 |
Progression-free Survival (PFS) Rate at 3 Years
"PFS was defined as the time from randomization to CLL progression or death, whichever occurred first. Progression is characterized by any of the following:~≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart~≥ 50% increase from nadir since start of tx in the size of liver and/or spleen~≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10^9/L to qualify as disease progression.~Transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with > 55% prolymphocytes). For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count > 5x10^9/L and/or recurrence of palpable lymphadenopathy > 1.5 cm by physical exam." (NCT02048813)
Timeframe: Assessed every 3 months until progression up to 4 years and 8 months
| Intervention | Proportion of participants (Number) |
|---|
| Arm A (Ibrutinib, Rituximab) | 0.894 |
| Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 0.729 |
Overall Survival (OS) Rate at 3 Years
Overall survival was defined as time from randomization to death from any cause or date last known alive. Overall survival rate at 3 years was estimated using the method of Kaplan-Meier. (NCT02048813)
Timeframe: Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5, up to 4 years and 8 months
| Intervention | Proportion of participants (Number) |
|---|
| Arm A (Ibrutinib, Rituximab) | 0.988 |
| Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 0.915 |
Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI-CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported. (NCT02049151)
Timeframe: Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months
| Intervention | subjects (Number) |
|---|
| TEAEs | Serious TEAEs | Grade 3 or 4 TEAEs | TEAEs Leading to Permanent Discontinuation | TEAEs leading to death | ISRs |
|---|
| Placebo + Saline | 13 | 1 | 2 | 1 | 0 | 3 |
,| Tecemotide (L-BLP25) + Cyclophosphamide | 14 | 4 | 5 | 2 | 0 | 0 |
Overall Survival
Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects. (NCT02049151)
Timeframe: Time from date of randomization until death, assessed maximum up to 16 months
| Intervention | subjects (Number) |
|---|
| Number of deaths | Number for censored |
|---|
| Placebo + Saline | 2 | 15 |
,| Tecemotide (L-BLP25) + Cyclophosphamide | 1 | 14 |
Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs
The Mann=Whitney U test was used to compare the fold change of intensity of PD-1 expression on Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms. (NCT02054104)
Timeframe: one month after first 6 vaccinations
| Intervention | fold change (Mean) |
|---|
| Cohort 1/Vaccine Plus Chemotherapy | 0.84 |
| Cohort 2/Vaccine Alone | 0.91 |
Number of Participants With an Immunologic Responses
Immunologic responses are defined as an appearance of new serologic reactivity, or increase in existing antibody response to cancer-testis on the X chromosome (CT-X) antigen. Antigens such as New York esophageal squamous cell carcinoma-1 (NY-ESO1) and melanoma antigen gene (MAGE) family members assessed by enzyme-linked immunosorbent assay (ELISA) one month after the 6th vaccine. (NCT02054104)
Timeframe: one month after the 6th vaccine
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1/Vaccine Plus Chemotherapy | 4 |
| Cohort 2/Vaccine Alone | 4 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02054104)
Timeframe: Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1/Vaccine Plus Chemotherapy | 8 |
| Cohort 2/Vaccine Alone | 6 |
Fold Change From Baseline of Percent Tregs
The Mann-Whitney U test was used to compare the fold change of percent Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms. (NCT02054104)
Timeframe: one month after first 6 vaccinations
| Intervention | fold change (Mean) |
|---|
| Cohort 1/Vaccine Plus Chemotherapy | 0.87 |
| Cohort 2/Vaccine Alone | 0.73 |
Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
"AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as hour*micrograms per milliliter (hr*mcg/mL)" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)
| Intervention | hr*mcg/mL (Mean) |
|---|
| Venetoclax 800mg + R-CHOP | .66 |
| Venetoclax 200 mg + R-CHOP | 2.51 |
| Venetoclax 400 mg + R-CHOP | 3.87 |
| Venetoclax 600 mg + R-CHOP | 3.70 |
| Venetoclax + R-CHOP 800 mg | 4.51 |
| Venetoclax 200mg + G-CHOP | 2.55 |
| Venetoclax 400mg + G-CHOP | 4.33 |
| Venetoclax 600mg + G-CHOP | 5.13 |
| Venetoclax + G-CHOP 800mg | 6.20 |
Safety: Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02055820)
Timeframe: Baseline up to approximately 36 months
| Intervention | Percentage of Participants (Number) |
|---|
| Venetoclax 200 mg + R-CHOP | 100.00 |
| Venetoclax 400 mg + R-CHOP | 100.00 |
| Venetoclax 600 mg + R-CHOP | 100.00 |
| Venetoclax 800mg + R-CHOP | 100.00 |
| Venetoclax + R-CHOP 800 mg Phase II | 99.0 |
| Venetoclax 200mg + G-CHOP | 100.00 |
| Venetoclax 400mg + G-CHOP | 100.00 |
| Venetoclax 600mg + G-CHOP | 100.00 |
| Venetoclax 800 mg + G-CHOP A | 100.00 |
| Venetoclax 800 mg + G-CHOP B | 100.00 |
Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs. (NCT02055820)
Timeframe: Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)
| Intervention | Participants (Number) |
|---|
| Venetoclax 200 mg + R-CHOP | 1 |
| Venetoclax 400 mg + R-CHOP | 0 |
| Venetoclax 600 mg + R-CHOP | 1 |
| Venetoclax 800mg + R-CHOP | 0 |
| Venetoclax 200mg + G-CHOP | 2 |
| Venetoclax 400mg + G-CHOP | 1 |
| Venetoclax 600mg + G-CHOP | 1 |
| Venetoclax 800 mg + G-CHOP A | 0 |
| Venetoclax 800 mg + G-CHOP B | 0 |
Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)
| Intervention | Percentage of participants (Number) |
|---|
| Venetoclax + R-CHOP 800 mg Phase II | 68.2 |
Rituximab PK: Cmin Within the Dosing Interval
Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2. (NCT02055820)
Timeframe: Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Venetoclax 800 mg | 26.1 |
Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to NCT02055820)
Timeframe: Baseline up to end of treatment (approx. 6 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Venetoclax + R-CHOP 800 mg Phase II | 37.4 |
Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)
| Intervention | Percentage of participants (Number) |
|---|
| Venetoclax + R-CHOP 800 mg Phase II | 66.7 |
Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC
"Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.~CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR" (NCT02055820)
Timeframe: Baseline to end of treatment (up to approximately 6 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Venetoclax + R-CHOP 800 mg Phase II | 81.5 |
Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
| Intervention | Hour (Mean) |
|---|
| Venetoclax + R-CHOP 100 mg | 4.0 |
| Venetoclax 200 mg + R-CHOP | 4.59 |
| Venetoclax 400 mg + R-CHOP | 6.50 |
| Venetoclax 600 mg + R-CHOP | 5.52 |
| Venetoclax 800mg + R-CHOP | 5.53 |
| Venetoclax 200mg + G-CHOP | 5.72 |
| Venetoclax 400mg + G-CHOP | 6.56 |
| Venetoclax 600mg + G-CHOP | 5.30 |
| Venetoclax + G-CHOP 800 mg | 5.79 |
Vincristine PK: Cmax
Cmax was determined using the post-dose Vincristine plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Venetoclax PK Popluation | 54.0 |
Prednisone Plasma PK: AUC
AUC was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
| Intervention | hr*mcg/mL (Mean) |
|---|
| Cycle 1, Day 1 | Cycle 2, Day 1 |
|---|
| Venetoclax PK Popluation | 195 | 184 |
Prednisone Plasma PK: Cmax
Cmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
| Intervention | Ng/ML (Mean) |
|---|
| Cycle 1, Day 1 | Cycle 2, Day 1 |
|---|
| Venetoclax PK Popluation | 49.9 | 43.2 |
Prednisone Plasma PK: Tmax
Tmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
| Intervention | Hour (Mean) |
|---|
| Cycle 1, Day 1 | Cycle 2, Day 1 |
|---|
| Venetoclax PK Popluation | 2.19 | 3.80 |
Relative Dose Intensity of Venetoclax
Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)
| Intervention | Percentage of Partcipants (Number) |
|---|
| <80% | 80-<85% | 85-<90% | >=90% |
|---|
| Venetoclax + G-CHOP 800 mg | 83.3 | 0.00 | 16.7 | 0.00 |
,| Venetoclax + G-CHOP 800mg B | 100.0 | 0.00 | 0.00 | 0.00 |
,| Venetoclax + R-CHOP 800 mg Phase II | 26.0 | 3.4 | 2.9 | 67.6 |
,| Venetoclax 200 mg + R-CHOP | 71.4 | 0.00 | 0.00 | 28.6 |
,| Venetoclax 200mg + G-CHOP | 100.00 | 0.00 | 0.00 | 0.00 |
,| Venetoclax 400 mg + R-CHOP | 0.00 | 0.00 | 0.00 | 100.00 |
,| Venetoclax 400mg + G-CHOP | 14.3 | 14.3 | 0.00 | 71.4 |
,| Venetoclax 600 mg + R-CHOP | 12.5 | 12.5 | 12.5 | 62.5 |
,| Venetoclax 600mg + G-CHOP | 50.0 | 16.7 | 0.00 | 33.3 |
,| Venetoclax 800mg + R-CHOP | 0.00 | 0.00 | 0.00 | 100.00 |
Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)
| Intervention | Percentage of participants (Number) |
|---|
| Cyclophosphamide | Doxorubicin | Vincristine | Prednisone |
|---|
| Venetoclax + R-CHOP Arm | 89.5 | 88.6 | 86.6 | 87.4 |
,| Venetoclax 600mg + G-CHOP | 77.4 | 77.4 | 78.1 | 81.3 |
Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Venetoclax + R-CHOP 100 mg | 0.0714 |
| Venetoclax 200 mg + R-CHOP | 0.522 |
| Venetoclax 400 mg + R-CHOP | 0.253 |
| Venetoclax 600 mg + R-CHOP | 0.387 |
| Venetoclax 800mg + R-CHOP | 0.640 |
| Venetoclax 200mg + G-CHOP | 0.134 |
| Venetoclax 400mg + G-CHOP | 0.395 |
| Venetoclax 600mg + G-CHOP | 0.612 |
| Venetoclax + G-CHOP 800 mg | 0.628 |
Cyclophosphamide PK: Cmax
Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Venetoclax PK Popluation | 32.1 |
Doxorubicin PK: Cmax
Cmax was determined using the post-dose Doxorubicin plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Venetoclax PK Popluation | 1260 |
Obinutuzumab PK: Cmax
Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Venetoclax 800 mg | 326 |
Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions. (NCT02055820)
Timeframe: Month 12
| Intervention | Percentage of Participants (Number) |
|---|
| Venetoclax 200 mg + R-CHOP | 85.71 |
| Venetoclax 400 mg + R-CHOP | 100.00 |
| Venetoclax 600 mg + R-CHOP | 87.50 |
| Venetoclax 800mg + R-CHOP | 66.67 |
| Venetoclax + R-CHOP 800 mg Phase II | 88.99 |
| Venetoclax 200mg + G-CHOP | 100.00 |
| Venetoclax 400mg + G-CHOP | 75.00 |
| Venetoclax 600mg + G-CHOP | 100.00 |
| Venetoclax 800 mg + G-CHOP A | 100.00 |
| Venetoclax 800 mg + G-CHOP B | 100.00 |
Rituximab PK: Cmax
Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
| Intervention | mcg/mL (Mean) |
|---|
| Venetoclax 800 mg | 173 |
Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
"Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as micrograms per milliliter" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
| Intervention | Ug/ML (Mean) |
|---|
| Venetoclax + R-CHOP 100 mg | .09 |
| Venetoclax 200 mg + R-CHOP | .58 |
| Venetoclax 400 mg + R-CHOP | .92 |
| Venetoclax 600 mg + R-CHOP | .85 |
| Venetoclax 800mg + R-CHOP | 1.15 |
| Venetoclax 200mg + G-CHOP | .52 |
| Venetoclax 400mg + G-CHOP | 1.26 |
| Venetoclax 600mg + G-CHOP | 1.00 |
| Venetoclax + G-CHOP 800 mg | 1.54 |
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT02062359)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|
| All Participants | 2 |
Overall Survival
What percentage of participants were alive at a certain time point after transplant (NCT02065154)
Timeframe: 2 Year Post Transplant
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide (Cytoxan) | 51 |
Relapse Rate
What percentage of participants relapsed (NCT02065154)
Timeframe: 2 years post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide (Cytoxan) | 21 |
Disease-free Survival
What percentage of participants did not have relapse of disease after transplant (NCT02065154)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide (Cytoxan) | 46.15 |
Grade II-IV Acute GVHD
To calculate the percentage of patients developing graft versus host disease, grade II-IV, in the first 100 days after transplant (NCT02065154)
Timeframe: Till 100 days post transplant
| Intervention | percentage of participants (Number) |
|---|
| Treatment | 30 |
Graft Failure
Number of participants with primary and/or secondary graft failure. (NCT02080195)
Timeframe: 60 days
| Intervention | Participants (Count of Participants) |
|---|
| Primary graft failure | Secondary graft failure |
|---|
| Nonmyeloablative Conditioning and BMT | 0 | 0 |
Acute Graft Versus Host Disease (GVHD)
Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). (NCT02080195)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Grades II-IV acute GVHD | Grades III-IV acute GVHD |
|---|
| Nonmyeloablative Conditioning and BMT | 0 | 0 |
Survival
Number of patients alive and alive without relapse, respectively. (NCT02080195)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Overall Survival | Event Free Survival |
|---|
| Nonmyeloablative Conditioning and BMT | 1 | 1 |
The Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide in Refractory SLE Patients With Donors Having Various Degrees of Matching
Number of participants who were alive at 1 year after transplant and who had not suffered graft rejection, acute or chronic GVHD, or Grade 3 or higher (CTCAE V4.0) adverse events. (NCT02080195)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Nonmyeloablative Conditioning and BMT | 1 |
Chronic Graft Versus Host Disease (GVHD)
"Percentage of participants who developed chronic GVHD as defined by the NIH consensus criteria. This system gives scores from 0 to 3 for Karnofsky performance score, skin, mouth, eyes, gastrointestinal, liver, lungs, joints, and genitals, as well as an overall severity (mild, moderate, or severe).~Mild chronic GVHD involves only 1 or 2 organs or sites (except the lung), with no clinically significant functional impairment (maximum of score 1 in all affected organs or sites).~Moderate chronic GVHD involves 1) at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) OR 2) 3 or more organs or sites with no clinically significant functional impairment (maximum score of 1 in all affected organs or sites).~Severe chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site)." (NCT02080195)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Nonmyeloablative Conditioning and BMT | 0 |
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Number of participants with concurrent administration of simvastatin with (neo)adjuvant anthracycline-based chemotherapy in early stage breast cancer patients who experience adverse events as defined by NCI CTCAE v4.0. (NCT02096588)
Timeframe: 52 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Simvastatin | 15 |
Change in Echocardiographic Global Longitudinal Strain (GLS)
To compare the absolute change in echocardiographic GLS (Global Longitudinal Strain) from baseline (T0) to 2-3 weeks after (T2) completion of 4 cycles of (neo)adjuvant anthracycline-based chemotherapy in early stage breast cancer patients who do and do not receive concurrent simvastatin therapy (NCT02096588)
Timeframe: up to 15 weeks
| Intervention | Percentage change in GLS (Mean) |
|---|
| Simvastatin | 0.42 |
| No Drug | 1.11 |
Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm C (LR Control) | 58.94 |
| Arm D (LR Blinatumomab) | 67.00 |
Overall Survival (OS) of LR Relapse Patients
OS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Three-year OS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm C (LR Control) | 88.29 |
| Arm D (LR Blinatumomab) | 90.37 |
Overall Survival (OS) of HR and IR Relapse Patients
OS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Two-year OS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 2 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm A (HR and IR Control) | 58.40 |
| Arm B (HR and IR Blinatumomab) | 71.33 |
Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks
T cell receptor (TCR) and vector presence was quantitated in peripheral blood mononuclear cells (PBMC) samples using flow cytometry. It is a process by which cells are suspended in a liquid so they can be counted. (NCT02111850)
Timeframe: 4 weeks
| Intervention | cells/uL (Median) |
|---|
| Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | 1.0792 |
| Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | 1.9656 |
| Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | 2.8676 |
| Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | 0.17248 |
| Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | 2.8 |
| Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | 0 |
| Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | 6.79 |
| Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | 31.9 |
| Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other | 84.86 |
| Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma | 24.95 |
Number of Participants With Dose-limiting Toxicity (DLT)
A dose-limiting toxicity (DLT) is all grade 3 and greater toxicities with the exception of myelosuppression, aldesleukin expected toxicities, expected chemotherapy toxicities, immediate hypersensitivity reactions occurring within 2 hours of cell infusion, grade 3 fever, grade 3 metabolic laboratory abnormalities without significant clinical sequela that resolve within grade 2 within 7 days, and grade 3 autoimmunity that resolves to less than or equal to a grade 2 autoimmune toxicity within 10 days. (NCT02111850)
Timeframe: Before progression to next-higher dose level, approximately 2 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 | 0 |
Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin
Highest dose at which less than or equal to 1 of 6 patients experienced a dose-limiting toxicity (DLT) (all grade 3 and greater toxicities with the exception of myelosuppression and grade 3 fever, for example) or the highest dose level studied if DLTs are not observed at any of the dose levels. (NCT02111850)
Timeframe: Before progression to next-higher dose level, at least two weeks
| Intervention | cells (Number) |
|---|
| All Participants on Phase 1 | 100,000,000,000 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02111850)
Timeframe: Date treatment consent signed to date off study, an average of 17 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | 1 |
| Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | 1 |
| Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | 1 |
| Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2 | 1 |
| Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | 2 |
| Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | 1 |
| Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | 1 |
| Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | 1 |
| Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | 6 |
| Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other | 5 |
| Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma | 1 |
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Percentage of participants who have a clinical response to treatment (objective tumor regression) measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter of target lesions. Progression is at least a 20% increase in the sum of longest diameter of target lesions or the appearance of one or more new lesions. And stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. (NCT02111850)
Timeframe: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x2 years, then per principal investigator discretion, approximately 6 years
| Intervention | percentage of participants (Number) |
|---|
| Complete Response | Partial Response | Progression | Stable Disease |
|---|
| Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other | 0 | 20 | 80 | 0 |
,| Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2 | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | 100 | 0 | 0 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | 0 | 0 | 100 | 0 |
,| Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | 0 | 22.2 | 77.8 | 0 |
Overall Survival (OS) of Patients Receiving a Lymphocyte Depleting Preparative Regimen
OS is defined as the time between the first day of treatment to the day of death or date last known alive. (NCT02111863)
Timeframe: up to 3 years
| Intervention | months (Median) |
|---|
| Lymphocyte Depleting Prep Regimen | 12 |
Count of Participants With Serious and Non-Serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02111863)
Timeframe: 2 years and 59 days
| Intervention | Participants (Count of Participants) |
|---|
| Lymphocyte Depleting Prep Regimen | 6 |
EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3
EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| VHR T-ALL MRD Undetectable | 25.0 |
| VHR T-ALL MRD Detectable | 88.9 |
Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase
Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (NCT02112916)
Timeframe: 3 years from start of therapy by patient
| Intervention | Percentage of participants (Number) |
|---|
| Total Patients | 78.0 |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| Isolated CNS Relapse | Isolated Bone Marrow Relapse | Combined Bone Marrow Relapse |
|---|
| AALL0434 T-ALL Patients | 2.2 | 3.0 | 1.8 |
,| AALL1231 T-ALL Patients | 3.6 | 1.4 | 1.3 |
EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond
EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| VHR T-LLy (CR/PR) | 0 |
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| Arm A (Combination Chemotherapy) | 81.7 |
| Arm B (Combination Chemotherapy, Bortezomib) | 85.1 |
Proportion of Patients With Complete Response
Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire. (NCT02116530)
Timeframe: 0 to 120 hours after chemotherapy
| Intervention | percentage of participants (Number) |
|---|
| 0-24 hours after chemotherapy | 25-120 hours after chemotherapy | 0-120 hours after chemotherapy |
|---|
| Olanzapine | 85.7 | 66.9 | 63.6 |
,| Placebo | 64.6 | 52.4 | 40.6 |
Proportion of Patients With no Nausea
No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy. (NCT02116530)
Timeframe: 0 to 120 hours after chemotherapy
| Intervention | percentage of participants (Number) |
|---|
| 0-24 hours after chemotherapy | 25-120 hours after chemotherapy | 0-120 hours after chemotherapy |
|---|
| Olanzapine | 73.8 | 42.4 | 37.3 |
,| Placebo | 45.3 | 25.4 | 21.9 |
Frequency of Rescue Medication
Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire. (NCT02116530)
Timeframe: Day 2 to Day 6 after chemotherapy
| Intervention | Participants (Count of Participants) |
|---|
| Day 272213840 | Day 272213839 | Day 372213839 | Day 372213840 | Day 472213839 | Day 472213840 | Day 572213840 | Day 572213839 | Day 672213839 | Day 672213840 |
|---|
| More than twice | Twice | None | Once |
|---|
| Olanzapine | 156 |
| Placebo | 117 |
| Olanzapine | 21 |
| Placebo | 35 |
| Placebo | 19 |
| Olanzapine | 2 |
| Olanzapine | 158 |
| Placebo | 124 |
| Olanzapine | 11 |
| Placebo | 24 |
| Olanzapine | 7 |
| Placebo | 20 |
| Olanzapine | 4 |
| Placebo | 10 |
| Olanzapine | 141 |
| Olanzapine | 16 |
| Olanzapine | 10 |
| Placebo | 17 |
| Olanzapine | 3 |
| Placebo | 11 |
| Olanzapine | 145 |
| Placebo | 131 |
| Olanzapine | 19 |
| Placebo | 23 |
| Olanzapine | 5 |
| Placebo | 7 |
| Olanzapine | 143 |
| Placebo | 130 |
| Olanzapine | 12 |
| Placebo | 16 |
| Placebo | 14 |
Survival at 12 Months
Evaluate the proportion of patients who are alive at 12 months following randomization (NCT02117024)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 8 |
| Chemotherapy Alone | 11 |
Time to Progression (TTP)
Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST (NCT02117024)
Timeframe: Up to 3 years
| Intervention | Days (Median) |
|---|
| immune-related TTP (irTTP) | Time to Progression (TTP) |
|---|
| Chemotherapy Alone | 71.0 | 73.5 |
,| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 67.0 | 67.5 |
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events (NCT02117024)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| At least one TEAE | At least one severe TEAE | At least one treatment-related TEAE | At least one SAE | Fatal TEAE | At least one TEAE Leading to Tx Discontinuation | At least one TEAE Leading to a Dose Reduction |
|---|
| Chemotherapy Alone | 20 | 11 | 15 | 8 | 0 | 2 | 2 |
,| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 41 | 25 | 32 | 17 | 7 | 7 | 0 |
Survival at 6 Months
Evaluate the proportion of patients who are alive at 6 months following randomization (NCT02117024)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 21 |
| Chemotherapy Alone | 17 |
Overall Survival (OS)
"Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive.~Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events" (NCT02117024)
Timeframe: Up to 3 years
| Intervention | Days (Median) |
|---|
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 176 |
| Chemotherapy Alone | 372 |
Progression-Free Survival (PFS)
Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors) (NCT02117024)
Timeframe: Up to 3 years
| Intervention | Days (Median) |
|---|
| immune-related PFS (irPFS) | Progression Free Survival (PFS) |
|---|
| Chemotherapy Alone | 190.0 | 190.0 |
,| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 76.0 | 70.0 |
Time to Neutrophil and Platelet Recovery
Time to neutrophil and platelet recovery in median days (NCT02120157)
Timeframe: 100 days
| Intervention | days (Median) |
|---|
| neutrophil | platelet |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 22 | 21 |
Cumulative Incidence of Non-relapse Mortality
Cumulative incidence (measured as a percentage) of non-relapse mortality at 180 days following myeloablative, Human Leukocyte Antigen (HLA)-mismatched bone marrow transplant (BMT) for patients with high risk hematologic malignancies. (NCT02120157)
Timeframe: Day 180
| Intervention | percent (Number) |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 0 |
Cumulative Incidence of Chronic GVHD
Cumulative incidence (measured as a percentage) of chronic graft versus host disease (GVHD). (NCT02120157)
Timeframe: 2 years
| Intervention | percent (Number) |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 11 |
Incidence of Donor Cell Engraftment
Incidence of donor cell engraftment measured as the percentage of donor cell engraftment. (NCT02120157)
Timeframe: 60 days
| Intervention | percentage of donor cell engraftment (Number) |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 84 |
Number of Participants With Donor Cell Engraftment
Number of Participants with Donor Cell Engraftment at Day 60 following myeloablative, HLA-mismatched BMT. (NCT02120157)
Timeframe: Day 60
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 27 |
Cumulative Incidence of Acute Graft Versus Host Disease (GVHD) Grades 2-4 and Grades 3-4
Cumulative incidence (measured as a percentage) of acute GVHD grades 2-4 (overall) and grades 3-4 (severe). (NCT02120157)
Timeframe: 100 days
| Intervention | percent (Number) |
|---|
| Grades 2-4 | Grades 3-4 |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 10 | 0 |
Primary and Secondary Graft Failure
Incidence (measured as a percentage) of primary and secondary graft failure. (NCT02120157)
Timeframe: 2 years
| Intervention | percentage of graft failure (Number) |
|---|
| Primary | Secondary |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 16 | 0 |
Steroid and Non-steroid Immunosuppressants
Number of participants who used steroid and non-steroid immunosuppressants to treat GVHD. (NCT02120157)
Timeframe: Two Years
| Intervention | Participants (Count of Participants) |
|---|
| Steroid immunosuppressants | Non-steroid immunosuppressants |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 4 | 2 |
Steroid and Non-steroid Immunosuppressants Use Duration
Duration of use of steroid and non-steroid immunosuppressants (in months) to treat GVHD. (NCT02120157)
Timeframe: Two Years
| Intervention | months (Number) |
|---|
| Steroid immunosuppressants | Non-steroid immunosuppressants |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 18 | 19 |
Survival
Estimate incidence of overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), event-free survival, and relapse-free GVHD-free survival (GRFS) in patients receiving myeloablative, HLA-mismatched BMT for patients with high risk hematologic malignancies at 1 year. Incidence as a percentage. (NCT02120157)
Timeframe: up to 1 years
| Intervention | percent (Number) |
|---|
| overall survival (OS) | progression-free survival (PFS) | disease-free survival (DFS) | event-free survival | Relapse-free GVHD-free survival (GRFS) |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 77 | 68 | 68 | 68 | 65 |
Survival
Estimate incidence of overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), event-free survival, and relapse-free GVHD-free survival (GRFS) in patients receiving myeloablative, HLA-mismatched BMT for patients with high risk hematologic malignancies at 2 years. Incidence as a percentage. (NCT02120157)
Timeframe: up to 2 years
| Intervention | percent (Number) |
|---|
| overall survival (OS) | progression-free survival (PFS) | disease-free survival (DFS) | event-free survival | Relapse-free GVHD-free survival (GRFS) |
|---|
| Haploidentical BMT With PTCy for Acute Leukemias and MDS | 73 | 64 | 64 | 64 | 52 |
The Remission Rate for Participants With High-risk Myeloma
Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy. (NCT02128230)
Timeframe: from baseline to either death or study completion for each subject (up to approximately 48 months)
| Intervention | Participants (Number) |
|---|
| Total Therapy 5B | 0 |
Percentage of Participants With Total Pathologic Complete Response (tpCR), Evaluated After Surgery
Total pathologic complete response (tpCR) was the pCR based on tumor and nodal staging (i.e., histological confirmation of pCR in breast and nodes at surgery) and was defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes (i.e., ypT0/is ypN0 tpCR). Participants who did not undergo surgery or did not have a valid pCR assessment were considered non-responders in the analysis. The 95% CIs were calculated using the Clopper-Pearson method. (NCT02132949)
Timeframe: After completion of neoadjuvant treatment and surgery (up to 25 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 61.8 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 60.7 |
Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Treatment-Free Follow-Up Period
LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. (NCT02132949)
Timeframe: From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years)
| Intervention | Percentage of participants (Number) |
|---|
| At Least One LVEF Significant Decline Event (Confirmed+Single) | At Least One Confirmed LVEF Significant Decline | At Least One Single LVEF Significant Decline |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 6.0 | 3.0 | 3.0 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 3.5 | 1.0 | 2.5 |
Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1 to 5 Years, Determined by the Investigator According to RECIST v1.1
The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Event-free survival (EFS) was defined as the time from enrollment to the first occurrence of progressive disease (PD), relapse, or death from any cause, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be free from progressive disease or relapse. Participants with no tumor evaluations after baseline were censored at the date of enrollment plus 1 day. (NCT02132949)
Timeframe: At 1, 2, 3, 4, and 5 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| 1 Year | 2 Years | 3 Years | 4 Years | 5 Years |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 98.47 | 95.80 | 93.58 | 92.39 | 90.84 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 97.48 | 92.86 | 90.78 | 89.73 | 89.20 |
Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1 to 5 Years
The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Overall survival (OS) was defined as the time from enrollment to death from any cause. Participants who were alive or lost to follow-up were censored at their last known date in the study. Participants with no post-baseline assessments were censored at the date of enrollment plus 1 day. (NCT02132949)
Timeframe: At 1, 2, 3, 4, and 5 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| 1 Year | 2 Years | 3 Years | 4 Years | 5 Years |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 99.48 | 98.96 | 97.86 | 97.86 | 96.10 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 100.00 | 97.94 | 96.38 | 94.81 | 93.75 |
Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period
"An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms severe and serious are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs." (NCT02132949)
Timeframe: From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Any Adverse Event (AE) | NCI-CTCAE Grade 3-5 AE | Serious AE | Deaths | Ejection Fraction Decreased (Any Grade) | Heart Failure (Any Grade) |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 171 | 23 | 15 | 0 | 15 | 0 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 171 | 40 | 17 | 0 | 20 | 2 |
Overview of the Number of Participants With at Least One Adverse Event During the Neoadjuvant Period
"An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms severe and serious are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs." (NCT02132949)
Timeframe: From first dose of any study drug prior to surgery through the day before the first dose of study drug after surgery (up to 25 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Any Adverse Event (AE) | NCI-CTCAE Grade 3-5 AE | Serious AE | Deaths | Ejection Fraction Decreased (Any Grade) | Heart Failure (Any Grade) |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 198 | 99 | 45 | 0 | 14 | 4 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 198 | 108 | 52 | 0 | 7 | 0 |
Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period
"An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms severe and serious are not synonymous. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), and a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness were independently assessed for each AE. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as ejection fraction decreased). During TFFU, only heart failure, pregnancies, and non-breast-related second primary malignancies, irrespective of causal relationship with study treatment, and drug-related SAEs were reported. Multiple occurrences of the same AE in 1 subject were counted only once." (NCT02132949)
Timeframe: From 42 days after the last dose of study treatment until the end of treatment-free follow-up (TFFU; up to 5 years)
| Intervention | Participants (Count of Participants) |
|---|
| Any Adverse Event (AE) | NCI-CTCAE Grade 3-5 AE | Serious AE | Deaths | Ejection Fraction Decreased (Any Grade) | Heart Failure (Any Grade) |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 3 | 2 | 3 | 7 | 1 | 0 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 7 | 5 | 7 | 13 | 1 | 1 |
Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline
ATAs to pertuzumab in serum samples were detected using a validated bridging enzyme-linked immunosorbent assay (ELISA) method. This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample. (NCT02132949)
Timeframe: Screening (baseline) then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 1 year, 3 months)
| Intervention | Percentage of participants (Number) |
|---|
| At Baseline | Anytime Post-Baseline |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 1.6 | 4.6 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 2.1 | 3.6 |
Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Adjuvant Treatment Period
LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. (NCT02132949)
Timeframe: From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)
| Intervention | percentage of participants (Number) |
|---|
| At Least One LVEF Significant Decline Event (Confirmed+Single) | At Least One Confirmed LVEF Significant Decline | At Least One Single LVEF Significant Decline |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 7.7 | 2.8 | 5.0 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 10.5 | 3.2 | 7.4 |
Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Neoadjuvant Treatment Period
LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Results include events with onset from the first dose of pertuzumab or trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab or trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever is later. (NCT02132949)
Timeframe: From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks)
| Intervention | percentage of participants (Number) |
|---|
| At Least One LVEF Significant Decline Event (Confirmed+Single) | At Least One Confirmed LVEF Significant Decline | At Least One Single LVEF Significant Decline |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 6.5 | 1.0 | 5.5 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 2.0 | 0.5 | 1.5 |
Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Invasive Disease-Free Survival (iDFS) at 1 to 4 Years, Determined by the Investigator According to RECIST v1.1
The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Invasive disease-free survival (iDFS) was defined as the time from the first date of no disease (the date of surgery) to the first documentation of progressive invasive disease, relapse, or death, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be alive and disease-free. Participants with no postbaseline information and participants who did not undergo surgery were excluded from the analysis. (NCT02132949)
Timeframe: At 1, 2, 3, and 4 years
| Intervention | Estimate of percentage of participants (Number) |
|---|
| 1 Year | 2 Years | 3 Years | 4 Years |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 98.91 | 95.57 | 94.42 | 92.60 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 96.34 | 94.25 | 91.06 | 91.06 |
Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period
The clinical response rate was defined as the percentage of participants in the ITT population who achieved a complete response (CR) or partial response (PR) prior to surgery, according to RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. Participants were classified as missing or unevaluable if no assessments were measured prior to surgery on the ipsilateral breast. The 95% CIs were calculated using the Clopper-Pearson method; they were only calculated for responses (not for missing or unevaluable data). (NCT02132949)
Timeframe: From Baseline until disease progression or death due to any cause up to 24 weeks (during the neoadjuvant treatment period; assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks])
| Intervention | Percentage of participants (Number) |
|---|
| Clinical Response Rate (CR+PR) | Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Missing or Unevaluable |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 67.3 | 39.7 | 27.6 | 7.0 | 0.5 | 25.1 |
,| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 60.2 | 23.9 | 36.3 | 10.0 | 1.0 | 28.9 |
Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period
Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. (NCT02132949)
Timeframe: From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years)
| Intervention | Percentage of participants (Number) |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 0 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 0.5 |
Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period
Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from first dose of pertuzumab/trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab/trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever was later. (NCT02132949)
Timeframe: From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 1.5 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 0 |
Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Period
Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. (NCT02132949)
Timeframe: From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 0 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 0.5 |
Number of Nucleated Cells Collected Within the Apheresis Products
the investigator will identify the number of cells collected within the apheresis products (NCT02139280)
Timeframe: 6 weeks
| Intervention | cells x10e10 (Median) |
|---|
| Arm 1: 1.5 Gms/m(2) Cyclophosphamide | 5.7 |
| Arm 2: Cyclophosphamide 3 Gms/m(2) | 3.8 |
Toxicities During the Mobilization and Apheresis Processes
Toxicities during the mobilization and apheresis processes Grade 3 and higher (NCT02139280)
Timeframe: participants will be followed approximately 6 weeks following initiation of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: 1.5 Gms/m(2) Cyclophosphamide | 4 |
| Arm 2: Cyclophosphamide 3 Gms/m(2) | 7 |
Resource Utilization- Incidence of Febrile Neutropenia
Resources used during the mobilization and apheresis processes will be captured. (NCT02139280)
Timeframe: participants will be followed approximately 6 weeks following initiation of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: 1.5 Gms/m(2) Cyclophosphamide | 2 |
| Arm 2: Cyclophosphamide 3 Gms/m(2) | 2 |
Resource Utilization- Hospitalizations
Resources used during the mobilization and apheresis processes will be captured. (NCT02139280)
Timeframe: participants will be followed approximately 6 weeks following initiation of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: 1.5 Gms/m(2) Cyclophosphamide | 1 |
| Arm 2: Cyclophosphamide 3 Gms/m(2) | 1 |
Number of CD34+ Cells Collected Within the Apheresis Products
the investigator will identify the number of CD34+ cells collected within the apheresis products (NCT02139280)
Timeframe: 6 weeks
| Intervention | cells x10e8 (Median) |
|---|
| Arm 1: 1.5 Gms/m(2) Cyclophosphamide | 7 |
| Arm 2: Cyclophosphamide 3 Gms/m(2) | 10.5 |
Number of Patients With Hematopoietic Engraftment
Engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10^8/L for 3 consecutive measurements. (NCT02145039)
Timeframe: 42 days
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical Stem Cell Transplant | 2 |
Number of Patients Experiencing Acute Graft-versus-host Disease by 100 Days
(NCT02145039)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical Stem Cell Transplant | 1 |
2 Year Survival
Percentage of patients that survive 2 years post-transplant (NCT02145039)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Haploidentical Stem Cell Transplant | 0 |
Number of Participants With Dose-Limiting Toxicity (DLT)
DLT is defined as follows: Grade 3-5 allergic reactions related to the study cell infusion. Grade 3 and greater autoimmune reactions. Grades 3 and greater organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy and occurring within 30 days of study cell infusion and does not resolve within 72 hours. Treatment-related death within 8 weeks of the study cell infusion. (NCT02153905)
Timeframe: Within 30 days of study cell infusion
| Intervention | Participants (Count of Participants) |
|---|
| Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2) | 1 |
| Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2) | 0 |
Number of Participants With Serious and Non-Serious Adverse Events
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02153905)
Timeframe: Date treatment consent signed to date off study, approximately 53 days for the Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2) Arm/Group, and 1 year and 4 months for the Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2) Arm/Group.
| Intervention | Participants (Count of Participants) |
|---|
| Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2) | 1 |
| Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2) | 2 |
Number of Patients With Objective Tumor Regression
Objective tumor regression is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT02153905)
Timeframe: 6 and 12 weeks after cell infusion on up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response |
|---|
| Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2) | 0 | 1 |
,| Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2) | 0 | 0 |
Number of Patients Who Had a Minimal Residual Disease (MRD) Negative Complete Response (CR) 2 Months After Chemotherapy
To determine the rate of minimal residual disease negative complete response (MRD negative CR) in the bone marrow at 2 months post last cycle of FCR, participants will have a bone marrow biopsy procedure 2 months after completing combination therapy (IPI-145+ FCR) in tandem with a chest,neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confirm morphological CR in the bone marrow, while MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. This will include all patients treated and evaluable at maximum tolerated dose, and at the recommended phase II dose ( RP2D) (NCT02158091)
Timeframe: 2 months after completion of combination therapy of IPI-145 and FCR
| Intervention | Percentage of participants (Number) |
|---|
| Phase I MTD and Phase II RP2D: IPI 145 25 mg BID + FCR | 23 |
Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I
To assess the safety of IPI145 in combination with FCR in previously untreated younger patients with CLL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 3 or greater hematologic toxicity (except Grade 3 or Grade 4 neutropenia or thrombocytopenia that lasts less than or equal to 10 days off treatment), any Grade 3 or greater non-hematologic toxicity (except Grade 3 or greater nausea, vomiting, diarrhea, Grade 3 infusion reactions), Grade 3 asymptomatic laboratory abnormalities that improve to grade 2 or less within 3 days, Inability to receive day 1 therapy of Cycle 2 even after a three week treatment delay due to drug related toxicity from prior cycle, and any Grade 4 or greater elevation in AST ALT values (NCT02158091)
Timeframe: . Participants were assessed every week or more often as needed during Cycle 1, and every Day 1 Cycles 2 and onward-Dose-limiting toxicities (DLTs) occurring during the first cycle of treatment will be used in determining the Phase II MTD/RP2D
| Intervention | Participants (Count of Participants) |
|---|
| Phase I Cohort 1: IPI-145 25mg Once Daily + FCR | 2 |
| Phase I Cohort 2 (MTD): IPI-145 25mg Twice Daily + FCR | 1 |
Area Under the Serum Concentration-time Curve at Steady State (AUCtau)
"AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained." (NCT02162771)
Timeframe: Core Cycle 4 (Week 12)
| Intervention | h*ug/mL (Geometric Mean) |
|---|
| CT-P10 | 41002.43 |
| Rituxan | 40099.08 |
Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria
"ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review.~Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression." (NCT02162771)
Timeframe: During the Core Study Period (up to 8 cycles; Week 24)
| Intervention | Participants (Count of Participants) |
|---|
| CT-P10 | 64 |
| Rituxan | 63 |
B-cell Kinetics (B-cell Depletion and Recovery)
B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL). (NCT02162771)
Timeframe: Cycles 1 to 8 during the Core Study Period
| Intervention | cells/uL (Median) |
|---|
| Core Cycle 1 (Predose) | Core Cycle 1 (1 hour after the end of infusion) | Core Cycle 2 (Predose) | Core Cycle 3 (Predose) | Core Cycle 4 (Predose) | Core Cycle 5 (Predose) | Core Cycle 6 (Predose) | Core Cycle 7 (Predose) | Core Cycle 8 (Predose) |
|---|
| CT-P10 | 92.5 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 |
,| Rituxan | 62.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 |
Maximum Serum Concentration at Steady State (Cmax,ss)
"Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained." (NCT02162771)
Timeframe: Core Cycle 4 (Week 12)
| Intervention | ug/mL (Geometric Mean) |
|---|
| CT-P10 | 256.19 |
| Rituxan | 254.49 |
Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy
| Intervention | Percentage of patients (Number) |
|---|
| Arm I (ABVE-PC) | 80.7 |
| ARM II (Bv-AVEPC) | 81.2 |
Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment
| Intervention | percentage of participants (Number) |
|---|
| Arm I (ABVE-PC) | 82.5 |
| ARM II (Bv-AVEPC) | 92.1 |
Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.
| Intervention | Percentage of patients (Number) |
|---|
| Arm I (ABVE-PC) | 5.5 |
| ARM II (Bv-AVEPC) | 6.7 |
Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria. (NCT02193880)
Timeframe: From baseline and before day +100 of transplant.
| Intervention | Participants (Count of Participants) |
|---|
| Alpha-beta Depleted T-cell Infusion | 0 |
Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria. (NCT02193880)
Timeframe: From baseline and before day +100 of transplant.
| Intervention | Participants (Count of Participants) |
|---|
| Alpha-beta Depleted T-cell Infusion | 0 |
Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| No Chronic GVHD | Mild | Moderate | Severe |
|---|
| Treatment | 11 | 0 | 0 | 1 |
Number of Participants With Event-free Survival (EFS)
"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided." (NCT02199041)
Timeframe: One year after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Treatment | 4 |
Number of Participants With Malignant Relapse
"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided" (NCT02199041)
Timeframe: One year after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Treatment | 7 |
Number of Participants With Neutrophil Engraftment
Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. (NCT02199041)
Timeframe: Until day 42 post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Treatment | 11 |
Number of Participants With Overall Survival (OS)
"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided." (NCT02199041)
Timeframe: One year after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Treatment | 6 |
Number of Participants With Secondary Graft Failure
"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided." (NCT02199041)
Timeframe: 100 days after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Treatment | 0 |
Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| No Acute GVHD | Grade I | Grade II | Grade III | Grade IV |
|---|
| Treatment | 8 | 0 | 1 | 2 | 1 |
Percentage of Participants With Chronic GVHD Requiring Immunosupressive Therapy
Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. This endpoint considers the occurrence of chronic GVHD that necessitated initiation of immunosuppressive therapy for treatment. (NCT02208037)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 29 |
| Tacrolimus/Methotrexate/Maraviroc | 33 |
| Tacrolimus/MMF/Cyclophosphamide | 22 |
Percentage of Participants With Disease-free Survival
Disease-free survival is defined as being alive and free of disease relapse or progression. (NCT02208037)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 58 |
| Tacrolimus/Methotrexate/Maraviroc | 56 |
| Tacrolimus/MMF/Cyclophosphamide | 60 |
Percentage of Participants With Grade III-IV Acute GVHD
"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL 1.2-3 mg/dL 2.3.01-6 mg/dL 3.6.01-15.0 mg/dL 4.>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4" (NCT02208037)
Timeframe: Day 180 Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 8 |
| Tacrolimus/Methotrexate/Maraviroc | 9 |
| Tacrolimus/MMF/Cyclophosphamide | 2 |
Percentage of Participants With GVHD-free Survival
GVHD-free survival is defined as being alive without previous onset of Grade III-IV acute GVHD or chronic GVHD requiring immunosuppressive therapy. (NCT02208037)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 43 |
| Tacrolimus/Methotrexate/Maraviroc | 34 |
| Tacrolimus/MMF/Cyclophosphamide | 53 |
Percentage of Participants With GVHD/Relapse or Progression-free Survival (GRFS)
GRFS is defined as being free of grade III-IV acute GVHD onset, chronic GVHD onset requiring systemic immunosuppressive therapy, disease relapse or progression, and death from any cause. (NCT02208037)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 35.5 |
| Tacrolimus/Methotrexate/Maraviroc | 27.2 |
| Tacrolimus/MMF/Cyclophosphamide | 44.1 |
Percentage of Participants With Overall Survival
(NCT02208037)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 68 |
| Tacrolimus/Methotrexate/Maraviroc | 66 |
| Tacrolimus/MMF/Cyclophosphamide | 71 |
Donor Cell Engraftment
Donor cell engraftment will be assessed with donor/recipient chimerism. Chimerism may be evaluated in bone marrow, whole blood, or CD3 fractions. Full donor chimerism is defined as the presence of ≥ 95% of donor cells as a proportion of total cells. Mixed chimerism is defined as the presence of donor cells, as a proportion of total cells, of < 95% but > 5% in the bone marrow or peripheral blood. Full and mixed chimerism will be evidence of donor cell engraftment. Donor cells of ≤ 5% will be considered as graft rejection. (NCT02208037)
Timeframe: Days 28 and 100 Post-transplant
| Intervention | Participants (Count of Participants) |
|---|
| Day 2872130179 | Day 2872130181 | Day 2872130180 | Day 10072130180 | Day 10072130181 | Day 10072130179 |
|---|
| Full Chimerism | Mixed Chimerism | Graft Rejection | Dead | No Assay Performed |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 58 |
| Tacrolimus/MMF/Cyclophosphamide | 64 |
| Tacrolimus/Methotrexate/Bortezomib | 11 |
| Tacrolimus/MMF/Cyclophosphamide | 8 |
| Tacrolimus/Methotrexate/Bortezomib | 1 |
| Tacrolimus/Methotrexate/Maraviroc | 1 |
| Tacrolimus/MMF/Cyclophosphamide | 2 |
| Tacrolimus/Methotrexate/Bortezomib | 2 |
| Tacrolimus/Methotrexate/Maraviroc | 4 |
| Tacrolimus/MMF/Cyclophosphamide | 0 |
| Tacrolimus/Methotrexate/Bortezomib | 17 |
| Tacrolimus/Methotrexate/Maraviroc | 21 |
| Tacrolimus/MMF/Cyclophosphamide | 18 |
| Tacrolimus/Methotrexate/Bortezomib | 63 |
| Tacrolimus/Methotrexate/Maraviroc | 56 |
| Tacrolimus/MMF/Cyclophosphamide | 62 |
| Tacrolimus/Methotrexate/Bortezomib | 14 |
| Tacrolimus/Methotrexate/Maraviroc | 17 |
| Tacrolimus/MMF/Cyclophosphamide | 13 |
| Tacrolimus/Methotrexate/Bortezomib | 5 |
| Tacrolimus/Methotrexate/Maraviroc | 3 |
| Tacrolimus/MMF/Cyclophosphamide | 3 |
| Tacrolimus/Methotrexate/Bortezomib | 4 |
| Tacrolimus/Methotrexate/Maraviroc | 10 |
| Tacrolimus/MMF/Cyclophosphamide | 5 |
| Tacrolimus/Methotrexate/Bortezomib | 3 |
| Tacrolimus/Methotrexate/Maraviroc | 6 |
| Tacrolimus/MMF/Cyclophosphamide | 9 |
Percentage of Participants With Neutrophil Recovery
Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) ≥ 500/mm^3 for three consecutive measurements on three different days. (NCT02208037)
Timeframe: Days 28 and 100 Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Day 28 | Day 100 |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 94 | 96 |
,| Tacrolimus/Methotrexate/Maraviroc | 93 | 95 |
,| Tacrolimus/MMF/Cyclophosphamide | 95 | 98 |
Percentage of Participants With Platelet Recovery
Platelet recovery is defined as the first day of a sustained platelet count >20,000/mm^3 with no platelet transfusion in the preceding seven days. (NCT02208037)
Timeframe: Days 60 and 100 Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Day 60 | Day 100 |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 91 | 91 |
,| Tacrolimus/Methotrexate/Maraviroc | 92 | 92 |
,| Tacrolimus/MMF/Cyclophosphamide | 90 | 96 |
Percentage of Participants With Grade II-IV Acute GVHD
"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4" (NCT02208037)
Timeframe: Day 180 Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 26 |
| Tacrolimus/Methotrexate/Maraviroc | 32 |
| Tacrolimus/MMF/Cyclophosphamide | 27 |
Percentage of Participants With Chronic GVHD
Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. (NCT02208037)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 39 |
| Tacrolimus/Methotrexate/Maraviroc | 43 |
| Tacrolimus/MMF/Cyclophosphamide | 28 |
Percentage of Participants With Disease Relapse or Progression
Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pretransplant features, or radiologic evidence of lymphoma. Progression of disease applies to patients with lymphoproliferative diseases (lymphoma or chronic lymphocytic leukemia) not in remission prior to transplantation and is defined as increase in size of prior sites of disease or evidence of new sites of disease. (NCT02208037)
Timeframe: 1 Year Post-transplant
| Intervention | percentage of participants (Number) |
|---|
| Tacrolimus/Methotrexate/Bortezomib | 24 |
| Tacrolimus/Methotrexate/Maraviroc | 31 |
| Tacrolimus/MMF/Cyclophosphamide | 28 |
Number of Participants With Dose Limiting Toxicities
Dose limiting toxicities are defined as follows: Grade 3 toxicities possibly or probably related to either the anti-BCMA CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions. (NCT02215967)
Timeframe: After the start of treatment and up to 60 days
| Intervention | Participants (Count of Participants) |
|---|
| Hypophosphatemia | Confusion | Dyspnea (intubated) | Ejection fraction decreased | Encephalopathy | Hypoxia | Acute kidney injury (CVVH) | Sepsis (Staph Aureus) | Muscle weakness lower limbs | Muscle weakness upper limbs | Platelet count decreased | Neutrophil count decreased | Acute kidney injury | Hypotension | CPK increased | Musculoskeletal/connective tissue disorders-Rhabd. |
|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| 1 x 10^6 CAR-BCMA T-cells Infused | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| 3 x 10^6 CAR-BCMA T-cells Infused | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| 9 x 10^6 CAR-BCMA T-cells Infused | 4 | 3 | 4 | 4 | 3 | 3 | 4 | 4 | 3 | 3 | 3 | 4 | 3 | 4 | 4 | 3 |
Number of Participants With Best Response
Best response was assessed by the International Myeloma Working Group response criteria. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein. Progressive Disease (PD) is increases of greater or equal to 25% from the lowest post-treatment (nadir) value in serum M-component or urine component or percentage of bone marrow plasma cells. Definite development of new bone lesions or new plasmacytoma. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis. Stringent Complete Remission (sCR) is normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry. Complete Remission is negative immunofixation on the serum and urine. Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or PD. (NCT02215967)
Timeframe: From start of treatment up to 84 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Partial Remission | Stable Disease | Very Good Partial Remission | Complete Remission | Stringent Complete Remission | Progressive Disease |
|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 1 | 2 | 0 | 0 | 0 | 0 |
,| 1 x 10^6 CAR-BCMA T-cells Infused | 0 | 3 | 0 | 0 | 0 | 0 |
,| 3 x 10^6 CAR-BCMA T-cells Infused | 0 | 3 | 1 | 0 | 0 | 0 |
,| 9 x 10^6 CAR-BCMA T-cells Infused | 4 | 2 | 6 | 1 | 2 | 1 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02215967)
Timeframe: Date treatment consent signed to date off study, approx. 3 mos and 7 days for DL 0.3 x 10^6 CAR + T cells, 4 mos and 4 days for 1.0 x 10^6 CAR + T cells, 9 mos and 13 days for 3.0 x 10^6 CAR + T cells, and 48 mos and 12 days for 9.0 x 10^6 CAR + T cells.
| Intervention | Participants (Count of Participants) |
|---|
| 0.3 x 10^6 CAR-BCMA T-cells Infused | 3 |
| 1 x 10^6 CAR-BCMA T-cells Infused | 3 |
| 3 x 10^6 CAR-BCMA T-cells Infused | 4 |
| 9 x 10^6 CAR-BCMA T-cells Infused | 16 |
Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85
Mean Percent Change of Urinary monocyte chemoattractant protein (MCP-1:creatinine) ratio from Baseline (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | percentage change from baseline (Mean) |
|---|
| Placebo BID Plus Standard of Care | -33.175 |
| CCX168 10 mg BID Plus Standard of Care | -34.802 |
| CCX168 30 mg BID Plus Standard of Care | 63.567 |
Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85
Renal responses among patients (who had hematuria or albuminuria at baseline determined secondary to ANCA-associated vasculitis) were defined as improvement in the following parameters of renal vasculitis: (1) increase from baseline to day 85 in eGFR [Modification of Diet in Renal Disease (MDRD equation)], (2) decrease from baseline to day 85 in hematuria (microscopic count of urinary red blood cells [RBC]), and (3) decrease from baseline to day 85 in albuminuria (first morning urinary albumin:creatinine ratio). (NCT02222155)
Timeframe: Day 85
| Intervention | proportion of participants (Number) |
|---|
| Placebo BID Plus Standard of Care | 0.17 |
| CCX168 10 mg BID Plus Standard of Care | 0.4 |
| CCX168 30 mg BID Plus Standard of Care | 0.63 |
Change in Estimated Glomerular Filtration Rate at Day 85
Mean Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula, for patients with renal disease at baseline. (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | ml/min/1.73 m^2 (Mean) |
|---|
| Placebo BID Plus Standard of Care | 2.0 |
| CCX168 10 mg BID Plus Standard of Care | 1.3 |
| CCX168 30 mg BID Plus Standard of Care | 6.2 |
Change From Baseline to Day 85 in the VDI
The Vasculitis Damage Index (VDI) is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health) (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | score on a scale (Mean) |
|---|
| Placebo BID Plus Standard of Care | 0.31 |
| CCX168 10 mg BID Plus Standard of Care | 0.09 |
| CCX168 30 mg BID Plus Standard of Care | 0.14 |
Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85
Mean Percent Change of Urinary Red Blood Cells (UBC) in Patients in Hematuria at Baseline. (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | percentage change from baseline (Mean) |
|---|
| Placebo BID Plus Standard of Care | -56.3 |
| CCX168 10 mg BID Plus Standard of Care | -31.5 |
| CCX168 30 mg BID Plus Standard of Care | -95.0 |
Percentage Change in Estimated Glomerular Filtration Rate at Day 85
Mean Percentage Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula. (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | % change from baseline (ml/min/1.73 m²) (Mean) |
|---|
| Placebo BID Plus Standard of Care | 6.2 |
| CCX168 10 mg BID Plus Standard of Care | 0.9 |
| CCX168 30 mg BID Plus Standard of Care | 7.7 |
Proportion of Patients Achieving Disease Response Based on BVAS at Day 85
Proportion of Patients achieving 50% reduction in the Birmingham Vasculitis Activity Score [BVAS] at Day 85 and no worsening in any body system component at day 85 (NCT02222155)
Timeframe: Day 85
| Intervention | proportion of participants (Number) |
|---|
| Placebo BID Plus Standard of Care | 0.85 |
| CCX168 10 mg BID Plus Standard of Care | 0.92 |
| CCX168 30 mg BID Plus Standard of Care | 0.8 |
Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.
Proportion of subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85. (NCT02222155)
Timeframe: Day 85
| Intervention | proportion of participants (Number) |
|---|
| Placebo BID Plus Standard of Care | 0.54 |
| CCX168 10 mg BID Plus Standard of Care | 0.67 |
| CCX168 30 mg BID Plus Standard of Care | 0.47 |
Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.
Proportion of subjects achieving early disease remission based on Birmingham Vasculitis Activity Score (BVAS) score of 0 at Days 29 and 85. (NCT02222155)
Timeframe: Day 29 and 85
| Intervention | proportion of participants (Number) |
|---|
| Placebo BID Plus Standard of Care | 0.15 |
| CCX168 10 mg BID Plus Standard of Care | 0.08 |
| CCX168 30 mg BID Plus Standard of Care | 0.2 |
Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85
Proportion of subjects requiring rescue glucocorticoid treatment from Baseline to Day 85 (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | proportion of participants (Number) |
|---|
| Placebo BID Plus Standard of Care | 0 |
| CCX168 10 mg BID Plus Standard of Care | 0 |
| CCX168 30 mg BID Plus Standard of Care | 0 |
Incidence of Adverse Events
This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms. (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | Participants (Count of Participants) |
|---|
| Placebo BID Plus Standard of Care | 13 |
| CCX168 10 mg BID Plus Standard of Care | 11 |
| CCX168 30 mg BID Plus Standard of Care | 15 |
Percent Change From Baseline to Day 85 in BVAS.
The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health. (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | percentage change from baseline (Mean) |
|---|
| Placebo BID Plus Standard of Care | -81.8 |
| CCX168 10 mg BID Plus Standard of Care | -95.6 |
| CCX168 30 mg BID Plus Standard of Care | -81.7 |
Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85
Mean Percent Change of Urinary Albumin:Creatinine Ratio in Patients with Albuminuria at Baseline (NCT02222155)
Timeframe: Baseline to Day 85
| Intervention | percentage change from baseline (Mean) |
|---|
| Placebo BID Plus Standard of Care | -66.281 |
| CCX168 10 mg BID Plus Standard of Care | -13.890 |
| CCX168 30 mg BID Plus Standard of Care | -57.596 |
Participants That Were GVHD Free, Relapse Free Survival (GRFS)
(NCT02224872)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 14 |
Number of Patients With Primary or Secondary Graft Failure Following Transplant
"Graft failure: < 5% donor chimerism in blood and/or bone marrow on ~Day 30 or after and on all subsequent measurements.~Primary graft failure: < 5% donor chimerism in blood and/or bone marrow by ~ Day 56 Secondary graft failure: achievement of > 5% donor chimerism, followed by sustained <5% donor chimerism in blood and/or bone marrow." (NCT02224872)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 17 |
Number of Patients That Have Acheived Full Donor Chimerism by Day 60 After Transplant
Donor chimerism will be measured in the peripheral blood around day 30 and day 60. Patients with >5% donor chimerism around day 60 will be considered as having engrafted. (NCT02224872)
Timeframe: 60 days
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 7 |
Number of Patients That Have Survived at One Year
(NCT02224872)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 18 |
Participants With Chronic GVHD at One Year
(NCT02224872)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 3 |
Is This Type of Transplantation for Severe Aplastic Anemia Feasible and Safe?
Feasibility will be met with the following conditions: the patient has the transplant, is assessed for the safety endpoint, and survives one year. The safety monitoring plan is included to monitor graft failure (day 60), grade 2-4 acute graft versus host disease (day100), 6 month mortality (day 180), and chronic graft versus host disease (day 180). (NCT02224872)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 18 |
Number of Participants With Grade II-IV or Grade III-IV Acute GVHD
Participants were graded during clinical visits based on evidence and extent of skin rash, liver involvement, and GI tract involvement (NCT02224872)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 17 |
Length of Time Required for Patients to Recover ANC and Platelet Counts After Transplant
CBC drawn daily with a WBC differential once the total WBC is greater than 100 until ANC > 500 for three days or two consecutive measurements over a three day period; then CBC drawn weekly with differential. (NCT02224872)
Timeframe: 1 year
| Intervention | days (Median) |
|---|
| Bone Marrow Transplant | 18.85 |
Secondary Outcome Measure
Effect of SB-728mR-T on plasma HIV-1 RNA levels following HAART interruption (NCT02225665)
Timeframe: 12 months
| Intervention | log copies/mL (Mean) |
|---|
| Cohort 1 | 3.218 |
| Cohort 2 | 1.228 |
Primary Outcome Measure
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion (NCT02225665)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 | 1 |
| Cohort 2 | 2 |
Secondary Outcome Measure
Change from baseline to month 12 in CD4+ T-cell counts in peripheral blood after repeat treatments with SB-728mR-T. (i.e. month 12 value - baseline value) (NCT02225665)
Timeframe: Baseline and 12 months
| Intervention | cells 10^9/L (Mean) |
|---|
| Cohort 1 | -0.178 |
| Cohort 2 | 0.078 |
Secondary Outcome Measure
Effect of repeat doses of SB-728mR-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells at Month 12. (NCT02225665)
Timeframe: 12 months
| Intervention | cells 10^9/L (Mean) |
|---|
| Cohort 1 | 0.090 |
| Cohort 2 | 0.162 |
Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration
Number of participants with stable or responding (<50% increase of serum CA19-9 concentration) at 120 days. (NCT02243371)
Timeframe: 120 days
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: CY/ GVAX/ CRS-207/ Nivolumab | 18 |
| Arm B: CY/ GVAX/ CRS-207 | 7 |
Overall Survival (OS)
OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). (NCT02243371)
Timeframe: 2 years and 7 months
| Intervention | months (Median) |
|---|
| Arm A: CY/ GVAX/ CRS-207/ Nivolumab | 5.88 |
| Arm B: CY/ GVAX/ CRS-207 | 6.11 |
12 Month Disease Free Survival Probability
The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier. (NCT02248597)
Timeframe: At 12 months
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Stem Cell Transplant With GVHD Prophylaxis) | 51.8 |
Relapse-free Mortality
Non-relapse mortality will be defined as time from registration to death due to anything other than relapse of hematological malignancy. Patients who relapse will be treated as a competing risk. (NCT02248597)
Timeframe: At 12 months
| Intervention | days (Mean) |
|---|
| Treatment (Stem Cell Transplant With GVHD Prophylaxis) | 86.8 |
Rate of Acute GvHD
Kaplan-Meier estimation of the rate of acute GvHD in the study population at one year with a 95% confidence interval. (NCT02248597)
Timeframe: 12 months
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Stem Cell Transplant With GVHD Prophylaxis) | 51.8 |
Progression Free Survival
Kaplan-Meier estimation of the percentage of patients who are alive without progressive disease at one year. (NCT02248597)
Timeframe: At 12 months
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Stem Cell Transplant With GVHD Prophylaxis) | 51.8 |
Overall Survival
The survival function will be estimated and plotted using the method of Kaplan and Meier. (NCT02248597)
Timeframe: At 12 months
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Stem Cell Transplant With GVHD Prophylaxis) | 66.7 |
Partial Response Rate (PRR)
PRR defined as the proportion of participants achieving partial response. Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008). (NCT02251548)
Timeframe: Response evaluated at 2 months post iFCR. Treatment up to 6 cycles (28 days each).
| Intervention | proportion of participant (Number) |
|---|
| FCR+ 420 mg Ibrutinib Daily | 0.61 |
Rate of MRD Negative CR After 3 Cycles of iFCR
To determine the rate of minimal residual disease negative complete response (MRD negative CR) in the bone marrow after 3 cycles of ibrutinib + FCR. Participants will have a bone marrow biopsy procedure after completing 3 cycles in tandem with a chest, neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confirm morphological CR in the bone marrow, while MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) (NCT02251548)
Timeframe: After 3 cycles of iFCR for each patient completing 3 cycles
| Intervention | Participants (Count of Participants) |
|---|
| FCR +420mg Ibrutinib Daily | 9 |
1-year Combined Response With MRD From Bone Marrow
Combined response with MRD from bone marrow reported as the MRD-negative CR. Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) (NCT02251548)
Timeframe: at 1 year
| Intervention | Participants (Count of Participants) |
|---|
| FCR+ 420 mg Ibrutinib Daily | 2 |
Number of Participants Who Convert From Bone Marrow MRD Negative PR to Bone Marrow MRD Negative CR After 1 Year of Ibrutinib Maintenance
To determine the rate of minimal residual disease negative complete response (MRD negative CR) in the bone marrow at 12 months from start of therapy, participants will have a bone marrow biopsy procedure at the 1 year timepoint after completing combination therapy (ibrutinib + FCR) in tandem with a chest, neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confirm morphological CR in the bone marrow, while MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) (NCT02251548)
Timeframe: 12 months ( 1year) after starting therapy
| Intervention | Participants (Count of Participants) |
|---|
| FCR+ 420 mg Ibrutinib Daily | 2 |
Number of Participants Who Convert From Bone Marrow MRD Negative PR to Bone Marrow MRD Negative CR After 2 Years on Treatment
MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)- Bone marrow biopsies will be performed at baseline, after cycle 3, 2 months post FCR, at 1 year and 2 years of ibrutinib maintenance, and as clinically indicated thereafter- Participants will have a bone marrow biopsy procedure 24 months after completing combination therapy (Ibrutinib+ FCR) in tandem with a chest, neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confirm morphological CR in the bone marrow, while MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. (NCT02251548)
Timeframe: 2 years (24 months) from start of therapy
| Intervention | Participants (Count of Participants) |
|---|
| FCR+ 420 mg Ibrutinib Daily | 9 |
Overall Response Rate
The objective response rate (ORR) was defined as the proportion of participants achieving CR+CRi+PR, Complete Response with incomplete count recovery (CRi) or partial response (PR) based on 2008 IW-CLL criteria criteria (Hallek et al., 2008). (NCT02251548)
Timeframe: Response evaluated at 2 months post iFCR. Treatment up to 6 cycles (28 days each).
| Intervention | proportion of participants (Number) |
|---|
| FCR+ 420 mg Ibrutinib Daily | 0.96 |
Participants Who Convert From Bone Marrow MRD Negativity to MRD Positivity in Participants Who Discontinue Ibrutinib
.MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) (NCT02251548)
Timeframe: Response evaluated at 2 months post iFCR. Treatment up to 6 cycles (28 days each).
| Intervention | Participants (Count of Participants) |
|---|
| FCR+Ibrutinib 420mg Daily | 0 |
Part I: Participants Who Achieve a Minimal Residual Disease (MRD) Negative Complete Response (CR) in the Bone Marrow at 2 Months Post FCR
To assess the number of participants who achieve an MRD negative complete response at the 2 months post last dose of FCR timepoint by 2008 IW-CLL criteria ( Hallek et. al). Participants will have a bone marrow biopsy procedure 2 months after completing combination therapy (Ibrutinib+ FCR) in tandem with a chest, neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confirm morphological CR in the bone marrow, while MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. (NCT02251548)
Timeframe: 2 months after completing combination therapy
| Intervention | Participants (Count of Participants) |
|---|
| FCR+ 420mg Ibrutinib Daily | 28 |
Complete Response Rate (CRR)
CRR defined as the proportion of participants achieving complete response. Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008). (NCT02251548)
Timeframe: Response evaluated at 2 months post iFCR. Treatment up to 6 cycles (28 days each).
| Intervention | proportion of participants (Number) |
|---|
| FCR+ 420 mg Ibrutinib Daily | 0.24 |
Mean of Days to Absolute Neutrophil Count (ANC) Engraftment
ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment. (NCT02259348)
Timeframe: Day 42 post transplantation
| Intervention | days (Mean) |
|---|
| Participants | 10.3 |
Incidence and Severity of Acute GvHD
The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe. (NCT02259348)
Timeframe: 100 days post transplantation
| Intervention | participants (Number) |
|---|
| Grade I | Grade II | Grade III | Grade IV |
|---|
| Participants | 0 | 0 | 3 | 1 |
Incidence of Malignant Relapse
The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The number of participants with incidence of malignant relapse is given. Relapse was evaluated using standard WHO criteria for each disease. (NCT02259348)
Timeframe: one year post transplantation
| Intervention | participants (Number) |
|---|
| Participants | 2 |
Event-free Survival (EFS)
The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given. (NCT02259348)
Timeframe: one year post transplantation
| Intervention | participants (Number) |
|---|
| Participants | 2 |
Incidence and Severity of Chronic GvHD
"The cumulative incidence of chronic GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of chronic GvHD will be described. Chronic GvHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with incidence by severity is given." (NCT02259348)
Timeframe: one year post transplantation
| Intervention | participants (Number) |
|---|
| Mild | Moderate | Severe |
|---|
| Participants | 0 | 0 | 0 |
Percentage of Participants Engrafted by Day 42 Post-transplant
To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment. (NCT02259348)
Timeframe: Day 42 post transplantation
| Intervention | percentage of participants (Number) |
|---|
| Participants | 100 |
Overall Survival (OS)
The Kaplan-Meier estimate of OS along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of transplant and all participants surviving at the time of analysis without events will be censored. The number of participants surviving to one-year post-transplantation is given. (NCT02259348)
Timeframe: one year post transplantation
| Intervention | participants (Number) |
|---|
| Participants | 2 |
Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 0 to Week 24 | Week 0 to Week 48 | Week 0 to Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 0 | 0 | 0 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 0 | 0 | 0 |
Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity. (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 0 to Week 24 | Week 0 to Week 48 | Week 0 to Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 18.2 | 45.5 | 63.6 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 14.3 | 28.6 | 47.6 |
Percentage of Participants With a Sustained Complete Response
"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 48, Week 96
| Intervention | percentage of participants (Number) |
|---|
| Rituximab/Cyclophosphamide (RC) | 26.7 |
| Rituximab/Cyclophosphamide/Belimumab (RCB) | 28.6 |
Count of Participants: Frequency of Non-renal Flares by Week 24
"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|
| 0 Non-renal flares | 1 Non-renal flare | 2 Non-renal flares |
|---|
| Rituximab/Cyclophosphamide (RC) | 21 | 1 | 0 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 20 | 0 | 1 |
Count of Participants: Frequency of Non-renal Flares by Week 48
"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 48
| Intervention | Participants (Count of Participants) |
|---|
| 0 Non-renal flares | 1 Non-renal flares | 2 Non-renal flare |
|---|
| Rituximab/Cyclophosphamide (RC) | 20 | 2 | 0 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 20 | 0 | 1 |
Count of Participants: Frequency of Non-renal Flares by Week 96
"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 96
| Intervention | Participants (Count of Participants) |
|---|
| 0 Non-renal flares | 1 Non-renal flare | 2 Non-renal flares |
|---|
| Rituximab/Cyclophosphamide (RC) | 18 | 4 | 0 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 19 | 1 | 1 |
Frequency of Specific Adverse Events of Interest By Event by Week 96
"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96
| Intervention | Events (Number) |
|---|
| Any event leading to death | ≥Grade 2 leukopenia or thrombocytopenia | Premature ovarian failure | Malignancy | Venous thromboembolic event |
|---|
| Rituximab/Cyclophosphamide (RC) | 0 | 13 | 0 | 0 | 3 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 0 | 16 | 0 | 0 | 0 |
Frequency of Specific Adverse Events of Interest By Participant, By Week 96
"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96
| Intervention | Participants (Count of Participants) |
|---|
| Any event leading to death | ≥Grade 2 leukopenia or thrombocytopenia | Premature ovarian failure | Malignancy | Venous thromboembolic event |
|---|
| Rituximab/Cyclophosphamide (RC) | 0 | 6 | 0 | 0 | 2 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 0 | 6 | 0 | 0 | 0 |
Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 24 | Week 48 | Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 57.1 | 55.0 | 61.1 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 30.0 | 30.0 | 27.8 |
Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 24 | Week 48 | Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 19.0 | 15.0 | 16.7 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 5.0 | 15.0 | 11.1 |
Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 24 | Week 48 | Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 23.8 | 35.0 | 33.3 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 30.0 | 42.1 | 42.9 |
Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 24 | Week 48 | Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 14.3 | 20.0 | 0.0 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 15.8 | 30.0 | 27.8 |
Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 24 | Week 48 | Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 46.7 | 60.0 | 53.3 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 55.0 | 73.7 | 71.4 |
Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs." (NCT02260934)
Timeframe: Week 0 to Week 96
| Intervention | percentage of participants (Number) |
|---|
| Week 0 to Week 24 | Week 0 to Week 48 | Week 0 to Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 9.1 | 22.7 | 27.3 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 4.8 | 9.5 | 9.5 |
Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96
| Intervention | Percentage of Participants (Number) |
|---|
| Week 24 | Week 48 | Week 96 |
|---|
| Rituximab/Cyclophosphamide (RC) | 31.3 | 35.7 | 40.0 |
,| Rituximab/Cyclophosphamide/Belimumab (RCB) | 6.3 | 11.8 | 30.8 |
Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells
Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment. (NCT02280811)
Timeframe: one month after treatment
| Intervention | % PD-1 circulating lymphocytes (Mean) |
|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 2 |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 3 |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 2.2 |
Number of Participants With a Dose Limiting Toxicity (DLT)
A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease. (NCT02280811)
Timeframe: 19 months and 7 days
| Intervention | Participants (Count of Participants) |
|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 0 |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 0 |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 0 |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 0 |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 0 |
Maximum Tolerated Dose (MTD)
The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels. (NCT02280811)
Timeframe: participants were followed for the duration of hospital stay, an average of 3 weeks
| Intervention | # of cells x 10^11 (Number) |
|---|
| All Treated Subjects | 2 |
Duration of Response
Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT02280811)
Timeframe: up to one year
| Intervention | months (Mean) |
|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | NA |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | NA |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | NA |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 1.5 |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | NA |
Number of Participants With Serious and Non-serious Adverse Events
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02280811)
Timeframe: 19 months and 7 days
| Intervention | Participants (Count of Participants) |
|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 2 |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 6 |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 2 |
Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders
Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry. (NCT02280811)
Timeframe: One month after treatment
| Intervention | percentage of cells (Mean) |
|---|
| Responders | Non-responders |
|---|
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 38 | 29.9 |
,| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | NA | 4.4 |
,| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | NA | 12.6 |
,| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | NA | 30.7 |
,| HPV-16 E6 mTCR PBL MTD + HD IL-2 | NA | 37.1 |
Objective Tumor Response Rate (Complete or Partial Response)
Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT02280811)
Timeframe: 4 years
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) |
|---|
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 0 | 2 |
,| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 0 | 0 |
,| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 0 | 0 |
,| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 0 | 0 |
,| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 0 | 0 |
Overall Survival
Number of Participants who Did Not Experience Treatment-Related Mortality (NCT02282514)
Timeframe: Mean 3.6 years
| Intervention | participants (Number) |
|---|
| Hematopoietic Stem Cell Transplantation | 23 |
Reduction of Muscle Relaxation Anti-spasmatic Medications
Decrease (50%) and complete discontinuation of muscle relaxation anti-spasmatic medications (NCT02282514)
Timeframe: Mean 3.6 years
| Intervention | Participants (Count of Participants) |
|---|
| Hematopoietic Stem Cell Transplantation | 14 |
To Determine the Efficacy of This Allogeneic Transplant Approach in Reconstituting Normal Hematopoiesis and Reversing the Clinical Phenotype of CGD
Patient will have donor chimerism of greater than 20% and resolution of infection or autoimmunity at end of follow up (NCT02282904)
Timeframe: 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Greater than 20% donor chimerism | Resolution of inflammation or infection |
|---|
| CGD Recipient | 7 | 7 |
Percentage of Participants Who Achieved an Objective Response
An objective response = percentage of participants who achieved a complete response or partial response after initiation of the treatment and prior to initiation of subsequent systemic anti-lymphoma therapy. A CR = complete metabolic response; Target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter; no new lesions. Participants who did not have any adequate response assessments during this period were not considered as responders. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm
| Intervention | Percentage of Participants (Number) |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | 90.9 |
| Placebo Plus R-CHOP | 90.9 |
K-M Estimate of Time to Next Lymphoma Therapy (TTNLT)
Time to next lymphoma therapy was defined as the time from randomization to the time of treatment change for the next lymphoma treatment. Participants without treatment change were censored at date last known alive. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as treatment change for the next lymphoma therapy if the decision to treat and the location to be treated were determined prior to randomization. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
| Intervention | Months (Median) |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
| Placebo Plus R-CHOP | NA |
Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire
The completion rate for FACT-Lym assessments was judged by looking at the number of completed FACT-Lym assessments at each time point. The FACT-Lym was considered completed if at least 1 calculable score was present. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The FACT-Lym is a health related quality of life (HRQoL) questionnaire targeted to the management of chronic illness, predominantly within oncology and is considered an extension of the FACT-General questionnaire. (NCT02285062)
Timeframe: Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
| Intervention | Percentage of Participants (Number) |
|---|
| Screening | Midcycle = After Cycle 3, but before Cycle 4 | End of Treatment (EoT) = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | 98.6 | 87.0 | 76.1 | 67.7 |
,| Placebo Plus R-CHOP | 98.2 | 86.3 | 79.6 | 69.5 |
Percentage of Participants Who Achieved a Complete Response (CR)
The percentage of participants who achieved a CR after initiation of the study treatment and prior to initiation of subsequent systemic antilymphoma therapy as assessed by the IRAC. A CR = complete metabolic response; target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow per International Working Group (IWG) 2014 for Non-Hodgkin's Lymphoma (NHL). Participants who did not have any adequate response assessments during this period were not considered as responders. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
| Intervention | Percentage of Participants (Number) |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | 69.1 |
| Placebo Plus R-CHOP | 64.9 |
Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI)
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The FACT-Lym TOI is calculated by summing the Physical Well-being, Functional Well-being and Additional Concerns scores and has a range of 0 to 116. Higher scores reflect better HRQoL or fewer symptoms." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
| Intervention | Units on a Scale (Mean) |
|---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | 2.6 | 5.9 | 9.1 | 13.5 |
,| Placebo Plus R-CHOP | 4.6 | 7.5 | 5.8 | 12.2 |
K-M Estimate of Overall Survival (OS)
Overall survival was assessed by the Independent Response Adjudication Committee (IRAC) and defined as time from randomization until death due to any cause. Participants who withdrew consent were censored at the time of withdrawal. Participants who were still alive before the clinical data cutoff date and participants who were lost to follow-up were censored at date last known alive. (NCT02285062)
Timeframe: From randomization until death due to any cause (up to approximately 86 months)
| Intervention | Months (Median) |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
| Placebo Plus R-CHOP | NA |
Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The physical well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
| Intervention | Units on a Scale (Mean) |
|---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | -0.7 | -0.0 | 1.5 | 2.8 |
,| Placebo Plus R-CHOP | 0.2 | 0.9 | 0.7 | 2.6 |
Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS)
EFS was defined as the time (months) from randomization until occurrence of one of the following events, whichever occurred first: • Disease progression • Initiation of subsequent systemic anti-lymphoma therapy • Death due to any cause The assessment of EFS was conducted by the IRAC using the International Working Group (IWG) criteria for NHL. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as an EFS event (initiation of subsequent systemic anti-lymphoma therapy) if the decision to treat and the location to be treated was determined prior to randomization. Participants who did not experience any of the events defined in the categories above before the clinical data cutoff date were censored at date last known alive. (NCT02285062)
Timeframe: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
| Intervention | Months (Median) |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
| Placebo Plus R-CHOP | NA |
K-M Estimate of Duration of Complete Response
Duration of complete response was calculated for complete responders only and was defined as the time from documented initial complete response prior to initiation of subsequent systemic antilymphoma therapy until documented disease progression or death, whichever occurred earlier. Participants who had not progressed or died at the time of the analysis were censored at the date of last response assessment demonstrating no disease progression. Participants who changed treatment without evidence of disease progression were censored at the last assessment showing no progression prior to treatment change. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months.
| Intervention | Months (Median) |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
| Placebo Plus R-CHOP | NA |
Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The functional well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
| Intervention | Units on a Scale (Mean) |
|---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | -0.5 | 0.0 | 1.0 | 2.3 |
,| Placebo Plus R-CHOP | 0.5 | 1.4 | 0.7 | 3.1 |
Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale
"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms such as pain, itching, night sweats,trouble sleeping, fatigue and trouble concentrating and concerns regarding lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The Additional Concerns subscale ranges from 0 to 60, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
| Intervention | Units on a Scale (Mean) |
|---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | 3.8 | 5.8 | 6.6 | 8.3 |
,| Placebo Plus R-CHOP | 4.1 | 5.2 | 4.5 | 6.5 |
Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score
"The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems. The instrument is scored as a single summary index using one of the available EQ-5D-3L value sets; in this study the UK scoring weights 9 were used. The UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health (-0.594 is considered 'worse than death')." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
| Intervention | Units on a Scale (Mean) |
|---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | 0.08 | 0.10 | 0.10 | 0.15 |
,| Placebo Plus R-CHOP | 0.08 | 0.14 | 0.06 | 0.09 |
Kaplan-Meier Estimate of Progression Free Survival (PFS)
Progression free survival was defined as the time (months) from the date of randomization to the date of disease progression or death (any cause), whichever occurred earlier and was assessed by the Independent Response Adjudication Committee (IRAC). Relapse from complete response (CR) was considered as disease progression throughout the study. Disease progression was determined based on the Revised Response Criteria for Malignant Lymphoma. The PFS analysis was based on the censoring rules using the Food and Drug Administration (FDA) Guidance. Participants who did not experience disease progression and who did not die before the clinical data cutoff date were censored at the date of last adequate response assessment. (NCT02285062)
Timeframe: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months
| Intervention | months (Median) |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | NA |
| Placebo Plus R-CHOP | NA |
Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS)
"The EQ-5D-3L questionnaire includes a visual analogue scale which records the respondent's self-rated health on a vertical, 0-100 scale where 100 = Best imaginable health state and 0 = Worst imaginable health state. Higher scores again indicate better HRQoL and positive change scores indicate that post screening values were higher than those observed at screening. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34
| Intervention | Units on a Scale (Mean) |
|---|
| Midcycle | C6 D1 | EoT = 3-4 weeks after C6 | Follow-Up Period: Week 34 |
|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) | 4.0 | 6.0 | 8.0 | 12.0 |
,| Placebo Plus R-CHOP | 3.0 | 9.0 | 6.0 | 9 |
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02298946)
Timeframe: Date treatment consent signed to date off study, approximately 24 months and 8 days
| Intervention | Participants (Count of Participants) |
|---|
| DL1 - CTX, SBRTx1 Day, & AMP-224 | 6 |
| DL2 - CTX, SBRTx3 Days, and AMP-224 | 9 |
Count of Participants With Post-Treatment Biopsies
Mandatory post treatment biopsies of the tumor were attempted on all patients. (NCT02298946)
Timeframe: Post treatment, day 29 +/- 7 days
| Intervention | Participants (Count of Participants) |
|---|
| DL1 - CTX, SBRTx1 Day, & AMP-224 | 6 |
| DL2 - CTX, SBRTx3 Days, and AMP-224 | 0 |
Number of Participants in Which Specimens Were Collected for Pre and Post Pharmacokinetic (PK) AMP-224 Analyses
This outcome measure only represents the number of participants with metastatic colorectal cancer who had specimens collected for pre and post pharmacokinetic (PK) AMP-224 analyses. (NCT02298946)
Timeframe: Baseline and post infusion AMP-224 (e.g. 15 minutes after infusion ended)
| Intervention | Participants (Count of Participants) |
|---|
| Pre AMP-224 | Post AMP-224 |
|---|
| DL1 - CTX, SBRTx1 Day, & AMP-224 | 6 | 6 |
,| DL2 - CTX, SBRTx3 Days, and AMP-224 | 9 | 9 |
Overall Survival in Patients With Colorectal Cancer Following Treatment With AMP-224 in Combination With SBRT
Overall survival is defined as the time from treatment start date until date of death or date last known alive. (NCT02298946)
Timeframe: Baseline to end of study, which is date of death. Average time participants were followed was 10.6 months.
| Intervention | months (Median) |
|---|
| DL1 - CTX, SBRTx1 Day, & AMP-224 | 4.3 |
| DL2 - CTX, SBRTx3 Days, and AMP-224 | 9.0 |
Objective Response Rate
"Objective response will be evaluated according to the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as Complete Response + Partial Response. Briefly, complete response (CR) is defined as the disappearance of all target lesions, and Partial Response is defined as at least 30% decrease in the sum of the diameters of the target lesions from baseline measurement." (NCT02298946)
Timeframe: Restaging was done every 8 weeks for an average of 2.6 months.
| Intervention | percentage of participants (Number) |
|---|
| DL1 - CTX, SBRTx1 Day, & AMP-224 | 0 |
| DL2 - CTX, SBRTx3 Days, and AMP-224 | 0 |
Overall Survival
Time from study enrollment to death or last patient contact. (NCT02306161)
Timeframe: 5 years after enrollment
| Intervention | Percent Probability (Number) |
|---|
| Regimen A (VDC/IE) | 44.93 |
| Regimen B (VDC/IE + Ganitumab) | 48.19 |
Frequency of Toxicity-events
The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event. (NCT02306161)
Timeframe: Up to 202 days
| Intervention | Reporting Periods (Number) |
|---|
| Regimen A (VDC/IE) | 10 |
| Regimen B (VDC/IE + Ganitumab) | 27 |
Event-free Survival
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT02306161)
Timeframe: 5 years after enrollment
| Intervention | percent probability of participants (Number) |
|---|
| Regimen A (VDC/IE) | 30.88 |
| Regimen B (VDC/IE + Ganitumab) | 30.4 |
Percentage of Participants With Secondary Graft Failure
Secondary graft failure will be assessed according to neutrophil count after initial hematologic recovery. Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in absolute neutrophil counts < 500 cells/µL, unresponsive to growth factor therapy, but cannot be explained by disease relapse or medications. Secondary graft failure will be analyzed using cumulative incidence function with death as a competing risk. (NCT02345850)
Timeframe: 2 Years
| Intervention | percentage of participants (Number) |
|---|
| CD34 Selected Graft | 2.9 |
| Post-Transplant Cyclophosphamide | 0 |
| Tacrolimus/Methotrexate Control | 0.9 |
Participants With Grade ≥ 3 Toxicity
All grades ≥ 3 toxicities according to CTCAE, version 4 will be tabulated for each intervention arm. The number of unique patients is counted. (NCT02345850)
Timeframe: 2 Years
| Intervention | Participants (Count of Participants) |
|---|
| Any Grade 3-5 Stem Cell Infusional Toxicities | Grades 3-5 Oral mucositis | Grades 3-5 Cystitis noninfective | Grades 3-5 Acute kidney injury | Grades 3-5 Chronic kidney disease | Grades 3-5 Hemorrhage | Grades 3-5 Hypotension | Grades 3-5 Hypertension | Grades 3-5 Cardiac arrhythmia | Grades 3-5 Left ventricular systolic dysfunction | Grades 3-5 Somnolence | Grades 3-5 Seizure | Grades 3-5 Thrombotic thrombocytopenic purpura | Grades 3-5 Capillary leak syndrome | Grades 3-5 Hypoxia | Grades 3-5 Dsypnea | Grades 3-4 ALT | Grades 3-4 AST | Grades 3-4 Bilirubin | Grades 3-4 Alkaline Phosphatase | Received dialysis | Abnormal liver function | SOS/VOD | IPS | Toxicities Within Day 100 | Toxicities Day 100 to 1 year | Toxicities 1 year to 2 years | Overall NCI CTCAE Grade 3-5 Toxicities |
|---|
| CD34 Selected Graft | 6 | 39 | 4 | 12 | 4 | 12 | 19 | 20 | 9 | 5 | 7 | 6 | 1 | 1 | 32 | 23 | 10 | 11 | 8 | 11 | 5 | 12 | 0 | 2 | 68 | 26 | 23 | 80 |
,| Post-Transplant Cyclophosphamide | 4 | 51 | 11 | 13 | 4 | 9 | 15 | 21 | 6 | 2 | 4 | 0 | 2 | 0 | 22 | 15 | 26 | 27 | 14 | 12 | 2 | 14 | 2 | 2 | 82 | 33 | 18 | 88 |
,| Tacrolimus/Methotrexate Control | 17 | 63 | 2 | 15 | 3 | 4 | 11 | 30 | 8 | 8 | 4 | 2 | 4 | 1 | 14 | 12 | 18 | 19 | 7 | 6 | 6 | 24 | 1 | 3 | 81 | 41 | 24 | 100 |
Percentage of Participants With Acute GVHD
Cumulative incidences of grade II-IV and III-IV acute GVHD were determined. Death prior to acute GVHD is treated as the competing risk. Grading of acute GVHD was derived by consensus grading (Przepiorka 1995) per BMTCTN manual of procedures (MOP). The acute GVHD algorithm calculates the grade based on the organ (skin, GI and liver) stage and etiology/biopsy reported on the weekly GVHD form. Staging for skin: Stage 1. <25% rash; 2. 25-50%; 3. >50%; 4. generalized erythroderma with bullae. Staging for GI: Stage 1. Diarrhea>500ml/d or persistent nausea; 2. >1000ml/d; 3. >1500ml/d; 4. Large volume diarrhea and severe abdominal pain +- ileus. Staging for Liver: Stage 1. bilirubin 2-3mg/dl; 2. bilirubin 3-6 mg/dl; 3. bilirubin 6-15 mg/dl; 4. bilirubin>15mg/dl. Grade 4 is the worst outcome. (NCT02345850)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| grade II-IV acute GVHD | grade III-IV acute GVHD |
|---|
| CD34 Selected Graft | 16.3 | 2.9 |
,| Post-Transplant Cyclophosphamide | 37.6 | 10.1 |
,| Tacrolimus/Methotrexate Control | 29.8 | 3.5 |
Percentage of Participants With Chronic GVHD
The cumulative incidence of chronic GVHD will be determined. Death prior to acute GVHD is treated as the competing risk. Data will be collected directly from providers and chart review according to the recommendations of the NIH Consensus Criteria. Eight organs will be scored on a 0-3 scale to reflect degree of chronic GVHD involvement. Liver and pulmonary function test results and use of systemic therapy for treatment of chronic GVHD will also be recorded. This secondary endpoint of chronic GVHD will include mild, moderate and severe chronic GVHD based on NIH Consensus Criteria. (NCT02345850)
Timeframe: 2 Years
| Intervention | percentage of participants (Number) |
|---|
| 1 year post-transplantation | 2 years post-transplantation |
|---|
| CD34 Selected Graft | 16.4 | 18.5 |
,| Post-Transplant Cyclophosphamide | 33.0 | 37.0 |
,| Tacrolimus/Methotrexate Control | 31.1 | 40.0 |
Percentage of Participants With Chronic GVHD-free Survival
The event for this endpoint includes moderate to severe chronic GVHD according to NIH consensus criteria global score, or death by any cause. (NCT02345850)
Timeframe: 2 Years
| Intervention | percentage of participants (Number) |
|---|
| 1 year post-transplantation | 2 years post-transplantation |
|---|
| CD34 Selected Graft | 71.0 | 55.4 |
,| Post-Transplant Cyclophosphamide | 67.4 | 54.2 |
,| Tacrolimus/Methotrexate Control | 65.8 | 47.1 |
Participants With Primary Graft Failure
Primary graft failure is defined as no neutrophil recovery to > 500 cells/µL by Day 28 post HSCT. (NCT02345850)
Timeframe: Day 28
| Intervention | Participants (Count of Participants) |
|---|
| CD34 Selected Graft | 3 |
| Post-Transplant Cyclophosphamide | 9 |
| Tacrolimus/Methotrexate Control | 4 |
Percentage of Participants With Relapse-free Survival
The events for this endpoint RFS are death and relapse of the underlying malignancy. The analyses of this endpoint use the transplanted populations and time is from transplant to the event of disease relapse or death, or last follow up, whichever comes first. (NCT02345850)
Timeframe: 2 Years
| Intervention | percentage of participants (Number) |
|---|
| 1 year post-transplantation | 2 years post-transplantation |
|---|
| CD34 Selected Graft | 64.1 | 57.1 |
,| Post-Transplant Cyclophosphamide | 78.8 | 70.3 |
,| Tacrolimus/Methotrexate Control | 70.1 | 66.5 |
Percentage of Participants With Platelet Recovery
Platelet recovery is defined as the first day of a sustained platelet count >20,000/mm^3 with no platelet transfusion in the preceding seven days. The first day of sustained platelet count above this threshold will be designated the day of platelet engraftment. The competing event is death without platelet recovery. (NCT02345850)
Timeframe: Day 60
| Intervention | percentage of participants (Number) |
|---|
| CD34 Selected Graft | 94.2 |
| Post-Transplant Cyclophosphamide | 91.6 |
| Tacrolimus/Methotrexate Control | 98.2 |
Percentage of Participants With Neutrophil Engraftment
Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) ≥ 500/mm^3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. (NCT02345850)
Timeframe: Day 28
| Intervention | percentage of participants (Number) |
|---|
| CD34 Selected Graft | 97.1 |
| Post-Transplant Cyclophosphamide | 91.7 |
| Tacrolimus/Methotrexate Control | 96.5 |
Participants With Immunosuppression-free Survival
Patients who are alive, relapse-free, and do not need ongoing immune suppression to control GVHD at one year post HSCT are considered successes for this endpoint. Immune suppression is defined as any systemic agents used to control or suppress GVHD. (NCT02345850)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| CD34 Selected Graft | 59 |
| Post-Transplant Cyclophosphamide | 73 |
| Tacrolimus/Methotrexate Control | 66 |
Percentage of Participants With Overall Survival (OS)
OS is a key secondary endpoint, with explicit control of the type I error rate through a gatekeeper approach. Formal significance testing of OS between a CNI-free strategy and the control will be conducted if the corresponding CRFS comparison is significant. This OS comparison will be done using a Bonferroni adjusted significance level of 0.05/3 to account for three potential CNI-free comparisons to the control. Otherwise, survival analyses will be considered exploratory. Death from any cause is considered as event for this endpoint. Participant is censored if lost to follow up. (NCT02345850)
Timeframe: 2 Years
| Intervention | percentage of participants (Number) |
|---|
| 1 year post-randomization | 2 year post-randomization | 1 year post-transplantation | 2 year post-transplantation |
|---|
| CD34 Selected Graft | 75.7 | 60.1 | 74.8 | 61.6 |
,| Post-Transplant Cyclophosphamide | 84.6 | 76.2 | 83.4 | 76.7 |
,| Tacrolimus/Methotrexate Control | 84.2 | 76.1 | 83.3 | 74.2 |
Participants Infected Post Transplant
All grade 2 and grade 3 infections, as defined by the BMT CTN Technical MOP, occurring post transplantation will be reported. The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each intervention arm. (NCT02345850)
Timeframe: 2 Years
| Intervention | Participants (Count of Participants) |
|---|
| Patients with Grades 2-3 infections | Patients with Grades 3 infections |
|---|
| CD34 Selected Graft | 72 | 31 |
,| Post-Transplant Cyclophosphamide | 66 | 23 |
,| Tacrolimus/Methotrexate Control | 50 | 16 |
Incidence of Infections
All grade 2 and grade 3 infections, as defined by the BMT CTN Technical MOP, occurring post transplantation will be reported. The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each intervention arm. (NCT02345850)
Timeframe: 2 years
| Intervention | number of Infection Events (Number) |
|---|
| CD34 Selected Graft | 157 |
| Post-Transplant Cyclophosphamide | 161 |
| Tacrolimus/Methotrexate Control | 123 |
Chronic GVHD-free, Relapse-free Survival (CRFS) Probability
The primary endpoint of the trial is Chronic GVHD/Relapse-Free Survival (CRFS), treated as a time to event variable. An event for this time to event outcome is defined as moderate to severe chronic GVHD, disease relapse, or death by any cause. Participant will be censored if lost to follow up prior to 2 years. Time is from randomization to the event of moderate to severe chronic GVHD, disease relapse, death, last follow up, or 2 years, whichever comes first. The primary analysis is performed using the intent-to-treat principle (ITT) so that all randomized patients are included in the analysis. (NCT02345850)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| 1 year Post Randomization | 2 years Post Randomization |
|---|
| CD34 Selected Graft | 60.2 | 50.6 |
,| Post-Transplant Cyclophosphamide | 60.3 | 48.1 |
,| Tacrolimus/Methotrexate Control | 52.6 | 41.0 |
Percentage of Participants With Disease Relapse
Relapse is defined by either morphological evidence of acute leukemia or MDS consistent with pre-transplant features, or radiologic evidence of lymphoma, documented or not by biopsy. The event is defined as increase in size of prior sites of disease or evidence of new sites of disease, documented or not by biopsy. Relapse is adjudicated by ERC. Disease relapse is analyzed using cumulative incidence function with death as a competing risk. The analyses of this endpoint use the transplanted populations, and the time will be measured from transplant to the earliest of death, relapse/progression, or last follow up. (NCT02345850)
Timeframe: 2 Years
| Intervention | percentage of participants (Number) |
|---|
| 1 year post transplantation | 2 years post transplantation |
|---|
| CD34 Selected Graft | 19.4 | 21.4 |
,| Post-Transplant Cyclophosphamide | 9.2 | 13.9 |
,| Tacrolimus/Methotrexate Control | 22.9 | 25.6 |
Phase 2: Progression-Free Survival (PFS) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007) or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Disease progression was defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion > 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis. KM estimates was used for analyses. (NCT02348216)
Timeframe: First infusion date to PD or death or data cutoff date 27 Jan 2017, 26 Apr 2018, 06 May 2019, 10 Sep 2020, and 16 Jun 2020 for Cohorts 1 and 2, 3, 4, 5, 6 respectively (maximum: 20, 35, 47.5, 64, and 61 months for Cohorts 1 and 2, 3, 4, 5, 6 respectively)
| Intervention | months (Median) |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 5.1 |
| Phase 2 (Pivotal Study): Cohort 2 | NA |
| Phase 2 (Safety Management Study): Cohort 3 | 6.2 |
| Phase 2 (Safety Management Study): Cohort 4 | NA |
| Phase 2 (Safety Management Study): Cohort 5 | 3.1 |
| Phase 2 (Safety Management Study): Cohort 6 | NA |
Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 4 and Grade 3 or Higher Resulting From Increased Parameter Value
Grading categories were determined by CTCAE version 4.03. Shifts to Grade 3 or higher has been reported for Phase 2 Cohort 3. For Phase 1 and all other cohorts of Phase 2, shifts to Grade 4 has been reported. (NCT02348216)
Timeframe: First infusion date to data cutoff 27 Jan 2017 (Phase 1,Cohorts 1,2), 26 Apr 2018, 6 May 2019, 10 Sep 2020, 16 Jun 2020 for Cohorts 3,4,5,6 respectively (maximum: 20 months for Phase 1,Cohorts 1,2; 35, 47.5, 64, 61 months for Cohorts 3,4,5,6 respectively)
| Intervention | percentage of participants (Number) |
|---|
| Hemoglobin | Neutrophils | Platelets | Potassium | Calcium | Magnesium | Sodium | Alanine Aminotransferase | Aspartate Aminotransferase | Bilirubin | Creatinine | Urate | Albumin | Leukocytes | Direct Bilirubin | Glucose | Lymphocytes | Phosphate | Alkaline Phosphatase |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Phase 2 (Pivotal Study): Cohort 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Phase 2 (Pivotal Study): Cohort 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Phase 2 (Safety Management Study): Cohort 3 | 0 | 0 | 0 | 3 | 3 | 8 | 0 | 21 | 16 | 5 | 5 | 13 | 0 | 0 | 18 | 8 | 0 | 0 | 5 |
,| Phase 2 (Safety Management Study): Cohort 4 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
,| Phase 2 (Safety Management Study): Cohort 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Phase 2 (Safety Management Study): Cohort 6 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pharmacodynamics: Peak Level of Cytokines (Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1) in Serum (Phase 2 Cohorts 4, 5, and 6)
Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: Ferritin, ICAM-1, IL-2 R, Perforin, and VCAM-1. (NCT02348216)
Timeframe: Enrollment up to Week 4
| Intervention | ng/mL (Median) |
|---|
| Ferritin | ICAM-1 | IL-2 R | Perforin | VCAM-1 |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 1086.36 | 907.97 | 10.78 | 17.22 | 1255.32 |
,| Phase 2 (Safety Management Study): Cohort 5 | 1516.11 | 636.74 | 7.82 | 10.85 | 854.63 |
,| Phase 2 (Safety Management Study): Cohort 6 | 903.50 | 654.81 | 6.43 | 10.12 | 836.04 |
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: IP-10, granzyme B, IFN-gamma, IL-1 RA, IL-2, IL-6, IL-7, IL-8, IL-10, IL-15, TNF alpha, and granulocyte-macrophage colony-stimulating factor (GM-CSF). (NCT02348216)
Timeframe: Enrollment up to Week 4
| Intervention | pg/mL (Median) |
|---|
| IP-10 | Granzyme B | IFN-gamma | IL-1 RA | IL-2 | IL-6 | IL-7 | IL-8 | IL-10 | IL-15 | TNF alpha | GM-CSF |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 1549.70 | 23.10 | 334.50 | 1093.70 | 11.20 | 136.70 | 33.10 | 67.40 | 19.60 | 45.80 | 5.70 | 4.40 |
,| Phase 2 (Safety Management Study): Cohort 5 | 1746.15 | 27.90 | 314.90 | 908.00 | 11.85 | 97.95 | 29.80 | 75.10 | 14.45 | 34.15 | 5.25 | 2.90 |
,| Phase 2 (Safety Management Study): Cohort 6 | 1560.03 | 18.40 | 207.95 | 1279.50 | 8.40 | 47.25 | 28.25 | 52.55 | 13.30 | 37.20 | 4.80 | 1.90 |
Pharmacodynamics: Peak Level of Cytokines in Serum (Phase 1 and Phase 2 Cohorts 1, 2, and 3)
Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: interferon-gamma induced protein 10 (IP-10), ferritin, granzyme B, intercellular adhesion molecule (ICAM-1), interferon-gamma (IFN-gamma), interleukin-1 receptor antagonist (IL-1RA), IL-2, interleukin-2 receptor alpha (IL-2 R alpha), IL-6, IL-7, IL-8, IL-10, IL-15, perforin, tumor necrosis factor alpha (TNF alpha), and vascular cell adhesion molecule- 1 (VCAM-1). (NCT02348216)
Timeframe: Enrollment up to Week 4
| Intervention | pg/mL (Median) |
|---|
| IP-10 | Granzyme B | ICAM-1 | IFN-gamma | IL-1 RA | IL-2 | IL-2 R alpha | IL-6 | IL-7 | IL-8 | IL-10 | IL-15 | Perforin | TNF alpha | VCAM-1 |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 2000.0 | 33.1 | 792754.3 | 792.0 | 2173.3 | 18.4 | 16872.7 | 305.3 | 51.5 | 86.4 | 52.5 | 57.1 | 5389.0 | 10.5 | 1387033.6 |
,| Phase 2 (Pivotal Study): Cohort 1 | 2000.0 | 31.1 | 1322829.3 | 493.8 | 2371.2 | 25.0 | 14383.7 | 89.4 | 38.9 | 118.4 | 43.9 | 56.5 | 11309.5 | 8.6 | 1478356.8 |
,| Phase 2 (Pivotal Study): Cohort 2 | 2000.0 | 17.3 | 989188.4 | 364.9 | 1999.9 | 13.4 | 7817.3 | 44.6 | 44.1 | 77.2 | 18.8 | 47.6 | 8278.7 | 6.8 | 1058453.9 |
,| Phase 2 (Safety Management Study): Cohort 3 | 2000.0 | 44.1 | 1009966.4 | 1857.2 | 2160.5 | 20.0 | 12386.4 | 921.8 | 38.8 | 120.9 | 48.2 | 50.3 | 15411.9 | 10.9 | 1367940.7 |
Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007
The best overall response for each participant was based on the assessments of response (CR, PR, stable disease [SD], PD, and not done [ND]) made by the the IRRC using IWG 2007 criteria (Cheson et al, 2007). CR and PR as defined in outcome measure 2. PD defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion > 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentage of participants with best overall response of CR, PR, SD, PD, and ND was reported. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 27 January 2017 (maximum: 20 months)
| Intervention | percentage of participants (Number) |
|---|
| CR | PR | SD | PD | ND |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 49 | 19 | 21 | 8 | 3 |
,| Phase 2 (Pivotal Study): Cohort 2 | 58 | 21 | 4 | 4 | 13 |
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or continuous venovenous hemodialysis (CVVHD), and Grade 5: Death. Neurologic toxicities were graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff of 26 April 2018 (maximum: 35 months)
| Intervention | percentage of participants (Number) |
|---|
| Worst Grade 1 CRS | Worst Grade 2 CRS | Worst Grade 3 CRS | Worst Grade 4 CRS | Worst Grade 5 CRS | Worst Grade ≥ 3 CRS | Worst Grade 1 Neurologic Toxicities | Worst Grade 2 Neurologic Toxicities | Worst Grade 3 Neurologic Toxicities | Worst Grade 4 Neurologic Toxicities | Worst Grade 5 Neurologic Toxicities | Worst Grade ≥ 3 Neurologic Toxicities |
|---|
| Phase 2 (Safety Management Study): Cohort 3 | 34 | 55 | 0 | 3 | 0 | 3 | 24 | 24 | 34 | 3 | 3 | 39 |
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff of 06 May 2019 (maximum: 47.5 months)
| Intervention | percentage of participants (Number) |
|---|
| Worst Grade 1 CRS | Worst Grade 2 CRS | Worst Grade 3 CRS | Worst Grade 4 CRS | Worst Grade 5 CRS | Worst Grade ≥ 3 CRS | Worst Grade 1 Neurologic Toxicities | Worst Grade 2 Neurologic Toxicities | Worst Grade 3 Neurologic Toxicities | Worst Grade 4 Neurologic Toxicities | Worst Grade 5 Neurologic Toxicities | Worst Grade ≥ 3 Neurologic Toxicities |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 32 | 59 | 2 | 0 | 0 | 2 | 34 | 10 | 17 | 0 | 0 | 17 |
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff of 10 September 2020 (maximum: 64 months)
| Intervention | percentage of participants (Number) |
|---|
| Worst Grade 1 CRS | Worst Grade 2 CRS | Worst Grade 3 CRS | Worst Grade 4 CRS | Worst Grade 5 CRS | Worst Grade ≥ 3 CRS | Worst Grade 1 Neurologic Toxicities | Worst Grade 2 Neurologic Toxicities | Worst Grade 3 Neurologic Toxicities | Worst Grade 4 Neurologic Toxicities | Worst Grade 5 Neurologic Toxicities | Worst Grade ≥ 3 Neurologic Toxicities |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 38 | 46 | 0 | 2 | 0 | 2 | 26 | 18 | 10 | 2 | 0 | 12 |
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff of 16 June 2020 (maximum: 61 months)
| Intervention | percentage of participants (Number) |
|---|
| Worst Grade 1 CRS | Worst Grade 2 CRS | Worst Grade 3 CRS | Worst Grade 4 CRS | Worst Grade 5 CRS | Worst Grade ≥ 3 CRS | Worst Grade 1 Neurologic Toxicities | Worst Grade 2 Neurologic Toxicities | Worst Grade 3 Neurologic Toxicities | Worst Grade 4 Neurologic Toxicities | Worst Grade 5 Neurologic Toxicities | Worst Grade ≥ 3 Neurologic Toxicities |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 35 | 45 | 0 | 0 | 0 | 0 | 25 | 18 | 8 | 5 | 3 | 15 |
Phase 2 Safety Management Study: EQ-5D Visual Analogue Scale (VAS) Score
EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D-VAS records the participant's self-rated health on a vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. (NCT02348216)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Week 4 | Month 3 | Month 6 |
|---|
| Phase 2 (Safety Management Study): Cohort 3 | 71.2 | 67.8 | 74.9 | 77.1 |
,| Phase 2 (Safety Management Study): Cohort 4 | 69.5 | 67.2 | 78.8 | 85.1 |
,| Phase 2 (Safety Management Study): Cohort 5 | 66.7 | 70.8 | 73.3 | 77.1 |
,| Phase 2 (Safety Management Study): Cohort 6 | 70.9 | 76.1 | 76.5 | 79.8 |
Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 4 and Grade 3 or Higher Resulting From Decreased Parameter Value
Grading categories were determined by CTCAE version 4.03. Shifts to Grade 3 or higher has been reported for Phase 2 Cohort 3. For Phase 1 and all other cohorts of Phase 2, shifts to Grade 4 has been reported. (NCT02348216)
Timeframe: First infusion date to data cutoff 27 Jan 2017 (Phase 1,Cohorts 1,2), 26 Apr 2018, 6 May 2019, 10 Sep 2020, 16 Jun 2020 for Cohorts 3,4,5,6 respectively (maximum: 20 months for Phase 1,Cohorts 1,2; 35, 47.5, 64, 61 months for Cohorts 3,4,5,6 respectively)
| Intervention | percentage of participants (Number) |
|---|
| Hemoglobin | Neutrophils | Platelets | Potassium | Calcium | Magnesium | Sodium | Alanine Aminotransferase | Aspartate Aminotransferase | Bilirubin | Creatinine | Urate | Albumin | Leukocytes | Direct Bilirubin | Glucose | Lymphocytes | Phosphate | Alkaline Phosphatase |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 0 | 100 | 57 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 0 | 0 | 100 | 0 | 0 |
,| Phase 2 (Pivotal Study): Cohort 1 | 0 | 82 | 35 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 84 | 0 | 0 | 100 | 0 | 0 |
,| Phase 2 (Pivotal Study): Cohort 2 | 0 | 79 | 17 | 0 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 75 | 0 | 0 | 100 | 0 | 0 |
,| Phase 2 (Safety Management Study): Cohort 3 | 47 | 97 | 68 | 13 | 24 | 0 | 16 | 0 | 0 | 0 | 0 | 0 | 13 | 97 | 0 | 3 | 100 | 42 | 0 |
,| Phase 2 (Safety Management Study): Cohort 4 | 0 | 90 | 17 | 2 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 93 | 0 | 0 | 71 | 2 | 0 |
,| Phase 2 (Safety Management Study): Cohort 5 | 0 | 86 | 38 | 2 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 88 | 0 | 0 | 46 | 4 | 0 |
,| Phase 2 (Safety Management Study): Cohort 6 | 0 | 78 | 23 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 85 | 0 | 0 | 95 | 0 | 0 |
Phase 2 Safety Management Study: Number of Participants With the European Quality of Life Five Dimension Five Level Scale (EQ-5D) Score
"EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was divided into 5 levels of severity: No problem, Slight problems, Moderate problems, Severe problems, and Extreme problems (unable to perform). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state)." (NCT02348216)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | Participants (Count of Participants) |
|---|
| Baseline: Mobility72294096 | Baseline: Mobility72294104 | Baseline: Mobility72294105 | Baseline: Mobility72294106 | Week 4: Mobility72294105 | Week 4: Mobility72294106 | Week 4: Mobility72294104 | Week 4: Mobility72294096 | Month 3: Mobility72294105 | Month 3: Mobility72294106 | Month 3: Mobility72294096 | Month 3: Mobility72294104 | Month 6: Mobility72294096 | Month 6: Mobility72294104 | Month 6: Mobility72294105 | Month 6: Mobility72294106 | Baseline: Self-care72294096 | Baseline: Self-care72294106 | Baseline: Self-care72294104 | Baseline: Self-care72294105 | Week 4: Self-care72294104 | Week 4: Self-care72294105 | Week 4: Self-care72294096 | Week 4: Self-care72294106 | Month 3: Self-care72294104 | Month 3: Self-care72294106 | Month 3: Self-care72294105 | Month 3: Self-care72294096 | Month 6: Self-care72294096 | Month 6: Self-care72294106 | Month 6: Self-care72294104 | Month 6: Self-care72294105 | Baseline: Usual activities72294096 | Baseline: Usual activities72294106 | Baseline: Usual activities72294104 | Baseline: Usual activities72294105 | Week 4: Usual activities72294096 | Week 4: Usual activities72294105 | Week 4: Usual activities72294106 | Week 4: Usual activities72294104 | Month 3: Usual activities72294106 | Month 3: Usual activities72294096 | Month 3: Usual activities72294104 | Month 3: Usual activities72294105 | Month 6: Usual activities72294104 | Month 6: Usual activities72294105 | Month 6: Usual activities72294096 | Month 6: Usual activities72294106 | Baseline: Pain/Discomfort72294104 | Baseline: Pain/Discomfort72294105 | Baseline: Pain/Discomfort72294106 | Baseline: Pain/Discomfort72294096 | Week 4: Pain/Discomfort72294096 | Week 4: Pain/Discomfort72294105 | Week 4: Pain/Discomfort72294104 | Week 4: Pain/Discomfort72294106 | Month 3: Pain/Discomfort72294096 | Month 3: Pain/Discomfort72294105 | Month 3: Pain/Discomfort72294104 | Month 3: Pain/Discomfort72294106 | Month 6: Pain/Discomfort72294096 | Month 6: Pain/Discomfort72294104 | Month 6: Pain/Discomfort72294105 | Month 6: Pain/Discomfort72294106 | Baseline: Anxiety/Depression72294096 | Baseline: Anxiety/Depression72294105 | Baseline: Anxiety/Depression72294104 | Baseline: Anxiety/Depression72294106 | Week 4: Anxiety/Depression72294104 | Week 4: Anxiety/Depression72294096 | Week 4: Anxiety/Depression72294105 | Week 4: Anxiety/Depression72294106 | Month 3: Anxiety/Depression72294105 | Month 3: Anxiety/Depression72294096 | Month 3: Anxiety/Depression72294106 | Month 3: Anxiety/Depression72294104 | Month 6: Anxiety/Depression72294096 | Month 6: Anxiety/Depression72294104 | Month 6: Anxiety/Depression72294105 | Month 6: Anxiety/Depression72294106 |
|---|
| No problem | Slight problem | Severe problem | Unable to perform | Moderate problem |
|---|
| Phase 2 (Safety Management Study): Cohort 3 | 30 |
| Phase 2 (Safety Management Study): Cohort 4 | 25 |
| Phase 2 (Safety Management Study): Cohort 5 | 33 |
| Phase 2 (Safety Management Study): Cohort 6 | 26 |
| Phase 2 (Safety Management Study): Cohort 4 | 9 |
| Phase 2 (Safety Management Study): Cohort 4 | 5 |
| Phase 2 (Safety Management Study): Cohort 5 | 7 |
| Phase 2 (Safety Management Study): Cohort 3 | 16 |
| Phase 2 (Safety Management Study): Cohort 4 | 21 |
| Phase 2 (Safety Management Study): Cohort 5 | 23 |
| Phase 2 (Safety Management Study): Cohort 6 | 20 |
| Phase 2 (Safety Management Study): Cohort 3 | 11 |
| Phase 2 (Safety Management Study): Cohort 5 | 9 |
| Phase 2 (Safety Management Study): Cohort 6 | 5 |
| Phase 2 (Safety Management Study): Cohort 3 | 4 |
| Phase 2 (Safety Management Study): Cohort 5 | 4 |
| Phase 2 (Safety Management Study): Cohort 3 | 0 |
| Phase 2 (Safety Management Study): Cohort 3 | 1 |
| Phase 2 (Safety Management Study): Cohort 3 | 14 |
| Phase 2 (Safety Management Study): Cohort 4 | 20 |
| Phase 2 (Safety Management Study): Cohort 6 | 22 |
| Phase 2 (Safety Management Study): Cohort 4 | 2 |
| Phase 2 (Safety Management Study): Cohort 3 | 10 |
| Phase 2 (Safety Management Study): Cohort 5 | 11 |
| Phase 2 (Safety Management Study): Cohort 6 | 15 |
| Phase 2 (Safety Management Study): Cohort 3 | 37 |
| Phase 2 (Safety Management Study): Cohort 4 | 38 |
| Phase 2 (Safety Management Study): Cohort 5 | 44 |
| Phase 2 (Safety Management Study): Cohort 6 | 32 |
| Phase 2 (Safety Management Study): Cohort 4 | 1 |
| Phase 2 (Safety Management Study): Cohort 5 | 3 |
| Phase 2 (Safety Management Study): Cohort 3 | 25 |
| Phase 2 (Safety Management Study): Cohort 4 | 33 |
| Phase 2 (Safety Management Study): Cohort 5 | 31 |
| Phase 2 (Safety Management Study): Cohort 6 | 24 |
| Phase 2 (Safety Management Study): Cohort 3 | 5 |
| Phase 2 (Safety Management Study): Cohort 5 | 6 |
| Phase 2 (Safety Management Study): Cohort 6 | 3 |
| Phase 2 (Safety Management Study): Cohort 6 | 0 |
| Phase 2 (Safety Management Study): Cohort 3 | 19 |
| Phase 2 (Safety Management Study): Cohort 4 | 29 |
| Phase 2 (Safety Management Study): Cohort 5 | 32 |
| Phase 2 (Safety Management Study): Cohort 6 | 25 |
| Phase 2 (Safety Management Study): Cohort 3 | 17 |
| Phase 2 (Safety Management Study): Cohort 6 | 7 |
| Phase 2 (Safety Management Study): Cohort 3 | 22 |
| Phase 2 (Safety Management Study): Cohort 4 | 22 |
| Phase 2 (Safety Management Study): Cohort 5 | 24 |
| Phase 2 (Safety Management Study): Cohort 6 | 16 |
| Phase 2 (Safety Management Study): Cohort 4 | 6 |
| Phase 2 (Safety Management Study): Cohort 6 | 2 |
| Phase 2 (Safety Management Study): Cohort 3 | 6 |
| Phase 2 (Safety Management Study): Cohort 4 | 12 |
| Phase 2 (Safety Management Study): Cohort 6 | 12 |
| Phase 2 (Safety Management Study): Cohort 3 | 13 |
| Phase 2 (Safety Management Study): Cohort 4 | 11 |
| Phase 2 (Safety Management Study): Cohort 5 | 13 |
| Phase 2 (Safety Management Study): Cohort 6 | 11 |
| Phase 2 (Safety Management Study): Cohort 5 | 8 |
| Phase 2 (Safety Management Study): Cohort 6 | 4 |
| Phase 2 (Safety Management Study): Cohort 6 | 1 |
| Phase 2 (Safety Management Study): Cohort 3 | 2 |
| Phase 2 (Safety Management Study): Cohort 3 | 8 |
| Phase 2 (Safety Management Study): Cohort 4 | 16 |
| Phase 2 (Safety Management Study): Cohort 5 | 19 |
| Phase 2 (Safety Management Study): Cohort 4 | 15 |
| Phase 2 (Safety Management Study): Cohort 4 | 7 |
| Phase 2 (Safety Management Study): Cohort 5 | 2 |
| Phase 2 (Safety Management Study): Cohort 5 | 1 |
| Phase 2 (Safety Management Study): Cohort 5 | 0 |
| Phase 2 (Safety Management Study): Cohort 3 | 18 |
| Phase 2 (Safety Management Study): Cohort 4 | 17 |
| Phase 2 (Safety Management Study): Cohort 5 | 16 |
| Phase 2 (Safety Management Study): Cohort 6 | 14 |
| Phase 2 (Safety Management Study): Cohort 3 | 12 |
| Phase 2 (Safety Management Study): Cohort 5 | 20 |
| Phase 2 (Safety Management Study): Cohort 6 | 17 |
| Phase 2 (Safety Management Study): Cohort 5 | 10 |
| Phase 2 (Safety Management Study): Cohort 6 | 9 |
| Phase 2 (Safety Management Study): Cohort 3 | 7 |
| Phase 2 (Safety Management Study): Cohort 3 | 9 |
| Phase 2 (Safety Management Study): Cohort 4 | 10 |
| Phase 2 (Safety Management Study): Cohort 4 | 14 |
| Phase 2 (Safety Management Study): Cohort 6 | 8 |
| Phase 2 (Safety Management Study): Cohort 4 | 23 |
| Phase 2 (Safety Management Study): Cohort 5 | 18 |
| Phase 2 (Safety Management Study): Cohort 6 | 21 |
| Phase 2 (Safety Management Study): Cohort 4 | 13 |
| Phase 2 (Safety Management Study): Cohort 5 | 17 |
| Phase 2 (Safety Management Study): Cohort 4 | 3 |
| Phase 2 (Safety Management Study): Cohort 4 | 0 |
| Phase 2 (Safety Management Study): Cohort 5 | 21 |
| Phase 2 (Safety Management Study): Cohort 6 | 23 |
| Phase 2 (Safety Management Study): Cohort 3 | 15 |
| Phase 2 (Safety Management Study): Cohort 5 | 12 |
| Phase 2 (Safety Management Study): Cohort 5 | 5 |
| Phase 2 (Safety Management Study): Cohort 4 | 19 |
| Phase 2 (Safety Management Study): Cohort 6 | 19 |
| Phase 2 (Safety Management Study): Cohort 4 | 8 |
| Phase 2 (Safety Management Study): Cohort 4 | 4 |
| Phase 2 (Safety Management Study): Cohort 6 | 18 |
| Phase 2 (Safety Management Study): Cohort 3 | 3 |
Pharmacodynamics: Peak Level of Cytokine (CRP) in Serum
Peak was defined as the maximum post-baseline level of the cytokine. (NCT02348216)
Timeframe: Enrollment up to Week 4
| Intervention | mg/mL (Median) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 112.6 |
| Phase 2 (Pivotal Study): Cohort 1 | 215.7 |
| Phase 2 (Pivotal Study): Cohort 2 | 186.6 |
| Phase 2 (Safety Management Study): Cohort 3 | 137.8 |
| Phase 2 (Safety Management Study): Cohort 4 | 126.53 |
| Phase 2 (Safety Management Study): Cohort 5 | 74.84 |
| Phase 2 (Safety Management Study): Cohort 6 | 76.11 |
Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood
Peak was defined as the maximum number of CAR T cells measured post-infusion. (NCT02348216)
Timeframe: Enrollment up to Month 6
| Intervention | cells/µL (Median) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 58.512 |
| Phase 2 (Pivotal Study): Cohort 1 | 31.512 |
| Phase 2 (Pivotal Study): Cohort 2 | 58.633 |
| Phase 2 (Safety Management Study): Cohort 3 | 53.670 |
| Phase 2 (Safety Management Study): Cohort 4 | 52.91 |
| Phase 2 (Safety Management Study): Cohort 5 | 26.63 |
| Phase 2 (Safety Management Study): Cohort 6 | 64.38 |
Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 2 Cohort 3)
Peak was defined as the maximum post-baseline level of the cytokine. (NCT02348216)
Timeframe: Enrollment up to Week 4
| Intervention | ng/mL (Median) |
|---|
| Phase 2 (Safety Management Study): Cohort 3 | 2440.2 |
Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 1 and Phase 2 Cohorts 1 and 2)
Peak was defined as the maximum post-baseline level of the cytokine. (NCT02348216)
Timeframe: Enrollment up to Week 4
| Intervention | pg/mL (Median) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 1973400.0 |
| Phase 2 (Pivotal Study): Cohort 1 | 3681400.0 |
| Phase 2 (Pivotal Study): Cohort 2 | 1979360.0 |
Phase 2: Duration of Response (DOR) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
Among participants who experience an objective response (OR), DOR was defined as the date of their first objective response (CR or PR which was subsequently confirmed) to disease progression per the revised IWG Response Criteria for Malignant Lymphoma or death regardless of cause. CR and PR as defined in outcome measure 2. Disease progression (PD) was defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion > 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis. Kaplan-Meier (KM) estimates was used for analyses. (NCT02348216)
Timeframe: First OR to data cutoff date of 27 Jan 2017, 26 Apr 2018, 6 May 2019, 10 Sep 2010, and 16 Jun 2020 for Cohorts 1 and 2, 3, 4, 5, and 6 respectively (median duration: 5.3, 4.9, 11.1, 5.2, 11.4, and 5.8 months for Cohorts 1, 2, 3, 4, 5, and 6 respectively)
| Intervention | months (Median) |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 4.2 |
| Phase 2 (Pivotal Study): Cohort 2 | NA |
| Phase 2 (Safety Management Study): Cohort 3 | NA |
| Phase 2 (Safety Management Study): Cohort 4 | NA |
| Phase 2 (Safety Management Study): Cohort 5 | NA |
| Phase 2 (Safety Management Study): Cohort 6 | NA |
Percentage of Participants With Positive Replication Competent Retrovirus (RCR)
RCR was analyzed in blood samples by central laboratory. Because axicabtagene ciloleucel comprised retroviral vector transduced T cells, the presence of RCR in the blood of treated participants was reported. (NCT02348216)
Timeframe: Day 0 (pre-infusion) to data cutoff 27 Jan 2017 (Phase 1,Cohorts 1,2), 26 Apr 2018, 6 May 2019, 10 Sep 2020, 16 Jun 2020 for Cohorts 3,4,5,6 respectively (maximum:20 months for Phase 1,Cohorts 1,2; 35, 47.5, 64, 61 months for Cohorts 3,4,5,6 respectively)
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 0 |
| Phase 2 (Pivotal Study): Cohort 1 | 0 |
| Phase 2 (Pivotal Study): Cohort 2 | 0 |
| Phase 2 (Safety Management Study): Cohort 3 | 0 |
| Phase 2 (Safety Management Study): Cohort 4 | 0 |
| Phase 2 (Safety Management Study): Cohort 5 | 0 |
| Phase 2 (Safety Management Study): Cohort 6 | 0 |
Phase 2 Pivotal Study (Cohorts 1 and 2): Duration of Response (DOR) Using IRRC Per Cheson 2007
Among participants who experience an objective response, DOR was defined as the date of their first objective response (CR or PR which was subsequently confirmed) to PD per the revised IWG Response Criteria for Malignant Lymphoma or death regardless of cause. CR and PR as defined in outcome measure 2. PD was defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion > 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis. Kaplan-Meier (KM) estimates was used for analyses. (NCT02348216)
Timeframe: First objective response to the data cutoff date of 27 January 2017 (maximum: 20 months)
| Intervention | months (Median) |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 5.4 |
| Phase 2 (Pivotal Study): Cohort 2 | NA |
Phase 2 Pivotal Study (Cohorts 1 and 2): ORR Per Independent Radiological Review Committee (IRRC)
ORR was defined as the percentage of participants achieving either a CR or a PR, as assessed by the IRRC using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; > 50% decrease in the greatest transverse diameter for single nodules. 95% CI was calculated by Clopper-Pearson method. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 27 January 2017 (maximum: 20 months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 69 |
| Phase 2 (Pivotal Study): Cohort 2 | 79 |
Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), as assessed by the study investigators using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; > 50% decrease in the greatest transverse diameter for single nodules. 95% confidence interval (CI) was calculated by Clopper-Pearson method. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 27 January 2017 (maximum: 20 months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 82 |
| Phase 2 (Pivotal Study): Cohort 2 | 83 |
Phase 2 Pivotal Study (Cohorts 1 and 2): PFS Using IRRC Per Cheson 2007
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007) or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. PD defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion > 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis. KM estimates was used for analyses. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the date of disease progression or death from any cause or the data cutoff date of 27 January 2017 (maximum: 20 months)
| Intervention | months (Median) |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 5.0 |
| Phase 2 (Pivotal Study): Cohort 2 | NA |
Percentage of Participants With Anti-Axicabtagene Ciloleucel Antibodies
(NCT02348216)
Timeframe: First infusion date to data cutoff 27 Jan 2017 (Phase 1,Cohorts 1,2), 26 Apr 2018, 6 May 2019, 10 Sep 2020, 16 Jun 2020 for Cohorts 3,4,5,6 respectively (maximum: 20 months for Phase 1,Cohorts 1,2; 35, 47.5, 64, 61 months for Cohorts 3,4,5,6 respectively)
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 0 |
| Phase 2 (Pivotal Study): Cohort 1 | 4 |
| Phase 2 (Pivotal Study): Cohort 2 | 0 |
| Phase 2 (Safety Management Study): Cohort 3 | 5 |
| Phase 2 (Safety Management Study): Cohort 4 | 0 |
| Phase 2 (Safety Management Study): Cohort 5 | 8 |
| Phase 2 (Safety Management Study): Cohort 6 | 8 |
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
An adverse event was defined as any untoward medical occurrence in a clinical trial participants. The event did not necessarily have a relationship with study treatment. Adverse events included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while on study, was not considered an adverse event. TEAE was defined as any AE with onset on or after the start of treatment. (NCT02348216)
Timeframe: First infusion date to data cutoff 27 Jan 2017 (Phase 1,Cohorts 1,2), 26 Apr 2018, 6 May 2019, 10 Sep 2020, 16 Jun 2020 for Cohorts 3,4,5,6 respectively (maximum: 20 months for Phase 1,Cohorts 1,2; 35, 47.5, 64, 61 months for Cohorts 3,4,5,6 respectively)
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 100 |
| Phase 2 (Pivotal Study): Cohort 1 | 100 |
| Phase 2 (Pivotal Study): Cohort 2 | 100 |
| Phase 2 (Safety Management Study): Cohort 3 | 100 |
| Phase 2 (Safety Management Study): Cohort 4 | 100 |
| Phase 2 (Safety Management Study): Cohort 5 | 100 |
| Phase 2 (Safety Management Study): Cohort 6 | 100 |
Phase 2 Safety Management Study (Cohorts 3, 4, 5, and 6): ORR as Assessed by Investigator Per the Revised IWG Response Criteria for Malignant Lymphoma
ORR was defined as the percentage of participants achieving either a CR or a PR, as assessed by the study investigators using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; > 50% decrease in the greatest transverse diameter for single nodules. 95% CI was calculated by Clopper-Pearson method. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 26 Apr 2018, 06 May 2019, 10 Sep 2020, and 16 Jun 2020 for Cohorts 3, 4, 5, and 6 respectively (maximum: 35, 47.5, 64, and 61 months for Cohorts 3, 4, 5, and 6 respectively)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2 (Safety Management Study): Cohort 3 | 63 |
| Phase 2 (Safety Management Study): Cohort 4 | 73 |
| Phase 2 (Safety Management Study): Cohort 5 | 72 |
| Phase 2 (Safety Management Study): Cohort 6 | 95 |
Phase 1 Study: ORR as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
ORR was defined as the percentage of participants achieving either a CR or a PR, as assessed by the study investigators using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; all lymph nodes and nodal masses must have regressed to normal size; spleen and/or liver must be normal size, not be palpable, and no nodules; bone marrow aspirate and biopsy must show no evidence of disease. PR: a ≥ 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease; multiple splenic and hepatic nodules (if present) must regress by ≥ 50% in the SPD; > 50% decrease in the greatest transverse diameter for single nodules. (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel to the data cutoff date of 27 January 2017 (maximum: 20 months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 71 |
Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)
"DLT was defined as axicabtagene ciloleucel-related events with onset within first 30 days following infusion:~Grade (GR) 4 neutropenia lasting > 21 days and GR 4 thrombocytopenia lasting > 35 days from day of cell transfer;~Any axicabtagene ciloleucel-related AE requiring intubation;~All other GR 3 toxicities lasting > 3 days and all GR 4 toxicities, with exception of following conditions which were not considered DLTs: aphasia/dysphasia or confusion/cognitive disturbance which resolved to GR ≤ 1 within 2 weeks and to baseline within 4 weeks; fever GR 3; myelosuppression defined as lymphopenia, decreased hemoglobin, neutropenia and thrombocytopenia unless neutropenia and thrombocytopenia met DLT definition described above; immediate hypersensitivity reactions occurring within 2 hours of cell infusion that were reversible to a ≤ GR 2 within 24 hours of cell administration with standard therapy; hypogammaglobulinemia GR 3 or 4." (NCT02348216)
Timeframe: First infusion date of axicabtagene ciloleucel up to 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy | 1 |
Phase 2: Overall Survival (OS)
OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses. (NCT02348216)
Timeframe: First infusion date to the death or data cutoff date of 27 Jan 2017, 26 Apr 2018, 6 May 2019, 10 Sep 2020, and 16 Jun 2020 for Cohorts 1 and 2, 3, 4, 5, 6 respectively (maximum: 20, 35, 47.5, 64, and 61 months for Cohorts 1 and 2, 3, 4, 5, 6 respectively)
| Intervention | months (Median) |
|---|
| Phase 2 (Pivotal Study): Cohort 1 | 11.5 |
| Phase 2 (Pivotal Study): Cohort 2 | NA |
| Phase 2 (Safety Management Study): Cohort 3 | 15.4 |
| Phase 2 (Safety Management Study): Cohort 4 | NA |
| Phase 2 (Safety Management Study): Cohort 5 | 14.6 |
| Phase 2 (Safety Management Study): Cohort 6 | NA |
Minimal Residual Disease
A bone marrow evaluation to determine study response and remission status will be performed on study Day 30 or upon adequate blood count recovery (ANC > 0.50 and platelet > 50,000), whichever occurs first. If the marrow is hypocellular and without evidence of normal tri-lineage hematopoiesis the marrow should be repeated at Day 42. (NCT02349178)
Timeframe: Day 30 or adequate blood recovery
| Intervention | Participants (Count of Participants) |
|---|
| MRD Positive | MRD Negative |
|---|
| Bridging Arm | 3 | 3 |
Overall Survival
Overall survival (OS), defined as the time from the start of treatment to death, will be described with the Kaplan-Meier curve. (NCT02354690)
Timeframe: Up to 40 months
| Intervention | Months (Median) |
|---|
| T Cell Therapy With Vemurafenib Pretreatment | 28.8 |
Progression Free Survival
"Progression-free survival (PFS), defined as the time from start of treatment to disease progression, relapse or death due to any cause, whichever is earlier, will be described with the Kaplan-Meier curve.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT02354690)
Timeframe: Up to 40 months
| Intervention | Months (Median) |
|---|
| T Cell Therapy With Vemurafenib Pretreatment | 4.8 |
Number of Reported Adverse Events
Determine the safety of the administration of vemurafenib in combination with TIL therapy including lymphodepleting chemotherapy and interleukin-2 treatment by collecting adverse events according to CTCAE v. 4.0. From start of treatment until 24 weeks after T cell infusion. (NCT02354690)
Timeframe: 0-40 weeks
| Intervention | Treatment related adverse events (Number) |
|---|
| Total | Grade 1-2 | Grade 3-4 |
|---|
| T Cell Therapy With Vemurafenib Pretreatment | 124 | 89 | 35 |
Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT02354690)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| T Cell Therapy With Vemurafenib Pretreatment | 9 |
Overall Survival
Overall survival (OS), defined as time from treatment initiation to death, described using the Kaplan Meier method (NCT02379195)
Timeframe: Up to 36 months
| Intervention | months (Median) |
|---|
| Arm A: TIL + IFNalpha | 11.75 |
Number of Participants With Adverse Events/Serious Adverse Events
Determine the safety of the administration of peginterferon in combination with TIL therapy including lymphodepleting chemotherapy and Interleukin-2 by reporting adverse events according to CTCAE v. 4.0 (NCT02379195)
Timeframe: 0-24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Adverse events | Treatment-related adverse events | Serious adverse events |
|---|
| Arm A: TIL + IFNalpha | 12 | 12 | 4 |
Progression Free Survival
Progression free survival (PFS), defined as the time from treatment initiation to disease progression, relapse or death due to any cause, which ever comes first, will be described with the Kaplan Meier method. (NCT02379195)
Timeframe: Up to 36 months
| Intervention | months (Median) |
|---|
| Arm A: TIL + IFNalpha | 2.8 |
Objective Response Rate
Clinical responses will be evaluated by RECIST 1.1 (Response Criteria In Solid Tumors Criteria version 1.1) and assessed by CT scan. Complete response (CR), disapperance of all lesions; Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR (NCT02379195)
Timeframe: Up to 36 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: TIL + IFNalpha | 2 |
Count of Patients for Which T Cells Are Successfully Generated and Infused and Whether Only TN or TCM Could be Generated
There were products generated for 11 participants and 10 participants were treated on the study. 8 participants received an infusion with Tn and Tcm cells. 1 participant received infusions with only Tn cells. 1 participant received their last infusion with only Tcm cells. The one participant that was not treated did successfully have Tn and Tcm cells generated but they were not treated due to their condition worsening. (NCT02408016)
Timeframe: Up to 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2) | 4 |
| Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2) | 4 |
| Arm II (T Lymphocytes, IL-2, Surgery) | 0 |
Number of Participants With Adverse Events
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. (NCT02408016)
Timeframe: Up to 6 months after the first T cell infusion
| Intervention | Participants (Count of Participants) |
|---|
| Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2) | 6 |
| Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2) | 3 |
| Arm II (T Lymphocytes, IL-2, Surgery) | 0 |
Persistence of Transduced T Cells
In vivo persistence of cells generated from the TN subset with cells generated from the TCM subset will be directly compared within each patient by high throughput T-cell receptor (TCR) beta sequencing. The one-sample T test will be used to assess the difference in mean persistence between groups, in which the outcome for each patient is the time to disappearance of infused cytotoxic T lymphocytes. (NCT02408016)
Timeframe: Up to 100 days after the last T cell infusion
| Intervention | Participants (Count of Participants) |
|---|
| Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2) | NA |
| Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2) | NA |
| Arm II (T Lymphocytes, IL-2, Surgery) | 0 |
Evaluation of the Response Rate of Ixazomib With Metronomic Cyclophosphamide and Dexamethasone for First-line Treatment of Multiple Myeloma.
(NCT02412228)
Timeframe: Through study treatment completion, an average of 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Ixazomib Regimen | 12 |
Evaluation of the Toxicities Associated With Ixazomib With Metronomic Cyclophosphamide and Dexamethasone.
(NCT02412228)
Timeframe: Assessed at baseline and end of study, up to 2 years, end of study reported
| Intervention | Participants (Count of Participants) |
|---|
| Ixazomib Regimen | 12 |
Number of Participants With Pathological Complete Response
To evaluate the pathological complete response rates with neoadjuvant chemotherapy regimens of carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide X 4 cycles and carboplatin plus docetaxel X 6 cycles in subjects with stage I-III triple-negative breast cancer. Pathological complete response is defined as no evidence of disease in the breast and axilla at the time of pathology review except for DCIS. (NCT02413320)
Timeframe: 20 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide | 26 |
| Carboplatin + Docetaxel | 28 |
Number of Participants With Minimal Residual Disease
To evaluate minimal residual disease rates (residual cancer burden 0+1) with two neoadjuvant chemotherapy regimens in subjects with stage I-III triple-negative breast cancer. (NCT02413320)
Timeframe: 20 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide | 31 |
| Carboplatin + Docetaxel | 35 |
Event Free Survival (EFS)
Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%. (NCT02419469)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Ofatumumab Plus Chemotherapy | NA |
Percentage of Participants With Adverse Events
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events. (NCT02419742)
Timeframe: Baseline up to approximately 5 years and 10 months
| Intervention | Participants (Count of Participants) |
|---|
| Trastuzumab With AC-TH Regimen | 46 |
| Trastuzumab With TCH Regimen | 51 |
Overall Survival (OS)
Overall survival was defined as time from the date of first study treatment until date of death, regardless of the cause of death. (NCT02419742)
Timeframe: Time from the date of first study treatment until date of death, regardless of the cause of death within 12 months from the last dose of Trastuzumab for every participant. The follow up period was 52 weeks from the last dose of treatment in both arms.
| Intervention | Months (Median) |
|---|
| Trastuzumab With AC-TH Regimen | NA |
| Trastuzumab With TCH Regimen | NA |
Disease Free Survival (DFS)
DFS was defined as time from the date of first study treatment to the date of local, regional or distant recurrence, contra-lateral breast cancer or death due to any cause. Local, regional or distant recurrence, and contra-lateral breast cancer was assessed by combination of physical examination, mammography and pelvic examination. (NCT02419742)
Timeframe: The date of first study treatment to the date of local, regional or distant recurrence, contra-lateral breast cancer or death due to any cause within 12 months from the last dose of Trastuzumab for every participant
| Intervention | Months (Median) |
|---|
| Trastuzumab With AC-TH Regimen | NA |
| Trastuzumab With TCH Regimen | NA |
Clinically Significant Changes in Cardiac Function As Determined by Left Ventricular Ejection Fraction (LVEF) Measurements Using Echocardiography
LVEF assessments were performed every three months (four cycles) using echocardiogram (NCT02419742)
Timeframe: Baseline to every 4 cycles up to Cycle 21 (AC-TH), every 4 cycles up to Cycle 17 (TCH) (each cycle is 21 days), at study treatment completion (12 months post baseline) at 6 month (18 months post baseline) and 12 month follow-up (24 months post baseline)
| Intervention | Percentage of LVEF (Mean) |
|---|
| Baseline | Cycle 5 | Cycle 9 | Cycle 13 | Cycle 17 | Cycle 21 | Study Completion Visit | 6 Month Follow Up | 12 Month Follow Up |
|---|
| Trastuzumab With AC-TH Regimen | 60.1 | -0.2 | -0.5 | -2.0 | -1.8 | -1.8 | -3.3 | -1.6 | -2.2 |
Clinically Significant Changes in Cardiac Function As Determined by Left Ventricular Ejection Fraction (LVEF) Measurements Using Echocardiography
LVEF assessments were performed every three months (four cycles) using echocardiogram (NCT02419742)
Timeframe: Baseline to every 4 cycles up to Cycle 21 (AC-TH), every 4 cycles up to Cycle 17 (TCH) (each cycle is 21 days), at study treatment completion (12 months post baseline) at 6 month (18 months post baseline) and 12 month follow-up (24 months post baseline)
| Intervention | Percentage of LVEF (Mean) |
|---|
| Baseline | Cycle 5 | Cycle 9 | Cycle 13 | Cycle 17 | Study Completion Visit | 6 Month Follow Up | 12 Month Follow Up |
|---|
| Trastuzumab With TCH Regimen | 62.1 | -0.4 | -1.0 | -1.0 | -1.1 | -0.7 | -0.3 | -0.4 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT02420717)
Timeframe: Up to 4 years 7 months
| Intervention | Months (Median) |
|---|
| Phase I Ruxolitinib 15mg | 4.8 |
| Phase I Ruxolitinib 20mg | 5.4 |
| Phase I Ruxolitinib 25mg | 38.5 |
Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II)
Complete Response (CR) is disappearance of all clinical and/or radiologic evidence of disease, Neutrophil count ≥ 1.0 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Normal bone marrow differential (≤ 5% blasts), No extra-medullary leukemia. Complete Remission with Incomplete Blood Count Recovery (CRi) is CR except for ANC < 1.0 x 10^9/L and/or platelets < 100 x 10^9/L. (NCT02420717)
Timeframe: 42 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase I Ruxolitinib 15mg | 0 |
| Phase I Ruxolitinib 20mg | 1 |
| Phase I Ruxolitinib 25mg | 0 |
Progression-free Survival
Time from date of treatment start until the date of first objective documentation of disease-relapse. (NCT02420717)
Timeframe: Up to 4 years 7 months
| Intervention | Months (Median) |
|---|
| Phase I Ruxolitinib 15mg | 2.3 |
| Phase I Ruxolitinib 20mg | 1.8 |
| Phase I Ruxolitinib 25mg | 1.9 |
Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I)
The method of Thall, Simon and Estey will be used for toxicity monitoring for this study. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 whenever possible. Safety data will be summarized by category, severity and frequency. (NCT02420717)
Timeframe: 42 days
| Intervention | Milligrams (mg) (Number) |
|---|
| Phase I Ruxolitinib 15mg | 25 |
Immunogenicity-CD4+ T Cell Responses
CD4+ T cell responses to 6 MHP: durable helper T cell response to 6MHP at 2 or more consecutive timepoints in the PBMC. (NCT02425306)
Timeframe: through day 85
| Intervention | Participants (Count of Participants) |
|---|
| Arm A:6MHP + Montanide ISA-51 | 0 |
| Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide | 2 |
| Arm C:6MHP + polyICLC + Montanide ISA-51 | 4 |
| Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide | 15 |
Number of Participants With Adverse Events
Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities. (NCT02425306)
Timeframe: 30 days after administration of the last dose of 6MHP or cyclophosphamide
| Intervention | participants (Number) |
|---|
| Arm A:6MHP + Montanide ISA-51 | 0 |
| Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide | 1 |
| Arm C:6MHP + polyICLC + Montanide ISA-51 | 0 |
| Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide | 2 |
Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)
increased infiltration of CD4+ and CD8+ T lymphocytes into melanoma metastases (NCT02425306)
Timeframe: through day 22
| Intervention | cells per mm2 of tumor (Number) |
|---|
| CD8 T cells per mm2 in tumor pre-vaccine (day 0) | CD8 T cells per mm2 in tumor day 22 | CD4 T cells per mm2 of tumor prevaccine (day 0) | CD4 T cells per mm2 tumor day 22 |
|---|
| Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide | 401 | 293 | 1202 | 1102 |
12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)
12-month PFS will be defined as the percentage of patients alive and progression free 12 months from start of therapy. Patients lost to follow up will be censored from last point of contact. PFS was calculated using a Kplan-meier estimation with the probability of patients being progression free at 12 months, presented as the percentage based on this probability. (NCT02481310)
Timeframe: Up to 12 months from initiation of treatment
| Intervention | probability (%) of patients alive (Number) |
|---|
| Treatment (Combination Chemotherapy, Rituximab, Ixazomib) | 75.84 |
To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R.
"The RP2D will be determined by the evaluation of dose-limiting toxicities (DLT) to find the Maximum Tolerated Dose (MTD) which will constitute the RP2D. DLTs will be defined as the occurrence of ≥ Grade 3 toxicity experienced during the first cycle (3 weeks or 21 days) of study treatment, will be determined, except for cytopenias.~The dose of ixazomib will start at 2.3 mg weekly (for phase I patients) when given concurrently with DA-EPOCH-R. Single-subject cohorts (escalating in ixazomib dose) will be enrolled until the MTD is encountered, after which expansion to 3-subject cohorts will be undertaken. The MTD from phase I will equate the RP2D for ixazomib given in conjunction with DA-EPOCH-R." (NCT02481310)
Timeframe: The first 21 days of treatment
| Intervention | mg (Number) |
|---|
| Treatment (Combination Chemotherapy, Rituximab, Ixazomib) | 3 |
Probability of Event Free Survival (EFS)
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression. (NCT02486952)
Timeframe: Up to 41 months
| Intervention | probability of EFS (Number) |
|---|
| Diffuse Large B-Cell Lymphoma | 0.695 |
Percentage of Participants Who Were Alive
Percentage of participants with survival was calculated 41 months after the first dose of study treatment. (NCT02486952)
Timeframe: Up to 41 months
| Intervention | percentage of participants (Number) |
|---|
| Diffuse Large B-Cell Lymphoma | 74.4 |
Rate of Achieving Targeted Area Under the Curve (AUC)
Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg*hr/L) within 4 cycles of therapy in patients > 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen. (NCT02502864)
Timeframe: Cycle 4 - Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| AUC mg*hr/L: 2.5-3.7 | AUC mg*hr/L: <2.5 |
|---|
| Standard of Care + Surveys | 5 | 3 |
Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia
The incidence of grade 3 and 4 neutropenia and febrile neutropenia in cycles following PK adjustment (cycles 2-4) will be compared with cycle 1 and historical non-PK guided therapy using the Wilcoxon-Rank sum assessment. (NCT02502864)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Participants with Grade 3 or 4 neutropenia | Participants with Febrile neutropenia |
|---|
| Standard of Care + Surveys | 2 | 0 |
Number of Participants Who Were Disease Progression-Free and Death-Free at 1 Year Post-transplant
Evaluation for engraftment, correction of the disease, transplant related complications and event-free survival and overall survival of the subjects post-transplant was undertaken by standard measures and evaluation of disease with disease-specific testing. (NCT02512679)
Timeframe: 1 yr
| Intervention | participants (Number) |
|---|
| 100 Day Event Free Survival Post Transplant | One Year Event Free Survival Post Transplant | Disease Progression-Free |
|---|
| Cyclophosphamide Dose Level 1 | 19 | 18 | 20 |
Number of Participants Who Developed Severe Mucositis, Veno-occlusive Disease (VOD), Toxicity of the Kidney, Liver, or Gastrointestinal (GI) Tract up to 1 Year Post-transplant
Assessment of conditioning regimen related toxicity was evaluated and documented with daily assessment during hospitalization and post-transplant follow-up up to one year. None of the subjects developed VOD necessitating any therapeutic intervention, severe mucositis, or toxicity of the Kidney, Liver or Gastrointestinal. (NCT02512679)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Veno-Occlusive Disease | Viral Infection | Toxicity of Kidney, Liver, or Gastrointestinal | Severe Mucositis |
|---|
| Cyclophosphamide Dose Level 1 | 0 | 8 | 0 | 0 |
Number of Participants With Neutrophil Engraftment (=/>500 Cells/uL) and Platelet Engraftment (>20K Cell/uL) at 30 Days
Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20,000 per cubic milimeter (20K) - evaluation by Chimerism Study (STR or FISH) at day +30 (NCT02512679)
Timeframe: 30 days
| Intervention | participants (Number) |
|---|
| Cyclophosphamide Dose Level 1 | 20 |
Number of Participants With Disease Recurrence at 1 Year Post-transplant
"assess rate of disease recurrence (late relapse) due to autologous recovery of recipient hematopoiesis at one year post-HSCT." (NCT02512679)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Cyclophosphamide Dose Level 1 | 0 |
Number of Participants Who Developed Graft-Versus-Host-Disease (GVHD) as Determined by the Glucksberg Scale
Clinical evaluation on a daily basis during hospitalization and at each post transplant clinical visit, up to one year, to determine incidence of acute and chronic graft-versus-host disease using Glucksberg grading scale. Acute graft-versus-host disease (aGVHD) develops within the first three months after transplantation and appears as a skin rash, often accompanied by hyperbilirubenemia, abnormal liver enzymes and gastrointestinal symptoms, as diarrhea, nausea and vomiting. Level of aGVHD is graded from 1-4. Chronic GVHD, typically a late complication of Blood and Marrow Transplantation (BMT) characterized by skin changes, sometimes sclerotic changes, with joint contractures, liver function abnormality, gastrointestinal symptoms and sometime other organ involvement such as eyes, lungs, and obliterative bronchiolitis (OB). Chronic GVHD is graded as absent, limited, or extensive. (NCT02512679)
Timeframe: 1 yr
| Intervention | participants (Number) |
|---|
| Acute GVHD (Grade 1-2) | Acute GVHD (Grade 3-4) | Chronic GVHD |
|---|
| Cyclophosphamide Dose Level 1 | 10 | 0 | 0 |
Progression-Free Survival (PFS)
Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis. (NCT02533401)
Timeframe: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
| Intervention | months (Mean) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 47.2 |
Percentage of Participants With Death or Disease Progression
Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. The percentage of participants with death or documented disease progression at any time during the study was calculated. (NCT02533401)
Timeframe: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 24 |
Percentage of Participants Who Died
Participants were followed for survival throughout the study. The percentage of participants who died of any cause during the study was calculated. (NCT02533401)
Timeframe: Up to 5 years (from Baseline until death)
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 14 |
Overall Survival (OS)
Participants were followed for survival throughout the study. OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis (NCT02533401)
Timeframe: Up to 5 years (from Baseline until death)
| Intervention | months (Mean) |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 49.5 |
Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)
Treatment response was monitored throughout the study and assessed using standardized criteria. CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values. Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR. The percentage of participants with each level of best overall response was calculated. (NCT02533401)
Timeframe: Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
| Intervention | percentage of participants (Number) |
|---|
| CR | nPR | PR |
|---|
| Rituximab + Fludarabine + Cyclophosphamide | 71 | 9 | 18 |
Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
The Primary Outcome measures toxicity, with particular attention to Events of Clinical Interest when adding MK-3475 to standard RCHOP therapy. The sample size of 30 patients will permit the estimation of a 40% incidence of grade 3-5 clinically relevant toxicity. (NCT02541565)
Timeframe: Up to 90 days after completion of study treatment
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Pembrolizumab, Combination Chemotherapy) | 13 |
Number of Participants Who Experience Disease Relapse, Days 60-180 (D60)
Number of participants who experience disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. (NCT02556931)
Timeframe: Between Day 60 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 10 |
Number of Number of Participants With Severe Chronic GVHD, Day 360 (D60)
Number of participants who experience severe chronic GVHD requiring additional immunosuppressive therapy by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 5 |
Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort)
This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 90. (NCT02556931)
Timeframe: Day 90
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 33 |
Number of Number of Participants Who Experience Graft Failure, Day 360 (D60)
Number of participants who experience graft failure by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 2 |
Number of Number of Participants Who Experience Graft Failure, Day 360 (D90)
Number of participants who experience graft failure by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 0 |
Number of Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D60)
Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 18 |
Number of Number of Participants With Severe Chronic GVHD, Day 360 (D90)
Number of participants who experience severe chronic GVHD requiring additional immunosuppressive therapy by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 7 |
Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort)
This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60. (NCT02556931)
Timeframe: Day 60
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 42 |
Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90)
Number of participants who experience grade III or IV acute GVHD between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. (NCT02556931)
Timeframe: Between Day 90 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 1 |
Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60)
Number of participants who experience grade III or IV acute GVHD between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. (NCT02556931)
Timeframe: Between Day 60 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 3 |
Number of Participants With Chronic GVHD, Days 90-180 (D90)
Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. (NCT02556931)
Timeframe: Between Day 90 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 2 |
Number of Participants With Chronic GVHD, Days 60-180 (D60)
Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. (NCT02556931)
Timeframe: Between Day 60 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 1 |
Number of Participants Who Experience Relapse, Day 360 (D90)
Number of participants who experience disease relapse by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 14 |
Number of Participants Who Experience Relapse, Day 360 (D60)
Number of participants who experience disease relapse by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 10 |
Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90)
Number of participants who die for any reason other than disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. (NCT02556931)
Timeframe: Between Day 90 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 1 |
Number of Participants Who Experience Non-relapse Mortality, Days 60-180 (D60)
Number of participants who die for any reason other than disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. (NCT02556931)
Timeframe: Between Day 60 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 2 |
Number of Participants Who Experience Non-relapse Mortality, Day 360 (D90)
Number of participants who die for any reason other than disease relapse by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 4 |
Number of Participants Who Experience Non-relapse Mortality, Day 360 (D60)
Number of participants who die for any reason other than disease relapse by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 4 |
Number of Participants Who Experience Graft Failure, Days 90-180 (D90)
Number of participants who experience graft failure between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. (NCT02556931)
Timeframe: Between Day 90 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 0 |
Number of Participants Who Experience Graft Failure, Days 60-180 (D60)
Number of participants who experience graft failure between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. (NCT02556931)
Timeframe: Between Day 60 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D60 | 1 |
Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D90)
Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable. (NCT02556931)
Timeframe: Day 360
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 16 |
Number of Participants Who Experience Disease Relapse, Days 90-180 (D90)
Number of participants who experience disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. (NCT02556931)
Timeframe: Between Day 90 and Day 180
| Intervention | Participants (Count of Participants) |
|---|
| PBSCT D90 | 14 |
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)
Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. (NCT02561273)
Timeframe: Up to 6 cycles of treatment (approximately 5 months)
| Intervention | Participants (Count of Participants) |
|---|
| grade 3,4 neutropenia | grade 3, 4 anemia | grade 3, 4 thrombocytopenia | grade 3,4 neutropenia fever | grade 3, 4 diarrhea | grade 3, 4 hyperglycemia | grade 3, 4 hypokalemia | grade 3, 4 hypotension | grade 3, 4 hyperbilirubinemia | grade 3, 4 mucositis | grade 3,4 nausea | grade 3,4 vomiting |
|---|
| 10 mg Lenalidomide Participants | 5 | 3 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| 15 mg Lenalidomide Participants | 4 | 3 | 3 | 0 | 2 | 2 | 1 | 1 | 1 | 2 | 2 | 1 |
Number of Participants With Adverse Events Graded According to CTC (Phase II)
"The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized.~39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group." (NCT02561273)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| grade 3,4 neutropenia | grade 3, 4 leukopenia | grade 3, 4 anemia | grade 3, 4 thrombocytopenia | grade 3, 4 lymphopenia | grade 3, 4 febrile neutropenia | grade 3, 4 diarrhea | grade 3, 4 Peripheral sensory neuropathy | grade 3, 4 fatigue | grade 3, 4 nausea | grade 3, 4 anorexia | grade 3, 4 vomiting | grade 3, 4 mucositis oral | grade 3, 4 Rash maculo-papular | grade 3, 4 hypotension | grade 3, 4 back pain |
|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 27 | 25 | 17 | 17 | 18 | 15 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Progression-free Survival
The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS rate at 2 years will be estimated. A 2-year PFS rate of 60% will be considered of interest. (NCT02561273)
Timeframe: Time from registration to progression or death due to any cause, assessed up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 55 |
Complete Response Rate (Phase II)
A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 49 |
Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment. (NCT02561273)
Timeframe: 21 days
| Intervention | milligrams (Number) |
|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 10 |
Overall Response Rate
The ORR will be estimated by the total number of patients who achieve a PR or CR at the end of six cycles of treatment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true ORR will be calculated. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 69 |
Overall Survival
The distribution of overall survival will be estimated using the method of Kaplan-Meier. (NCT02561273)
Timeframe: Time from registration to death due to any cause, assessed up to 1 year
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 89 |
Part A: Number of Subjects Reporting Adverse Events (AEs)
Treatment-emergent AEs (TEAEs) defined as events occurring on or after cycle 1, day 1 up to and including 30 days after last dose (approximately 114 days). (NCT02561832)
Timeframe: From day 1 cycle 1, up to and including 30 days after last dose
| Intervention | Participants (Number) |
|---|
| Cohort 1 | 8 |
| Cohort 2 | 7 |
Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. (NCT02566993)
Timeframe: Every six weeks up to progression disease, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 4.8 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 4.4 |
Overall Survival in Patients Without Central Nervous System Involvement at Baseline
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 9.1 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 7.7 |
Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 10.3 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 8.7 |
Overall Survival in Patients With Chemotherapy-free Interval < 90 Days
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 5.7 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 5.3 |
Overall Survival (OS)
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 8.6 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 7.6 |
Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline
"Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 33.0 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 30.7 |
Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days
"Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 37.0 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 35.1 |
Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days
"Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 20.2 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 18.8 |
Overall Response Rate in Patients With Central Nervous System Involvement at Baseline
"Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 23.9 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 24.5 |
Overall Response Rate by Independent Review Committee
"Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 31.6 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 29.7 |
Duration of Response in Patients Without Central Nervous System Involvement at Baseline
"Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 5.7 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 4.0 |
Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days
"Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 6.9 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 4.0 |
Duration of Response in Patients With Chemotherapy-free Interval <90 Days
"Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 3.0 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 2.8 |
Duration of Response in Patients With Central Nervous System Involvement at Baseline
"Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 1.5 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 2.7 |
Progression-free Survival (PFS) by Independent Review Committee
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. (NCT02566993)
Timeframe: Every six weeks up to progression disease, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 4.0 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 4.0 |
Progression-free Survival Rate at 6 Months by Independent Review Committee
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. (NCT02566993)
Timeframe: At 6 months
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 31.3 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 24.4 |
Progression-free Survival Rate at 12 Months by Independent Review Committee
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. (NCT02566993)
Timeframe: at 12 months
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 10.8 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 4.4 |
Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. (NCT02566993)
Timeframe: Every six weeks up to progression disease, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 4.2 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 4.1 |
Overall Survival in Patients With Central Nervous System Involvement at Baseline
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 4.6 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 6.6 |
Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. (NCT02566993)
Timeframe: Every six weeks up to progression disease, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 1.6 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 2.8 |
Progression-free Survival in Patients With Central Nervous System Involvement at Baseline
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. (NCT02566993)
Timeframe: Every six weeks up to progression disease, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 1.9 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 2.8 |
Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: At 18 months
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 13.9 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 15.9 |
Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: At 24 months
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 8.6 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 8.7 |
Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). (NCT02566993)
Timeframe: At 12 months
| Intervention | percentage of participants (Number) |
|---|
| Lurbinectedin/Doxorubicin | 29.6 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 24.4 |
Duration of Response by Independent Review Committee
"Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.~CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown" (NCT02566993)
Timeframe: Every three months up to death or study termination, a period of approximately 3.5 years
| Intervention | months (Median) |
|---|
| Lurbinectedin/Doxorubicin | 5.7 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | 3.8 |
Relapse Incidence
Number of patients with disease reoccurrence at 1 and 2 years post-transplant (NCT02581007)
Timeframe: 2 years
| Intervention | percentage of patients (Number) |
|---|
| 1 yr post-transplant | 2 yr post-transplant |
|---|
| Reduced-Intensity Mismatched Transplant | 24 | 36 |
Overall Survival
Number of participants still alive 2 years after transplant (NCT02581007)
Timeframe: 2 years
| Intervention | percentage of patients (Number) |
|---|
| 1 yr post-transplant | 2 yr post-transplant |
|---|
| Reduced-Intensity Mismatched Transplant | 68 | 56 |
GVHD Incidence
The number of participants that developed graft-versus-host-disease before or at 100 days after transplant (NCT02581007)
Timeframe: 100 days
| Intervention | percentage of patients (Number) |
|---|
| Grades II to IV acute GVHD | Grades III to IV acute GVHD | Moderate chronic GVHD | Severe chronic GVHD |
|---|
| Reduced-Intensity Mismatched Transplant | 20 | 8 | 16 | 12 |
Graft Rejection
Measurement of donor cells vs. recipient cells (NCT02581007)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Reduced-Intensity Mismatched Transplant | 3 |
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed Partial response (PR) or Complete response (CR) as the Best overall response (BOR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Confidence Interval (CI) was calculated using the exact method. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters. (NCT02588612)
Timeframe: Up to 24 Months
| Intervention | Percentage of participants (Number) |
|---|
| Lete-cel | 20 |
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a stable disease (SD) or better as the BOR (Confirmed PR, confirmed CR, or SD >=12 weeks), as assessed by the investigator per RECIST v1.1. CI was calculated using the exact method. (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Percentage of participants (Number) |
|---|
| Lete-cel | 20 |
Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
12-lead ECGs were recorded in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate and measured PR, RR, QRS and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings for worst case post-Baseline have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Abnormal, NCS | Abnormal, CS |
|---|
| Lete-cel | 2 | 1 |
Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is clinically significant or requires intervention to prevent one of the outcomes listed before. Number of participants with common (greater than or equal to [>=]5 percent[%]) non-serious AEs and SAEs are presented. (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Non SAEs | SAEs |
|---|
| Lete-cel | 6 | 4 |
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst-case post-Baseline is presented (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Hemoglobin increased | Hemoglobin (Anemia) | Lymphocytes increased | Lymphocytes decreased | Neutrophils | Platelets | Leukocytes (Leukocytosis) | Leukocytes (Leukopenia) |
|---|
| Lete-cel | 0 | 3 | 1 | 5 | 5 | 5 | 0 | 5 |
Number of Participants With Any Grade Increase in Clinical Chemistry Parameters
Blood samples were collected for analysis of clinical chemistry parameters: glucose (Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bil), creatinine (Creat), potassium (Pot), magnesium (Mg), phosphate (Ph), sodium (Sod) and calcium. Laboratory parameters were graded according to NCI-CTCAE version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst-case post-Baseline is presented. (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Gl, Hyperglycemia | Gl, Hypoglycemia | Albumin | ALP | ALT | AST | Bil | Creat | Pot, Hyperkalemia | Pot, Hypokalemia | Mg, Hypermagnesemia | Mg, Hypomagnesemia | Ph | Sod, Hypernatremia | Sod, Hyponatremia | Calcium, Hypercalcemia | Calcium, Hypocalcemia |
|---|
| Lete-cel | 2 | 0 | 2 | 2 | 3 | 4 | 1 | 1 | 2 | 1 | 0 | 2 | 4 | 0 | 1 | 1 | 3 |
Duration of Response
Duration of response (DoR), defined as the interval of time in months from first documented evidence of PR or better to the time when disease progression is documented as assessed by RECIST v1.1 or death due to any cause among participants with a confirmed PR or CR as the BOR. (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Months (Number) |
|---|
| Lete-cel | 6.18 |
Change From Baseline in Oxygen Saturation
Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen saturation was measured using a pulse oximeter. Baseline is the most recent, non-missing value within 7 days prior to initiating the lymphodepleting chemotherapy. Change from Baseline is the post-Baseline visit value minus Baseline value. (NCT02588612)
Timeframe: Baseline, Day 1 (pre-dose, 5, 15, and 30 minutes, 1, 1.5, 2, and 4 hours post dose), Days 2, 3, 4, 5, 8 and Week 2
| Intervention | Percentage of oxygen (Median) |
|---|
| Day 1, pre dose, n=5 | Day 1, 5 minutes post dose, n=4 | Day 1, 15 minutes post dose, n=4 | Day 1, 30 minutes post dose, n=4 | Day 1, 1 hour post dose, n=5 | Day 1, 1.5 hours post dose, n=2 | Day 1, 2 hours post dose, n=3 | Day 1, 4 hours post dose, n=4 | Day 2, n=4 | Day 3, n=5 | Day 4 , n=5 | Day 5, n=5 | Day 8, n=4 | Week 2, n=4 |
|---|
| Lete-cel | 2.0 | 2.5 | 2.0 | 3.0 | 2.0 | 1.5 | 3.0 | -1.0 | 2.5 | 1.0 | 1.0 | -2.0 | 0.0 | 1.5 |
Time to Response
Time to response is defined as the interval of time (in months) between the date of T-cell infusion and the first documented evidence of response (PR or CR) in the subset of participants with a confirmed PR or CR as the BOR as assessed by the investigator per RECIST v1.1. (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Months (Number) |
|---|
| Lete-cel | 12.09 |
Progression-Free Survival (PFS) by Investigator Assessment
Progression-free survival (PFS) is defined as the interval of time (in months) between the date of T-cell infusion and the earlier of the date of disease progression as assessed by the investigator and the date of death due to any cause. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Median and inter-quartile range (first quartile and third quartile) are presented. (NCT02588612)
Timeframe: Up to 24 months
| Intervention | Months (Median) |
|---|
| Lete-cel | 1.81 |
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
"Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was any time prior to dose for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported." (NCT02596971)
Timeframe: Baseline up to approximately 4 years
| Intervention | percentage of participants (Number) |
|---|
| Baseline | Induction Cycle 2 Day 1 | Consolidation Cycle 16 | Atezolizumab Day 120 Follow up | Atezo PK and Immunogenicity Follow Up (1YR) |
|---|
| Atezo-R-CHOP Cohort (Expansion Phase) | 14.3 | 2.6 | 5.9 | 9.1 | 5.6 |
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria
Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake ] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 90.0 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 87.5 |
Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria
CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. (NCT02596971)
Timeframe: Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years])
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 80.0 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 75.0 |
Observed Serum Rituximab Concentration
"Predose time point was any time prior to dose for Cycle 1 and within 5 hour prior to dose for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour." (NCT02596971)
Timeframe: Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years)
| Intervention | ug/mL (Median) |
|---|
| C1 - Cmax after dosing C1 | C1 - Ctrough after dosing C1 | C8 - Cmax after dosing C8 | C8 - Ctrough after dosing C8 |
|---|
| Atezo-R-CHOP Cohort (Expansion Phase) | 159 | 26.1 | 229 | 105.5 |
Observed Serum Atezolizumab Concentration
"Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was within 5 hour prior to dose for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes." (NCT02596971)
Timeframe: Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)
| Intervention | ug/mL (Median) |
|---|
| Cycle 2 - Cmax after 1st infusion | C2 - Cmin before 2nd infusion | C8 - Cmax after 7th infusion | C8 - Cmin before 8th infusion |
|---|
| Atezo-R-CHOP Cohort (Expansion Phase) | 332 | 82.1 | 486.5 | 184 |
Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. (NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 80.0 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 75.0 |
Observed Serum Obinutuzumab Concentration
"Predose time point was any time prior to dose for Cycle (Cy) 1 and within 5 hour prior to dose for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour." (NCT02596971)
Timeframe: Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)
| Intervention | ug/mL (Median) |
|---|
| C1 Cmax after 1st infusion | C1 Cmin after the last infusion on C1 | C6 - Cmax after last dosing of induction | C6 - Cmin after last dosing of induction |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 329 | 322 | 544 | 203 |
,| Atezo-G-CHOP Cohort (Safety Run-In Phase) | 400 | 399 | 659 | 245 |
Observed Serum Atezolizumab Concentration
"Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was within 5 hour prior to dose for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes." (NCT02596971)
Timeframe: Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)
| Intervention | ug/mL (Median) |
|---|
| Cycle 2 - Cmax after 1st infusion | C2 - Cmin before 2nd infusion | C6 - Cmin after 6th infusion |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 275 | 83 | 256 |
,| Atezo-G-CHOP Cohort (Safety Run-In Phase) | 424 | 94 | 195 |
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years) (NCT02596971)
Timeframe: Baseline up to approximately 4 years
| Intervention | percentage of participants (Number) |
|---|
| Induction Cycle 1 Day 1 | Induction Cycle 5 Day 1 | Induction Cycle 6 Day 1 | Maintenance Month 1 | Study Drug Completion or Early Discontinuation | Obinutuzumab Day 120 Follow up |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 2.4 | 0 | 0 | 0 | 0 | 0 |
Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years) (NCT02596971)
Timeframe: Baseline up to approximately 4 years
| Intervention | percentage of participants (Number) |
|---|
| Baseline | Induction Cycle 1 Day 1 | Induction Cycle 5 Day 1 | Induction Cycle 8 Day 1 | Rituximab Day 120 Follow up | Rituximab 1 Year Follow up | Study Drug Completion or Early Discontinuation |
|---|
| Atezo-R-CHOP Cohort (Expansion Phase) | 14.3 | 0 | 0 | 0 | 0 | 0 | 0 |
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 90.0 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 90.0 |
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02596971)
Timeframe: Baseline up to approximately 4 years
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 100 |
| Atezo-G-CHOP Cohort (Safety Run-In Phase) | 100 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 100 |
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
"Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was any time prior to dose for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported." (NCT02596971)
Timeframe: Baseline up to approximately 4 years
| Intervention | percentage of participants (Number) |
|---|
| Baseline | Induction Cycle 2 Day 1 | Atezolizumab Day 120 Follow up | Atezo PK and Immunogenicity Follow Up (1YR) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 2.4 | 0 | 0 | 0 |
,| Atezo-G-CHOP Cohort (Safety Run-In Phase) | 0 | 0 | 0 | 0 |
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 95.0 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 87.5 |
Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake ] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 95.0 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 87.5 |
Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 75.0 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 77.5 |
Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 87.5 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 77.5 |
Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria
Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [NCT02596971)
Timeframe: Up to approximately 6 months
| Intervention | percentage of participants (Number) |
|---|
| Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | 75 |
| Atezo-R-CHOP Cohort (Expansion Phase) | 77.5 |
Overall Survival
Median time to death in months will be reported (NCT02597062)
Timeframe: 3 years
| Intervention | months (Median) |
|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 27.43 |
Progression-free Survival
"Median time to progression or death assessed by biochemistry, radiology and immunology tests will be reported. Progression is evaluated in this study using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) with any one or more of the following:~Increase of ≥ 25% from lowest response value in: Serum M-component and/or Urine M-component and/or Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels or Bone marrow plasma cell percentages.~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL (0.115 g/L) or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder." (NCT02597062)
Timeframe: 3 years
| Intervention | months (Median) |
|---|
| Carfilzomib Plus Cyclophosphamide Plus Dexamethasone | 17.15 |
Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score
"The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported." (NCT02601313)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No problems doing usual activities | Baseline: Slight problems doing usual activities | Baseline: Moderate problems doing usual activities | Baseline: Severe problems doing usual activities | Baseline: Unable to do usual activities | Week 4: No problems doing usual activities | Week 4: Slight problems doing usual activities | Week 4: Moderate problems doing usual activities | Week 4: Severe problems doing usual activities | Week 4: Unable to do usual activities | Month 3: No problems doing usual activities | Month 3: Slight problems doing usual activities | Month 3: Moderate problems doing usual activities | Month 3: Severe problems doing usual activities | Month 3: Unable to do usual activities | Month 6: No problems doing usual activities | Month 6: Slight problems doing usual activities | Month 6: Moderate problems doing usual activities | Month 6: Severe problems doing usual activities | Month 6: Unable to do usual activities |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 82 | 14 | 5 | 0 | 0 | 43 | 24 | 22 | 6 | 6 | 69 | 16 | 7 | 4 | 4 | 73 | 17 | 7 | 0 | 2 |
,| Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel | 75 | 17 | 8 | 0 | 0 | 36 | 55 | 9 | 0 | 0 | 64 | 36 | 0 | 0 | 0 | 70 | 30 | 0 | 0 | 0 |
Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score
"The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported." (NCT02601313)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No problems washing or dressing, | Baseline: Slight problems washing or dressing | Baseline: Moderate problems washing or dressing | Baseline: Severe problems washing or dressing | Baseline: Unable to wash or dress | Week 4: No problems washing or dressing, | Week 4: Slight problems washing or dressing | Week 4: Moderate problems washing or dressing | Week 4: Severe problems washing or dressing | Week 4: Unable to wash or dress | Month 3: No problems washing or dressing, | Month 3: Slight problems washing or dressing | Month 3: Moderate problems washing or dressing | Month 3: Severe problems washing or dressing | Month 3: Unable to wash or dress | Month 6: No problems washing or dressing, | Month 6: Slight problems washing or dressing | Month 6: Moderate problems washing or dressing | Month 6: Severe problems washing or dressing | Month 6: Unable to wash or dress |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 95 | 3 | 2 | 0 | 0 | 67 | 17 | 4 | 8 | 4 | 83 | 11 | 4 | 2 | 0 | 93 | 3 | 0 | 5 | 0 |
,| Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel | 100 | 0 | 0 | 0 | 0 | 91 | 9 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 0 |
Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score
"The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported." (NCT02601313)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No problems walking | Baseline: Slight problems walking | Baseline: Moderate problems walking | Baseline: Severe problems walking | Baseline: Unable to walk | Week 4: No problems walking | Week 4: Slight problems walking | Week 4: Moderate problems walking | Week 4: Severe problems walking | Week 4: Unable to walk | Month 3: No problems walking | Month 3: Slight problems walking | Month 3: Moderate problems walking | Month 3: Severe problems walking | Month 3: Unable to walk | Month 6: No problems walking | Month 6: Slight problems walking | Month 6: Moderate problems walking | Month 6: Severe problems walking | Month 6: Unable to walk |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 85 | 11 | 3 | 0 | 0 | 49 | 33 | 6 | 8 | 4 | 69 | 19 | 7 | 4 | 2 | 75 | 13 | 8 | 5 | 0 |
,| Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel | 83 | 17 | 0 | 0 | 0 | 73 | 9 | 18 | 0 | 0 | 91 | 9 | 0 | 0 | 0 | 90 | 10 | 0 | 0 | 0 |
Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score
"The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The Percentage of participants with each level of problem are reported." (NCT02601313)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | percentage of participants (Number) |
|---|
| Baseline: Not anxious or depressed | Baseline: Slight anxious or depressed | Baseline: Moderate anxious or depressed | Baseline: Severe anxious or depressed | Baseline: Extreme anxious or depressed | Week 4: Not anxious or depressed | Week 4: Slight anxious or depressed | Week 4: Moderate anxious or depressed | Week 4: Severe anxious or depressed | Week 4: Extreme anxious or depressed | Month 3: Not anxious or depressed | Month 3: Slight anxious or depressed | Month 3: Moderate anxious or depressed | Month 3: Severe anxious or depressed | Month 3: Extreme anxious or depressed | Month 6: Not anxious or depressed | Month 6: Slight anxious or depressed | Month 6: Moderate anxious or depressed | Month 6: Severe anxious or depressed | Month 6: Extreme anxious or depressed |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 75 | 20 | 5 | 0 | 0 | 67 | 26 | 6 | 2 | 0 | 69 | 22 | 9 | 0 | 0 | 62 | 26 | 12 | 0 | 0 |
,| Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel | 67 | 33 | 0 | 0 | 0 | 73 | 27 | 0 | 0 | 0 | 91 | 9 | 0 | 0 | 0 | 90 | 10 | 0 | 0 | 0 |
Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score
"The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported." (NCT02601313)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | percentage of participants (Number) |
|---|
| Baseline: No pain or discomfort | Baseline: Slight pain or discomfort | Baseline: Moderate pain or discomfort | Baseline: Severe pain or discomfort | Baseline: Extreme pain or discomfort | Week 4: No pain or discomfort | Week 4: Slight pain or discomfort | Week 4: Moderate pain or discomfort | Week 4: Severe pain or discomfort | Week 4: Extreme pain or discomfort | Month 3: No pain or discomfort | Month 3: Slight pain or discomfort | Month 3: Moderate pain or discomfort | Month 3: Severe pain or discomfort | Month 3: Extreme pain or discomfort | Month 6: No pain or discomfort | Month 6: Slight pain or discomfort | Month 6: Moderate pain or discomfort | Month 6: Severe pain or discomfort | Month 6: Extreme pain or discomfort |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 66 | 22 | 9 | 3 | 0 | 63 | 19 | 19 | 0 | 0 | 60 | 16 | 18 | 4 | 2 | 67 | 21 | 10 | 2 | 0 |
,| Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel | 75 | 8 | 17 | 0 | 0 | 64 | 18 | 18 | 0 | 0 | 64 | 27 | 9 | 0 | 0 | 70 | 10 | 20 | 0 | 0 |
Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score
EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. A positive change indicates an improvement. (NCT02601313)
Timeframe: Baseline, Week 4, Month 3, and Month 6
| Intervention | scores on the scale (Mean) |
|---|
| Baseline | Week 4 | Month 3 | Month 6 |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 82.0 | 74.5 | 80.1 | 84.8 |
,| Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel | 82.8 | 71.4 | 86.4 | 89.9 |
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2
OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake ≤ mediastinum) / 3(uptake > mediastinum but ≤ liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi; no extralymphatic sites of disease;absent non-measured lesion NMLs; organ enlargement regress to normal; no new sites; bone marrow normal by morphology. PMR: score 4(uptake moderately > liver) /5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at EOT. PRR: ≥ 50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal. (NCT02601313)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel | 93 |
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1
OR: complete metabolic response(CMR),complete radiological response(CRR),partial MR response(PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤ mediastinum)/3(uptake > mediastinum but ≤ liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion(LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal;no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately > liver)/5(uptake markedly > liver, new lesions)with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT).PRR: ≥ 50% decrease in sum of the product of the diameters(SPD)of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by > 50% in length beyond normal. (NCT02601313)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 93 |
Phase 2: MRD Negative Rate Among Complete Remission (CR) Participants
Percentage of participants with MRD negative remission among CR participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. CR: ≤5% blasts by morphology in BM; ANC ≥ 1000 and Plt ≥ 100000 in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 97 |
Phase 2: Overall Survival (OS)
OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to death or data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | months (Median) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 18.2 |
Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review
OCR rate: percentage of participants achieving CR+CRi. CR: ≤5% blasts by morphology in bone marrow (BM); absolute neutrophil count (ANC) ≥1000 and platelets (Plt) ≥100000 in peripheral blood (PB); central nervous system extramedullary disease (CNS EMD) of CNS-1 (no detectable leukemia in cerebrospinal fluid [CSF]); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative positron emission tomography (PET) baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses >1.5 cm in greatest transverse diameter [GTD] at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and >1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000 and Plt <100000 or ANC <1000 and Plt ≥100000. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 70.9 |
Phase 2: OCR Rate (CR + CRi) Per Investigator Review
OCR rate: percentage of participants achieving CR+CRi. CR: ≤ 5% blasts by morphology in BM; ANC ≥1000 and Plt ≥ 100000 in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses >1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and >1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000 and Plt <100000 or ANC <1000 and Plt ≥100000. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 72.7 |
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
"EQ-5D-5L is a self-reported questionnaire used for assessing the overall health status of a participant scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was divided into 5 levels of severity: No problem, Slight problems, Moderate problems, Severe problems, and Extreme problems or Unable to." (NCT02614066)
Timeframe: Baseline, Day 28, Month 3, Month 6, Month 9, Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Baseline: Mobility (No problem) | Baseline: Mobility (Slight problem) | Baseline: Mobility (Moderate problem) | Baseline: Mobility (Severe problem) | Baseline: Mobility (Unable to walk) | Day 28: Mobility (No problem) | Day 28: Mobility (Slight problem) | Day 28: Mobility (Moderate problem) | Day 28: Mobility (Severe problem) | Day 28: Mobility (Unable to walk) | Month 3: Mobility (No problem) | Month 3: Mobility (Slight problem) | Month 3: Mobility (Moderate problem) | Month 3: Mobility (Severe problem) | Month 3: Mobility (Unable to walk) | Month 6: Mobility (No problem) | Month 6: Mobility (Slight problem) | Month 6: Mobility (Moderate problem) | Month 6: Mobility (Severe problem) | Month 6: Mobility (Unable to walk) | Month 9: Mobility (No problem) | Month 9: Mobility (Slight problem) | Month 9: Mobility (Moderate problem) | Month 9: Mobility (Severe problem) | Month 9: Mobility (Unable to walk) | Month 12: Mobility (No problem) | Month 12: Mobility (Slight problem) | Month 12: Mobility (Moderate problem) | Month 12: Mobility (Severe problem) | Month 12: Mobility (Unable to walk) | Baseline: Self-care (No problem) | Baseline: Self-care (Slight problem) | Baseline: Self-care (Moderate problem) | Baseline: Self-care (Severe problem) | Baseline: Self-care (Unable to wash or dress) | Day 28: Self-care (No problem) | Day 28: Self-care (Slight problem) | Day 28: Self-care (Moderate problem) | Day 28: Self-care (Severe problem) | Day 28: Self-care (Unable to wash or dress) | Month 3: Self-care (No problem) | Month 3: Self-care (Slight problem) | Month 3: Self-care (Moderate problem) | Month 3: Self-care (Severe problem) | Month 3: Self-care (Unable to wash or dress) | Month 6: Self-care (No problem) | Month 6: Self-care (Slight problem) | Month 6: Self-care (Moderate problem) | Month 6: Self-care (Severe problem) | Month 6: Self-care (Unable to wash or dress) | Month 9: Self-care (No problem) | Month 9: Self-care (Slight problem) | Month 9: Self-care (Moderate problem) | Month 9: Self-care (Severe problem) | Month 9: Self-care (Unable to wash or dress) | Month 12: Self-care (No problem) | Month 12: Self-care (Slight problem) | Month 12: Self-care (Moderate problem) | Month 12: Self-care (Severe problem) | Month 12: Self-care (Unable to wash or dress) | Baseline: Usual activities (No problem) | Baseline: Usual activities (Slight problem) | Baseline: Usual activities (Moderate problem) | Baseline: Usual activities (Severe problem) | Baseline: Usual activities (Unable to do usual activities) | Day 28: Usual activities (No problem) | Day 28: Usual activities (Slight problem) | Day 28: Usual activities (Moderate problem) | Day 28: Usual activities (Severe problem) | Day 28: Usual activities (Unable to do usual activities) | Month 3: Usual activities (No problem) | Month 3: Usual activities (Slight problem) | Month 3: Usual activities (Moderate problem) | Month 3: Usual activities (Severe problem) | Month 3: Usual activities (Unable to do usual activities) | Month 6: Usual activities (No problem) | Month 6: Usual activities (Slight problem) | Month 6: Usual activities (Moderate problem) | Month 6: Usual activities (Severe problem) | Month 6: Usual activities (Unable to do usual activities) | Month 9: Usual activities (No problem) | Month 9: Usual activities (Slight problem) | Month 9: Usual activities (Moderate problem) | Month 9: Usual activities (Severe problem) | Month 9: Usual activities (Unable to do usual activities) | Month 12: Usual activities (No problem) | Month 12: Usual activities (Slight problem) | Month 12: Usual activities (Moderate problem) | Month 12: Usual activities (Severe problem) | Month 12: Usual activities (Unable to do usual activities) | Baseline: Pain/Discomfort (No problem) | Baseline: Pain/Discomfort (Slight problem) | Baseline: Pain/Discomfort (Moderate problem) | Baseline: Pain/Discomfort (Severe problem) | Baseline: Pain/Discomfort (Extreme Pain or discomfort) | Day 28: Pain/Discomfort (No problem) | Day 28: Pain/Discomfort (Slight problem) | Day 28: Pain/Discomfort (Moderate problem) | Day 28: Pain/Discomfort (Severe problem) | Day 28: Pain/Discomfort (Extreme Pain or discomfort) | Month 3: Pain/Discomfort (No problem) | Month 3: Pain/Discomfort (Slight problem) | Month 3: Pain/Discomfort (Moderate problem) | Month 3: Pain/Discomfort (Severe problem) | Month 3: Pain/Discomfort (Extreme Pain or discomfort) | Month 6: Pain/Discomfort (No problem) | Month 6: Pain/Discomfort (Slight problem) | Month 6: Pain/Discomfort (Moderate problem) | Month 6: Pain/Discomfort (Severe problem) | Month 6: Pain/Discomfort (Extreme Pain or discomfort) | Month 9: Pain/Discomfort (No problem) | Month 9: Pain/Discomfort (Slight problem) | Month 9: Pain/Discomfort (Moderate problem) | Month 9: Pain/Discomfort (Severe problem) | Month 9: Pain/Discomfort (Extreme Pain or discomfort) | Month 12: Pain/Discomfort (No problem) | Month 12: Pain/Discomfort (Slight problem) | Month 12: Pain/Discomfort (Moderate problem) | Month 12: Pain/Discomfort (Severe problem) | Month 12: Pain/Discomfort (Extreme Pain or discomfort) | Baseline: Anxiety/Depression (No problem) | Baseline: Anxiety/Depression (Slight problem) | Baseline: Anxiety/Depression (Moderate problem) | Baseline: Anxiety/Depression (Severe problem) | Baseline: Anxiety/Depression (Extreme Anxious or Depressed) | Day 28: Anxiety/Depression (No problem) | Day 28: Anxiety/Depression (Slight problem) | Day 28: Anxiety/Depression (Moderate problem) | Day 28: Anxiety/Depression (Severe problem) | Day 28: Anxiety/Depression (Extreme Anxious or Depressed) | Month 3: Anxiety/Depression (No problem) | Month 3: Anxiety/Depression (Slight problem) | Month 3: Anxiety/Depression (Moderate problem) | Month 3: Anxiety/Depression (Severe problem) | Month 3: Anxiety/Depression (Extreme Anxious or Depressed) | Month 6: Anxiety/Depression (No problem) | Month 6: Anxiety/Depression (Slight problem) | Month 6: Anxiety/Depression (Moderate problem) | Month 6: Anxiety/Depression (Severe problem) | Month 6: Anxiety/Depression (Extreme Anxious or Depressed) | Month 9: Anxiety/Depression (No problem) | Month 9: Anxiety/Depression (Slight problem) | Month 9: Anxiety/Depression (Moderate problem) | Month 9: Anxiety/Depression (Severe problem) | Month 9: Anxiety/Depression (Extreme Anxious or Depressed) | Month 12: Anxiety/Depression (No problem) | Month 12: Anxiety/Depression (Slight problem) | Month 12: Anxiety/Depression (Moderate problem) | Month 12: Anxiety/Depression (Severe problem) | Month 12: Anxiety/Depression (Extreme Anxious or Depressed) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 39 | 7 | 4 | 1 | 0 | 19 | 10 | 9 | 1 | 3 | 19 | 5 | 1 | 0 | 1 | 16 | 6 | 2 | 0 | 1 | 8 | 1 | 0 | 0 | 1 | 11 | 3 | 0 | 0 | 0 | 44 | 5 | 1 | 1 | 0 | 31 | 6 | 1 | 2 | 2 | 23 | 1 | 1 | 0 | 0 | 23 | 0 | 1 | 1 | 0 | 9 | 0 | 0 | 1 | 0 | 14 | 0 | 0 | 0 | 0 | 24 | 14 | 9 | 3 | 1 | 17 | 13 | 8 | 3 | 1 | 14 | 9 | 1 | 1 | 0 | 17 | 4 | 2 | 2 | 0 | 9 | 0 | 0 | 0 | 1 | 11 | 3 | 0 | 0 | 0 | 23 | 16 | 12 | 0 | 0 | 19 | 14 | 9 | 0 | 0 | 11 | 9 | 6 | 0 | 0 | 11 | 5 | 7 | 2 | 0 | 7 | 1 | 2 | 0 | 0 | 7 | 6 | 1 | 0 | 0 | 30 | 12 | 7 | 2 | 0 | 28 | 11 | 3 | 0 | 0 | 17 | 6 | 3 | 0 | 0 | 18 | 4 | 3 | 0 | 0 | 9 | 0 | 1 | 0 | 0 | 10 | 2 | 2 | 0 | 0 |
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | Participants (Count of Participants) |
|---|
| Hematology: Lymphocytes | Hematology: Leukocytes | Hematology: Hemoglobin | Hematology: Neutrophils | Hematology: Platelets | Chemistry: Creatinine | Chemistry: Glucose | Chemistry: Aspartate Aminotransferase | Chemistry: Alanine Aminotransferase | Chemistry: Bilirubin | Chemistry: Alkaline Phosphatase | Chemistry: Direct Bilirubin | Chemistry: Urate | Chemistry: Sodium | Chemistry: Potassium | Chemistry: Magnesium | Chemistry: Calcium | Chemistry: Albumin | Chemistry: Phosphate |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 1 | 4 | 0 | 0 | 0 | 4 | 13 | 14 | 17 | 5 | 3 | 8 | 11 | 1 | 2 | 3 | 0 | 0 | 0 |
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Grading categories are determined by CTCAE version 4.03. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | Participants (Count of Participants) |
|---|
| Hematology: Hemoglobin | Hematology: Leukocytes | Hematology: Platelets | Hematology: Lymphocytes | Hematology: Neutrophils | Chemistry: Calcium | Chemistry: Albumin | Chemistry: Phosphate | Chemistry: Magnesium | Chemistry: Sodium | Chemistry: Potassium | Chemistry: Glucose | Chemistry: Alanine Aminotransferase | Chemistry: Alkaline Phosphatase | Chemistry: Aspartate Aminotransferase | Chemistry: Bilirubin | Chemistry: Creatinine | Chemistry: Direct Bilirubin | Chemistry: Urate |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 42 | 54 | 46 | 52 | 53 | 9 | 5 | 27 | 0 | 11 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Phase 2: Change From Baseline Over Time in EQ-5D: Visual Analogue Scale (VAS)
EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. (NCT02614066)
Timeframe: Baseline, Day 28, Month 3, Month 6, Month 9, Month 12
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Change at Day 28 | Change at Month 3 | Change at Month 6 | Change at Month 9 | Change at Month 12 |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 68.2 | 4.1 | 9.2 | 10.6 | 2.2 | 16.1 |
Phase 2: Relapse-free Survival (RFS)
RFS: time from brexucabtagene autoleucel infusion to date of disease relapse or death from any cause. Participants not meeting criteria for relapse by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who had not achieved a CR or CRi at analysis data cutoff were evaluated as an RFS event at Day 0. CR and CRi are defined in Outcome Measures 4 and 5. Relapse is defined in Outcome Measure 6. KM estimates was used for analyses. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to relapse/death or data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | months (Median) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 11.6 |
Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies
(NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 7 |
Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT)
(NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 18 |
Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant after brexucabtagene autoleucel infusion, which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs included all AEs with onset on or after initiation of the brexucabtagene autoleucel infusion. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 100 |
Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
"DLT is drug-related events with onset within first 28 days following infusion:~Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia) if not attributable to underlying disease~All drug-related GR 3 lasting for > 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1/baseline within 2 weeks or baseline within 4 weeks, fever GR 3/ 4, immediate hypersensitivity reactions within 2 hours of drug infusion that are reversible ≤ GR 2 within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, GR 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, GR 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within < 72 hours, hypogammaglobulinemia GR 3/ 4 and GR 3 nausea and/or anorexia)." (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation
| Intervention | percentage of participants (Number) |
|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 0 |
Phase 2: Complete Remission (CR) Rate Per Independent Review
CR: ≤ 5% blasts by morphology in BM; ANC ≥ 1000 and Plt ≥ 100000 in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CR was reported. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 56.4 |
Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review
CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000 and Plt < 100000 or ANC < 1000 and Plt ≥ 100000 in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CRi was reported. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 14.5 |
Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate
MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. Percentage of participants with MRD negative remission was reported. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 76 |
Phase 2: Duration of Remission (DOR) Per Independent Review
DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse. CR and CRi are defined in Outcome Measures 4 and 5. Relapse: ≤ 5% blasts by morphology in BM; or circulating leukemia present in PB; or CNS EMD of CNS-2 (detectable CSF blast cells in a sample of CSF with < 5 white blood cells [WBCs] per mm^3 with neurological changes) or CNS-3 (detectable CSF blast cells in a sample of CSF with ≥ 5 WBCs per mm^3 with or without neurological changes); or progressive disease (PD): at least one of the following (≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis; ≥ 50% increase in size of splenic, hepatic or any other non-nodal lesion). Kaplan-Meier (KM) estimates was used for analyses. (NCT02614066)
Timeframe: From first CR or CRi (Phase 2) to relapse/death or data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | months (Median) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 12.8 |
Phase 2: MRD Negative Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants
Percentage of participants with MRD negative remission among CRi participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000 and Plt < 100000 or ANC < 1000 and Plt ≥ 100000 in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses >1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and >1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. (NCT02614066)
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) to data cutoff date of 09 September 2020 (Maximum duration: 23 Months)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 100 |
AUC (W1-W26)
Area under the serum concentration-time curve measured after the first administration (Week 1) until Week 26 (AUC(1-26)) (NCT02617485)
Timeframe: Week 1 until Week 26
| Intervention | (μg*day)/mL (Mean) |
|---|
| MabionCD20 | 28413.6 |
| MabThera | 26955.3 |
Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])
Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion). (NCT02617485)
Timeframe: Baseline to Week 4
| Intervention | (μg*day)/mL (Mean) |
|---|
| MabionCD20 | 1559.51 |
| MabThera | 1509.79 |
T1/2 (Post 5th and 8th Infusions)
Elimination half-life at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 to Week 16 and Week 22 to Week 26
| Intervention | days (Mean) |
|---|
| 5th infusion | 8th infusion |
|---|
| MabionCD20 | 14.801 | 18.301 |
,| MabThera | 15.217 | 16.997 |
Kel (Post 5th and 8th Infusions)
Elimination Rate Constant at steady stade after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)
| Intervention | 1/day (Mean) |
|---|
| 5th infusion | 8th infusion |
|---|
| MabionCD20 | 0.05663 | 0.04335 |
,| MabThera | 0.05418 | 0.04379 |
Immunogenicity
Percentage of patients with positive ADA or NAb results in a given category. Data pertain to the entire follow-up period (from Baseline to Week 46). (NCT02617485)
Timeframe: from baseline to Week 46
| Intervention | participants (Number) |
|---|
| Treatment-induced ADA | Persistent ADA | Transient ADA | Treatment-boosted ADA | NAb positive |
|---|
| MabionCD20 | 6 | 4 | 2 | 0 | 0 |
,| MabThera | 1 | 1 | 0 | 0 | 0 |
Efficacy Assessment at Week 26
An efficacy assessment was made after 8 treatment cycles (at Week 26) based on tumour responses classified according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). Response was assessed based on clinical, radiologic (CT scan) and pathologic (bone marrow) criteria. Possible efficacy responses were: complete response, partial response, stable disease, and progressive disease. Efficacy reported here includes all patients included in the ITT set. (NCT02617485)
Timeframe: Week 26
| Intervention | Participants (Count of Participants) |
|---|
| Complete | Partial | Stable disease | Progressive disease | Missing |
|---|
| MabionCD20 | 34 | 42 | 10 | 10 | 4 |
,| MabThera | 14 | 18 | 4 | 2 | 2 |
CLss (Post 5th and 8th Infusions)
Clearance at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 to Week 16 and Week 22 to Week 26
| Intervention | mL/day (Mean) |
|---|
| 5th infusion | 8th infusion |
|---|
| MabionCD20 | 198.701 | 179.168 |
,| MabThera | 206.905 | 191.272 |
Adverse Events
Percentage of patients with at least one AE in a given category. Data from the entire follow-up are included (Period 1 and Period 2). (NCT02617485)
Timeframe: from baseline to Week 46
| Intervention | percent (Number) |
|---|
| all AEs | TEAEs | TESAEs | severe TEAEs | related TEAEs | related severe TEAEs | related TESAEs | TEAEs leading to death | related TEAEs leading to death |
|---|
| MabionCD20 | 71.0 | 71.0 | 19.0 | 40.0 | 53.0 | 29.0 | 13.0 | 8.0 | 2.0 |
,| MabThera | 67.5 | 65.0 | 12.5 | 22.5 | 42.5 | 22.5 | 5.0 | 0 | 0 |
Ctrough (Before 8th Infusion)
Trough serum concentration measured at the end of a dosing interval at steady state, taken directly before eighth infusion. (NCT02617485)
Timeframe: Week 22
| Intervention | μg/mL (Mean) |
|---|
| MabionCD20 | 102.246 |
| MabThera | 90.61 |
AUC (W1-W26) B-cell
Area under the serum concentration-time curve of CD19+ B cell counts, measured from the first administration to the final time point at Week 26 (AUC(1-26) B-cell). (NCT02617485)
Timeframe: baseline to Week 26
| Intervention | cells*days/mL blood (Mean) |
|---|
| MabionCD20 | 3395.82 |
| MabThera | 10476.2 |
Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])
Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC[W13-W26]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion). (NCT02617485)
Timeframe: Week 13 to Week 26
| Intervention | (μg*day)/mL (Mean) |
|---|
| MabionCD20 | 16498.9 |
| MabThera | 15647.4 |
Cmax (Post 5th and 8th Infusion)
Maximum serum drug concentration (Cmax) at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)
| Intervention | μg/mL (Mean) |
|---|
| 5th infusion | 8th infusion |
|---|
| MabionCD20 | 273.356 | 296.784 |
,| MabThera | 266.439 | 296.462 |
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE either prior to or after definitive surgery is presented. (NCT02622074)
Timeframe: Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A: KNp / KAC | 10 |
| Cohort B: KNpCb (Regimen 1) / KAC | 10 |
| Cohort C: KNpCb (Regimen 2) / KAC | 10 |
| Cohort D: KNpCb (Regimen 3) / KAC | 10 |
| Cohort E: KTCb (Regimen 1) / KAC | 10 |
| Cohort F: KTCb (Regimen 2) / KAC | 10 |
Event-Free Survival (EFS) Rate at Month 6
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019). (NCT02622074)
Timeframe: Month 6
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 90.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 100.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 100.00 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 100.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 100.0 |
Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 (No Invasive Residual in Breast or Nodes; Noninvasive Breast Residuals Allowed)
pCR rate (ypT0/Tis ypN0; no invasive residual in breast or nodes; noninvasive breast residuals allowed) was defined as the rate of absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by AJCC staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the alternative definition of ypT0/Tis ypN0 is presented. (NCT02622074)
Timeframe: Up to approximately 9 months (at the time of definitive surgery)
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 60.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 80.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 80.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 60.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 30.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 50.0 |
Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0 (No Invasive or Noninvasive Residual in Breast or Nodes)
pCR rate (ypT0 ypN0; no invasive or noninvasive residual in breast or nodes) was defined as the rate of absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the definition of ypT0 ypN0 is presented. (NCT02622074)
Timeframe: Up to approximately 9 months (at the time of definitive surgery)
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 50.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 80.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 80.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 60.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 20.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 50.0 |
Overall Survival (OS) Rate at Month 6
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 6 are presented (through Final Analysis cut-off of 18-Nov-2019). (NCT02622074)
Timeframe: Month 6
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 100.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 100.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 100.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 100.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 100.0 |
Overall Survival (OS) Rate at Month 24
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019). (NCT02622074)
Timeframe: Month 24
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 70.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 100.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 100.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 90.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 100.0 |
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented. (NCT02622074)
Timeframe: Up to approximately 28 months (through Interim database cut-off date of 31-May-2018)
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A: KNp / KAC | 1 |
| Cohort B: KNpCb (Regimen 1) / KAC | 2 |
| Cohort C: KNpCb (Regimen 2) / KAC | 1 |
| Cohort D: KNpCb (Regimen 3) / KAC | 5 |
| Cohort E: KTCb (Regimen 1) / KAC | 2 |
| Cohort F: KTCb (Regimen 2) / KAC | 5 |
Overall Survival (OS) Rate at Month 12
OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019). (NCT02622074)
Timeframe: Month 12
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 80.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 100.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 100.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 100.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 100.0 |
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: Second Combination Regimen
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the second combination regimen is presented. (NCT02622074)
Timeframe: After completion of the second combination regimen (KAC; Cycle 9) but prior to surgery (Up to ~9 months); Each cycle was 21 days.
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 80.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 100 |
| Cohort C: KNpCb (Regimen 2) / KAC | 100 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 70.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 90.0 |
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: First Combination Regimen
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the first combination regimen is presented. (NCT02622074)
Timeframe: At the end of Cycle 5 following treatment with the first combination regimen (KNp, KNpCb, or KTCb) (Up to ~4 months); Each cycle was 21 days.
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 60.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 90.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 90.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 60.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 80.0 |
Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
"The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:~Hematologic:~Grade 4 neutropenia lasting ≥8 days;~Febrile neutropenia Grade 3 or Grade 4; or~Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding~Non-hematologic:~Grade 4 toxicity;~Grade ≥3 symptomatic hepatic toxicities lasting >48 hours, or Grade ≥3 asymptomatic hepatic toxicities lasting ≥7 days; or~Grade ≥3 non-hematologic, non-hepatic organ toxicity, with exceptions~Other:~Any treatment delays for ≥14 days due to unresolved toxicity;~Grade 5 treatment-related adverse event (AE);~A dose reduction of study treatment during the DLT evaluation period." (NCT02622074)
Timeframe: Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A: KNp / KAC | 2 |
| Cohort B: KNpCb (Regimen 1) / KAC | 4 |
| Cohort C: KNpCb (Regimen 2) / KAC | 6 |
| Cohort D: KNpCb (Regimen 3) / KAC | 6 |
| Cohort E: KTCb (Regimen 1) / KAC | 0 |
| Cohort F: KTCb (Regimen 2) / KAC | 4 |
Event-Free Survival (EFS) Rate at Month 12
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 12 are presented (through Final Analysis cut-off of 18-Nov-2019). (NCT02622074)
Timeframe: Month 12
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 80.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 100.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 100.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 100.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 100.0 |
Event-Free Survival (EFS) Rate at Month 24
EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 24 are presented (through Final Analysis cut-off of 18-Nov-2019). (NCT02622074)
Timeframe: Month 24
| Intervention | Percentage of Participants (Number) |
|---|
| Cohort A: KNp / KAC | 60.0 |
| Cohort B: KNpCb (Regimen 1) / KAC | 100.0 |
| Cohort C: KNpCb (Regimen 2) / KAC | 100.0 |
| Cohort D: KNpCb (Regimen 3) / KAC | 90.0 |
| Cohort E: KTCb (Regimen 1) / KAC | 90.0 |
| Cohort F: KTCb (Regimen 2) / KAC | 100.0 |
Pathologic Complete Response Rate
Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR. (NCT02623972)
Timeframe: Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks.
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Eribulin Followed by AC | 6.25 |
| Arm B: AC Followed by Eribulin | 0 |
Residual Cancer Burden (RCB)
"Residual cancer burden is calculated and then categorized based on level of residual disease after neoadjuvant therapy and several other factors as assessed by pathologists.~This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III.(RCB category Unknown if unable to determine RCB or missing data.) The previous categories are in order of increasing severity of RCB. Measurement of residual breast cancer burden can predict survival after neoadjuvant chemotherapy." (NCT02623972)
Timeframe: Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such summed up to 20 weeks.
| Intervention | percentage of participants (Number) |
|---|
| RCB-0 | RCB-I | RCB-II | RCB-III | Unknown |
|---|
| Arm A: Eribulin Followed by AC | 6.25 | 12.5 | 25 | 56.25 | 0 |
,| Arm B: AC Followed by Eribulin | 0 | 0 | 50 | 33.33 | 16.67 |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events. (NCT02643420)
Timeframe: From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)
| Intervention | Participants (Count of Participants) |
|---|
| TEAE | SAE |
|---|
| Arm 1: SPI-2012 and TC - Follow up Period | 95 | 8 |
,| Arm 1: SPI-2012 and TC -Treatment Period | 192 | 36 |
,| Arm 2: Pegfilgrastim and TC - Follow up Period | 83 | 2 |
,| Arm 2: Pegfilgrastim and TC -Treatment Period | 204 | 29 |
Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4
RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles. (NCT02643420)
Timeframe: Cycles 1 to 4 (each cycle was 21 days)
| Intervention | percentage of planned dose (Mean) |
|---|
| Docetaxel | Cyclophosphamide |
|---|
| Arm 1: SPI-2012 and TC | 99.1 | 99.3 |
,| Arm 2: Pegfilgrastim and TC | 98.1 | 99.0 |
Number of Participants With Neutropenic Complications in Cycle 1
Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia. (NCT02643420)
Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: SPI-2012 and TC | 8 |
| Arm 2: Pegfilgrastim and TC | 8 |
Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1
Depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or Pegfilgrastim) in Cycle 1. (NCT02643420)
Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
| Intervention | 10^9 ANC/L (Mean) |
|---|
| Arm 1: SPI-2012 and TC | 2.56 |
| Arm 2: Pegfilgrastim and TC | 2.53 |
Duration of Severe Neutropenia (DSN) in Cycle 1
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count [ANC] <0.5×10^9/L), after the administration of study drug in Cycle 1. (NCT02643420)
Timeframe: Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)
| Intervention | days (Mean) |
|---|
| Arm 1: SPI-2012 and TC | 0.20 |
| Arm 2: Pegfilgrastim and TC | 0.35 |
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
FN was defined as an oral temperature > 38.3 degrees Celsius (C) (101.0 degrees Fahrenheit [F]) or two consecutive readings of >=38.0 degrees C (100.4 degrees F) for 2 hours and ANC <1.0×10^9/L. (NCT02643420)
Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: SPI-2012 and TC | 4 |
| Arm 2: Pegfilgrastim and TC | 2 |
Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10^9/L. (NCT02643420)
Timeframe: Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
| Intervention | days (Mean) |
|---|
| Arm 1: SPI-2012 and TC | 3.24 |
| Arm 2: Pegfilgrastim and TC | 3.49 |
Duration of Severe Neutropenia in Cycle 2, 3 and 4
DSN was defined as the number of days of severe neutropenia (ANC <0.5×10^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4. (NCT02643420)
Timeframe: Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)
| Intervention | days (Mean) |
|---|
| Cycle 2 | Cycle 3 | Cycle 4 |
|---|
| Arm 1: SPI-2012 and TC | 0.13 | 0.11 | 0.11 |
,| Arm 2: Pegfilgrastim and TC | 0.09 | 0.08 | 0.09 |
Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4
FN was defined as an oral temperature > 38.3 degrees C (101.0 degrees Fahrenheit [F]) or two consecutive readings of >=38.0 degrees C (100.4 degrees F) for 2 hours and ANC <1.0×10^9/L. (NCT02643420)
Timeframe: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle was 21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Cycle 2 | Cycle 3 | Cycle 4 |
|---|
| Arm 1: SPI-2012 and TC | 1 | 4 | 2 |
,| Arm 2: Pegfilgrastim and TC | 1 | 1 | 0 |
Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells
"Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration.~The count of patients not meeting the preparation criteria are reported." (NCT02650986)
Timeframe: 1 month
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | 0 |
| Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | 1 |
| Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 0 |
| Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 0 |
Number of Participants With Dose Limiting Toxicities
"Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment.~the number of patients experiencing a DLT are reported." (NCT02650986)
Timeframe: Up to 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | 0 |
| Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | 0 |
| Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 0 |
| Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 0 |
Number of Participants With Severe Chronic GVHD
The number of participants with severe chronic GVHD by Day +180 will be reported. (NCT02652468)
Timeframe: Day +180
| Intervention | Participants (Count of Participants) |
|---|
| Peripheral Blood Stem Cell Transplant | 0 |
Overall Survival (OS)
(NCT02652468)
Timeframe: Median follow up of 1689 days
| Intervention | days (Median) |
|---|
| Peripheral Blood Stem Cell Transplant | 352 |
Progression-free Survival
Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow, (NCT02652468)
Timeframe: Median follow up of 1689 days
| Intervention | days (Median) |
|---|
| Peripheral Blood Stem Cell Transplant | 352 |
Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days
To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma. (NCT02652468)
Timeframe: At day 28 after transplantation
| Intervention | Participants (Count of Participants) |
|---|
| Peripheral Blood Stem Cell Transplant | 11 |
Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria
The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported. (NCT02652468)
Timeframe: Day +100
| Intervention | Participants (Count of Participants) |
|---|
| Peripheral Blood Stem Cell Transplant | 3 |
Number of Participants With Graft Failure
Graft failure - defined as < 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved. (NCT02652468)
Timeframe: Up to 2 years after graft
| Intervention | Participants (Count of Participants) |
|---|
| Peripheral Blood Stem Cell Transplant | 0 |
Number of Participants With a Duration of Best Response in Months
Best Response defined as the first documentation of response was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. (NCT02659943)
Timeframe: Response duration is the time from first documentation of response, which is one month after cell infusion in all participants, until progression, initiation of off-study treatment or the last documentation on ongoing response, approx. one month -5 years.
| Intervention | Participants (Count of Participants) |
|---|
| Stable Disease - 1 Month | Stable Disease - 1 Month (first of two treatments) | Stable Disease - 1 Month After First Re-Treatment | Stable Disease - 2 Months (first of three treatments) | Stable Disease - 2 Months After Second Re-Treatment | Partial Remission - 1 Month After First Re-Treatment | Partial Remission - 2 months | Partial Remission - 3 Months | Complete Remission - 4 Months (first of two treatments) | Progressive Disease - After first Re-treatment | Complete Remission - 40 Months (first of two treatments) | Complete Remission - 5 Months After First Re-Treatment | Complete Remission - 6 Months | Complete Remission - 6 Months (first of two treatments) | Complete Remission - 29+ Months | Complete Remission - 35+ Months | Complete Remission - 45+ Months | Progressive Disease |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
,| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
,| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 1 |
Number of Participants With Evidence of Immunogenicity of the Chimeric Antigen Receptor (CAR) T-cell Product
Enzyme-linked spot (ELISPOT) assays were performed to look for anti-CAR T-cell responses. (NCT02659943)
Timeframe: 9 days to 6 weeks after CAR T-cell infusion
| Intervention | Participants (Count of Participants) |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 0 |
| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 0 |
| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 0 |
| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 0 |
| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 0 |
| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 0 |
Maximum Feasible Dose
Maximum feasible dose is the dose determined when the maximum tolerated dose (MTD) cannot be reached. (NCT02659943)
Timeframe: Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion
| Intervention | CAR+T cells/kg (Number) |
|---|
| All Participants | 0.000006 |
MTD
The maximum tolerated dose is the dose at which a maximum of 1 of 6 patients has a dose limiting toxicity (DLT- Grade 3 toxicities possibly or probably related to toxicities possibly or probably related to either the anti-CD19 CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days . Grade 4 toxicities possibly or probably related to the study interventions.). (NCT02659943)
Timeframe: Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion
| Intervention | T-cells/kg (Number) |
|---|
| All Participants | NA |
Number of Participants Who Had Anti-Lymphoma Activity
Depending on the type of disease, we use PET/CT imaging, tumor biopsies as well as bone marrow biopsies using immunohistochemistry and flow cytometry. (NCT02659943)
Timeframe: 14 days up to 5 years post cell infusion.
| Intervention | Participants (Count of Participants) |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 3 |
| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 2 |
| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 1 |
| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 2 |
| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 1 |
| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 6 |
Number of Participants With a Dose-Limiting Toxicity (DLT)
Number of participants with DLT's defined as follows: Grade 3 toxicities possibly or probably related to toxicities possibly or probably related to either the anti-CD19 CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions. (NCT02659943)
Timeframe: Within 60 days of Chimeric Antigen Receptor (CAR) T cells infusion
| Intervention | Participants (Count of Participants) |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 1 |
| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 0 |
| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 0 |
| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 2 |
| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 0 |
| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 1 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02659943)
Timeframe: Date treatment consent signed to date off study, approximately 49 months and 19 days.
| Intervention | Participants (Count of Participants) |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 3 |
| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 2 |
| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 1 |
| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 4 |
| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 2 |
| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 9 |
Percentage of Enrolled Participants Who Actually Get Treated
Percentage of participants enrolled who received treatment with Chimeric Antigen Receptor (CAR) T cells, Fludarabine and cyclophosphamide. (NCT02659943)
Timeframe: 4-5 weeks after the first dose
| Intervention | percentage of participants (Number) |
|---|
| All Participants | 76.9 |
Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events
Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal. (NCT02659943)
Timeframe: Date treatment consent signed to date off study, approximately 49 months and 19 days.
| Intervention | Adverse events (Number) |
|---|
| < Grade 2 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 2 | 0 | 0 | 1 | 0 |
,| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 2 | 0 | 0 | 0 | 0 |
,| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 1 | 0 | 0 | 0 | 0 |
,| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 3 | 1 | 0 | 0 | 0 |
,| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 2 | 0 | 0 | 0 | 0 |
,| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 6 | 2 | 0 | 0 | 0 |
Number of Participants Who Had a Best Response of Complete Remission (CR), Partial Remission (PR), Stable Disease (SD), and Progressive Disease (PD)
Response was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Complete Remission is complete disappearance of all detectable clinical evidence of disease. Partial Remission is ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive Disease is ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. (NCT02659943)
Timeframe: 30 days post Chimeric Antigen Receptor (CAR) T-cells up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Complete Remission After First Re-Treatment | Complete Remission After Second Re-Treatment | Partial Remission After Second Re-Treatment | Stable Disease After First Re-Treatment | Stable Disease After Second Re-Treatment | Stable Disease After Third Re-Treatment | Progressive Disease After Second Re-Treatment |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
,| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 0 | 0 | 1 | 1 | 1 | 1 | 0 |
,| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of Participants Who Had a Second or Third Infusion of Chimeric Antigen Receptor (CAR)+ T Cells
Number of participants who had a second or third Infusion Chimeric Antigen Receptor (CAR)+ T cells. Participants were eligible for a subsequent CAR T-cell infusion if the response at one month after CAR T-cell infusion was partial remission (PR) or stable disease (SD). Participants could also receive a subsequent CAR T-cell infusion if the response was complete remission (CR) but the malignancy later relapsed. CR, PR, and SD was assessed by the Revised Response Criteria for Malignant Lymphoma, and Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Complete Remission is complete disappearance of all detectable clinical evidence of disease. Partial Remission is ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. (NCT02659943)
Timeframe: Participants could receive subsequent cell infusions any time 1 month after CAR T-cell infusion until 5 years after cell infusion.
| Intervention | Participants (Count of Participants) |
|---|
| Second infusion | Third infusion |
|---|
| LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only | 0 | 0 |
,| LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells | 2 | 0 |
,| LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 1 | 0 |
,| LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only | 0 | 0 |
,| LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | 1 | 1 |
,| LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | 0 | 0 |
Area Under the Curve (AUC) of JCAR014 by Flow Cytometry
Absolute CD4+ and CD8+ CAR-T cell counts were determined by multiplying the percentages of CD3+CD4+CD8-EGFRt+ and CD3+CD4-CD8+EGFRt+ events, respectively, in a viable CD45+ lymphocyte forward/side scatter gate by an absolute lymphocyte count performed on the same day. Subjects had samples analyzed at approximately days 0, 3, 7, 10, 14, 21, and 28 after CAR-T cell infusion to generate the AUC from day 0 to 28. The areas under the curve of CAR T-cell counts by flow cytometry and qPCR between time points were calculated by using a trapezoidal rule computational algorithm. Excluding 1 patient in Group 2 Dose Level 5 who received an out-of-specification JCAR014 product. (NCT02706405)
Timeframe: Up to 28 days
| Intervention | Days x CD3+ CAR-T cells/μL (Mean) |
|---|
| Group I (JCAR014, Durvalumab) - Dose Level 1 | 844.77 |
| Group I (JCAR014, Durvalumab) - Dose Level 2 | 104.33 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 47.96 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 32.44 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 90.78 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 160.94 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 71.97 |
Objective Response Rate by Investigator Assessment Using Lugano Criteria
ORR, defined as a count of participant with a best response of either complete response or partial response. 1 patient in Group 1 Early Dose Level 2 could not be analyzed for the outcome because they expired before their first response assessment. (NCT02706405)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 1 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 1 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 2 |
Maximum JCAR014 Cmax by Flow Cytometry
Absolute CD4+ and CD8+ CAR-T cell counts were determined by multiplying the percentages of CD3+CD4+CD8-EGFRt+ and CD3+CD4-CD8+EGFRt+ events, respectively, in a viable CD45+ lymphocyte forward/side scatter gate by an absolute lymphocyte count performed on the same day. Excluding 1 patient in Group 2 Dose Level 5 who received an out-of-specification JCAR014 product. (NCT02706405)
Timeframe: Up to 12 months
| Intervention | CD3+ CAR-T cells/μL (Mean) |
|---|
| Group I (JCAR014, Durvalumab) - Dose Level 1 | 201.21 |
| Group I (JCAR014, Durvalumab) - Dose Level 2 | 13.71 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 8.27 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 3.01 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 13.15 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 18.13 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 7.53 |
Maximum JCAR014 Cmax in Blood by Quantitative Polymerase Chain Reaction (qPCR) Analysis
The number of copies of the CAR transgene/μg of DNA in the blood was determined by using quantitative polymerase chain reaction (qPCR) to detect the integrated Flap-EF1⍺ sequence, with a lower limit of detection of 10 transgene copies/μg of DNA. Excluding 1 patient in Group 2 Dose Level 5 who received an out-of-specification JCAR014 product. (NCT02706405)
Timeframe: Up to 12 months
| Intervention | CAR transgene copies/μg DNA (Mean) |
|---|
| Group I (JCAR014, Durvalumab) - Dose Level 1 | 37647.95 |
| Group I (JCAR014, Durvalumab) - Dose Level 2 | 10043.68 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 3690.24 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 1949.22 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 8295.36 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 27841.31 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 26297.43 |
AUC of JCAR014 Cells by qPCR Analysis
The number of copies of the CAR transgene/μg of DNA in the blood was determined by using quantitative polymerase chain reaction (qPCR) to detect the integrated Flap-EF1⍺ sequence, with a lower limit of detection of 10 transgene copies/μg of DNA. Subjects had samples analyzed at approximately days 0, 3, 7, 10, 14, 21, and 28 after CAR-T cell infusion to generate the AUC from day 0 to 28.The areas under the curve of CAR T-cell counts by flow cytometry and qPCR between time points were calculated by using a trapezoidal rule computational algorithm. Excluding 1 patient in Group 2 Dose Level 5 who received an out-of-specification JCAR014 product. (NCT02706405)
Timeframe: Up to 28 days
| Intervention | CAR transgene copies/μg DNA x days (Mean) |
|---|
| Group I (JCAR014, Durvalumab) - Dose Level 1 | 296188.95 |
| Group I (JCAR014, Durvalumab) - Dose Level 2 | 104088.38 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 18710.77 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 16721.68 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 63778.63 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 353471.10 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 389065.24 |
Count of Participants Who Experienced Adverse Events
Toxicity graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. (NCT02706405)
Timeframe: 28 days post last infusion of Durvalumab, up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 5 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 3 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 3 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 3 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 6 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 7 |
Dose Limiting Toxicity (DLT) Rates
Will be summarized based on the dose limiting toxicity evaluable analysis set. The target toxicity rate for the maximum tolerated dose is 30%. Outcome will be reported as a count of patients in each arm that experienced a DLT. (NCT02706405)
Timeframe: 28 days post first infusion of Durvalumab (for participants in Group 1) or 28 days post infusion of JCAR (for participants in Group 2)
| Intervention | Participants (Count of Participants) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 1 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 0 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 1 |
Duration of Response
Duration of response will be an average amount of days from first response assessment until progression or death for treated patients. Total number analyzed will be the patients that progressed or died, excluding those that did not progress or die. 1 patient in Group 1 Early Dose Level 2 could not be analyzed for the outcome because they expired before their first response assessment. (NCT02706405)
Timeframe: From first response to progressive disease or death, assessed up to 1 year
| Intervention | days (Mean) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 72.5 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 47.5 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 42 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 35 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 31 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 97.75 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 18.14 |
Highest Treatment Dose Administered on Study
Reporting outcome as the maximum durvalumab dose that we reached on the study. Patients were monitored for 28 days post infusion for dose limiting toxicities. The DLT rate was used to determine dose escalation. The study was terminated prior to reaching the maximum tolerated dose. (NCT02706405)
Timeframe: 28 days
| Intervention | mg (Number) |
|---|
| All Treated Patients | 750 |
Overall Survival
Outcome will be reported as a count of participants who survived while on study. Survival was assessed up to 1 year. (NCT02706405)
Timeframe: From date of first study treatment to death, assessed up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 2 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 1 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 3 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 3 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 3 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 3 |
Progression Free Survival
Outcome will be reported as a count of those who did not progress and did not die while on study. (NCT02706405)
Timeframe: From date of first study treatment to progressive disease or death, assessed up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 2 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 1 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 0 |
Time to Loss of JCAR014 Detection in Blood by qPCR Analysis
The number of copies of the CAR transgene/μg of DNA in the blood was determined by using quantitative polymerase chain reaction (qPCR) to detect the integrated Flap-EF1⍺ sequence, with a lower limit of detection of 10 transgene copies/μg of DNA. Excluding 1 patient in Group 2 Dose Level 5 who received an out-of-specification JCAR014 product. (NCT02706405)
Timeframe: Up to 12 months, +/- 30 days
| Intervention | days (Mean) |
|---|
| Group I (JCAR014, Durvalumab) - Dose Level 1 | 113 |
| Group I (JCAR014, Durvalumab) - Dose Level 2 | 191 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 28 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 199 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 183 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 64 |
Rate of Partial Response (PR) by Investigator Assessment Using Lugano Criteria
This outcome is a count of participants who experienced a best response of partial response (PR) by investigator assessment using Lugano criteria. 1 patient in Group 1 Early Dose Level 2 could not be analyzed for the outcome because they expired before their first response assessment. (NCT02706405)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 1 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 0 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 1 |
Rate of Complete Response (CR) by Investigator Assessment Using Lugano Criteria
This outcome is a count of participants who experienced a best response of complete response (CR) by investigator assessment using Lugano criteria. 1 patient in Group 1 Early Dose Level 2 could not be analyzed for the outcome because they expired before their first response assessment. (NCT02706405)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Group I (JCAR014, Durvalumab) Early - Dose Level 2 | 1 |
| Group I (JCAR014, Durvalumab) Late- Dose Level 1 | 1 |
| Group I (JCAR014, Durvalumab) Late - Dose Level 2 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 1 | 0 |
| Group II (Durvalumab, JCAR014) - Dose Level 2 | 1 |
| Group II (Durvalumab, JCAR014) - Dose Level 3 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 4 | 2 |
| Group II (Durvalumab, JCAR014) - Dose Level 5 | 1 |
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
"The observed serum concentration at the end of a dosing interval when intensive samples are collected was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 3059 | 7729 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 7739 | 32982 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 604 | 2527 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 790 | 1262 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1533 | 6906 |
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
"The area under the serum concentration-time curve from time 0 to time t was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 |
|---|
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 2399055 |
,| Escalation Part 1: BMS 20 mg Q2W | 577541 |
,| Escalation Part 1: BMS 320 mg Q2W | 9981469 |
,| Escalation Part 1: BMS 40 mg Q2W | 1678196 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 609426 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1653102 |
,| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 390424 |
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
"The observed serum concentration at the end of a dosing interval when intensive samples are collected was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 657 |
,| Escalation Part 1: BMS 320 mg Q2W | 16514 |
,| Escalation Part 1: BMS 40 mg Q2W | 2577 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 756 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 885 |
,| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 2335 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 42.9 |
,| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0.004 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1535 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 1725 |
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
"The average concentration over a dosing interval (AUC(TAU)/tau) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 160 mg Q2W | 45155 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 45878 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 148579 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 9746 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 9903 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 19538 |
,| Escalation Part 1: BMS 80 mg Q2W | 11826 |
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
"The average concentration over a dosing interval (AUC(TAU)/tau) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 4964 |
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
"The average concentration over a dosing interval (AUC(TAU)/tau) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 4 DAY 1 |
|---|
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 10739 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 25131 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 3715 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 55386 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 4379 |
Cmax: Maximum Observed Serum Concentration
"The maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 80 mg Q2W | 19254 | 23200 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 39182 | 72991 |
,| Escalation Part 1: BMS 160 mg Q2W | 36143 | 61500 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 17586 | 30922 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 11699 | 17392 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 76445 | 207853 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 19547 | 23097 |
Cmax: Maximum Observed Serum Concentration
"The maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 19012 | 16912 |
Cmax: Maximum Observed Serum Concentration
"The maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 17979 | 20900 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 55790 | 69922 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 7860 | 8960 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 65472 | 117839 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 9345 | 10273 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 15424 | 14143 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 11139 | 11261 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 21399 | 31800 |
Cmax: Maximum Observed Serum Concentration
"The maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 |
|---|
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 3270 |
,| Escalation Part 1: BMS 20 mg Q2W | 4964 |
,| Escalation Part 1: BMS 320 mg Q2W | 68774 |
,| Escalation Part 1: BMS 40 mg Q2W | 11245 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 14267 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 9424 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 11300 |
CLT: Total Body Clearance
"The total body clearance was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | L/H (Geometric Mean) |
|---|
| CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 80 mg Q2W | 0.020 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 0.010 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 0.006 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 0.012 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 0.024 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 0.013 |
,| Escalation Part 1: BMS 160 mg Q2W | 0.012 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 160 mg Q2W | 2.33 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 2.61 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 7.55 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 2.40 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 1.22 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 3.49 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 1.05 |
CLT: Total Body Clearance
"The total body clearance was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | L/H (Geometric Mean) |
|---|
| CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 0.024 |
CLT: Total Body Clearance
"The total body clearance was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | L/H (Geometric Mean) |
|---|
| CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 0.013 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 0.011 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 0.018 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0.011 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0.022 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 336 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 0 h |
|---|
| Escalation Part 1: BMS 320 mg Q2W | 16514 | 21571 | 26090 | 35200 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 1.22 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 1.89 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 1.90 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 2.72 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 2.47 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 0.000 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 9 DAY 1 |
|---|
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1.40 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 1.29 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 1.66 |
,| Escalation Part 1: BMS 160 mg Q2W | 1.89 |
,| Escalation Part 1: BMS 80 mg Q2W | 1.45 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 1.83 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 2.56 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 1.02 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 1.67 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 1.40 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 0.793 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 1.52 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 1.05 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1.21 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1.03 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 1.32 |
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
"The area under the serum concentration-time curve in 1 dosing interval was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 9 DAY 1 |
|---|
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 2602049 | 6176469 |
,| Escalation Part 1: BMS 80 mg Q2W | 3142196 | 3952990 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 11483961 | 50254284 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 2551115 | 3307867 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 5458640 | 16483279 |
,| Escalation Part 1: BMS 160 mg Q2W | 5854143 | 13024914 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1515139 | 3345948 |
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
"The area under the serum concentration-time curve in 1 dosing interval was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 2734577 | 3335668 |
Tmax: Time of Maximum Observed Serum Concentration
The time of maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | Hours (Median) |
|---|
| CYCLE 1 DAY 1 | CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 80 mg Q2W | 4.58 | 0.467 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 0.517 | 4.47 |
,| Escalation Part 1: BMS 160 mg Q2W | 2.30 | 22.7 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 4.09 | 3.94 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 0.650 | 2.38 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 0.792 | 4.05 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 2.34 | 0.567 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 160 mg Q2W | 2.21 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 2.78 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 4.40 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1.85 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 0.748 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 2.32 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 1.21 |
The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
"The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.~DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment." (NCT02737475)
Timeframe: From first dose to 28 days after first dose
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 0 |
| Escalation Part 1: BMS 40 mg Q2W | 0 |
| Escalation Part 1: BMS 80 mg Q2W | 0 |
| Escalation Part 1: BMS 160 mg Q2W | 0 |
| Escalation Part 1: BMS 320 mg Q2W | 0 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 0 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 0 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 1 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 1 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 1 |
| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 0 |
| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 0 |
Frequency of Positive Anti-Drug Antibodies (ADA) to Ipilimumab.
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of Ipilimumab administered with BMS-986178 ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. (NCT02737475)
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 1 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 1 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 0 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0 |
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
"The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 1.77 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 1.28 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 0.000 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 2.13 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1.37 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 1.56 |
Frequency of Positive Anti-Drug Antibodies (ADA) to Nivolumab
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of Nivolumab administered with BMS-986178 ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. (NCT02737475)
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 336, 696 hours post dose)
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 0 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 3 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 0 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 1 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 0 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 336 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 0 h | CYCLE 7 DAY 1 0 h |
|---|
| Escalation Part 1: BMS 40 mg Q2W | 2372 | 4244 | 4593 | 6600 | 5390 |
Objective Response Rate (ORR)
"The total number of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) based on assessment of tumor response using RECIST v1.1.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.~Overall Response (OR) = CR + PR Baseline is defined as the last non-missing measurement prior to the first dosing date and time." (NCT02737475)
Timeframe: From baseline up to approximately 2.5 years
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 0 |
| Escalation Part 1: BMS 40 mg Q2W | 0 |
| Escalation Part 1: BMS 80 mg Q2W | 0 |
| Escalation Part 1: BMS 160 mg Q2W | 0 |
| Escalation Part 1: BMS 320 mg Q2W | 0 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 2 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 0 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 1 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 0 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 2 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 0 |
| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | NA |
Progression Free Survival (PFS) Rate at 24 Weeks
The percentage of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. (NCT02737475)
Timeframe: 24 weeks after first dose
| Intervention | Percentage of participants (Number) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 0.0 |
| Escalation Part 1: BMS 40 mg Q2W | 0.0 |
| Escalation Part 1: BMS 80 mg Q2W | 0.0 |
| Escalation Part 1: BMS 160 mg Q2W | 25.0 |
| Escalation Part 1: BMS 320 mg Q2W | 25.0 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 17.9 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 42.9 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 16.7 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 28.6 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 37.5 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 0.0 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 11.1 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 0.0 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 0.0 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 40.0 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 22.2 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 9.2 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 0.0 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 28.6 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | NA |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0.0 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 33.3 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0.0 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 0.0 |
| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 0.0 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 50.0 |
The Number of Participant Deaths
The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. (NCT02737475)
Timeframe: From first dose to study completion (up to approximately 4 years 5 months)
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 4 |
| Escalation Part 1: BMS 40 mg Q2W | 4 |
| Escalation Part 1: BMS 80 mg Q2W | 3 |
| Escalation Part 1: BMS 160 mg Q2W | 4 |
| Escalation Part 1: BMS 320 mg Q2W | 4 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 3 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 7 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 11 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 6 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 6 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 4 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 9 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 7 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 8 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 2 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 16 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 11 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 3 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 3 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 5 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 4 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 2 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 2 |
| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 1 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 1 |
| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 1 |
The Number of Participants Experiencing Adverse Events (AEs)
"The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.~An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment." (NCT02737475)
Timeframe: From first dose to 100 days after last dose (up to approximately 2.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 4 |
| Escalation Part 1: BMS 40 mg Q2W | 4 |
| Escalation Part 1: BMS 80 mg Q2W | 4 |
| Escalation Part 1: BMS 160 mg Q2W | 3 |
| Escalation Part 1: BMS 320 mg Q2W | 4 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 7 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 8 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 12 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 7 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 8 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 4 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 10 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 7 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 8 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 6 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 18 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 12 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 6 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 6 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 6 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 9 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 2 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 2 |
| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 2 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 2 |
| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 1 |
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
"The area under the serum concentration-time curve in 1 dosing interval was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 4 DAY 1 |
|---|
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1410042 | 3590883 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 11966698 | 27936423 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 1521223 | 2210404 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1568004 | 1837861 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 7464248 | 12666237 |
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
"The area under the serum concentration-time curve in 1 dosing interval was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 |
|---|
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 447709 |
,| Escalation Part 1: BMS 20 mg Q2W | 577541 |
,| Escalation Part 1: BMS 320 mg Q2W | 9981469 |
,| Escalation Part 1: BMS 40 mg Q2W | 1599886 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 1383126 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 663257 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 3500606 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1705864 |
,| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 3133192 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 2812249 |
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
"The area under the serum concentration-time curve from time 0 to time t was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 9 DAY 1 |
|---|
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1495494 | 2971409 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 2324225 | 1247687 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 2351794 | 4537054 |
,| Escalation Part 1: BMS 80 mg Q2W | 1825502 | 3952990 |
,| Escalation Part 1: BMS 160 mg Q2W | 5024906 | 13024914 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 5458640 | 16483279 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 8694104 | 28499982 |
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
"The area under the serum concentration-time curve from time 0 to time t was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 2000522 | 2520673 |
Tmax: Time of Maximum Observed Serum Concentration
The time of maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | Hours (Median) |
|---|
| CYCLE 1 DAY 1 | CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 0.550 | 0.550 |
Tmax: Time of Maximum Observed Serum Concentration
The time of maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | Hours (Median) |
|---|
| CYCLE 1 DAY 1 | CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 4.00 | 0.583 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 2.55 | 4.00 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 0.667 | 0.583 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 4.13 | 2.58 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 4.00 | 4.00 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0.475 | 0.467 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0.583 | 0.517 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 2.30 | 4.03 |
Tmax: Time of Maximum Observed Serum Concentration
The time of maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | Hours (Median) |
|---|
| CYCLE 1 DAY 1 |
|---|
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0.533 |
,| Escalation Part 1: BMS 20 mg Q2W | 0.675 |
,| Escalation Part 1: BMS 320 mg Q2W | 0.558 |
,| Escalation Part 1: BMS 40 mg Q2W | 0.575 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 4.83 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 0.467 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 4.00 |
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
"The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.~Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time" (NCT02737475)
Timeframe: From baseline to 100 days after last dose (up to approximately 2.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| SODIUM, SERUM GRADE 1 | SODIUM, SERUM GRADE 2 | SODIUM, SERUM GRADE 3 | POTASSIUM, SERUM GRADE 1 | POTASSIUM, SERUM GRADE 2 | POTASSIUM, SERUM GRADE 3 | POTASSIUM, SERUM GRADE 4 | CALCIUM, TOTAL GRADE 1 | CALCIUM, TOTAL GRADE 2 | CALCIUM, TOTAL GRADE 3 | MAGNESIUM, SERUM GRADE 1 | MAGNESIUM, SERUM GRADE 2 | MAGNESIUM, SERUM GRADE 3 | GLUCOSE, FASTING SERUM GRADE 1 | GLUCOSE, FASTING SERUM GRADE 2 | GLUCOSE, FASTING SERUM GRADE 3 | ALBUMIN GRADE 1 | ALBUMIN GRADE 2 | ALBUMIN GRADE 3 | AMYLASE, TOTAL GRADE 1 | AMYLASE, TOTAL GRADE 2 | AMYLASE, TOTAL GRADE 3 | AMYLASE, TOTAL GRADE 4 | LIPASE, TOTAL GRADE 1 | LIPASE, TOTAL GRADE 2 | LIPASE, TOTAL GRADE 3 | LIPASE, TOTAL GRADE 4 |
|---|
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 2 | 0 | 0 | 2 | 0 | 1 | 0 | 4 | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 6 | 0 | 0 | 4 | 0 | 1 | 0 | 5 | 1 | 0 | 1 | 2 | 0 | 4 | 2 | 0 | 0 | 5 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 5 | 0 | 1 | 3 | 0 | 0 | 1 | 4 | 3 | 0 | 3 | 0 | 0 | 2 | 1 | 1 | 4 | 3 | 0 | 3 | 0 | 0 | 0 | 1 | 1 | 2 | 0 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 1: BMS 160 mg Q2W | 2 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 2 | 0 | 0 | 3 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 4 | 0 | 0 | 4 | 0 | 0 | 6 | 1 | 0 | 2 | 4 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 0 |
,| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 2 | 0 | 0 | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 5 | 1 | 0 | 5 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 4 | 0 | 2 | 8 | 3 | 1 | 1 | 9 | 1 | 1 | 6 | 1 | 0 | 2 | 1 | 0 | 3 | 5 | 0 | 2 | 2 | 1 | 0 | 2 | 1 | 2 | 2 |
,| Escalation Part 1: BMS 20 mg Q2W | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 0 |
,| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 4 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | 1 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 1 | 3 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 1 |
,| Escalation Part 1: BMS 320 mg Q2W | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 1: BMS 40 mg Q2W | 3 | 0 | 0 | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
,| Escalation Part 1: BMS 80 mg Q2W | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 4 | 0 | 1 | 2 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 2 | 0 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 4 | 0 | 0 | 2 | 0 | 0 | 1 | 3 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
"The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.~Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time" (NCT02737475)
Timeframe: From baseline to 100 days after last dose (up to approximately 2.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| SODIUM, SERUM GRADE 1 | SODIUM, SERUM GRADE 2 | SODIUM, SERUM GRADE 3 | POTASSIUM, SERUM GRADE 1 | POTASSIUM, SERUM GRADE 2 | POTASSIUM, SERUM GRADE 3 | POTASSIUM, SERUM GRADE 4 | CALCIUM, TOTAL GRADE 1 | CALCIUM, TOTAL GRADE 2 | CALCIUM, TOTAL GRADE 3 | MAGNESIUM, SERUM GRADE 1 | MAGNESIUM, SERUM GRADE 2 | MAGNESIUM, SERUM GRADE 3 | ALBUMIN GRADE 1 | ALBUMIN GRADE 2 | ALBUMIN GRADE 3 | AMYLASE, TOTAL GRADE 1 | AMYLASE, TOTAL GRADE 2 | AMYLASE, TOTAL GRADE 3 | AMYLASE, TOTAL GRADE 4 | LIPASE, TOTAL GRADE 1 | LIPASE, TOTAL GRADE 2 | LIPASE, TOTAL GRADE 3 | LIPASE, TOTAL GRADE 4 |
|---|
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
,| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 3 | 0 | 0 | 3 | 1 | 0 | 0 | 4 | 2 | 0 | 2 | 2 | 0 | 4 | 2 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 1 | 1 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
"The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.~Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time" (NCT02737475)
Timeframe: From baseline to 100 days after last dose (up to approximately 2.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| ALKALINE PHOSPHATASE GRADE 1 | ALKALINE PHOSPHATASE GRADE 2 | ALKALINE PHOSPHATASE GRADE 3 | ASPARTATE AMINOTRANSFERASE GRADE 1 | ASPARTATE AMINOTRANSFERASE GRADE 2 | ASPARTATE AMINOTRANSFERASE GRADE 3 | ASPARTATE AMINOTRANSFERASE GRADE 4 | ALANINE AMINOTRANSFERASE GRADE 1 | ALANINE AMINOTRANSFERASE GRADE 2 | ALANINE AMINOTRANSFERASE GRADE 3 | ALANINE AMINOTRANSFERASE GRADE 4 | BILIRUBIN, TOTAL GRADE 1 | BILIRUBIN, TOTAL GRADE 2 | BILIRUBIN, TOTAL GRADE 3 | BILIRUBIN, TOTAL GRADE 4 | CREATININE GRADE 1 | CREATININE GRADE 2 | CREATININE GRADE 3 |
|---|
| Escalation Part 1: BMS 160 mg Q2W | 1 | 2 | 0 | 1 | 1 | 1 | 1 | 2 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 0 |
,| Escalation Part 1: BMS 20 mg Q2W | 2 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
,| Escalation Part 1: BMS 320 mg Q2W | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
,| Escalation Part 1: BMS 40 mg Q2W | 2 | 1 | 0 | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 |
,| Escalation Part 1: BMS 80 mg Q2W | 2 | 1 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 5 | 1 | 0 | 3 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 6 | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 4 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 2 | 1 | 2 | 4 | 0 | 2 | 0 | 4 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 3 | 0 | 0 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 5 | 0 | 2 | 2 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 6 | 0 | 1 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 4 | 1 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 2 | 1 | 0 | 0 | 0 | 2 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 0 | 1 | 1 | 2 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 3 | 2 | 0 | 4 | 1 | 0 | 0 | 4 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
,| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 7 | 3 | 2 | 10 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 7 | 3 | 2 |
,| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 2 | 2 | 0 | 2 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 |
,| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 3 | 1 | 0 | 5 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1 | 1 | 0 | 3 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
,| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 6 | 1 | 0 | 5 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 2 | 0 | 1 | 4 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
,| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
"The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.~Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time" (NCT02737475)
Timeframe: From baseline to 100 days after last dose (up to approximately 2.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| HEMOGLOBIN GRADE 1 | HEMOGLOBIN GRADE 2 | HEMOGLOBIN GRADE 3 | PLATELET COUNT GRADE 1 | PLATELET COUNT GRADE 2 | PLATELET COUNT GRADE 3 | LEUKOCYTES GRADE 1 | LEUKOCYTES GRADE 2 | LEUKOCYTES GRADE 3 | LEUKOCYTES GRADE 4 | ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 1 | ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 2 | ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 3 | ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 4 |
|---|
| Escalation Part 1: BMS 160 mg Q2W | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 1: BMS 20 mg Q2W | 2 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Escalation Part 1: BMS 320 mg Q2W | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 1: BMS 40 mg Q2W | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 1: BMS 80 mg Q2W | 4 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 1 | 4 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 3 | 2 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 0 | 0 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 6 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 4 | 2 | 1 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 3 | 0 | 0 | 1 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 3 | 5 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 5 | 1 | 2 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 1 | 4 | 1 | 2 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 4 | 6 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 2 | 3 | 1 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 9 | 6 | 3 | 4 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
,| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 7 | 2 | 0 | 2 | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 1 | 0 |
,| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 2 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 3 | 2 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 4 | 5 | 1 | 3 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8. A threshold of 80% receptor occupancy following treatment was applied. (NCT02737475)
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 24, 168, 336, 672, 1848 hours post dose)
| Intervention | Participants (Count of Participants) |
|---|
| Peripheral OX40 receptor occupancy (CD4+ T cells) | Peripheral OX40 receptor occupancy (Tregs) |
|---|
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 1 | 1 |
,| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 2 | 1 |
,| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 1 | 1 |
,| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 0 | 0 |
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
The effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | Hr (Mean) |
|---|
| CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 160 mg Q2W | 331 |
,| Escalation Part 1: BMS 80 mg Q2W | 0.000 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 593 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 607 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 315 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 0.000 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 312 |
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
The effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | Hr (Mean) |
|---|
| CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 447 |
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
The effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | Hr (Mean) |
|---|
| CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 345 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 429 |
,| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 229 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 146 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 261 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 0.000 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 336 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 0 h | CYCLE 7 DAY 1 0 h | CYCLE 9 DAY 1 0 h | CYCLE 10 DAY 1 336 h | CYCLE 17 DAY 1 0 h |
|---|
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 4070 | 5055 | 7252 | 9811 | 11471 | 12905 | 13400 | 16600 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 10413 | 16379 | 20800 | 26813 | 32753 | 29902 | 28988 | 48500 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 1 DAY 15 336 h | CYCLE 1 DAY 29 0 h | CYCLE 2 DAY 1 0 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 4 DAY 29 0 | CYCLE 4 DAY 15 336 h | CYCLE 6 DAY 1 0 h |
|---|
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1912 | 1108 | 1107 | 2469 | 5461 | 1856 | 2130 | 604 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 336 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 0 h | CYCLE 7 DAY 1 0 h | CYCLE 9 DAY 1 0 h | CYCLE 10 DAY 1 336 h |
|---|
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1995 | 1825 | 2095 | 1301 | 4777 | 6397 | 8264 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 4006 | 4498 | 5108 | 7468 | 12527 | 13536 | 5686 |
,| Escalation Part 1: BMS 160 mg Q2W | 10852 | 16974 | 20703 | 13300 | 22073 | 31300 | 33600 |
,| Escalation Part 1: BMS 80 mg Q2W | 5354 | 5903 | 7169 | 13491 | 10217 | 6300 | 6470 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 18596 | 28282 | 47108 | 90700 | 76970 | 106710 | 131520 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 336 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 0 h | CYCLE 7 DAY 1 0 h | CYCLE 10 DAY 1 336 h |
|---|
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 561 | 614 | 358 | 386 | 946 | 1190 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 672 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 0 h | CYCLE 6 DAY 1 672 h |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 676 | 1480 | 1466 | 1671 | 62.5 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 504 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 504 h | CYCLE 9 DAY 1 0 h |
|---|
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 745 | 689 | 754 | 1262 | 579 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 504 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 504 h | CYCLE 10 DAY 1 0 h |
|---|
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 7739 | 20410 | 32150 | 18771 | 29100 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 504 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h | CYCLE 5 DAY 1 504 h |
|---|
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 591 | 2049 | 1971 | 2527 |
The Number of Participants Experiencing Serious Adverse Events (SAEs)
"The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.~A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event." (NCT02737475)
Timeframe: From first dose to 100 days after last dose (up to approximately 2.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 3 |
| Escalation Part 1: BMS 40 mg Q2W | 4 |
| Escalation Part 1: BMS 80 mg Q2W | 2 |
| Escalation Part 1: BMS 160 mg Q2W | 3 |
| Escalation Part 1: BMS 320 mg Q2W | 3 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 3 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 6 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 7 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 4 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 5 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 2 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 6 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 6 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 5 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 2 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 11 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 7 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 4 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 4 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 6 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 5 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 1 |
| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 1 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 1 |
| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 1 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 504 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h |
|---|
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 1921 | 2766 | 12649 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 456 | 323 | 1080 |
,| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 2401 | 4894 | 5140 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 336 h | CYCLE 3 DAY 1 0 h | CYCLE 4 DAY 1 0 h |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 657 | 1290 | 3420 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 1 DAY 15 336 h | CYCLE 1 DAY 29 0 h | CYCLE 2 DAY 1 0 h |
|---|
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1535 | 1354 | 1391 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 504 h | CYCLE 3 DAY 1 0 h |
|---|
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 2166 | 62.5 |
Ctrough: Trough Observed Plasma Concentration
"Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
| Intervention | ng/mL (Geometric Mean) |
|---|
| CYCLE 2 DAY 1 504 h |
|---|
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1030 |
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
"The observed serum concentration at the end of a dosing interval when intensive samples are collected was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 9 DAY 1 |
|---|
| Escalation Part 1: BMS 80 mg Q2W | 5354 | 6470 |
,| Escalation Part 1: BMS 160 mg Q2W | 10852 | 33600 |
,| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 10413 | 34303 |
,| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 18596 | 131520 |
,| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1904 | 5510 |
,| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 3598 | 5686 |
,| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 3928 | 13400 |
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
"The observed serum concentration at the end of a dosing interval when intensive samples are collected was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 5 DAY 1 |
|---|
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 544 | 1412 |
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. (NCT02737475)
Timeframe: From first dose to 100 days after last dose (up to approximately 2.5 years)
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 0 |
| Escalation Part 1: BMS 40 mg Q2W | 0 |
| Escalation Part 1: BMS 80 mg Q2W | 0 |
| Escalation Part 1: BMS 160 mg Q2W | 0 |
| Escalation Part 1: BMS 320 mg Q2W | 0 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 2 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 0 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 2 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 0 |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | 0 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 2 |
| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 0 |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 2 |
| Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 0 |
| Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 1 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W | 0 |
| Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine | 0 |
Duration of Response (DOR)
"The time between the date of first response and the subsequent date of disease progression or death (death after re-treatment will not be considered), whichever occurs first in participants with a best overall response (BOR) of complete response (CR) or partial response (PR).~Best overall response (BOR) is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.~Baseline is defined as the last non-missing measurement prior to the first dosing date and time.~Due to high percentage of censored response, median estimate may be misleading" (NCT02737475)
Timeframe: From baseline up to approximately 2.5 years
| Intervention | Weeks (Median) |
|---|
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | NA |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 17.14 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | NA |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | NA |
| Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) | NA |
| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 64.14 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | NA |
Frequency of Positive Anti-Drug Antibodies (ADA) to BMS-986178
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab. ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. (NCT02737475)
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)
| Intervention | Participants (Count of Participants) |
|---|
| Escalation Part 1: BMS 20 mg Q2W | 0 |
| Escalation Part 1: BMS 40 mg Q2W | 0 |
| Escalation Part 1: BMS 80 mg Q2W | 1 |
| Escalation Part 1: BMS 160 mg Q2W | 0 |
| Escalation Part 1: BMS 320 mg Q2W | 0 |
| Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W | 3 |
| Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W | 3 |
| Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W | 1 |
| Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W | 0 |
| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 1 |
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 3 |
| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 1 |
| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 4 |
| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 2 |
| Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W | 1 |
| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 0 |
| Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W | 0 |
| Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W | 0 |
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
"The area under the serum concentration-time curve from time 0 to time t was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.~Note: The geometric CV was not calculated. Arithmetic % CV is reported instead." (NCT02737475)
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
| Intervention | H*NG/ML (Geometric Mean) |
|---|
| CYCLE 1 DAY 1 | CYCLE 4 DAY 1 |
|---|
| Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W | 1197507 | 2210404 |
,| Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W | 7257441 | 10729551 |
,| Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W | 1047354 | 773957 |
,| Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W | 10580541 | 23851864 |
,| Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W | 2774058 | 2400433 |
,| Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) | 864500 | 504998 |
,| Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) | 1251698 | 1837861 |
,| Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W | 3216650 | 2699238 |
Late Graft Rejection Rate
The absence of donor hematopoietic cells in peripheral blood beyond day 42 up to 1 year in a patient who had initial evidence of hematopoietic recovery with > 20% donor cells will be considered a late graft rejection. (NCT02757885)
Timeframe: Day 42 Post transplant up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 0 |
Overall Survival Rate
Overall survival is defined as survival with or without sickle cell disease (SCD) after hematopoietic cell transplantation (HCT). (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 6 |
Primary Graft Rejection Rate
Primary graft rejection is defined as the absence of donor cells assessed by peripheral blood chimerism assays on day 42. Primary graft rejection can be accompanied by pancytopenia and marrow aplasia or by autologous hematopoietic reconstitution without aplasia. (NCT02757885)
Timeframe: Day 42
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 1 |
Frequency of Stroke
An overt stroke is defined as a focal neurologic event and neurologic deficit lasting > 24 hours with neuroimaging changes. (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 0 |
Rate of Central Nervous System (CNS) Toxicity
CNS toxicity will be defined as seizures, CNS hemorrhage, or PRES. PRES is defined as an increased diffusion coefficient in areas of T2 hyperintensity on diffusion-weighted imaging in the context of clinical symptoms or physical findings including headache, seizures, visual disturbances, and altered level of consciousness. (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 2 |
Rate of Disease Recurrence
Disease recurrence is defined as the return of sickle erythropoiesis (HbS level > 70%) and the absence of donor cell representation. (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 1 |
Veno-occlusive Disease (VOD) Rate
"VOD is diagnosed by the presence of ≥ 2 of the following with no other identifiable cause for liver disease:~Jaundice (direct bilirubin ≥ 2 mg/dL or > 34 μmol/L)~Hepatomegaly with right upper quadrant pain~Ascites and/or weight gain (> 5% over baseline)" (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 0 |
Frequency of Idiopathic Pneumonia Syndrome (IPS)
"IPS is diagnosed by evidence of widespread alveolar injury:~Radiographic evidence of bilateral, multi-lobar infiltrates (by chest x-ray or CT scan); AND~Evidence of abnormal respiratory physiology based upon oxygen saturation (SpO2) < 93% on room air or the need for supplemental oxygen to maintain oxygen saturation ≥ 93%; AND~Absence of active lower respiratory tract infection" (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 0 |
Event-free Survival (EFS) Rate
Event-free Survival (EFS) is defined as the survival with stable donor erythropoiesis with no new clinical evidence of sickle cell disease (SCD). Primary or late graft rejection with disease recurrence or death will count as events for this endpoint. (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 5 |
Cumulative Incidence of Neutrophil Engraftment and Platelet Engraftment.
"Cumulative incidence of Neutrophil Engraftment and Platelet Engraftment. Neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of ≥ 500/µL after conditioning.~Platelet engraftment is defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count > 50,000/µL and did not receive a platelet transfusion in the previous 7 days." (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 5 |
Chimerism Rate Following Hematopoietic Cell Transplantation for Sickle Cell Disease
Genomic DNA extracted from peripheral blood will be analyzed for variable number of tandem repeats (VNTR) to detect donor engraftment in myeloid and lymphoid fractions. (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 5 |
Infection Rate
Significant infections will be recorded including but not limited to bacterial or fungal sepsis, CMV reactivation with/without clinical disease, adenovirus infection, EBV PTLD, other significant viral reactivations or community-acquired viral infections and invasive mold infections. (NCT02757885)
Timeframe: Up to One Year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Recipient | 5 |
1RG-CART Counts in the Peripheral Blood
Number of patients with 1RG-CART levels in peripheral blood above the limit of quantification for the assay (10 cells/µL) by flow cytometry. (NCT02761915)
Timeframe: From Day 0 until end of trial (median 38.5 days, range 20 to 233 days)
| Intervention | Participants (Count of Participants) |
|---|
| Dose Level 1 | 0 |
| Dose Level 2 | 0 |
| Dose Level 3 | 0 |
| Dose Level 4 | 0 |
| Dose Level 5 | 1 |
To Evaluate Anti-tumour Activity (Progression Free Survival)
Progression free survival (progression by RECIST criteria). (NCT02761915)
Timeframe: Up to 2 years
| Intervention | Days (Median) |
|---|
| Dose Level 1 | 122 |
| Dose Level 2 | 34 |
| Dose Level 3 | 113 |
| Dose Level 4 | 39.5 |
| Dose Level 5 | 27 |
Safety and Tolerability of 1RG-CART Therapy
Number of serious adverse events, non-serious adverse events and adverse events that are related to fludarabine, cyclophosphamide or 1RG-CART. (NCT02761915)
Timeframe: From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
| Intervention | Events (Number) |
|---|
| SAEs | NSAEs | Fludarabine Related AEs | Cyclophosphamide Related AEs | 1RG-CART Related AEs |
|---|
| Dose Level 1 | 0 | 31 | NA | NA | 4 |
,| Dose Level 2 | 0 | 13 | NA | 8 | 2 |
,| Dose Level 3 | 0 | 15 | 7 | 7 | 0 |
,| Dose Level 4 | 5 | 75 | 18 | 18 | 25 |
,| Dose Level 5 | 7 | 86 | 25 | 27 | 33 |
Assessment of Tumour Response From Baseline (RECIST)
Assessment of best tumour response from baseline according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. (NCT02761915)
Timeframe: Day 28, 2 months and 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Best Response (RECIST) stable disease (SD) | Best Response (RECIST) progressive disease (PD) |
|---|
| Dose Level 1 | 2 | 1 |
,| Dose Level 2 | 0 | 1 |
,| Dose Level 3 | 1 | 0 |
,| Dose Level 4 | 1 | 1 |
,| Dose Level 5 | 1 | 2 |
Assessment of Tumour Response From Baseline (irRC)
Assessment of best tumour response from baseline according to Immune Related Response Criteria (irRC). (NCT02761915)
Timeframe: Day 28, 2 months and 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Best Response (irRC) stable disease (irSD) | Best Response (irRC) progressive disease (irPD) | Best Response (irRC) not evaluable (NE) |
|---|
| Dose Level 1 | 2 | 1 | 0 |
,| Dose Level 2 | 0 | 1 | 0 |
,| Dose Level 3 | 1 | 0 | 0 |
,| Dose Level 4 | 1 | 0 | 1 |
,| Dose Level 5 | 1 | 1 | 1 |
To Evaluate Anti-tumour Activity (Overall Survival)
Overall survival. (NCT02761915)
Timeframe: Up to 2 years
| Intervention | Days (Median) |
|---|
| Dose Level 1 | 170 |
| Dose Level 2 | 261 |
| Dose Level 3 | 113 |
| Dose Level 4 | 60 |
| Dose Level 5 | NA |
To Determine Recommended Phase II Regimen by Assessing the Number of DLTs at Each Dose Level
Number of dose limiting toxicities (DLTs) at each dose level. (NCT02761915)
Timeframe: From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
| Intervention | DLT events (Number) |
|---|
| Dose Level 1 | 0 |
| Dose Level 2 | 0 |
| Dose Level 3 | 0 |
| Dose Level 4 | 0 |
| Dose Level 5 | 0 |
Treatment Associated Toxicity
"Treatment Associated Toxicity is defined as the number of participants with Grade 3-4 adverse events associated with study treatment.~Adverse Events were classified and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4 based on changes in laboratory parameters, vital signs, and other safety assessments per standard of care." (NCT02768701)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| White blood cell decreased | Pericardial tamponade | Pain | Neutrophil count decreased | Lymphocyte count decreased | Immune system disorders | Hypoalbuminemia | Headache | Generalized muscle weakness | Gastrointestinal disorders | Fatigue | Dyspnea | Dry mouth | Diarrhea | Colitis | Blood bilirubin increased | Aspartate aminotransferase increased | Anorexia | Anemia | Alkaline phosphatase increased | Alanine aminotransferase increased |
|---|
| Experimental: Single Arm | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 2 | 1 | 2 | 1 | 1 | 2 | 1 | 2 | 1 | 1 |
The Progression Free Survival (PFS)
"PFS is defined as the time from day1 of the study treatment until disease progression or death. Disease progression is defined as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST)1.1 based on computerized tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) images or assessment of the physician.~RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT02768701)
Timeframe: Up to 5 years
| Intervention | months (Median) |
|---|
| Experimental: Single Arm | 1.8 |
Disease Control Rate (DCR)
"DCR is defined as the percentage of participants, who achieve [compete response (CR) + partial response (PR) and stable disease (SD) per RECIST1.1. If best response is SD, then it must last more than 6 months to be included in calculation of DCR, to be considered to have received clinical benefit from the treatment regimen.~RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions." (NCT02768701)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Experimental: Single Arm | 28 |
Overall Survival (OS)
OS is defined as the time from D1 of study treatment to death from any cause. (NCT02768701)
Timeframe: Up to 3 years
| Intervention | months (Median) |
|---|
| Experimental: Single Arm | 6.3 |
Quantification of the Change in Regulatory T Cells (Tregs) During the Study Treatment.
Regulatory T cells (Tregs) are counted before the treatment start and during the treatment. Methods: Blood Sample collection. (NCT02768701)
Timeframe: Up to 2 years
| Intervention | Percent Change in Tregs (Median) |
|---|
| C1D1-C1D2 | -3.3 |
| C1D1-C2D1 | 10 |
| C1D2-C2D1 | 21.7 |
Duration of Response (DOR)
DOR is defined as the time from documentation of tumor response by RECIST1.1 [(CR) + (PR)] to disease progression by RECIST 1.1. It will be measured from when the time measurement criteria are first met for complete response or partial response (whichever status is recorded first) until the first date of progressive disease or death. Patients who neither progress nor die will be censored on the date of their last tumor assessment. (NCT02768701)
Timeframe: Up to 3 years
| Intervention | months (Median) |
|---|
| Experimental: Single Arm | 20.4 |
Overall Response Rate (ORR)
"ORR is defined as the percentage of patients with [compete response (CR) + partial response (PR)] per RECIST1.1 based on computerized tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) images.~RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;" (NCT02768701)
Timeframe: Up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Experimental: Single Arm | 21 |
Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0
Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. (NCT02774291)
Timeframe: Up to 15 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (mTCR, Aldesleukin) | 2 |
Delay in Chemotherapy Administration Due to Prolonged Neutrophil Recovery
incidence of delay in chemotherapy administration due to prolonged neutrophil recovery (NCT02786719)
Timeframe: through study completion, approximately 5 months
| Intervention | chemotherapy cycles (Number) |
|---|
| High Risk Neuroblastoma Patients | 9 |
Incidence of Infection
Incidence of infections in chemotherapy cycles NOT followed by hematopoietic growth factors (NCT02786719)
Timeframe: through study completion, approximately 5 months
| Intervention | infections (Number) |
|---|
| High Risk Neuroblastoma Patients | 6 |
Interleukin-10 Change in the Peripheral Blood.
Peripheral Interleukin-10 level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence. (NCT02793856)
Timeframe: Baseline, 1 month and 3 month
| Intervention | pg/ml (Median) |
|---|
| baseline | 1 month |
|---|
| A Cohort | 5.00 | 5.00 |
Interleukin-10 Change in the Peripheral Blood.
Peripheral Interleukin-10 level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence. (NCT02793856)
Timeframe: Baseline, 1 month and 3 month
| Intervention | pg/ml (Median) |
|---|
| baseline | 1 month | 3 month |
|---|
| B Cohort | 5.00 | 19.05 | 27.10 |
,| C Cohort | 5.00 | 5.00 | 5.00 |
,| Pre-A Cohort | 5.00 | 5.00 | 5.00 |
Overall Survival (OS)
OS is defined as the time interval from date of first edited T cell infusion to the date of death due to any reason (NCT02793856)
Timeframe: The duration from date of first edited T cell infusion to the date of death due to any reason
| Intervention | weeks (Median) |
|---|
| Pre-A Cohort | 47.5 |
| A Cohort | 51.4 |
| B Cohort | 32.6 |
| C Cohort | 51.6 |
Number of Patients With Overall Response
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT02793856)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Pre-A Cohort | 0 |
| A Cohort | 0 |
| B Cohort | 0 |
| C Cohort | 0 |
Number of Patients With Disease Control at 8 Weeks
Response will be evaluated according to RECIST v1.1 for target lesions at Week 8：Complete Response (CR), Disappearance of all extranodal target lesions; Partial Response (PR) ≥ 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Disease control = CR +PR+SD (NCT02793856)
Timeframe: 8 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Pre-A Cohort | 1 |
| A Cohort | 0 |
| B Cohort | 1 |
| C Cohort | 0 |
Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA)
Driver genes mutaion stauts of Participants in ctDNA from peripheral blood were assessed by next generation sequencing (NGS), to explore the positive rate of sepicif driver genes (e.g. EGFR, ALK, ROS1, etc.) and the relationship between gene mutation status and clinical response (NCT02793856)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) |
|---|
| Pre-A Cohort | 0 |
| A Cohort | 1 |
| B Cohort | 1 |
| C Cohort | 1 |
Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients
(NCT02793856)
Timeframe: Dose Escalation - Approximately 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Pre-A Cohort | 2 |
| A Cohort | 4 |
| B Cohort | 3 |
| C Cohort | 2 |
Interleukin-6 Change in the Peripheral Blood.
Peripheral Interleukin-6 level at different timepoint (Baseline, 1 month and 3 month) was measured using rate nephelometry (NCT02793856)
Timeframe: Baseline, 1 month and 3 month
| Intervention | pg/ml (Median) |
|---|
| baseline | 1 month |
|---|
| A Cohort | 3.27 | 4.37 |
Progression Free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT02793856)
Timeframe: The time from the date of first edited T cell infusion to the date of disease progression or death due to any reason.
| Intervention | weeks (Median) |
|---|
| Pre-A Cohort | 11.7 |
| A Cohort | 8.0 |
| B Cohort | 8.1 |
| C Cohort | 6.1 |
Tumor Necrosis Factor-a Change in the Peripheral Blood.
Peripheral Tumor Necrosis Factor-a level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence. (NCT02793856)
Timeframe: Baseline, 1 month and 3 month
| Intervention | pg/ml (Median) |
|---|
| baseline | 1 month | 3 month |
|---|
| B Cohort | 8.89 | 10.40 | 10.90 |
,| C Cohort | 5.06 | 16.4 | 11.70 |
,| Pre-A Cohort | 13.84 | 10.68 | 6.97 |
Tumor Necrosis Factor-a Change in the Peripheral Blood.
Peripheral Tumor Necrosis Factor-a level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence. (NCT02793856)
Timeframe: Baseline, 1 month and 3 month
| Intervention | pg/ml (Median) |
|---|
| baseline | 1 month |
|---|
| A Cohort | 6.07 | 7.84 |
Interleukin-6 Change in the Peripheral Blood.
Peripheral Interleukin-6 level at different timepoint (Baseline, 1 month and 3 month) was measured using rate nephelometry (NCT02793856)
Timeframe: Baseline, 1 month and 3 month
| Intervention | pg/ml (Median) |
|---|
| baseline | 1 month | 3 month |
|---|
| B Cohort | 51.97 | 23.92 | 4.03 |
,| C Cohort | 10.59 | 14.77 | 12.49 |
,| Pre-A Cohort | 10.68 | 12.9 | 18.45 |
Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1)
Non-progression is defined as complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as a >=30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at baseline (SSD); Stable disease (SD) is defined as Neither sufficient shrinkage (compared to baseline) to qualify for PR or CR nor sufficient increase (taking as reference the SSD or while on study, whichever is smallest) to qualify for progressive disease (PD). (NCT02805725)
Timeframe: Phase II : 6 months after the start of treatment
| Intervention | percentage of participants (Number) |
|---|
| Interim analysis (Stage 1 of Simon's design) | Overall (stage 2 of Simon's design) |
|---|
| Phase II: Trabectedin 0.50 mg/m2 IV + CP | 23.1 | 12.5 |
Phase I: Number of Patients Who Experienced Dose-Limiting Toxicities (DLTs)
"A DLT was defined as a treatment-related (at least possibly related) adverse event using the CTCAE V4.0, occuring during the fist cycle of treatment (28 days), that meets one of the following criteria:~Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment)~Grade-3 non-haematological toxicity lasting > 7days (except for 1rst episode of nausea without maximal symptomatic/ prophylactic treatment and if toxicity is transaminitis, which may last > 7 days if total bilirubin is normal or grade-1)~Grade-3 hematologic toxicity lasting for > 7days~Grade 4 neutropenia with fever~Grade > 2 thrombocytopenia with bleeding~Is unrelated to disease, disease progression, inter-current illness, or concomitant medications." (NCT02805725)
Timeframe: During the first cycle (28 days)
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1: Trabectedin 0.30 mg/m2 IV + CP | 0 |
| Cohort 2: Trabectedin 0.40 mg/m2 IV + CP | 0 |
| Cohort 3: Trabectedin 0.50 mg/m2 IV + CP | 0 |
| Cohort 4: Trabectedin 0.60 mg/m2 IV + CP | 2 |
Phase I: Percentage of Patients With Objective Response (RECIST V1.1)
Objective response is defined as complete or partial response (CR, PR) as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as a >=30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at baseline (SSD). (NCT02805725)
Timeframe: Throughout the treatment period, an average of 6 months
| Intervention | percentage of participants (Number) |
|---|
| Cohort 1: Trabectedin 0.30 mg/m2 IV + CP | 0 |
| Cohort 2: Trabectedin 0.40 mg/m2 IV + CP | 0 |
| Cohort 3: Trabectedin 0.50 mg/m2 IV + CP | 0 |
| Cohort 4: Trabectedin 0.60 mg/m2 IV + CP | 0 |
Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP.
MTD was determined by testing increasing doses of trabectedin up to 0.60 mg/m2 via IV on dose escalation cohorts 1 to 4 with 3 to 6 participants each.The MTD is defined as the highest dose at which no more than 1 in 6 of the patients in the cohort experienced a DLT in the first treatment cycle. See subsequent primary outcome measure for the DLT definition. (NCT02805725)
Timeframe: During the first cycle (28 days)
| Intervention | mg/m^2 (Number) |
|---|
| Phase I: Evaluable for Safety | 0.50 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 74.52 |
Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration. (NCT02828358)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|
| KMT2A-Rearranged | 6.45 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 78.17 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 76.5 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 75.54 |
GVHD-free Relapse-free Survival (GRFS)
Number of participants alive, without relapse, and without GVHD at 1 year. (NCT02833805)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 19 |
Number of Participants Who Experience Grades III-IV Acute GVHD
Number of participants who experience grade III or IV acute GVHD by Day 100. (NCT02833805)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 2 |
Probability of Platelet Recovery as Assessed by Number of Participants Who Have Recovered Platelet Counts
Probability of platelet recovery will be assessed by the number of participants who have recovered platelet counts at 1 year. (NCT02833805)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 20 |
Number of Participants Who Experience Chronic GVHD
Number of participants who experience chronic GVHD by two years after BMT. (NCT02833805)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 1 |
Number of Participants Who Experience Grades II-IV Acute GVHD
Number of participants who experience grade II, III, or IV acute GVHD by Day 100. (NCT02833805)
Timeframe: Day 100
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 4 |
Number of Participants Who Experience Primary Graft Failure
Number of participants who experience primary graft failure by one year after BMT. (NCT02833805)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 21 |
Number of Participants Who Experience Secondary Graft Failure
Number of participants who experience secondary graft failure by one year after BMT. (NCT02833805)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 19 |
Number of Participants With Full Donor Chimerism
Number of participants with full donor chimerism at Day 60. (NCT02833805)
Timeframe: Day 60
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 21 |
Overall Survival and Engraftment at One Year
Number of enrolled participants who receive BMT, achieve engraftment, and are alive at one year post bone marrow transplant (BMT). (NCT02833805)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 19 |
Overall Survival at One Year
Number of participants alive at one year after BMT. (NCT02833805)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 19 |
Probability of Neutrophil Recovery as Assessed by the Number of Participants Who Have Recovered Neutrophil Counts
Probability of neutrophil recovery will be assessed by the number of participants who have recovered neutrophil counts at 1 year (>500 ANC). (NCT02833805)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Bone Marrow Transplant | 21 |
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events
The highest observed adverse event will be tabulated by grade across all dose levels and cycles. (NCT02853318)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| No Adverse Events | Grade I | Grade II | Grade III | Grade IV | Grade V |
|---|
| Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide) | 1 | 9 | 20 | 9 | 1 | 0 |
Progression-free Survival (PFS)
Will be summarized using standard Kaplan-Meier methods, with estimates of median survival and given survival rates will be obtained with 90% confidence intervals. (NCT02853318)
Timeframe: Time from the start of the study treatment until PFS event, assessed up to 1 year after the last subject enrolls
| Intervention | months (Median) |
|---|
| Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide) | 10.0 |
Duration of Overall Survival
Will be summarized using standard Kaplan-Meier methods, with estimates of median survival and given survival rates will be obtained with 90% confidence intervals. (NCT02853318)
Timeframe: Up to 1 year after enrollment of the last subject
| Intervention | months (Median) |
|---|
| Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide) | 16.0 |
Objective Tumor Response Assessed by Modified RECIST Version 1.1 Criteria
"Frequency of response will be summarized with a 90% confidence interval.~An objective response is defined as a CR or PR, while a non-responder is defined as a SD or PD." (NCT02853318)
Timeframe: Up to 6 months after enrollment start of treatment
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Pembrolizumab, Bevacizumab, Cyclophosphamide) | 0.475 |
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported. (NCT02855359)
Timeframe: Up to 183 days
| Intervention | Participants (Count of Participants) |
|---|
| Alanine aminotransferase increased | Hypoalbuminemia | Alkaline phosphatase increased | Aspartate aminotransferase increased | Blood bilirubin increased | Hypercalcemia | Hypocalcemia | Hyperglycemia | Hypoglycemia | Hypermagnesemia | Hypomagnesemia | Hypophosphatemia | Hypokalemia | Hypernatremia | Hyponatremia | Hyperuricemia | Anemia | Leukopenia | Lymphopenia | Neutropenia | Thrombocytopenia |
|---|
| Denintuzumab Mafodotin + RCHOP | 4 | 4 | 8 | 9 | 4 | 0 | 5 | 11 | 4 | 4 | 4 | 5 | 7 | 1 | 12 | 1 | 12 | 13 | 13 | 11 | 13 |
,| Denintuzumab Mafodotin + RCHP | 3 | 3 | 5 | 5 | 0 | 3 | 5 | 8 | 1 | 0 | 4 | 5 | 6 | 1 | 4 | 0 | 10 | 10 | 9 | 9 | 10 |
Part A and Part B Outcome Measure: Incidence of Adverse Events
Part A data only; study did not progress to Part B. (NCT02855359)
Timeframe: 54.7 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Any Treatment-emergent adverse event (TEAE) | Any Grade 3-5 TEAE | Any Treatment-related Adverse Event (AE) | Any DM treatment-related AE | Any RCHOP/RCHP treatment-related AE | Any AE with Outcome of Death | Any Serious Adverse Event (SAE) | Any Treatment-Related SAE | Any DM Treatment-Related SAE |
|---|
| Denintuzumab Mafodotin + RCHOP | 13 | 12 | 13 | 13 | 13 | 1 | 4 | 3 | 2 |
,| Denintuzumab Mafodotin + RCHP | 11 | 11 | 10 | 9 | 10 | 2 | 5 | 4 | 2 |
Immune Reconstitution of Flow Cytometry
Quantitative assessments of peripheral blood CD3, CD4, CD8, CD19, and CD56 positive lymphocytes will be done through flow cytometric analysis. (NCT02918292)
Timeframe: Baseline, Days 100, 180, and 365
| Intervention | cells/uL (Mean) |
|---|
| CD3 at Baseline | CD3 at Day 100 | CD3 at 6 Months | CD3 at 1 Year | CD4 at Baseline | CD4 at Day 100 | CD4 at 6 Months | CD4 at 1 Year | CD8 at Baseline | CD8 at Day 100 | CD8 at 6 Months | CD8 at 1 Year | CD19 at Baseline | CD19 at Day 100 | CD19 at 6 Months | CD19 at 1 Year | CD56 at Baseline | CD56 at Day 100 | CD56 at 6 Months | CD56 at 1 Year |
|---|
| Haplo Bone Marrow HSCT | 862 | 550.8 | 640.5 | 1121 | 434.1 | 122.3 | 172.6 | 472.7 | 326.9 | 272.9 | 333.3 | 569.7 | 106.2 | 221.1 | 204.8 | 264.6 | 124.6 | 237.6 | 260.3 | 293.2 |
Immune Reconstitution of Quantitative Immunoglobulins
Quantitative immunoglobulins of IgA, IgG, IgM were done at baseline and 1-year post-transplant. (NCT02918292)
Timeframe: baseline and 1-year
| Intervention | mg/dL (Mean) |
|---|
| IgA at Baseline | IgA at 1 Year | IgG at Baseline | IgG at 1 Year | IgM at Baseline | IgM at 1 Year |
|---|
| Haplo Bone Marrow HSCT | 172.3 | 111.6 | 987.5 | 1004 | 102.8 | 96 |
Percentage of Participants With Graft-Failure-Free Survival
Events for Graft-Failure-Free Survival (GFFS) including death, primary graft failure, secondary graft failure. The time to this event is the time from transplant to death from any cause, or graft failure, or last follow-up, or 1 year from transplant, whichever occurs first. For patients experiencing primary graft failure, Day 0.1 was used for primary graft failure event date to count the event in. The one-year GFFS probability and its 95% confidence interval were estimated using the Kaplan-Meier estimator and Greenwood's formula. (NCT02918292)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Haplo Bone Marrow HSCT | 77.4 |
Percentage of Participants With Primary Graft Failure
Primary graft failure is defined by the lack of neutrophil engraftment by Day 56 post-HSCT or failure to achieve at least 5% donor chimerism (whole blood or marrow) on any measurements up to and including Day +56. For this protocol, lineage-specific, myeloid, and T cell chimerisms are required. Myeloid engraftment might not proceed at the same rate as T cell engraftment. If myeloid has greater than or equal to 5% donor, even if T cell compartment does not, this is not considered primary graft failure. Secondary graft failure is defined by initial neutrophil engraftment (ANC greater than or equal to 0.5 x 10^8/L measured for 3 consecutive measurements on different days) followed by sustained subsequent decline in ANC to less than 0.5 x 10^9/L for three consecutive measurements on different days or initial whole blood or marrow donor chimerism greater than or equal to 5%, but then declining to less than 5% on subsequent measurements or second infusion/transplant given for graft failure. (NCT02918292)
Timeframe: Day 56
| Intervention | percentage of participants (Number) |
|---|
| Haplo Bone Marrow HSCT | 12.9 |
Frequencies of Infections Categorized by Infection Type
The number of systemic infections is reported. Infections are categorized by infection type. A participant can report multiple types of infections, so the categories are not mutually exclusive for participants. All grade 2 and grade 3 infections, as defined by the BMT CTN Technical MOP, occurring post transplantation were reported on the study. (NCT02918292)
Timeframe: 1 Year
| Intervention | infections (Number) |
|---|
| Bacterial infection | Viral infection | Fungal infection | Protozoal infection | Other infection |
|---|
| Haplo Bone Marrow HSCT | 26 | 32 | 3 | 0 | 3 |
Percentage of Participants With Acute Graft-vs-host-disease (GVHD)
Acute GVHD is graded by consensus grading (Przepiorka 1995) per BMTCTN manual of procedures (MOP). Acute GVHD is graded by consensus grading (Przepiorka 1995) per BMTCTN manual of procedures (MOP). The time of onset of grades II-IV and grades III-IV acute GVHD were recorded. This endpoint is evaluated through 100 days post-transplant. Cumulative percentage of acute GVHD post-transplant are estimated using the cumulative incidence function, treating death prior to acute GVHD as the competing risk. (NCT02918292)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| Haplo Bone Marrow HSCT | 16.1 |
Percentage of Participants With Chronic GVHD
The event for this secondary endpoint is any chronic GVHD based on 2014 NIH Consensus Criteria. This includes mild, moderate and severe chronic GVHD. The analyses of Chronic GVHD use the site-reported data. The cumulative percentage of chronic GVHD is computed using the cumulative incidence function, treating death prior to chronic GVHD as a competing risk. Eight organs will be scored on a 0-3 scale to reflect degree of chronic GVHD involvement. Liver and pulmonary function test results and use of systemic therapy for treatment of chronic GVHD will also be recorded. This secondary endpoint of chronic GVHD will include mild, moderate and severe chronic GVHD based on NIH Consensus Criteria. (NCT02918292)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Haplo Bone Marrow HSCT | 25.8 |
Percentage of Participants With Overall Survival (OS)
Overall survival (OS) is the primary endpoint of this study. The time to this event is the time from transplant to death from any cause or last follow-up or 1 year from transplant, whichever occurs first. The one-year OS probability and its 95% confidence interval were estimated using the Kaplan-Meier estimator and Greenwood's formula. (NCT02918292)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Haplo Bone Marrow HSCT | 80.6 |
Percentage of Participants With Platelet Recovery
Platelet recovery is defined by achieving a platelet count > 20 x 10^9/L with no platelet transfusions in the preceding seven days. The first day of the sustained platelet count will be defined as the day of platelet engraftment. The cumulative percentage of platelet engraftment was estimated with a 95% confidence interval using the Aalen-Johansen estimator with death prior to platelet engraftment treated as a competing risk. (NCT02918292)
Timeframe: Day 100
| Intervention | percentage of participants (Number) |
|---|
| Haplo Bone Marrow HSCT | 77.4 |
Participants With Grade 3-5 Toxicities by SOC
Toxicities are evaluated for the study participants at Day 28, Day 56, Day 100, Day 180 and Day 365 post-transplant and graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3-5 toxicities are reported with higher grade indicating worse outcomes. Toxicities are summarized here by system organ class (SOC). A participant can report multiple toxicities, so the categories are not mutually exclusive for participants. (NCT02918292)
Timeframe: 1 Year
| Intervention | Participants (Count of Participants) |
|---|
| Abnormal Liver Symptoms | Blood and Lymphatic Disorders | Cardiovascular Disorders | Chemistry/Investigations | GI Disorders | General Disorders | Hemorrhagic Disorders | Hepatic Disorders | Immune System Disorders | Metabolism and Nutrition Disorders | Musculoskeletal and Connective Tissue Disorders | Nervous System Disorders | Renal Disorders | Respiratory, Thoracic and Mediastinal Disorders | Total (any of above SOC) |
|---|
| Haplo Bone Marrow HSCT | 7 | 1 | 15 | 2 | 10 | 5 | 3 | 6 | 1 | 7 | 1 | 4 | 5 | 8 | 23 |
Percentage of Participants With Neutrophil Recovery
Neutrophil recovery is achieving an absolute neutrophil count (ANC) > 0.5 x10^9/L for three consecutive measurements on different days, with the first of the three days being defined as the day of neutrophil engraftment. The cumulative percentage of neutrophil engraftment was estimated with a 95% confidence interval using the Aalen-Johansen estimator with death prior to neutrophil engraftment treated as a competing risk. (NCT02918292)
Timeframe: Day 28 and 56
| Intervention | percentage of participants (Number) |
|---|
| Day 28 | Day 56 |
|---|
| Haplo Bone Marrow HSCT | 93.5 | 93.5 |
Percentage of Participants With Cytomegalovirus (CMV), Epstein Barr Virus (EBV) or Post-Transplant Lymphoproliferative Disease (PTLD)
CMV viremia and disease, EBV viremia, and PTLD are monitored and reported per protocol. The cumulative percentage of each outcome was estimated with a 95% confidence interval using the Aalen-Johansen estimator with death prior to event treated as a competing risk. (NCT02918292)
Timeframe: 1 Year
| Intervention | percentage of participants (Number) |
|---|
| Cumulative Percentage of Participants with EBV | Cumulative Percentage of Participants with CMV | Cumulative Percentage of Participants with PTLD |
|---|
| Haplo Bone Marrow HSCT | 9.7 | 22.6 | 6.5 |
Percentage of Participants With Secondary Graft Failure
"Secondary graft failure is defined as any one of the following:~Initial neutrophil engraftment (ANC greater than or equal to 0.5 x10^9/L measured for three consecutive measurements on different days) followed by sustained subsequent decline in ANC to less than 0.5 x 10^9/L for three consecutive measurements on different days;~Initial whole blood or marrow donor chimerism greater than or equal to 5%, but then declining to less than 5% on subsequent measurements;~Second infusion/transplant given after Day 56 for graft failure." (NCT02918292)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Haplo Bone Marrow HSCT | 3.2 |
Phase 1 and 2: Percentage of Participants With Anti-KTE-C19 Antibodies
(NCT02926833)
Timeframe: Baseline up to approximately 2.5 years
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 0 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 0 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 |
Phase 1 and 2: Percentage of Participants With Anti-Atezolizumab Antibodies
(NCT02926833)
Timeframe: Baseline up to approximately 2.5 years
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 0 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 0 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 |
Phase 1 and 2: Percentage of Participants Experiencing Adverse Events (AEs)
(NCT02926833)
Timeframe: Enrollment up to 30 days after completion of the final dose of atezolizumab, or 3 months after the KTE-C19 infusion, whichever was longer (up to approximately 2.5 years)
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 100 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 100 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 100 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 100 |
Phase 1 and 2: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood
(NCT02926833)
Timeframe: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
| Intervention | ng/mL (Median) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | 17.25 |
Phase 1 and 2: Atezolizumab Levels in Blood
(NCT02926833)
Timeframe: Days 1, 14, 21, 22, 35, 42, 43, 56, 63, 64, 77, 84, 154, and 174
| Intervention | ng/mL (Mean) |
|---|
| Day 14 | Day 35 | Day 56 | Day 77 |
|---|
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 435000 | 84200 | 176000 | 240000 |
Phase 1 and 2: Peak Serum Levels of C-Reactive Protein (CRP) in Blood
(NCT02926833)
Timeframe: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
| Intervention | mg/L (Median) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | 174.03 |
Phase 1 and 2: Peak Anti-CD19 CAR T-Cell (KTE-C19) Level (Maximum Observed Plasma Concentration) in Blood
(NCT02926833)
Timeframe: Pre-infusion (Baseline); Post-infusion: Days 7 (Phase 2), 14, 22 (Phase 2), 28 (Phase 2; optional), 35 (Phase 1, Cohort 3; optional), 43, 49 (optional), 64, 69 (optional), 94; long-term follow-up: every 3 months from Month 6 to Month 18, and Month 24
| Intervention | cells/μL (Mean) |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 86.87 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 167.88 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 60.71 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 60.22 |
Phase 1 and 2: Overall Survival (OS)
OS was defined as the time from KTE-C19 infusion to the date of death from any cause. The Kaplan-Meier approach was used to estimate OS. (NCT02926833)
Timeframe: From the date of first KTE-C19 infusion to the date of death regardless of cause (up to approximately 2.5 years)
| Intervention | months (Median) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | NA |
Phase 1 and 2: Complete Response Rate (CRR)
CRR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. (NCT02926833)
Timeframe: Month 6
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | 46 |
Phase 1 and 2: Duration of Response (DOR)
DOR for participants who experienced an objective response was defined as the date of their first confirmed objective response (CR or PR) to disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death regardless of cause. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate DOR. (NCT02926833)
Timeframe: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 2.5 years)
| Intervention | months (Median) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | NA |
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values
(NCT02926833)
Timeframe: Enrollment up to 30 days after completion of the final dose of atezolizumab, or 3 months after the KTE-C19 infusion, whichever was longer (up to approximately 2.5 years)
| Intervention | percentage of participants (Number) |
|---|
| Shift to Grade 3 albumin | Shift to Grade 3 calcium | Shift to Grade 4 calcium | Shift to Grade 3 phosphate | Shift to Grade 4 phosphate | Shift to Grade 3 potassium | Shift to Grade 3 sodium | Shift to Grade 4 glucose |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 33 | 33 | 0 | 67 | 0 | 0 | 67 | 0 |
,| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 0 | 0 | 0 | 67 | 0 | 0 | 0 | 0 |
,| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 | 0 | 0 | 33 | 0 | 0 | 17 | 17 |
,| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 9 | 5 | 18 | 36 | 36 | 14 | 14 | 0 |
Phase 1 and 2: Objective Response Rate (ORR)
ORR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a CR or partial response (PR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Participants who did not meet the criteria for objective response by the analysis cutoff date were considered non-responders. (NCT02926833)
Timeframe: From enrollment until first occurrence of CR or PR (up to approximately 2.5 years)
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | 75 |
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Values
(NCT02926833)
Timeframe: Enrollment up to 30 days after completion of the final dose of atezolizumab, or 3 months after the KTE-C19 infusion, whichever was longer (up to approximately 2.5 years)
| Intervention | percentage of participants (Number) |
|---|
| Shift to Grade 3 hemoglobin | Shift to Grade 3 leukocytes | Shift to Grade 4 leukocytes | Shift to Grade 4 lymphocytes | Shift to Grade 3 neutrophils | Shift to Grade 4 neutrophils | Shift to Grade 3 platelets | Shift to Grade 4 platelets |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 100 | 0 | 100 | 100 | 0 | 100 | 33 | 33 |
,| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 67 | 0 | 100 | 100 | 33 | 67 | 0 | 67 |
,| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 83 | 33 | 67 | 100 | 17 | 83 | 17 | 17 |
,| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 59 | 18 | 77 | 86 | 14 | 73 | 18 | 32 |
Phase 1 and 2: Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-8, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood
(NCT02926833)
Timeframe: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
| Intervention | pg/mL (Median) |
|---|
| CXCL 10 | IFN-γ | IL-1RA | IL-2 | IL-6 | IL-8 | IL-15 | TNF-α |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | 2000.00 | 587.80 | 2801.20 | 17.55 | 121.55 | 180.65 | 48.95 | 8.20 |
Phase 1 and 2: Atezolizumab Levels in Blood
(NCT02926833)
Timeframe: Days 1, 14, 21, 22, 35, 42, 43, 56, 63, 64, 77, 84, 154, and 174
| Intervention | ng/mL (Mean) |
|---|
| Day 21 | Day 42 | Day 63 | Day 84 | Day 174 |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 403000 | 98800 | 175000 | 209000 | 91000 |
Phase 1 and 2: Atezolizumab Levels in Blood
(NCT02926833)
Timeframe: Days 1, 14, 21, 22, 35, 42, 43, 56, 63, 64, 77, 84, 154, and 174
| Intervention | ng/mL (Mean) |
|---|
| Day 1 | Day 22 | Day 43 | Day 64 | Day 154 |
|---|
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 323000 | 110000 | 136000 | 199000 | 66800 |
Phase 1 and 2: Peak Serum Levels of Ferritin in Blood
(NCT02926833)
Timeframe: Baseline (pre-conditioning chemotherapy); Day 0 (pre-KTE-C19 infusion); Days 1, 4, 7, and 14, and 22 , optional Day 28 (Phase 2) or Day 35 (Phase 1 Cohort 3), optional Day 49, optional Day 69, and Day 94 post-KTE-C19 infusion
| Intervention | μg/mL (Median) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | 1.54 |
Phase 1 and 2: Percentage of Participants With Serum Chemistry Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values
ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase. (NCT02926833)
Timeframe: Enrollment up to 30 days after completion of the final dose of atezolizumab, or 3 months after the KTE-C19 infusion, whichever was longer (up to approximately 2.5 years)
| Intervention | percentage of participants (Number) |
|---|
| Shift to Grade 3 ALT | Shift to Grade 4 ALT | Shift to Grade 3 ALP | Shift to Grade 3 AST | Shift to Grade 4 AST | Shift to Grade 3 bilirubin | Shift to Grade 4 calcium | Shift to Grade 3 creatinine | Shift to Grade 4 creatinine | Shift to Grade 3 direct bilirubin | Shift to Grade 3 glucose | Shift to Grade 4 glucose |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 33 | 0 | 0 |
,| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 33 | 0 | 0 |
,| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 | 0 | 0 |
,| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 5 | 5 | 14 | 9 | 5 | 9 | 5 | 9 | 5 | 14 | 18 | 14 |
Phase 1 and 2: Atezolizumab Levels in Blood
(NCT02926833)
Timeframe: Days 1, 14, 21, 22, 35, 42, 43, 56, 63, 64, 77, 84, 154, and 174
| Intervention | ng/mL (Mean) |
|---|
| Day 1 | Day 22 | Day 43 | Day 64 |
|---|
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 373000 | 73900 | 138000 | 159000 |
Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
A DLT was defined as the following KTE-C19-related or ATZ-related events with an onset from immediately after the first ATZ infusion through 21 days after the first ATZ infusion: Grade 4 hematologic toxicity lasting > 30 days (except lymphopenia or B-cell aplasia); All KTE-C19- or ATZ-related Grade 3 non-hematologic toxicities lasting for > 7 days and all KTE-C19- or ATZ-related Grade 4 non-hematologic toxicities regardless of duration. (NCT02926833)
Timeframe: Baseline up to 21 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 0 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 0 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 1 |
Phase 1 and 2: Progression-Free Survival (PFS)
PFS was defined as the time from the KTE-C19 infusion date to the date of disease progression per the revised International Working Group Response Criteria for Malignant Lymphoma (Cheson, 2007) or death from any cause. Disease progression was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. The Kaplan-Meier approach was used to estimate PFS. (NCT02926833)
Timeframe: From the date of first KTE-C19 infusion to disease progression or death regardless of cause (up to approximately 2.5 years )
| Intervention | months (Median) |
|---|
| Phase 1 (Cohort 3) + Phase 2: KTE-C19 + ATZ | NA |
Phase 1 and 2: Percentage of Participants With Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values
(NCT02926833)
Timeframe: Enrollment up to 30 days after completion of the final dose of atezolizumab, or 3 months after the KTE-C19 infusion, whichever was longer (up to approximately 2.5 years)
| Intervention | percentage of participants (Number) |
|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19) | 0 |
| Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19) | 0 |
| Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 |
| Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19) | 0 |
Overall Survival (OS)
Overall survival (OS) was measured from the date of first dose (start of induction) to the date of death due to any cause. (NCT02951819)
Timeframe: Up to 36 months
| Intervention | Months (Median) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | NA |
| Relapsed Multiple Myeloma (RMM) | NA |
Percentage of Participants With Treatment Emergent-Adverse Event
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and approximately up to 36 months that were absent before treatment or that worsened relative to pre-treatment state. (NCT02951819)
Timeframe: Up to 36 months
| Intervention | Percentage of participants (Number) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | 100.0 |
| Relapsed Multiple Myeloma (RMM) | 100.0 |
Time to Disease Progression (TTP)
TTP was defined as the time between the date of first dose (start of induction) and the date of first documented evidence of confirmed PD, as defined in the IMWG response criteria. PD per IMWG criteria: Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/deciliter (dL) and >=200 mg/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow PC% (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. (NCT02951819)
Timeframe: Approximately 15 months
| Intervention | Months (Median) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | NA |
| Relapsed Multiple Myeloma (RMM) | 13.31 |
Duration of Response (DOR)
DOR was defined for participants with a confirmed response (PR or better) as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria or death due to progressive disease. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200 mg/24hours. If serum and urine M-protein are unmeasurable, a >=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in PCs is required in place of M-protein, provided baseline bone marrow PCs % was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT02951819)
Timeframe: Up to 36 months
| Intervention | Months (Median) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | NA |
| Relapsed Multiple Myeloma (RMM) | 20.7 |
Progression Free Survival (PFS)
PFS: duration from date of first dose (start of induction) to date of first documented evidence of progressive disease (PD) based on computerized algorithm per IMWG criteria or death due to any cause, whichever occurred first. PD: 25% increase from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/dL and >=200 mg/24 hours respectively);Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase>10 mg/dL);Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow PC% (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. (NCT02951819)
Timeframe: Up to 36 months
| Intervention | Months (Median) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | NA |
| Relapsed Multiple Myeloma (RMM) | 21.7 |
Time to Partial Response (PR) or Better
Time to PR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (PR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. PR is defined as per IMWG criteria as >= 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >= 90% or to < 200 mg/24hours. If the serum and urine M-protein are unmeasurable, a>= 50% decrease in the difference between involved and uninvolved Free light chain (FLC) levels is required in the place of the M-protein criteria. If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cells percentage was >=30%. In addition to the above listed criteria, if present at baseline, a >= 50% reduction in the size of soft tissue plasmacytomas is also required. (NCT02951819)
Timeframe: Up to 12 months
| Intervention | Months (Median) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | 1.0 |
| Relapsed Multiple Myeloma (RMM) | 1.0 |
Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR)
Percentage of participants who achieved CR or VGPR (as per International Myeloma Working Group [IMWG] criteria) was reported. CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percent (%) plasma cells (PC) in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90% reduction in serum M-protein plus urine M-protein level < 100 milligram per 24 hours (mg/24hours). (NCT02951819)
Timeframe: After 4 cycles of Induction (Approximately 4 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | 44.2 |
| Relapsed Multiple Myeloma (RMM) | 57.1 |
Time to Very Good Partial Response (VGPR) or Better
Time to VGPR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (VGPR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. VGPR is defined by IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90 % reduction in serum M-protein plus urine M-protein level < 100 milligram/24 hours (mg/24 hours). (NCT02951819)
Timeframe: Up to 36 months
| Intervention | Months (Median) |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | 3.8 |
| Relapsed Multiple Myeloma (RMM) | 1.8 |
Overall Response Rate (ORR)
ORR: percentage of participants achieved PR or better (PR,VGPR,CR,sCR) per IMWG. CR:negative immunofixation on serum, urine, disappearance of soft tissue plasmacytomas,<5% PCs in bone marrow(BM). sCR:CR plus normal FLC ratio,absence of clonal cells in BM by immunohistochemistry, immunofluorescence. VGPR:Serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24hours. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200mg/24hours. If serum, urine M-protein unmeasurable, a>=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum, urine M-protein not measurable, serum free light assay is not measurable,>=50% reduction in PCs required in place of M-protein,provided baseline bone marrow PCs% >=30%, if present at baseline, a >=50% reduction in size of soft tissue plasmacytomas is also required. (NCT02951819)
Timeframe: After 4 Cycles of Induction (4 months), at End of Induction (4 to 8 months) and at the End of Maintenance (12 months)
| Intervention | Percentage of participants (Number) |
|---|
| After 4 Cycles of Induction | At the End of Induction | At the End of Maintenance |
|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | 79.1 | 87.2 | 89.5 |
,| Relapsed Multiple Myeloma (RMM) | 71.4 | 78.6 | 85.7 |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events. (NCT02953340)
Timeframe: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
| Intervention | Participants (Count of Participants) |
|---|
| TEAEs | SAEs | Death |
|---|
| (Arm 1): SPI-2012 and TC | 115 | 12 | 0 |
,| (Arm 1): SPI-2012 and TC: Follow-up Period | 33 | 2 | 0 |
,| (Arm 2): Pegfilgrastim and TC | 116 | 19 | 1 |
,| Arm 2: Pegfilgrastim and TC: Follow-up Period | 48 | 4 | 0 |
Relative Dose Intensity (RDI) of TC Chemotherapy
RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles. (NCT02953340)
Timeframe: Cycles 1, 2, 3 and 4 (each cycle = 21 days)
| Intervention | Percentage of planned dose (Mean) |
|---|
| Docetaxel | Cyclophosphamide |
|---|
| (Arm 1): SPI-2012 and TC | 96.9 | 98.4 |
,| (Arm 2): Pegfilgrastim and TC | 98.4 | 98.8 |
Depth of ANC Nadir in Cycle 1
The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1. (NCT02953340)
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
| Intervention | 10^9 cells/L (Mean) |
|---|
| (Arm 1): SPI-2012 and TC | 2.67 |
| (Arm 2): Pegfilgrastim and TC | 2.06 |
Duration of Severe Neutropenia (DSN) in Cycle 1
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count [ANC] <0.5×10^9 per liter [L]) from the first occurrence of ANC below the threshold. (NCT02953340)
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
| Intervention | Days (Mean) |
|---|
| (Arm 1): SPI-2012 and TC | 0.31 |
| (Arm 2): Pegfilgrastim and TC | 0.39 |
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
FN was defined as an oral temperature >38.3 degree Celsius (°C) (101.0 degrees Fahrenheit [°F]) or two consecutive readings of >38.0°C (100.4°F) for 2 hours and ANC <1.0×10^9/L. (NCT02953340)
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
| Intervention | Participants (Count of Participants) |
|---|
| (Arm 1): SPI-2012 and TC | 1 |
| (Arm 2): Pegfilgrastim and TC | 4 |
Number of Participants With Neutropenic Complications in Cycle 1
Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia. (NCT02953340)
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
| Intervention | Participants (Count of Participants) |
|---|
| (Arm 1): SPI-2012 and TC | 1 |
| (Arm 2): Pegfilgrastim and TC | 5 |
Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
Time to ANC recovery was defined as the time from chemotherapy administration until the participants ANC increased to >=1.5×10^9/L after the expected nadir. For participants with ANC value >=1.5×10^9/L at all times, time to ANC Recovery was assigned a value of 0. (NCT02953340)
Timeframe: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
| Intervention | Days (Mean) |
|---|
| (Arm 1): SPI-2012 and TC | 3.49 |
| (Arm 2): Pegfilgrastim and TC | 3.35 |
Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
DSN was defined as the number of days of severe neutropenia (ANC <0.5×10^9/L) from the first occurrence of ANC below the threshold. (NCT02953340)
Timeframe: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
| Intervention | Days (Mean) |
|---|
| Cycle 2 | Cycle 3 | Cycle 4 |
|---|
| (Arm 1): SPI-2012 and TC | 0.08 | 0.07 | 0.07 |
,| (Arm 2): Pegfilgrastim and TC | 0.09 | 0.07 | 0.08 |
Number of Participants With Clinically Significant Laboratory Abnormalities
The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase [ALT], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03. (NCT02953340)
Timeframe: Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
| Intervention | Participants (Count of Participants) |
|---|
| Hematology: Basophils | Hematology: Basophils/Leukocytes | Hematology: Eosinophils | Hematology: Eosinophils/Leukocytes | Hematology: Hematocrit | Hematology: Hemoglobin | Hematology: Lymphocytes | Hematology: Lymphocytes/Leukocytes | Hematology: Monocytes | Hematology: Monocytes/Leukocytes | Hematology: Neutrophils | Hematology: Neutrophils/Leukocytes | Hematology: Platelets | Hematology: White Blood Cells | Chemistry: Alanine aminotransferase | Chemistry: Alkaline phosphatase | Chemistry: Aspartate aminotransferase | Chemistry: Bilirubin | Chemistry: Calcium | Chemistry: Cholesterol | Chemistry: Creatinine | Chemistry: Potassium | Chemistry: Sodium | Chemistry: Triglycerides |
|---|
| (Arm 1): SPI-2012 and TC | 0 | 0 | 0 | 0 | 4 | 6 | 0 | 6 | 0 | 0 | 17 | 12 | 10 | 16 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,| (Arm 2): Pegfilgrastim and TC | 0 | 0 | 0 | 0 | 2 | 4 | 0 | 13 | 0 | 0 | 23 | 9 | 2 | 18 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 2 | 0 |
Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
FN was defined as an oral temperature >38.3°C (101.0°F) or two consecutive readings of >38.0°C (100.4°F) for 2 hours and ANC <1.0×10^9/L. (NCT02953340)
Timeframe: Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
| Intervention | Participants (Count of Participants) |
|---|
| Cycle 2 | Cycle 3 | Cycle 4 |
|---|
| (Arm 1): SPI-2012 and TC | 0 | 0 | 0 |
,| (Arm 2): Pegfilgrastim and TC | 2 | 0 | 0 |
Evaluation of Myeloid-derived Suppressor Cells (MDSC) Identified in Blood Samples Post-pembrolizumab Compared to MDSC Found in Blood Samples Collected at Baseline.
Evaluate the level of circulating MDSC per ml of blood at baseline, following treatment with pembrolizumab administered after decitabine. (NCT02957968)
Timeframe: Assessed at end of administration of decitabine and pembrolizumab Day- Window of time Days 25-29
| Intervention | Absolute cell count per ml of blood (Mean) |
|---|
| Baseline- Granulocytic | Post Pembrolizumab- Granulocytic | Change(Post Pembro-Baseline) Granulocytic | Baseline- Monocytic | Post Pembrolizumab- Monocytic | Change (Post Pembro- Baseline)- Monocytic | Baseline- Total MDSC | Post Pembrolizumab- Total MDSC | Change (Post Pembro-Baseline)- Total MDSC |
|---|
| Cohort A: Triple Negative Breast Cancer (TNBC) | 13271.20 | 33099.40 | 19828.20 | 59222.05 | 22499.95 | -36722.10 | 83927.60 | 74569.75 | -9357.85 |
,| Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab | 77038.71 | 63045.29 | -13993.43 | 15843.29 | 18028.43 | 2185.14 | 138957.43 | 133082.00 | -5875.43 |
,| Cohort B: HER2-negative Hormone Receptor-positive Tumors | 22575.50 | 25780.33 | 3204.83 | 45450.33 | 21651.56 | -23798.78 | 213321.11 | 78836.72 | -134484.39 |
The Percentage of Increase in Tumor and Stroma With Infiltrating Lymphocytes (TIL) From Baseline Pre-treatment Biopsy to Post-immunotherapy Biopsy Following Administration of Decitabine Followed by Pembrolizumab.
To determine and quantify if treatment with neoadjuvant decitabine followed by pembrolizumab increases lymphocyte infiltration into tumor and/or stroma in patients with locally advanced, HER2-negative breast cancer. (NCT02957968)
Timeframe: Baseline pre-treatment biopsy to post-immunotherapy biopsy following administration of decitabine followed by pembrolizumab, 3-7 day window after Day 22 medication administration, about one month
| Intervention | % of stromal area occupied by TIL (Mean) |
|---|
| Baseline | Post Treatment | Absolute Change Value |
|---|
| Cohort A: Triple Negative Breast Cancer (TNBC) | 27.35 | 35.00 | 7.65 |
,| Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab | 25.83 | 32.50 | 6.67 |
,| Cohort B: HER2-negative Hormone Receptor-positive Tumors | 17.50 | 23.57 | 6.07 |
Evaluation of Expression of Protein Programmed Death-Ligand 1 (PD-L1) Within Tumor, Stroma, and Infiltrating Immune Cells Combined, at Baseline and Following Immunotherapy.
To evaluate the correlation of pre-existing and post-immunotherapy immune response signatures with response to neoadjuvant chemotherapy. The number of PD-L1 positive cells (including tumor cells, lymphocytes, and macrophages) divided by the total number of tumor cells (PD-L1 positive or negative) in an area. (NCT02957968)
Timeframe: Assessed at end of administration of decitabine and pembrolizumab Day- Window of time Days 25-29
| Intervention | Number of PD-L1 positive cells (Mean) |
|---|
| Baseline (Bx 1) | Post Immunotherapy | Change (Bx2-Bx1) |
|---|
| Cohort A: Triple Negative Breast Cancer (TNBC) | 31.00 | 50.00 | 19.00 |
,| Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab | 22.50 | 35.50 | 13.00 |
,| Cohort B: HER2-negative Hormone Receptor-positive Tumors | 13.07 | 29.07 | 16.00 |
Number of Adverse Events (AEs) Reported During and After Immune Treatment (ie, Decitabine and Pembrolizumab)
"Using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0), all adverse events (AEs) regardless of grade or attribution, will be captured from the beginning of study treatment (initiation of decitabine) until initiation of standard neoadjuvant chemotherapy.~For patients who do not initiate pembrolizumab, all AEs will be captured until 30 days following the last dose of decitabine or until another cancer treatment is initiated, whichever occurs first.For patients who initiate pembrolizumab, immune related adverse events (irAEs) (clinically significant and non-clinically significant) will be captured from the initiation of pembrolizumab through the end of the 30- day post-surgery (or post-treatment, for those who don't have surgery) follow-up period and at a 12-month follow-up time point." (NCT02957968)
Timeframe: Time of study registration until 30 days following the last dose of decitabine, or until another cancer treatment was initiated, or 30 days following surgery, 12- months.
| Intervention | Adverse Events Reported (Number) |
|---|
| Cohort A: Triple Negative Breast Cancer (TNBC) | 215 |
| Cohort B: HER2-negative Hormone Receptor-positive Tumors | 151 |
| Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab | 98 |
Number of Patients Meeting Criteria for Lymphocyte-predominant Breast Cancer (LPBC) Following Treatment With Decitabine and Pembrolizumab
To determine if the study treatment increases the proportion of tumors with ≥ 60% tumor or stromal area infiltrated with lymphocytes (ie, LPBC). The percentage of patients meeting criteria for LPBC following treatment with decitabine and pembrolizumab compared to the percentage before treatment (LPBC is defined as breast cancer with ≥ 60% intratumoral or stromal area with infiltrating lymphocytes.) (NCT02957968)
Timeframe: Assessed at end of administration of decitabine and pembrolizumab Day- Window of time Days 25-29
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A: Triple Negative Breast Cancer (TNBC) | 3 |
| Cohort B: HER2-negative Hormone Receptor-positive Tumors | 0 |
| Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab | 0 |
Number of Patients With Pathologic Complete Response (pCR) in the Breast and Post-therapy Lymph Nodes.
To determine the rate of pCR in the breast and lymph nodes (pCR breast and nodes). The number of patients with pCR in the breast and post-therapy lymph nodes defined as the absence of any invasive cancer in the resected breast specimen and absence of cancer on H&E evaluation of all resected lymph nodes following completion of neoadjuvant therapy (ypT0/is; ypN0). (NCT02957968)
Timeframe: 30 days following surgery or last dose of therapy
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A: Triple Negative Breast Cancer (TNBC) | 10 |
| Cohort B: HER2-negative Hormone Receptor-positive Tumors | 3 |
| Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab | 1 |
Evaluation of Myeloid-derived Suppressor Cells (MDSC) Identified in Blood Samples Post-decitabine Compared to MDSC Found in Blood Samples Collected at Baseline.
Evaluate the level of circulating MDSC per ml of blood at baseline, following treatment with decitabine alone. (NCT02957968)
Timeframe: Assessed at end of administration of decitabine and pembrolizumab Day- Window of time Days 25-29
| Intervention | absolute cell count per ml of blood (Mean) |
|---|
| Baseline Granulocytic | Post Decitabine- Granulocytic | Change- Granulocytic | Baseline- Monocytic | Post Decitabine- Monocytic | Change | Baseline- Total-MDSC | Post Decitabine- Total MDSC | Change- Total MDSC |
|---|
| Cohort A: Triple Negative Breast Cancer (TNBC) | 13271.20 | 6279.00 | -6992.20 | 59222.05 | 20524.50 | -38697.55 | 83927.60 | 35606.00 | -48321.60 |
,| Cohort A2: Triple Negative Breast Cancer (TNBC) With Extended Pembrolizumab | 77038.71 | 43120.00 | -33918.71 | 15843.29 | 16081.57 | 238.29 | 138957.43 | 92662.71 | -46294.71 |
,| Cohort B: HER2-negative Hormone Receptor-positive Tumors | 22575.50 | 38759.50 | 16184.00 | 45450.33 | 18886.00 | -26564.33 | 213321.11 | 146345.39 | -66975.72 |
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs)
"All Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity of AEs was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are those that occurred or worsened after administration of the first dose of study treatment.~Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment." (NCT02963831)
Timeframe: up to 31 months (90 days after the last dose of study medication).
| Intervention | Participants (Count of Participants) |
|---|
| Treatment-emergent Adverse Event (TEAE) | Treatment-related Adverse Event (TRAE) | Serious Adverse Event (SAE) | Treatment-related SAE | Dose-limiting Toxicity (DLT) | Death | DLTs |
|---|
| Cohort 1: Epithelial Ovarian Cancer | 19 | 17 | 9 | 2 | 0 | 6 | 0 |
,| Cohort 2: Metastatic Colorectal Cancer | 36 | 30 | 22 | 4 | 0 | 9 | 0 |
,| Cohort A: ONCOS-102 Dose Escalation | 4 | 4 | 3 | 0 | 0 | 1 | 0 |
,| Cohort B ONCOS-102 Dose Escalation | 5 | 5 | 3 | 2 | 0 | 1 | 0 |
Objective Response Rate (ORR)
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. (NCT02981524)
Timeframe: up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| CY/GVAX With Pembrolizumab | 0 |
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 4.0. (NCT02981524)
Timeframe: up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| CY/GVAX With Pembrolizumab | 6 |
Progression Free Survival (PFS)
Progression-free Survival (PFS) is defined as the number of days from cycle 1, day 1 of immunotherapy until first documented local progression or death due to any cause. PD is >20% increase in sum of diameters of target lesions as assessed using RECIST (version 1.1). (NCT02981524)
Timeframe: up to 1 year
| Intervention | days (Median) |
|---|
| CY/GVAX With Pembrolizumab | 82 |
Overall Survival (OS)
OS is defined as the number of days from start of study treatment to time of death. Individuals will be censored at the date of the last study visit if no event occurs. The estimation method used was Kaplan-Meier. (NCT02981524)
Timeframe: Up to 1 year
| Intervention | days (Median) |
|---|
| CY/GVAX With Pembrolizumab | 213 |
Duration of Response (DOR) Assessed by Independent Reviewer
Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Months (Median) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | NA |
| Standard Lymphodepletion Dose Plus GSK3377794 | 7.16 |
Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794
Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days). (NCT02992743)
Timeframe: Up to 28 days
| Intervention | Days*copies per microgram genomic DNA (Geometric Mean) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 727135.6 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 1142798.27 |
Time to Cmax (Tmax)
Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax. (NCT02992743)
Timeframe: Day 2 to Day 15
| Intervention | Days (Median) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 2 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 4 |
Progression Free Survival (PFS) Assessed by Investigator
Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Months (Median) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 5.36 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 8.74 |
Number of Participants With Positive Anti-drug Antibodies (ADAs)
Serum samples were collected to analyze for the presence of ADAs using validated immunoassays. (NCT02992743)
Timeframe: Up to 24 Months
| Intervention | Participants (Count of Participants) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 0 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 0 |
Number of Participants With Insertional Oncogenesis
Peripheral blood mononuclear cells (PBMC) samples were collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. DNA from participant identified with >1% PBMC at >=1 year post T-cell infusion was sent for integration site analysis. Integration site analysis was used to assess the possibility of insertional oncogenesis. Participants with insertional oncogenesis were participants with any clones representing >20% of the total. (NCT02992743)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 0 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 0 |
Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval
Triplicate 12-Lead ECGs were collected at baseline visit and single ECGs at other timepoints. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value. (NCT02992743)
Timeframe: Baseline, Day 1, Day 4 and Day 8
| Intervention | Milliseconds (msec) (Mean) |
|---|
| PR Interval, BASELINE | PR Interval, DAY 1 | PR Interval, DAY 4 | PR Interval, DAY 8 | QRS Duration, BASELINE | QRS Duration, DAY 1 | QRS Duration, DAY 4 | QRS Duration, DAY 8 | QT Interval, BASELINE | QT Interval, DAY 1 | QT Interval, DAY 4 | QT Interval, DAY 8 | QTcB Interval, BASELINE | QTcB Interval, DAY 1 | QTcB Interval, DAY 4 | QTcB Interval, DAY 8 | QTcF Interval, BASELINE | QTcF Interval, DAY 1 | QTcF Interval, DAY 4 | QTcF Interval, DAY 8 | RR Interval, BASELINE | RR Interval, DAY 1 | RR Interval, DAY 4 | RR Interval, DAY 8 |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 152.9 | -2.3 | -10.7 | -8.1 | 91.2 | 2.8 | 2.3 | -2.7 | 401.1 | -6.4 | -49.4 | -16.7 | 427 | 28 | 10 | 1 | 429.9 | -10.1 | -25.3 | -7.5 | 842.6 | -15.8 | -162.5 | -71.6 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 142 | -2.2 | -4 | 1 | 86.1 | 0.9 | 0.8 | -1 | 389.3 | -8.1 | -72.5 | -4.4 | 423.3 | 36.3 | 8 | 47 | 425.3 | 1.3 | 3.3 | 16.2 | 807.6 | 5.3 | -188 | -138.5 |
Number of Participants With Replication Competent Lentivirus (RCL)
RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G). (NCT02992743)
Timeframe: Day 1 (pre-infusion), and at Week 12, Week 24, and 1 year post-infusion
| Intervention | Participants (Count of Participants) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 0 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 0 |
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer
Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via independent reviewer assessment per RECIST v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Percentage of participants (Number) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 20 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 40 |
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Percentage of participants (Number) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 20 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 40 |
Progression Free Survival (PFS) Assessed by Independent Reviewer
Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by independent reviewer per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Months (Median) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 4.67 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 9.03 |
Maximum Transgene Expansion (Cmax) of GSK3377794
Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax. (NCT02992743)
Timeframe: Day 2 to Day 15
| Intervention | Copies per microgram genomic DNA (Geometric Mean) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 66991.71 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 108485.91 |
Duration of Response (DOR) Assessed by Investigator
Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Months (Median) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 5.31 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 7.47 |
Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Hemoglobin Anemia | Lymphocyte count decreased | Neutrophils | Platelets | Leukocytes |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 9 | 10 | 10 | 9 | 10 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 10 | 10 | 10 | 10 | 10 |
Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline
Blood samples were collected for the analysis clinical chemistry parameters: glucose, albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, sodium, phosphate, calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Glucose Hyperglycemia | Glucose Hypoglycemia | Albumin | Alkaline Phosphatase | ALT | AST | Bilirubin | Creatinine | Potassium Hyperkalemia | Potassium Hypokalemia | Magnesium Hypermagnesemia | Magnesium Hypomagnesemia | Phosphate | Sodium Hypernatremia | Sodium Hyponatremia | Calcium Corrected for Albumin Hypercalcemia | Calcium Corrected for Albumin Hypocalcemia |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 5 | 1 | 9 | 4 | 7 | 8 | 3 | 4 | 1 | 5 | 5 | 2 | 9 | 2 | 8 | 2 | 1 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 8 | 4 | 9 | 6 | 7 | 8 | 2 | 2 | 1 | 9 | 2 | 6 | 10 | 1 | 9 | 1 | 7 |
Number of Participants With Adverse Event of Special Interest (AESI)
An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. The AESI included events of Cytokine release syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus host disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), and Guillain-Barre syndrome. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Participants with any AESI | Cytokine release syndrome | Haematopoietic cytopenias (including pancytopenia and aplastic anaemia) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 10 | 6 | 10 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 10 | 10 | 10 |
Change From Baseline in ECG Mean Heart Rate
Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value. (NCT02992743)
Timeframe: Baseline, Day 1 (Pre-dose), Day 4 and Day 8
| Intervention | Beats per minute (beats/minute) (Mean) |
|---|
| BASELINE | DAY 1 | DAY 4 | DAY 8 |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 73.0 | 1.6 | 20.1 | 5.4 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 78.0 | 4.8 | 38.9 | 9.1 |
Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] > Confirmed Partial Response [PR] > Stable Disease [SD] > Progressive Disease [PD] > Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST v1.1 Criteria. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable (NE) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 0 | 2 | 8 | 0 | 0 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 0 | 4 | 5 | 1 | 0 |
Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment
The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] > Confirmed Partial Response [PR] > Stable Disease [SD] > Progressive Disease [PD] > Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by independent reviewer per RECIST v1.1 criteria. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable (NE) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 0 | 2 | 8 | 0 | 0 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 0 | 4 | 3 | 0 | 3 |
Time to Response (TTR) Assessed by Investigator
Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Months (Median) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 1.856 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 1.938 |
Time to Response (TTR) Assessed by Independent Reviewer
Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Months (Median) |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 2.366 |
| Standard Lymphodepletion Dose Plus GSK3377794 | 1.889 |
Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above. (NCT02992743)
Timeframe: Up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| SAEs | Non-SAEs |
|---|
| Reduced Lymphodepletion Dose Plus GSK3377794 | 5 | 13 |
,| Standard Lymphodepletion Dose Plus GSK3377794 | 7 | 10 |
Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period
"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52
| Intervention | percentage of participants (Number) |
|---|
| Prednisone Group | 21.0 |
| Avacopan Group | 10.1 |
Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index
"SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)~EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels~The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health)." (NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | Change from baseline (Least Squares Mean) |
|---|
| SF-36v2: Physical Component Score (Week 26) | SF-36v2: Physical Component Score (Week 52) | SF-36v2: Physical Functioning (Week 26) | SF-36v2: Physical Functioning (Week 52) | SF-36v2: Role Physical (Week 26) | SF-36v2: Role Physical (Week 52) | SF-36v2: Bodily Pain (Week 26) | SF-36v2: Bodily Pain (Week 52) | SF-36v2: General Health Perception (Week 26) | SF-36v2: General Health Perception (Week 52) | SF-36v2: Mental Component Score (Week 26) | SF-36v2: Mental Component Score (Week 52) | SF-36v2: Mental Health (Week 26) | SF-36v2: Mental Health (Week 52) | SF-36v2: Role Emotional (Week 26) | SF-36v2: Role Emotional (Week 52) | SF-36v2: Social Functioning (Week 26) | SF-36v2: Social Functioning (Week 52) | SF-36v2: Vitality (Week 26) | SF-36v2: Vitality (Week 52) | EQ-5D-5L VAS Score (Week 26) | EQ-5D-5L VAS Score (Week 52) | EQ-5D-5L Index Score (Week 26) | EQ-5D-5L Index Score (Week 52) |
|---|
| Avacopan Group | 4.445 | 4.980 | 7.31 | 9.55 | 16.78 | 17.12 | 14.75 | 16.12 | 3.12 | 5.84 | 4.849 | 6.394 | 8.29 | 10.89 | 7.32 | 9.38 | 14.50 | 18.06 | 12.03 | 14.36 | 9.1 | 13.0 | 0.0229 | 0.0474 |
,| Prednisone Group | 1.344 | 2.626 | 1.88 | 4.82 | 7.52 | 12.27 | 9.82 | 11.87 | -2.89 | -0.17 | 3.271 | 4.694 | 6.84 | 9.66 | 1.40 | 4.14 | 11.09 | 13.56 | 6.42 | 10.48 | 5.5 | 7.1 | -0.0010 | -0.0038 |
Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points
VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). (NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Week 26 | Week 52 |
|---|
| Avacopan Group | 1.06 | 1.17 |
,| Prednisone Group | 0.97 | 1.15 |
Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI
"GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;~GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;~The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health)." (NCT02994927)
Timeframe: Baseline, Week 13 and 26
| Intervention | Glucocorticoid Toxicity Index (Least Squares Mean) |
|---|
| GTI-CWS (Week 13) | GTI-CWS (Week 26) | GTI-AIS (Week 13) | GTI-AIS (Week 26) |
|---|
| Avacopan Group | 25.7 | 39.7 | 9.9 | 11.2 |
,| Prednisone Group | 36.6 | 56.6 | 23.2 | 23.4 |
In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks
"BVAS=Birmingham Vasculitis Activity Score~UACR=Urinary albumin:creatinine ratio" (NCT02994927)
Timeframe: Baseline, Week 4, 26 and 52
| Intervention | Percentage change (Least Squares Mean) |
|---|
| Week 4 | Week 26 | Week 52 |
|---|
| Avacopan Group | -40 | -63 | -74 |
,| Prednisone Group | 0 | -70 | -77 |
Change From Baseline in Vital Signs (5/5)
BMI=Body Mass Index (NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | kilogram(s)/ square meter (Mean) |
|---|
| BMI (Week 26) | BMI (Week 52) |
|---|
| Avacopan Group | 0.67 | 0.94 |
,| Prednisone Group | 1.13 | 1.12 |
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | U/L (Mean) |
|---|
| Lactate Dehydrogenase (Week 26) | Lactate Dehydrogenase (Week 52) | Alkaline Phosphatase (Week 26) | Alkaline Phosphatase (Week 52) | Creatine Kinase (Week 26) | Creatine Kinase (Week 52) | Alanine Aminotransferase (Week 26) | Alanine Aminotransferase (Week 52) | Aspartate Aminotransferase (Week 26) | Aspartate Aminotransferase (Week 52) |
|---|
| Avacopan Group | -6.1 | -10.7 | -3.9 | -4.0 | 76.8 | 76.3 | -6.1 | -7.2 | 2.5 | 2.0 |
,| Prednisone Group | 2.3 | -8.6 | -0.6 | 0.8 | 47.6 | 57.6 | -6.8 | -8.2 | 1.9 | 0.5 |
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | 10^9 cells/L (Mean) |
|---|
| Eosinophils (Week 26) | Eosinophils (Week 52) | Basophils (Week 26) | Basophils (Week 52) | Monocytes (Week 26) | Monocytes (Week 52) | Platelets (Week 26) | Platelets (Week 52) |
|---|
| Avacopan Group | 0.07 | 0.07 | -0.00 | -0.01 | -0.04 | -0.01 | -77.1 | -73.8 |
,| Prednisone Group | 0.07 | 0.05 | -0.01 | -0.01 | 0.01 | 0.01 | -73.9 | -75.5 |
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | 10^3 cells/μL (Mean) |
|---|
| Leukocytes (Week 26) | Leukocytes (Week 52) | Neutrophils (Week 26) | Neutrophils (Week 52) | Lymphocytes (Week 26) | Lymphocytes (Week 52) |
|---|
| Avacopan Group | -5.94 | -5.62 | -5.24 | -4.95 | -0.84 | -0.82 |
,| Prednisone Group | -5.69 | -5.54 | -5.10 | -4.89 | -0.62 | -0.67 |
Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity
"WBC=White Blood Cell~TEAE=Treatment-Emergent Adverse Event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
| Intervention | Participants (Count of Participants) |
|---|
| Any Treatment-Emergent Infection | Any Serious Treatment-Emergent Infection | Any Severe Treatment-Emergent Infection | Any Treatment-Emergent Infection Leading to Study Withdrawal | Any Treatment-Emergent Life-threatening Infection | Any Treatment-Emergent Infection Leading to Death | Any TEAE Associated with Hepatic Abnormalities | Any TEAE Associated with Low WBC Counts | Any TEAE Associated with hypersensitivity |
|---|
| Avacopan Group | 113 | 22 | 12 | 4 | 1 | 1 | 22 | 31 | 68 |
,| Prednisone Group | 124 | 25 | 10 | 5 | 2 | 2 | 19 | 39 | 70 |
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | 10^12 cells/L (Mean) |
|---|
| Erythrocytes (Week 26) | Erythrocytes (Week 52) |
|---|
| Avacopan Group | 0.252 | 0.279 |
,| Prednisone Group | 0.226 | 0.244 |
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | g/dL (Mean) |
|---|
| Hemoglobin (Week 26) | Hemoglobin (Week 52) |
|---|
| Avacopan Group | 1.10 | 1.27 |
,| Prednisone Group | 1.07 | 1.20 |
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | mg/dL (Mean) |
|---|
| Creatinine (Week 26) | Creatinine (Week 52) | Urea Nitrogen (Week 26) | Urea Nitrogen (Week 52) | Protein (Week 26) | Protein (Week 52) | Cholesterol (Week 26) | Cholesterol (Week 52) | LDL Cholesterol (Week 26) | LDL Cholesterol (Week 52) | Bilirubin (Week 26) | Bilirubin (Week 52) |
|---|
| Avacopan Group | -0.195 | -0.244 | -11.0 | -11.9 | 220 | 250 | 7.4 | 9.3 | 12.0 | 11.9 | 0.078 | 0.057 |
,| Prednisone Group | -0.105 | -0.200 | -9.4 | -7.8 | 50 | 160 | 19.0 | 13.8 | 22.7 | 21.7 | 0.065 | 0.053 |
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks
"Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.~eGFR=estimated glomerular filtration rate~BVAS=Birmingham Vasculitis Activity Score~MDRD=Modification of Diet in Renal Disease" (NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | Change in eGFR (mL/min/1.73 m^2) (Least Squares Mean) |
|---|
| Week 26 | Week 52 |
|---|
| Avacopan Group | 5.8 | 7.3 |
,| Prednisone Group | 2.9 | 4.1 |
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks
"BVAS=Birmingham Vasculitis Activity Score~MCP-1=monocyte chemoattractant protein-1" (NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | Percentage change (Least Squares Mean) |
|---|
| Week 26 | Week 52 |
|---|
| Avacopan Group | -67 | -73 |
,| Prednisone Group | -64 | -71 |
Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator
AE=Adverse Event (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
| Intervention | Participants (Count of Participants) |
|---|
| Relationship of avacopan/placebo to an AE | Relationship of glucocorticoid use to an AE | Relationship of cyclophosphamide IV use to an AE | Relationship of oral cyclophosphamide use to an AE | Relationship of rituximab use to an AE | Relationship of azathioprine use to an AE | Relationship of mycophenolate use to an AE |
|---|
| Avacopan Group | 100 | 107 | 31 | 8 | 50 | 28 | 6 |
,| Prednisone Group | 103 | 131 | 30 | 4 | 61 | 35 | 9 |
Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs
"AEs=Adverse events~SAEs=Serious adverse events~TEAE=Treatment-emergent adverse event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
| Intervention | Number (Number) |
|---|
| Number of subjects with at least one TEAE | Number of TEAEs | Number of subjects with SAEs | Number of SAEs | Subjects with TEAE leading to discontinuation |
|---|
| Avacopan Group | 164 | 1779 | 70 | 116 | 27 |
,| Prednisone Group | 161 | 2139 | 74 | 166 | 28 |
Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study
"BVAS=Birmingham Vasculitis Activity Score;~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
| Intervention | Participants (Count of Participants) |
|---|
| Prednisone Group | 33 |
| Avacopan Group | 16 |
Change From Baseline in Vital Signs (1/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | mmHg (Mean) |
|---|
| Systolic Blood Pressure (Week 26) | Systolic Blood Pressure (Week 52) | Diastolic Blood Pressure (Week 26) | Diastolic Blood Pressure (Week 52) |
|---|
| Avacopan Group | -2.6 | -1.0 | 0.5 | 1.4 |
,| Prednisone Group | -2.5 | -2.4 | 2.7 | 1.4 |
Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | percentage of red blood cells (Mean) |
|---|
| Hematocrit (Week 26) | Hematocrit (Week 52) |
|---|
| Avacopan Group | 2.7 | 3.2 |
,| Prednisone Group | 2.6 | 3.0 |
Change From Baseline in Vital Signs (2/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | beats/min (Mean) |
|---|
| Pulse Rate (Week 26) | Pulse Rate (Week 52) |
|---|
| Avacopan Group | 0.9 | -0.3 |
,| Prednisone Group | 2.2 | -1.3 |
Change From Baseline in Vital Signs (3/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | degree Celsius (Mean) |
|---|
| Temperature (Week 26) | Temperature (Week 52) |
|---|
| Avacopan Group | -0.11 | -0.11 |
,| Prednisone Group | -0.03 | 0.04 |
Percentage of Subjects Achieving Sustained Disease Remission at Week 52
"Sustained remission at Week 52 was defined as:~Disease remission at Week 26 as defined above;~Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;~No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee." (NCT02994927)
Timeframe: Week 52
| Intervention | percentage of participants (Number) |
|---|
| Prednisone Group | 54.9 |
| Avacopan Group | 65.7 |
Change From Baseline in Vital Signs (4/5)
(NCT02994927)
Timeframe: Baseline, Week 26 and 52
| Intervention | kilogram(s) (Mean) |
|---|
| Weight (Week 26) | Weight (Week 52) |
|---|
| Avacopan Group | 1.93 | 2.59 |
,| Prednisone Group | 3.33 | 3.27 |
Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study
"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52
| Intervention | percentage of participants (Number) |
|---|
| Prednisone Group | 12.2 |
| Avacopan Group | 7.5 |
Percentage of Subjects Achieving Disease Remission at Week 26
"Disease remission at Week 26 was defined as:~Achieving a BVAS of 0 as determined by the Adjudication Committee;~No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;~No BVAS >0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment)." (NCT02994927)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|
| Prednisone Group | 70.1 |
| Avacopan Group | 72.3 |
Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC
"AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|
| Prednisone Group | 68.9 |
| Avacopan Group | 62.7 |
Number of Subjects With Clinically Significant ECG Changes From Baseline
"Clinical significance was assessed by the individual reading of the ECGs~ECG=Electrocardiogram" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)
| Intervention | Participants (Count of Participants) |
|---|
| Prednisone Group | 8 |
| Avacopan Group | 12 |
Progression-free Survival (PFS)
Defined as the time from HSCT until relapse, disease progression, or death, whichever occurs first. Kaplan-Meier estimates (percentage of participants) of PFS were calculated at 24 months post HSCT. (NCT02999854)
Timeframe: 24 months post-HSCT
| Intervention | percentage of participants (Number) |
|---|
| ATIR101 | 44 |
| PTCy | 73 |
Graft-versus-host Disease-free, Relapse-free Survival (GRFS)
Defined as the time until acute GVHD grade III/IV, chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first. Kaplan-Meier estimates (percentage of participants) of GRFS were calculated at 24 months post HSCT. (NCT02999854)
Timeframe: 24 months post-HSCT
| Intervention | Percentage of participants (Number) |
|---|
| ATIR101 | 25 |
| PTCy | 62 |
Overall Survival (OS)
OS is defined as the time from HSCT until death from any cause. Kaplan-Meier estimates (percentage of participants) of OS were calculated at 24 months post HSCT. (NCT02999854)
Timeframe: 24 months post-HSCT
| Intervention | percentage of participants (Number) |
|---|
| ATIR101 | 49 |
| PTCy | 77 |
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
| Intervention | percentage of participants (Number) |
|---|
| High Group for PDL1 % of Tumor Cells | 64 |
| Low Group for PDL1 % of Tumor Cells | 56 |
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
| Intervention | percentage of participants (Number) |
|---|
| High Group for CD8 Density | 67 |
| Low Group for CD8 Density | 64 |
Participants With Treatment Emergent Adverse Events (TEAE)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator. (NCT03003520)
Timeframe: From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. (Up to approximately 72 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| >= 1 Treatment-emergent adverse event (TEAE) | >=1 TEAE related to durvalumab | >=1 TEAE related to R-CHOP | >=1 TEAE related to lenalidomide | >=1 TEAE related to durvalumab or any other IP | >=1 TEAE severity grade 3-4 | >=1 TEAE severity grade 3-4 related to durvalumab | >=1 TEAE severity grade 3-4 related to R-CHOP | >=1 TEAE severity grade 3-4 related to lenalidomid | >=1 TEAE severity grade 3-4 related to any IP | >=1 TEAE severity grade 5 | >=1 TEAE severity grade 5 related to any IP | >=1 serious TEAE | >=1 serious TEAE related to durvalumab | >=1 serious TEAE related to R-CHOP | >=1 serious TEAE related to lenalidomide | >=1 serious TEAE related to any IP | >=1 leading to discontinuation of durvalumab | >=1 leading to discontinuation of R-CHOP | >=1 leading to discontinuation of lenalidomide | >=1 leading to discontinuation of any IP | >=1 leading to interruption of durvalumab | >=1 leading to interruption of R-CHOP | >=1 leading to interruption of lenalidomide | >=1 leading to interruption of any IP | >=1 leading to infusion interruption of durvalumab | >=1 leading to dose reduction of vincristine | >=1 leading to dose reduction of lenalidomide |
|---|
| DUR + R2-CHOP | 3 | 3 | 3 | 3 | 3 | 3 | 1 | 3 | 2 | 3 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 3 | 0 | 1 | 1 |
Participants With Treatment Emergent Adverse Events (TEAE)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator. (NCT03003520)
Timeframe: From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. (Up to approximately 72 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| >= 1 Treatment-emergent adverse event (TEAE) | >=1 TEAE related to durvalumab | >=1 TEAE related to R-CHOP | >=1 TEAE related to durvalumab or any other IP | >=1 TEAE severity grade 3-4 | >=1 TEAE severity grade 3-4 related to durvalumab | >=1 TEAE severity grade 3-4 related to R-CHOP | >=1 TEAE severity grade 3-4 related to any IP | >=1 TEAE severity grade 5 | >=1 TEAE severity grade 5 related to any IP | >=1 serious TEAE | >=1 serious TEAE related to durvalumab | >=1 serious TEAE related to R-CHOP | >=1 serious TEAE related to any IP | >=1 leading to discontinuation of durvalumab | >=1 leading to discontinuation of R-CHOP | >=1 leading to discontinuation of any IP | >=1 leading to interruption of durvalumab | >=1 leading to interruption of R-CHOP | >=1 leading to interruption of any IP | >=1 leading to infusion interruption of durvalumab | >=1 leading to dose reduction of vincristine |
|---|
| DUR + R-CHOP | 43 | 33 | 40 | 41 | 37 | 18 | 27 | 31 | 3 | 0 | 23 | 10 | 10 | 14 | 13 | 4 | 13 | 15 | 12 | 18 | 2 | 4 |
Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018)
The percentage of participants who achieved a partial response (PR) or complete response (CR) at the end of Induction and continued into consolidation period in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined in outcome #1. PR was defined as a partial metabolic response and radiographic evidence showing ≥ 50% decrease in sum of perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length beyond normal, and residual bone marrow involvement improved from baseline. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis was rejected if the lower limit of the confidence interval for the rate of subjects who continue consolidation therapy out of all subjects. (NCT03003520)
Timeframe: From first dose of study drug to completion of at least one cycle in the Consolidation Period (Day 1 up to Week 52)
| Intervention | percentage of participants (Number) |
|---|
| DUR + R-CHOP | 67.6 |
| DUR + R2-CHOP | 66.7 |
Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy
The primary efficacy analysis evaluated the complete response rate (CRR) at the end of the induction therapy in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined as a complete metabolic response and radiographic evidence showing target nodes/nodal masses regressed to ≤ 1.5 cm in longest diameter, no new lesions, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis for the primary endpoint was rejected if the lower limit of the confidence interval for the complete response rate at the completion of the induction therapy in the efficacy evaluable population is above 55%. (NCT03003520)
Timeframe: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
| Intervention | percentage of participants (Number) |
|---|
| DUR + R-CHOP | 54.1 |
| DUR + R2-CHOP | 66.7 |
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
| Intervention | percentage of participants (Number) |
|---|
| High Group for RNA IFN Gamma Score | 43 |
| Low Group for RNA IFN Gamma Score | 60 |
Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage
Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).
| Intervention | percentage of participants (Number) |
|---|
| High Group for PDL1 % of Total Cells | 75 |
| Low Group for PDL1 % of Total Cells | 20 |
Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
(NCT03003676)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Number of patients with Treatment Emergent Adverse Event (TEAE) | Number of patients with Treatment Emergent Adverse Serious Event (TESAE) | Number of patients with Grade 3 or 4 Treatment Emergent Adverse Event (TEAE) | Number of patients with Treatment Emergent Adverse Event related to any of the study treatments | Number of patients with fatal events | Number of patients discontinuing for Adverse Events |
|---|
| Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1 | 9 | 4 | 5 | 8 | 0 | 0 |
,| Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2 | 12 | 2 | 4 | 11 | 0 | 1 |
Incidence of Grade II-IV Acute Graft vs. Host Disease (GVHD)
Cumulative incidence of grade II-IV acute GVHD by day 100 after HCT. Acute GVHD organ staging and assessment of overall grade will use standard consensus criteria. The cumulative incidence of acute and chronic GVHD will be estimated, considering malignancy relapse and non-relapse death as competing risk events. (NCT03018223)
Timeframe: 100 days post hematopoietic cell transplant (HCT)
| Intervention | percentage of participants (Number) |
|---|
| Conditioning/HCT/GVHD Prophylaxis | 18.8 |
Overall Survival (OS)
Overall survival is defined as time from transplant to death or last follow-up, and is reported as percentage of surviving participants. (NCT03018223)
Timeframe: Up to 1 year post HCT
| Intervention | percentage of participants (Number) |
|---|
| Conditioning/HCT/GVHD Prophylaxis | 70.2 |
Progression Free Survival (PFS)
Progression-free survival defined by the time interval from transplant to relapse/recurrence, to death or to last follow-up. Reported as percentage of participants who are disease free one year post HCT. (NCT03018223)
Timeframe: Up to 1 year post HCT
| Intervention | percentage of participants (Number) |
|---|
| Conditioning/HCT/GVHD Prophylaxis | 56.6 |
Incidence of Chronic GVHD
Cumulative incidence of chronic GVHD by 1 year. Chronic GVHD diagnosis follow National Institutes of Health (NIH) Consensus guidelines. (NCT03018223)
Timeframe: 1 year post HCT
| Intervention | percentage of participants (Number) |
|---|
| Conditioning/HCT/GVHD Prophylaxis | 20.0 |
Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate
"Response was determined by having no detectable disease by multiparameter flow cytometry (MFC-). For Ph+ subjects, complete molecular response (CMR) by BCR-ABL RT-PCR was assigned when MFC was undetectable.~When no measurable residual disease was detected by MFC (MFC-) per EuroFlow criteria, high-throughput sequencing-based MRD testing (HTS; ClonoSEQ) was performed." (NCT03023046)
Timeframe: Within 4 cycles of study therapy
| Intervention | Participants (Count of Participants) | Participants (Count of Participants) |
|---|
| MFC-72545885 | MFC-72545886 | CMR72545885 | HTS-72545885 | HTS-72545886 |
|---|
| Achieve within 4 cycles | Not achieved within 4 cycles |
|---|
| Ph+ Subjects | 20 |
| Ph- Subjects | 9 |
| Ph+ Subjects | 11 |
| Ph+ Subjects | 17 |
| Ph+ Subjects | 8 |
| Ph- Subjects | 6 |
| Ph+ Subjects | 16 |
| Ph- Subjects | 16 |
Event-free Survival
Events were defined as any of the following: (1) unable to achieve either morphologic complete remission (CR) or MRD- by MFC, (2) relapse after CR, (3) MRD recurrence after achieving MRD-, or (4) death from any cause. (NCT03023046)
Timeframe: Up to 2 years
| Intervention | Percentage of Participants (Number) |
|---|
| Treatment (Chemotherapy) | 32 |
Number of Participants With Morphological Complete Response Rate
Morphological complete remission (CR) was determined by bone marrow aspirate morphology and defined as <5% blasts by morphology, absolute neutrophil count >1000/uL, and platelet count >100,000/uL. (NCT03023046)
Timeframe: Within 4 cycles of study therapy
| Intervention | Participants (Count of Participants) |
|---|
| Ph+ Subjects | 27 |
| Ph- Subjects | 20 |
Overall Survival
Alive at 2 years after enrollment (NCT03023046)
Timeframe: Up to 2 years
| Intervention | Percentage of Participants (Number) |
|---|
| Treatment (Chemotherapy) | 70 |
Number of Participants With Adverse Events
Grade 1 or higher non-hematologic adverse events will be assessed by Common Terminology Criteria for Adverse Events version 5.0. (NCT03023046)
Timeframe: Within 28 days of the last dose of the study drugs
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy) | 44 |
Number of Patients With Durable Tumor and Symptomatic Response
Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months. (NCT03043105)
Timeframe: From baseline to the time point when a patient achieves treatment response for 24 weeks.
| Intervention | Participants (Count of Participants) |
|---|
| TCP Treatment Group | 12 |
Overall Survival
Overall survival, defined as the time to patients' death, is measured. (NCT03043105)
Timeframe: From date of randomization until the date of death from any cause, assessed up to 36 months.
| Intervention | months (Mean) |
|---|
| TCP Treatment Group | 32.16 |
Progression-free Survival
Progression-free survival (PFS) is defined as the time to death or treatment failure. Treatment failure is defined as: sustained increase in grade ≥2 disease-related symptoms persisting ≥12 weeks; new disease-related grade ≥3 symptoms; sustained >1 point increase in ECOG-PS persisting for ≥12 weeks; radiological progression; or initiation of another treatment for MCD. (NCT03043105)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
| Intervention | months (Mean) |
|---|
| TCP Treatment Group | 23.32 |
Change in SF-36 Score
SF-36 score is a self-administered scoring system which reflects a patient's general health status. SF-36 contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. Each dimension ranges from 0 to 100. Higher scores mean better outcome. SF-36 score at baseline was compared with SF-36 score at 24 weeks. (NCT03043105)
Timeframe: From baseline to 24 weeks after treatment.
| Intervention | score on a scale (Mean) |
|---|
| physical functioning | role physical | role emotional | vitality | mental health | social functioning | bodily pain | general health |
|---|
| TCP Treatment Group | 15.1 | 26.7 | 19.6 | 11.1 | 8.5 | 13.6 | 15.8 | 9.1 |
Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR). (NCT03049449)
Timeframe: From time of infusion until 1 month after infusion
| Intervention | peak percentage (Number) |
|---|
| Participant #1 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #2 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #4 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #1 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #2 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #4 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion |
|---|
| Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 2.505994998 | 1.003513397 | 0.257878064 | NA | NA | NA |
Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR). (NCT03049449)
Timeframe: From time of infusion until 1 month after infusion
| Intervention | peak percentage (Number) |
|---|
| Participant #19 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participants #19 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion |
|---|
| Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | NA | NA |
Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR). (NCT03049449)
Timeframe: From time of infusion until 1 month after infusion
| Intervention | peak percentage (Number) |
|---|
| Participant #11 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #12 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #13 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant 14 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #15 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #18 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #26 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #11 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #12 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #13 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #14 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #15 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #18 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #26 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion |
|---|
| Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 25.06555951 | 2.061723582 | 0.951813793 | 3.770199852 | 21.6416809 | 6.193353177 | 25.56426658 | NA | 2.061723582 | NA | 2.361884069 | 1.584343701 | 6.193353177 | NA |
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression as Their Best Response
Response was measured using the Cheson et al. Revised Response Criteria for Malignant Lymphoma, Journal of Clinical Oncology 2007 and Recommendations for Initial Evaluation, Staging, and Response Assessment of Non-Hodgkin Lymphoma: The Lugano Classification Journal of Clinical Oncology, 2014). Complete Response (CR) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial Response (PR) is ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progressive Disease (PD) ≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT03049449)
Timeframe: Responses will be assessed as long as the patient is on-study at the following time-points: 1, 2, 3, 4, 6, 9, and 12 months after CAR T-cell infusion. Then responses were assessed every 6 months up until 3 years after CAR T-cell infusion.
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response | Stable Disease | Progressive Disease |
|---|
| Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 2 | 1 | 0 |
,| Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 1 | 0 | 2 | 0 |
,| Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 3 | 4 | 0 |
,| Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 2 | 2 | 1 |
,| Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 1 | 2 | 0 |
,| Dose Escalation Cohort 2 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | NA | NA | NA | NA |
Number of Participants With a Dose Limiting Toxicity (DLT)
A DLT is defined as toxicities occurring within 30 days of CAR T-cell infusion. DLT's are Grade 3 or Grade 4 toxicities possibly, probably, or definitely related to either the anti-CD30 CAR T cells or the fludarabine and cyclophosphamide chemotherapy conditioning regimen and lasting more than 7 days. A DLT will only be considered in participants who have received CAR T-cell infusions. (NCT03049449)
Timeframe: 30 days within CAR T-cell infusion
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3 possibly related | Grade 3 probably related | Grade 3 definitely related | Grade 4 possibly related | Grade 4 probably related | Grade 4 definitely related |
|---|
| Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 0 | 0 | 0 | 0 | 0 |
,| Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 0 | 0 | 0 | 0 | 0 |
,| Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 0 | 0 | 0 | 0 | 0 |
,| Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 0 | 0 | 1 | 1 | 0 |
,| Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 0 | 0 | 0 | 0 | 0 |
,| Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 0 | 0 | 0 | 0 | 0 | 0 |
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03049449)
Timeframe: Date treatment consent signed to date off study, approximately 11 months and 26 days, 7 months and 10 days, 39 months and 7 days, 17 months and 3 days, 6 months and 15 days, and 1 month and 7 days for each group respectively.
| Intervention | Participants (Count of Participants) |
|---|
| Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3 |
| Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3 |
| Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 7 |
| Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 5 |
| Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3 |
| Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 1 |
Maximum Tolerated Dose of Anti-Tumor Necrosis Factor (TNF) Receptor Superfamily Member 8 (CD30) Chimeric Antigen Receptor (CAR) in Participants With Advanced CD30-expressing Lymphomas
Maximum tolerated dose is defined as the dose at which a maximum of 1 of 6 participants has a dose-limiting toxicity (DLT). A DLT is defined as toxicities occurring within 30 days of CAR T-cell infusion. DLT's are Grade 3 or Grade 4 toxicities possibly, probably, or definitely related to either the anti-CD30 CAR T cells or the fludarabine and cyclophosphamide chemotherapy conditioning regimen and lasting more than 7 days. A DLT will only be considered in participants who have received CAR T-cell infusions. (NCT03049449)
Timeframe: 4-5 weeks after first dose
| Intervention | million CAR T-cells/kg (Number) |
|---|
| All Participants | 3 |
Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR). (NCT03049449)
Timeframe: From time of infusion until 1 month after infusion
| Intervention | peak percentage (Number) |
|---|
| Participant #20 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #21 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #22 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #24 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #25 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #20 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #21 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #22 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #24 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #25 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion |
|---|
| Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 3.484185735 | 51.30355798 | 29.40752103 | 22.45790377 | 55.04760657 | 1.110480727 | 8.51303351 | 11.65873475 | 0.289276145 | 18.33580648 |
Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR). (NCT03049449)
Timeframe: From time of infusion until 1 month after infusion
| Intervention | peak percentage (Number) |
|---|
| Participant #9 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant 10 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #17 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #9 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | #10 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #17 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion |
|---|
| Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 10.425784436 | 1.173870125 | 9.701843954 | 0.145937491 | 0.006382466 | 0.09701347 |
Peak Percentage and Persistence at 1 Month of Peripheral Blood Mononuclear Cells (PBMC) That Expressed the Chimeric Antigen Receptor (CAR) T-cells
Peak percentage and the percentage 1 month after infusion of peripheral blood mononuclear cells (PBMC) that expressed the Chimeric Antigen Receptor (CAR) T-cells assessed by polymerase chain reaction (PCR). (NCT03049449)
Timeframe: From time of infusion until 1 month after infusion
| Intervention | peak percentage (Number) |
|---|
| Participant #5 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #6 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #7 - Peak percentage of CAR+ cells among peripheral blood mononuclear cells | Participant #5 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #6 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion | Participant #7 - %CAR+ cells among peripheral blood mononuclear cells 1 month after infusion |
|---|
| Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg | 5.692026394 | 0.066168665 | 0.875579553 | 0.036582556 | 0.010607229 | 0.002843526 |
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
To evaluate the number of patients with toxicity events while on SV-BR-1-GM, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) (NCT03066947)
Timeframe: Through study completion, an average of 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Patients with Adverse Events | Erythema injection site | Pruritis injection site | Induration injection site | Fatigue | Nausea | Constipation | Abdominal pain | Flu like symptoms | Diarrhea | GGTP increased | Injection site reaction | Urinary Tract Infection | Vomiting | Abdominal distension | Alkaline Phosphatase Increased | ALT Increased | Anorexia | AST Increased | Back Pain | Chills | Decreased appetite | Dehydration | Dizziness | Erythema Multiforme | Glucose increased | Hematocrit Decreased | Hypercalcemia | Lymphocytes Decreased | Myalgia | Pleural Effusion |
|---|
| SV-BR-1-GM Monotherapy | 24 | 11 | 8 | 7 | 6 | 6 | 5 | 4 | 4 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
Duration of Treatment Emergent Adverse Events [Safety]
To evaluate the duration of toxicity events while on SV-BR-1-GM, as defined by CTCAE (NCT03066947)
Timeframe: Through study completion, an average of 1 year
| Intervention | Days (Median) |
|---|
| Median Duration | 8 |
Durability of Tumor Response
Durability of response, as defined as complete response (disappearance of all tumors), partial response (30% or greater reduction in the sum of diameters of target lesions (tumors) with stable disease in non-target lesions) or stable disease (less than 20% increase in the sum of diameters of target lesions with no new lesions appearing) by evaluating those patients eligible to complete the optional treatments from 9-12 months (NCT03066947)
Timeframe: Through study completion, an average of 1 year
| Intervention | days (Median) |
|---|
| SV-BR-1-GM Monotherapy | 105.5 |
Rate of Non-progression of Tumors
Non-progressive rate, defined as CR, PR or stable disease (SD) per RECIST and iRECIST criteria (NCT03066947)
Timeframe: Through study completion, an average of 1 year
| Intervention | Participants (Count of Participants) |
|---|
| SV-BR-1-GM Monotherapy | 4 |
Objective Tumor Response Rate
Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) and immune-related RECIST (iRECIST) criteria. (NCT03066947)
Timeframe: Through study completion, an average of 1 year
| Intervention | Participants (Count of Participants) |
|---|
| SV-BR-1-GM Monotherapy | 0 |
Phases 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the protocol-specified toxicities occurring up to and including Day 28 for the cohorts where mFOLFOX6 and nab-paclitaxel/gemcitabine are administered and Day 21 for all other chemotherapy regimens in Phase 1, except those with a clear alternative explanation (eg, disease progression) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. (NCT03085914)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Group A: Epa + Pembrolizumab + mFOLFOX6 | 2 |
| Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine | 0 |
| Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin | 0 |
| Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent | 0 |
| Group E: Epa + Pembrolizumab + Cyclophosphamide | 0 |
| Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent | 3 |
| Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent | 0 |
Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of epacadostat, pembrolizumab, or chemotherapy. Serious adverse event is defined as an event that meets 1 of the following criteria: is fatal or life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, incapacity, or a substantial disruption of a person's ability to conduct normal life functions, constitutes a congenital anomaly or birth defect,is a medically important event that may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the outcomes listed above. (NCT03085914)
Timeframe: Up to 21 months
| Intervention | Participants (Count of Participants) |
|---|
| TEAE | Serious TEAE |
|---|
| Group A: Epa + Pembrolizumab + mFOLFOX6 | 9 | 5 |
,| Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine | 9 | 5 |
,| Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin | 11 | 3 |
,| Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent | 9 | 6 |
,| Group E: Epa + Pembrolizumab + Cyclophosphamide | 13 | 4 |
,| Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent | 8 | 6 |
,| Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent | 11 | 5 |
Phases 1 and 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. (NCT03085914)
Timeframe: Up to Week 18
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response | Partial Response |
|---|
| Group A: Epa + Pembrolizumab + mFOLFOX6 | 0 | 5 |
,| Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine | 1 | 2 |
,| Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin | 0 | 3 |
,| Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent | 0 | 2 |
,| Group E: Epa + Pembrolizumab + Cyclophosphamide | 0 | 3 |
,| Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent | 0 | 1 |
,| Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent | 0 | 5 |
Overall Survival
Number of participants alive 1 year post transplant. (NCT03096782)
Timeframe: Up to 12 months after transplant
| Intervention | Participants (Count of Participants) |
|---|
| Chemotherapy Plus Cord Blood Transplant | 4 |
Disease-free Survival
Number of participants that were in remission post transplant. (NCT03096782)
Timeframe: Up to12 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete Remission at 30 days | Complete Remission at 12 months |
|---|
| Chemotherapy Plus Cord Blood Transplant | 6 | 4 |
Time to Engraftment
Number of days from transplant when participants achieved engraftment measure by ANC of 0.5 for three consecutive days. (NCT03096782)
Timeframe: Up to 12 months after transplant
| Intervention | Participants (Count of Participants) |
|---|
| Twenty Two Days | Twenty Nine Days | Thirty Days | Nine Days | Thirty Two Days |
|---|
| Chemotherapy Plus Cord Blood Transplant | 2 | 1 | 1 | 1 | 1 |
Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval. (NCT03113500)
Timeframe: Up to the end of the CHEP-BV treatment
| Intervention | percentage of response rate (Number) |
|---|
| Treatment (CHEP-BV) | 79 |
Overall Survival at 1 Year
Overall survival (OS) was measured from enrollment to death from any cause. OS was estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. (NCT03113500)
Timeframe: The time from enrollment to death from any cause assessed up to 1 year.
| Intervention | percentage of survival probability (Number) |
|---|
| Treatment (CHEP-BV) | 91 |
Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) at 1 Year
Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be censored at his/her date of last contact. (NCT03128359)
Timeframe: From stem cell infusion to grade 3-4 acute graft versus host disease (GVHD), moderate-severe chronic GVHD, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.
| Intervention | percentage of survival probability (Number) |
|---|
| Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) | 53 |
| Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis) | 84 |
Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading
Acute graft versus host disease is graded according to the 1994 Keystone Consensus Grading. aGVHD grade was evaluated from day 0 through 100 days post-transplant. The first day of acute GVHD onset at grades 2-4 was used to calculate the cumulative incidence. Relapse/death prior to onset was considered competing events. (NCT03128359)
Timeframe: Up to 100 days post-stem cell infusion
| Intervention | percentage of probability (Number) |
|---|
| Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) | 47 |
| Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis) | 53 |
Overall Survival (OS) at 1 Year
Estimates was calculated using the Kaplan-Meier method, Greenwood formula was used to calculate SE, and log-log transformation method was used to construct 95% confidence intervals. Each patient's vital status was monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event was censored at his/her date of last contact. (NCT03128359)
Timeframe: From start of transplant to death, or last follow up, whichever occurs first, assessed for up to 1 year.
| Intervention | percentage of probability (Number) |
|---|
| Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) | 68 |
| Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis) | 100 |
Maximum Persistence (Cmax) of GSK3377794
Blood samples were collected to measure persistence of infused GSK3377794 using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC). (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Copies per microgram genomic DNA (Geometric Mean) |
|---|
| GSK3377794 | 38509.67 |
| GSK3377794+Pembrolizumab | 89640.56 |
Progression-free Survival
Progression Free Survival is defined as the interval between the date of T-cell infusion and the initial assessment date of confirmed progressive disease as assessed by the investigator per IMWG (2016) or date of death. Progressive disease is defined as an increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >=0.5 grams per deciliter (g/dL); Serum M-protein increase >=1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >=200 mg per 24 hours). (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Months (Median) |
|---|
| GSK3377794 | 2.79 |
| GSK3377794+Pembrolizumab | 2.78 |
Number of Participants With Worst-case Results for Coagulation Parameters Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected for the assessment of following coagulation parameters: prothrombin time and partial thromboplastin time (PTT). A laboratory value that is outside the normal range is considered either high abnormal (value above the upper limit of the normal range) or low abnormal (value below the lower limit of the normal range). Participants were counted twice if the participant had values in 'Decreased to low' and 'Increased to high' during the post-Baseline period. Data for worst case post Baseline is presented. (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Prothrombin Time; decrease to low | Prothrombin Time; To normal or no change | Prothrombin Time; increase to high | PTT; decrease to low | PTT; To normal or no change | PTT; increase to high |
|---|
| GSK3377794 | 0 | 0 | 1 | 0 | 1 | 0 |
Number of Participants With Worst-case Hematology Results by Any Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the assessment of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Laboratory parameters were graded according to NCI-CTCAE version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case post Baseline is presented. (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Hemoglobin (Anemia) | Hemoglobin increased | Lymphocyte count decreased | Lymphocyte count increased | Neutrophil count decreased | Platelet count decreased | Leukocyte count decreased |
|---|
| GSK3377794 | 2 | 0 | 3 | 0 | 3 | 3 | 3 |
,| GSK3377794+Pembrolizumab | 3 | 0 | 3 | 0 | 3 | 3 | 3 |
Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC[0-28])
Blood samples were collected to measure persistence of infused GSK3377794 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC. (NCT03168438)
Timeframe: Up to Day 28
| Intervention | Days*Copies per microgram genomic DNA (Geometric Mean) |
|---|
| GSK3377794 | 463989.35 |
| GSK3377794+Pembrolizumab | 1498869.21 |
Number of Participants With Treatment Limiting Toxicities-GSK3377794+Pembrolizumab Arm Only
The following toxicities were considered to be treatment limiting toxicities: any >=Grade 4 AE; Grade 3 non-infectious pneumonitis and any other Grade 3 AE (excluding pneumonitis), that did not improve to Grade 2 within 7 days after onset despite medical management and supportive care. Exceptions included the following: Grade 3 or 4 leukopenia, lymphopenia, neutropenia, or febrile neutropenia; Grade 3 or 4 thrombocytopenia not associated with significant bleeding; Grade 3 anemia; Grade 4 cytokine release syndrome (CRS) or toxicities related to CRS that resolved to Grade <=2 within 7 days; other Grade 3 laboratory abnormality determined to be not clinically significant by the Investigator; Grade 3 or 4 fever and chills; Grade 3 or 4 hypoalbuminemia or abnormal electrolytes that responded to supplementation/correction; AE related to the cancer or its progression. (NCT03168438)
Timeframe: Up to 3 weeks
| Intervention | Participants (Count of Participants) |
|---|
| GSK3377794+Pembrolizumab | 0 |
Duration of Response
Duration of response is defined as the interval between the initial date of the confirmed response (sCR, CR, VGPR, or PR) and the initial assesment date of confirmed progressive disease or death among participants with a confirmed response per IMWG (2016). (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Months (Median) |
|---|
| GSK3377794 | 2.1 |
| GSK3377794+Pembrolizumab | 2.1 |
Number of Participants With Worst-case Chemistry Results by Any Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the assessment of following clinical chemistry parameters: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, phosphate, sodium and calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case post Baseline is presented. (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Glucose (Hyperglycemia) | Glucose (Hypoglycemia) | Albumin (Hypoalbuminemia) | ALP increased | ALT increased | AST increased | Bilirubin increased | Creatinine increased | Potassium (Hyperkalemia) | Potassium (Hypokalemia) | Magnesium (Hypermagnesemia) | Magnesium (Hypomagnesemia) | Phosphate (Hypophosphatemia) | Sodium (Hypernatremia) | Sodium (Hyponatremia) | Calcium (Hypercalcemia) | Calcium (Hypocalcemia) |
|---|
| GSK3377794 | 2 | 0 | 3 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 2 | 0 | 2 | 1 | 2 |
,| GSK3377794+Pembrolizumab | 2 | 0 | 2 | 1 | 1 | 1 | 1 | 3 | 0 | 2 | 0 | 1 | 2 | 0 | 1 | 0 | 3 |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant who received a study treatment and the event need not necessarily have a causal relationship with study treatment. An SAE is any AE that results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in a persistent or significant disability; is a congenital anomaly/birth defect; is clinically significant or requires intervention to prevent one of the outcomes listed before. (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Any AE | Any SAE |
|---|
| GSK3377794 | 3 | 2 |
,| GSK3377794+Pembrolizumab | 3 | 2 |
Time to Response
Time to response is defined as the time interval (in months) from T-cell infusion to initial date of documented confirmed response (PR or better) in the subset of participants who showed a confirmed BOR of PR or better by Investigator assessment per IMWG (2016). (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Months (Median) |
|---|
| GSK3377794 | 0.7 |
| GSK3377794+Pembrolizumab | 0.7 |
Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings
ECG was recorded using an ECG machine that automatically calculated the heart rate and measured PR, RR, QRS and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal clinically significant ECG findings for worst case post-Baseline has been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Participants (Count of Participants) |
|---|
| GSK3377794 | 0 |
| GSK3377794+Pembrolizumab | 1 |
Time to Maximum Persistence
Blood samples were collected to measure persistence of infused GSK3377794 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC. (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Days (Median) |
|---|
| GSK3377794 | 8.0 |
| GSK3377794+Pembrolizumab | 8.0 |
Overall Response Rate
Overall response rate is defined as the percentage of participants with a best overall response (BOR) of confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per International Myeloma Working Group (IMWG) Response Criteria (2016); where, PR: >=50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >=90% or to <200 milligrams (mg) per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <= 5% plasma cells in bone marrow; or sCR: CR as defined by normal free light chain (FLC) ratio and absence of clonal cells by immunohistochemistry. Confidence intervals were calculated using the exact (Clopper-Pearson) method. (NCT03168438)
Timeframe: Up to 108 weeks
| Intervention | Percentage of participants (Number) |
|---|
| GSK3377794 | 33.3 |
| GSK3377794+Pembrolizumab | 66.7 |
Event Free Survival (EFS)
Estimate the one year after transplantation event free survival (EFS) rate using a Kaplan-Meier curve with a 90% confidence interval. An event for EFS is defined as the first of any of the following failures: relapse or disease progression or death from any cause (NCT03187756)
Timeframe: One Year
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide | 1 |
Cumulative Incidences of Systemic Steroid Initiation
Estimate the cumulative incidence of systemic steroid initiation, by 1 year after HSCT. This is will be reported as number of participants who started steroids over the course of the study. (NCT03187756)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide | 6 |
Number of Participants With Chronic GVHD and Grades I-IV GVHD
Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease (skin involvement alone), Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening. The diagnosis of a chronic GVHD per NIH criteria requires a) at least 1 diagnostic manifestation or b) 1 distinctive manifestation confirmed by biopsy or testing of the same or other involved organ. (NCT03187756)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| chronic GVHD | acute grade IV GVHD | acute grade III GVHD | acute grade II GVHD | acute grade I GVHD |
|---|
| Cyclophosphamide | 0 | 0 | 0 | 0 | 2 |
Time to Platelet Recovery
Platelet recovery is defined as sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first of three consecutive measurements on different days will be designated as the day of initial platelet recovery. (NCT03187756)
Timeframe: 1 year
| Intervention | days (Mean) |
|---|
| Cyclophosphamide | 9.4 |
Time to Neutrophil Recovery
Neutrophil recovery is defined as post-nadir ANC greater than or equal to 500/mm3 for three consecutive measurements on different days. The first of the three days will be designated as the day of neutrophil recovery. (NCT03187756)
Timeframe: 1 year
| Intervention | days (Mean) |
|---|
| Cyclophosphamide | 24.17 |
Graft Failure Frequency
Graft failure and death, or graft failure, death and treatment of relapse/progressions. This will be reported as the number of participants with graft failures. (NCT03187756)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Cyclophosphamide | 0 |
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis. (NCT03190265)
Timeframe: 18 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207 | 0 |
| Arm B: Nivolumab, Ipilimumab, CRS-207 | 2 |
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Maximum observed atezolizumab concentration (Cmax). (NCT03197935)
Timeframe: Day 1 of Cycle 1 post dose (cycle length = 28 days)
| Intervention | µg/mL (Mean) |
|---|
| Atezolizumab and Chemotherapy | 334 |
Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants. (NCT03197935)
Timeframe: From surgery and up to study final analysis data cut off on 28 September 2022.
| Intervention | Months (Median) |
|---|
| Placebo and Chemotherapy | NA |
| Atezolizumab and Chemotherapy | NA |
Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status. (NCT03197935)
Timeframe: From surgery and up to study final analysis data cut off on 28 September 2022.
| Intervention | Months (Median) |
|---|
| Placebo and Chemotherapy | NA |
| Atezolizumab and Chemotherapy | NA |
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Minimum observed serum atezolizumab concentration. (NCT03197935)
Timeframe: Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)
| Intervention | µg/mL (Mean) |
|---|
| Cycle 2 Day 1 | Cycle 3 Day 1 | Cycle 4 Day 1 | Cycle 6 Day 1 | Cycle 8 Day 1 | Cycle 12 Day 1 | Cycle 16 Day 1 |
|---|
| Atezolizumab and Chemotherapy | 142 | 189 | 207 | 78.7 | 204 | 267 | 303 |
Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease. (NCT03197935)
Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.
| Intervention | Months (Number) |
|---|
| Placebo and Chemotherapy | NA |
| Atezolizumab and Chemotherapy | NA |
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab. (NCT03197935)
Timeframe: Baseline up to approximately 20 months
| Intervention | Percentage of participants (Number) |
|---|
| Baseline evaluable participants | Post-baseline evaluable participants |
|---|
| Atezolizumab and Chemotherapy | 2.5 | 13.4 |
Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR. (NCT03197935)
Timeframe: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
| Intervention | Number of Participants (Number) |
|---|
| Placebo and Chemotherapy | 69 |
| Atezolizumab and Chemotherapy | 95 |
Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell [IC] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR. (NCT03197935)
Timeframe: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
| Intervention | Number of Participants (Number) |
|---|
| Placebo and Chemotherapy | 37 |
| Atezolizumab and Chemotherapy | 53 |
Overall Survival (OS) in All Participants
Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants. (NCT03197935)
Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.
| Intervention | Months (Median) |
|---|
| Placebo and Chemotherapy | NA |
| Atezolizumab and Chemotherapy | NA |
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). (NCT03197935)
Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.
| Intervention | Score on a 0-100 scale (Mean) |
|---|
| GHS/QoL Baseline | GHS/QoL Cycle 2 Day 1 | GHS/QoL Cycle 3 Day 1 | GHS/QoL Cycle 4 Day 1 | GHS/QoL Cycle Cycle 5 Day 1 | GHS/QoL Cycle 6 Day 1 | GHS/QoL Cycle 7 Day 1 | GHS/QoL Cycle 8 Day 1 | GHS/QoL Cycle 9 Day 1 | GHS/QoL Cycle 10 Day 1 | GHS/QoL Cycle 11 Day 1 | GHS/QoL Cycle 12 Day 1 | GHS/QoL Cycle 13 Day 1 | GHS/QoL Cycle 14 Day 1 | GHS/QoL Cycle 15 Day 1 | GHS/QoL Cycle 16 Day 1 | GHS/QoL Study Drug Completion/ Early Discontinuation | GHS/QoL Survival Follow-Up Month 3 | GHS/QoL Survival Follow-Up Month 6 | GHS/QoL Survival Follow-Up Month 9 | GHS/QoL Survival Follow-Up Month 12 | GHS/QoL Survival Follow-Up Month 18 | GHS/QoL Survival Follow-Up Month 24 | GHS/QoL Survival Follow-Up Month 30 | GHS/QoL Survival Follow-Up Month 36 | GHS/QoL Survival Follow-Up Month 48 | Physical Functioning Baseline | Physical Functioning Cycle 2 Day 1 | Physical Functioning Cycle 3 Day 1 | Physical Functioning Cycle 4 Day 1 | Physical Functioning Cycle 5 Day 1 | Physical Functioning Cycle 6 Day 1 | Physical Functioning Cycle 7 Day 1 | Physical Functioning Cycle 8 Day 1 | Physical Functioning Cycle 9 Day 1 | Physical Functioning Cycle 10 Day 1 | Physical Functioning Cycle 11 Day 1 | Physical Functioning Cycle 12 Day 1 | Physical Functioning Cycle 13 Day 1 | Physical Functioning Cycle 14 Day 1 | Physical Functioning Cycle 15 Day 1 | Physical Functioning Cycle 16 Day 1 | Physical Functioning Drug Completion/Early Discontinuation | Physical Functioning Survival Follow-Up Month 3 | Physical Functioning Survival Follow-Up Month 6 | Physical Functioning Survival Follow-Up Month 9 | Physical Functioning Survival Follow-Up Month 12 | Physical Functioning Survival Follow-Up Month 18 | Physical Functioning Survival Follow-Up Month 24 | Physical Functioning Survival Follow-Up Month 30 | Physical Functioning Survival Follow-Up Month 36 | Physical Functioning Survival Follow-Up Month 48 | Role Functioning Baseline | Role Functioning Cycle 2 Day 1 | Role Functioning Cycle 3 Day 1 | Role Functioning Cycle 4 Day 1 | Role Functioning Cycle 5 Day 1 | Role Functioning Cycle 6 Day 1 | Role Functioning Cycle 7 Day 1 | Role Functioning Cycle 8 Day 1 | Role Functioning Cycle 9 Day 1 | Role Functioning Cycle 10 Day 1 | Role Functioning Cycle 11 Day 1 | Role Functioning Cycle 12 Day 1 | Role Functioning Cycle 13 Day 1 | Role Functioning Cycle 14 Day 1 | Role Functioning Cycle 15 Day 1 | Role Functioning Cycle 16 Day 1 | Role Functioning Study Drug Completion/Early Discontinuation | Role Functioning Survival Follow-Up Month 3 | Role Functioning Survival Follow-Up Month 6 | Role Functioning Survival Follow-Up Month 9 | Role Functioning Survival Follow-Up Month 12 | Role Functioning Survival Follow-Up Month 18 | Role Functioning Survival Follow-Up Month 24 | Role Functioning Survival Follow-Up Month 30 | Role Functioning Survival Follow-Up Month 36 | Role Functioning Survival Follow-Up Month 48 |
|---|
| Atezolizumab and Chemotherapy | 79.24 | 71.55 | 62.65 | 59.84 | 53.60 | 70.14 | 73.57 | 72.06 | 72.18 | 70.56 | 71.93 | 72.40 | 72.87 | 71.19 | 74.07 | 74.93 | 72.51 | 72.65 | 75.61 | 75.19 | 74.87 | 75.60 | 74.46 | 73.50 | 76.93 | 63.10 | 90.85 | 84.93 | 77.29 | 69.02 | 64.27 | 78.01 | 80.78 | 81.75 | 83.99 | 83.88 | 84.24 | 83.44 | 83.36 | 84.96 | 84.28 | 84.33 | 82.34 | 82.35 | 84.17 | 83.48 | 83.17 | 84.29 | 85.43 | 84.54 | 85.80 | 88.57 | 89.44 | 77.18 | 69.48 | 56.60 | 51.08 | 62.88 | 69.92 | 72.95 | 74.32 | 75.27 | 75.68 | 75.14 | 74.38 | 75.50 | 77.59 | 78.65 | 74.09 | 75.47 | 76.10 | 76.39 | 76.98 | 77.98 | 80.09 | 78.24 | 81.64 | 76.19 |
,| Placebo and Chemotherapy | 76.45 | 71.90 | 65.30 | 62.36 | 60.37 | 74.25 | 76.50 | 77.17 | 75.62 | 75.22 | 75.98 | 75.84 | 74.72 | 74.79 | 75.00 | 77.70 | 75.38 | 76.97 | 74.93 | 75.00 | 75.15 | 76.39 | 78.31 | 78.33 | 78.63 | 58.33 | 90.03 | 83.50 | 78.33 | 70.42 | 67.91 | 79.49 | 82.73 | 85.15 | 84.19 | 84.78 | 85.48 | 86.97 | 86.16 | 86.22 | 84.69 | 87.19 | 84.21 | 85.29 | 84.96 | 85.11 | 85.05 | 85.23 | 85.69 | 87.08 | 86.24 | 90.00 | 88.86 | 80.39 | 70.39 | 61.11 | 56.06 | 66.17 | 73.77 | 77.59 | 77.13 | 78.51 | 79.97 | 81.79 | 81.79 | 80.81 | 79.02 | 83.03 | 80.00 | 81.93 | 78.53 | 81.61 | 81.68 | 81.86 | 79.47 | 81.54 | 85.48 | 83.33 |
Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). (NCT03197935)
Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.
| Intervention | Score on a 0-100 scale. (Mean) |
|---|
| GHS/QoL Cycle 2 Day 1 | GHS/QoL Cycle 3 Day 1 | GHS/QoL Cycle 4 Day 1 | GHS/QoL Cycle Cycle 5 Day 1 | GHS/QoL Cycle 6 Day 1 | GHS/QoL Cycle 7 Day 1 | GHS/QoL Cycle 8 Day 1 | GHS/QoL Cycle 9 Day 1 | GHS/QoL Cycle 10 Day 1 | GHS/QoL Cycle 11 Day 1 | GHS/QoL Cycle 12 Day 1 | GHS/QoL Cycle 13 Day 1 | GHS/QoL Cycle 14 Day 1 | GHS/QoL Cycle 15 Day 1 | GHS/QoL Cycle 16 Day 1 | GHS/QoL Study Drug Completion/ Early Discontinuation | GHS/QoL Survival Follow-Up Month 3 | GHS/QoL Survival Follow-Up Month 6 | GHS/QoL Survival Follow-Up Month 9 | GHS/QoL Survival Follow-Up Month 12 | GHS/QoL Survival Follow-Up Month 18 | GHS/QoL Survival Follow-Up Month 24 | GHS/QoL Survival Follow-Up Month 30 | GHS/QoL Survival Follow-Up Month 36 | GHS/QoL Survival Follow-Up Month 48 | Physical Functioning Cycle 2 Day 1 | Physical Functioning Cycle 3 Day 1 | Physical Functioning Cycle 4 Day 1 | Physical Functioning Cycle 5 Day 1 | Physical Functioning Cycle 6 Day 1 | Physical Functioning Cycle 7 Day 1 | Physical Functioning Cycle 8 Day 1 | Physical Functioning Cycle 9 Day 1 | Physical Functioning Cycle 10 Day 1 | Physical Functioning Cycle 11 Day 1 | Physical Functioning Cycle 12 Day 1 | Physical Functioning Cycle 13 Day 1 | Physical Functioning Cycle 14 Day 1 | Physical Functioning Cycle 15 Day 1 | Physical Functioning Cycle 16 Day 1 | Physical Functioning Study Drug Completion/Early Discontinuation | Physical Functioning Survival Follow-Up Month 3 | Physical Functioning Survival Follow-Up Month 6 | Physical Functioning Survival Follow-Up Month 9 | Physical Functioning Survival Follow-Up Month 12 | Physical Functioning Survival Follow-Up Month 18 | Physical Functioning Survival Follow-Up Month 24 | Physical Functioning Survival Follow-Up Month 30 | Physical Functioning Survival Follow-Up Month 36 | Physical Functioning Survival Follow-Up Month 48 | Role Functioning Cycle 2 Day 1 | Role Functioning Cycle 3 Day 1 | Role Functioning Cycle 4 Day 1 | Role Functioning Cycle 5 Day 1 | Role Functioning Cycle 6 Day 1 | Role Functioning Cycle 7 Day 1 | Role Functioning Cycle 8 Day 1 | Role Functioning Cycle 9 Day 1 | Role Functioning Cycle 10 Day 1 | Role Functioning Cycle 11 Day 1 | Role Functioning Cycle 12 Day 1 | Role Functioning Cycle 13 Day 1 | Role Functioning Cycle 14 Day 1 | Role Functioning Cycle 15 Day 1 | Role Functioning Cycle 16 Day 1 | Role Functioning Study Drug Completion/Early Discontinuation | Role Functioning Survival Follow-Up Month 3 | Role Functioning Survival Follow-Up Month 6 | Role Functioning Survival Follow-Up Month 9 | Role Functioning Survival Follow-Up Month 12 | Role Functioning Survival Follow-Up Month 18 | Role Functioning Survival Follow-Up Month 24 | Role Functioning Survival Follow-Up Month 30 | Role Functioning Survival Follow-Up Month 36 | Role Functioning Survival Follow-Up Month 48 |
|---|
| Atezolizumab and Chemotherapy | -7.91 | -17.07 | -19.80 | -26.02 | -8.78 | -5.40 | -6.69 | -6.13 | -8.40 | -7.04 | -6.56 | -5.85 | -7.47 | -4.67 | -3.73 | -6.20 | -6.57 | -3.37 | -4.42 | -4.50 | -4.17 | -6.17 | -9.14 | -5.56 | -21.43 | -5.73 | -12.90 | -21.68 | -26.43 | -12.20 | -8.96 | -7.70 | -5.74 | -6.17 | -5.73 | -6.61 | -6.72 | -5.07 | -5.89 | -5.79 | -8.66 | -8.54 | -6.91 | -7.78 | -7.46 | -6.61 | -6.30 | -10.46 | -8.70 | -11.43 | -12.42 | -19.84 | -33.56 | -38.97 | -26.14 | -18.36 | -14.89 | -13.80 | -13.39 | -12.98 | -13.52 | -14.46 | -13.82 | -11.78 | -10.82 | -16.42 | -14.44 | -13.97 | -13.76 | -12.83 | -12.05 | -10.96 | -16.44 | -12.56 | -21.43 |
,| Placebo and Chemotherapy | -4.62 | -12.72 | -14.49 | -17.06 | -2.49 | -0.61 | 0.77 | -0.28 | -1.17 | 0.35 | -0.63 | -1.26 | -1.05 | 0.00 | 2.10 | 0.06 | 0.64 | -2.00 | -0.93 | -1.65 | -0.98 | 1.31 | -2.18 | -1.08 | -25.00 | -6.37 | -12.17 | -19.48 | -21.59 | -10.20 | -7.43 | -4.80 | -5.40 | -4.87 | -3.99 | -2.59 | -3.63 | -3.42 | -4.24 | -2.42 | -5.58 | -4.16 | -5.21 | -3.97 | -4.43 | -4.90 | -4.07 | -3.36 | -4.06 | -3.33 | -8.08 | -19.54 | -28.29 | -32.99 | -22.39 | -14.21 | -10.50 | -10.74 | -9.36 | -8.26 | -6.86 | -6.30 | -7.28 | -8.63 | -4.65 | -8.46 | -5.98 | -10.67 | -7.61 | -7.66 | -7.03 | -9.96 | -8.72 | -5.65 | -16.67 |
Percentage of Participants With at Least One Adverse Events (AEs)
Percentage of participants with at least one adverse event. (NCT03197935)
Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.
| Intervention | Percentage of participants (Number) |
|---|
| Atezolizumab and Chemotherapy | 100 |
| Placebo and Chemotherapy | 100 |
Event-Free Survival (EFS) in All Participants
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease. (NCT03197935)
Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.
| Intervention | Months (Median) |
|---|
| Placebo and Chemotherapy | NA |
| Atezolizumab and Chemotherapy | NA |
Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status
Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status. (NCT03197935)
Timeframe: From randomization and up to study final analysis data cut off on 28 September 2022.
| Intervention | Months (Median) |
|---|
| Placebo and Chemotherapy | NA |
| Atezolizumab and Chemotherapy | NA |
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain (iFLC) is less than (<) upper limit of normal (ULN) and serum and urine Immunofixation electrophoresis (IFE) are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for complete response (CR). (NCT03201965)
Timeframe: Up to 2.4 years
| Intervention | percentage of participants (Number) |
|---|
| CyBorD | 18.1 |
| Daratumumab Plus CyBorD | 53.3 |
Rate of Dose Limiting Toxicity (DLT)
Investigators plan to demonstrate that treatment with nivolumab in patients undergoing TIL therapy is safe with a continuous Pocock-type stopping boundary for serious toxicity of < 17%, with safety reported based upon Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria. DLT defined as: any grade ≥3 immune-related adverse event definitely attributable to nivolumab. DLT related to adoptive cell therapy will be defined as a non-hematologic grade 4 or higher adverse event that is immediately life-threatening occurring upon or after the start of therapy that is immediately life-threatening and not related to non-small cell lung cancer or other pre-existing condition. Safety: Toxicity will be assessed within 4 weeks of the adoptive TIL transfer. The accrual will be halted if excessive numbers of participants with toxicity are seen. For example, if there are 5 or more out of 10 participants (full follow-up) with toxicity, the trial will be stopped. (NCT03215810)
Timeframe: Up to 40 months
| Intervention | % participants w severe toxicity (Number) |
|---|
| TIL+ Nivolumab | 17 |
Number of Participants With Objective Response
Participants displaying objective response associated with the treatment regimen per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. (NCT03215810)
Timeframe: Up to 40 months
| Intervention | Participants (Count of Participants) |
|---|
| Confirmed | Unconfirmed |
|---|
| TIL+ Nivolumab | 3 | 3 |
Progression Free Survival
Progression free survival (PFS): Time from TIL infusion to disease progression, relapse or death due to any cause, which ever comes first, will be used as an event. (NCT03287674)
Timeframe: Up to 12 months after TIL infusion
| Intervention | Days (Median) |
|---|
| TIL Treated Patients | 93 |
Overall Survival
Overall Survival (OS), defined as time from TIL infusion to death (NCT03287674)
Timeframe: Up to 3 years after TIL infusion
| Intervention | Days (Median) |
|---|
| TIL Treated Patients | 247 |
Number of Participants With Reported Adverse Events by Type
Determine the safety of TIL therapy in combination with checkpoint inhibitors for patients with ovarian-, fallopian tube or primary peritoneal cancer by reporting adverse events according to CTCAE v. 4.0. (NCT03287674)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Performance status drop | Fatigue | Nausea | Vomiting | Diarrhea | Hyponatremia | Infection | Neutropenia | Trombocytopenia | Anemia | Agammaglobulinemia | Dyspnea | Fever | Colitis | Dry skin |
|---|
| TIL Treated Patients | 3 | 3 | 1 | 1 | 1 | 3 | 2 | 6 | 6 | 6 | 1 | 1 | 3 | 1 | 1 |
Total Dose of Chemotherapy Administered
To evaluate the total dose of weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the dose amount of chemotherapy administered. (NCT03301350)
Timeframe: Week 12 to week 18 to account for possible delays
| Intervention | doses administered (Number) |
|---|
| Carboplatin dose AUC of 2.0 - full dose | paclitaxel dose: 80 mg/m2 - full dose | Carboplatin reduced dose AUC 1.6 | Carboplatin reduced dose AUC 1.5 | Paclitaxel - reduced dose |
|---|
| Neoadjuvant Chemotherapy | 285 | 279 | 15 | 2 | 23 |
Number of Cycles of Chemotherapy Administered
To evaluate the number of cycles low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the number of cycles of chemotherapy administered. (NCT03301350)
Timeframe: Week 12 to week 18 to account for possible delays
| Intervention | Participants (Count of Participants) |
|---|
| 4 complete cycles | Less than 1 cycle |
|---|
| Neoadjuvant Chemotherapy | 25 | 3 |
Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders. (NCT03301350)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Neoadjuvant Chemotherapy | 8 |
Delays of Administered Chemotherapy
To evaluate the delays of low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the delays of chemotherapy administered. (NCT03301350)
Timeframe: Week 12 to week 18 to account for possible delays
| Intervention | Participants (Count of Participants) |
|---|
| Participants with no delays | Participants with single 1 week delay | Participants with single 2 week delay | Participants with more than 1 delay |
|---|
| Neoadjuvant Chemotherapy | 12 | 7 | 3 | 4 |
Non-relapse Mortality (NRM) at Day 365
NRM is defined as death due to GVHD, infections, sepsis, organ (lung, liver, kidney) toxicity. Death from underlying disease (i.e. progression or relapse) is not considered NRM. (NCT03303950)
Timeframe: Up to day 365
| Intervention | Participants (Count of Participants) |
|---|
| All Participants - Treatment | 2 |
Non-relapse Mortality (NRM) at Day 100
NRM is defined as death due to GVHD, infections, sepsis, organ (lung, liver, kidney) toxicity. Death from underlying disease (i.e. progression or relapse) is not considered NRM. (NCT03303950)
Timeframe: Up to day 100
| Intervention | Participants (Count of Participants) |
|---|
| All Participants - Treatment | 1 |
Incidence of Chronic GVHD
Chronic GVHD will be assessed based on criteria established by the National Institutes of Health Consensus Development Project in 2005, and recently updated in 2014. This will be reported as a count of participants diagnosed with chronic GVHD (NCT03303950)
Timeframe: Up to day 365
| Intervention | Participants (Count of Participants) |
|---|
| All Particpants - Treatment | 1 |
Number of Participants With Minimal Residual Disease (MRD) Response
After bone marrow transplant, bone marrow was collected every 3-6 months (as clinically indicated per treating investigator) for up to one year after bone marrow transplant. Bone marrow was evaluated by a clinical pathologist for any evidence of multiple myeloma (MM) or myelofibrosis (MF). Evidence of MM or MF in the bone marrow is referred to as minimal residual disease (MRD). A participant with evidence of MRD is MRD-positive. A participant with no evidence of MRD is MRD-negative, which is considered an MRD response. This outcome reports the number participants with MRD responses any time between bone marrow transplant up to one year of follow-up. (NCT03303950)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| All Particpants - Treatment | 5 |
Incidence of Acute Graft Versus Host Disease (GVHD)
Cases of acute graft versus host disease (GVHD) will be diagnosed by the treating physician and will be reported as a count of participants with acute GVHD. (NCT03303950)
Timeframe: Up to day 365
| Intervention | Participants (Count of Participants) |
|---|
| All Particpants - Treatment | 2 |
Overall Survival at One Year
Overall survival is defined as the number of participants remaining alive up to one year following stem cell transplant. (NCT03303950)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| All Particpants - Treatment | 3 |
Disease Free Survival at One Year
Disease free survival is defined as an absence of disease relapse or progression up to one year following stem cell transplant. (NCT03303950)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| All Particpants - Treatment | 3 |
Number of Participants With Different Clinical Responses
Clinical Responses were determined by disease-specific criteria taking into account multiple clinical and molecular markers. Multiple Myeloma (MM) response was determined using International Myeloma Working Group (IMWG) consensus criteria for response. Participants with MM had either Stringent Complete Response (sCR) or Very Good Partial Response (VGPR). Myelofibrosis (MF) response was determined using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) consensus criteria. Participants with MF had either Complete Response (CR) or Stable Disease (SD) (also referred to in the protocol as no response). (NCT03303950)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Stringent Complete Response (sCR) | Very Good Partial Response (VGPR) | Complete Response (CR) | Stable Disease (SD) |
|---|
| All Particpants - Treatment | 1 | 1 | 2 | 1 |
Overall Survival (OS)
Overall survival is defined as the time from the first dose date of study drug to the date of death from any cause. Analysis was done using KM estimate. Participants who have not died by the analysis data cutoff date were censored at their last date known to be alive or cutoff date, whichever is earlier. (NCT03318861)
Timeframe: From KITE-585 infusion to date of data cutoff (maximum: 17.6 months)
| Intervention | months (Median) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | NA |
| Dose Escalation: 1 x 10^8 KITE-585 | 5.1 |
| Dose Escalation: 3 x 10^8 KITE-585 | 6.9 |
| Dose Escalation: 1 x 10^9 KITE-585 | NA |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | 12.2 |
Objective Response Rate (ORR) as Determined by Study Investigators According to the International Myeloma Working Group (IMWG) Consensus Panel 1 Criteria
ORR: Percentage of participants who achieved a stringent CR (sCR), complete response (CR), partial response (PR), or very good PR (VGPR), as determined by IMWG Consensus Panel 1 Criteria. sCR: CR+normal free light chain (FLC) ratio, no clonal cells in BM by immunohistochemistry or immunofluorescence; CR: negative immunofixation (IFX) on serum and urine, no soft tissue plasmacytomas (STP), <5% plasma cells in bone marrow (BM); PR: ≥50% decrease of serum M-protein + 24hr urinary M-protein decrease by ≥90% or <200 mg/24hr. If unmeasurable serum and urine M-protein; and serum-free light assay; requires ≥ 50% decrease in the difference between involved and uninvolved FLC levels / ≥ 50% reduction in plasma cells (PC), provided baseline BM PC percentage was ≥ 30%, respectively. If present at baseline, ≥ 50% reduction in the size of STP is also required; VGPR: serum and urine M-protein detected by IFX but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hr. (NCT03318861)
Timeframe: From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)
| Intervention | percentage of participants (Number) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | 33.3 |
| Dose Escalation: 1 x 10^8 KITE-585 | 0 |
| Dose Escalation: 3 x 10^8 KITE-585 | 0 |
| Dose Escalation: 1 x 10^9 KITE-585 | 0 |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | 0 |
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Clinically significant laboratory abnormalities were defined as per investigator's discretion. (NCT03318861)
Timeframe: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)
| Intervention | percentage of participants (Number) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | 0 |
| Dose Escalation: 1 x 10^8 KITE-585 | 0 |
| Dose Escalation: 3 x 10^8 KITE-585 | 0 |
| Dose Escalation: 1 x 10^9 KITE-585 | 0 |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | 0 |
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
"A DLT is a KITE-585-related event with onset in the first 28 days following infusion. DLTs are defined by events and duration of events, including:~Any duration: Grade (GR) 4 cytokine release syndrome (CRS), KITE-585-related GR 5 adverse events (AE) and GR 4 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 3 or better in ≤ 72 hours, hypogammaglobulinemia, tumor lysis syndrome, acute renal toxicity requiring dialysis for ≤ 7 days, intubation for airway protection for ≤ 7 days and AE resolves to ≤ GR 1 within 2 weeks and baseline within 4 weeks~≥ 72 hours: GR 3 CRS and GR 3 nonhematologic AE with the exceptions of fever, nausea, hepatic toxicity that resolves to GR 2 or better in ≤ 14 days, hypogammaglobulinemia and tumor lysis syndrome~≥ 30 days: GR 4 hematologic AE with the exceptions of cytopenias attributable to ongoing or recurrent multiple myeloma" (NCT03318861)
Timeframe: From KITE-585 infusion until 28 days after KITE-585 infusion
| Intervention | percentage of participants (Number) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | 0 |
| Dose Escalation: 1 x 10^8 KITE-585 | 0 |
| Dose Escalation: 3 x 10^8 KITE-585 | 0 |
| Dose Escalation: 1 x 10^9 KITE-585 | 0 |
Progression Free Survival (PFS) as Determined by Study Investigators According to the IMWG Consensus Panel 1
PFS: Interval from first study drug dose date to the earlier of first documentation of definitive progressive disease (PD) per IMWG Consensus Panel 1 Criteria or death from any cause. PD: an increase of 25% from the lowest response value in 1 of the following: Serum and urine M-protein (absolute increase ≥ 0.5 g/dL and ≥ 200 mg/24 hours, respectively); In participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels (absolute increase > 10 mg/dL); In participants without measurable serum and urine M-protein and without measurable disease by FLC levels, bone marrow PC percentage (absolute percentage ≥ 10%). Definite development of new bone lesions or STP or definite increase in the size of existing bone lesions or STPs; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. Analysis was done using Kaplan-Meier (KM) estimate. (NCT03318861)
Timeframe: From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)
| Intervention | months (Median) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | 1.1 |
| Dose Escalation: 1 x 10^8 KITE-585 | 1.0 |
| Dose Escalation: 3 x 10^8 KITE-585 | 0.8 |
| Dose Escalation: 1 x 10^9 KITE-585 | 1.0 |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | NA |
Time to Next Treatment (TTNT)
TTNT is defined as the length of time between the date of KITE-585 infusion to the date of initiation of the next therapy or death due to any cause, whichever is earlier. (NCT03318861)
Timeframe: From KITE-585 infusion to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)
| Intervention | months (Number) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | NA |
| Dose Escalation: 1 x 10^8 KITE-585 | NA |
| Dose Escalation: 3 x 10^8 KITE-585 | NA |
| Dose Escalation: 1 x 10^9 KITE-585 | NA |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | NA |
Duration of Response (DOR) as Determined by Study Investigators According to the IMWG Consensus Panel 1
DOR is defined for participants who experience an objective response and is defined as the time from the date of their first objective response (which is subsequently confirmed) to PD per IMWG Consensus Panel 1 Criteria or death from any cause, whichever is earlier. Objective response is defined in Outcome measure 2. (NCT03318861)
Timeframe: From first response to the earlier date of data cutoff and first administration of other anti-cancer therapies including stem cell transplant (maximum: 17.6 months)
| Intervention | months (Number) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | NA |
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
(NCT03318861)
Timeframe: Enrollment through 24 months after treatment with KITE-585 or up to disease progression or initiation of another anti-cancer therapy, whichever occurs first (maximum: 2.9 months)
| Intervention | percentage of participants (Number) |
|---|
| Dose Escalation: 3 x 10^7 KITE-585 | 100.0 |
| Dose Escalation: 1 x 10^8 KITE-585 | 100.0 |
| Dose Escalation: 3 x 10^8 KITE-585 | 100.0 |
| Dose Escalation: 1 x 10^9 KITE-585 | 100.0 |
| Dose Expansion (Renal Impairment): 3 x 10^7 KITE-585 | 100.0 |
Number of Non-cardiac Toxicities
The frequency of adverse events categorized using CTCAE v4.03 (NCT03329378)
Timeframe: 2 years
| Intervention | events (Number) |
|---|
| ddACTHP | 63 |
| TCHP | 120 |
Number of Participants With Breast Conservation
"Number of participants with breast-conserving surgery for patients for whom mastectomy was planned before treatment. It would be based on surgical opinion at time of surgery if the tumor was appropriately downstaged to perform breast conserving surgery on patients previously recommended to have a mastectomy." (NCT03329378)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| ddACTHP | 0 |
| TCHP | 0 |
Number of Participants With Pathologic Complete Response (pCR)
Pathologic complete response (pCR) defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy. (NCT03329378)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| ddACTHP | 1 |
| TCHP | 4 |
Number of Participants Alive at the End of the Study
Overall Survival - Number of participants alive at the end of the study. (NCT03329378)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| ddACTHP | 2 |
| TCHP | 5 |
Number of Cardiac Toxicity Events
"Determination of cardiac toxicity as measured by LVEF, longitudinal strain and troponin.~Left ventricular ejection fraction (LVEF) measurement of amount of blood being pumped out of the left ventricle of the heart with each contraction.~Peak systolic longitudinal strain is calculated by averaging the values of peak systolic strain in the basal, mid and apical segments of the LV in 4-, 3- and 2-chamber views on echocardiograms. A value of <-18% or a >15% decline in strain from patient's baseline value will be used as a cut-off value.~A value of troponin I > 0.08 ng/ml will be considered elevated." (NCT03329378)
Timeframe: 2 years
| Intervention | events (Number) |
|---|
| ddACTHP | 2 |
| TCHP | 2 |
Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells
Persistence of CART cells is tested by qPCR in PBMC. (NCT03338972)
Timeframe: Assessed from Baseline up to a maximum of 537 days
| Intervention | Days (Median) |
|---|
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | 134 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | 110 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | 386 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | 236 |
Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28
(NCT03338972)
Timeframe: Baseline up to Day 28
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | 5 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | 7 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | 5 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | 2 |
Count of Patients That Experienced Adverse Events
Toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. (NCT03338972)
Timeframe: Up to 28 days after CAR T-cell infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | 7 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | 8 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | 7 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | 3 |
Dose-limiting Toxicities (DLT) Rate
Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome will be reported as count of participants in each arm who experienced a DLT. No patients received more than one CAR T cell infusion, so DLT assessment period was only 28 days after first and only CAR T infusion for all patients. (NCT03338972)
Timeframe: Up to 28 days after CAR T cell infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | 0 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | 0 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | 1 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | 0 |
Objective Response Rate (ORR)
Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working group response criteria. (NCT03338972)
Timeframe: Baseline up to 3 months after CART infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | 7 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | 8 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | 7 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | 3 |
Overall Survival (OS)
Outcome is reported as a count of participants who were alive at the 1 year post-infusion timepoint. (NCT03338972)
Timeframe: Assessed up to 1 year after CART infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | 3 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | 5 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | 7 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | 3 |
Progression-free Survival (PFS)
Outcome is reported as the count of participants who were alive at the 1 year post treatment mark and did not experience disease progression by the 1 year post treatment mark. (NCT03338972)
Timeframe: Assessed up to 1 year after CART infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 | 3 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 | 5 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 | 5 |
| Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 | 2 |
Overall Response Rate (ORR)
For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of >=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions. (NCT03384654)
Timeframe: Up to 4 years 4 months
| Intervention | Percentage of participants (Number) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 14.3 |
| Cohort 2: T-Cell ALL (1-17 Years) | 83.3 |
| Cohort 2: T-Cell ALL (18-30 Years) | 80.0 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 50.0 |
Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arms only. (NCT03384654)
Timeframe: End of Cycle 1 (that is, up to 28 days)
| Intervention | Percentage of participants (Number) |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 41.7 |
| Cohort 2: T-Cell ALL (18-30 Years) | 60.0 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 30.0 |
Event-free Survival (EFS)
EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is [ie], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis. (NCT03384654)
Timeframe: Up to 4 years 4 months
| Intervention | Months (Median) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 1.1 |
| Cohort 2: T-Cell ALL (1-17 Years) | 8.9 |
| Cohort 2: T-Cell ALL (18-30 Years) | 10.3 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 2.9 |
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. (NCT03384654)
Timeframe: Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1 Day 1 predose | Cycle 2 Day 1 predose |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | NA | 0.573 |
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported. (NCT03384654)
Timeframe: Up to 4 years 4 months
| Intervention | Percentage of participants (Number) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 14.3 |
| Cohort 2: T-Cell ALL (1-17 Years) | 75.0 |
| Cohort 2: T-Cell ALL (18-30 Years) | 60.0 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 30.0 |
Overall Survival (OS)
OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event. (NCT03384654)
Timeframe: Up to 4 years 4 months
| Intervention | Months (Median) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 3.2 |
| Cohort 2: T-Cell ALL (1-17 Years) | 10.9 |
| Cohort 2: T-Cell ALL (18-30 Years) | 12.0 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 4.2 |
Relapse-free Survival (RFS)
RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis. (NCT03384654)
Timeframe: Up to 4 years 4 months
| Intervention | Months (Median) |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 19.4 |
| Cohort 2: T-Cell ALL (18-30 Years) | 9.4 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | NA |
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax was defined as maximum observed serum concentration of daratumumab. (NCT03384654)
Timeframe: Cohort 1: B-cell ALL: End of infusion (EOI) on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): EOI on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): EOI on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): EOI on Day 22 of Cycle 2
| Intervention | Micrograms per milliliter (mcg/mL) (Mean) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 494 |
| Cohort 2: T-Cell ALL (1-17 Years) | 763 |
| Cohort 2: T-Cell ALL (18-30 Years) | 501 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 758 |
Number of Participants With Anti-daratumumab Antibodies
Number of participants with anti-daratumumab antibodies was reported. (NCT03384654)
Timeframe: Up to 4 years 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 0 |
| Cohort 2: T-Cell ALL (1-17 Years) | 0 |
| Cohort 2: T-Cell ALL (18-30 Years) | 0 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 0 |
Minimum Observed Serum Concentration (Cmin) of Daratumumab
Cmin was defined as minimum observed serum concentration of daratumumab. (NCT03384654)
Timeframe: Cohort 1: B-cell ALL: Predose on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): Predose on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): Predose on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): Predose on Day 22 of Cycle 2
| Intervention | mcg/mL (Mean) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 172 |
| Cohort 2: T-Cell ALL (1-17 Years) | 369 |
| Cohort 2: T-Cell ALL (18-30 Years) | 172 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 365 |
Minimal Residual Disease (MRD) Negative Rate
MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry. (NCT03384654)
Timeframe: Up to 4 years 4 months
| Intervention | Percentage of participants (Number) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 0 |
| Cohort 2: T-Cell ALL (1-17 Years) | 45.8 |
| Cohort 2: T-Cell ALL (18-30 Years) | 20.0 |
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 50.0 |
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. (NCT03384654)
Timeframe: Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1 Day 1 predose | Cycle 1 Day 15 predose | Cycle 2 Day 2 predose | Cycle 2 Day 15 predose |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | NA | 0.907 | 0.915 | 0.934 |
,| Cohort 2: T-Cell ALL (18-30 Years) | NA | 0.319 | 0.296 | 0.163 |
,| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | NA | 0.456 | 1.23 | 1.06 |
Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)
Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (>)100*10^9 cells/liter (L) and absolute neutrophil count (ANC) >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arm only. (NCT03384654)
Timeframe: Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)
| Intervention | Percentage of participants (Number) |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 0 |
Stage 1: Dosing Schedule of Low-dose Cyclophosphamide
Number of participants with adverse events (NCT03417154)
Timeframe: 4 weeks from start of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Nivolumab Every 2 Weeks and Cyclophosphamide Daily | 6 |
| Arm 2: Nivolumab Every 2 Weeks and Cyclophosphamide Every 7 Days | 6 |
Progression Free Survival (PFS)
Incidence of progression free survival. (NCT03417154)
Timeframe: 6 months from start of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Nivolumab Every 2 Weeks and Cyclophosphamide Daily | 0 |
| Arm 2: Nivolumab Every 2 Weeks and Cyclophosphamide Every 7 Days | 0 |
Overall Survival (OS)
Incidence of overall survival. (NCT03417154)
Timeframe: 6 months from start of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Nivolumab Every 2 Weeks and Cyclophosphamide Daily | 4 |
| Arm 2: Nivolumab Every 2 Weeks and Cyclophosphamide Every 7 Days | 5 |
Objective Response Rate (ORR)
Incidence of overall response. (NCT03417154)
Timeframe: 30 days from start of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Nivolumab Every 2 Weeks and Cyclophosphamide Daily | 0 |
| Arm 2: Nivolumab Every 2 Weeks and Cyclophosphamide Every 7 Days | 0 |
Clinical Benefit and Immunologic Response of the Combination Therapy
"Overall response rate at 90 days from treatment start. Response is defined as CR + CRi + CRp + PR in AML and CR/PR/hematologic improvement (HI) in MDS.~Complete Remission (CR) - subjects must have bone marrow regenerating normal hematopoietic cells and achieve a morphologic leukemia-free state, an ANC > 1 x 109/L and platelet count ≥ 100 x 109/L and normal marrow differential with < 5% blasts, and they will be RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There should be no evidence of extramedullary leukemia~Complete Remission with Incomplete Hematologic Recovery (CRi) - subjects must fulfill all the criteria for CR except for incomplete hematological recovery~Complete Remission with Incomplete Platelet Recovery (CRp) - subjects must achieve CR except for incomplete platelet recovery~Partial Remission (PR) - subjects must have ≥50% bone marrow blast reduction or decrease to 5 to 25%" (NCT03417154)
Timeframe: 90 days from start of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Nivolumab Every 2 Weeks and Cyclophosphamide Daily | 0 |
| Arm 2: Nivolumab Every 2 Weeks and Cyclophosphamide Every 7 Days | 0 |
Overall Survival (OS)
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons B vs A (NCT03440411)
Timeframe: 57 months
| Intervention | Participants (Count of Participants) |
|---|
| Death | Censored |
|---|
| Arm A | 2 | 2 |
,| Arm B | 0 | 4 |
Event-Free Survival
Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 24 |
Number of Participants With Adverse Events
For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting. (NCT03488225)
Timeframe: Start of treatment up to 30 days after last dose received.
| Intervention | Participants (Count of Participants) |
|---|
| Neutropenic Fever | Peripheral Sensory Neuropathy | Allergic Reaction | Muscle Weakness |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 2 | 1 | 1 | 1 |
Participants to Achieve Complete Remission (CR):
Complete Remission (CR) is defined as - Normalization of the peripheral blood and bone marrow blasts /= 100X10^9/L and complete resolution of all sites of extramedullary disease. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 4 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 24 |
Number of Participants With Minimal Residual Disease (MRD) Negativity
MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10-4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 4 |
Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8)
The observed trastuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement. (NCT03493854)
Timeframe: Pre-dose on Cycle 8, Day 1 (up to 21 weeks)
| Intervention | micrograms per milllilitre (μg/mL) (Geometric Mean) |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 43.2 |
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 57.5 |
Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8)
The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement. (NCT03493854)
Timeframe: Pre-dose on Cycle 8, Day 1 (up to 21 weeks)
| Intervention | micrograms per millilitre (μg/mL) (Geometric Mean) |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 72.4 |
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 88.7 |
Number of Participants With a Primary Cardiac Event
A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event [e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia] without documented etiology). (NCT03493854)
Timeframe: From Baseline until the primary completion date (up to 1 year, 1 month)
| Intervention | Participants (Count of Participants) |
|---|
| Any Primary Cardiac Event | Heart Failure and Significant LVEF Decline | Cardiac Death (Definite or Probable) |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 0 | 0 | 0 |
,| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 2 | 1 | 1 |
Number of Participants With a Secondary Cardiac Event
A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of <50% confirmed by a second assessment within approximately 3 weeks (NCT03493854)
Timeframe: From Baseline until the primary completion date (up to 1 year, 1 month)
| Intervention | Participants (Count of Participants) |
|---|
| Any Secondary Cardiac Event | Identified by Initial LVEF Assessment | Confirmed by Second LVEF Assessment |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 9 | 9 | 2 |
,| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 4 | 4 | 1 |
Number of Participants With Laboratory Test Abnormalities at the Highest NCI CTCAE v4 Grade Post-Baseline
Clinical laboratory tests were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a participant with multiple post-baseline abnormalities, only the highest (worst) grade for a given laboratory test is reported. 'Any Grade' indicates the total number of participants with a post-baseline abnormality of any grade for the specified test. Abs. = absolute count; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase (NCT03493854)
Timeframe: Day 1 of Cycles 1 to 8 (up to 21 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Albumin, Low - Any Grade | Albumin, Low - Grade 1 | Albumin, Low - Grade 2 | Albumin, Low - Grade 3 | Alkaline Phosphatase, High - Any Grade | Alkaline Phosphatase, High - Grade 1 | Alkaline Phosphatase, High - Grade 2 | SGPT/ALT, High - Any Grade | SGPT/ALT, High - Grade 1 | SGPT/ALT, High - Grade 2 | SGPT/ALT, High - Grade 3 | SGOT/AST, High - Any Grade | SGOT/AST, High - Grade 1 | SGOT/AST, High - Grade 2 | SGOT/AST, High - Grade 3 | Creatinine, High - Any Grade | Creatinine, High - Grade 1 | Creatinine, High - Grade 2 | Creatinine, High - Grade 3 | Glucose, Low - Any Grade | Glucose, Low - Grade 1 | Glucose, Low - Grade 2 | Glucose, Low - Grade 3 | Glucose, High - Any Grade | Glucose, High - Grade 3 | Hemoglobin, Low - Any Grade | Hemoglobin, Low - Grade 1 | Hemoglobin, Low - Grade 2 | Hemoglobin, Low - Grade 3 | Hemoglobin, High - Any Grade | Hemoglobin, High - Grade 1 | Lymphocytes, Abs., Low - Any Grade | Lymphocytes, Abs., Low - Grade 1 | Lymphocytes, Abs., Low - Grade 2 | Lymphocytes, Abs., Low - Grade 3 | Lymphocytes, Abs., Low - Grade 4 | Lymphocytes, Abs., High - Any Grade | Lymphocytes, Abs., High - Grade 1 | Neutrophils, Total, Abs., Low - Any Grade | Neutrophils, Total, Abs., Low - Grade 1 | Neutrophils, Total, Abs., Low - Grade 2 | Neutrophils, Total, Abs., Low - Grade 3 | Neutrophils, Total, Abs., Low - Grade 4 |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 49 | 40 | 8 | 1 | 34 | 32 | 2 | 166 | 146 | 14 | 6 | 137 | 129 | 6 | 2 | 193 | 187 | 5 | 1 | 22 | 18 | 3 | 1 | 3 | 3 | 231 | 131 | 90 | 10 | 10 | 10 | 140 | 29 | 59 | 45 | 7 | 3 | 3 | 108 | 27 | 29 | 16 | 36 |
,| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 39 | 34 | 5 | 0 | 41 | 40 | 1 | 138 | 123 | 12 | 3 | 113 | 110 | 1 | 2 | 194 | 186 | 8 | 0 | 21 | 21 | 0 | 0 | 4 | 4 | 220 | 138 | 76 | 6 | 4 | 4 | 138 | 19 | 67 | 48 | 4 | 3 | 3 | 106 | 35 | 22 | 24 | 25 |
Summary of the Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 (NCI CTCAE v4)
"The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms severe and serious are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade." (NCT03493854)
Timeframe: From Baseline until the primary completion date (up to 1 year, 1 month)
| Intervention | Participants (Count of Participants) |
|---|
| Any Adverse Event (AE): Any Grade | Any AE: Grade 1 | Any AE: Grade 2 | Any AE: Grade 3 | Any AE: Grade 4 | Any AE: Grade 5 | Any AE: Grades 3 to 5 | Any Serious AE | Anaphylaxis and Hypersensitivity AEs | Infusion/Admin.-Related Reactions Within 24 hrs | Serious Rash/Skin Reactions | Diarrhoea | Cardiac Dysfunction | Interstitial Lung Disease | Neutropenia/Febrile Neutropenia | Serious Mucositis | Pregnancy- and Neonatal-Related AEs |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 251 | 11 | 107 | 87 | 45 | 1 | 133 | 45 | 5 | 34 | 0 | 139 | 41 | 2 | 133 | 4 | 1 |
,| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 248 | 9 | 118 | 79 | 41 | 1 | 121 | 40 | 4 | 43 | 1 | 145 | 41 | 3 | 119 | 3 | 1 |
Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment
Total pCR (tpCR) was defined as eradication of invasive disease in the breast and axilla; that is, ypT0/is ypN0, according to the local pathologists' assessment. Pathologic response to therapy was determined at the time of surgery. The tpCR rate is the percentage of participants in the ITT population who achieved a tpCR. Participants with missing data for tpCR (i.e., do not undergo surgery or have an invalid pCR assessment) were included in the analysis and classified as non-responders. Rates of tpCR were calculated in each treatment arm and were assessed using the difference between the Arm B: Pertuzumab and Trastuzumab FDC SC and the Arm A: Pertuzumab IV and Trastuzumab IV tpCR rates and corresponding 95% Clopper-Pearson confidence intervals (CIs). The difference between the tpCR rates along with corresponding 95% Hauck-Anderson CIs were calculated. The lower bound of the CI will reliably reflect the largest tpCR difference that can be considered unlikely. (NCT03493854)
Timeframe: Following completion of surgery (up to 33 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 59.5 |
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 59.7 |
Duration of Response
"Response date to loss of response or last follow up. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L).~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts." (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month
| Intervention | Months (Median) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 4.4 |
Number of Participants Negative for Minimal Residual Disease (MRD)
Minimal Residual Disease (MRD) was assessed by flow cytometry. MRD negativity: Absence of detectable leukemia using multiparameter flow cytometry with a sensitivity of NCT03518112)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 4 |
Participants With a Response
"defined as the percentage of patients achieving complete response (CR) or CR with inadequate count recovery (CRi). Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L)." (NCT03518112)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 4 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month
| Intervention | Months (Median) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 16.7 |
Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death
"Time from date of treatment start until the date of first objective documentation of disease-relapse. Relapse and resistant disease will be defined based on morphological assessment of bone marrow and peripheral blood.~Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L).~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts." (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month
| Intervention | Months (Median) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 5.7 |
Objective Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR. (NCT03556358)
Timeframe: End of Treatment (Week 24) or Early Termination Visit
| Intervention | Participants (Count of Participants) |
|---|
| TX05 (Trastuzumab) | 332 |
| Herceptin® | 340 |
Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0). (NCT03556358)
Timeframe: 3-7 weeks following last dose of study treatment
| Intervention | participants (Number) |
|---|
| Subjects who do not Meet pCR Criteria | Subjects Meeting pCR Criteria |
|---|
| Herceptin® | 185 | 153 |
,| TX05 (Trastuzumab) | 172 | 164 |
Survival of Treatment
Survival of Hematopoietic Stem Cell Transplant during treatment and post treatment up to 1 year. (NCT03593902)
Timeframe: During Treatment and Post Treatment up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Hematopoietic Stem Cell Transplantation | 9 |
Change in Skin Score by mRSS
Defined by at least a 25% improvement (decline) in skin score by modified Rodnan skin score (mRSS) if skin score is greater than 14 on enrollment. If skin score is less than 14 on enrollment, improvement is defined by at least a 5% improvement on mRSS. The modified Rodnan skin score (MRSS) is a measure for skin disease in scleroderma and is calculated by summation of skin thickness in 17 different body sites. The scale ranges from at total score of normal skin thickness (0) to severe thickness (51). (NCT03593902)
Timeframe: Pre Treatment and Post Treatment
| Intervention | units on a scale (Mean) |
|---|
| Pre Treatment | Post Treatment |
|---|
| Hematopoietic Stem Cell Transplantation | 25 | 16 |
Number of Participants at Each Dose Level Who Experience a Dose-Limiting Toxicity (DLT)
A DLT is Grade 3 toxicities possibly or probably or definitely related to the anti-B cell maturation antigen (BCMA) - chimeric antigen receptor (CAR)-T cells and lasting more than 9 days. Grade 4 toxicities possibly or probably or definitely related to the anti-BCMA CAR T cells. Grade 3 is severe, and Grade 4 is life-threatening. (NCT03602612)
Timeframe: First 28 days of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1 Dose Escalation (Esc) Dose Level 1 - 0.75x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 1 |
| Arm 1 Dose Escalation Dose Level 2 - 1.5x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 0 |
| Arm 1 Dose Escalation Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 0 |
| Arm 1 Dose Escalation Dose Level 4 - 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 0 |
| Arm 1 Dose Escalation Dose Level 5 - 12.0x1^06 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 0 |
| Arm 2 Dose Expansion (Exp) 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 0 |
| Arm 1 DoseEsc DL 3-3.0x10^6 CAR+T Cells Per kg Followed by Arm 2 DoseExp 6.0x10^6 CAR+T Cells Per kg | 0 |
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03602612)
Timeframe: Date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each Arm/Group respectively.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1 Dose Escalation (Esc) Dose Level 1 - 0.75x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 6 |
| Arm 1 Dose Escalation Dose Level 2 - 1.5x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 3 |
| Arm 1 Dose Escalation Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 2 |
| Arm 1 Dose Escalation Dose Level 4 - 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 3 |
| Arm 1 Dose Escalation Dose Level 5 - 12.0x1^06 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 3 |
| Arm 2 Dose Expansion (Exp) 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg | 8 |
| Arm 1 DoseEsc DL 3-3.0x10^6 CAR+T Cells Per kg Followed by Arm 2 DoseExp 6.0x10^6 CAR+T Cells Per kg | 1 |
Maximum Tolerated Dose (MTD) of Anti-B Cell Maturation Antigen (BCMA) - Chimeric Antigen Receptor (CAR)-T Cells
The MTD is the dose at which a maximum of 1 of 6 patients has a DLT. A DLT is Grade 3 toxicities possibly or probably or definitely related to the Anti-B cell maturation antigen (BCMA) - chimeric antigen receptor (CAR)-expressing T-Cells lasting more than 9 days. Grade 4 toxicities possibly or probably or definitely related to the anti-BCMA CAR T cells. Grade 3 is severe, and Grade 4 is life-threatening. (NCT03602612)
Timeframe: First 28 days of treatment
| Intervention | million CAR + T cells (Number) |
|---|
| All Arm 1 Dose Escalation Dose Participants | 6 |
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs were defined as AEs with onset on or after the initiation of brexucabtagene autoleucel infusion. (NCT03624036)
Timeframe: First infusion date up to last follow up visit (maximum duration: 42 months)
| Intervention | percentage of participants (Number) |
|---|
| First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 100 |
| First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 100 |
| Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 100 |
| Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 100 |
Peak Level of Anti-CD19 CAR T-Cells in Blood
Peak was defined as the maximum number of CAR T cells measured post-infusion. (NCT03624036)
Timeframe: First infusion date up to 3 months post-infusion (approximately 3 months)
| Intervention | cells/μL (Median) |
|---|
| First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 1.46 |
| First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 1.08 |
| Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 42.18 |
| Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 1.00 |
Objective Response Rate (ORR) Per Investigator Review Assessed by International Workshop on CLL (IWCLL) 2018 Criteria
ORR was defined as percentage of participants achieving either complete response (CR), complete response with incomplete hematopoetic recovery (CRi) or partial response (PR). Criteria for CR: no lymphadenopathy >1.5 cm or hepatomegaly/splenomegaly, lymphocytes <4000/microliters (μL), bone marrow sample must be normocellular with 30% lymphocytes and no B-lymphoid nodules, platelets ≥100,000/µL, hemoglobin ≥11 grams per deciliter (g/dL). CRi: All CR criteria were met except with platelet count <100,000/μL, hemoglobin <11 g/dL or neutrophil count <500/μL. PR: ≥1 of these: ≥50% decrease in lymphocytes, lymphadenopathy, size of liver and spleen, 50% decrease in bone marrow infiltrates; and ≥1 of these: platelets ≥100,000/µL or ≥50% increase from Baseline, hemoglobin ≥11 g/dL or ≥50% increase from Baseline. Participants who did not meet criteria were considered nonresponders. 95% confidence interval (CI) was calculated by Clopper-Pearson method. (NCT03624036)
Timeframe: First infusion date up to last follow up visit (maximum duration: 42 months)
| Intervention | percentage of participants (Number) |
|---|
| First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 50 |
| First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 33 |
| Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 100 |
| Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 0 |
Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLTs refer to toxicities with onset experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLTs evaluated may include with some exceptions: All brexucabtagene autoleucel related Grade 3 non-hematologic toxicities lasting for more than 7 days, Grade 4 non-hematologic toxicities regardless of duration, and Grade 4 hematologic toxicity lasting more than 30 days if not attributable to underlying disease. (NCT03624036)
Timeframe: First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but Grade 4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation.
| Intervention | Participants (Count of Participants) |
|---|
| First Stage Cohort 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 0 |
| First Stage Cohort 2: 2 x 10^6 Anti-CD19 CAR T Cells/kg | 0 |
| Second Stage Cohort 3: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 1 |
| Second Stage Cohort 4A: 1 x 10^6 Anti-CD19 CAR T Cells/kg | 0 |
Number of Subjects Experiencing 3 or More Dose Limiting Toxicities [Phase 2] Within a 100-day DLT Window After Receiving BPX-501
"If any of the following adverse events that occur within the DLT window they will be considered a DLT:~Grade III or IV acute GVHD attributable to rivogenlecleucel and non-responsive to > 1 dose of rimiducid treatment (plus standard doses (at least 1 mg/kg) of methylprednisone or dose equivalent of other corticosteroids, and/or calcineurin inhibitor) within 14 days~Grade 3-4 neurologic events attributable to rivogenlecleucel~Death due to any cause other than underlying disease~Any CTCAE Grade 3-5 adverse events related to rivogenlecleucel (including allergic reactions, infusion reactions, and any other related adverse reactions whether expected or unexpected). in case 3 or more DLTs are observed with 3 x 10E6 dose, another cohort would have been enrolled to receive the 1 x 10E6 cell dose (never happened as study terminated early)" (NCT03699475)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase II, Cohort 1 | 1 |
Number of Participants With Treatment-Emergent ADAs to Pertuzumab
Participants were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 titer units greater than the titer of the baseline sample (treatment unaffected). (NCT03726879)
Timeframe: Day 1 of Cycle (C) 1, 8, 12, and at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-12, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year).
| Intervention | Participants (Count of Participants) |
|---|
| BL: ADA Positive | BL: ADA Negative | Post-BL: Treatment-Emergent ADA Positive | Post-BL: Treatment-Emergent ADA Negative |
|---|
| Atezolizumab +ddAC-PacHP | 6 | 215 | 13 | 203 |
,| Placebo + ddAC-PacHP | 3 | 208 | 12 | 202 |
Number of Participants With Treatment-Emergent ADAs to Trastuzumab
Participants were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 titer units greater than the titer of the baseline sample (treatment unaffected). (NCT03726879)
Timeframe: Day 1 Cycle (C) 1, 8, 12 and at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-12, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year).
| Intervention | Participants (Count of Participants) |
|---|
| BL: ADA Positive | BL: ADA Negative | Post-BL: Treatment-Emergent ADA Positive | Post-BL: Treatment-Emergent ADA Negative |
|---|
| Atezolizumab +ddAC-PacHP | 2 | 218 | 1 | 215 |
,| Placebo + ddAC-PacHP | 1 | 210 | 0 | 214 |
Number of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) to Atezolizumab
Participants were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 titer units greater than the titer of the baseline sample (treatment unaffected). (NCT03726879)
Timeframe: Day 1 Cycle (C) 1, 2, 3, 4, 8, 12, 16, at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-16, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year).
| Intervention | Participants (Count of Participants) |
|---|
| Baseline (BL): ADA Positive | BL: ADA Negative | Post-BL: Treatment-Emergent ADA Positive | Post-BL: Treatment-Emergent ADA Negative |
|---|
| Atezolizumab +ddAC-PacHP | 1 | 224 | 7 | 218 |
Percentage of Participants With pCR Based on Hormone Receptor Status
pCR (ypT0/is ypN0) based upon hormone receptor status (estrogen receptor [ER]/progesterone receptor [PgR] positive or ER/PgR negative). (NCT03726879)
Timeframe: From randomization to approximately 24 months
| Intervention | Percentage of Participants (Number) |
|---|
| ER+ and/or PgR+ | ER- and/or PgR- |
|---|
| Atezolizumab +ddAC-PacHP | 50.9 | 74.5 |
,| Placebo + ddAC-PacHP | 54.7 | 71.2 |
Percentage of Participants With pCR Based on PIK3CA Mutation Status
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST) (i.e., ypT0/is ypN0 in the current American Joint Committee on Cancer [AJCC] staging system, 8th edition). (NCT03726879)
Timeframe: From randomization to approximately 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Mutated | Wildtype | Missing |
|---|
| Atezolizumab +ddAC-PacHP | 40 | 98 | 3 |
,| Placebo + ddAC-PacHP | 34 | 101 | 8 |
Trough Concentration (Ctrough) for Pertuzumab and Trastuzumab in Serum
(NCT03726879)
Timeframe: Pre-dose on Day 1 Cycle (C) 8, 12, and at treatment discontinuation visit (ATDV) (an average of 1 year). C 1-4, each C is 14 days. C 8-12, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year).
| Intervention | ug/mL (Mean) |
|---|
| Pertuzumab: C8D1/predose | Pertuzumab: C12D1/predose | Trastuzumab: C8D1/predose | Trastuzumab: C12D1/predose |
|---|
| Atezolizumab +ddAC-PacHP | 93.2 | 87.7 | 58.5 | 62.4 |
,| Placebo + ddAC-PacHP | 94.8 | 91.6 | 56.5 | 60.4 |
Percentage of Participants With pCR in the PD-L1-Negative Population
pCR (ypT0/is ypN0) in the IC 0 Population (NCT03726879)
Timeframe: From randomization to approximately 24 months
| Intervention | Percentage of Participants (Number) |
|---|
| Atezolizumab +ddAC-PacHP | 60.7 |
| Placebo + ddAC-PacHP | 53.8 |
Mean Changes From Baseline in Function (Role, Physical)
EORTC QLQ-C30 is a self-reported questionnaire that included functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), global health scale/quality of life (GHS/QOL) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Questions 1-28 on the QLQ-C30 were on a 4-point scale (1=Not at All to 4=Very Much). Questions 29-30 (GHS scale) were on a 7-point scale (1=Very Poor to 7=Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). (NCT03726879)
Timeframe: Baseline; Day 1 of Cycle 1-9, on Day 1 of every other cycle thereafter until Cycle 22; at the treatment discontinuation or early termination visit and follow up visit. Cycle 1-4, each cycle is 14 days. Cycle 5-22, each cycle is 21 days.
| Intervention | Units on a scale (Mean) |
|---|
| Role: Baseline | Role: Cycle (C) 2 Day (D) 1 | Role: C3D1 | Role: C4D1 | Role: C5D1 | Role: C6D1 | Role: C7D1 | Role: C8D1 | Role: Adjuvant Week 1 D1 | Role: Adjuvant Week 7 D43 | Role: Adjuvant Week 13 D85 | Role: Adjuvant Week 19 D127 | Role: Adjuvant Week 25 D169 | Role: Adjuvant Week 31 D211 | Role: Adjuvant Week 37 D253 | Role: End of Treatment (EOT) | Role: Follow-Up (FU) 1 D1 | Role: FU2D92 | Role: FU3D183 | Role: FU4D274 | Physical: Baseline | Physical: C2D1 | Physical: C3D1 | Physical: C4D1 | Physical: C5D1 | Physical: C6D1 | Physical: C7D1 | Physical: C8D1 | Physical: Adjuvant Week 1 D1 | Physical: Adjuvant Week 7 D43 | Physical: Adjuvant Week 13 D85 | Physical: Adjuvant Week 19 D127 | Physical: Adjuvant Week 25 D169 | Physical: Adjuvant Week 31 D211 | Physical: Adjuvant Week 37 D253 | Physical: EOT | Physical: FU1D1 | Physical: FU2D92 | Physical: FU3D183 | Physical: FU4D274 |
|---|
| Atezolizumab +ddAC-PacHP | 91.70 | -13.06 | -17.88 | -22.27 | -24.08 | -20.70 | -19.21 | -21.25 | -22.82 | -15.48 | -14.42 | -14.30 | -13.68 | -13.24 | -9.34 | -14.04 | -11.02 | -9.17 | -16.67 | -27.78 | 92.74 | -4.32 | -6.82 | -11.98 | -12.84 | -12.25 | -11.33 | -13.30 | -12.27 | -8.96 | -8.38 | -9.22 | -9.35 | -7.80 | -7.77 | -8.20 | -8.06 | -3.33 | 2.22 | 0.00 |
Mean Changes From Baseline in Function (Role, Physical)
EORTC QLQ-C30 is a self-reported questionnaire that included functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), global health scale/quality of life (GHS/QOL) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Questions 1-28 on the QLQ-C30 were on a 4-point scale (1=Not at All to 4=Very Much). Questions 29-30 (GHS scale) were on a 7-point scale (1=Very Poor to 7=Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). (NCT03726879)
Timeframe: Baseline; Day 1 of Cycle 1-9, on Day 1 of every other cycle thereafter until Cycle 22; at the treatment discontinuation or early termination visit and follow up visit. Cycle 1-4, each cycle is 14 days. Cycle 5-22, each cycle is 21 days.
| Intervention | Units on a scale (Mean) |
|---|
| Role: Baseline | Role: Cycle (C) 2 Day (D) 1 | Role: C3D1 | Role: C4D1 | Role: C5D1 | Role: C6D1 | Role: C7D1 | Role: C8D1 | Role: Adjuvant Week 1 D1 | Role: Adjuvant Week 7 D43 | Role: Adjuvant Week 13 D85 | Role: Adjuvant Week 19 D127 | Role: Adjuvant Week 25 D169 | Role: Adjuvant Week 31 D211 | Role: Adjuvant Week 37 D253 | Role: End of Treatment (EOT) | Role: Follow-Up (FU) 1 D1 | Role: FU2D92 | Role: FU3D183 | Role: FU4D274 | Role: FU5D457 | Physical: Baseline | Physical: C2D1 | Physical: C3D1 | Physical: C4D1 | Physical: C5D1 | Physical: C6D1 | Physical: C7D1 | Physical: C8D1 | Physical: Adjuvant Week 1 D1 | Physical: Adjuvant Week 7 D43 | Physical: Adjuvant Week 13 D85 | Physical: Adjuvant Week 19 D127 | Physical: Adjuvant Week 25 D169 | Physical: Adjuvant Week 31 D211 | Physical: Adjuvant Week 37 D253 | Physical: EOT | Physical: FU1D1 | Physical: FU2D92 | Physical: FU3D183 | Physical: FU4D274 | Physical: FU5D457 |
|---|
| Placebo + ddAC-PacHP | 90.85 | -9.83 | -15.15 | -17.98 | -19.79 | -18.60 | -16.67 | -17.79 | -26.24 | -15.15 | -15.24 | -15.42 | -15.88 | -14.55 | -15.43 | -18.10 | -17.16 | -14.65 | -10.42 | -25.00 | -33.33 | 92.20 | -3.88 | -7.18 | -9.48 | -10.67 | -11.40 | -11.45 | -11.56 | -12.19 | -8.60 | -8.88 | -10.03 | -8.45 | -9.88 | -10.78 | -13.05 | -11.57 | -9.90 | -14.17 | -6.67 | 60.00 |
Mean Changes From Baseline in Global Health Status
EORTC QLQ-C30 is a self-reported questionnaire that included functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), GHS/QOL and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Questions 1-28 on the QLQ-C30 were on a 4-point scale (1=Not at All to 4=Very Much). Questions 29-30 (GHS scale) were on a 7-point scale (1=Very Poor to 7=Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). (NCT03726879)
Timeframe: Baseline; Day 1 of Cycle 1-9, on Day 1 of every other cycle thereafter until Cycle 22; at the treatment discontinuation or early termination visit and follow up visit. Cycle 1-4, each cycle is 14 days. Cycle 5-22, each cycle is 21 days.
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | C2D1 | C3D1 | C4D1 | C5D1 | C6D1 | C7D1 | C8D1 | Adjuvant Week 1 D1 | Adjuvant Week 7 D43 | Adjuvant Week 13 D85 | Adjuvant Week 19 D127 | Adjuvant Week 25 D169 | Adjuvant Week 31 D211 | Adjuvant Week 37 D253 | EOT | FU1D1 | FU2D92 | FU3D183 | FU4D274 |
|---|
| Atezolizumab +ddAC-PacHP | 76.49 | -7.28 | -10.96 | -13.67 | -14.14 | -12.33 | -11.47 | -12.72 | -7.89 | -7.51 | -7.07 | -7.20 | -8.02 | -7.29 | -5.95 | -5.96 | -3.90 | -1.25 | -8.33 | -13.89 |
Mean Changes From Baseline in Global Health Status
EORTC QLQ-C30 is a self-reported questionnaire that included functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), GHS/QOL and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Questions 1-28 on the QLQ-C30 were on a 4-point scale (1=Not at All to 4=Very Much). Questions 29-30 (GHS scale) were on a 7-point scale (1=Very Poor to 7=Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). (NCT03726879)
Timeframe: Baseline; Day 1 of Cycle 1-9, on Day 1 of every other cycle thereafter until Cycle 22; at the treatment discontinuation or early termination visit and follow up visit. Cycle 1-4, each cycle is 14 days. Cycle 5-22, each cycle is 21 days.
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | C2D1 | C3D1 | C4D1 | C5D1 | C6D1 | C7D1 | C8D1 | Adjuvant Week 1 D1 | Adjuvant Week 7 D43 | Adjuvant Week 13 D85 | Adjuvant Week 19 D127 | Adjuvant Week 25 D169 | Adjuvant Week 31 D211 | Adjuvant Week 37 D253 | EOT | FU1D1 | FU2D92 | FU3D183 | FU4D274 | FU5D457 |
|---|
| Placebo + ddAC-PacHP | 76.79 | -6.31 | -8.33 | -10.88 | -12.63 | -9.99 | -10.52 | -10.86 | -7.14 | -5.21 | -6.75 | -6.01 | -5.05 | -7.80 | -6.03 | -9.41 | -5.15 | -3.03 | -7.29 | -31.94 | -16.67 |
pCR in the ITT Population
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST) (i.e., ypT0/is ypN0 in the current American Joint Committee on Cancer [AJCC] staging system, 8th edition). Treatment comparison was made using Cochran-Mantel-Haenszel test stratified by disease stage (T2 vs. T3-4) and hormone receptor status (ER positive and/or PgR positive vs. ER negative and PgR negative). (NCT03726879)
Timeframe: From randomization to approximately 6 months
| Intervention | Percentage of Participants (Number) |
|---|
| Atezolizumab +ddAC-PacHP | 62.4 |
| Placebo + ddAC-PacHP | 62.7 |
Minimum Serum Concentration (Cmin) of Atezolizumab
Cmin is the minimum (or trough) concentration that a study drug achieves in the body. (NCT03726879)
Timeframe: Pre-dose on Day 1 Cycle (C) 2, 3, 4, 8, 12, 16, ATDV (an average of 1 year). C 2-4, each C is 14 days. C 8-16, each C is 21 days. With protocol version 5, collection is only required ATDV/completion (an average of 1 year).
| Intervention | ug/mL (Mean) |
|---|
| C2D1/predose | C3D1/predose | C4D1/predose | C8D1/predose | C12D1/predose | C16D1/predose |
|---|
| Atezolizumab +ddAC-PacHP | 103 | 163 | 204 | 225 | 217 | 226 |
Maximum Serum Concentration (Cmax) of Atezolizumab
Cmax is the maximum (or peak) concentration that a study drug achieves in the body. (NCT03726879)
Timeframe: 30 minutes post infusion on Day 1 Cycle (C) 1.
| Intervention | micrograms/milliliters (ug/mL) (Mean) |
|---|
| Atezolizumab +ddAC-PacHP | 348 |
Percentage of Participants With Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3)
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST) (i.e., ypT0/is ypN0 in the current American Joint Committee on Cancer [AJCC] staging system, 8th edition). Treatment comparison was made using Cochran-Mantel-Haenszel test stratified by disease stage (T2 vs. T3-4) and hormone receptor status (estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive vs. ER negative and PgR negative). (NCT03726879)
Timeframe: From randomization to approximately 6 months
| Intervention | Percentage of Participants (Number) |
|---|
| Atezolizumab +ddAC-PacHP | 64.2 |
| Placebo + ddAC-PacHP | 72.5 |
Percentage of Participants With Adverse Events
(NCT03726879)
Timeframe: From randomization up until clinical cut-off date (approximately 24 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Atezolizumab +ddAC-PacHP | 100 |
| Placebo + ddAC-PacHP | 100 |
Number of Participants Who Had a Pathological Complete Response (pCR)
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0). (NCT03742986)
Timeframe: up to 16 weeks
| Intervention | Participants (Count of Participants) |
|---|
| HER2-negative, Including TNBC or HR-positive | 0 |
| HER2-positive, Independent of HR Status | 3 |
Number of Participants Who Had a Pathological Complete Response (pCR)
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0). (NCT03742986)
Timeframe: up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| HER2-negative, Including TNBC or HR-positive | 1 |
| HER2-positive, Independent of HR Status | 3 |
Relapse With Central Nervous Disease (CNS) Disease
Relapse with CNS disease was defined as the time from the axicabtagene ciloleucel infusion date to the earliest date of CNS involvement with lymphoma as determined by typical symptoms, cerebrospinal fluid (CSF) evaluation, and/or diagnostic imaging. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (Up to approximately 26.2 months)
| Intervention | months (Median) |
|---|
| Axicabtagene Ciloleucel | 0 |
Progression-Free Survival (PFS)
PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (Up to approximately 26.2 months)
| Intervention | months (Median) |
|---|
| Axicabtagene Ciloleucel | NA |
Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood
Peak was defined as the maximum number of CAR T cells in blood measured after infusion. (NCT03761056)
Timeframe: From enrollment up to Month 24
| Intervention | cells/µL (Median) |
|---|
| Axicabtagene Ciloleucel | 36.27 |
Peak Serum Level of Ferritin
Peak is defined as the maximum post-baseline level of cytokine from baseline to Week 4. (NCT03761056)
Timeframe: From enrollment up to Week 4
| Intervention | ng/mL (Median) |
|---|
| Axicabtagene Ciloleucel | 749.1 |
Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators
Complete Response Rate (CRR): percentage of participants with CR [complete metabolic response (CMR); complete radiological response (CRR)]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (maximum duration: 26.2 months)
| Intervention | percentage of participants (Number) |
|---|
| Axicabtagene Ciloleucel | 78 |
Duration of Response (DOR) Per the Lugano Classification
DOR is defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and is the time from the first objective response to disease progression or death from any cause. Objective response is defined in outcome measure (OM) 2. (NCT03761056)
Timeframe: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 26.2 months)
| Intervention | months (Median) |
|---|
| Axicabtagene Ciloleucel | NA |
Event-Free Survival (EFS)
EFS was defined as time from axicabtagene ciloleucel infusion date to earliest date of disease progression (Lugano classification), commencement of subsequent new anti-lymphoma therapy including stem cell transplant, or death from any cause. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (Up to approximately 26.2 months)
| Intervention | months (Median) |
|---|
| Axicabtagene Ciloleucel | NA |
Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators
ORR: percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR:target nodes/nodal masses regressed to ≤ 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR:scores 4 (uptake moderately > liver),5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT).PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by > 50% in length beyond normal;no new sites. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (maximum duration: 26.2 months)
| Intervention | percentage of participants (Number) |
|---|
| Axicabtagene Ciloleucel | 89 |
Overall Survival (OS)
OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (Up to approximately 26.2 months)
| Intervention | months (Median) |
|---|
| Axicabtagene Ciloleucel | 24.5 |
Peak Serum Level of C-Reactive Protein (CRP)
Peak is defined as the maximum post-baseline level of cytokine from baseline to Week 4. (NCT03761056)
Timeframe: From enrollment up to Week 4
| Intervention | mg/L (Median) |
|---|
| Axicabtagene Ciloleucel | 208.4 |
Time to Peak Serum Level of Granzyme B, Interferon-gamma (IFNg), Interleukin (IL)-2, IL-5, IL-6, IL-8, CRP, and Ferritin
Time to peak is defined as the number of days from axicabtagene ciloleucel infusion to the date when the cytokine first reached the maximum post-baseline level. (NCT03761056)
Timeframe: From enrollment up to Week 4
| Intervention | days (Median) |
|---|
| Granzyme B | IFNg | IL-2 | IL-5 | IL-6 | IL-8 | CRP | Ferritin |
|---|
| Axicabtagene Ciloleucel | 8 | 4 | 4 | 1 | 8 | 8 | 4 | 8 |
Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Serious Adverse Events (SAE)
An AE was any untoward medical occurrence in a participant in a clinical trial participant, which did not necessarily have a causal relationship with the treatment. Treatment-emergent adverse events were defined as any adverse event with onset on or after the axicabtagene ciloleucel infusion. Serious adverse event was defined as an event that resulted in the following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; and medically important event or reaction. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (Up to approximately 26.2 months)
| Intervention | percentage of participants (Number) |
|---|
| TEAE | Treatment-Emergent SAE |
|---|
| Axicabtagene Ciloleucel | 100 | 45 |
Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value
Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (Up to approximately 26.2 months)
| Intervention | percentage of participants (Number) |
|---|
| Hemoglobin | Alanine Aminotransferase | Alkaline Aminotransferase | Aspartate Aminotransferase | Bilirubin | Calcium | Creatinine | Glucose | Magnesium | Sodium | Urate |
|---|
| Axicabtagene Ciloleucel | 3 | 8 | 0 | 5 | 20 | 5 | 5 | 15 | 5 | 0 | 18 |
Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value
Grading categories were determined by CTCAE version 5.0. (NCT03761056)
Timeframe: First infusion date of axicabtagene ciloleucel to data cut off date of 17 May 2021 (Up to approximately 26.2 months)
| Intervention | percentage of participants (Number) |
|---|
| Hemoglobin | Leukocytes | Lymphocytes | Neutrophils | Platelets | Albumin | Calcium | Glucose | Magnesium | Potassium | Sodium |
|---|
| Axicabtagene Ciloleucel | 40 | 93 | 75 | 95 | 25 | 3 | 10 | 0 | 3 | 5 | 23 |
Peak Serum Level of Granzyme B, Interferon-gamma (IFNg), Interleukin (IL)-2, IL-5, IL-6, IL-8
Peak is defined as the maximum post-baseline level of cytokine from baseline to Week 4. (NCT03761056)
Timeframe: From enrollment up to Week 4
| Intervention | pg/mL (Median) |
|---|
| Granzyme B | IFNg | IL-2 | IL-5 | IL-6 | IL-8 |
|---|
| Axicabtagene Ciloleucel | 28.5 | 409.4 | 16.4 | 6.3 | 35.1 | 63.0 |
Overall Survival
Kaplan-Meier method was used to estimate overall survival (OS). OS was defined as the time from study enrollment to death. 1-year OS is provided. (NCT03786783)
Timeframe: Up to 1 year
| Intervention | Percent Probability (Number) |
|---|
| Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 95.0 |
Percentage of Participants With Unacceptable Toxicity
Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Assessed by estimation of the combined toxic death and unacceptable toxicity rate during Induction cycles 3-5 together with a 95% confidence interval. (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment
| Intervention | percentage of patients (Number) |
|---|
| Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 0.0 |
"Percentage of Participants Who Are Feasibility Failure"
"Feasibility failures were defined as patients that did not receive >= 75% of the planned dinutuximab doses during Induction cycles 3-5. Assessed by estimation of the feasibility failure rate together with a 95% confidence interval." (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment
| Intervention | Percentage of patients (Number) |
|---|
| Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 0.0 |
Event-free Survival
Per the revised INRC, progressive disease is: 1) > 20% increase in the longest diameter of the primary tumor, taking as reference the smallest sum and ¬> increase of 5 mm in longest dimension, 2) Any new soft tissue lesion detected by CT/MRI that is MIBG avid or FDG-PET avid, 3) Any new soft tissue lesion seen on CT/MRI that is biopsied and found to be neuroblastoma or ganglioneuroblastoma, 4) Any new bone site that is MIBG avid, 5) Any new bone site that is FDG-PET avid and has CT/MRI findings of tumor or is histologically neuroblastoma or ganglioneuroblastoma 6) A metastatic soft tissue site with > 20% increase in longest diameter, taking as reference the smallest sum on study, and with > 5mm in sum of diameters of target soft tissue lesions, 7) A relative MIBG score ¬> 1.2, 8) Bone marrow without tumor infiltration that becomes >5% tumor infiltration, 9) Bone marrow with tumor infiltration that increases by > 2-fold and has > 20% tumor infiltration on reassessment. (NCT03786783)
Timeframe: Up to 1 year
| Intervention | Percent Probability (Number) |
|---|
| Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 82.6 |
Response Rate
Per the revised INRC, response is comprised by responses in 3 components: primary tumor, soft tissue and bone metastases, and bone marrow. Primary and metastatic soft tissue sites were assessed using Response Evaluation Criteria in Solid Tumors and MIBG scans or FDG-PET scans if the tumor was MIBG non-avid. Bone marrow was assessed by histology or immunohistochemistry and cytology or immunocytology. Complete response (CR) - All components meet criteria for CR. Partial response (PR) - PR in at least one component and all other components are either CR, minimal disease (in bone marrow), PR (soft tissue or bone) or not involved (NI; no component with progressive disease (PD). Minor response (MR) - PR or CR in at least one component but at least one other component with stable disease; no component with PD. Stable disease (SD) - Stable disease in one component with no better than SD or NI in any other component; no component with PD. Progressive disease (PD) - Any component with PD. (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment
| Intervention | Percentage of patients (Number) |
|---|
| Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT) | 78.6 |
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study, recurrence of an intermittent medical condition, deterioration in a laboratory value or other clinical test or were related to a protocol-mandated intervention were also considered AEs. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. (NCT03817853)
Timeframe: Baseline up to clinical cut off date (up to approximately 1.5 years)
| Intervention | Percentage of Participants (Number) |
|---|
| All Participants | 99.1 |
| Maintenance: Obinutuzumab | 41.1 |
| Follow-up | 35.3 |
Time to IRR From Infusion to Onset of the IRR During Cycle 2
Time to IRR (of any grade) in Cycle 2 was defined as the time from the start of infusion (i.e., start date/time of infusion of the first component of study treatment) in Cycle 2 to the onset of the IRR (of any grade) during Cycle 2. (NCT03817853)
Timeframe: From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)
| Intervention | Hours (Mean) |
|---|
| All Participants | 11.800 |
Duration (In Minutes) of Obinutuzumab Administration by Cycle
The duration of obinutuzumab administration (in minutes) by cycle was defined as the difference between the end time and the start time of obinutuzumab administration. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)
| Intervention | Minutes (Mean) |
|---|
| Cycle(C) 1 Day(D) 1 | C1D8 | C1D15 | C2 | C3 | C4 | C5 | C6 | C7 | C8 | Maintenance Week 1 | Maintenance Week 9 | Maintenance Week 17 | Maintenance Week 25 | Maintenance Week 33 | Maintenance Week 41 |
|---|
| All Participants | 295.96 | 215.97 | 207.52 | 101.48 | 102.97 | 98.33 | 98.26 | 99.49 | 99.56 | 94.54 | 101.48 | 97.21 | 97.64 | 93.83 | 92.50 | 90.00 |
Objective Response Rate (ORR) at the End of Induction (EOI) Therapy
ORR at EOI therapy was defined as the percentage of particpants with either a CR, CR unconfirmed or PR at the EOI visit, as determined by the investigator and according to the guidelines used at the site. (NCT03817853)
Timeframe: Baseline up to end of induction therapy (up to approximately 6 months)
| Intervention | Percentage of Participants (Number) |
|---|
| Complete Response | Partial Response |
|---|
| All Participants | 72.1 | 19.1 |
Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
The duration, in minutes, of IRRs during all cycles, where obinutuzumab was administered as an SDI. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)
| Intervention | Minutes (Mean) |
|---|
| All Participants | 165.0 |
Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
(NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)
| Intervention | Percentage of Participants (Number) |
|---|
| Cycle (C) 5- Hypertension | C5 - Renal failure | C5 - Weight increased |
|---|
| All Participants | 33.3 | 33.3 | 33.3 |
Percentage of IRRs Regardless of Grade by Cycle
IRRs were defined as all adverse events (AEs) that occurred during or within 24 hours from the end of study treatment infusion and were judged as related to infusion of study treatment components by the investigator. (NCT03817853)
Timeframe: Within 24 hours from the end of study treatment infusion in all cycles, including maintenance ((1 cycle: 21 or 28 days depending on the chemotherapy selected); up to approximately 2.5 years)
| Intervention | Percentage of Participants (Number) |
|---|
| Cycle 1 Day 1 | Cycle 1 Day 2 | Cycle 1 Day 8 | Cycle 1 Day 15 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Cycle 7 |
|---|
| All Participants | 49.6 | 7.8 | 4.5 | 4.5 | 11.8 | 8.3 | 4.9 | 6.2 | 3.6 | 4.4 |
Number of Participants With Infusion Reactions (IRs)
An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator. (NCT03860844)
Timeframe: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
| Intervention | Participants (Count of Participants) |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 9 |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 5 |
| Acute Myeloid Leukemia (AML) | 15 |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first. (NCT03860844)
Timeframe: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)
| Intervention | Participants (Count of Participants) |
|---|
| Any TEAE | Any TESAE |
|---|
| Acute Myeloid Leukemia (AML) | 26 | 16 |
,| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 27 | 19 |
,| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 13 | 12 |
B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab
Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. (NCT03860844)
Timeframe: From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10
| Intervention | mg*hour (h)/Liter (L) (Mean) |
|---|
| Week 0 to Week 1 | Week 0 to Week 5 | Week 0 to Week 10 |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 31703 | 299071 | 582686 |
,| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 29057 | 289167 | 540375 |
AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab. (NCT03860844)
Timeframe: Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1: Day 8 | Cycle 1: Day 15 | Cycle 2: Day 1 | Cycle 2: Day 15 |
|---|
| Acute Myeloid Leukemia (AML) | 126 | 217 | 115 | 420 |
Percentage of Participants With Complete Response (CR) Rate
The complete response rate (CR + CRi [complete response with incomplete peripheral recovery]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as <5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) >=1000/microliter (mcL); platelets >100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant's underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). (NCT03860844)
Timeframe: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
| Intervention | percentage of participants (Number) |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 52.0 |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 45.5 |
| Acute Myeloid Leukemia (AML) | 60.9 |
B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab. (NCT03860844)
Timeframe: Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57
| Intervention | microgram/milliliter (mcg/mL) (Mean) |
|---|
| Cycle 1: Day 8 | Cycle 1: Day 15 | Cycle 1: Day 22 | Cycle 1: Day 29 | Cycle 2: Day 43 | Cycle 2: Day 57 |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 114 | 272 | 388 | 475 | 504 | 531 |
,| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 127 | 263 | 323 | 426 | 357 | 478 |
Overall Response Rate (ORR)
ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: <5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC >=1000/mcL; platelets >100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant's underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). PR: >50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site. (NCT03860844)
Timeframe: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks
| Intervention | percentage of participants (Number) |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 52.0 |
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 54.5 |
| Acute Myeloid Leukemia (AML) | 65.2 |
CD38 Receptor Occupancy
Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100. (NCT03860844)
Timeframe: Pre-dose on Day 15
| Intervention | percent receptor occupancy (Mean) |
|---|
| Blood plasma cells: Non CR/CRi; | Blood NK cells: CR/CRi | Blood NK cells: Non CR/CRi |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 44.0 | 55.6 | 61.3 |
AML: Ceoi of Isatuximab
Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. (NCT03860844)
Timeframe: At end of infusion on Cycle 1 Days 1 and 15
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1: Day 1 | Cycle 1: Day 15 |
|---|
| Acute Myeloid Leukemia (AML) | 363 | 562 |
CD38 Receptor Occupancy
Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100. (NCT03860844)
Timeframe: Pre-dose on Day 15
| Intervention | percent receptor occupancy (Mean) |
|---|
| Blood plasma cells: CR/CRi | Blood plasma cells: Non CR/CRi; | Blood NK cells: CR/CRi | Blood NK cells: Non CR/CRi |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 40.5 | 55.0 | 66.7 | 70.0 |
B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab
Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. (NCT03860844)
Timeframe: At end of infusion on Cycle 1 Days 1 and 29
| Intervention | mcg/mL (Mean) |
|---|
| Cycle 1: Day 1 | Cycle 1: Day 29 |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 452 | 835 |
,| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 259 | 745 |
AML: AUC of Isatuximab
Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. (NCT03860844)
Timeframe: From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8
| Intervention | mg*h/L (Mean) |
|---|
| Week 0 to Week 1 | Week 0 to Week 3 | Week 0 to Week 8 |
|---|
| Acute Myeloid Leukemia (AML) | 28592 | 130862 | 291962 |
Cluster of Differentiation (CD)38 Receptor Density
"Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10^(Logarithm(Mean Fluorescence Intensity)*a+b) where a was the slope and b was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity [sABC]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control." (NCT03860844)
Timeframe: Pre-dose on Day 1
| Intervention | sABC (Mean) |
|---|
| Blood blast cells: CR/CRi | Blood blast cells: Non CR/CRi; | Blood immune cells (Natural Killer [NK] cells): CR/CRi | Blood immune cells (NK cells): Non CR/CRi |
|---|
| Acute Myeloid Leukemia (AML) | 19502.0 | 9815.0 | 11220.3 | 22530.0 |
,| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 20345.6 | 31080.0 | 13506.2 | 16650.0 |
,| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 12780.0 | 22952.0 | 22639.0 | 33859.0 |
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
Defined by any grade 3 or NCI CTCAE toxicities and modified CRS grading as applicable. (NCT03873805)
Timeframe: Up to 28 days post treatment
| Intervention | Participants (Count of Participants) |
|---|
| Dose Level 1 | 0 |
| Dose Level 2 | 2 |
| Dose Level 3 | 0 |
Grade 3 Toxicity Profile
Grade 3 toxicity profile as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 and modified Cytokine Release Syndrome (CRS) grading as applicable post chimeric antigen receptor (CAR) T cell infusion. (NCT03873805)
Timeframe: Up to 32 months
| Intervention | Participants (Count of Participants) |
|---|
| Anemia : Yes | Anemia : No | Lymphocyte count decreased : Yes | Lymphocyte count decreased : No | Fatigue : Yes | Fatigue : No | Pain : Yes | Pain : No | Cystitis noninfective : Yes | Cystitis noninfective : No | Hematuria : Yes | Hematuria : No | Rash maculo-papular : Yes | Rash maculo-papular : No |
|---|
| Dose Level 1 | 2 | 1 | 1 | 2 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 |
,| Dose Level 2 | 2 | 4 | 0 | 6 | 2 | 4 | 1 | 5 | 2 | 4 | 1 | 5 | 1 | 5 |
,| Dose Level 3 | 0 | 5 | 1 | 4 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 |
Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)
A DLT is defined as protocol-defined KITE-439 related Grade 3 events with onset within the first 21 days following KITE-439 infusion and which do not resolve to ≤Grade 2 events within 48 hours, ≥Grade 4 events with onset within the first 21 days following KITE-439 infusion, regardless of duration. (NCT03912831)
Timeframe: First infusion date of KITE-439 up to 21 days
| Intervention | percentage of participants (Number) |
|---|
| Phase 1A: 1 x 10^6 KITE-439 (Cohort 1) | 0 |
| Phase 1A: 3 x 10^6 KITE-439 (Cohort 2) | 0 |
| Phase 1A: 1 x 10^7 KITE-439 (Cohort 3) | 0 |
| Phase 1A: 3 x 10^7 KITE-439 (Cohort 4) | 0 |
| Phase 1A: 1 x 10^8 KITE-439 (Cohort 5) | 0 |
| Phase 1A: 1 x 10^8 KITE-439 (Cohort 6) | 0 |
Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT03918499)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2) | 0 |
Overall Survival
Estimated using the product-limit method of Kaplan and Meier. From the time of initial treatment until death from any cause. (NCT03918499)
Timeframe: Up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2) | 2.9 |
Progression-free Survival
Estimated using the product-limit method of Kaplan and Meier. From initial treatment until progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT03918499)
Timeframe: From first day of study drug administration to disease progression or death, assessed up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2) | 1.1 |
Percentage of Participants Who Experience Acute GvHD
Rate of acute GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis. (NCT03945591)
Timeframe: Day 120 Post-Transplant
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide and Bortezomib | 38.46 |
Percentage of Participants Who Experience Moderate to Severe Chronic GvHD
Rate of chronic GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis. (NCT03945591)
Timeframe: Day 365 Post-Transplant
| Intervention | percentage of participants (Number) |
|---|
| Cyclophosphamide and Bortezomib | 36.36 |
Number of Participants With a Response
Response was assessed by the International Uniform Response Criteria for Multiple myeloma 2016 updated version. Complete Remission (CR) is negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis, or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 h. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein (or to less than 200mg per 24 h). Progressive Disease (PD) is serum M-component (minimum absolute increase of 0.5g/dL), or urine M-component (minimum absolute increase of 200mg/24h). Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or progressive disease. (NCT03958656)
Timeframe: At two and five weeks for stable disease and partial remission, respectively, and up to 5 months and 23 days for progressive disease
| Intervention | Participants (Count of Participants) |
|---|
| Partial Remission at 5 Weeks | Stable Disease at 2 Weeks | Progressive Disease |
|---|
| LEVEL 1 - 0.66x10^6 Per Kilogram (kg) | 0 | 2 | 1 |
,| LEVEL 2 - 2.0x10^6 Per kg | 1 | 1 | 1 |
,| LEVEL 3 - 6.0x10^6 Per kg | 0 | 2 | 1 |
,| LEVEL 4 - 12.0x10^6 Per kg | 0 | 1 | 0 |
Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)
Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal. (NCT03958656)
Timeframe: Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
| Intervention | Participants (Count of Participants) |
|---|
| < Grade 2 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
|---|
| LEVEL 1 - 0.66x10^6 Per Kilogram (kg) | 0 | 3 | 3 | 3 | 0 |
,| LEVEL 2 - 2.0x10^6 Per kg | 0 | 3 | 3 | 3 | 0 |
,| LEVEL 3 - 6.0x10^6 Per kg | 1 | 3 | 3 | 3 | 0 |
,| LEVEL 4 - 12.0x10^6 Per kg | 0 | 1 | 1 | 1 | 0 |
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03958656)
Timeframe: Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
| Intervention | Participants (Count of Participants) |
|---|
| LEVEL 1 - 0.66x10^6 Per Kilogram (kg) | 3 |
| LEVEL 2 - 2.0x10^6 Per kg | 3 |
| LEVEL 3 - 6.0x10^6 Per kg | 3 |
| LEVEL 4 - 12.0x10^6 Per kg | 1 |
Complete Remission (CR) Rate at Day 30 Post HSCT
The CR rate at 30 days (Day +30) post stem cell transplant infusion (NCT04002115)
Timeframe: 30 days
| Intervention | percentage of Participants (Number) |
|---|
| Clofarabine 30 mg/m^2 | 100 |
Neutrophil Engraftment
Rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days (NCT04002115)
Timeframe: 1 year
| Intervention | percentage of Participants (Number) |
|---|
| Clofarabine 30 mg/m^2 | 0 |
Rate of Chronic GVHD
The rate of any grade (1-4) of Chronic GvHD as measured from Day +100 to Year 1 post-transplantation using the Glucksberg criteria. (NCT04002115)
Timeframe: 1 year
| Intervention | percentage of Participants (Number) |
|---|
| Clofarabine 30 mg/m^2 | 0 |
Severity of Chronic GVHD
The highest overall grade (1-4) of chronic GvHD experienced by participants as measured from Day +100 to Year 1 post-transplantation using the Glucksberg criteria (NCT04002115)
Timeframe: 1 year
| Intervention | percentage of Participants (Number) |
|---|
| Clofarabine 30 mg/m^2 | 0 |
Severity of Acute Graft-versus-host Disease (GVHD)
The highest grade (1-4) of acute GvHD experienced by participants as measured from day of transplantation to Day +100 using the Glucksberg criteria (NCT04002115)
Timeframe: 100 days
| Intervention | percentage of Participants (Number) |
|---|
| Clofarabine 30 mg/m^2 | 0 |
Rate of Acute Graft-versus-host Disease (GVHD)
The rate of any grade (1-4) of acute GvHD as measured from day of transplantation to Day +100 using the Glucksberg criteria. (NCT04002115)
Timeframe: 100 days
| Intervention | percentage of Participants (Number) |
|---|
| Clofarabine 30 mg/m^2 | 0 |
Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment
Total pathological complete response (tpCR) was defined as eradication of invasive disease in the breast and axilla; that is, ypT0/is ypN0, according to the local pathologists' assessment. Pathologic response to therapy was determined at the time of surgery. The tpCR rate is the percentage of participants in the ITT population who achieved a tpCR. Participants with missing data for tpCR (i.e., do not undergo surgery or have an invalid pCR assessment) were included in the analysis and classified as non-responders. Rates of tpCR were calculated in each treatment arm and were assessed using the difference between the Arm B: Pertuzumab and Trastuzumab FDC SC and the Arm A: Pertuzumab IV and Trastuzumab IV tpCR rates and corresponding 95% Clopper-Pearson confidence intervals (CIs). The difference between the tpCR rates along with corresponding 95% Hauck-Anderson CIs were calculated. (NCT04024462)
Timeframe: Following completion of surgery (up to 33 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 56.4 |
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 55.6 |
Serum Trough Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8)
The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a Cycle 7 subcutaneous injection site other than thigh was used, if the Cycle 8 IV pre-dose and post-dose PK samples were switched, and an assay error impacting Ctrough measurement. (NCT04024462)
Timeframe: Pre-dose at Cycle 8 (one cycle is 21 days)
| Intervention | micrograms per millilitre (μg/mL) (Geometric Mean) |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 69.9 |
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 74.6 |
Serum Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8)
The observed trastuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a Cycle 7 subcutaneous injection site other than thigh was used, if the Cycle 8 IV pre-dose and post-dose PK samples were switched, and an assay error impacting Ctrough measurement. (NCT04024462)
Timeframe: Pre-dose at Cycle 8 (one cycle is 21 days)
| Intervention | micrograms per milllilitre (μg/mL) (Geometric Mean) |
|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 33.6 |
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 52.1 |
Objective Response Rate
Objective response rate (ORR) is a measure of clinical activity as response in NHL by the revised Lugano Classification (Cheson et al, 2016) or a response in CLL/SLL by the International Workshop on Chronic Lymphocytic Leukemia 2018 guidelines. (NCT04030195)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Responders | Complete Response | Partial Response | Non-responders |
|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 2 | 1 | 1 | 6 |
,| Dose Level 2 of PBCAR20A CAR T Cells | 1 | 0 | 1 | 2 |
,| Dose Level 3 of PBCAR20A CAR T Cells | 3 | 0 | 3 | 4 |
Progression-free Survival (PFS)
Progression-free survival is defined as the duration (days) from Day 0 to disease progression or death. (NCT04030195)
Timeframe: 1 year
| Intervention | Days (Median) |
|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 29.5 |
| Dose Level 2 of PBCAR20A CAR T Cells | 29.0 |
| Dose Level 3 of PBCAR20A CAR T Cells | 29.0 |
Number of Participants With Dose-Limiting Toxicities
Dose-limiting toxicities (DLT) are certain Grade 3 and Grade 4 toxic reactions as defined by the protocol and CTCAE v5.0. (NCT04030195)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 1 |
| Dose Level 2 of PBCAR20A CAR T Cells | 0 |
| Dose Level 3 of PBCAR20A CAR T Cells | 0 |
Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) is the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy. (NCT04030195)
Timeframe: Day 1 to Day 28
| Intervention | 10^6 CAR T cells (Number) |
|---|
| PBCAR20A CAR T Cells | NA |
Recurrence-free Survival (RFS)
RFS is defined as local/regional invasive recurrence, invasive ipsilateral breast tumor recurrence, distant recurrence, inoperable (meaning no surgery because of progression), and/or death from breast cancer (per standard of care according to physician discretion) or any cause. RFS will be calculated from the time of treatment to event. The median RFS was estimated using standard Kaplan-Meier methods (where NR = not reached). (NCT04081389)
Timeframe: At 3 years
| Intervention | months (Median) |
|---|
| Arm 1: Interferon Alpha-2b at DL 1 | 12.0 |
| Arm 2: Interferon Alpha-2b at DL 2 | NA |
| Arm 3: Interferon Alpha-2b at DL 3 | 11.4 |
| Arm 4: Interferon Alpha-2b at DL 4 | 11.5 |
Overall Survival (OS)
OS is defined by death from breast cancer, non-breast cancer, unknown, or any other cause and will be calculated from the time of study entry to event. The median OS is estimated using standard Kaplan-Meier methods (where NR = not reached). (NCT04081389)
Timeframe: At 3 years
| Intervention | months (Median) |
|---|
| Arm 1: Interferon Alpha-2b at DL 1 | 21.7 |
| Arm 2: Interferon Alpha-2b at DL 2 | NA |
| Arm 3: Interferon Alpha-2b at DL 3 | NA |
| Arm 4: Interferon Alpha-2b at DL 4 | NA |
Number of Patients With Pathological Complete Response (pCR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, where Complete Response (CR) corresponds to the disappearance of all target lesions. (NCT04081389)
Timeframe: Up to 4 week post-treatment (with a range of 7 to 11 weeks).
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Interferon Alpha-2b at DL 1 | 0 |
| Arm 2: Interferon Alpha-2b at DL 2 | 1 |
| Arm 3: Interferon Alpha-2b at DL 3 | 2 |
| Arm 4: Interferon Alpha-2b at DL 4 | 2 |
Number of Patients With Dose Limiting Toxicities
"Safety and toxicity will be assessed using the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). The resulting dose limiting toxicity (DLT) information is used to identify the appropriate dose level of CKM and paclitaxel for future clinical exploration.~The following events will be considered a DLT:~The event occurs within 3 weeks following 1st dose of combination CKM + paclitaxel therapy and subsequent enrollment for dose-escalation will only proceed after the 3-week period has been completed.~The toxicity has been determined by the investigator to be possibly, probably or definitely related to celecoxib, rintatolimod, interferon-α2b or paclitaxel.~Any death not clearly due to th" (NCT04081389)
Timeframe: Within 21 days of treatment adminstration
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1: Interferon Alpha-2b at DL 1 | 0 |
| Arm 2: Interferon Alpha-2b at DL 2 | 0 |
| Arm 3: Interferon Alpha-2b at DL 3 | 0 |
| Arm 4: Interferon Alpha-2b at DL 4 | 0 |
Objective Response Rate (ORR)
"ORR is defined as percentage of participants with complete response (CR) and partial response (PR) per International Myeloma Working Group (IMWG) criteria below.~CR = Negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas, and <5% plasma cells in bone marrow~Stringent CR = Above definition plus normal FLC ration and absence of clonal cells in bone marrow by IHC or 2-4 color flow cytometry~PR = At least 50% reduction of serum M-protein and reduction in 24 urinary M-protein by at least 90% or to <200 mg/24 h. If serum and urine M-protein unmeasurable, require at least 50% decrease in difference between involved and uninvolved FLC levels. If serum free light assay also unmeasurable, require at least 50% reduction in plasma cells, provided baseline was at least 30%~Very Good PR (VGPR) = Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or >90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h" (NCT04119336)
Timeframe: up to 8 months
| Intervention | percentage of participants (Number) |
|---|
| Nivolumab and Ixazomib | 0 |
Progression Free Survival
"Progression-free survival (PFS) is defined as the time from starting study treatment to disease progression or death from any cause. The International Myeloma Working Group (IMWG) criteria defines progressive disease (PD) as at least 25% increase from lowest response value of any of the following:~Serum M-component (absolute increase must be at least 0.5 g/dL)~Urine M-component (absolute increase must be at least 200 mg/24 h)~If serum and urine M-protein unmeasurable, absolute increase in free light chain (FLC) must be >10 mg/dL. If FLC levels also unmeasurable, absolute increase in bone marrow plasma cell percentage must be at least 10%.~Definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder" (NCT04119336)
Timeframe: Up to 2 years
| Intervention | months (Median) |
|---|
| Nivolumab and Ixazomib | 3.96 |
Percentage of Peak Blood Chimeric Antigen Receptors (CAR) T Cells
We measured CAR T-cell persistence by detecting the CAR gene in peripheral blood mononuclear cells (PBMC) by polymerase chain reaction (PCR). (NCT04160195)
Timeframe: 119 days after CAR T-cell infusion
| Intervention | percentage of PBMC (Number) |
|---|
| 1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation | 10.5 |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT04160195)
Timeframe: Date treatment consent signed to date off study, approximately 7 months and 18 days.
| Intervention | Participants (Count of Participants) |
|---|
| 1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation | 1 |
| 2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase | 0 |
Maximum Tolerated Dose (MTD) of Chimeric Antigen Receptors (CAR) T Cells
The maximum tolerated dose is the dose at which a maximum of 1 of 6 participants has a dose-limiting toxicity (DLT). A DLT are defined as toxicities that are possibly, probably, or definitely attributable to protocol interventions and occurring between the first protocol treatment through 28 days after the CAR T-cell infusion. (NCT04160195)
Timeframe: First protocol treatment through 28 days after the CAR T-cell infusion.
| Intervention | T cells (Number) |
|---|
| All Participants | NA |
Last Time-Point at Which Chimeric Antigen Receptors (CAR) T Cells Were Detected in the Blood
Chimeric Antigen Receptors (CAR) T cell persistence was measured in the blood by quantitative polymerase chain reaction (PCR). CAR T cells that are detected in the participant's blood that persist for a significant length of time is a positive finding. (NCT04160195)
Timeframe: 119 days after CAR T-cell infusion
| Intervention | Days (Number) |
|---|
| 1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation | 119 |
Number of Participants Administered T Cells Expressing a Novel Fully- Human Anti-cluster of Differentiation 19 (CD19) and Anti-cluster of Differentiation 20 (CD20) Chimeric Antigen Receptors (CAR) Who Experienced a Dose-limiting Toxicity (DLT)
A DLT are defined as toxicities assessed by the Common Terminology Criteria for Adverse Events v5.0 that are possibly, probably, or definitely attributable to protocol interventions and occurring between the first protocol treatment through 28 days after the CAR T-cell infusion. (NCT04160195)
Timeframe: First protocol treatment through 28 days after the CAR T-cell infusion.
| Intervention | Participants (Count of Participants) |
|---|
| Peripheral Motor Neuropathy Possibly Related | Guillain-Barre Syndrome Possibly Related |
|---|
| 1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation | 1 | 1 |
,| 2/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Expansion Phase | 0 | 0 |
Number of Participants With Clinical Response
Response for lymphoma was assessed by the Revised Response Criteria for Malignant Lymphoma and The Lugano Classification. Complete Remission (CR) is complete disappearance of all detectable clinical evidence of disease. Partial Remission (PR) is ≥ 50% decrease in nodes or masses. Progressive Disease (PD) is Response ≥ 50% increase in a single node. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor PD. For participants with Chronic Lymphocytic Leukemia (CLL),response was assessed by the International Workshop on CLL. CR is no lymph nodes ≥ 1.5 cm on physical exam or relevant computed tomography. PR is a ≥ 50% decrease in peripheral B lymphocyte count from pre-treatment value. PD is a ≥ 50% increase in the greatest diameter of any lymph node that was enlarged pretreatment. And SD are participants who do not fulfill the criteria for CR, PR or PD. (NCT04160195)
Timeframe: Approximately 1 year 5 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete Remission | Partial Remission | Progressive Disease | Stable Disease |
|---|
| 1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation | 0 | 1 | 0 | 0 |
Percentage of Peripheral Blood Mononuclear Cells (PBMC) of Chimeric Antigen Receptors (CAR) T Cells
Peak blood levels of Chimeric Antigen Receptors (CAR) T cells were measured by exact Wilcoxon rank sum test. (NCT04160195)
Timeframe: pretreatment and multiple days from day 1 to day 173 after infusion.
| Intervention | percentage of PBMC (Number) |
|---|
| 1/Conditioning Chemotherapy Plus Chimeric Antigen Receptors (CAR) T-cells Dose Escalation | 10.47 |
Number of Patients With a Partial Response
The proportion of each type of response with a 95% CI will be reported for all evaluable patients, assuming a binomial distribution. (NCT04205240)
Timeframe: Approximately 11 months
| Intervention | patients (Number) |
|---|
| Treatment (Conditioning Regimen, Stem Cell Transplant) | 1 |
Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD)
The event will be onset of grade II-IV aGvHD and time to aGvHD will be defined as the period of time from transplantation to the event of aGvHD. Death and early relapse without aGvHD will be competing risks. Cumulative incidence rate of aGVHD with 95% confidence intervals will be estimated from the cumulative incidence curves. To evaluate the association between patient characteristics and aGVHD, the Gray's test accounting for competing risks will be used to compare the cumulative incidence curves and a proportional hazards model for the sub distribution of competing risks will be used to estimate the hazard ratio. The cumulative incidence of chronic GVHD (cGVHD) will be similarly analyzed. (NCT04205240)
Timeframe: Up to 6 weeks
| Intervention | participants (Number) |
|---|
| Treatment (Conditioning Regimen, Stem Cell Transplant) | 0 |
Percentage of Participants With Grade II-IV Acute GvHD by Day +120
"The first day of grade II-IV acute GvHD will be used to calculate the cumulative incidence. The cumulative incidence will be defined as the percentage of participants with grade II-IV acute GvHD. The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.~Overall Grades of Acute GvHD:~0 = none;~= mild;~= moderate;~= severe;~= life threatening" (NCT04503616)
Timeframe: 120 days
| Intervention | Percentage of participants (Number) |
|---|
| HSCT Patients | 17.4 |
Peripheral Blood Concentration of Infused Transgenic T Cells Over Time
Results will be reported by sample for the single treated patient. Patient samples were tested using a WPRE assay showing transgenic T cells in blood. This was detected by qPCR. (NCT04639245)
Timeframe: 1 year post infusion
| Intervention | WPRE copies/Cell (Number) |
|---|
| BU712PRETX | BU712I1D000 | BU712I1D001 | BU712I1D003 | BU712I1D007 | BU712I1D014 | BU712I1D021 | BU712I1D028 | BU712I1D056 | BU712I1D180 | BU712I2D03 | BU712I2D07 | BU712I2D14 | BU712I2D21 | BU712I2D28 | BU712I2D56 | BU712I2D84 |
|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0.0 | 0.0 | 0.0101 | 0.0303 | 0.0379 | 0.0379 | 0.0111 | 0.0087 | 0.0107 | 0.0062 | 0.1167 | 0.0795 | 0.0353 | 0.0267 | 0.0333 | 0.0027 | 0.0070 |
Progression-free Survival
Outcome will be reported as a count of participants that were alive as the 1 year post infusion timepoint and also had not experienced progression at that timepoint. (NCT04639245)
Timeframe: 1 year post infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Participants That Displayed Transgenic T Cells in Tumor Tissue
Outcome will be reported as a count of participants that displayed transgenic T cells in their tumor tissue after treatment. This was assessed by WRPE staining and scRNA sequencing. Unfortunately, no transgenic cells were detected on the one treated patient's tumors. (NCT04639245)
Timeframe: 1 year post infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Overall Survival
Outcome will be reported as a count of participants that were alive at the 1 year post infusion timepoint. (NCT04639245)
Timeframe: 1 year post infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Objective Response Rates
Evaluated by immune-related RECIST criteria. Outcome will be reported as a count of participants that experienced a Complete Response or Partial Response per RECIST criteria. A complete response (CR) will be defined as total regression of all tumors, a Partial Response as 30% or greater decrease in the sum of the longest diameter of target lesions compared to baseline and Progressive Disease as 20% increase in the sum of the longest diameter of target lesions compared to the smallest prior diameter. If the disease does not fall in either category it will be considered Stable Disease (RECIST v1.1 criteria). (NCT04639245)
Timeframe: 1 year post infusion
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (FH-MagIC TCR-T Cells, Atezolizumab) | 0 |
Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma
Per LRC, CR based on positron emission tomography- computed tomography (PET-CT) was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Rituximab IV+CHOP | 62.5 |
| Rituximab SC+CHOP | 80.8 |
CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines
CRR was assessed according to the IWG Response Criteria for NHL 1999 guidelines and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Rituximab IV+CHOP | 58.3 |
| Rituximab SC+CHOP | 65.4 |
CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma
Per LRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Rituximab IV+CHOP | 58.3 |
| Rituximab SC+CHOP | 76.9 |
Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV)
For this pharmacokinetics (PK) primary outcome measure the serum rituximab Ctrough for SC and IV administrations were measured at Cycle 7, 21 days after study treatment administration for Cycle 7 (pre-dose of Cycle 8). Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis. (NCT04660799)
Timeframe: At Cycle 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks
| Intervention | micrograms/milliliter (mcg/mL) (Geometric Mean) |
|---|
| Rituximab IV+CHOP | 90.7 |
| Rituximab SC+CHOP | 137.4 |
Area Under the Curve (AUC) of Rituximab
AUC is the area under the serum concentration curve over the dosing interval of 21 days during Cycle 2 and Cycle 7. (NCT04660799)
Timeframe: During Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
| Intervention | day*mcg/mL (Geometric Mean) |
|---|
| Cycle 2 | Cycle 7 |
|---|
| Rituximab IV+CHOP | 1730 | 3050 |
,| Rituximab SC+CHOP | 2130 | 3810 |
Maximum Observed Serum Concentration (Cmax) of Rituximab
(NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
| Intervention | micrograms per milliliter (mcg/mL) (Geometric Mean) |
|---|
| Cycle 2 | Cycle 7 |
|---|
| Rituximab IV+CHOP | 200 | 255 |
,| Rituximab SC+CHOP | 144 | 228 |
Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab
Reported here is the number of participants who had a positive ADA assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced ADAs and treatment-induced ADAs. Treatment-enhanced ADAs are participants with a positive ADA result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced ADAs include participants with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. (NCT04660799)
Timeframe: From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | Post-baseline: Treatment-enhanced | Post-baseline: Treatment-induced |
|---|
| Rituximab IV+CHOP | 2 | 1 | 1 |
,| Rituximab SC+CHOP | 1 | 0 | 1 |
Number of Participants Positive for Anti-rHuPH20 Antibodies
Reported here is the number of participants who had a positive anti-rHuPH20 antibody assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced anti-rHuPH20 antibodies and treatment-induced anti-rHuPH20 antibodies. Treatment-enhanced anti-rHuPH20 antibodies are participants with a positive anti-rHuPH20 antibody result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced anti-rHuPH20 antibodies include participants with negative or missing baseline anti-rHuPH20 antibody result(s) and at least one positive post-baseline anti-rHuPH20 antibody result. (NCT04660799)
Timeframe: From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | Post-baseline: Treatment-enhanced | Post-baseline: Treatment-induced |
|---|
| Rituximab SC+CHOP | 2 | 1 | 1 |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs. SAEs: any event that met any of these criteria: fatal, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, medically significant or required intervention to prevent any of the outcomes listed here. (NCT04660799)
Timeframe: AEs were reported up to 28 days after the last dose (up to approximately 7 months), and SAEs were reported up to 6 months after the last dose of study treatment (up to approximately 1 year)
| Intervention | Participants (Count of Participants) |
|---|
| AEs | SAEs |
|---|
| Rituximab IV+CHOP | 24 | 11 |
,| Rituximab SC+CHOP | 26 | 8 |
Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma
ORR=CR+PR. Per LRC: CR by PET-CT: complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions, no FDG-avid disease in bone marrow; CR by CT: complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi, no extralymphatic disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow; PR by PET-CT: partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline + residual masses of any size; no new lesions, residual uptake higher than in normal bone marrow but reduced compared with baseline; PR by CT: ≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target nodes and extranodal sites; non-measured lesion absent/normal, regressed, but no increase; spleen regressed by >50 % in length beyond normal; no new lesions. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Investigator | IRC |
|---|
| Rituximab IV+CHOP | 70.8 | 66.7 |
,| Rituximab SC+CHOP | 88.5 | 80.8 |
Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv)
The area under the curve (AUC) for serum rituximab concentration versus time after dosage was measured for SC and IV administrations during Cycle 7. Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis. (NCT04660799)
Timeframe: During Cycle 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
| Intervention | day*mcg/mL (Geometric Mean) |
|---|
| Rituximab IV+CHOP | 3050.7 |
| Rituximab SC+CHOP | 3806.7 |
Time to Cmax (Tmax) of Rituximab
(NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks
| Intervention | day (Median) |
|---|
| Cycle 2 | Cycle 7 |
|---|
| Rituximab IV+CHOP | 0.14 | 0.16 |
,| Rituximab SC+CHOP | 5.42 | 1.99 |
Trough Serum Concentration (Ctrough) of Rituximab
Ctrough was measured at Cycle 2 and Cycle 7, 21 days after study treatment administration for each cycle (pre-dose of Cycle 3 and Cycle 8, respectively). (NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Cycle 2 | Cycle 7 |
|---|
| Rituximab IV+CHOP | 43.2 | 90.7 |
,| Rituximab SC+CHOP | 63.5 | 137 |
Number of SAEs (Zandelisib When Combined With Rituximab)
Measured by the number of SAEs (NCT04745832)
Timeframe: 1 year 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Rituximab Plus Zandelisib | 12 |
| Rituximab Plus Chemotherapy | 8 |
Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)
Measured by the number of Treatment Emergent AEs (NCT04745832)
Timeframe: 1 year 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Rituximab Plus Zandelisib | 38 |
| Rituximab Plus Chemotherapy | 37 |
Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28])
Area under the persistence-time curve from time zero to Day 28. Blood samples were collected for PK analysis. (NCT05993299)
Timeframe: Up to 28 days
| Intervention | Days*copies per microgram genomic DNA (Geometric Mean) |
|---|
| Letetresgene Autoleucel (Lete-cel) | 1911782.96 |
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with a minimal 12 weeks (84 days ± 7 day window) duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by local investigators per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. The disease progression (PD) is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. 95% CI is based on Clopper-Pearson exact confidence interval. (NCT05993299)
Timeframe: Up to approximately 36 months
| Intervention | Percentage of Participants (Number) |
|---|
| Letetresgene Autoleucel (Lete-cel) | 80.0 |
Maximum Transgene Expansion (Cmax)
Cmax was defined as maximum observed persistence, determined directly from the persistence-time data. Blood samples were collected for PK analysis. (NCT05993299)
Timeframe: Day 1 to Day 14
| Intervention | Copies per microgram genomic DNA (Geometric Mean) |
|---|
| Letetresgene Autoleucel (Lete-cel) | 119701.64 |
Time to Cmax (Tmax)
Tmax was defined as time to reach Cmax, determined directly from the persistence-time data. Blood samples were collected for PK analysis. (NCT05993299)
Timeframe: Day 1 to Day 14
| Intervention | Days (Median) |
|---|
| Letetresgene Autoleucel (Lete-cel) | 6.90 |
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval. (NCT05993299)
Timeframe: Up to approximately 36 months
| Intervention | percentage of participants (Number) |
|---|
| Letetresgene Autoleucel (Lete-cel) | 80 |