Trial | Phase | Enrollment | Study Type | Start Date | Status |
Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma [NCT00958854] | Phase 2 | 37 participants (Anticipated) | Interventional | 2006-01-31 | 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 |
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 |
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 |
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 |
A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00086580] | Phase 3 | 335 participants (Actual) | Interventional | 2004-07-31 | Completed |
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) |
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 |
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) |
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 |
A Phase I/II Pilot Study of Memory-like NK Cells to Consolidate TCRαβ T Cell Depleted Haploidentical Transplant in High-risk AML [NCT06158828] | Phase 1/Phase 2 | 48 participants (Anticipated) | Interventional | 2024-03-31 | Not yet 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 Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations [NCT05521087] | Phase 1 | 80 participants (Anticipated) | Interventional | 2024-05-29 | Not yet 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 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 |
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 |
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 |
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 |
Allogeneic Hematopoietic Cell Transplantation for Patients With Non-Malignant Disorders Using Treosulfan, Fludarabine, and Thiotepa [NCT03980769] | Phase 2 | 40 participants (Anticipated) | Interventional | 2021-05-05 | 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 |
Phase 1b Study Evaluating the Safety and Efficacy of Autologous CD30.CAR-T in Combination With PD-1 Checkpoint Inhibitor (Nivolumab) in Relapsed or Refractory Classical Hodgkin Lymphoma Patients After Failure of Frontline Therapy (ACTION) [NCT05352828] | Phase 1 | 15 participants (Actual) | Interventional | 2022-07-25 | 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 |
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 |
Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma [NCT01156350] | Phase 2 | 10 participants (Anticipated) | Interventional | 2011-09-30 | Not yet 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 |
A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies [NCT02333162] | Phase 1 | 30 participants (Anticipated) | Interventional | 2014-12-05 | 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 Multicenter, Prospective, Non-randomized, Phase I-II Trial to Assess the Efficacy and Safety of the Combination of Oral Quizartinib and the FLAG-IDA Chemotherapy Regimen in First Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Patients [NCT04112589] | Phase 1/Phase 2 | 63 participants (Actual) | Interventional | 2019-12-26 | Active, not recruiting |
A Phase II Trial of Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors [NCT03615144] | Phase 2 | 1 participants (Actual) | Interventional | 2018-07-23 | Terminated(stopped due to Participant accrual low and the study was closed) |
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.) |
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 |
A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML) [NCT02642965] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2016-05-02 | Completed |
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.) |
A Phase I Trial of Ruxolitinib Combined With Tacrolimus and Sirolimus as Acute Graft-versus-Host Disease (aGVHD) Prophylaxis During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis [NCT02528877] | Phase 1 | 0 participants (Actual) | Interventional | 2015-11-30 | Withdrawn(stopped due to The study design was revised so a new protocol will be opened.) |
Population Pharmacokinetics of the Nucleoside Analogues Clofarabine and Fludarabine in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (alloHCT) [NCT03609814] | | 30 participants (Actual) | Observational | 2016-01-26 | Completed |
A Phase I Dose Escalation Trial of WT1-specific Donor-derived T Cells Following T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma [NCT01758328] | Phase 1 | 29 participants (Anticipated) | Interventional | 2012-12-31 | Active, not 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 |
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 |
Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia [NCT00448019] | Phase 2 | 64 participants (Actual) | Interventional | 2007-02-28 | Completed |
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 |
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT) [NCT06028828] | Phase 2 | 60 participants (Anticipated) | Interventional | 2023-09-11 | Recruiting |
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 |
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 |
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 |
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 |
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 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) |
A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML [NCT05183035] | Phase 3 | 98 participants (Anticipated) | Interventional | 2022-10-01 | 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 |
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 |
Allogeneic Hematopoietic Cell Transplantation With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings [NCT00603954] | Phase 2 | 107 participants (Actual) | Interventional | 2008-01-31 | Completed |
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 |
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 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 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) |
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.) |
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 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 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) |
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 |
Phase 1 Study of FLAG-Ida With Pivekimab Sunirine (PVEK [IMGN632]) for Adults With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms [NCT06034470] | Phase 1 | 30 participants (Anticipated) | Interventional | 2024-01-13 | Recruiting |
An Open-label, Phase II, Two-stage, Study of Bisantrene(Xantrene) in Combination With Fludarabine and Clofarabine as Salvage Therapy for Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) [NCT04989335] | Phase 2 | 29 participants (Anticipated) | Interventional | 2021-08-02 | Recruiting |
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 Feasibility Trial of MLN4924 (Pevonedistat, TAK 924) Given in Combination With Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome [NCT03813147] | Phase 1 | 12 participants (Actual) | Interventional | 2019-05-17 | Active, not recruiting |
A Phase II Study Of Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) [NCT03204188] | Phase 2 | 15 participants (Actual) | Interventional | 2017-09-22 | 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 |
Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in Refractory/Relapsed Acute Lymphoblastic Leukemia [NCT05578378] | Phase 2/Phase 3 | 32 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
Population Pharmacokinetics of Fludarabine in Pediatric Patients Undergoing Hematopoietic Cell Transplantation [NCT01316549] | | 67 participants (Actual) | Observational | 2011-01-01 | Completed |
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 |
Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib After Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma (BMT CTN 1302) [NCT02440464] | Phase 2 | 57 participants (Actual) | Interventional | 2015-08-31 | Completed |
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 |
Phase I Trial of Escalated Doses of Targeted Marrow Irradiation (TMI) Combined With Fludarabine and Busulfan as Conditioning Regimen for Allogeneic Hematopoietic Progenitor Cell Transplantation [NCT02129582] | Phase 1 | 14 participants (Actual) | Interventional | 2014-11-05 | Completed |
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 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 |
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 |
Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma:a Single-center, Open-label, Pragmatic Clinical Trial [NCT05020392] | Phase 3 | 24 participants (Anticipated) | Interventional | 2021-09-14 | Recruiting |
Modified TBF Regimen as Conditioning Regimen Prior to Allogeneic Hematopoietic Cell Transplantation for T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma:Phase II Study [NCT05598593] | Phase 2 | 70 participants (Anticipated) | Interventional | 2022-10-23 | Recruiting |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma [NCT00117156] | Phase 2 | 26 participants (Actual) | Interventional | 2003-12-31 | Completed |
A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia [NCT00096018] | Phase 1/Phase 2 | 43 participants (Actual) | Interventional | 2002-05-31 | 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 |
Randomized Trial of Unmanipulated Versus Expanded Cord Blood [NCT00067002] | Phase 2 | 110 participants (Actual) | Interventional | 2003-04-30 | Completed |
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial [NCT05586074] | Phase 3 | 324 participants (Anticipated) | Interventional | 2023-03-03 | Recruiting |
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 |
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 II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes [NCT03121014] | Phase 2 | 38 participants (Anticipated) | Interventional | 2017-04-24 | 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 |
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 |
Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphoh [NCT00027560] | Phase 2 | 51 participants (Actual) | Interventional | 2001-07-31 | Completed |
Phase IIa Study of Addition of Itacitinib With Tacrolimus/Sirolimus Regimen for GVHD Prophylaxis in Fludarabine and Melphalan Non-Myeloablative Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, MDS or MF [NCT04339101] | Phase 2 | 59 participants (Actual) | Interventional | 2020-11-11 | Active, not recruiting |
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 |
Allogeneic Transplantation Using Venetoclax, Timed Sequential Busulfan,Cladribine, and Fludarabine Conditioning in Patients With AML and MDS [NCT02250937] | Phase 2 | 116 participants (Anticipated) | Interventional | 2014-10-27 | Active, not 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.) |
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 |
Novel BCMA-targeted CAR-T Cell Therapy for Multiple Myeloma [NCT04706936] | Phase 1 | 25 participants (Anticipated) | Interventional | 2021-04-01 | 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 |
Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases [NCT04965597] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-04-19 | 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) |
A Pilot Phase II Study Using Ibrutinib and Short-Course Fludarabine in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) [NCT02514083] | Phase 2 | 29 participants (Actual) | Interventional | 2015-12-09 | 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 |
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 |
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 |
CBA Versus FBA Conditioning Followed by Allogeneic HSCT in Treatment of High Risk and Refractory AML [NCT03384212] | Phase 3 | 120 participants (Anticipated) | Interventional | 2016-08-01 | Recruiting |
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 |
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 |
Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT03530085] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2018-06-15 | 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.) |
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 III, MULTICENTRE, RANDOMIZED, OPEN LABEL CLINICAL TRIAL OF AZACYTIDINE (VIDAZA®) VERSUS FLUDARABINE AND CYTARABINE (FLUGA SCHEME) IN ELDERLY PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA. [NCT02319135] | Phase 3 | 289 participants (Actual) | Interventional | 2014-10-31 | Completed |
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) |
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 |
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 |
A Phase 2 Study of Cytokine-induced Memory-like NK Cells in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed AML [NCT04354025] | Phase 2 | 0 participants (Actual) | Interventional | 2023-06-30 | Withdrawn(stopped due to Principal investigator decided not to move forward with the study.) |
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 |
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 |
A Pilot Study of EBV-TCR-T(YT-E001) in NPC Patients [NCT03648697] | Phase 2 | 20 participants (Anticipated) | Interventional | 2018-10-10 | 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 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 |
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 |
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 |
Risk Stratified Treatment for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia: A Phase I/II Non-randomized Study of Trametinib and Azacitidine With or Without Chemotherapy (IND #164058) [NCT05849662] | Phase 1/Phase 2 | 58 participants (Anticipated) | Interventional | 2023-11-30 | Not yet 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 |
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 |
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 |
A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutate [NCT03591510] | Phase 2 | 23 participants (Anticipated) | Interventional | 2019-03-13 | 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 |
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 Randomized Placebo-controlled Phase II Trial of Irradiated, Adenovirus Vector Transferred GM-CSF Secreting Autologous Leukemia Cell Vaccination (GVAX) Versus Placebo Vaccination in Patients With Advanced MDS/AML After Allogeneic Hematopoietic Stem Cell [NCT01773395] | Phase 2 | 123 participants (Actual) | Interventional | 2013-01-08 | Terminated(stopped due to Recommendation by the Data and Safety Monitoring Board due to efficacy concerns) |
Hematopoietic Cell Transplantation in the Treatment of Infant Leukemia and Myelodysplastic Syndrome [NCT00357565] | Phase 2 | 20 participants (Anticipated) | Interventional | 2005-11-30 | Recruiting |
An Investigator Sponsored Phase I Trial of Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML [NCT03661515] | Phase 1 | 16 participants (Actual) | Interventional | 2018-07-17 | Completed |
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 |
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 |
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 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 |
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 |
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 |
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.) |
Fludarabine-Based Conditioning for Matched Related Donor Bone Marrow Transplantation in Patients With Bone Marrow Failure Syndromes [NCT02928991] | Early Phase 1 | 75 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
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 |
Anti-CD22 Immunoconjugate Inotuzumab Ozogamicin (CMC-544) Added to Fludarabine, Bendamustine and Rituximab and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies [NCT01664910] | Phase 1/Phase 2 | 27 participants (Actual) | Interventional | 2012-10-29 | Completed |
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 |
Radiation- and Alkylator-free Hematopoietic Cell Transplantation for Bone Marrow Failure Due to Dyskeratosis Congenita / Telomere Disease [NCT01659606] | Phase 2 | 40 participants (Anticipated) | Interventional | 2012-07-31 | Active, not recruiting |
A Phase 1/2 Trial of Uproleselan Combined With High Dose Busulfan Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for Patients With Chemotherapy Resistant Acute Myeloid Leukemia [NCT05569512] | Phase 1/Phase 2 | 28 participants (Anticipated) | Interventional | 2022-10-06 | 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 |
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) |
Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT) [NCT03326921] | Phase 1 | 24 participants (Anticipated) | Interventional | 2018-02-23 | Suspended(stopped due to Pause in funding) |
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 |
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 |
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 |
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 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 Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Ovarian [NCT03412526] | Phase 2 | 15 participants (Anticipated) | Interventional | 2018-01-21 | Recruiting |
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 |
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 |
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 |
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 |
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 |
Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer [NCT00074269] | Phase 2 | 5 participants (Actual) | Interventional | 2003-07-31 | Terminated(stopped due to Terminated early due to poor enrollment) |
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 |
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 |
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 |
Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS) [NCT05991908] | Phase 3 | 222 participants (Anticipated) | Interventional | 2023-10-19 | Recruiting |
A Prospective Study of Tocilizumab for the Prevention of Graft Failure and Graft-versus-Host Disease in Haplo-Cord Transplantation [NCT04395222] | Phase 2 | 21 participants (Actual) | Interventional | 2020-10-07 | Active, not recruiting |
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 |
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 |
Fludarabine/Clofarabine/Busulfan Combined With SAHA in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia [NCT02083250] | Phase 1 | 70 participants (Actual) | Interventional | 2014-03-06 | Completed |
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 |
A Phase 1 Study of Adding Venetoclax to a Reduced Intensity Conditioning Regimen and to Maintenance in Combination With a Hypomethylating Agent After Allogeneic Hematopoietic Cell Transplantation for Patients With High Risk AML, MDS, and MDS/MPN Overlap S [NCT03613532] | Phase 1 | 78 participants (Anticipated) | Interventional | 2018-10-24 | 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 |
Itacitinib to Prevent Graft Versus Host Disease [NCT04859946] | Phase 1 | 30 participants (Anticipated) | Interventional | 2022-01-11 | 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 |
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 |
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 |
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 |
A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab [NCT00850499] | Phase 2 | 12 participants (Actual) | Interventional | 2009-09-30 | Terminated |
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 |
Phase IB Followed by Phase II Study of Trastuzumab Combined With Autologous Chimeric Receptor T Cells in HER2+ Advanced Breast Cancer and Other Solid Tumors [NCT06027983] | Phase 1/Phase 2 | 36 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
Umbilical Cord Blood Transplant for Congenital Pediatric Disorders [NCT00950846] | | 40 participants (Actual) | Interventional | 2009-09-30 | Completed |
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for B-Cell Non-Hodgkin Lymphoma Using Zevalin, Fludarabine and Melphalan [NCT00577278] | Phase 2 | 41 participants (Actual) | Interventional | 2007-10-03 | Active, not recruiting |
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) |
A Randomized Study of Once Daily Fludarabine-Clofarabine Versus Fludarabine Alone Combined With Intervenous Busulfan Followed by Allogeneic Hemopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) [NCT01471444] | Phase 3 | 256 participants (Actual) | Interventional | 2011-11-02 | Completed |
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 |
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 |
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 |
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 |
A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Antifungal Prophylaxis With Posaconazole. [NCT03434704] | Phase 2 | 10 participants (Actual) | Interventional | 2018-06-18 | Completed |
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 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.) |
A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome [NCT03071276] | Phase 2 | 37 participants (Actual) | Interventional | 2016-01-14 | Terminated(stopped due to Due to slow enrollment) |
Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia [NCT02162420] | | 50 participants (Anticipated) | Interventional | 2015-01-10 | Recruiting |
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 |
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) |
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 |
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 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 Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies [NCT00423826] | | 0 participants | Expanded Access | 2007-01-31 | No longer available |
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 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 |
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 |
A Phase 1 Study of Obatoclax Mesylate (GX15-070MS) in Combination With Fludarabine-Based Chemoimmunotherapy in Previously Treated Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL) [NCT00612612] | Phase 1 | 28 participants (Actual) | Interventional | 2008-01-31 | Terminated |
Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplant [NCT00909948] | Phase 1 | 7 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to Slow Accrual) |
Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies [NCT05735717] | Phase 2 | 150 participants (Anticipated) | Interventional | 2023-05-11 | 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) |
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) |
Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the In [NCT00750126] | Phase 2 | 30 participants (Anticipated) | Interventional | 2007-04-30 | 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 Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome [NCT01019317] | Phase 2 | 151 participants (Actual) | Interventional | 2009-11-30 | Completed |
A Study Evaluating Escalating Doses of 90Y-DOTA-BC8 (Anti-CD45) Antibody Followed by Allogeneic Stem Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML) Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) [NCT01300572] | Phase 1 | 16 participants (Actual) | Interventional | 2012-01-31 | Completed |
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.) |
Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders [NCT00636909] | Phase 2 | 25 participants (Actual) | Interventional | 1999-07-31 | Completed |
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 |
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.) |
Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy. [NCT00738829] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2008-10-31 | 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 |
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 |
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 |
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 |
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 |
Trial of the Efficacy and Safety of High-dose Immunosuppressive Therapy Based on Fludarabine and Cyclophosphamide-containing Conditioning Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis. [NCT05832515] | Phase 1 | 200 participants (Anticipated) | Interventional | 2020-10-01 | Recruiting |
Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies [NCT00806767] | Phase 2 | 82 participants (Anticipated) | Interventional | 2007-03-31 | Completed |
Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia [NCT00623935] | Phase 2 | 56 participants (Actual) | Interventional | 2007-03-31 | Completed |
Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL [NCT00840385] | Phase 2 | 30 participants (Anticipated) | Interventional | 2007-11-30 | Recruiting |
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan [NCT00619645] | Phase 2 | 8 participants (Actual) | Interventional | 2007-06-30 | 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 |
A Multicenter Pilot Study of Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation With In-vivo T-cell Depletion to Evaluate the Role of NK Cells and KIR Mis-matches in Relapsed or Refractory High-risk Neuroblastoma. [NCT00874315] | Phase 2 | 0 participants (Actual) | Interventional | 2008-09-30 | Withdrawn(stopped due to lack of accrual) |
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 |
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 |
Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis [NCT04022239] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2020-03-13 | Recruiting |
Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients With Myelofibrosis [NCT02917096] | Phase 1 | 18 participants (Actual) | Interventional | 2016-11-13 | Completed |
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 Trial of Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions for Patients With Relapsed or High-Risk Multiple Myeloma [NCT01131169] | Phase 2 | 66 participants (Actual) | Interventional | 2010-05-31 | Completed |
Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02 [NCT00258427] | Phase 2 | 14 participants (Actual) | Interventional | 2002-03-26 | Completed |
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 |
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 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 Phase II Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia [NCT03324243] | Phase 2 | 0 participants (Actual) | Interventional | 2018-01-31 | Withdrawn(stopped due to Withdrawn: Study halted prior to enrollment of first participant) |
An Open-label, Randomised Phase II Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer [NCT03335241] | Phase 2 | 140 participants (Anticipated) | Interventional | 2017-03-01 | Recruiting |
Phase II Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases [NCT02483325] | Phase 2 | 33 participants (Actual) | Interventional | 2014-09-30 | 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) |
Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study [NCT02926586] | Phase 4 | 200 participants (Anticipated) | Interventional | 2017-01-01 | Recruiting |
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 |
Epigenetic Reprogramming in Relapse AML: A Phase 1 Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults With Relapsed/Refractory AML [NCT03263936] | Phase 1 | 37 participants (Actual) | Interventional | 2017-07-11 | Completed |
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 |
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 Phase I/II Study of HLA-matched Mobilized Peripheral Blood Hematopoietic Stem Cell Transplantation for Advanced Mycosis Fungoides/Sezary Syndrome Using Nonmyeloablative Conditioning With Campath-1H [NCT00047060] | Phase 1/Phase 2 | 5 participants (Actual) | Interventional | 2002-07-30 | Completed |
CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML [NCT03384225] | Phase 3 | 120 participants (Anticipated) | Interventional | 2016-08-01 | Recruiting |
Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies [NCT02128945] | Phase 1 | 10 participants (Actual) | Interventional | 2014-04-30 | Completed |
A PALG Prospective Multicenter Clinical Trial to Compare the Efficacy of Two Standard Induction Therapies (DA-90 vs DAC) and Two Standard Salvage Regimens (FLAG-IDA vs CLAG-M) in AML Patients ≤ 60 Years Old [NCT03257241] | Phase 3 | 582 participants (Anticipated) | Interventional | 2017-07-03 | Recruiting |
T-Cell Depleted, Alternative Donor Transplant in Pediatric and Adult Patients With Severe Sickle Cell Disease (SCD) and Other Transfusion-Dependent Anemias [NCT03653338] | Phase 1/Phase 2 | 5 participants (Anticipated) | Interventional | 2018-08-02 | Recruiting |
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 |
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)) |
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 |
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.) |
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 |
Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies [NCT01359254] | Phase 2 | 1 participants (Actual) | Interventional | 2010-04-30 | Terminated(stopped due to did not accrue enough patients.) |
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 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 |
Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major [NCT03171831] | Phase 4 | 30 participants (Anticipated) | Interventional | 2017-04-01 | Recruiting |
A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia [NCT05955261] | Phase 2 | 70 participants (Anticipated) | Interventional | 2023-07-25 | 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 |
A Pilot Trial Examining Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic Stem Cell Transplant Recipients Using Myeloablative Busulfan and Fludarabine [NCT02916979] | Phase 1 | 20 participants (Actual) | Interventional | 2016-09-06 | Completed |
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 Randomized Study of Once Daily IV Busulfan With Fludarabine With Hemopoietic Stem Cell Transplantation for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) [NCT00469144] | Phase 3 | 233 participants (Actual) | Interventional | 2005-06-30 | 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 |
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) |
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 |
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 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 |
A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies [NCT05476770] | Phase 1 | 54 participants (Anticipated) | Interventional | 2022-11-11 | 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 |
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 |
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.) |
Fludarabine, Campath, TBI T-Cell Deplete NMSCT With Post-Transplant T-Cell Infusions for CML Failing Imatinib Therapy With Imatinib (STI571) [NCT00416884] | Phase 2 | 1 participants (Actual) | Interventional | 2003-05-31 | Terminated(stopped due to Low enrollment) |
Toward a Less Toxic Yet Highly Effective Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Children and Adolescents With Severe Sickle Cell Disease: A Pilot Study [NCT00968162] | Phase 1 | 8 participants (Actual) | Interventional | 2009-02-28 | Completed |
Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma [NCT04008888] | | 50 participants (Anticipated) | Interventional | 2018-01-05 | Recruiting |
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 |
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 |
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 |
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 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) |
Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H [NCT00058825] | Phase 1/Phase 2 | 27 participants (Actual) | Interventional | 2000-08-31 | Terminated(stopped due to Slow accrual due to practice changes meant study would take too long to finish) |
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 Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL) [NCT00206726] | Phase 2 | 60 participants (Actual) | Interventional | 2005-05-31 | Completed |
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 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 |
A Multi-center Phase III Study Comparing Nonmyeloablative Conditioning With TBI Versus Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies [NCT00075478] | Phase 3 | 87 participants (Actual) | Interventional | 2003-10-31 | 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 |
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 |
Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure [NCT03500731] | Phase 1/Phase 2 | 8 participants (Anticipated) | Interventional | 2018-04-19 | Recruiting |
A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies [NCT00943319] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2012-03-31 | 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 |
Total Body Irradiation With Fludarabine Conditioning Followed by Transplantation With Combined Umbilical Cord Blood Grafts [NCT00606437] | Phase 1 | 40 participants (Actual) | Interventional | 2005-09-30 | 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 |
Phase 2 Study BRIDGING PRE-TRANSPLANT INFLAMMATORY DAMPENING for PRIMARY IMMUNE REGULATORY DISORDERS (BRIDGE Trial) [NCT05787574] | Phase 2 | 39 participants (Anticipated) | Interventional | 2023-03-15 | 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 |
A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients [NCT00925873] | Phase 3 | 303 participants (Actual) | Interventional | 1996-06-30 | 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.) |
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 |
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 |
HLA-Identical Sibling Donor Bone Marrow Transplantation for Individuals With Severe Sickle Cell Disease Using a Reduced Intensity Conditioning Regimen [NCT02776202] | Phase 2 | 15 participants (Anticipated) | Interventional | 2016-05-31 | 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.) |
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 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) |
"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 |
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 |
Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy [NCT02638428] | Phase 2 | 90 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting |
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 |
A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma [NCT00875667] | Phase 2 | 254 participants (Actual) | Interventional | 2009-04-30 | 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 1 Trial of the Wee1 Kinase Inhibitor AZD1775 in Combination With Flag Chemotherapy in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia [NCT02791919] | Phase 1 | 0 participants (Actual) | Interventional | 2017-05-25 | Withdrawn(stopped due to Other - Protocol moved to Disapproved) |
Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial [NCT00693927] | Phase 2 | 54 participants (Actual) | Interventional | 2002-03-31 | Completed |
A Pilot Study of Sequential Autologous Stem Cell Transplantation and Immunotherapy With Reduced Intensity Allogeneic Stem Cell Transplant for High Risk Neuroblastoma [NCT00670410] | Phase 1 | 15 participants (Actual) | Interventional | 2003-11-30 | Terminated(stopped due to Poor accrual) |
[NCT02577094] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn |
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 |
A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors [NCT02653196] | Early Phase 1 | 1 participants (Actual) | Interventional | 2015-09-30 | Terminated(stopped due to The Principal Investigator left the institution.) |
Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors Using Fludarabine, Busulfan, 400 cGy Total Body Irradiation, and Thymoglobulin [NCT00679536] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2008-05-31 | Recruiting |
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 |
Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Treosulfan Based Preparative Regimen [NCT00796068] | Phase 2 | 130 participants (Actual) | Interventional | 2009-02-24 | 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 |
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 |
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 |
Phase I/II Study of Reduced Toxicity Myeloablative Conditioning Regimen for Wiskott-Aldrich Syndrome [NCT00885833] | Phase 1/Phase 2 | 5 participants (Anticipated) | Interventional | 2007-02-28 | Completed |
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 Trial of Targeted Immune-Depleting Chemotherapy and Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation Using 8/8 and 7/8 HLA-matched Unrelated Donors and Utilizing Two Graft-versus-Host Disease Prophylaxis Regimens for the Treat [NCT00520130] | Phase 1/Phase 2 | 92 participants (Actual) | Interventional | 2007-10-30 | Completed |
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 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation [NCT02421939] | Phase 3 | 371 participants (Actual) | Interventional | 2015-10-20 | 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 |
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 |
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) |
Rasburicase to Prevent Graft -Versus-Host Disease [NCT00513474] | Phase 1 | 46 participants (Actual) | Interventional | 2008-01-31 | Completed |
T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma. [NCT00937625] | Phase 1/Phase 2 | 31 participants (Actual) | Interventional | 2009-06-30 | Completed |
Busulfan-Fludarabine-Clofarabine With Allogeneic Stem Cell Transplantation for Advanced Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Advanced, Gleevec Refractory Chronic Myeloid Leukemia. A Randomized Phase II Study. [NCT00469014] | Phase 2 | 72 participants (Actual) | Interventional | 2006-09-30 | Completed |
Evaluation of Fludarabine, Busulfan and Alemtuzumab as a Reduced Toxicity Ablative Bone Marrow Stem Cell Transplant Regimen for Children With Stem Cell Defects, Marrow Failure Syndromes, or Myelodysplastic Syndrome (MDS)/Leukemia [NCT00301834] | Phase 2 | 35 participants (Actual) | Interventional | 2005-01-31 | 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 |
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 |
Infusion of Expanded Cord Blood T Cells Following Cord Blood Transplantation [NCT00972101] | Phase 1 | 0 participants (Actual) | Interventional | 2009-09-30 | Withdrawn(stopped due to Development of other studies led to termination without recruitment.) |
Hematopoietic Cell Transplantation for Patients With High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) Using Radiolabeled DOTA-Biotin Pretargeted by BC8 Antibody-Streptavidin Conjugate [NCT00988715] | Phase 1 | 17 participants (Actual) | Interventional | 2010-04-21 | 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.) |
A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis [NCT00001422] | Phase 2 | 20 participants | Interventional | 1995-06-30 | Completed |
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 |
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 |
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) |
IIT2017-03-Merin-HaploBFR: Bendamustine, Fludarabine, And Rituximab Conditioning For Haploidentical Stem Cell Transplantation With CD56-Enriched Donor Cell Infusion For Relapsed/Refractory Lymphoma, Multiple Myeloma, and CLL [NCT03524235] | Phase 1 | 30 participants (Anticipated) | Interventional | 2018-07-18 | Active, not recruiting |
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 |
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 |
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 Multi-Center Study of Conditioning With Treosulfan, Fludarabine and Escalating Doses of TBI for Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS), and Acute Lymphoblastic Leukemia [NCT00860574] | Phase 2 | 96 participants (Actual) | Interventional | 2009-02-28 | Completed |
A Phase I and Dose Expansion Cohort Study of Panobinostat in Combination With Fludarabine and Cytarabine in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome [NCT02676323] | Phase 1 | 19 participants (Actual) | Interventional | 2016-05-03 | Terminated(stopped due to Slow accrual) |
A Pilot Trial Of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan, And Low Dose Total Body Irradiation [NCT00856388] | | 62 participants (Actual) | Interventional | 2009-01-14 | 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.) |
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 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) |
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 |
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 |
A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 2 [NCT00688883] | Phase 2 | 52 participants (Actual) | Interventional | 2003-02-28 | 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 |
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 |
Reduced Intensity Conditioning With Fludarabine and Busulfan Versus Fludarabine and Melphalan Before Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndrome: A Randomised, Single-Center, Phase III Study [NCT05674539] | Phase 3 | 200 participants (Anticipated) | Interventional | 2022-12-28 | Recruiting |
Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related o [NCT00582933] | Phase 2 | 96 participants (Actual) | Interventional | 2001-05-31 | 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 |
G-CSF and Plerixafor With Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias [NCT00822770] | Phase 1/Phase 2 | 47 participants (Actual) | Interventional | 2009-01-31 | Completed |
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 |
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 |
Reduced Intensity Conditioning Hematopoietic Cell Transplantation for Pediatric Patients With Hematologic Malignancies at High Risk for Transplant Related Mortality With Standard Transplantation [NCT00795132] | Phase 2 | 47 participants (Actual) | Interventional | 2004-04-30 | Completed |
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 |
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 |
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 |
Early Diagnosis and Stem Cell Transplantation for Severe Immunodeficiency Diseases [NCT00613561] | Phase 2 | 25 participants (Anticipated) | Interventional | 2007-12-31 | 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 |
Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia: A Phase I Study (AflacLL1401) [NCT02680951] | Phase 1 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn(stopped due to Withdrawn due to lack of participants.) |
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 |
A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes [NCT00608374] | Phase 3 | 400 participants (Anticipated) | Interventional | 2006-06-30 | Completed |
High-dose MIBG With Subsequent Transplantation of Haploidentical Stem Cells in Children With Therapy Resistant Neuroblastoma [NCT00790413] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2005-08-31 | Active, not 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 Study of Fludarabine (F), Rituxan (R) and Avastin (A) Followed by RA Maintenance in Patients With Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (CLL) [NCT00845104] | Phase 2 | 0 participants (Actual) | Interventional | 2009-01-31 | Withdrawn(stopped due to No patients enrolled.) |
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 Study to Compare Bone Marrow Transplantation to Standard Care in Adolescents and Young Adults With Severe Sickle Cell Disease (BMT CTN 1503) [NCT02766465] | Phase 2 | 138 participants (Actual) | Interventional | 2016-11-30 | Completed |
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)) |
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 |
Study of FT538 in Combination With Daratumumab in Acute Myeloid Leukemia [NCT04714372] | Phase 1 | 11 participants (Actual) | Interventional | 2021-11-03 | 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 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 Phase I Study of Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematological Malignancies. [NCT00890500] | Phase 1 | 12 participants (Actual) | Interventional | 2011-01-31 | 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 |
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 |
A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma [NCT00907036] | Phase 2 | 49 participants (Anticipated) | Interventional | 2009-07-31 | Not yet recruiting |
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.) |
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.) |
A Pilot Study of Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed CNS Involvement by Lymphoma [NCT02724904] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2017-05-31 | Withdrawn(stopped due to Drug logistics) |
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 |
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 |
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 |
Fludarabine, Bendamustine, and Rituximab (FBR) Non-Myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies [NCT00880815] | Phase 1 | 60 participants (Actual) | Interventional | 2009-02-17 | Completed |
Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation [NCT03856216] | Phase 2 | 44 participants (Anticipated) | Interventional | 2019-10-28 | 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 |
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 |
A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) With Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed and Refractory Hematologic Malign [NCT03696537] | Phase 1 | 6 participants (Actual) | Interventional | 2018-08-29 | Terminated(stopped due to Extreme toxicity) |
Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV [NCT01423032] | Phase 2/Phase 3 | 96 participants (Actual) | Interventional | 2001-09-30 | 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 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 |
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 |
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) |
A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies [NCT00593554] | Phase 2 | 9 participants (Actual) | Interventional | 2007-08-07 | Terminated(stopped due to Slow accrual) |
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 |
Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation For Patients With Disease Relapse Or Myelodysplasia After Prior Autologous Transplantation [NCT00053196] | Phase 2 | 82 participants (Actual) | Interventional | 2002-12-31 | Completed |
Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin [NCT00915811] | Phase 2 | 20 participants (Anticipated) | Interventional | 2007-06-30 | Terminated(stopped due to FB ATG is now a standard for sib allo MDS patients) |
A Multi-center Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD [NCT00914940] | Phase 2 | 41 participants (Actual) | Interventional | 2009-12-17 | Terminated(stopped due to Did not reach one of the primary endpoints of decreased total acute GVHD) |
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) |
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 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 |
Romidepsin Therapy in Conditioning and Maintenance in Patients With T-Cell Malignancies Receiving Allogeneic Stem Cell Transplant [NCT02512497] | Phase 1 | 10 participants (Anticipated) | Interventional | 2017-12-08 | Recruiting |
Safety and Efficacy Study of Busulfan/FLAG Conditioning Regimen in Patients With Relapsed/Refractory Acute Leukemia Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation [NCT02784561] | Phase 4 | 80 participants (Anticipated) | Interventional | 2016-07-31 | Not yet recruiting |
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 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 |
A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies [NCT00943293] | Phase 1 | 1 participants (Actual) | Interventional | 2003-05-31 | Terminated(stopped due to Poor accrual; did not enter phase 2) |
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 |
Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies [NCT00815568] | Phase 2 | 114 participants (Anticipated) | Interventional | 2008-08-31 | Recruiting |
Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML) [NCT00813124] | Phase 2 | 24 participants (Actual) | Interventional | 2008-12-31 | 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 |
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 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 |
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 |
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 |
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 |
Delayed Tolerance Through Mixed Chimerism [NCT05900401] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2023-10-01 | Recruiting |
A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Myelodysplastic Syndrome [NCT05617625] | Phase 2 | 50 participants (Anticipated) | Interventional | 2024-03-31 | Suspended(stopped due to The study has been put on hold while pending CMS approval) |
An Open-label, Non-randomized, Prospective Trial to Evaluate the Effect of Renal Function Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics in Patients With AML or MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT05534620] | Phase 1 | 36 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
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 |
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 |
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 |
Gemtuzumab Ozogamicin (GO), Fludarabine, And Low-Dose TBI Followed By Donor Stem Cell Transplantation For Patients With Advanced Acute Myeloid Leukemia Or Myelodysplastic Syndrome [NCT00008151] | Phase 2 | 0 participants | Interventional | 2000-10-31 | Completed |
Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation [NCT00008307] | Phase 2 | 52 participants (Anticipated) | Interventional | 1998-04-30 | 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 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 |
Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma [NCT00802568] | Phase 2 | 48 participants (Anticipated) | Interventional | 2007-04-30 | Completed |
A Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Chronic Myeloid Leukemia (CML) and Adoptive Cellular Immunotherapy Only in Patients With Persistent Disease and Matched Family Donors [NCT00531310] | Phase 2 | 5 participants (Actual) | Interventional | 2003-01-31 | Terminated(stopped due to Poor accrual) |
A Pilot Study of Reduced Intensity Conditioning (RIC) and Allogeneic Stem Cell Transplantation (ALLOSCT) In Children With Recessive Dystrophic Epidermolysis Bullosa (RDEB) [NCT00881556] | Early Phase 1 | 3 participants (Actual) | Interventional | 2009-08-20 | Terminated |
Phase I Study of Escalating Doses of Radiation Therapy Using Helical Tomotherapy in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation in Patients With Advanced and [NCT00800150] | Phase 1 | 6 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to Protocol objective could not be met. A new study with amended eligibility criteria will be developed.) |
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 |
Phase II Study of Early Allogeneic Blood Stem Cell Transplantation During Induction-chemotherapy Induced Aplasia in High-risk Acute Myeloid Leukemia [NCT00188136] | Phase 2 | 32 participants (Actual) | Interventional | 2002-08-31 | Completed |
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 |
A Phase II Trial of Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic [NCT00629798] | Phase 2 | 64 participants (Actual) | Interventional | 2008-02-12 | 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.) |
Haploidentical Hematopoietic Stem Cell Transplantation for Pediatric Patients With Wiskott-Aldrich Syndrome: A Pilot Study [NCT00160355] | Phase 1 | 4 participants (Actual) | Interventional | 2005-05-31 | 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 |
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.) |
Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia [NCT00274846] | Phase 2 | 21 participants (Actual) | Interventional | 2005-03-31 | Completed |
A Phase II Study of R-FND, Followed by Zevalin Radioimmunotherapy, and Subsequent Maintenance Rituximab for Advanced Stage Follicular Lymphoma With High-Risk Features [NCT00290511] | Phase 2 | 49 participants (Actual) | Interventional | 2004-06-29 | Completed |
Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer [NCT00429572] | Phase 2 | 19 participants (Actual) | Interventional | 1998-01-31 | 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 |
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.) |
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 |
Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia [NCT00187096] | | 49 participants (Actual) | Interventional | 2005-09-30 | 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 |
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 |
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 |
Phase Ib Study of Fludarabine, Cytarabine (Ara-C) and Pegylated Erwinase (Pegcrisantaspase) in Patients With Relapsed or Refractory Leukemia [NCT04526795] | Phase 1 | 62 participants (Anticipated) | Interventional | 2021-04-09 | Recruiting |
A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) P [NCT04240002] | Phase 1/Phase 2 | 97 participants (Anticipated) | Interventional | 2020-09-04 | Recruiting |
Timed Sequential Busulfan and Post Transplant Cyclophosphamide for Allogeneic Transplantation [NCT02861417] | Phase 2 | 204 participants (Actual) | Interventional | 2016-08-05 | Active, not recruiting |
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 of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma [NCT00510887] | Phase 2 | 14 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Low accrual.) |
Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL) [NCT00506129] | Phase 2 | 33 participants (Actual) | Interventional | 2003-09-30 | Completed |
Conditioning for Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies [NCT01056614] | Phase 2 | 23 participants (Actual) | Interventional | 2004-09-30 | 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 |
Imatinib Mesylate, Busulfan, Fludarabine, Antithymocyte Globulin and Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia [NCT00499889] | Phase 2 | 42 participants (Actual) | Interventional | 2003-02-28 | Terminated(stopped due to Support issue.) |
Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Acute Myelogenous Leukemia/Myelodysplastic Syndrome/Juvenile Myelomonocytic Leukemia (AML/MDS/JMML) [NCT01020539] | Phase 1 | 18 participants (Actual) | Interventional | 2002-09-11 | Completed |
Phase II Trial of Rituximab/Fludarabine Followed by CAMPATH-1H in the First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) [NCT00193466] | Phase 2 | 40 participants | Interventional | 2002-01-31 | Completed |
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 |
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 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 |
A Phase II Study of Reduced Intensity Conditioning in Pediatric Patients and Young Adults ≤55 Years of Age With Non-Malignant Disorders Undergoing Umbilical Cord Blood, Bone Marrow, or Peripheral Blood Stem Cell Transplantation [NCT01962415] | Phase 2 | 100 participants (Anticipated) | Interventional | 2014-02-04 | Recruiting |
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 |
Phase I/II Trial of De-Escalation of Busulfan With Fludarabine and Antithymocyte Globulin as Preparative Therapy for Hematopoietic Stem Cell Transplant for the Treatment of Severe Congenital T-Cell Immunodeficiency [NCT00228852] | Phase 1/Phase 2 | 0 participants | Interventional | | Completed |
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 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 |
Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma [NCT00243009] | Phase 2 | 1 participants (Actual) | Interventional | 2005-06-30 | Terminated(stopped due to Due to a lack of a referal base, study was terminated.) |
A Study of Low-dose Lenalidomide After Non-myeloablative Allogeneic Stem Cell Transplant With Bortezomib as GVHD Prophylaxis in High Risk Multiple Myeloma [NCT01954784] | Phase 1 | 8 participants (Actual) | Interventional | 2013-10-07 | Terminated(stopped due to Funding unavailable) |
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 |
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 |
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 |
Personalized NK Cell Therapy in CBT [NCT02727803] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-05-19 | Recruiting |
A Phase I/IIa, Open-label, Non-randomized, Study of ASC-101 in Patients With Hematologic Malignancies or Myelodysplastic Syndrome (MDS) Who Are Candidates for Dual-cord Umbilical Cord Blood Transplantation (UCBT) [NCT01983761] | Phase 1/Phase 2 | 25 participants (Anticipated) | Interventional | 2013-11-30 | Active, not recruiting |
Pilot Study of Crenolanib Combined With Standard Salvage Chmetherapy in Subjects With Relapsed/Refractory Acute Myeloid Leukemia [NCT02626338] | Phase 1/Phase 2 | 16 participants (Actual) | Interventional | 2016-02-29 | Completed |
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 |
Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia in 2nd or 3rd Line of Treatment: A Pilot Trial (FLUSALEM) for the Determination of Safety, Efficacy an [NCT00565981] | Phase 2 | 10 participants (Actual) | Interventional | 2004-03-31 | Completed |
Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma [NCT00566332] | Phase 3 | 414 participants (Actual) | Interventional | 2001-06-30 | Completed |
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 |
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 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 |
Phase I Study of Bortezomib With or Without Total Marrow Irradiation (TMI) Using Intensity Modulated Radiation Therapy (IMRT) in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) T [NCT01163357] | Phase 1 | 18 participants (Actual) | Interventional | 2011-01-28 | 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 Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia [NCT02024308] | Phase 4 | 62 participants (Anticipated) | Interventional | 2010-11-30 | Recruiting |
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 |
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 |
[NCT00005898] | Phase 1/Phase 2 | 30 participants | Interventional | 2000-02-29 | 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 I/II Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma. A Multi-Center Trial. [NCT00005851] | Phase 1/Phase 2 | 11 participants (Actual) | Interventional | 2000-02-29 | Completed |
Protocol for Patients With High Risk (Resistant, Refractory, Relapsed or Adverse Cytogenetic) AML [NCT00005863] | Phase 3 | 0 participants | Interventional | 1998-08-31 | Completed |
Phase II Pilot Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low Dose TBI and Post-Transplant Cyclosporine and Mycophenolate Mofetil Followed by Donor Lymphocyte Infusion for Therapy of Advanced [NCT00005941] | Phase 2 | 0 participants | Interventional | 1999-11-30 | Completed |
A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease [NCT00006100] | Phase 1 | 0 participants | Interventional | 2000-04-30 | Active, not recruiting |
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma [NCT00006250] | Phase 3 | 500 participants (Anticipated) | Interventional | 2000-05-31 | Active, not recruiting |
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 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 |
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 |
Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma [NCT00577161] | Phase 3 | 0 participants (Actual) | Interventional | 2007-09-30 | Withdrawn(stopped due to closed to enrollment) |
MINIALO-VELCADE2005: A Phase II National, Open-label, Multicenter, no Controlled Study of Treated With Bortezomib (Velcade) Multiple Myeloma Patients Pre and Post Allogeneic Haematopoietic Progenitor Cell Transplant With no Myeloablative Conditioning [NCT00564200] | Phase 2 | 30 participants (Anticipated) | Interventional | 2007-11-30 | 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 |
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome Using Reduced Intensity Busulfan and Fludarabine Conditioning [NCT00475020] | Phase 2 | 63 participants (Actual) | Interventional | 2006-01-04 | Completed |
A Phase I Study Evaluating The Use Of Rft5-Dga To Deplete Alloreactive Cells For Patients With Fanconi Anemia After Haploidentical Stem Cell Transplantation [NCT00586274] | Phase 1 | 1 participants (Actual) | Interventional | 2002-03-31 | Terminated(stopped due to Poor accrual) |
A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell [NCT01088048] | Phase 1 | 241 participants (Actual) | Interventional | 2010-03-25 | 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/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 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.) |
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 I Clinical Trial Testing the Safety of IL-21-Expanded, Off-the-shelf, Third-party Natural Killer Cells (KDS-1001) for the Induction of Relapsed/Refractory Acute Myeloid Leukemia [NCT04220684] | Phase 1 | 21 participants (Anticipated) | Interventional | 2020-06-01 | 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 Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT03164057] | Phase 2 | 206 participants (Actual) | Interventional | 2017-06-15 | Active, not 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 |
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 |
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 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 |
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 |
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 |
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 |
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 |
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 |
A Prospective Study of Optimal Cord Selection for Haplo-Cord Transplantation: Targeting the Inherited Paternal Antigen (IPA) and Matching for the Non-Inherited Maternal Antigen (NIMA) [NCT01810588] | Phase 2 | 273 participants (Actual) | Interventional | 2012-10-16 | Active, not 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 |
Phase II Trial of Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma [NCT01173679] | Phase 2 | 10 participants (Actual) | Interventional | 2010-07-31 | Terminated(stopped due to Slow accrual) |
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 |
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) |
Fludarabine and 400 CGY Total Body Irradiation for Recipients of HLA-Matched or Mis-Matched Family or Unrelated Donor Hematopoietic Stem Cell Transplants Who Have Rejected Their First Allogeneic Stem Cell Transplant [NCT00472329] | Phase 2 | 20 participants (Anticipated) | Interventional | 2007-03-31 | Recruiting |
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 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 II Study of a Reduced-toxicity Submyeloablative Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies" [NCT00841724] | Phase 2 | 82 participants (Actual) | Interventional | 2009-01-31 | Completed |
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 |
Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies [NCT02718755] | Phase 2 | 0 participants (Actual) | Interventional | 2018-05-31 | Withdrawn(stopped due to Problem with drug supply) |
A Pilot Study of a Novel Sequential Treatment Utilizing CPX-351 as Salvage Chemotherapy Followed by Allogeneic Stem-Cell Transplantation (SCT) Utilizing a Haplo-cord Graft for Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome [NCT03393611] | Phase 1 | 14 participants (Actual) | Interventional | 2012-11-30 | 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 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 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia [NCT05761171] | Phase 2 | 78 participants (Anticipated) | Interventional | 2023-11-20 | 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 |
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 Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134 [NCT01186458] | Phase 2 | 4 participants (Actual) | Interventional | 2010-10-31 | Terminated(stopped due to Slow accrual) |
Abatacept for Graft Versus Host Disease Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease: a Sickle Transplant Alliance for Research Trial [NCT02867800] | Phase 1 | 24 participants (Actual) | Interventional | 2016-07-31 | Active, not 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 |
Allogeneic Stem Cell Transplantation for Children and Adolescents With CML: Conditioning Regimen, Donor Selection, Supportive Care and Diagnostic Procedures [NCT02707393] | Phase 2/Phase 3 | 13 participants (Actual) | Interventional | 2009-04-30 | Completed |
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 |
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 |
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 |
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 |
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 |
Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning For Patients With Hematological Malignancies [NCT00627666] | Phase 2 | 52 participants (Anticipated) | Interventional | 2003-01-31 | 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 |
Allogeneic Stem Cell Transplant to Induce Mixed Donor Chimerism in Patients With Sickle Cell Disease and Thalassemia [NCT00408447] | Phase 2 | 53 participants (Actual) | Interventional | 2004-09-30 | Active, not recruiting |
A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of FP253 in Combination With Fludarabine Phosphate [NCT00625430] | Phase 1 | 18 participants (Anticipated) | Interventional | 2008-03-31 | Recruiting |
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 |
Nonmyeloablative Stem Cell Transplantation With or Without Lenalidomide for Chronic Lymphocytic Leukemia (RV-CLL-PI-0294) [NCT00899431] | Phase 2 | 39 participants (Actual) | Interventional | 2009-05-06 | Terminated(stopped due to Terminated per PI's request at the time of continuing review) |
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 |
Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy [NCT00948922] | Phase 2 | 124 participants (Actual) | Interventional | 2009-06-18 | Completed |
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 |
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 |
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 |
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 Randomized Phase III Trial Comparing the Combination of Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) With the Combination of Fludarabine and Rituximab (F-R) in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymph [NCT00551239] | Phase 3 | 0 participants (Actual) | Interventional | 2007-08-31 | Withdrawn |
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia [NCT01423500] | Phase 3 | 405 participants (Anticipated) | Interventional | 2007-01-31 | Active, not recruiting |
A Phase II Study to Evaluate the Efficacy and Safety of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL [NCT00185445] | Phase 2 | 62 participants (Actual) | Interventional | 2004-06-30 | Completed |
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia [NCT01423747] | Phase 3 | 400 participants (Anticipated) | Interventional | 2003-07-31 | Active, not recruiting |
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 |
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 |
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 |
Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation [NCT03159702] | Phase 2 | 43 participants (Anticipated) | Interventional | 2017-12-08 | Recruiting |
An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Activity and Safety of a Combination of Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma. [NCT00169208] | Phase 2 | 50 participants (Actual) | Interventional | 2001-04-30 | Completed |
Phase II Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low-Dose TBI, and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil (MMF) Followed by Donor Lymphocyte Infusion [NCT00006233] | Phase 2 | 0 participants | Interventional | 2000-01-31 | Completed |
Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil [NCT00006251] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2000-05-31 | 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 Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies [NCT00202917] | Phase 1/Phase 2 | 61 participants (Actual) | Interventional | 2004-02-29 | Completed |
Phase II Study of Reduced Toxicity Myeloablative Conditioning Regimen for Cord Blood Transplantation in Pediatric Acute Myeloid Leukemia [NCT00887042] | Phase 1/Phase 2 | 35 participants (Anticipated) | Interventional | 2006-06-30 | Active, not recruiting |
Dose-escalation Study of Graft-versus-host Disease Prophylaxis With High-dose Post-transplantation Bendamustine in Patients With Refractory Acute Leukemia [NCT02799147] | Phase 1/Phase 2 | 27 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 |
UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies [NCT00714259] | Phase 2/Phase 3 | 5 participants (Actual) | Interventional | 2008-07-31 | Terminated(stopped due to Accrual goals could not be met within a timely manner) |
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 |
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 Phase I, Single-arm, Open Label, Dose Escalation, Multicenter Study of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) [NCT05712278] | Phase 1 | 12 participants (Anticipated) | Interventional | 2023-06-16 | Recruiting |
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 |
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 |
A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16) [NCT00187083] | Phase 3 | 40 participants (Actual) | Interventional | 1997-02-28 | Completed |
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 |
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 |
A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma [NCT00183989] | Phase 2 | 30 participants (Anticipated) | Interventional | 2000-08-31 | Terminated(stopped due to Insufficient accrual) |
[NCT00186797] | | 28 participants | Interventional | 2002-12-31 | Completed |
A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic L [NCT00220311] | Phase 4 | 10 participants (Actual) | Interventional | 2000-11-30 | 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 |
Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases [NCT01962636] | | 200 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
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 |
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 |
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.) |
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 |
A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies Using Melphalan for T-Cell Tolerization [NCT01350258] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2011-04-30 | Terminated(stopped due to Poor accrual) |
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 |
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 |
Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies [NCT01471067] | Phase 1 | 33 participants (Actual) | Interventional | 2012-07-13 | Completed |
A Single-center Open-label Phase I Study of ALT-801 for ex Vivo Maturation and in Vivo Retargeting of Haploidentical Natural Killer Cells Delivered Following Fludarabine, Cytarabine, and G-CSF in Patients With Relapsed/Refractory Acute Myeloid Leukemia [NCT01478074] | Phase 1 | 0 participants (Actual) | Interventional | 2011-11-30 | Withdrawn(stopped due to The treatment planned was determined to be of low feasibility as no subject was found eligible and able to enroll after screening over 30 subjects) |
Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia. [NCT00344825] | | 300 participants (Actual) | Observational | 2004-01-31 | Completed |
FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia [NCT00488709] | Phase 4 | 47 participants (Actual) | Interventional | 2003-05-31 | Completed |
Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission [NCT00043810] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2002-07-31 | Terminated |
Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia) [NCT01247493] | Phase 2 | 108 participants (Actual) | Interventional | 2007-06-30 | Completed |
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 |
FLAG-IDA Chemotherapy Induction Follow by Intensive Chemotherapy Postremission +/- Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemi [NCT00487448] | Phase 4 | 200 participants (Anticipated) | Interventional | 1998-07-31 | Completed |
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.) |
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 1 and Pharmacokinetic Study of Uproleselan (GMI-1271, NSC #801708) in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia Myelodysplastic Syndrome or Mixed Phenotype Acute Leukemia That Expresses E-Selectin Ligand [NCT05146739] | Phase 1 | 18 participants (Anticipated) | Interventional | 2023-12-23 | 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 |
NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING [NCT00521430] | | 30 participants (Anticipated) | Interventional | 2004-04-30 | Completed |
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation [NCT00516152] | Phase 2 | 36 participants (Anticipated) | Interventional | 2002-11-30 | Completed |
A Phase II Study of Fludarabine + Rituximab Induction Followed by Alemtuzumab (Campath-1H, NSC #715969, IND #10864) Administered Subcutaneously as Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00098670] | Phase 2 | 102 participants (Actual) | Interventional | 2004-10-31 | Completed |
T Cell Therapy for Patients With Metastatic Renal Cell Carcinoma [NCT02926053] | Phase 1 | 6 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
[NCT00529880] | Phase 2 | 19 participants (Anticipated) | Interventional | 2004-12-31 | 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 I Study of the Administration of T Lymphocytes Co-Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed/Refractory CD30+ Hodgkin Lymphoma and Cutaneous T-Cell Lymphoma [NCT03602157] | Phase 1 | 59 participants (Anticipated) | Interventional | 2018-12-12 | 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 |
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.) |
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 |
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 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 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 |
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 |
Ma-Spore ALL 2010 Study [NCT02894645] | Phase 4 | 500 participants (Anticipated) | Interventional | 2008-10-31 | Recruiting |
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 |
A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL [NCT00543114] | Phase 1 | 9 participants (Actual) | Interventional | 2007-10-31 | Terminated(stopped due to lack of efficacy and tolerability) |
A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia [NCT05320380] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2023-08-01 | Withdrawn(stopped due to Withdrawn per CS0150757) |
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 |
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 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 |
Cord Blood Ex-Vivo MSC Expansion Plus Fucosylation to Enhance Homing and Engraftment [NCT03096782] | Phase 2 | 6 participants (Actual) | Interventional | 2017-10-13 | 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 |
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 |
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 |
Sequential Myeloablative Stem Cell Transplantation and Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma and Hodgkin's Disease [NCT00802113] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2003-06-30 | Completed |
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) |
Lenalidomide Following Rituximab and Fludarabine in Untreated Chronic Lymphocytic Leukemia [NCT00860457] | Phase 2 | 22 participants (Actual) | Interventional | 2008-02-29 | Completed |
Allogeneic Hematopoietic Cell Transplantation for Patients With Nonmalignant Inherited Disorders Using a Treosulfan Based Preparative Regimen [NCT00919503] | Phase 2 | 98 participants (Actual) | Interventional | 2009-07-31 | Completed |
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.) |
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 Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine [NCT00004194] | Phase 1/Phase 2 | 0 participants | Interventional | | Active, not recruiting |
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 |
A Study to Determine the Safety and Efficacy of Using CD8-High Density Microparticles (CD8-HDM) to Deplete CD8+ Cells From Donor Lymphocyte Infusion in Order to Reduce Graft-versus-Host Disease (GvHD) Without Compromising an Anti-Leukemia Effect in Patien [NCT00004878] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to study never opened) |
Phase I Study of Bryostatin 1 (NSC 339555) and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma [NCT00005580] | Phase 1 | 54 participants (Actual) | Interventional | 1998-09-30 | Completed |
Chemotherapy (CT) Followed by Donor Lymphocyte Infusion (DLI) Plus Interleukin 2 (IL-2) for Patients With Relapse Acute Myeloid or Lymphoid Leukemia After Allogeneic Hematopoietic Transplant [NCT00005802] | Phase 1/Phase 2 | 0 participants | Interventional | 1999-06-30 | Completed |
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 |
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 |
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation [NCT01472055] | Phase 2 | 46 participants (Anticipated) | Interventional | 2011-10-31 | Recruiting |
A Phase II Study of Thiotepa Added to Fludarabine and Melphalan as the Preparative Regime for Alternative Donor Transplantation [NCT03342196] | Phase 2 | 40 participants (Actual) | Interventional | 2018-03-21 | Active, not recruiting |
A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) [NCT01894477] | Phase 2 | 102 participants (Actual) | Interventional | 2013-11-30 | Active, not recruiting |
Natural Killer Cells in Allogeneic Cord Blood Transplantation [NCT01619761] | Phase 1 | 13 participants (Actual) | Interventional | 2013-05-03 | Active, not recruiting |
A Phase I Trial of PS-341 and Fludarabine for Relapsed and Refractory Indolent Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia [NCT00068315] | Phase 1 | 18 participants (Actual) | Interventional | 2003-07-31 | Completed |
Safety And Efficacy of Sub-Myeloablative Allogeneic Stem Cell Transplantation For Patients With Myeloproliferative Disorder (MPD), Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia [NCT00069992] | Phase 2 | 7 participants (Actual) | Interventional | 2001-12-31 | Terminated(stopped due to Closed due to competing protocols) |
Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia [NCT00262795] | Phase 3 | 206 participants (Actual) | Interventional | 2003-09-30 | Completed |
A Multi-Center Phase II Study of Nonmyeloablative Conditioning With TBI and Fludarabine for HLA-Matched Related Hematopoietic Cell Transplantation for Treatment of Chronic Myeloid Leukemia in Chronic and Accelerated Phase [NCT00110058] | Phase 2 | 40 participants (Anticipated) | Interventional | 2005-02-28 | 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 |
A Phase I Trial Of Sequential Administration Of Triapine (3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone) Followed By Fludarabine In Adults With Relapsed And Refractory Leukemias And Myelodysplasias [NCT00077558] | Phase 1 | 0 participants | Interventional | 2004-01-31 | Completed |
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 |
Fludarabine and Low-Dose TBI Dose Escalation to Determine the Optimal Regimen for Achieving High Rates Engraftment of Unrelated Donor Peripheral Blood Stem Cell in Patients With Chronic Myeloid Leukemia - A Multi-Center Trial [NCT00119340] | Phase 1/Phase 2 | 75 participants (Anticipated) | Interventional | 2005-04-30 | Completed |
Abbreviated Fludarabine / Mitoxantrone / Rituximab Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma [NCT00119730] | Phase 2 | 30 participants (Actual) | Interventional | 2005-02-28 | Completed |
Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy [NCT00086775] | Phase 2 | 0 participants | Interventional | 2003-07-31 | Completed |
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation [NCT00301912] | Phase 2 | 0 participants (Actual) | Interventional | 2002-01-31 | Withdrawn(stopped due to Withdrawn because study never opened to accrual) |
Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies [NCT00301951] | Phase 1 | 7 participants (Actual) | Interventional | 2004-09-30 | Completed |
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies [NCT00304018] | Phase 1 | 5 participants (Actual) | Interventional | 2002-10-31 | Completed |
Low-Dose Allogeneic Peripheral Blood Stem Cell Transplantation for High-Risk Low Grade Hematologic Malignancies [NCT00296023] | | 25 participants (Actual) | Interventional | 1999-01-31 | 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 |
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia [NCT06001788] | Phase 1 | 171 participants (Anticipated) | Interventional | 2023-12-31 | 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 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 |
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 |
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 |
A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma [NCT00091143] | Phase 1 | 20 participants (Anticipated) | Interventional | 2004-07-31 | 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.) |
The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells [NCT00084695] | Phase 2 | 25 participants (Anticipated) | Interventional | 2003-09-30 | Recruiting |
A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma [NCT00093522] | Phase 2 | 28 participants (Anticipated) | Interventional | 2004-08-31 | Active, not recruiting |
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 |
Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Chemotherapy (FLAG) in Patients With AML or Acute Leukemia of Ambiguous Lineage [NCT01701323] | Phase 1 | 7 participants (Actual) | Interventional | 2012-12-10 | Terminated |
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 |
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 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 |
Alloreactive NK Cells With Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplantation for AML and MDS [NCT00402558] | Phase 1 | 15 participants (Actual) | Interventional | 2006-05-31 | Completed |
Low-Dose Total Body Irradiation and Fludarabine Followed By Unrelated Donor Stem Cell Transplantation for Patients With Fanconi Anemia - A Multicenter Trial [NCT00093743] | Phase 1 | 2 participants (Actual) | Interventional | 2000-01-31 | Completed |
Reduced Intensity Conditioning Regimen for Haplo-identical Family Donor Stem Cell Transplants for Hematologic Malignancies With Delayed Add-back of Non-alloreactive T Cells [NCT00104975] | Phase 1 | 20 participants (Anticipated) | Interventional | 2005-02-28 | Completed |
A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome [NCT00454480] | Phase 2/Phase 3 | 2,000 participants (Anticipated) | Interventional | 2006-08-31 | Completed |
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 |
Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis [NCT00133367] | Phase 2 | 32 participants (Anticipated) | Interventional | 2005-08-31 | 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 |
Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies (UCAML) [NCT01247701] | | 16 participants (Actual) | Interventional | 2010-11-30 | Completed |
Phase 2 Study of 5 Days Azacytidine Priming Prior to Fludarabine, Cytarabine and Granulocyte-Colony Stimulating Factor (G-CSF) Combination for Patients With Relapsed or Refractory AML [NCT02275663] | Phase 2 | 37 participants (Anticipated) | Interventional | 2014-12-31 | 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 |
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 |
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS [NCT04708054] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-10-21 | 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 |
A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia [NCT00801489] | Phase 2 | 270 participants (Anticipated) | Interventional | 2007-04-04 | Recruiting |
Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease [NCT00385788] | Phase 2 | 52 participants (Actual) | Interventional | 2005-07-31 | 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 |
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) |
Hematopoietic Cell Transplantation for Treatment of Patients With Primary Immunodeficiencies and Other Nonmalignant Inherited Disorders Using Low-Dose TBI and Fludarabine With or Without Campath® [NCT00553098] | Phase 2 | 29 participants (Actual) | Interventional | 2006-06-30 | Completed |
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.) |
Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis [NCT00618540] | Phase 2 | 1 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Slow accrual) |
Phase II Study of the Addition of Azacitidine (NSC#102816) to Reduced-Intensity Conditioning Allogeneic Transplantation for Myelodysplasia (MDS) and Older Patients With AML [NCT01168219] | Phase 2 | 68 participants (Actual) | Interventional | 2010-07-15 | Completed |
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) |
Umbilical Cord Blood Transplantation From Unrelated Donors [NCT03016806] | Phase 1 | 30 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases [NCT00582894] | | 17 participants (Actual) | Interventional | 2005-02-28 | Completed |
Cd45 (Yth-24 and Yth 54) and Cd52 (Campath-1H) Monoclonal Antibody Conditioning Regimen for Allogeneic Donor Stem Cell Transplantation of Patients With Fanconi Anemia [NCT00590460] | Phase 1/Phase 2 | 5 participants (Actual) | Interventional | 2001-07-31 | Terminated(stopped due to slow accrual) |
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) |
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies [NCT00683046] | Phase 2 | 204 participants (Actual) | Interventional | 2001-11-30 | 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 |
Tandem Autologous HCT/Nonmyeloablative Allogeneic HCT From HLA-Matched Related and Unrelated Donors Followed by Bortezomib Maintenance Therapy for Patients With High-Risk Multiple Myeloma [NCT00793572] | Phase 2 | 32 participants (Actual) | Interventional | 2008-10-31 | Completed |
Combined Haploidentical-Cord Blood Transplantation for Adults and Children [NCT00943800] | | 87 participants (Actual) | Interventional | 2006-10-09 | Completed |
A Pilot Trial of Unrelated Donor Hematopoietic Cell Transplantation for Children With Severe Thalassemia Using a Reduced Intensity Conditioning Regimen (The URTH Trial) [NCT01005576] | Phase 2 | 21 participants (Actual) | Interventional | 2010-01-31 | 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 |
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) |
A Phase I/II Clinical Trial of Fludarabine, Bendamustine, and Rituximab (FBR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL) [NCT01096992] | Phase 1/Phase 2 | 51 participants (Actual) | Interventional | 2010-04-19 | Completed |
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 |
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 |
A Phase II Study of Hematopoietic Stem Cell Therapy for Young Adults With Severe Sickle Cell Disease [NCT01565616] | Phase 2 | 22 participants (Actual) | Interventional | 2012-03-31 | Completed |
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 |
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 |
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 |
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 |
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 |
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 |
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC) [NCT01666080] | | 30 participants (Anticipated) | Interventional | 2012-08-31 | Recruiting |
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 |
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 |
A Feasibility Trial of Post-Transplant Infusion of Allogeneic Regulatory T Cells and Allogeneic Conventional T Cells in Patients With Hematologic Malignancies Undergoing Allogeneic Myeloablative Hematopoietic Cell Transplantation From Haploidentical-Relat [NCT01050764] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2009-06-30 | Terminated(stopped due to Safety) |
Dose Escalation Trial of Cloretazine (VNP40101M) and Hematopoietic Cell Transplantation for Patients With Selected, Poor-Prognosis Hematologic Malignancies [NCT00521859] | Phase 1 | 5 participants (Actual) | Interventional | 2007-08-31 | Completed |
HDAC Inhibitor Valproic Acid as an Effective Therapy for Chronic Lymphocytic Leukemia [NCT00524667] | Phase 2 | 6 participants (Actual) | Interventional | 2008-01-31 | Terminated(stopped due to Terminated due to poor accrual.) |
Pacritinib Prior to Transplant for Patients With Myeloproliferative Neoplasms (MPN) [NCT02410551] | Phase 2 | 4 participants (Actual) | Interventional | 2015-06-15 | Terminated |
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 |
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 |
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 |
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.) |
A Phase II Trial of High-Dose 90Y-Ibritumomab Tiuxetan (Anti-CD20) Followed by Fludarabine and Low-Dose Total Body Irradiation and HLA-Matched Allogeneic Hematopoietic Transplantation for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma [NCT01434472] | Phase 2 | 20 participants (Actual) | Interventional | 2011-11-16 | Terminated(stopped due to Terminated due to insufficient funding) |
A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning [NCT05031897] | Phase 2 | 67 participants (Anticipated) | Interventional | 2021-10-25 | Recruiting |
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 |
[NCT01540812] | | 418 participants (Actual) | Observational | 2012-02-29 | Completed |
Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission [NCT00101140] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn |
A Phase I/II Combination Study of Topotecan, Fludarabine, Cytosine Arabinoside and G-CSF (T-FLAG) Induction Therapy in Patients With Poor Prognosis AML, MDS and Relapsed/Refractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic A [NCT00003619] | Phase 1/Phase 2 | 0 participants | Interventional | 1998-02-28 | Completed |
A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older [NCT00110071] | Phase 1 | 38 participants (Actual) | Interventional | 2005-01-31 | Completed |
A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants [NCT00112567] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2003-04-30 | Completed |
A Phase I Study Combining Escalating Doses of Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to Establish Mixed or Full Donor Chimerism [NCT00008177] | Phase 1 | 79 participants (Actual) | Interventional | 1999-07-27 | Completed |
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 |
Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine [NCT00009984] | Phase 2 | 70 participants (Actual) | Interventional | 2002-03-31 | Terminated |
Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia) [NCT00020800] | Phase 2 | 7 participants (Actual) | Interventional | 2001-09-30 | Completed |
Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma [NCT00025519] | Phase 2 | 0 participants (Actual) | Interventional | 2001-06-30 | Withdrawn |
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Sibling Donors For Treatment Of Patients With High Risk Acute Lymphocytic Leukemia In Complete Remission [NCT00027547] | Phase 1/Phase 2 | 0 participants | Interventional | 2001-07-31 | Completed |
Low-Dose TBI and Fludarabine Followed by Nonmyeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation Using Enhanced Postgrafting Immunosuppression for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial [NCT00027820] | Phase 1/Phase 2 | 106 participants (Actual) | Interventional | 2001-08-31 | Completed |
Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma [NCT00028600] | Phase 2 | 60 participants (Actual) | Interventional | 2001-11-30 | Completed |
Allogeneic Stem Cell Transplantation Following Nonmyeloablative Chemotherapy in Patients With Hemoglobinopathies [NCT00034528] | Phase 2 | 2 participants (Actual) | Interventional | 2001-09-30 | Terminated(stopped due to Due to slow recruitment) |
Nonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based Immunosuppression [NCT00014235] | | 160 participants (Anticipated) | Interventional | 2000-12-31 | Completed |
Allo SCT From HLA Haploidentical Related Donors Using Sub-Myeloablative Conditioning For Patients With High Risk Hemoglobinopathies: Hemo SS, Hemo SC, Hemo SB0/+ Thalassemia, Homozygous B0/+ Thalassemia or Severe B0/+ Thalassemia Variants [NCT00040417] | Phase 2 | 15 participants | Interventional | 2000-08-31 | Terminated(stopped due to unable to accrue patients) |
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 |
Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis [NCT00001586] | Phase 2 | 105 participants (Actual) | Interventional | 1997-09-30 | Completed |
Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM) [NCT00048412] | Phase 1/Phase 2 | 40 participants | Interventional | 2000-06-30 | Completed |
A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia [NCT00049075] | Phase 2 | 128 participants (Actual) | Interventional | 2002-08-08 | 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 |
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 |
Phase II Study of Fludarabine, Carboplatin, and Topotecan With Thalidomide for Patients With Relapsed/Refractory or High Risk Acute Myelogenous Leukemia, Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes [NCT00053287] | Phase 2 | 42 participants (Actual) | Interventional | 2002-09-30 | Completed |
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 |
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 |
A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease [NCT00423709] | | 46 participants (Actual) | Interventional | 1998-01-31 | Completed |
Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma [NCT00073879] | | 0 participants | Interventional | 2003-04-30 | Completed |
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 |
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 |
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 |
Randomized Study for Patients With Follicular Lymphoma Needing Treatment [NCT00140569] | Phase 3 | 400 participants | Interventional | 1994-01-31 | Completed |
Feasibility/Phase II Trial of Fludarabine, Rituximab, and Alemtuzumab for Previously Treated B-Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) [NCT00143065] | Phase 2 | 8 participants (Actual) | Interventional | 2005-08-31 | Completed |
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 |
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 |
[NCT00010361] | | 20 participants | Interventional | 2000-11-30 | 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 |
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 |
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 |
Fludarabine And Busulfan As Conditioning For Patients With Chronic Myeloid Leukemia Or Myelodysplastic Syndrome Transplanted With Hematopoietic Stem Cells From HLA-Compatible Related Or Unrelated Donors [NCT00027924] | Phase 2 | 0 participants | Interventional | 2001-10-31 | 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 |
Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen [NCT00615589] | Phase 2 | 22 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Low accrual) |
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 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 |
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 |
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 |
Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies [NCT00019838] | Phase 1 | 0 participants | Interventional | 1999-07-31 | Completed |
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 |
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 |
Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation [NCT00055653] | Phase 2 | 0 participants | Interventional | 2003-01-31 | 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 |
Anti-CD45 (YTH-24 & YTH 54) and ANTI-CD52 (CAMPATH-1H) Monoclonal Antibody Conditioning Regimen for Allogeneic Stem Cell Transplantation of Patients With Inherited Metabolic Storage Diseases [NCT00056979] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2002-06-30 | Terminated |
A Phase I Study of Flavopiridol, Fludarabine and Rituximab in Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma [NCT00058227] | Phase 1 | 37 participants (Actual) | Interventional | 2003-04-30 | Completed |
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Unrelated Donors for Treatment of Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission - A Multicenter Trial [NCT00031655] | Phase 2 | 30 participants (Anticipated) | Interventional | 2001-09-30 | Completed |
A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma [NCT00060684] | Phase 1 | 30 participants | Interventional | 2001-12-31 | Completed |
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.) |
Phase I/II Evaluation of Safety and Activity of Mylotarg Plus Melphalan and Fludarabine as Preparative Therapy for Older or Medically Infirm Patients Undergoing Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation [NCT00038831] | Phase 1/Phase 2 | 47 participants (Actual) | Interventional | 2001-05-31 | 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 |
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 |
Protocol for the Treatment of Adults Aged = 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial) [NCT00209833] | Phase 2/Phase 3 | 200 participants | Interventional | 1999-01-31 | 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) |
A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia [NCT00078234] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2003-11-30 | Completed |
Prolonged Mycophenolate Mofetil and Truncated Cyclosporine Postgrafting Immunosuppression to Reduce Life-Threatening GVHD After Unrelated Donor Peripheral Blood Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Maligna [NCT00078858] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2003-09-30 | Completed |
Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study [NCT00044954] | Phase 2 | 0 participants | Interventional | 1999-11-30 | Completed |
A Phase II Study of Single Agent Depsipeptide (NSC 630176) Followed by a Phase I Study of Rituximab/Fludarabine Combination With an Escalating Dose of Depsipeptide in Relapsed or Refractory Low Grade B Cell Lymphomas [NCT00079443] | Phase 2 | 60 participants (Actual) | Interventional | 2004-01-31 | 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 |
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 |
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 |
Phase I/II Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma [NCT00045513] | Phase 1/Phase 2 | 0 participants | Interventional | 2002-06-30 | Completed |
Phase I/II Study of CD45 Antibodies and Alemtuzumab Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases [NCT00056966] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2002-11-30 | Completed |
Pilot/Feasibility Study To Evaluate The Safety Of Cellular Immunotherapy For CD19+ Follicular Lymphoma Using Autologous Cytolytic T Cells Genetically-Modified To Be CD19-Specific And Co-Express HyTK [NCT00182650] | Phase 1 | 5 participants (Anticipated) | Interventional | 2004-06-30 | Completed |
Phase I/II Study of Allogeneic Stem Cell Transplantation For Patients With Graft Failure Following Allogeneic Transplantation Using MHC Identical or Near Identical Donors and Submyeloablative Conditioning With CAMPATH 1H (CAMGRAFT) [NCT00048399] | Phase 1/Phase 2 | 40 participants | Interventional | 2000-12-31 | Terminated(stopped due to accrual was slow) |
Treatment of Elderly Patients (>60 Years) With Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem C [NCT00199147] | Phase 4 | 250 participants | Interventional | 2000-01-31 | Recruiting |
A Trial of Reduced Intensity Conditioning and Transplantation of Haplotype Mismatched and KIR Class I Epitope-Mismatched Highly Purified CD34 Cells [NCT00085449] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2006-05-31 | Withdrawn(stopped due to Funding cut, no patients enrolled) |
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 |
Low-Dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection After Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders - A Multi-Cen [NCT00397813] | Phase 2 | 77 participants (Actual) | Interventional | 2006-01-31 | Completed |
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.) |
Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Ineligible or Inappropriate for Treatment With a More Intensive Therapeutic Regimen [NCT00448201] | Phase 2 | 71 participants (Actual) | Interventional | 2011-01-07 | 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) |
Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Undergoing Dose-Adjusted Treatment With A Maximally Intensive Busulfex-Based Therapeutic Regimen [NCT00448357] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2005-10-31 | Completed |
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 Phase I-II Study of Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation, Prolymphocytic Leukemia, Aggressive, Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia [NCT00472849] | Phase 1/Phase 2 | 92 participants (Actual) | Interventional | 2007-05-31 | Completed |
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 I/II Study of Fludarabine, Rituximab, and Lenalidomide in Minimally Treated and Untreated Patients With Chronic Lymphocytic Leukemia [NCT00536341] | Phase 1/Phase 2 | 64 participants (Actual) | Interventional | 2008-01-31 | Completed |
A Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With High Risk Hemoglobinopathy Using a Non-Myeloablative Preparative Regimen to Achieve Stable Mixed Chimerism [NCT00427661] | | 8 participants (Actual) | Interventional | 2002-06-30 | Completed |
Phase I/II Trial of Fludarabine in Combination With Intravenous Busulfan and Allogeneic Progenitor Cell Support for Patients With Hematologic Malignancies [NCT00506857] | Phase 1/Phase 2 | 82 participants (Actual) | Interventional | 2003-11-30 | Completed |
Transplantation of Haploidentical CD34+ Purified Peripheral Blood Stem Cells With NK-Cell Add-Back Following Conditioning With Total Body Irradiation, Thiotepa, Fludarabine and OKT3 [NCT00450983] | Phase 2 | 1 participants (Actual) | Interventional | 2006-12-31 | Terminated |
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.) |
A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma [NCT00505895] | Phase 2 | 52 participants (Actual) | Interventional | 2002-01-31 | Completed |
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 |
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 Phase II Study of High-Dose Intravenous Busulfan and Fludarabine With Allogeneic Marrow and Peripheral Blood Progenitor Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes [NCT00502905] | Phase 2 | 200 participants (Actual) | Interventional | 2003-10-31 | Completed |
CD45 and Alemtuzumab Monoclonal Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Severe Combined Immunodeficiency Disease (SCID) And Other Primary Immunodeficiency Disorders [NCT00579137] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2007-10-31 | Terminated(stopped due to slow accrual) |
Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis [NCT00622895] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2006-09-01 | Completed |
Reduced-Intensity Preparative Regiment With Fludarabine, Busulfan, And Alemtuzumab (Campath 1H) Followed By Allogeneic Hematopoietic Stem Cell Transplant For Malignant And Non-Malignant Hematological Diseases [NCT00579111] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2007-06-30 | Terminated(stopped due to slow accrual) |
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 |
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.) |
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 |
Exploratory Study Evaluating the Interest of PET to 18F-Fludarabine for the Initial Assessment and End-treatment Evaluation of Patients With Symptomatic Multiple Myeloma in the First Line of Treatment, Not Candidates for Marrow Autograft [NCT03832127] | Phase 1 | 35 participants (Anticipated) | Interventional | 2022-04-01 | Not yet recruiting |
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 |
Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies [NCT00827099] | Phase 2 | 5 participants (Actual) | Interventional | 2006-06-30 | Terminated(stopped due to Unacceptable morbidity & mortality) |
"A Feasibility Study of Early Allogeneic Hematopoietic Cell Transplantation for Relapsed or Refractory High-Grade Myeloid Neoplasms" [NCT02756572] | Phase 2 | 30 participants (Actual) | Interventional | 2016-09-22 | Completed |
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 |
Phase 1/2, Open-label Study Evaluating Safety of Repeat Administration of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally Followed by Intravenous Fludarabine Phosphate) in Subjects With Recurrent, Local Head and Neck Cancer [NCT03754933] | Phase 1/Phase 2 | 10 participants (Anticipated) | Interventional | 2019-02-11 | 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 I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML [NCT01861002] | Phase 1 | 15 participants (Actual) | Interventional | 2013-05-22 | Completed |
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 |
Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH [NCT04540380] | Phase 1 | 6 participants (Anticipated) | Interventional | 2021-09-01 | Recruiting |
Hematopoietic Stem Cell Transplant for Sickle Cell Disease [NCT02065596] | Phase 1/Phase 2 | 25 participants (Anticipated) | Interventional | 2015-10-19 | 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).) |
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 |
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 |
Study of Fludarabine Based Conditioning for Allogeneic Stem Cell Transplantation for Myelofibrosis [NCT00572897] | Phase 2 | 66 participants (Actual) | Interventional | 2007-08-31 | 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 |
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 |
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/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome [NCT02212561] | Phase 1 | 19 participants (Actual) | Interventional | 2014-08-31 | Completed |
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.) |
Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia [NCT00262782] | Phase 3 | 877 participants (Actual) | Interventional | 1997-04-30 | Completed |
A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Immune Function Disorders Using a Reduced Intensity Preparatory Regime [NCT01821781] | Phase 2 | 20 participants (Anticipated) | Interventional | 2013-03-31 | Recruiting |
A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma [NCT00119392] | Phase 2 | 42 participants (Actual) | Interventional | 2004-06-30 | Completed |
First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL) [NCT00278265] | Phase 2 | 12 participants (Actual) | Interventional | 2005-06-30 | Terminated(stopped due to slow recruitment) |
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 |
Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity [NCT00281892] | Phase 3 | 97 participants (Actual) | Interventional | 2004-09-30 | 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 |
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 |
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 |
Stem Cell Enriched, T Cell Depleted Haplocompatible Peripheral Blood Transplantation for Children With Myelodysplastic Disease, Leukemia, Marrow Failure Syndromes, or Severe Immunodeficiency Diseases [NCT00295971] | Phase 1 | 21 participants (Actual) | Interventional | 2005-04-30 | Completed |
Feasibility of Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation Followed by Donor Lymphocyte Infusions for Children at High Risk for Complications With Conventional Transplantation [NCT00301860] | | 8 participants (Actual) | Interventional | 2003-01-31 | Terminated(stopped due to lack of efficacy) |
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 |
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 |
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 |
Evaluation of Safety and Efficacy of Treosulfan-cytarabine-fludarabine (FLAT) Combination Prior to Autologous Stem Cell Transplant (HSCT) in Elderly Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) [NCT03961919] | Phase 2 | 15 participants (Actual) | Interventional | 2009-02-10 | Completed |
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 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 |
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 |
Bone Marrow Stem Cell Transplantation for Children With Stem Cell Defects, Marrow Failure Syndromes, or Myeloid Leukemia in 1Remission [NCT00305708] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2000-08-31 | Completed |
A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral [NCT00311129] | Phase 2 | 41 participants (Actual) | Interventional | 2005-12-31 | Completed |
A Dose Ranging Trial of MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines With Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma [NCT00313508] | Phase 1 | 18 participants (Actual) | Interventional | 2006-02-28 | 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 |
A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) Followed by Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed and Refractory Hematologic [NCT05201183] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2023-10-31 | Withdrawn(stopped due to insufficient staff and updates in standard practice have made it difficult to recruit participants) |
A Phase II Study Of Pooled Unrelated Donor Umbilical Cord Blood (UCB) Transplant For Patients With Hematologic Malignancies Needing Allogeneic Stem Cell Transplant But Do Not Have A Related HLA-Matched Donor [NCT01500161] | Phase 2 | 1 participants (Actual) | Interventional | 2011-11-30 | Terminated(stopped due to Insufficient accruals) |
A Phase I Study of 90Y-BC8-DOTA Monoclonal Antibody, Fludarabine and TBI Followed by HLA-Matched, Allogeneic Peripheral Blood Stem Cell Transplant for the Treatment of Multiple Myeloma [NCT01503242] | Phase 1 | 15 participants (Actual) | Interventional | 2012-01-09 | Completed |
Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies and Non-malignant Disorders [NCT04644016] | Phase 2 | 31 participants (Anticipated) | Interventional | 2020-11-20 | 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 |
Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies [NCT01622556] | Phase 2 | 6 participants (Actual) | Interventional | 2012-01-31 | Terminated |
A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas [NCT01625351] | Phase 1 | 23 participants (Actual) | Interventional | 2012-08-20 | Completed |
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) |
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 |
Phase I Trial of Fludarabine and Methoxyamine (TRC102) for Relapsed or Refractory Hematologic Malignancies [NCT01658319] | Phase 1 | 20 participants (Actual) | Interventional | 2011-05-31 | Completed |
Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT00427557] | Phase 2 | 31 participants (Actual) | Interventional | 2006-10-31 | 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 I Study of Venetoclax to Augment Epigenetic Modification and Chemotherapy in Pediatric and Young Adult Patients With Relapsed and Refractory Acute Myeloid Leukemia [NCT05317403] | Phase 1 | 40 participants (Anticipated) | Interventional | 2023-03-31 | Recruiting |
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 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 |
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 |
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 |
Epigenetic Priming With 5-Azacytidine Prior to in Vivo T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With High Risk Myeloid Malignancies in Morphologic Remission [NCT02497404] | Phase 2 | 40 participants (Actual) | Interventional | 2015-02-13 | Completed |
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 |
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 |
A Phase II Study of Myeloablative and Reduced-Intensity Conditioning Regimens for Children and Young Adults With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT02626715] | Phase 2 | 22 participants (Actual) | Interventional | 2015-09-04 | Completed |
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 |
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 |
A Phase I/II Clinical Trial Testing the Safety and Feasibility of IL-21-Expanded Natural Killer Cells for the Induction of Relapsed/Refractory Acute Myeloid Leukemia [NCT01787474] | Phase 1 | 30 participants (Actual) | Interventional | 2014-05-19 | Completed |
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 |
A Phase II Multicentre, Randomized, Controlled Open-label Study on the Use of Anti-thymocyte Globulin and Rituximab for Immunomodulation of Graft-versus-host Disease in Allogeneic Matched Transplants for Non Malignancies [NCT01810926] | Phase 2 | 130 participants (Anticipated) | Interventional | 2011-09-30 | Recruiting |
Prospective, Phase II Randomized Study to Compare Busulfan-fludarabine Reduced-intensity Conditioning (RIC) With Thiotepa-fludarabine RIC Regimen Prior to Allogeneic Transplantation of Hematopoietic Cells for the Treatment of Myelofibrosis [NCT01814475] | Phase 2 | 62 participants (Actual) | Interventional | 2011-07-31 | Completed |
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 |
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 1 Trial of Ivosidenib and FLAG Chemotherapy in Relapsed/Refractory IDH1+ Acute Myeloid Leukemia (AML) [NCT04250051] | Phase 1 | 25 participants (Anticipated) | Interventional | 2020-12-21 | Recruiting |
A Randomized Phase III Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancie [NCT01231412] | Phase 3 | 174 participants (Actual) | Interventional | 2010-11-30 | Completed |
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.) |
Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis After Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation [NCT00282282] | Phase 2 | 31 participants (Actual) | Interventional | 2006-01-31 | Completed |
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 |
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 |
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 |
Treatment Protocol: Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients With High Risk Leukemia and Myelodysplasia Using Conditioning Regimen Without Radiation [NCT02007863] | | 2 participants (Actual) | Interventional | 2008-08-31 | 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 |
Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation [NCT01118013] | Phase 2 | 6 participants (Actual) | Interventional | 2010-12-31 | Terminated |
Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc) [NCT00684255] | Phase 1 | 1 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to inactive) |
A Randomized Study of Combined Haplo-identical Umbilical Cord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies [NCT01745913] | Phase 2 | 2 participants (Actual) | Interventional | 2012-10-26 | Terminated(stopped due to Slow accrual) |
Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor [NCT01598025] | | 3 participants (Actual) | Interventional | 2012-05-02 | Terminated(stopped due to Closed due to poor accrual) |
A Pilot Study Using High Dose Busulfan and Bortezomib as Part of Allogeneic Transplant Conditioning Regimen for High Risk Multiple Myeloma Patients. [NCT01534143] | Phase 2 | 1 participants (Actual) | Interventional | 2012-02-29 | Terminated(stopped due to Data was not collected, because funding was unavailable to continue study.) |
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor [NCT00523809] | Phase 2 | 5 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to Slow accrual.) |
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 |
Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy [NCT00001677] | Phase 2 | 40 participants | Interventional | 1998-06-30 | Completed |
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 |
A Phase I and Expansion Cohort Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia [NCT04898894] | Phase 1 | 42 participants (Anticipated) | Interventional | 2021-11-15 | Recruiting |
NK Cells With HLA Compatible Hematopoietic Transplantation for High Risk Myeloid Malignancies [NCT01823198] | Phase 1/Phase 2 | 63 participants (Actual) | Interventional | 2013-06-11 | Completed |
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 |
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 |
Multicenter, Prospective, Open-label, Single-arm, Phase I-II Clinical Trial to Analyze Induction Therapy With a Combination of Fludarabine, Idarubicin, Cytarabine, G-CSF and Plerixafor for the Treatment of Young Patients With Relapsed or Refractory AML [NCT01435343] | Phase 1/Phase 2 | 55 participants (Actual) | Interventional | 2012-07-31 | 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 |
Reduced Intensity Matched Sibling Bone Marrow Transplantation for Sickle Cell Anemia in Patients 2-30 Years Old [NCT01877837] | Phase 3 | 30 participants (Actual) | Interventional | 2011-06-30 | Completed |
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 |
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 |
A Phase 2 Multi-Center Study Evaluating the Safety and Efficacy of CD30-Directed Genetically Modified Autologous T Cells (CD30.CAR-T) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma [NCT04268706] | Phase 2 | 97 participants (Anticipated) | Interventional | 2021-02-01 | Active, not 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 |
Delayed Infusion of Ex Vivo Anergized Peripheral Blood Mononuclear Cells Following CD34 Selected Peripheral Blood Stem Cell Transplantation From a Haploidentical Donor for Patients With Acute Leukemia and Myelodysplasia [NCT00376480] | Phase 1 | 19 participants (Actual) | Interventional | 2005-06-30 | Completed |
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) |
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 |
PRO#0118: A Phase I Study of Decitabin in Combination With Fludarabin and Busulfan as a Reduced Intensity Conditioning Regimen for the Treatment of Myeloid Malignancies [NCT01455506] | Phase 1 | 20 participants (Actual) | Interventional | 2009-05-31 | 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 |
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 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 |
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 |
Phase II Study of Timed Sequential Busulfan in Combination With Fludarabine in Allogeneic Stem Cell Transplantation [NCT01572662] | Phase 2 | 201 participants (Actual) | Interventional | 2012-04-11 | 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 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 |
Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99) [NCT00199056] | Phase 4 | 225 participants | Interventional | 1999-10-31 | Completed |
A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00004246] | Phase 1 | 16 participants (Actual) | Interventional | 1995-06-07 | Completed |
Nonmyeloablative Conditioning With Pre- and Post-Transplant Rituximab Followed by Related or Unrelated Donor Hematopoietic Cell Transplantation for Patients With Advanced Chronic Lymphocytic Leukemia: A Multi-Center Trial [NCT00104858] | Phase 2 | 66 participants (Actual) | Interventional | 2004-12-31 | Completed |
Phase I, Open-label Study Evaluating the Safety of Escalating Doses of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally With Co-administration of Fludarabine Phosphate Intravenously) in Subjects With Advanced Solid Tumors [NCT01310179] | Phase 1 | 12 participants (Actual) | Interventional | 2011-02-28 | Completed |
Campath (Alemtuzumab) Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class II Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies: A Multicenter Trial [NCT00118352] | Phase 2 | 12 participants (Actual) | Interventional | 2005-03-31 | Completed |
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 |
An International Randomised Clinical Trial of Therapeutic Interventions to Assess the Effects on Outcome in Adults With Acute Myeloid Leukaemia and High Risk Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation. [NCT04217278] | Phase 2/Phase 3 | 333 participants (Actual) | Interventional | 2020-01-27 | Active, not recruiting |
Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies [NCT00544466] | Phase 1/Phase 2 | 75 participants (Actual) | Interventional | 2006-07-31 | 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) |
Phase I/II Randomized Study of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome [NCT01289457] | Phase 1/Phase 2 | 282 participants (Actual) | Interventional | 2011-02-02 | 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) |
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 Multicenter, Prospective Trial to Evaluate the Role of NK Cell KIR Epitope Mismatch on Mortality and Disease Relapse in T-Cell Depleted Hematopoietic Stem Cell Transplantation From HLA-C Mismatched, Unrelated Donors for Myeloid Malignancies [NCT00392782] | Phase 2 | 24 participants (Actual) | Interventional | 2005-07-31 | Terminated |
Phase II Trial of Triapine (NSC #663249, 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbone) Plus Fludarabine (NSC #312887, Fludarabine Monophosphate) in Adults With Aggressive Myeloproliferative Disorders (MPDs) Including Chronic Myelomonocytic Leukemia (C [NCT00381550] | Phase 2 | 35 participants (Actual) | Interventional | 2006-08-31 | Completed |
Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas [NCT01456351] | Phase 3 | 230 participants (Actual) | Interventional | 2003-09-30 | Completed |
Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin's and Non-Hodgkin's Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation - A Multicenter Phase II Study [NCT01203020] | Phase 2 | 22 participants (Actual) | Interventional | 2010-10-12 | Completed |
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.) |
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 |
Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA [NCT03821987] | | 55 participants (Anticipated) | Interventional | 2018-12-17 | Recruiting |
A Phase 1/2 Study of Vadastuximab Talirine Administered in Sequence With Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) [NCT02614560] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2015-11-30 | Terminated |
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 |
Multi-Center Study Using Allogeneic Stem Cell Transplantation Following Reduced Intensity Chemotherapy in Patients With Hemoglobinopathies [NCT00153985] | Phase 2 | 2 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen [NCT00070135] | Phase 2 | 121 participants (Actual) | Interventional | 2004-01-31 | Completed |
A Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation [NCT01596699] | Phase 2 | 16 participants (Actual) | Interventional | 2012-05-24 | Terminated(stopped due to Triggering of futility rule; Interim analysis suggested no statistical superiority over historic controls) |
Donor Statin Treatment for Prevention of Severe Acute GVHD After Nonmyeloablative Hematopoietic Cell Transplantation [NCT01527045] | Phase 2 | 47 participants (Actual) | Interventional | 2012-09-25 | 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 |
A Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate M [NCT00089011] | Phase 2 | 150 participants (Actual) | Interventional | 2004-04-30 | 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 |
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.) |
A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning fo [NCT00105001] | Phase 2 | 210 participants (Actual) | Interventional | 2004-11-30 | Completed |
Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma - A Multi-Center Trial [NCT00054353] | Phase 1/Phase 2 | 16 participants (Actual) | Interventional | 2002-10-31 | Completed |
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) |
Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission [NCT00045435] | Phase 2 | 17 participants (Actual) | Interventional | 2002-04-30 | Completed |
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 |
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 |
A Study of a Reduced-Intensity Conditioning Regimen With Treosulfan and Fludarabine for Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Leukemia [NCT00253513] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2005-06-30 | Completed |
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) |
Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases [NCT00038857] | Phase 2 | 29 participants (Actual) | Interventional | 2001-09-30 | Completed |
AML Therapy With Irradiated Allogeneic Cells [NCT02105116] | | 6 participants (Actual) | Interventional | 2014-02-28 | Terminated(stopped due to No patients were eligible to receive the experimental component of the protocol therapy.) |
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, 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 |
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 |
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 |
A Phase II Trial of Fludarabine in Combination With Daunorubicin and Cytarabine Liposome for Adults With Newly-diagnosed Acute Myeloid Leukemia: University of California Hematologic Malignancies Consortium Protocol 1914 [NCT04425655] | Phase 2 | 2 participants (Actual) | Interventional | 2020-08-05 | Terminated(stopped due to Original investigator for the trial has left) |
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 |
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 |
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 |
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 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) |
Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine. [NCT00373594] | Phase 2 | 30 participants (Anticipated) | Interventional | 2005-06-30 | Completed |
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 |
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 |
A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected Allograft [NCT04982354] | Phase 1/Phase 2 | 20 participants (Anticipated) | Interventional | 2022-07-05 | Recruiting |
Phase 2 Study of a Reduced-toxicity Myeloablative Conditionning Regimen Using Fludarabine and Full Doses of iv Busulfan in Pediatric Patients Not Eligible for Standard Myeloablative Conditioning Regimens [NCT01572181] | Phase 2 | 50 participants (Actual) | Interventional | 2012-04-30 | Completed |
A Phase II Investigation of Vorinostat in Combination With Intravenous Fludarabine, Mitoxantrone, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma [NCT01578343] | Phase 2 | 20 participants (Actual) | Interventional | 2012-06-30 | Terminated(stopped due to we collected data of a total of 19 patients for an interim analysis. but there are less than 7 responses out of the initial 19 patients.) |
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 |
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 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 |
Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas [NCT02859402] | Phase 2 | 34 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive Ph+ Acute Leukemia ? A Multi-center Trial [NCT00036738] | Phase 2 | 28 participants (Actual) | Interventional | 2001-07-13 | 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) |
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 |
Busulfan Dose Escalation Study Based on AUC in the Setting of Busulfan/Fludarabine Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) [NCT00361140] | Phase 4 | 72 participants (Actual) | Interventional | 2005-08-31 | 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 |
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 |
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) |
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 |
A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Re [NCT03793478] | Phase 1/Phase 2 | 65 participants (Anticipated) | Interventional | 2018-08-15 | Recruiting |
Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation [NCT03182244] | Phase 3 | 276 participants (Actual) | Interventional | 2018-01-15 | Active, not 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 |
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma [NCT00317759] | Phase 1 | 12 participants (Anticipated) | Interventional | 2003-05-31 | Completed |
Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies [NCT00346359] | Phase 2 | 40 participants (Anticipated) | Interventional | 2006-03-31 | 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 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.) |
Combination of Cyclophosphamide and Fludarabine for Lupus Nephritis: Tolerance, Toxicity, Efficacy and Effects on B and T Lymphocyte Regeneration [NCT00001676] | Phase 1 | 15 participants | Interventional | 1998-01-31 | Completed |
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.) |
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.) |
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) |
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 |
A Randomized Phase II Study of Concurrent Fludarabine + Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 (Rituximab) [NSC# 687451] Induction Followed By Rituximab Consolidation In Untreated Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00003248] | Phase 2 | 104 participants (Actual) | Interventional | 1998-03-31 | Completed |
PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA [NCT00002779] | Phase 2 | 34 participants (Actual) | Interventional | 1998-02-28 | Completed |
A Phase I Study of G3139 (NSC 683428) in Combination With Salvage Chemotherapy for Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) [NCT00004862] | Phase 1 | 24 participants (Actual) | Interventional | 1999-10-31 | Completed |
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.) |
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis [NCT00002833] | Phase 2 | 53 participants (Actual) | Interventional | 1994-10-31 | Completed |
Induction of Mixed Hematopoietic Chimerism Using Fludarabine, Low Dose TBI , PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion In Patients With Chronic Myeloid Leuke [NCT00003145] | Phase 2 | 18 participants (Actual) | Interventional | 1997-08-31 | 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 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 |
Phase I Study of Fludarabine, Carboplatin, and Topotecan for Patients With Relapsed/Refractory Acute Leukemia and Advanced Myelodysplastic Syndromes [NCT00005593] | Phase 1 | 31 participants (Actual) | Interventional | 1998-09-30 | 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 |
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) |
Transplantation of Unrelated Donor Hematopoietic Stem Cells for the Treatment of Hematological Malignancies [NCT00281879] | Phase 2 | 200 participants (Actual) | Interventional | 2006-02-28 | Terminated |
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 |
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 |
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 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 |
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 |
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 |
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 |
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 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 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 |
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 |
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 |
Phase 3 Multicenter Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. Therapy and Control Sub-groups in Older Patients With R/R AML [NCT03504410] | Phase 3 | 200 participants (Actual) | Interventional | 2018-11-12 | Terminated(stopped due to Futile) |
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) |
A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00004857] | Phase 2 | 86 participants (Actual) | Interventional | 2000-01-31 | Completed |
Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children [NCT00003729] | Phase 2 | 13 participants (Actual) | Interventional | 1998-12-31 | Terminated(stopped due to low accrual) |
Phase I/II Study of Induction of Stable Mixed Chimerism After Bone Marrow Transplantation From HLA-Identical Donors in Children With Sickle Cell Disease [NCT00004485] | Phase 1/Phase 2 | 50 participants | Interventional | 1999-12-31 | Completed |
Low-Dose TBI and Fludarabine Followed by Unrelated Donor Stem Cell Transplantation for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial [NCT00005799] | | 55 participants (Actual) | Interventional | 1999-11-30 | Completed |
A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation [NCT01408563] | Phase 2 | 33 participants (Actual) | Interventional | 2011-12-31 | Completed |
Phase 3 Randomized Trial of DFP-10917 vs Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, [NCT03926624] | Phase 3 | 450 participants (Anticipated) | Interventional | 2019-11-22 | Recruiting |
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 |
Multicenter Phase II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts After a Reduced Intensity Conditioning Regimen for Adult Patients With Acute Leukemia [NCT00961142] | Phase 2 | 23 participants (Actual) | Interventional | 2009-06-30 | Terminated(stopped due to slow recruitment) |
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 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 |
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) |
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 |
Reduced Toxicity Conditioning Prior to Unrelated Cord Cell Transplantation for High Risk Myeloid Malignancies [NCT02333838] | Phase 2 | 31 participants (Actual) | Interventional | 2015-05-31 | 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.) |
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 |
AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) [NCT01564784] | Phase 3 | 326 participants (Actual) | Interventional | 2012-08-02 | 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 Oxaliplatin, Fludarabine, and Cytarabine in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes at First Relapse With Complete Remission Duration < 1 Year [NCT00480987] | Phase 1/Phase 2 | 27 participants (Actual) | Interventional | 2007-07-31 | Terminated(stopped due to Lack of support.) |
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 |
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 |
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 |
Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes [NCT03235973] | Phase 1 | 29 participants (Anticipated) | Interventional | 2018-04-28 | Recruiting |
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 |
Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients: A Randomised, Placebo Controlled, Double Blind Phase II Trial: NMSG #13/03 [NCT00382694] | Phase 2 | 80 participants | Interventional | 2005-05-31 | Active, not 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.) |
A Randomized,Open,Multicenter and Prospective Study of the Optimized Dose of Anti-Thymoglobuline in Haploidentical Allogeneic Stem Cell Transplantation [NCT03190733] | Phase 4 | 192 participants (Anticipated) | Interventional | 2017-08-30 | 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 |
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, 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 |
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 |
Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations [NCT02400281] | Phase 1/Phase 2 | 28 participants (Actual) | Interventional | 2015-09-30 | Completed |
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 |
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 |
Epigenetic Reprogramming in Relapse AML: A Phase 1 Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults With Relapsed/Refractory AML [NCT02412475] | Phase 1 | 3 participants (Actual) | Interventional | 2015-02-21 | Terminated(stopped due to We opened a competing study with the TACL consortium) |
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies [NCT05084027] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-10-07 | 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 |
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.) |
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 Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndr [NCT03128034] | Phase 1/Phase 2 | 75 participants (Anticipated) | Interventional | 2017-10-24 | Suspended(stopped due to Administrative - FDA Comments) |
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 |
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 |
FLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine/Busulfan vs Fludarabine/Busulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation [NCT05917405] | Phase 2 | 302 participants (Anticipated) | Interventional | 2023-09-14 | 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 |
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.) |
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 |
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 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 I Study of Escalating Doses of Total Marrow and Lymphoid Irradiation (TMLI) Combined With Fludarabine and Melphalan as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Leukemia or Myelodysplastic Syndro [NCT03494569] | Phase 1 | 36 participants (Anticipated) | Interventional | 2018-07-06 | Recruiting |
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 |
A Phase III Intergroup CLL Study of Asymptomatic Patients With Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation With Later Treatment in the High Risk Genetic Subset With IGVH Unmutated Disease [NCT00513747] | Phase 3 | 84 participants (Actual) | Interventional | 2008-01-31 | Terminated(stopped due to Insufficient accrual) |
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 |
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) |
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.) |
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 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 |
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 |
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) |
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies [NCT01499147] | | 100 participants (Actual) | Interventional | 2000-02-29 | Completed |
Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients:a Single Arm, Open-labelled, Phase 2 Study [NCT03016988] | Phase 2 | 50 participants (Anticipated) | Interventional | 2017-01-31 | Not yet 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) |
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) IN PATIENTS WITH HIGH RISK HEMOGLOBINOPATHIES LIKE SICKLE CELL DISEASE AND β-THALESSEMIA-MAJOR USING REDUCED INTENSITY CONDITIONING REGIMEN [NCT02435901] | Phase 1/Phase 2 | 29 participants (Actual) | Interventional | 2008-12-31 | Completed |
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 1/2 Trial Evaluating Treatment of Emergent Graft Versus Host Disease (GvHD) With AP1903 After Planned Donor Infusions (DLIs) of T-cells Genetically Modified With the iCasp9 Suicide Gene in Patients With Hematologic Malignancies [NCT01875237] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2013-12-27 | Terminated |
Phase I Study of Escalating Doses of 90Y-DOTA-Anti-CD25 Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan, and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Trans [NCT05139004] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-07-19 | Recruiting |
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 |
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 |
Phase 2 Study of Planned Donor Lymphocyte Infusion After Reduced Intensity Allogeneic Stem Cell Transplantation [NCT01518153] | Phase 2 | 16 participants (Actual) | Interventional | 2012-02-29 | Terminated(stopped due to Objectives not met.) |
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 |
Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning for Patients With Chronic Lymphocytic Leukemia - A Multi-center Trial [NCT00060424] | Phase 2 | 21 participants (Actual) | Interventional | 2003-03-31 | Completed |
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.) |
Bone Marrow Transplantation for Non-Malignant Congenital Bone Marrow Failure Disorders [NCT00176878] | Phase 2/Phase 3 | 10 participants (Actual) | Interventional | 2000-06-30 | Completed |
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) |
Campath® [Alemtuzumab] Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class I Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies - A Multi-Center Trial [NCT00040846] | Phase 2 | 60 participants (Actual) | Interventional | 2001-11-30 | 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 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 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 |
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 |
A Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Pediatric and Adolescent-Young Adults Patients With High Risk Solid Tumors [NCT04530487] | Phase 2 | 40 participants (Anticipated) | Interventional | 2020-08-19 | Recruiting |
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 II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD in Children [NCT01858740] | Phase 2 | 20 participants (Actual) | Interventional | 2013-12-17 | Completed |
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) |
Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study) [NCT00121186] | Phase 2 | 1 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to poor accrual) |
S0125, A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study) [NCT00053014] | Phase 2 | 5 participants (Actual) | Interventional | 2003-04-30 | Terminated(stopped due to Poor accrual) |
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 |
A Phase I-II Study of Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Patients With Richter's Transformation, Prolymphocytic Leukemia or Refractory/Relapsed B-Cell Chronic Lymphocytic Leukemia [NCT00452374] | Phase 1/Phase 2 | 48 participants (Actual) | Interventional | 2004-11-30 | 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 |
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 |
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 |
A Phase II Randomized Study to Assess Outcomes With Treosulfan-Based Versus Clofarabine-Based Conditioning in Patients With Myelodysplastic Syndromes With Excess Blasts (MDS-EB), or Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Tra [NCT04994808] | Phase 2 | 80 participants (Anticipated) | Interventional | 2023-08-11 | Recruiting |
Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation [NCT02771197] | Phase 2 | 20 participants (Actual) | Interventional | 2016-09-28 | 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 |
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 |
"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 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 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 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 |
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 |
Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia [NCT00003816] | Phase 2/Phase 3 | 361 participants (Actual) | Interventional | 1998-10-19 | Completed |
A Clinical Study of Low-dose Total Body Irradiation and Fludarabine/Busulfan/Melphalan as a Conditioning Regimen for Secondary Umbilical Cord Blood Transplantation in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT [NCT06125483] | | 38 participants (Anticipated) | Interventional | 2023-11-01 | Recruiting |
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 |
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia [NCT01117441] | Phase 3 | 6,136 participants (Actual) | Interventional | 2010-06-30 | Completed |
Haploidentical Donor Hematopoietic Stem Cell Transplantation [NCT02660281] | Phase 1 | 74 participants (Actual) | Interventional | 2015-10-31 | Completed |
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 |
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 |
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 |
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 |
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 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 |
Haplocompatible Transplant Using TCRα/β Depletion Followed by CD45RA-Depleted Donor Lymphocyte Infusions for Severe Combined Immunodeficiency (SCID) [NCT03597594] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2021-09-02 | Active, not recruiting |
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 |
PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant [NCT01366612] | Phase 3 | 53 participants (Actual) | Interventional | 2010-06-16 | Terminated(stopped due to Lack of Accrual) |
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 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 |
Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features [NCT00462332] | Phase 2 | 86 participants (Actual) | Interventional | 2007-05-31 | Completed |
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 |
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) |
A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation [NCT01529827] | Phase 2 | 94 participants (Actual) | Interventional | 2012-02-28 | Completed |
In-Vivo Activated T-Cell Depletion to Prevent GVHD [NCT00594308] | | 10 participants (Actual) | Interventional | 2007-10-31 | Terminated(stopped due to Treatment ineffective) |
A Pilot Study of Reduced Intensity Conditioning in Pediatric Patients <21 Years of Age With Non-Malignant Disorders Undergoing Umbilical Cord Blood Transplantation [NCT00744692] | Phase 1 | 22 participants (Actual) | Interventional | 2008-10-31 | 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 Phase II Study to Assess Immunosuppression With Sirolimus Combined With Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) for Prevention of Acute GVHD After Non-Myeloablative HLA Class I or II Mismatched Donor Hematopoietic Cell Transplantation- A Mult [NCT01251575] | Phase 2 | 77 participants (Actual) | Interventional | 2010-12-01 | Completed |
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.) |
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 |
Dose-Intense Yttrium-90 Ibritumomab Tiuxetan (Zevalin)-Containing Non-Myeloablative Conditioning for Allogeneic Stem Cell Transplantation in B-cell Malignancies [NCT01490723] | Phase 2 | 20 participants (Actual) | Interventional | 2013-01-31 | Completed |
Natural Killer (NK) Cells and Nonmyeloablative Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML) [NCT01390402] | Phase 2 | 6 participants (Actual) | Interventional | 2012-01-31 | Completed |
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.) |
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.) |
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) |
Itacitinib to Prevent Graft Versus Host Disease [NCT04127721] | Phase 2 | 0 participants (Actual) | Interventional | 2020-09-22 | Withdrawn(stopped due to 0 ACTUAL Enrollment must have Overall Recruitment Status) |
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib [NCT01453101] | Phase 2 | 54 participants (Actual) | Interventional | 2010-06-09 | Completed |
Single Arm Phase II Study of Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia (ALL) in Older Patients Using Fludarabine and Total Body Irradiation (FluTBI) Regimen [NCT01991457] | Phase 2 | 19 participants (Actual) | Interventional | 2013-08-27 | 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 |
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 |
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 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 |
Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) and Peripheral Blood Stem Cells (PBSC) After a Myeloablative Conditioning Regimen, With Administration of Interleukin-2, in Patients With Advanced Malignancies [NCT03240861] | Phase 1 | 5 participants (Actual) | Interventional | 2017-07-26 | Terminated(stopped due to slow accrual) |
Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myelo [NCT03250338] | Phase 3 | 322 participants (Anticipated) | Interventional | 2018-06-05 | 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)) |
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 |
Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation [NCT02161783] | | 50 participants (Anticipated) | Observational | 2014-10-06 | Recruiting |
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 |
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 |
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 |
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.) |
Compassionate Use Re-Infusion of ATLCAR.CD30 [NCT03914885] | | 0 participants | Expanded Access | | No longer available |
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) |
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 |
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 |
A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies [NCT05417971] | | 20 participants (Anticipated) | Observational | 2022-08-29 | 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 |
Reduced-Intensity Fludarabine, Melphalan, and Total Body Irradiation Conditioning for Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies [NCT04191187] | Phase 2 | 37 participants (Anticipated) | Interventional | 2019-12-06 | Active, not recruiting |
Early HLA Matched Sibling Hematopoietic Stem Cell Transplantation for Children With Sickle Cell Disease: A Sickle Transplant Advocacy and Research Alliance (STAR) Trial [NCT04018937] | Phase 2 | 58 participants (Anticipated) | Interventional | 2019-03-22 | 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 |
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 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) |
A Phase 3, Open-Label, Multicenter, Randomized Study of SKLB1028 Versus Salvage Chemotherapy in Patients With FLT3-mutated Acute Myeloid Leukemia Refractory to or Relapsed After First-line Treatment(ALIVE) [NCT04716114] | Phase 3 | 315 participants (Anticipated) | Interventional | 2021-03-24 | 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 |
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 |
A Phase I/II Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation [NCT00245037] | Phase 1/Phase 2 | 147 participants (Actual) | Interventional | 2005-06-30 | Completed |
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 |
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 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 |
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 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 |
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 |
A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory AML [NCT03214562] | Phase 1/Phase 2 | 116 participants (Anticipated) | Interventional | 2017-09-26 | 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 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 |
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 |
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 |
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 |
A Pilot Study of Allogeneic Hematopoietic Cell Transplantation for Patients With High Grade Central Nervous System Malignancies [NCT04521946] | Phase 1 | 0 participants (Actual) | Interventional | 2021-01-14 | Withdrawn(stopped due to No participants enrolled.) |
A Pilot Study of Condensed Busulfan, Melphalan, and Fludarabine Conditioning Prior to Ex-vivo CD34+ Selected Allogeneic Hematopoietic Cell Transplantation [NCT04098393] | Phase 1 | 45 participants (Anticipated) | Interventional | 2019-09-18 | Recruiting |
Phase 1 A/B Study of LY2606368 in Combination With Cytarabine and Fludarabine in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HRMDS) [NCT02649764] | Phase 1 | 15 participants (Actual) | Interventional | 2016-05-04 | Completed |
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Immunologic or Histiocytic Disorders Using a Non-Myeloablative Preparative Regimen to Achieve Stable Mixed Chimerism [NCT00176865] | Phase 2 | 19 participants (Actual) | Interventional | 2002-08-31 | 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 |
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination Wi [NCT00112593] | | 5 participants (Actual) | Interventional | 1999-11-30 | 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 |
A Phase II Trial Combining Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine and Low Dose TBI Followed by Related or Unrelated PBSC Infusion and Post-Transplant Immunosuppression for Patients With Advanced AML or High Risk Myelodysplastic Syndrome [NCT00119366] | Phase 2 | 18 participants (Actual) | Interventional | 2003-05-31 | Terminated(stopped due to Funding ended before target accrual was reached; participants are no longer being examined or receiving intervention.) |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00001586 (2) [back to overview] | Change in Gene Expression Post Chemo |
NCT00001586 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00001832 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00001832 (2) [back to overview] | Clinical Response |
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 |
NCT00003659 (3) [back to overview] | Overall Survival Status |
NCT00003816 (4) [back to overview] | 4 yr OS |
NCT00003816 (4) [back to overview] | 4 Year PFS |
NCT00003816 (4) [back to overview] | Toxicity/TRM at Day 100 |
NCT00003816 (4) [back to overview] | CR Rate |
NCT00005803 (4) [back to overview] | Progression Free-survival (PFS) |
NCT00005803 (4) [back to overview] | Overall Survival (OS) |
NCT00005803 (4) [back to overview] | Non-Relapse Mortality |
NCT00005803 (4) [back to overview] | Engraftment of HLA Identical PBSC Allografts |
NCT00006184 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00006184 (2) [back to overview] | Immune Response |
NCT00027560 (6) [back to overview] | Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients |
NCT00027560 (6) [back to overview] | Extensive Chronic Graft-versus-Host Disease Matched Related Patients |
NCT00027560 (6) [back to overview] | Overall Survival |
NCT00027560 (6) [back to overview] | Overall Survival |
NCT00027560 (6) [back to overview] | Acute Graft-versus-Host Disease Matched Related Patients |
NCT00027560 (6) [back to overview] | Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients |
NCT00036738 (5) [back to overview] | Relapse Free Survival |
NCT00036738 (5) [back to overview] | Transplant-related Mortality |
NCT00036738 (5) [back to overview] | Overall Survival |
NCT00036738 (5) [back to overview] | Leukemia-free Survival |
NCT00036738 (5) [back to overview] | Transplant-related Mortality |
NCT00038857 (1) [back to overview] | Number of Participants With Absolute Neutrophil Count Engraftment |
NCT00040846 (5) [back to overview] | Evaluate the Risk for Disease Progression and Relapse |
NCT00040846 (5) [back to overview] | Evaluate the Risk of Transplant Related Mortality. |
NCT00040846 (5) [back to overview] | Evaluate the Risk/Incidence of Infections |
NCT00040846 (5) [back to overview] | Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. |
NCT00040846 (5) [back to overview] | Evaluate the Risk of Occurrence of Acute and Chronic GVHD |
NCT00043979 (14) [back to overview] | Number of Participants With Engraftment |
NCT00043979 (14) [back to overview] | Toxicity |
NCT00043979 (14) [back to overview] | Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin) |
NCT00043979 (14) [back to overview] | Median Survival From Date of Progression |
NCT00043979 (14) [back to overview] | Number of Participants to Complete Conversion to >95% Donor Chimerism |
NCT00043979 (14) [back to overview] | Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy |
NCT00043979 (14) [back to overview] | Median Time to Reach Absolute Neutrophil Count of 500/mm(3) |
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 With Acute and Chronic GVHD |
NCT00043979 (14) [back to overview] | Median Time to Reach a Platelet Count of 50,000/mm(3) |
NCT00043979 (14) [back to overview] | Median Progression Free Survival |
NCT00043979 (14) [back to overview] | Cluster of Differentiation 4 (CD4) Reconstitution |
NCT00043979 (14) [back to overview] | Number of Participants Who Experienced Graft Versus Tumor Effect (GVT) |
NCT00043979 (14) [back to overview] | Early Post Transplantation Relapse |
NCT00045435 (6) [back to overview] | Disease-free Survival-incidence of Survival Without Relapse |
NCT00045435 (6) [back to overview] | Incidence of Rejection |
NCT00045435 (6) [back to overview] | Incidence of Acute and Chronic GVHD |
NCT00045435 (6) [back to overview] | Overall Survival |
NCT00045435 (6) [back to overview] | Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death |
NCT00045435 (6) [back to overview] | Incidence of Relapse |
NCT00047060 (11) [back to overview] | Number of Participants Who Experienced Transplant Related Mortality |
NCT00047060 (11) [back to overview] | Number of Participants That Remained Disease-free |
NCT00047060 (11) [back to overview] | Number of Participants That Experienced Red Blood Cell Recovery |
NCT00047060 (11) [back to overview] | Efficacy of Nonmyeloablative Preparative Regimen |
NCT00047060 (11) [back to overview] | Number of Participants That Experienced Platelet Recovery |
NCT00047060 (11) [back to overview] | Number of Participants That Experienced Graft Failure |
NCT00047060 (11) [back to overview] | Number of Participants That Experienced Engraftment |
NCT00047060 (11) [back to overview] | Number of Participants Overall Survival |
NCT00047060 (11) [back to overview] | Number of Participants Who Experienced Acute GVHD Grades II-IV |
NCT00047060 (11) [back to overview] | Number of Participant Who Experienced Chronic Graft Versus Host Disease |
NCT00047060 (11) [back to overview] | Median Time in Months to Achieve Full Myeloid and Full Donor T-cell Chimerism |
NCT00048737 (1) [back to overview] | Number of Participants With Graft Failure |
NCT00048893 (1) [back to overview] | Number of Participants With Adverse Events |
NCT00049504 (3) [back to overview] | Donor Engraftment (Chimerism) |
NCT00049504 (3) [back to overview] | Non-relapse-related Mortality |
NCT00049504 (3) [back to overview] | Incidence of Grades III-IV Acute GVHD |
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] | Median Time to Neutrophil Recovery |
NCT00051311 (9) [back to overview] | Median Time to Platelet Recovery |
NCT00051311 (9) [back to overview] | Number of Recipients Evaluable Who Achieved Full Donor Chimerism at Day+100 |
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 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 |
NCT00051311 (9) [back to overview] | Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST) |
NCT00053014 (2) [back to overview] | Serious Adverse Events |
NCT00053014 (2) [back to overview] | Overall Survival |
NCT00053989 (4) [back to overview] | Acute GvHD |
NCT00053989 (4) [back to overview] | OS |
NCT00053989 (4) [back to overview] | PFS |
NCT00053989 (4) [back to overview] | Day 100 TRM |
NCT00054353 (8) [back to overview] | PFS |
NCT00054353 (8) [back to overview] | Relapse Rate |
NCT00054353 (8) [back to overview] | Response Rate |
NCT00054353 (8) [back to overview] | Engraftment |
NCT00054353 (8) [back to overview] | Incidence of Acute GVHD (Grades III-IV) |
NCT00054353 (8) [back to overview] | OS |
NCT00054353 (8) [back to overview] | Non-relapse Mortality |
NCT00054353 (8) [back to overview] | Incidence of Chronic (Extensive) GVHD |
NCT00058825 (9) [back to overview] | Median Time to Engraftment With the Isolex/CLINIMACs System |
NCT00058825 (9) [back to overview] | 2-year Overall Survival |
NCT00058825 (9) [back to overview] | Donor Chimerism Engraftment of Greater Than 50% |
NCT00058825 (9) [back to overview] | Transplant Related Mortality (TRM) |
NCT00058825 (9) [back to overview] | Number of Patients Who Engrafted With the Isolex/CLINIMACs System |
NCT00058825 (9) [back to overview] | Time in Days to ANC Engraftment |
NCT00058825 (9) [back to overview] | Acute Graft Versus Host Disease |
NCT00058825 (9) [back to overview] | Chronic Graft Versus Host Disease |
NCT00058825 (9) [back to overview] | 2-year Relapse-free Survival |
NCT00060424 (5) [back to overview] | Transplant-related Mortality |
NCT00060424 (5) [back to overview] | Rate of Relapse |
NCT00060424 (5) [back to overview] | Acute Grade II-IV GVHD and Chronic (Extensive) GVHD |
NCT00060424 (5) [back to overview] | Rate and Types of Infections |
NCT00060424 (5) [back to overview] | Overall Survival |
NCT00067002 (5) [back to overview] | Number of Participants Severity of Acute GVHD by Treatment Arm |
NCT00067002 (5) [back to overview] | Rate of Chronic GVHD |
NCT00067002 (5) [back to overview] | Number of Participants With Engraftment |
NCT00067002 (5) [back to overview] | Rate of Acute Graft Versus Host Disease (GVHD) |
NCT00067002 (5) [back to overview] | Time To Neutrophil Engraftment |
NCT00070135 (3) [back to overview] | Non-relapse Mortality (NRM) |
NCT00070135 (3) [back to overview] | 2 Year Disease Free Survival In Unrelated Donor Recipient Group |
NCT00070135 (3) [back to overview] | 2 Year DFS for All Patients |
NCT00074269 (7) [back to overview] | Response as Measured at 12 Months Post Allografting |
NCT00074269 (7) [back to overview] | Progression-free Survival |
NCT00074269 (7) [back to overview] | Overall Survival |
NCT00074269 (7) [back to overview] | Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes |
NCT00074269 (7) [back to overview] | Number of Participants With Adverse Events |
NCT00074269 (7) [back to overview] | Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD) |
NCT00074269 (7) [back to overview] | Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting |
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] | Percentage of Patients to Receive T Cell Infusion |
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) |
NCT00075478 (8) [back to overview] | Incidence of Graft Rejection |
NCT00075478 (8) [back to overview] | Incidence of Relapse-related Mortality |
NCT00075478 (8) [back to overview] | Incidence of Relapse/Progression |
NCT00075478 (8) [back to overview] | Incidence of Non-relapse Mortality |
NCT00075478 (8) [back to overview] | Incidence of Grades II-IV Acute GVHD |
NCT00075478 (8) [back to overview] | Incidence of Chronic Extensive GVHD |
NCT00075478 (8) [back to overview] | Progression-free Survival |
NCT00075478 (8) [back to overview] | Overall Survival |
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] | Cluster of Differentiation 3 (CD3) + Cells |
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] | Natural Killer Cells |
NCT00076752 (16) [back to overview] | Platelet Count |
NCT00076752 (16) [back to overview] | Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) |
NCT00076752 (16) [back to overview] | Number of Participants With Adverse Events |
NCT00076752 (16) [back to overview] | White Blood Cells |
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 |
NCT00085423 (3) [back to overview] | Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST |
NCT00085423 (3) [back to overview] | Number of Participants With Lymphocyte Recovery as Measured by Blood Count |
NCT00085423 (3) [back to overview] | Time to Progression as Measured by RECIST |
NCT00086580 (20) [back to overview] | Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment |
NCT00086580 (20) [back to overview] | Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) |
NCT00086580 (20) [back to overview] | Total Volume of Distribution (Vss) of Fludarabine |
NCT00086580 (20) [back to overview] | Participants With Minimal Residual Disease (MRD) |
NCT00086580 (20) [back to overview] | Mean Systemic Clearance (CL) of Fludarabine |
NCT00086580 (20) [back to overview] | Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment |
NCT00086580 (20) [back to overview] | Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline |
NCT00086580 (20) [back to overview] | Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau) |
NCT00086580 (20) [back to overview] | Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline |
NCT00086580 (20) [back to overview] | Maximum Plasma Concentration (Cmax) of Fludarabine |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates of Overall Survival Time |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates for Time to Alternative Therapy |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP) |
NCT00086580 (20) [back to overview] | Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP) |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV |
NCT00086580 (20) [back to overview] | Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II |
NCT00086580 (20) [back to overview] | Summary of Participants With Adverse Experiences (AEs) |
NCT00089011 (8) [back to overview] | Incidences of Grades II-IV Acute GVHD |
NCT00089011 (8) [back to overview] | Incidence of Grade III/IV GVHD |
NCT00089011 (8) [back to overview] | Incidences of Graft Rejection |
NCT00089011 (8) [back to overview] | Overall Survival |
NCT00089011 (8) [back to overview] | Incidence of Chronic Extensive GVHD |
NCT00089011 (8) [back to overview] | Rates of Relapse-related Mortality |
NCT00089011 (8) [back to overview] | Rates of Disease Progression |
NCT00089011 (8) [back to overview] | Rate and Duration of Steroid Use for the Treatment of Chronic GVHD |
NCT00090051 (15) [back to overview] | Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment |
NCT00090051 (15) [back to overview] | Final Analysis: Time to Overall Survival Event |
NCT00090051 (15) [back to overview] | Final Analysis: Percentage of Participants With Complete Response |
NCT00090051 (15) [back to overview] | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) |
NCT00090051 (15) [back to overview] | Number of Participants With Disease-free Survival (DFS) Events |
NCT00090051 (15) [back to overview] | Number of Participants With Event-free Survival (EFS) Events |
NCT00090051 (15) [back to overview] | Number of Participants With Overall Survival (OS) Events |
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: Time to Disease-Free Survival Event |
NCT00090051 (15) [back to overview] | Overall Survival (OS) |
NCT00090051 (15) [back to overview] | Disease-free Survival (DFS) |
NCT00090051 (15) [back to overview] | Final Analysis: Time to Progression-Free Survival Event |
NCT00090051 (15) [back to overview] | Final Analysis: Duration of Response |
NCT00090051 (15) [back to overview] | Final Analysis: Time to Event-Free Survival Event |
NCT00090051 (15) [back to overview] | Event-free Survival (EFS) |
NCT00096018 (2) [back to overview] | Duration of Response |
NCT00096018 (2) [back to overview] | Overall Responders (Complete and Partial Response) |
NCT00096382 (2) [back to overview] | Clinical Tumor Regression |
NCT00096382 (2) [back to overview] | Safety |
NCT00096460 (1) [back to overview] | Lymphoma Progression-free Survival |
NCT00098670 (5) [back to overview] | Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab |
NCT00098670 (5) [back to overview] | Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab |
NCT00098670 (5) [back to overview] | 2 Year Survival |
NCT00098670 (5) [back to overview] | 2 Year Progression Free Survival |
NCT00098670 (5) [back to overview] | Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab |
NCT00104858 (8) [back to overview] | Number of Participants With Regimen-related Toxicity and Infections |
NCT00104858 (8) [back to overview] | Number of Participants With Grade II-III and III-IV Acute GVHD and Chronic GVHD |
NCT00104858 (8) [back to overview] | Rituxan Concentration |
NCT00104858 (8) [back to overview] | Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse |
NCT00104858 (8) [back to overview] | Overall Survival |
NCT00104858 (8) [back to overview] | Number of Patients Achieving Complete Response and Partial Response (Overall Response Rate) |
NCT00104858 (8) [back to overview] | Number of Participants With Treatment-related Mortality |
NCT00104858 (8) [back to overview] | Number of Participants With Relapse/Progression |
NCT00105001 (5) [back to overview] | Number of Participants Surviving Without Progression |
NCT00105001 (5) [back to overview] | Number of Participants Utilizing High-Dose Corticosteroids |
NCT00105001 (5) [back to overview] | Number of Non-Relapse Mortalities |
NCT00105001 (5) [back to overview] | Number of Participants Surviving Overall |
NCT00105001 (5) [back to overview] | Number of Participants With Grades II-IV Acute GVHD |
NCT00112593 (6) [back to overview] | Progression of HIV |
NCT00112593 (6) [back to overview] | Death From Regimen Toxicity or Opportunistic Infection |
NCT00112593 (6) [back to overview] | Death From GVHD |
NCT00112593 (6) [back to overview] | Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin |
NCT00112593 (6) [back to overview] | Reconstitution of HIV-specific Immunity |
NCT00112593 (6) [back to overview] | Overall Survival |
NCT00117156 (5) [back to overview] | Delayed Pneumonia Toxicity Rate |
NCT00117156 (5) [back to overview] | Objective Response Rate |
NCT00117156 (5) [back to overview] | Delayed Bone Marrow Toxicity Rate |
NCT00117156 (5) [back to overview] | 3.1-Year Progression-Free Survival |
NCT00117156 (5) [back to overview] | 3.1-Year Overall Survival |
NCT00118352 (6) [back to overview] | Incidence of Non-relapse Mortality |
NCT00118352 (6) [back to overview] | Disease Progression/Relapse |
NCT00118352 (6) [back to overview] | Incidence of Infection |
NCT00118352 (6) [back to overview] | Incidence of Grade III-IV Acute GVHD |
NCT00118352 (6) [back to overview] | Incidence of High-dose Corticosteroid Utilization. |
NCT00118352 (6) [back to overview] | Incidence of Graft Rejection |
NCT00119366 (3) [back to overview] | Participant Disease Response Within 4 Weeks After Transplant |
NCT00119366 (3) [back to overview] | Number of Participants With 100% Donor Chimerism at Day 28 and Day 84 |
NCT00119366 (3) [back to overview] | Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen |
NCT00119392 (5) [back to overview] | Overall and Progression-free Survival |
NCT00119392 (5) [back to overview] | Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD. |
NCT00119392 (5) [back to overview] | Engraftment and Hematopoietic Toxicity |
NCT00119392 (5) [back to overview] | Treatment Related Mortality (TRM) |
NCT00119392 (5) [back to overview] | Response Rates |
NCT00121186 (2) [back to overview] | Overall Survival |
NCT00121186 (2) [back to overview] | Progression-free Survival |
NCT00134004 (5) [back to overview] | Progression-free Survival |
NCT00134004 (5) [back to overview] | Graft Failure Rate |
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] | Relapse Rate |
NCT00134004 (5) [back to overview] | Transplant-related Mortality |
NCT00145626 (13) [back to overview] | Number of Transplant-Related Adverse Outcomes: Engraftment Failure |
NCT00145626 (13) [back to overview] | Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation |
NCT00145626 (13) [back to overview] | Kinetics of Lymphohematopoietic Reconstitution |
NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Minimal Residual Disease (MRD) |
NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Median Dose of NK Cells |
NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Donor Type |
NCT00145626 (13) [back to overview] | Factors Affecting One-year Survival: Disease Status at HSCT |
NCT00145626 (13) [back to overview] | One-year Survival |
NCT00145626 (13) [back to overview] | Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality |
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 Age of Donor at HSCT |
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: Match N/6 HLA Loci |
NCT00153985 (3) [back to overview] | The Incidence of Grade II-IV Acute Graft vs. Host Disease. |
NCT00153985 (3) [back to overview] | Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy. |
NCT00153985 (3) [back to overview] | Solid Organ Toxicity Related to the Conditioning Regimen. |
NCT00167206 (9) [back to overview] | Immune Reconstitution - Mean Value (1 Year) |
NCT00167206 (9) [back to overview] | Number of Patients Who Exhibited Regimen-related Toxicity (RRT) |
NCT00167206 (9) [back to overview] | Number of Patients Who Exhibited Secondary Graft Failure |
NCT00167206 (9) [back to overview] | Number of Patients With Acute Graft Versus-Host Disease (aGVHD) |
NCT00167206 (9) [back to overview] | Number of Patients With Chronic Graft Versus-Host Disease (GVHD) |
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] | Number of Patients Alive at 2 Years |
NCT00167206 (9) [back to overview] | Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment |
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 Chronic Graft Versus Host Disease (Chronic GVHD) |
NCT00176852 (15) [back to overview] | The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD) |
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] | Number of Patients Who Experienced Grade 3-5 Treatment Related Toxicity |
NCT00176852 (15) [back to overview] | Overall 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] | The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD) |
NCT00176852 (15) [back to overview] | The Incidence of Chimerism at 1 Year |
NCT00176852 (15) [back to overview] | Overall Survival |
NCT00176852 (15) [back to overview] | The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD) |
NCT00176852 (15) [back to overview] | Disease Free Survival |
NCT00176852 (15) [back to overview] | The Incidence of Chimerism at 100 Days |
NCT00176865 (9) [back to overview] | Percentage of Donor Chimerism at 100 Days |
NCT00176865 (9) [back to overview] | Number of Subjects With Mixed Chimerism |
NCT00176865 (9) [back to overview] | Incidence of Chronic Graft Versus Host Disease (cGVHD) |
NCT00176865 (9) [back to overview] | Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD) |
NCT00176865 (9) [back to overview] | Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD) |
NCT00176865 (9) [back to overview] | Number of Subjects Alive at One Year |
NCT00176865 (9) [back to overview] | Number of Subjects Alive at 100 Days |
NCT00176865 (9) [back to overview] | Percentage of Donor Chimerism at 365 Days |
NCT00176865 (9) [back to overview] | Percentage of Donor Chimerism at 180 Days |
NCT00176878 (6) [back to overview] | Number of Patients With Disease Recurrence |
NCT00176878 (6) [back to overview] | Number of Patients With Grade 2-4 Acute Graft Versus Host Disease |
NCT00176878 (6) [back to overview] | Number of Patients With Succcessful Engraftment After Transplantation |
NCT00176878 (6) [back to overview] | Number of Patients Alive at Three Years (Survival) |
NCT00176878 (6) [back to overview] | Number of Patients With Chronic Graft Versus Host Disease |
NCT00176878 (6) [back to overview] | Number of Patients Alive (Survival) at 2 Years |
NCT00187096 (10) [back to overview] | Duration of Engraftment of Natural Killer (NK) Cells |
NCT00187096 (10) [back to overview] | Overall Survival |
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] | Percent of Peak NK Cell Chimerism |
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] | Relapse-free Survival |
NCT00187096 (10) [back to overview] | Number of KIR-mismatched NK Cells |
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 Detectable Donor NK Cells at Day 28 |
NCT00187096 (10) [back to overview] | Day That Maximum NK Cell Engraftment Was Reached |
NCT00206726 (6) [back to overview] | Percentage of Participants With Overall Response at Different Observation Times |
NCT00206726 (6) [back to overview] | Complete Response (CR) |
NCT00206726 (6) [back to overview] | Overall Survival (OS) |
NCT00206726 (6) [back to overview] | Overall Response (OR) |
NCT00206726 (6) [back to overview] | Progression-free Survival (PFS) |
NCT00206726 (6) [back to overview] | Number of Participants With Minimal Residual Disease (MRD) |
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. |
NCT00230282 (2) [back to overview] | Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR) |
NCT00230282 (2) [back to overview] | Duration of Response |
NCT00245037 (7) [back to overview] | Progression-Free Survival |
NCT00245037 (7) [back to overview] | Acute Graft-Versus-Host Disease (aGVHD) Outcome |
NCT00245037 (7) [back to overview] | Chronic Graft-Versus-Host Disease (cGVHD) Outcome |
NCT00245037 (7) [back to overview] | Non-relapse Mortality |
NCT00245037 (7) [back to overview] | Overall Survival |
NCT00245037 (7) [back to overview] | Relapse Mortality |
NCT00245037 (7) [back to overview] | Regimen-Related Toxicities |
NCT00253513 (4) [back to overview] | Number of Patients Experiencing Regimen-related Toxicity Events in Study Population |
NCT00253513 (4) [back to overview] | Number of Patients Experiencing Graft Failure |
NCT00253513 (4) [back to overview] | Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival. |
NCT00253513 (4) [back to overview] | Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only) |
NCT00254163 (9) [back to overview] | Infective Event Rate |
NCT00254163 (9) [back to overview] | Hematologic Recovery |
NCT00254163 (9) [back to overview] | Infection Rate |
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 |
NCT00254163 (9) [back to overview] | Progression-free Survival (PFS) Rate at 2-year |
NCT00254163 (9) [back to overview] | Complete Remission (CR) |
NCT00254410 (4) [back to overview] | Clinical Response Rate at 6 Months |
NCT00254410 (4) [back to overview] | Clinical Response Rate at 3 Months |
NCT00254410 (4) [back to overview] | Molecular Response Rate at 3 Months |
NCT00254410 (4) [back to overview] | Molecular Response Rate at 6 Months |
NCT00255684 (2) [back to overview] | Number of Participants Who Survived 100 Days or Longer |
NCT00255684 (2) [back to overview] | Number of Participants Who Developed Acute Graft Versus Host Disease |
NCT00258427 (8) [back to overview] | Number of Participants Experiencing Major Infections |
NCT00258427 (8) [back to overview] | Number of Participants Experiencing Acute Graft-Versus-Host Disease |
NCT00258427 (8) [back to overview] | Number of Participants Experiencing Acute 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 Chronic Graft-Versus-Host Disease |
NCT00258427 (8) [back to overview] | Number of Participants Experiencing Graft Failure |
NCT00258427 (8) [back to overview] | Number of Participants Experiencing Overall Survival |
NCT00258427 (8) [back to overview] | Number of Participants Experiencing Relapse |
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 Natural Killer (NK) Cell Expansion |
NCT00274846 (4) [back to overview] | Number of Patients With Complete Remission |
NCT00278512 (1) [back to overview] | Survival |
NCT00280241 (4) [back to overview] | Overall Survival Rate |
NCT00280241 (4) [back to overview] | Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL |
NCT00280241 (4) [back to overview] | Duration of Response |
NCT00280241 (4) [back to overview] | Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL |
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] | Event-free Survival (EFS) |
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] | Overall Survival (OS) |
NCT00281918 (11) [back to overview] | Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response |
NCT00281918 (11) [back to overview] | Final Analysis: Time to Event-free Survival Event |
NCT00281918 (11) [back to overview] | Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL) |
NCT00281918 (11) [back to overview] | Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). |
NCT00281918 (11) [back to overview] | Progression-free Survival (PFS) |
NCT00282282 (3) [back to overview] | Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation |
NCT00282282 (3) [back to overview] | Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus. |
NCT00282282 (3) [back to overview] | Disease Response. |
NCT00282412 (1) [back to overview] | Survival |
NCT00290511 (7) [back to overview] | Median Progression Free Survival |
NCT00290511 (7) [back to overview] | Overall Survival |
NCT00290511 (7) [back to overview] | Percentage of Participants With Overall Survival Rate at 10 Years |
NCT00290511 (7) [back to overview] | Number of Participants With Time to Progression (TTP) |
NCT00290511 (7) [back to overview] | Tolerance and Efficacy of Maintenance Therapy With Rituximab |
NCT00290511 (7) [back to overview] | Tolerance and Efficacy of Maintenance Therapy With Yttrium-90 Ibritumomab Tiuxetan (YIT) |
NCT00290511 (7) [back to overview] | Progression Free Survival at 10 Years |
NCT00301834 (5) [back to overview] | Disease-free Survival With Correction of Disease at One Year Post Transplantation |
NCT00301834 (5) [back to overview] | Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation |
NCT00301834 (5) [back to overview] | Cytomegalovirus (CMV) Viral Infection and Disease Symptoms |
NCT00301834 (5) [back to overview] | Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation |
NCT00301834 (5) [back to overview] | Treatment-related Mortality at 100 Days and 1 Year Post Transplantation |
NCT00303667 (9) [back to overview] | Number of Patients With Treatment-Related Mortality |
NCT00303667 (9) [back to overview] | Number of Patients With Graft Failure |
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] | In Vivo Expansion of a Donor NK Cells NK Cell Product |
NCT00303667 (9) [back to overview] | Incidence of Chronic Graft Versus Host Disease |
NCT00303667 (9) [back to overview] | Incidence of Grade III-IV Acute Graft Versus Host Disease |
NCT00303667 (9) [back to overview] | Incidence of Post-transplant Lymphoproliferative Disorder (PTLD) |
NCT00303667 (9) [back to overview] | Number of Patients With Disease Relapse |
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] | Transplant Related Mortality |
NCT00303719 (5) [back to overview] | Serious Adverse Events |
NCT00305682 (15) [back to overview] | Number of Participants With Chronic Graft-Versus-Host Disease |
NCT00305682 (15) [back to overview] | Number of Participants Experiencing Relapse (Incidence of Relapse) |
NCT00305682 (15) [back to overview] | Number of Participants Experiencing Relapse (Incidence of Relapse) at 2 Years |
NCT00305682 (15) [back to overview] | Number of Participants Who Were Alive at 1 Year Post Transplant |
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 With Acute Graft-versus-host Disease (GVHD) |
NCT00305682 (15) [back to overview] | Number of Participants Who Were Alive at 2 Years Post Transplant |
NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 180 Days |
NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 21 Days |
NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 365 Days |
NCT00305682 (15) [back to overview] | Number of Participants Experiencing Progression-free Survival |
NCT00305682 (15) [back to overview] | Number of Participants Experiencing Progression-free Survival at 2 Years |
NCT00305682 (15) [back to overview] | Number of Participants With Neutrophil Engraftment |
NCT00305682 (15) [back to overview] | Number of Participants With Platelet Engraftment |
NCT00305682 (15) [back to overview] | Percentage of Donor Chimerism at 100 Days |
NCT00309842 (11) [back to overview] | Number of Participants With Neutrophil Engraftment |
NCT00309842 (11) [back to overview] | Number of Participants With Chronic Graft-Versus-Host Disease |
NCT00309842 (11) [back to overview] | Number of Participants Who Were Alive at 1 Year Transplant Overall Survival |
NCT00309842 (11) [back to overview] | Number of Participants Who Died Due to Transplant |
NCT00309842 (11) [back to overview] | Number of Participants With Platelet Engraftment |
NCT00309842 (11) [back to overview] | Percentage Chimerism at 1 Year |
NCT00309842 (11) [back to overview] | Number of Participants With Acute Graft-Versus-Host Disease |
NCT00309842 (11) [back to overview] | Percentage Chimerism on Day 21 |
NCT00309842 (11) [back to overview] | Percentage Chimerism on Day 100 |
NCT00309842 (11) [back to overview] | Percentage Chimerism at 6 Months |
NCT00309842 (11) [back to overview] | Percentage Chimerism at 2 Years |
NCT00314106 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00314106 (2) [back to overview] | Complete Response |
NCT00322101 (6) [back to overview] | Incidence and Severity of Acute and Chronic Graft-vs-host Disease |
NCT00322101 (6) [back to overview] | Progression-free Survival |
NCT00322101 (6) [back to overview] | Non-relapse Mortality |
NCT00322101 (6) [back to overview] | Donor Cell Engraftment |
NCT00322101 (6) [back to overview] | Overall Survival |
NCT00322101 (6) [back to overview] | Incidence of Disease Progression/Relapse |
NCT00326417 (5) [back to overview] | Chronic GVHD |
NCT00326417 (5) [back to overview] | Overall Survival (OS) |
NCT00326417 (5) [back to overview] | Disease-free Survival (DFS) |
NCT00326417 (5) [back to overview] | Cumulative Incidence of Graft Failure |
NCT00326417 (5) [back to overview] | Acute Graft vs Host Disease (GVHD) |
NCT00328861 (2) [back to overview] | Safety |
NCT00328861 (2) [back to overview] | Objective Response |
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 IgG Levels as a Measure of Immune Reconstitution After Transplant by 365 Days |
NCT00352976 (18) [back to overview] | Number of Participants With Secondary Graft Failure at 100 Days |
NCT00352976 (18) [back to overview] | Number of Participant With Neutrophil Recovery |
NCT00352976 (18) [back to overview] | Number of Participants Experiencing Overall Survival |
NCT00352976 (18) [back to overview] | Number of Participants Experiencing Infections by Day 365 |
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 180 Days |
NCT00352976 (18) [back to overview] | Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 100 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 Experiencing Infections by Day 180 |
NCT00352976 (18) [back to overview] | Number of Participants Experiencing Infections by Day 100 |
NCT00352976 (18) [back to overview] | Number of Participants Experiencing Grade ≥3 Regimen Related Toxicity |
NCT00352976 (18) [back to overview] | Number of Participants Experiencing Chronic GVHD |
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] | Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD) |
NCT00352976 (18) [back to overview] | Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 100 Days |
NCT00352976 (18) [back to overview] | Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 180 Days |
NCT00354172 (15) [back to overview] | Chimerism After Double Umbilical Cord Blood Transplant (UCBT) |
NCT00354172 (15) [back to overview] | Number of Participants (Patients) Who Died Due to Transplant. |
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 Experienced Relapse by 12 Months |
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 Acute Graft-versus-Host Disease at Grade III-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 |
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] | 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] | Graft Rejection |
NCT00358657 (9) [back to overview] | Immune Reconstitution |
NCT00358657 (9) [back to overview] | Graft Failure |
NCT00358657 (9) [back to overview] | Incidence of Grade III/IV Acute Graft Versus Host Disease (GVHD) |
NCT00361140 (2) [back to overview] | Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS) |
NCT00361140 (2) [back to overview] | Non-relapse Mortality |
NCT00376805 (4) [back to overview] | Overall Median Number of Days Patients Alive After Treatment |
NCT00376805 (4) [back to overview] | Number of Patients Who Had Expansion of Natural Killer Cells |
NCT00376805 (4) [back to overview] | Number of Patients by Disease Response |
NCT00376805 (4) [back to overview] | Number of Patients Who Died While on Study |
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 Who Developed Limited Chronic GVHD |
NCT00378534 (5) [back to overview] | Number of Participants With Relapse of Disease |
NCT00378534 (5) [back to overview] | Number of Participants Who Develop Extensive GVHD |
NCT00378534 (5) [back to overview] | Number of Participants Who Developed Acute GVHD Grades I, II, III, IV |
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. |
NCT00381004 (3) [back to overview] | Number of Participants Progression-free |
NCT00381550 (2) [back to overview] | Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0 |
NCT00381550 (2) [back to overview] | Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation |
NCT00385788 (1) [back to overview] | Transplant Related Mortality Rate |
NCT00387959 (1) [back to overview] | Survival at 1 Year After Transplantation |
NCT00392782 (7) [back to overview] | Incidence of Chronic Graft-versus-host Disease (GVHD) |
NCT00392782 (7) [back to overview] | Incidence of Disease Relapse |
NCT00392782 (7) [back to overview] | Incidence of Disease-free Survival |
NCT00392782 (7) [back to overview] | Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD) |
NCT00392782 (7) [back to overview] | Incidence of Graft Failure |
NCT00392782 (7) [back to overview] | Overall Survival |
NCT00392782 (7) [back to overview] | Transplant-related Mortality |
NCT00393029 (3) [back to overview] | Clinical Tumor Regression |
NCT00393029 (3) [back to overview] | In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants |
NCT00393029 (3) [back to overview] | The Number of Participants With Adverse Events |
NCT00397813 (5) [back to overview] | Number of Patients Who Engrafted |
NCT00397813 (5) [back to overview] | Number of Patients Who Had Infections |
NCT00397813 (5) [back to overview] | Number of Patients With HCT Failure. |
NCT00397813 (5) [back to overview] | Number of Patients With Relapse/Progression |
NCT00397813 (5) [back to overview] | Number of Patients With Progression-free Survival |
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] | Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4) |
NCT00410163 (18) [back to overview] | Progression-Free Survival |
NCT00410163 (18) [back to overview] | Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death |
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] | 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] | Number of Participants (Par.) Who Were Classified as Responders and Non-responders |
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] | CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20) |
NCT00410163 (18) [back to overview] | Duration of Response |
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] | 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 (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion |
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 Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60) |
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] | Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia) |
NCT00410163 (18) [back to overview] | Number of Participants With Progression or Death |
NCT00412360 (9) [back to overview] | Percentage of Participants With Treatment-related Mortality |
NCT00412360 (9) [back to overview] | Percentage of Participants With Acute Graft-versus-host Disease (GVHD) |
NCT00412360 (9) [back to overview] | Percentage of Participants With Chronic GVHD |
NCT00412360 (9) [back to overview] | Percentage of Participants With Neutrophil and Platelet Engraftment |
NCT00412360 (9) [back to overview] | Time to Neutrophil and Platelet Engraftment |
NCT00412360 (9) [back to overview] | Percentage of Participants With Disease-free Survival |
NCT00412360 (9) [back to overview] | Number of Participants With Engraftment Syndrome |
NCT00412360 (9) [back to overview] | Percentage of Participants With Overall Survival |
NCT00412360 (9) [back to overview] | Percentage of Participants With Relapse |
NCT00416884 (1) [back to overview] | Number of Participants With Treatment-related Mortality |
NCT00425802 (8) [back to overview] | Incidence of Chronic GVHD 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] | Overall Survival at 1 Year |
NCT00425802 (8) [back to overview] | Time to Neutrophil Engraftment |
NCT00425802 (8) [back to overview] | Immune Reconstruction/CD4+ Count at 3 Months |
NCT00425802 (8) [back to overview] | Time to Platelet Engraftment |
NCT00425802 (8) [back to overview] | Immune Reconstruction/CD4+ Count at 6 Months |
NCT00425802 (8) [back to overview] | Immune Reconstruction/CD4+ Count at 1 Year |
NCT00427336 (1) [back to overview] | Number of Patients With Engraftment Response |
NCT00427557 (1) [back to overview] | Number of Participants With Engraftment |
NCT00427661 (3) [back to overview] | Engraftment at 1 Year Post BMT. |
NCT00427661 (3) [back to overview] | Development of GVHD Within 1 Year of BMT |
NCT00427661 (3) [back to overview] | Incidence of Grade 2-4 Acute GVHD. |
NCT00429416 (5) [back to overview] | Number of Patients Who Achieve a CD4 Count > 200/Micro-liters |
NCT00429416 (5) [back to overview] | Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD) |
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] | Rate of Serious Infectious Complications |
NCT00429416 (5) [back to overview] | Rate of Engraftment of Non-Myeloablative Transplants |
NCT00429572 (5) [back to overview] | Grade II-IV Toxicity |
NCT00429572 (5) [back to overview] | Time to Progressive Disease |
NCT00429572 (5) [back to overview] | Overall Survival |
NCT00429572 (5) [back to overview] | Number of Participants With Tumor Response |
NCT00429572 (5) [back to overview] | Number of Participants With Acute or Chronic GVHD And Response to Therapy |
NCT00448019 (3) [back to overview] | Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL |
NCT00448019 (3) [back to overview] | Progression Free Survival (PFS) Rate |
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) |
NCT00448201 (4) [back to overview] | Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant |
NCT00448201 (4) [back to overview] | Graft-vs-host Disease at 6 Months Post-transplant |
NCT00448201 (4) [back to overview] | Treatment-related Mortality |
NCT00448201 (4) [back to overview] | 5-year Disease-free Survival |
NCT00448357 (6) [back to overview] | Incidence of DNA Chimerism in Patients Between One Month Post Transplant |
NCT00448357 (6) [back to overview] | Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912) |
NCT00448357 (6) [back to overview] | Overall Survival |
NCT00448357 (6) [back to overview] | Number of Participants With Dose Limiting Toxicities (DLTs) |
NCT00448357 (6) [back to overview] | Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen |
NCT00448357 (6) [back to overview] | Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant |
NCT00450983 (4) [back to overview] | Risk for Graft Failure |
NCT00450983 (4) [back to overview] | Risk for Mortality From Infection Before Day 180 |
NCT00450983 (4) [back to overview] | Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD) |
NCT00450983 (4) [back to overview] | Risk for Life-threatening Infections |
NCT00452374 (2) [back to overview] | Number of Participants With a Complete Response or Partial Response |
NCT00452374 (2) [back to overview] | Maximum Tolerated Dose (MTD) Oxaliplatin |
NCT00453388 (4) [back to overview] | Number of Patients Who Engraft at Each Dose of TBI Used |
NCT00453388 (4) [back to overview] | Incidence of Transplant-related Mortality |
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] | Overall Survival |
NCT00455312 (10) [back to overview] | Overall Survival |
NCT00455312 (10) [back to overview] | Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD) |
NCT00455312 (10) [back to overview] | Incidence of Chronic GVHD |
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 Late Secondary Malignancies |
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] | Incidence of Pulmonary Complications |
NCT00462332 (2) [back to overview] | Length of Survival |
NCT00462332 (2) [back to overview] | Number of Patients With Complete Response |
NCT00469014 (1) [back to overview] | Treatment Related Mortality |
NCT00469144 (2) [back to overview] | 3 Year Progression Free Survival |
NCT00469144 (2) [back to overview] | Treatment-related Mortality (TRM) |
NCT00472849 (2) [back to overview] | Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days) |
NCT00472849 (2) [back to overview] | Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission |
NCT00475020 (2) [back to overview] | Rate of Non-relapse Mortality at 100 Days Post-transplant |
NCT00475020 (2) [back to overview] | Efficacy of This Therapy 3 Years Post-transplant |
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 Donor Derived Cells in Skin |
NCT00478244 (10) [back to overview] | Number of Patients With Neutrophil Engraftment |
NCT00478244 (10) [back to overview] | Number of Patients With Platelet Engraftment |
NCT00478244 (10) [back to overview] | Number of Patients With Resistance to Blister Formation |
NCT00478244 (10) [back to overview] | Number of Patients With Transplant-Related Mortality |
NCT00478244 (10) [back to overview] | Number of Patients With >70% Donor Chimerism |
NCT00478244 (10) [back to overview] | Overall Survival |
NCT00480987 (1) [back to overview] | Number of Participants With Objective Response |
NCT00489281 (3) [back to overview] | Transplant-related Mortality |
NCT00489281 (3) [back to overview] | Donor Chimerism at 1 Year |
NCT00489281 (3) [back to overview] | Donor Chimerism at 30 Days |
NCT00499889 (3) [back to overview] | Number of Participants in Complete Molecular Remission at 1 Year |
NCT00499889 (3) [back to overview] | Participants' With mCR Response to Post Transplant DLI |
NCT00499889 (3) [back to overview] | Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy |
NCT00502905 (1) [back to overview] | Number of Participants With Successful Engraftment |
NCT00505895 (2) [back to overview] | Number of Participants With Successful Engraftment at Day 100 |
NCT00505895 (2) [back to overview] | Acute Grade II-IV Graft Versus Host Disease (GVHD) |
NCT00505921 (1) [back to overview] | Participant Progression Free Survival at 2 Years |
NCT00506129 (2) [back to overview] | Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) |
NCT00506129 (2) [back to overview] | Average Overall Survival (OS) Length |
NCT00506857 (2) [back to overview] | Maximum Tolerated Dose (MTD) |
NCT00506857 (2) [back to overview] | Number of Participants With Graft Versus Host Disease (GVHD) |
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 |
NCT00510887 (6) [back to overview] | Number of Participants With Neuropathy, Any Grade |
NCT00510887 (6) [back to overview] | Percentage of Subjects Experiencing Progression Free Survival |
NCT00510887 (6) [back to overview] | Percentage of Subjects Experiencing Overall Survival |
NCT00510887 (6) [back to overview] | Number of Participants With a Grade 3-4 Hematologic Toxicity. |
NCT00510887 (6) [back to overview] | Duration of Response |
NCT00510887 (6) [back to overview] | Complete and Partial Response |
NCT00513474 (3) [back to overview] | Number of Participant With Adverse Events (AE) |
NCT00513474 (3) [back to overview] | Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD) |
NCT00513474 (3) [back to overview] | Uric Acid Levels |
NCT00513604 (2) [back to overview] | Clinical Response |
NCT00513604 (2) [back to overview] | Toxicity |
NCT00513747 (5) [back to overview] | Overall Survival (OS) for High Risk Patients |
NCT00513747 (5) [back to overview] | Disease-Free Survival in High Risk Patients |
NCT00513747 (5) [back to overview] | Time to Second Treatment in High Risk Patients |
NCT00513747 (5) [back to overview] | Time to First Treatment Survival in Low Risk Patients |
NCT00513747 (5) [back to overview] | Overall Survival in Low Risk Patients |
NCT00520130 (17) [back to overview] | Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD) |
NCT00520130 (17) [back to overview] | Days to Engraftment of Platelets |
NCT00520130 (17) [back to overview] | Early Treatment Related Mortality |
NCT00520130 (17) [back to overview] | Overall Survival |
NCT00520130 (17) [back to overview] | Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD) |
NCT00520130 (17) [back to overview] | Days to Engraftment of Neutrophils |
NCT00520130 (17) [back to overview] | Percentage of Participants With Late Treatment Related Mortality |
NCT00520130 (17) [back to overview] | Toxicities |
NCT00520130 (17) [back to overview] | Changes in CD8 T Cell Receptor Vbeta Repertoire |
NCT00520130 (17) [back to overview] | Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations |
NCT00520130 (17) [back to overview] | Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations |
NCT00520130 (17) [back to overview] | Immune Reconstitution of Normal Killer (NK) Cells |
NCT00520130 (17) [back to overview] | Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) |
NCT00520130 (17) [back to overview] | Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells |
NCT00520130 (17) [back to overview] | Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells |
NCT00520130 (17) [back to overview] | Days to Engraftment of Lymphocytes |
NCT00520130 (17) [back to overview] | Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire |
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 |
NCT00536341 (4) [back to overview] | Complete Response Rate |
NCT00536341 (4) [back to overview] | Overall Survival |
NCT00536341 (4) [back to overview] | Number of Adverse Events as a Measure of Safety and Tolerability |
NCT00536341 (4) [back to overview] | Progression-Free Survival |
NCT00544115 (2) [back to overview] | Two-year Overall Survival |
NCT00544115 (2) [back to overview] | Neutrophil Engraftment - The Days Till ANC Recovery |
NCT00544466 (2) [back to overview] | Overall Survival on Day 180 Days Post-transplant |
NCT00544466 (2) [back to overview] | Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation. |
NCT00545714 (14) [back to overview] | Percentage of Participants With Immunoglobulin Heavy Locus (IgH) Rearrangement |
NCT00545714 (14) [back to overview] | Overall Survival (OS) |
NCT00545714 (14) [back to overview] | Duration of Response (DOR) |
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 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] | Treatment-Free Survival (TFS) |
NCT00545714 (14) [back to overview] | Progression-Free Survival (PFS) |
NCT00545714 (14) [back to overview] | Percentage of Participants With CR With Incomplete Bone Marrow Recovery (CRi) |
NCT00545714 (14) [back to overview] | Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen |
NCT00545714 (14) [back to overview] | Percentage of Participants Who Died |
NCT00545714 (14) [back to overview] | Percentage of Participants With PD or Death |
NCT00547196 (2) [back to overview] | Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB) |
NCT00547196 (2) [back to overview] | Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB) |
NCT00553098 (11) [back to overview] | Overall Survival |
NCT00553098 (11) [back to overview] | Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism |
NCT00553098 (11) [back to overview] | Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant |
NCT00553098 (11) [back to overview] | Immune Reconstitution by 1 Year Post Transplant |
NCT00553098 (11) [back to overview] | Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD |
NCT00553098 (11) [back to overview] | Number of Patients Diagnosed With Acute GVHD |
NCT00553098 (11) [back to overview] | Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD |
NCT00553098 (11) [back to overview] | Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant |
NCT00553098 (11) [back to overview] | Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant |
NCT00553098 (11) [back to overview] | Disease Response by 1 Year Post Transplant |
NCT00553098 (11) [back to overview] | Number of Patients Diagnosed With Chronic GVHD |
NCT00562965 (7) [back to overview] | Percentage of Participants With Objective Response (OR) |
NCT00562965 (7) [back to overview] | Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) |
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 Laboratory Findings |
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 QT Interval Findings |
NCT00562965 (7) [back to overview] | Progression-Free Survival (PFS) |
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] | 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] | Disease-Free Survival (DFS) |
NCT00566696 (7) [back to overview] | Event-free Survival (EFS) |
NCT00566696 (7) [back to overview] | Incidence of Regimen-related Mortality |
NCT00566696 (7) [back to overview] | Overall Survival (OS) |
NCT00566696 (7) [back to overview] | Incidence of Non-hematologic Regimen-related Toxicities |
NCT00572897 (6) [back to overview] | Response Outcomes |
NCT00572897 (6) [back to overview] | Transplant-related Mortality |
NCT00572897 (6) [back to overview] | The Primary Endpoint is Progression-free Survival. |
NCT00572897 (6) [back to overview] | PLT |
NCT00572897 (6) [back to overview] | Absolute Neutrophil Count (ANC) |
NCT00572897 (6) [back to overview] | Overall Survival |
NCT00574496 (3) [back to overview] | Disease Relapse or Progression as Measured by CT Scan or PET |
NCT00574496 (3) [back to overview] | Overall Survival |
NCT00574496 (3) [back to overview] | Progression-free Survival at 1 Year |
NCT00577278 (3) [back to overview] | Overall Survival at Two Years |
NCT00577278 (3) [back to overview] | Relapse/Progression Rate at Two Years |
NCT00577278 (3) [back to overview] | Progression-free Survival at Two Years |
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] | 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 CHRONIC GVHD |
NCT00578292 (8) [back to overview] | Number of Participants With Infectious Complications |
NCT00578292 (8) [back to overview] | Number of Participants With Stable Mixed Hematopoietic Chimerism (HC) |
NCT00578292 (8) [back to overview] | Number of Participants With Transient Mixed Hematopoietic Chimerism (HC) |
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. |
NCT00579111 (2) [back to overview] | Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity |
NCT00579111 (2) [back to overview] | Number of Patients With Successful Donor Engraftment |
NCT00579137 (4) [back to overview] | Patients Alive at 1 Year |
NCT00579137 (4) [back to overview] | Number of Patients With Grade III to IV Acute GVHD |
NCT00579137 (4) [back to overview] | Number of Patients With Grade III or IV Toxicity |
NCT00579137 (4) [back to overview] | Number of Patients With Donor Engraftment |
NCT00582894 (4) [back to overview] | Number of Participants Experiencing Engraftment Donor Chimerism (EDC) |
NCT00582894 (4) [back to overview] | Number of Participants Relapse-Free |
NCT00582894 (4) [back to overview] | Number of Participants Overall Survival as a Function of Time. |
NCT00582894 (4) [back to overview] | Number of Participants Experiencing Transplant Related Mortality (TRM) |
NCT00582933 (1) [back to overview] | Death From GVHD |
NCT00589316 (1) [back to overview] | Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen |
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] | Occurence of Sinusoidal Obstructive Syndrome (SOS) |
NCT00589563 (14) [back to overview] | Non-relapse Mortality at Two Years 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 |
NCT00589563 (14) [back to overview] | Non-relapse Mortality at 100 Days Post HSCT |
NCT00589563 (14) [back to overview] | Severity of Chronic GVHD |
NCT00589563 (14) [back to overview] | Severity of Acute GVHD |
NCT00589563 (14) [back to overview] | Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation |
NCT00589563 (14) [back to overview] | Time to Platelet Count Recovery (Engraftment) |
NCT00589563 (14) [back to overview] | Time to Absolute Neutrophil Count Recovery (Engraftment) |
NCT00590460 (10) [back to overview] | Patients With Treated Related Death |
NCT00590460 (10) [back to overview] | Patients With Limited Chronic GVHD From Day 100 to 365 |
NCT00590460 (10) [back to overview] | Patients With Grade III - IV Acute GVHD |
NCT00590460 (10) [back to overview] | Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD) |
NCT00590460 (10) [back to overview] | Days to Absolute Neutrophil Count (ANC) of 500/mm3 |
NCT00590460 (10) [back to overview] | Patients With Extensive Chronic GVHD From Day 100 to 365 |
NCT00590460 (10) [back to overview] | Number of Patients With Donor Engraftment |
NCT00590460 (10) [back to overview] | Number of Patients Alive at 1 Year Post Transplant |
NCT00590460 (10) [back to overview] | Number of Patients With Graft Failure |
NCT00590460 (10) [back to overview] | Days to Platelet Count of 20,000/mm3 Without Transfusions |
NCT00593554 (7) [back to overview] | Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation |
NCT00593554 (7) [back to overview] | Time to Platelet Engraftment |
NCT00593554 (7) [back to overview] | Acute Graft vs. Host Disease (GvHD) |
NCT00593554 (7) [back to overview] | Chronic Graft vs. Host Disease (GvHD) |
NCT00593554 (7) [back to overview] | Frequency of Infection |
NCT00593554 (7) [back to overview] | Regimen-related Toxicity |
NCT00593554 (7) [back to overview] | Time to Neutrophil Engraftment |
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] | Number of Days for Absolute Neutrophil Count to Recover |
NCT00594308 (5) [back to overview] | Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). |
NCT00594308 (5) [back to overview] | Time to Resolution of Cytopenias: Platelet Transfusion Independence |
NCT00595127 (1) [back to overview] | Incidence & Quality of Engraftment & Hematopoietic Reconstitution |
NCT00597519 (1) [back to overview] | Overall Response |
NCT00602459 (6) [back to overview] | Time-to-progression in Patients With Del(11q22.3) |
NCT00602459 (6) [back to overview] | Time-to-progression 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] | Overall Response Rate in Patients Without Del(11q22.3) |
NCT00602459 (6) [back to overview] | 2-Year Progression Free Survival (PFS) Rate |
NCT00603954 (11) [back to overview] | Quality and Timing of Immunologic Reconstitution: Concentration of ATG Levels |
NCT00603954 (11) [back to overview] | Percentage of 4-year Progression Free Survival in the 2 Groups |
NCT00603954 (11) [back to overview] | Percentage of 5-year Overall Survival in the 2 Groups |
NCT00603954 (11) [back to overview] | Percentage of Participants With Chronic GVHD in the 2 Groups |
NCT00603954 (11) [back to overview] | Percentage of 5-year Progression Free Survival in the 2 Groups |
NCT00603954 (11) [back to overview] | Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism |
NCT00603954 (11) [back to overview] | Percentage of 4-year Overall Survival in the 2 Groups |
NCT00603954 (11) [back to overview] | Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups. |
NCT00603954 (11) [back to overview] | Percentage of Non Relapse Mortality in the 2 Groups |
NCT00603954 (11) [back to overview] | Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups |
NCT00603954 (11) [back to overview] | Percentage of Relapse Rate in the 2 Groups |
NCT00608517 (7) [back to overview] | Number of Participants With 100-day Non-relapse Mortality |
NCT00608517 (7) [back to overview] | Number of Participants With Chronic Graft Versus Host Disease (GVHD) |
NCT00608517 (7) [back to overview] | Number of Subjects With All-cause Mortality |
NCT00608517 (7) [back to overview] | Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells |
NCT00608517 (7) [back to overview] | Overall Survival |
NCT00608517 (7) [back to overview] | Number of Participants Who Relapsed at 1 Year |
NCT00608517 (7) [back to overview] | Number of Participants With Acute Graft-versus-host Disease (GVHD) |
NCT00610311 (2) [back to overview] | Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR) |
NCT00610311 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00612222 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00612222 (2) [back to overview] | Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR) |
NCT00615589 (5) [back to overview] | The Percentage of Patients Free From Progression at 1 Year |
NCT00615589 (5) [back to overview] | Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression |
NCT00615589 (5) [back to overview] | The Percentage of Patients Alive 1 Year Post Transplant |
NCT00615589 (5) [back to overview] | Percentage of Patients With Treatment Related Mortality (TRM) |
NCT00615589 (5) [back to overview] | Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD) |
NCT00618540 (8) [back to overview] | Overall Survival |
NCT00618540 (8) [back to overview] | Platelet Engraftment |
NCT00618540 (8) [back to overview] | Incidence of Chronic GVHD |
NCT00618540 (8) [back to overview] | Transplantation-related Death |
NCT00618540 (8) [back to overview] | Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) |
NCT00618540 (8) [back to overview] | Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) |
NCT00618540 (8) [back to overview] | Neutrophil Engraftment |
NCT00618540 (8) [back to overview] | Disease-free Survival at 12 Months Post Transplantation |
NCT00619645 (2) [back to overview] | Number of Patients With Day 100 Transplant-related Mortality |
NCT00619645 (2) [back to overview] | Number of Patients Alive 24 Months Post Day 100 Transplant |
NCT00622895 (10) [back to overview] | Skin Score |
NCT00622895 (10) [back to overview] | Event-free Survival (EFS) |
NCT00622895 (10) [back to overview] | EFS |
NCT00622895 (10) [back to overview] | Incidence of Graft Rejection |
NCT00622895 (10) [back to overview] | Overall Survival |
NCT00622895 (10) [back to overview] | The Percent of Participants With Definite and Probable Viral, Fungal, and Bacterial Infections |
NCT00622895 (10) [back to overview] | Treatment-related Mortality |
NCT00622895 (10) [back to overview] | Incidence and Severity of Graft-versus-host Disease (GVHD) |
NCT00622895 (10) [back to overview] | Quality of Life as Assessed by the Medical Outcome Short Form (36) Health Survey Instrument (SF-36) |
NCT00622895 (10) [back to overview] | Quality of Life as Assessed by the Modified Scleroderma Health Assessment Questionnaire (SHAQ) |
NCT00623935 (2) [back to overview] | Percentage of Participants Alive at 1 Year |
NCT00623935 (2) [back to overview] | Percentage of Participants With Relapse Free Survival at 1 Year |
NCT00625729 (6) [back to overview] | Number of Patients Whose Disease Progressed After Treatment |
NCT00625729 (6) [back to overview] | Number of Patients Exhibiting Natural Killer Cell Expansion |
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 With Overall Response |
NCT00630253 (5) [back to overview] | Number of Participants With Chronic Graft-Versus-Host Disease (GVHD) |
NCT00630253 (5) [back to overview] | Number of Participants With Transplant Related Deaths |
NCT00630253 (5) [back to overview] | Number of Participants Experiencing Overall Survival |
NCT00630253 (5) [back to overview] | Number of Participants With Acute Graft-Versus-Host Disease (GVHD) |
NCT00630253 (5) [back to overview] | Number of Participants Experiencing Graft Failure |
NCT00636155 (3) [back to overview] | Progression Free Survival |
NCT00636155 (3) [back to overview] | Overall Survival |
NCT00636155 (3) [back to overview] | Number of Patients With an Overall Response (Complete Response + Partial Response) |
NCT00652899 (4) [back to overview] | Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product |
NCT00652899 (4) [back to overview] | Median Overall Survival Number of Days Patients Alive After Treatment |
NCT00652899 (4) [back to overview] | Median Number of Days to Progression |
NCT00652899 (4) [back to overview] | Number of Patients Per Disease Response |
NCT00670748 (3) [back to overview] | Number of Participants With Serious and Non-Serious Adverse Events |
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 In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells |
NCT00683046 (2) [back to overview] | Median Disease-free Survival |
NCT00683046 (2) [back to overview] | Median Overall Survival |
NCT00691015 (8) [back to overview] | Severity of Acute Graft-versus-host Disease (GVHD) |
NCT00691015 (8) [back to overview] | Incidence of Acute Graft-versus-host Disease (GVHD) |
NCT00691015 (8) [back to overview] | Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] ) |
NCT00691015 (8) [back to overview] | Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment. |
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] | Karnofsky Performance Status Performance Status |
NCT00691015 (8) [back to overview] | Overall Survival. |
NCT00704938 (2) [back to overview] | Clinical Response (Complete Response + Partial Response) |
NCT00704938 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00714259 (7) [back to overview] | Composite Incidence of Acute and Chronic Graft Versus Host Disease |
NCT00714259 (7) [back to overview] | Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant |
NCT00714259 (7) [back to overview] | Progression Free Survival Post Transplant |
NCT00714259 (7) [back to overview] | Progressive Free Survival Post Transplant |
NCT00714259 (7) [back to overview] | Progressive Free Survival Post Transplant |
NCT00714259 (7) [back to overview] | Progressive Free Survival Post Transplant |
NCT00714259 (7) [back to overview] | Non-relapse Treatment Related Mortality |
NCT00719849 (16) [back to overview] | Probability of Progression-free Survival at 1 Year |
NCT00719849 (16) [back to overview] | Probability of Progression-free Survival at 2 Years |
NCT00719849 (16) [back to overview] | Probability of Survival at 1 Year |
NCT00719849 (16) [back to overview] | Probability of Survival at 2 Years |
NCT00719849 (16) [back to overview] | Incidence of Neutrophil Engraftment at Day 42 |
NCT00719849 (16) [back to overview] | Chimerism |
NCT00719849 (16) [back to overview] | Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year |
NCT00719849 (16) [back to overview] | Incidence of Clinically Significant Infections at 1 Year |
NCT00719849 (16) [back to overview] | Incidence of Clinically Significant Infections at 6 Months |
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 Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100 |
NCT00719849 (16) [back to overview] | Incidence of Clinically Significant Infections at 2 Years |
NCT00719849 (16) [back to overview] | Incidence of Non-relapse Mortality at 6 Months |
NCT00719849 (16) [back to overview] | Incidence of Platelet Engraftment at 6 Months |
NCT00719849 (16) [back to overview] | Incidence of Relapse at 1 Year |
NCT00719849 (16) [back to overview] | Incidence of Relapse at 2 Years |
NCT00723099 (9) [back to overview] | Number of Participants With Graft Failure/Rejection |
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] | Median Time to ANC > 500 |
NCT00727415 (6) [back to overview] | Number of Patients Reaching Disease-free Survival (DSF) Overall |
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] | Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.). |
NCT00727415 (6) [back to overview] | Toxicity as Assessed by NCI CTCAE v3.0 |
NCT00727415 (6) [back to overview] | Overall Complete Response (CR) Rate (Phase II) |
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 Platelet Engraftment |
NCT00739141 (4) [back to overview] | Percentage of Participants With Sustained CB-derived Neutrophil Engraftment |
NCT00741455 (3) [back to overview] | Number of Participants With Successful Bone Marrow Engraftment |
NCT00741455 (3) [back to overview] | Number of Participants Who Achieve Complete Donor Chimerism |
NCT00741455 (3) [back to overview] | Overall Survival Measured in Participants |
NCT00744692 (9) [back to overview] | To Describe the Incidence of Grade 3-4 Organ Toxicity |
NCT00744692 (9) [back to overview] | To Evaluate the Incidence of Late Graft Failures at 2 Years Post-transplant |
NCT00744692 (9) [back to overview] | To Evaluate Long-term Complications, Such as Sterility, Endocrinopathy, and Growth Failure |
NCT00744692 (9) [back to overview] | To Evaluate the Pace of Immune Reconstitution. |
NCT00744692 (9) [back to overview] | To Describe the Pace of Neutrophil Recovery |
NCT00744692 (9) [back to overview] | Determine the Feasibility of Attaining Acceptable Rates of Donor Cell Engraftment (>25% Donor Cells at 180 Days) Following RIC Regimens in Children < 21 Years Receiving UCBT for Non-malignant Disorders. |
NCT00744692 (9) [back to overview] | To Describe the Pace of Platelet Recovery |
NCT00744692 (9) [back to overview] | To Determine the Overall Survival at day180 Post-transplant |
NCT00744692 (9) [back to overview] | To Describe Incidence of Acute Graft Versus Host Disease (GVHD) (II - IV) |
NCT00759798 (1) [back to overview] | Number of Participants With Complete Remission (CR) |
NCT00775931 (4) [back to overview] | Transplant Related Mortality at 100 Days |
NCT00775931 (4) [back to overview] | Number of Patients Who Achieved Donor Cell Engraftment |
NCT00775931 (4) [back to overview] | Incidence of Grade II - IV Acute Graft-versus-host Disease |
NCT00775931 (4) [back to overview] | Transplant Related Toxicity |
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] | Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT) |
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] | 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] | Disease Free Survival at Day 100 |
NCT00782379 (11) [back to overview] | Overall 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 30 Post-transplantation |
NCT00782379 (11) [back to overview] | Disease Free Survival at 12 Months |
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 Day 100 |
NCT00782379 (11) [back to overview] | Incidence of Graft Rejection for Patients at Day 100 |
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] | T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism) |
NCT00787761 (8) [back to overview] | Disease-free Survival (DFS) at 24 Months |
NCT00787761 (8) [back to overview] | Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD) |
NCT00787761 (8) [back to overview] | Non-relapse Mortality (NRM) at Day 180 Post-transplantation |
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] | Overall Survival (OS) at 24 Months |
NCT00787761 (8) [back to overview] | T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%) |
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 With Relapsed Disease |
NCT00789776 (7) [back to overview] | Number of Subjects Surviving Post-transplant. |
NCT00789776 (7) [back to overview] | Number of Participants Who Experienced Chronic Extensive GVHD |
NCT00789776 (7) [back to overview] | Number of Non-relapse Participant Mortalities |
NCT00789776 (7) [back to overview] | Number of Participants Who Experienced Graft Failure |
NCT00793572 (6) [back to overview] | Number of Patients Surviving Overall |
NCT00793572 (6) [back to overview] | Number of Patients Surviving Progression-free |
NCT00793572 (6) [back to overview] | Number of Patients With Chronic GVHD |
NCT00793572 (6) [back to overview] | Number of Patients With Grade II-IV Acute GVHD |
NCT00793572 (6) [back to overview] | Number of Patients With Toxicities Related to Bortezomib Maintenance Therapy |
NCT00793572 (6) [back to overview] | Number of Patients With Non-relapse Mortality |
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) |
NCT00795132 (3) [back to overview] | Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments |
NCT00795132 (3) [back to overview] | Two Year Overall Survival |
NCT00795132 (3) [back to overview] | Number of Participants Who Experienced Transplantation-related Mortality (TRM) |
NCT00796068 (12) [back to overview] | Non-relapse Mortality |
NCT00796068 (12) [back to overview] | Incidence of Clinically Significant Infections |
NCT00796068 (12) [back to overview] | Incidence of Acute or Chronic Graft-versus-host Disease (GVHD) |
NCT00796068 (12) [back to overview] | Duration (Days) Until Participants Obtained Platelet Engraftment |
NCT00796068 (12) [back to overview] | The Number of Participants Alive at Two-years Follow up. |
NCT00796068 (12) [back to overview] | Number of Patients With Non-relapse Mortality (NRM) |
NCT00796068 (12) [back to overview] | Number of Participants With Secondary Graft Failure |
NCT00796068 (12) [back to overview] | Number of Participants With Graft Failure/Rejection |
NCT00796068 (12) [back to overview] | Number of Participants With Acute Graft-versus-host Disease (GVHD) Grade II-IV by Day 100 |
NCT00796068 (12) [back to overview] | Number of Participants Surviving up to 2 Years Without Disease Progression |
NCT00796068 (12) [back to overview] | Incidence of Relapse or Disease Progression |
NCT00796068 (12) [back to overview] | Number of Participants Surviving by 1 Year |
NCT00800839 (6) [back to overview] | 2-year Progression-Free Survival |
NCT00800839 (6) [back to overview] | Cumulative Incidence of Grade II to IV Acute GVHD |
NCT00800839 (6) [back to overview] | Day-100 Treatment-Related Mortality |
NCT00800839 (6) [back to overview] | Rate of Engraftment |
NCT00800839 (6) [back to overview] | Cumulative Incidence of Grade III to IV Acute GVHD |
NCT00800839 (6) [back to overview] | 2-year Overall Survival |
NCT00802113 (7) [back to overview] | Time to Neutrophil Engraftment |
NCT00802113 (7) [back to overview] | Time to Platelet Engraftment |
NCT00802113 (7) [back to overview] | Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT |
NCT00802113 (7) [back to overview] | Total Number of Subjects That Experienced Transplant-related Mortality (TRM) |
NCT00802113 (7) [back to overview] | Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT) |
NCT00802113 (7) [back to overview] | Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD) |
NCT00802113 (7) [back to overview] | Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT |
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 |
NCT00813124 (1) [back to overview] | Number of Participants With Molecular Response |
NCT00818961 (11) [back to overview] | Overall Survival at 1 Year |
NCT00818961 (11) [back to overview] | Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant |
NCT00818961 (11) [back to overview] | Platelet Engraftment |
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] | Complete Donor Chimerism |
NCT00818961 (11) [back to overview] | Non-relapse Mortality at 1 Year Post-transplant |
NCT00818961 (11) [back to overview] | Neutrophil Recovery |
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] | Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant |
NCT00818961 (11) [back to overview] | Survival at Day 100 |
NCT00822770 (3) [back to overview] | Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30 |
NCT00822770 (3) [back to overview] | Number of Participants Alive With no Disease Progression at Time of Allo Transplant |
NCT00822770 (3) [back to overview] | Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor |
NCT00827099 (2) [back to overview] | Number of Participants With 100 Day Transplant-related Mortality (TRM) |
NCT00827099 (2) [back to overview] | Number of Patients That Engrafted Blood Counts by 30 Days After Transplant |
NCT00850499 (2) [back to overview] | Overall Response Rate |
NCT00850499 (2) [back to overview] | Complete Response Rate |
NCT00856388 (8) [back to overview] | Rate of Complete Donor Chimerism - Blood |
NCT00856388 (8) [back to overview] | Median Time to Platelet Engraftment |
NCT00856388 (8) [back to overview] | 1 yr Extenstive Chronic GVHD |
NCT00856388 (8) [back to overview] | 3 yr Overall Survival |
NCT00856388 (8) [back to overview] | Acute GVHD Grade III-IV |
NCT00856388 (8) [back to overview] | Day 100 TRM |
NCT00856388 (8) [back to overview] | Median Time to ANC Engraftment |
NCT00856388 (8) [back to overview] | Rate of Complete Donor Chimerism - Blood |
NCT00860457 (1) [back to overview] | Complete Response Rate |
NCT00860574 (8) [back to overview] | Incidence of Chronic GVHD |
NCT00860574 (8) [back to overview] | Incidence of Grades II-IV Acute GVHD |
NCT00860574 (8) [back to overview] | Median Donor CD3 + T Lymphocyte Chimerism in Peripheral Blood |
NCT00860574 (8) [back to overview] | Non Relapse Mortality (NRM) Incidence |
NCT00860574 (8) [back to overview] | Non Relapse Mortality Incidence |
NCT00860574 (8) [back to overview] | Relapse-free Survival |
NCT00860574 (8) [back to overview] | Overall Survival (OS) |
NCT00860574 (8) [back to overview] | Relapse Incidence |
NCT00871689 (8) [back to overview] | Number of Patients With Successful Natural Killer Expansion |
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] | 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 |
NCT00871689 (8) [back to overview] | Number of Patients With Transplant-Related Death (TRD) |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Fatigue Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate of Time to Treatment Failure (TTF) as Assessed by the Investigator |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate of Time to Treatment Failure as Assessed by the Investigator at the Final Analysis |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Constipation |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Diarhoea |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Insomnia Domain |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Nausea / Vomiting Domain |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Pain Domain |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain |
NCT00875667 (47) [back to overview] | Number of Participants With Treatment Emergent Adverse Events |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Diarhoea Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Pain Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Constipation Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate of Time to Progression According to the IRC Central Review |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate of Time to First Response as Assessed by the Investigator at the Final Analysis |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate of Time to First Response (TTFR) According to the IRC Central Review |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate for Overall Survival as Assessed by the Investigator at the Final Analysis |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate for Overall Survival (OS) According to the IRC Central Review |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain |
NCT00875667 (47) [back to overview] | Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis |
NCT00875667 (47) [back to overview] | Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review |
NCT00875667 (47) [back to overview] | Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis |
NCT00875667 (47) [back to overview] | Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Insomnia Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Maximum Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Discontinuation Visit |
NCT00875667 (47) [back to overview] | Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
NCT00899431 (1) [back to overview] | Percentage of Participants With GVHD (Graft Versus Host Disease) |
NCT00914940 (4) [back to overview] | Number of Participants Who Did Not Engraft After Receiving a CD45RA+ T Cell Depleted PBSC Transplant |
NCT00914940 (4) [back to overview] | Number of Participants Who Have Relapsed Within 5 Years of CD45RA+ T Cell Depleted PBSC Transplant |
NCT00914940 (4) [back to overview] | Number of Participants With Chronic GVHD |
NCT00914940 (4) [back to overview] | Transplant-related Mortality by Day 100 |
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] | Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I) |
NCT00918723 (4) [back to overview] | Overall Survival |
NCT00918723 (4) [back to overview] | Percentage of Patients With Progression-free Survival at 2 Years |
NCT00919503 (10) [back to overview] | Number of Participants With Infections |
NCT00919503 (10) [back to overview] | Number of Patients With Grade II-IV Acute Graft-versus-host Disease |
NCT00919503 (10) [back to overview] | Number of Patients With of Chronic Graft-versus-host Disease |
NCT00919503 (10) [back to overview] | Overall Survival |
NCT00919503 (10) [back to overview] | Preliminary Efficacy |
NCT00919503 (10) [back to overview] | Donor Chimerism CD3 at 100 Days Post Transplant |
NCT00919503 (10) [back to overview] | Donor Chimerism CD33 at Day 100 Post Transplant |
NCT00919503 (10) [back to overview] | Immune Reconstitution Following Hematopoietic Cell Transplantation |
NCT00919503 (10) [back to overview] | Disease Response at One Year Following Hematopoietic Cell Transplantation |
NCT00919503 (10) [back to overview] | Non-relapse Mortality |
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] | Overall Survival |
NCT00923364 (7) [back to overview] | Incidence of Acute and Chronic Graft-versus-host Disease (GVHD) |
NCT00923364 (7) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
NCT00923364 (7) [back to overview] | Number of Participants With Disease Free Survival |
NCT00923364 (7) [back to overview] | Days to Platelet Engraftment |
NCT00923364 (7) [back to overview] | Days to Neutrophil Engraftment |
NCT00923364 (7) [back to overview] | Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2) |
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] | Duration of Response (Complete Response + Partial Response) |
NCT00924170 (17) [back to overview] | Half Life (t1/2) of LMB-2 |
NCT00924170 (17) [back to overview] | Number of Participants With Dose Limiting Toxicity (DLT) |
NCT00924170 (17) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
NCT00924170 (17) [back to overview] | Overall Survival (OS) |
NCT00924170 (17) [back to overview] | Peak Level of LMB-2 in Adult T-Cell Lymphoma |
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] | Plasma Clearance (CL) of LMB-2 |
NCT00924170 (17) [back to overview] | Progression Free Survival (PFS) |
NCT00924170 (17) [back to overview] | Volume of Distribution of LMB-2 |
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] | Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders |
NCT00924170 (17) [back to overview] | Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders |
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] | Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry |
NCT00924287 (2) [back to overview] | Number of Participants With Adverse Events |
NCT00924287 (2) [back to overview] | Number of Participants With In Vivo Survival of Transfused Cells |
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). |
NCT00924326 (2) [back to overview] | Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma |
NCT00943319 (3) [back to overview] | Maximum Tolerated Dose |
NCT00943319 (3) [back to overview] | Overall Survival |
NCT00943319 (3) [back to overview] | Disease Free Survival |
NCT00943800 (3) [back to overview] | Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD) |
NCT00943800 (3) [back to overview] | Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years |
NCT00943800 (3) [back to overview] | Percentage of Participants With Neutrophil Engraftment |
NCT00946023 (12) [back to overview] | Relapse |
NCT00946023 (12) [back to overview] | Progression-free Survival |
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] | Overall Survival |
NCT00946023 (12) [back to overview] | Overall Survival |
NCT00946023 (12) [back to overview] | Progression-free Survival |
NCT00946023 (12) [back to overview] | Relapse |
NCT00948922 (3) [back to overview] | Overall Survival (OS) Rate |
NCT00948922 (3) [back to overview] | Progression Free Survival (PFS) |
NCT00948922 (3) [back to overview] | Percentage of Participants With Acute or Chronic Graft-versus-host Disease (GVHD) Following Transplant |
NCT00950846 (6) [back to overview] | Number of Participants With Chronic GvHD |
NCT00950846 (6) [back to overview] | Overall Survival at 1 Year After Umbilical Cord Blood Transplant in Pediatric Patients. |
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. |
NCT00950846 (6) [back to overview] | Incidence of Severe Grade III-IV Acute GvHD at Day 100. |
NCT00963872 (20) [back to overview] | Incidence of Grades III-IV Graft-vs-host Disease |
NCT00963872 (20) [back to overview] | Neutrophil Engraftment |
NCT00963872 (20) [back to overview] | Non-Relapse Mortality |
NCT00963872 (20) [back to overview] | Non-relapse Mortality |
NCT00963872 (20) [back to overview] | Number of Patients With the Complement 3a (C3a) Unit Predominating |
NCT00963872 (20) [back to overview] | Overall Survival |
NCT00963872 (20) [back to overview] | Overall Survival at Day 720 |
NCT00963872 (20) [back to overview] | Relapse of Disease |
NCT00963872 (20) [back to overview] | Relapse of 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 |
NCT00963872 (20) [back to overview] | Bone Marrow Chimerism |
NCT00963872 (20) [back to overview] | Platelet Recovery |
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] | Overall Survival at 3 Years |
NCT00987480 (4) [back to overview] | Disease-free Survival at 3 Years |
NCT01005576 (4) [back to overview] | Incidence of Disease Recurrence |
NCT01005576 (4) [back to overview] | Median Time to ANC Engraftment |
NCT01005576 (4) [back to overview] | Median Time to Platelet Engraftment |
NCT01005576 (4) [back to overview] | Primary Objective: Event-free Survival at 1 Year. |
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] | 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 Relapsed/Progressive Disease |
NCT01008462 (7) [back to overview] | Overall Survival |
NCT01008462 (7) [back to overview] | Non-relapse Mortality (NRM) |
NCT01010217 (6) [back to overview] | Number of Participants With Non-relapse Mortality (NRM) |
NCT01010217 (6) [back to overview] | Grade III-IV aGVHD |
NCT01010217 (6) [back to overview] | Disease Free Survival |
NCT01010217 (6) [back to overview] | cGVHD |
NCT01010217 (6) [back to overview] | Number of Participants With Non Related Mortality (NRM) |
NCT01010217 (6) [back to overview] | Engraftments |
NCT01019317 (1) [back to overview] | Participants With a Complete Response |
NCT01027000 (1) [back to overview] | 2-year Progression-free Survival in Early Disease Participants |
NCT01028716 (12) [back to overview] | Disease-free Survival |
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] | Relapse of Malignancy After Transplantation |
NCT01028716 (12) [back to overview] | Incidence of Grades III/IV Acute Graft Versus Host Disease |
NCT01028716 (12) [back to overview] | Time to Neutrophil Recovery |
NCT01028716 (12) [back to overview] | Time to Platelet Recovery |
NCT01028716 (12) [back to overview] | Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System |
NCT01028716 (12) [back to overview] | Incidence of Primary Graft Failure |
NCT01028716 (12) [back to overview] | Non-relapse Mortality at 1 Year |
NCT01028716 (12) [back to overview] | Number of Platelet Transfusions |
NCT01028716 (12) [back to overview] | Number of Red Blood Cell Transfusions |
NCT01044745 (4) [back to overview] | Transplant-related Mortality (TRM) |
NCT01044745 (4) [back to overview] | Overall Survival |
NCT01044745 (4) [back to overview] | Event-free Survival |
NCT01044745 (4) [back to overview] | Number of Participants With Grades II-IV Acute GVHD |
NCT01050764 (6) [back to overview] | Serious Infections |
NCT01050764 (6) [back to overview] | Overall Survival (OS), 1 Year |
NCT01050764 (6) [back to overview] | Maximum-tolerated Dose (MTD) of Regulatory and Conventional T-cells |
NCT01050764 (6) [back to overview] | To Measure the Incidence and Severity of Acute and Chronic GvHD |
NCT01050764 (6) [back to overview] | Acute Graft-versus-Host-Disease (aGvHD) |
NCT01050764 (6) [back to overview] | Median Overall Survival (OS) |
NCT01082939 (1) [back to overview] | Number of Participants With an Overall Response |
NCT01088048 (15) [back to overview] | Plasma Concentration of IDELA (Cohort 4) |
NCT01088048 (15) [back to overview] | Plasma Concentration of IDELA (Cohort 6) |
NCT01088048 (15) [back to overview] | Plasma Concentration of IDELA (Cohort 7) |
NCT01088048 (15) [back to overview] | Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5) |
NCT01088048 (15) [back to overview] | Overall Survival |
NCT01088048 (15) [back to overview] | Progression-free Survival |
NCT01088048 (15) [back to overview] | Time to Response |
NCT01088048 (15) [back to overview] | Toxicity of Administration of IDELA |
NCT01088048 (15) [back to overview] | Duration of Exposure to IDELA |
NCT01088048 (15) [back to overview] | Plasma Concentration of Lenalidomide |
NCT01088048 (15) [back to overview] | Sub-study: Plasma Concentration of IDELA (Cohorts 1-4) |
NCT01088048 (15) [back to overview] | Plasma Concentration of Bendamustine |
NCT01088048 (15) [back to overview] | Overall Response Rate |
NCT01088048 (15) [back to overview] | Plasma Concentration of Everolimus |
NCT01088048 (15) [back to overview] | Duration of Response |
NCT01096992 (2) [back to overview] | Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) |
NCT01096992 (2) [back to overview] | Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) |
NCT01105650 (4) [back to overview] | Response Rate |
NCT01105650 (4) [back to overview] | Overall Survival |
NCT01105650 (4) [back to overview] | Time to Disease Progression |
NCT01105650 (4) [back to overview] | Number of Participants With Progressive Disease at One Year |
NCT01106950 (6) [back to overview] | Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion |
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 Incidence of Relapse |
NCT01106950 (6) [back to overview] | Percent of Patients With Disease Free Survival |
NCT01106950 (6) [back to overview] | Percent of Patients With Complete Remission of Disease |
NCT01106950 (6) [back to overview] | Number of Patients With Treatment-Related Death |
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] | 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] | 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. |
NCT01131169 (2) [back to overview] | Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS) |
NCT01131169 (2) [back to overview] | Proportion of Participants With Relapsed Multiple Myeloma Alive at 2 Years |
NCT01135329 (1) [back to overview] | Graft Failure |
NCT01144403 (4) [back to overview] | Number of Participant With Adverse Event (AE) |
NCT01144403 (4) [back to overview] | Progression-free Survival (PFS) |
NCT01144403 (4) [back to overview] | Overall Survival (OS) |
NCT01144403 (4) [back to overview] | Overall Response Rate (ORR) |
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. |
NCT01145209 (6) [back to overview] | Median Relationship of CD20 Expression With MRD Negativity Rate |
NCT01168219 (3) [back to overview] | Progression-free Survival |
NCT01168219 (3) [back to overview] | Overall Survival (OS) |
NCT01168219 (3) [back to overview] | 100-day Mortality |
NCT01173679 (2) [back to overview] | Toxicities |
NCT01173679 (2) [back to overview] | Progression-Free and Overall Survival |
NCT01181258 (4) [back to overview] | Number of Patients With an Objective Response |
NCT01181258 (4) [back to overview] | Time to Disease Progression |
NCT01181258 (4) [back to overview] | Serious Adverse Events |
NCT01181258 (4) [back to overview] | Patients With Expansion of NK Cells |
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] | Cumulative Incidence of Disease Relapse |
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 Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant |
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 |
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] | Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD) |
NCT01181271 (12) [back to overview] | Cumulative Incidence of Extensive Chronic Graft-versus-host-disease |
NCT01186458 (1) [back to overview] | Toxicity |
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 |
NCT01187017 (4) [back to overview] | Number of Participants With Clonal Evolution |
NCT01203020 (9) [back to overview] | Rates of Acute and Chronic Graft Versus Host Disease (GVHD). |
NCT01203020 (9) [back to overview] | Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year. |
NCT01203020 (9) [back to overview] | Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years. |
NCT01203020 (9) [back to overview] | Relapse Rate (RR) Following Transplantation at 2-year. |
NCT01203020 (9) [back to overview] | Relapse Rate (RR) Following Transplantation at 1-year. |
NCT01203020 (9) [back to overview] | Percentage of 1 Year Overall Survival (OS) |
NCT01203020 (9) [back to overview] | Percentage of 2-year Progression Free Survival (PFS) |
NCT01203020 (9) [back to overview] | Percentage of 2 Year Overall Survival (OS) |
NCT01203020 (9) [back to overview] | Percentage of 1-year Progression Free Survival (PFS) |
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 |
NCT01231412 (6) [back to overview] | Number of Non-Relapse Mortalities |
NCT01231412 (6) [back to overview] | Number of of Participants Surviving Overall |
NCT01231412 (6) [back to overview] | Number of Participants With Relapse/Progression |
NCT01231412 (6) [back to overview] | Number of Patients With Chronic Extensive GVHD |
NCT01231412 (6) [back to overview] | Number of Patients With Grades II-IV Acute GVHD |
NCT01231412 (6) [back to overview] | Number of Patients With Grades III-IV Acute GVHD |
NCT01236573 (3) [back to overview] | Maximum Tolerated Dose (MTD) |
NCT01236573 (3) [back to overview] | Number of Participants With Adverse Events |
NCT01236573 (3) [back to overview] | Response (Complete Response (CR) + Partial Response (PR)) to Therapy |
NCT01247701 (7) [back to overview] | Number of Participants With Chronic GvHD |
NCT01247701 (7) [back to overview] | Number of Participants With Platelet Engraftment |
NCT01247701 (7) [back to overview] | Number of Participants With Severe Acute GVHD Grade III-IV |
NCT01247701 (7) [back to overview] | Number of Participants With Donor Engraftment After Transplant. |
NCT01247701 (7) [back to overview] | Number of Participants With Relapse Rate After Transplant |
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 Neutrophil Engraftment |
NCT01251575 (3) [back to overview] | Number of Patients With Grade III-IV Acute GVHD |
NCT01251575 (3) [back to overview] | Number of Non-Relapse Mortalities |
NCT01251575 (3) [back to overview] | Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD) |
NCT01256398 (6) [back to overview] | Disease Free Survival (DFS) |
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] | 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] | 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. |
NCT01256398 (6) [back to overview] | Response |
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] | Hospitalization Days |
NCT01263704 (6) [back to overview] | Overall Response Rate |
NCT01263704 (6) [back to overview] | Progression-free Survival (PFS) |
NCT01263704 (6) [back to overview] | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT01271010 (10) [back to overview] | Event-free Survival |
NCT01271010 (10) [back to overview] | Duration of Response |
NCT01271010 (10) [back to overview] | Percentage of Participants With Phenotypic Remission |
NCT01271010 (10) [back to overview] | Progression-free Survival |
NCT01271010 (10) [back to overview] | Percentage of Participants With Partial Remission |
NCT01271010 (10) [back to overview] | Percentage of Participants With Disease Progression |
NCT01271010 (10) [back to overview] | Percentage of Participants With Complete Remission |
NCT01271010 (10) [back to overview] | Percentage of Participants With Stable Disease |
NCT01271010 (10) [back to overview] | Overall Survival |
NCT01271010 (10) [back to overview] | Percentage of Participants With Adverse Events (AEs) and Serious AEs |
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 |
NCT01283386 (10) [back to overview] | Duration of Response |
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 |
NCT01289457 (4) [back to overview] | Overall Survival |
NCT01289457 (4) [back to overview] | Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) |
NCT01289457 (4) [back to overview] | Event-Free Survival (EFS) at 2 Years |
NCT01289457 (4) [back to overview] | Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine |
NCT01292603 (15) [back to overview] | Part 2: 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: 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 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: 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: Percentage of Participants With Anti-Rituximab Antibodies |
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: Rituximab C Trough Levels at Cycle 5 |
NCT01300247 (7) [back to overview] | Number of Participants With Human Anti-Human Antibodies (HAHAs) |
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 Had B-Cell Recovery |
NCT01300247 (7) [back to overview] | Percentage of Participants Who Had B-Cell Depletion |
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 Were Alive and Progression Free |
NCT01300247 (7) [back to overview] | Percentage of Participants Who Were Alive |
NCT01300572 (9) [back to overview] | Rates of Non-relapse Mortality |
NCT01300572 (9) [back to overview] | Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor |
NCT01300572 (9) [back to overview] | The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS. |
NCT01300572 (9) [back to overview] | Rates of Engraftment |
NCT01300572 (9) [back to overview] | Rates of Donor Chimerism |
NCT01300572 (9) [back to overview] | Achievement of Remission |
NCT01300572 (9) [back to overview] | Duration of Remission |
NCT01300572 (9) [back to overview] | Disease-free Survival |
NCT01300572 (9) [back to overview] | Overall Survival |
NCT01310179 (2) [back to overview] | Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment |
NCT01310179 (2) [back to overview] | Treatment Outcome and Percent Change in Tumor Volume |
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) |
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 |
NCT01339910 (10) [back to overview] | Number of Participants With Primary Graft Failure |
NCT01339910 (10) [back to overview] | Number of Participants With Donor Cell Engraftment |
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] | Number of Participants With Secondary Graft Failure |
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] | Percentage of Participants With Chronic GVHD |
NCT01339910 (10) [back to overview] | Percentage of Participants With Treatment-related Mortality |
NCT01343043 (8) [back to overview] | Time to Maximum Persistence of NY-ESO-1 Genetically Engineered T Cells |
NCT01343043 (8) [back to overview] | Duration of Overall Response |
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] | Objective Response Rate (ORR) |
NCT01343043 (8) [back to overview] | Best Overall Response |
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 |
NCT01366612 (1) [back to overview] | To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment |
NCT01369875 (2) [back to overview] | Number of Participants With Clinical Tumor Regression. |
NCT01369875 (2) [back to overview] | Number of Participants With Serious and Non-Serious Adverse Events |
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 |
NCT01390402 (1) [back to overview] | Number of Participants With Molecular Complete Remission at 3 Month Post Transplant |
NCT01408563 (12) [back to overview] | Relapse-free Survival |
NCT01408563 (12) [back to overview] | Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days |
NCT01408563 (12) [back to overview] | Rate of Post-transplant Lymphoma |
NCT01408563 (12) [back to overview] | Overall Survival |
NCT01408563 (12) [back to overview] | Median Time to Neutrophil Engraftment |
NCT01408563 (12) [back to overview] | Number of Participants With Primary Graft Failure |
NCT01408563 (12) [back to overview] | Median Time to Platelet Engraftment |
NCT01408563 (12) [back to overview] | Median Thrombopoietin Levels After Transplant |
NCT01408563 (12) [back to overview] | Immune Reconstitution - Median CD4 Count at 12 Months |
NCT01408563 (12) [back to overview] | 100-day Treatment Related Mortality |
NCT01408563 (12) [back to overview] | 1 Year Relapse Rate |
NCT01408563 (12) [back to overview] | The Rate of Chronic GVHD |
NCT01410344 (7) [back to overview] | Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD) |
NCT01410344 (7) [back to overview] | Percentage of Participants With Relapse/Progression |
NCT01410344 (7) [back to overview] | Chimerism |
NCT01410344 (7) [back to overview] | Percentage of Participants Recovering Hematologic Function |
NCT01410344 (7) [back to overview] | Percentage of Participants With Overall Survival |
NCT01410344 (7) [back to overview] | Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD) |
NCT01410344 (7) [back to overview] | Percentage of Participants With Non-Relapse Mortality |
NCT01427881 (9) [back to overview] | Chronic GVHD Requiring Systemic Immunosuppressive Treatment |
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] | Hematologic Recovery |
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] | Disease-free Survival |
NCT01434472 (7) [back to overview] | Progression-free Survival |
NCT01434472 (7) [back to overview] | Overall Survival |
NCT01434472 (7) [back to overview] | Hematopoietic Toxicity |
NCT01434472 (7) [back to overview] | Absolute Neutrophil Count (ANC) Engraftment |
NCT01434472 (7) [back to overview] | Treatment-related Mortality |
NCT01434472 (7) [back to overview] | Platelet Engraftment |
NCT01434472 (7) [back to overview] | Response Rates |
NCT01445821 (2) [back to overview] | Number of Participants With Treatment Failure |
NCT01445821 (2) [back to overview] | Survival of Treatment |
NCT01453101 (3) [back to overview] | Overall Response Rate |
NCT01453101 (3) [back to overview] | Overall Survival (OS) |
NCT01453101 (3) [back to overview] | Progression Free Survival |
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 Patients With an Objective Response |
NCT01454596 (5) [back to overview] | Number of Treatment Related Adverse Events |
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) |
NCT01454596 (5) [back to overview] | Progression Free Survival |
NCT01464359 (9) [back to overview] | Incidence of Graft Failure |
NCT01464359 (9) [back to overview] | Incidence of Acute Graft-Versus-Host Disease |
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] | Disease Free Survival |
NCT01464359 (9) [back to overview] | Clinical Disease Response |
NCT01464359 (9) [back to overview] | Clinical Disease Response |
NCT01464359 (9) [back to overview] | Transplant-Related Mortality |
NCT01468818 (1) [back to overview] | Objective Response in Patients With Metastatic Melanoma |
NCT01471444 (4) [back to overview] | Overall Survival (OS) Post Transplant at 1, 3 and 5 Years |
NCT01471444 (4) [back to overview] | Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant. |
NCT01471444 (4) [back to overview] | Number of Participants With Non Relapse Mortality at 100 Day Post Transplant |
NCT01471444 (4) [back to overview] | Progression-Free Survival (PFS) |
NCT01490723 (2) [back to overview] | Treatment-Related Mortality (TRM) |
NCT01490723 (2) [back to overview] | Overall Survival (OS) |
NCT01495572 (2) [back to overview] | Number of Participants With Adverse Events |
NCT01495572 (2) [back to overview] | Clinical Tumor Response |
NCT01499147 (4) [back to overview] | Participants With 100 Day Transplant-related Mortality. |
NCT01499147 (4) [back to overview] | Number of Participants With Engraftment. |
NCT01499147 (4) [back to overview] | Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD). |
NCT01499147 (4) [back to overview] | Time to ANC and Platelet Engraftment |
NCT01518153 (2) [back to overview] | Overall Survival (OS) |
NCT01518153 (2) [back to overview] | Success Rate |
NCT01527045 (8) [back to overview] | Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD) |
NCT01527045 (8) [back to overview] | Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy |
NCT01527045 (8) [back to overview] | Number of Non-relapse Mortalities |
NCT01527045 (8) [back to overview] | Number of Donors Discontinuing Atorvastatin Due to Toxicity |
NCT01527045 (8) [back to overview] | Number of Patients With Recurrent or Progressive Malignancy |
NCT01527045 (8) [back to overview] | Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant |
NCT01527045 (8) [back to overview] | Number of Patients With Chronic Extensive GVHD |
NCT01527045 (8) [back to overview] | Number of Patients Surviving Overall |
NCT01529827 (4) [back to overview] | Progression Free Survival (PFS) at One Year |
NCT01529827 (4) [back to overview] | Median Time to Neutrophil Engraftment |
NCT01529827 (4) [back to overview] | Clinical Response |
NCT01529827 (4) [back to overview] | Transplant Related Mortality (TRM) |
NCT01564784 (12) [back to overview] | Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) |
NCT01564784 (12) [back to overview] | Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing |
NCT01564784 (12) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score |
NCT01564784 (12) [back to overview] | Change From Baseline in EQ-5D VAS |
NCT01564784 (12) [back to overview] | Progression-Free Survival (PFS) |
NCT01564784 (12) [back to overview] | Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT |
NCT01564784 (12) [back to overview] | Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) |
NCT01564784 (12) [back to overview] | Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score |
NCT01564784 (12) [back to overview] | Overall Survival (OS) |
NCT01564784 (12) [back to overview] | Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) |
NCT01564784 (12) [back to overview] | Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) |
NCT01564784 (12) [back to overview] | Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) |
NCT01565616 (8) [back to overview] | Graft Failure |
NCT01565616 (8) [back to overview] | Chronic Graft Versus Host Disease (GVHD) |
NCT01565616 (8) [back to overview] | Time to Neutrophil and Platelet Engraftment |
NCT01565616 (8) [back to overview] | PROMIS-57 Scores Health Related Quality of Life |
NCT01565616 (8) [back to overview] | Event -Free Survival Rate |
NCT01565616 (8) [back to overview] | Transplant Related Outcomes |
NCT01565616 (8) [back to overview] | Acute Graft Versus Host Disease (GVHD) |
NCT01565616 (8) [back to overview] | Overall Survival |
NCT01570348 (11) [back to overview] | EFS |
NCT01570348 (11) [back to overview] | Event-free Survival (EFS) |
NCT01570348 (11) [back to overview] | Incidence and Severity of GVHD |
NCT01570348 (11) [back to overview] | Incidence of Disease-modifying Drugs for CD Initiated Post-transplant |
NCT01570348 (11) [back to overview] | Overall Survival |
NCT01570348 (11) [back to overview] | Quality of Life Measured Using the Previously Validated Short Inflammatory Bowel Disease Questionnaire |
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] | Incidence of Graft Rejection |
NCT01570348 (11) [back to overview] | Development of Infectious Complications |
NCT01570348 (11) [back to overview] | Disease Activity |
NCT01572662 (3) [back to overview] | Overall Survival |
NCT01572662 (3) [back to overview] | Overall Survival |
NCT01572662 (3) [back to overview] | Non-Relapse Mortality Rate (NRM) |
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 |
NCT01596699 (3) [back to overview] | Number of Participants With Treatment-Related Adverse Events as a Measure of Safety and Tolerability |
NCT01596699 (3) [back to overview] | Engraftment Rate of Patients With Non-malignant Diseases (Stratum A) |
NCT01596699 (3) [back to overview] | Mixed-donor Chimerism Rate of Patients With High-risk Myeloid Malignancies (Stratum B) |
NCT01640301 (11) [back to overview] | Treatment-related Toxicity Rate (Arm II) |
NCT01640301 (11) [back to overview] | Treatment-related Toxicity Rate (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] | Maintenance of Function of Transduced T Cells (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 I) |
NCT01640301 (11) [back to overview] | Anti-leukemic Potential Efficacy, in Terms of Duration of Response (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] | 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 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] | Number of Participants With Progression Free Survival (PFS) |
NCT01659151 (3) [back to overview] | Percentage of Participants With Overall Response (OR) |
NCT01659151 (3) [back to overview] | Percentage of Participant Drop Out Rate |
NCT01690520 (6) [back to overview] | Time to Platelet Engraftment (20k) |
NCT01690520 (6) [back to overview] | Time to Neutrophil Engraftment |
NCT01690520 (6) [back to overview] | Overall Survival |
NCT01690520 (6) [back to overview] | Proportion of Patients With Severe Acute Graft Versus Host Disease |
NCT01690520 (6) [back to overview] | Proportion of Participants With Chronic Graft Versus Host Disease |
NCT01690520 (6) [back to overview] | Non-relapse Mortality |
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] | Progression Free Survival (PFS) |
NCT01701674 (4) [back to overview] | Overall Response Rate (ORR) |
NCT01707004 (8) [back to overview] | Progression Free Survival |
NCT01707004 (8) [back to overview] | Percentage of Participants With Platelet Recovery by Day 30 |
NCT01707004 (8) [back to overview] | Time to Neutrophil Recovery |
NCT01707004 (8) [back to overview] | Cumulative Incidence of Chronic GVHD According to BMTCTN |
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] | Number of Participants With Primary Graft Failure |
NCT01707004 (8) [back to overview] | Overall Survival (OS) |
NCT01723839 (2) [back to overview] | Overall Response Rate |
NCT01723839 (2) [back to overview] | Complete 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 Overall Survival Rate |
NCT01749293 (3) [back to overview] | Number of Participants That Had an Event Free Survival Rate |
NCT01773395 (5) [back to overview] | 18-Month Overall Survival |
NCT01773395 (5) [back to overview] | Percentage of Participants Experiencing Grade 3 or Higher Non-Hematologic or Grade 4 or Higher Hematologic Adverse Events |
NCT01773395 (5) [back to overview] | Percentage of Participants Experiencing Acute and Chronic Graft-Versus-Host Disease |
NCT01773395 (5) [back to overview] | Percentage of Participants With Relapse and/or Non-Relapse Mortality |
NCT01773395 (5) [back to overview] | 18-Month Progression Free Survival |
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 |
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 |
NCT01807611 (6) [back to overview] | Number of Transplant Recipients With Successful Engraftment |
NCT01807611 (6) [back to overview] | Number of Transplant Recipients With Transplant-related Mortality (TRM) |
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 |
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 |
NCT01823198 (3) [back to overview] | Overall Survival |
NCT01823198 (3) [back to overview] | Number of Participants With Grade 3 Toxicities |
NCT01823198 (3) [back to overview] | Number of Participants Who Experienced Dose-limiting Toxicities (DLT) |
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 |
NCT01824693 (4) [back to overview] | Number of Participants Who Experience Treatment-Related Mortality (TRM) by Day 100 |
NCT01861002 (1) [back to overview] | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) |
NCT01875237 (8) [back to overview] | To Assess the Proportions of GvHD Response Post-administration of AP1903. |
NCT01875237 (8) [back to overview] | To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD |
NCT01875237 (8) [back to overview] | To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903. |
NCT01875237 (8) [back to overview] | To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events. |
NCT01875237 (8) [back to overview] | To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism |
NCT01875237 (8) [back to overview] | To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903. |
NCT01875237 (8) [back to overview] | To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI. |
NCT01875237 (8) [back to overview] | Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD. |
NCT01877837 (2) [back to overview] | Overall Survival |
NCT01877837 (2) [back to overview] | Number of Participants With Graft Failure |
NCT01894477 (2) [back to overview] | Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
NCT01894477 (2) [back to overview] | Number of Participants That Did Not Progress Within 6 Months |
NCT01898793 (8) [back to overview] | Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) |
NCT01898793 (8) [back to overview] | Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I) |
NCT01898793 (8) [back to overview] | Time to Progression (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) |
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 of Particular Interest (AEPIs) |
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 Duration of Response (DoR) |
NCT01905943 (12) [back to overview] | Median Time to New Anti-Leukemia Therapy (TTNT) |
NCT01905943 (12) [back to overview] | Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry |
NCT01905943 (12) [back to overview] | Median Time to Event-Free Survival (EFS) |
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 |
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 |
NCT01991457 (1) [back to overview] | Number of Subjects Disease-free Survival |
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] | Overall Response Rate (ORR) |
NCT01993719 (13) [back to overview] | Overall Response Rate (ORR) |
NCT01993719 (13) [back to overview] | Progression-free Survival (PFS) |
NCT01993719 (13) [back to overview] | Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) |
NCT01993719 (13) [back to overview] | Overall Response Rate (ORR) |
NCT01993719 (13) [back to overview] | Number of Treatment-related Adverse Events for Participants Who Received Pembrolizumab |
NCT01993719 (13) [back to overview] | Progression-free Survival (PFS) |
NCT01993719 (13) [back to overview] | Progression-free Survival (PFS) |
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 With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P |
NCT02007863 (1) [back to overview] | Number of Successful Unrelated Cord Blood (UCB) Transplants |
NCT02013817 (6) [back to overview] | Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment) |
NCT02013817 (6) [back to overview] | Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment) |
NCT02013817 (6) [back to overview] | Time to Next Treatment - Percentage of Participants With an Event |
NCT02013817 (6) [back to overview] | Time to Next Treatment - Time to Event |
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) |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Engraftment Syndrome |
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 Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
NCT02029638 (18) [back to overview] | Number of Participants Free From Return to Immunosuppression for the Duration of the Study |
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] | Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant |
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 Days From Transplant to Platelet Count Recovery |
NCT02029638 (18) [back to overview] | Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery |
NCT02029638 (18) [back to overview] | Duration in Days of Graft-versus-Host Disease in Transplanted Participants |
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] | Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants With Acute Renal Allograft Rejection |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Died |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation |
NCT02029638 (18) [back to overview] | Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal |
NCT02029638 (18) [back to overview] | Percent of Participants Who Achieved Operational Tolerance |
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 |
NCT02048813 (2) [back to overview] | Overall Survival (OS) Rate at 3 Years |
NCT02048813 (2) [back to overview] | Progression-free Survival (PFS) Rate at 3 Years |
NCT02062359 (1) [back to overview] | Number of Participants With Adverse Events |
NCT02080195 (5) [back to overview] | Acute Graft Versus Host Disease (GVHD) |
NCT02080195 (5) [back to overview] | Survival |
NCT02080195 (5) [back to overview] | Graft Failure |
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) |
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 Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks |
NCT02111850 (6) [back to overview] | Number of Participants With Dose-limiting Toxicity (DLT) |
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] | Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment |
NCT02111850 (6) [back to overview] | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) |
NCT02111863 (3) [back to overview] | Count of Participants With Serious and Non-Serious Adverse Events |
NCT02111863 (3) [back to overview] | Overall Survival (OS) of Patients Receiving a Lymphocyte Depleting Preparative Regimen |
NCT02111863 (3) [back to overview] | Objective Response Rate of Patients With Metastatic Melanoma |
NCT02145039 (4) [back to overview] | Number of Patients With Hematopoietic Engraftment |
NCT02145039 (4) [back to overview] | 2 Year Survival |
NCT02145039 (4) [back to overview] | Number of Patients Experiencing Acute Graft-versus-host Disease by 100 Days |
NCT02145039 (4) [back to overview] | Number of Patients Experiencing Transplant Related Mortality (TRM) |
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 |
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 |
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 |
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 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 Malignant Relapse |
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 |
NCT02199041 (9) [back to overview] | Number of Participants With Event-free Survival (EFS) |
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) |
NCT02215967 (3) [back to overview] | Number of Participants With Dose Limiting Toxicities |
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 Non-relapsed-related Mortality Following Transplant |
NCT02224872 (11) [back to overview] | Participants With Chronic GVHD at One Year |
NCT02224872 (11) [back to overview] | Length of Time Required for Patients to Recover ANC and Platelet Counts After Transplant |
NCT02224872 (11) [back to overview] | Number of Participants With Grade II-IV or Grade III-IV Acute GVHD |
NCT02224872 (11) [back to overview] | Participants That Were GVHD Free, Relapse Free Survival (GRFS) |
NCT02224872 (11) [back to overview] | Number of Patients That Have Survived at One Year |
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 Participants With Major Toxicities Related to Transplant |
NCT02224872 (11) [back to overview] | Is This Type of Transplantation for Severe Aplastic Anemia Feasible and Safe? |
NCT02248597 (5) [back to overview] | 12 Month Disease Free Survival Probability |
NCT02248597 (5) [back to overview] | Progression Free Survival |
NCT02248597 (5) [back to overview] | Rate of Acute GvHD |
NCT02248597 (5) [back to overview] | Overall Survival |
NCT02248597 (5) [back to overview] | Relapse-free Mortality |
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] | Rate of MRD Negative CR After 3 Cycles of iFCR |
NCT02251548 (12) [back to overview] | Complete Response Rate (CRR) |
NCT02251548 (12) [back to overview] | Overall Response Rate |
NCT02251548 (12) [back to overview] | Partial Response Rate (PRR) |
NCT02251548 (12) [back to overview] | 1-year Combined Response With MRD From Bone Marrow |
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] | 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] | 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] | Median Overall Survival (OS) |
NCT02251548 (12) [back to overview] | Median Progression-Free Survival (PFS) |
NCT02251548 (12) [back to overview] | Median Time to Bone Marrow MRD Negativity |
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] | Mean of Days to Absolute Neutrophil Count (ANC) Engraftment |
NCT02259348 (9) [back to overview] | Incidence of Malignant Relapse |
NCT02259348 (9) [back to overview] | Median Days to Absolute Neutrophil Count (ANC) Engraftment |
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] | Incidence and Severity of Acute GvHD |
NCT02259348 (9) [back to overview] | Rate of Transplant-related Mortality (TRM) |
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] | Maximum Tolerated Dose (MTD) |
NCT02280811 (7) [back to overview] | Number of Participants With a Dose Limiting Toxicity (DLT) |
NCT02280811 (7) [back to overview] | Number of Participants With Serious and Non-serious Adverse Events |
NCT02280811 (7) [back to overview] | Objective Tumor Response Rate (Complete or Partial Response) |
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] | Duration of Response |
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. |
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 |
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] | Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood |
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 1 Study: ORR as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma |
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] | Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 1 and Phase 2 Cohorts 1 and 2) |
NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokine (CRP) in Serum |
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] | 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: Progression-Free Survival (PFS) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma |
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] | Phase 2 Pivotal Study (Cohorts 1 and 2): ORR Per Independent Radiological Review Committee (IRRC) |
NCT02348216 (29) [back to overview] | Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 2 Cohort 3) |
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 Positive Replication Competent Retrovirus (RCR) |
NCT02348216 (29) [back to overview] | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
NCT02348216 (29) [back to overview] | Percentage of Participants With Anti-Axicabtagene Ciloleucel Antibodies |
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 2 Safety Management Study: EQ-5D Visual Analogue Scale (VAS) Score |
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] | Phase 2: Overall Survival (OS) |
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] | 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 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades |
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] | 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] | 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) |
NCT02354690 (5) [back to overview] | Treatment Related Immune Responses |
NCT02354690 (5) [back to overview] | Number of Reported Adverse Events |
NCT02354690 (5) [back to overview] | Objective Response Rate |
NCT02354690 (5) [back to overview] | Overall Survival |
NCT02354690 (5) [back to overview] | Progression Free Survival |
NCT02379195 (5) [back to overview] | Objective Response Rate |
NCT02379195 (5) [back to overview] | Number of Participants With Adverse Events/Serious Adverse Events |
NCT02379195 (5) [back to overview] | Treatment Related Immune Responses |
NCT02379195 (5) [back to overview] | Progression Free Survival |
NCT02379195 (5) [back to overview] | Overall Survival |
NCT02421939 (12) [back to overview] | Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm |
NCT02421939 (12) [back to overview] | Percentage of Participants Who Achieved Transfusion Conversion and Maintenance |
NCT02421939 (12) [back to overview] | Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant |
NCT02421939 (12) [back to overview] | Change From Baseline in Brief Fatigue Inventory (BFI) |
NCT02421939 (12) [back to overview] | Percentage of Participants With Composite Complete Remission (CRc Rate) |
NCT02421939 (12) [back to overview] | Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh) |
NCT02421939 (12) [back to overview] | Percentage of Participants With Complete Remission (CR) Rate |
NCT02421939 (12) [back to overview] | Duration of Remission |
NCT02421939 (12) [back to overview] | Duration of Overall Survival (OS) |
NCT02421939 (12) [back to overview] | Duration of Leukemia-Free Survival (LFS) |
NCT02421939 (12) [back to overview] | Duration of Event-Free Survival (EFS) |
NCT02421939 (12) [back to overview] | Number of Participants With Adverse Events |
NCT02435901 (3) [back to overview] | Event Free Survival; Number of Participants Who Survived at 2 Years |
NCT02435901 (3) [back to overview] | Assessment of Treatment Related Mortality and Morbidity |
NCT02435901 (3) [back to overview] | Number of Participants With Sustained Cell Engraftment of Donor Cells |
NCT02440464 (14) [back to overview] | Percentage of Participants With Infections Post-randomization by Infection Type |
NCT02440464 (14) [back to overview] | Percentage of Participants With Disease Progression |
NCT02440464 (14) [back to overview] | Percentage of Participants With Overall Survival (OS) |
NCT02440464 (14) [back to overview] | Percentage of Participants With Progression-Free Survival |
NCT02440464 (14) [back to overview] | Percentage of Participants With Toxicities Post-randomization by Toxicity Type |
NCT02440464 (14) [back to overview] | Percentage of Participants With Treatment-Related Mortality (TRM) |
NCT02440464 (14) [back to overview] | Percentage of Participants With Best Response to Treatment After Randomization |
NCT02440464 (14) [back to overview] | Percentage of Participants With Response to Treatment |
NCT02440464 (14) [back to overview] | Percentage of Participants With Infections Post-randomization by Time Point |
NCT02440464 (14) [back to overview] | Percentage of Participants With Acute GVHD (Grades III-IV) |
NCT02440464 (14) [back to overview] | Medical Outcomes Study (MOS) - Short Form 36 (SF-36) Score |
NCT02440464 (14) [back to overview] | Percentage of Participants With Chronic GVHD |
NCT02440464 (14) [back to overview] | Functional Assessment of Cancer Therapy (FACT) - Bone Marrow Transplant (BMT) Total Score |
NCT02440464 (14) [back to overview] | Percentage of Participants With Toxicities Post-randomization by Time Point |
NCT02497404 (9) [back to overview] | Acute Graft-versus-Host Disease (GVHD) |
NCT02497404 (9) [back to overview] | Disease Free Survival at 1 Year Post-transplant |
NCT02497404 (9) [back to overview] | Overall Survival at 6 Months Post-transplant |
NCT02497404 (9) [back to overview] | Disease Free Survival at 6 Months Post-transplant |
NCT02497404 (9) [back to overview] | Graft Failure |
NCT02497404 (9) [back to overview] | High-Risk Extensive Chronic Graft-versus-Host-Disease |
NCT02497404 (9) [back to overview] | Overall Survival at 1 Year Post-Transplant |
NCT02497404 (9) [back to overview] | Overall Survival at 2 Years Post-Transplant |
NCT02497404 (9) [back to overview] | Disease Free Survival at 2 Years Post-transplant |
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) |
NCT02556931 (22) [back to overview] | Number of Participants Who Experience Disease Relapse, Days 90-180 (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 Non-relapse Mortality, Day 360 (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 Grades III-IV GVHD, 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 Relapse, Day 360 (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 Graft Failure, Days 90-180 (D90) |
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 (D90) |
NCT02556931 (22) [back to overview] | Number of Number of Participants With Severe Chronic GVHD, Day 360 (D60) |
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 Grades III-IV GVHD, Day 360 (D60) |
NCT02556931 (22) [back to overview] | Number of Participants With Chronic 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 Grades III-IV Acute GVHD, Days 60-180 (D60) |
NCT02556931 (22) [back to overview] | Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (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 Number of Participants With Severe Chronic GVHD, Day 360 (D90) |
NCT02556931 (22) [back to overview] | Number of Participants Who Experience Disease Relapse, Days 60-180 (D60) |
NCT02556931 (22) [back to overview] | Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90) |
NCT02581007 (4) [back to overview] | Graft Rejection |
NCT02581007 (4) [back to overview] | GVHD Incidence |
NCT02581007 (4) [back to overview] | Overall Survival |
NCT02581007 (4) [back to overview] | Relapse Incidence |
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 Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT02588612 (10) [back to overview] | Disease Control Rate (DCR) |
NCT02588612 (10) [back to overview] | Duration of Response |
NCT02588612 (10) [back to overview] | Overall Response Rate (ORR) |
NCT02588612 (10) [back to overview] | Progression-Free Survival (PFS) by Investigator Assessment |
NCT02588612 (10) [back to overview] | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings |
NCT02588612 (10) [back to overview] | Time to Response |
NCT02588612 (10) [back to overview] | Change From Baseline in Oxygen Saturation |
NCT02588612 (10) [back to overview] | Number of Participants With Any Grade Increase in Clinical Chemistry Parameters |
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) Usual Activity Scale 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] | Change Over Time in EQ-5D Visual Analogue Scale (VAS) 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 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] | 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: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
NCT02614066 (18) [back to overview] | Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies |
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: 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: 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 With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale |
NCT02614066 (18) [back to overview] | Phase 2: Relapse-free Survival (RFS) |
NCT02614066 (18) [back to overview] | Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) |
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: Duration of Remission (DOR) Per Independent Review |
NCT02614066 (18) [back to overview] | Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate |
NCT02614066 (18) [back to overview] | Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) |
NCT02614066 (18) [back to overview] | Phase 2: MRD Negative Rate Among Complete Remission (CR) Participants |
NCT02614066 (18) [back to overview] | Phase 2: Complete Remission (CR) Rate Per Independent Review |
NCT02614066 (18) [back to overview] | Phase 2: MRD Negative Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants |
NCT02614066 (18) [back to overview] | Phase 2: OCR Rate (CR + CRi) Per Investigator Review |
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: Overall Survival (OS) |
NCT02614560 (7) [back to overview] | Incidence of Laboratory Abnormalities |
NCT02614560 (7) [back to overview] | Rate of MRD Negativity |
NCT02614560 (7) [back to overview] | Best Response of CR or CRi |
NCT02614560 (7) [back to overview] | Duration of Response |
NCT02614560 (7) [back to overview] | Overall Survival |
NCT02614560 (7) [back to overview] | Incidence of Adverse Events |
NCT02614560 (7) [back to overview] | 1-year Survival Rate |
NCT02626338 (1) [back to overview] | Clinical Response to Crenolanib With Standard Salvage Chemotherapy |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Cytarabine Time of Maximum Concentration |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Cytarabine Volume of Distribution |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Daunorubicin Area Under the Curve |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Daunorubicin Clearance |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Daunorubicin Volume of Distribution |
NCT02642965 (11) [back to overview] | Number of Participants With a Dose-limiting Toxicity |
NCT02642965 (11) [back to overview] | Percentage of Responders (Complete Response or Complete Remission With Partial or Incomplete Platelet Recovery) After First Cycle of Therapy |
NCT02642965 (11) [back to overview] | Percentage of Responders (Complete Response or Complete Remission With Partial Platelet Recovery) After up to 2 Cycles |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Daunorubicin Time of Maximum Concentration |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Cytarabine Area Under the Curve |
NCT02642965 (11) [back to overview] | Liposome-encapsulated Cytarabine Clearance |
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] | Overall Survival (OS) |
NCT02652468 (7) [back to overview] | Number of Participants With Severe Chronic GVHD |
NCT02652468 (7) [back to overview] | Number of Participants With Graft Failure |
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] | Progression-free Survival |
NCT02652468 (7) [back to overview] | Number of Participants With Treatment-related Mortality |
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] | Number of Participants With Evidence of Immunogenicity of the Chimeric Antigen Receptor (CAR) T-cell Product |
NCT02659943 (12) [back to overview] | Number of Participants With a Dose-Limiting Toxicity (DLT) |
NCT02659943 (12) [back to overview] | Number of Participants Who Had Anti-Lymphoma Activity |
NCT02659943 (12) [back to overview] | MTD |
NCT02659943 (12) [back to overview] | Median Peak Chimeric Antigen Receptor (CAR) T Cells Level for Participants Treated |
NCT02659943 (12) [back to overview] | Maximum Feasible Dose |
NCT02659943 (12) [back to overview] | Number of Participants With a Duration of Best Response in Months |
NCT02659943 (12) [back to overview] | Number of Participants Who Had a Second or Third Infusion of Chimeric Antigen Receptor (CAR)+ T Cells |
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 That Had Any Grade 2, 3, 4 and 5 Adverse Events |
NCT02659943 (12) [back to overview] | Percentage of Enrolled Participants Who Actually Get Treated |
NCT02706405 (14) [back to overview] | Highest Treatment Dose Administered on Study |
NCT02706405 (14) [back to overview] | Rate of Complete Response (CR) by Investigator Assessment Using Lugano Criteria |
NCT02706405 (14) [back to overview] | Progression Free Survival |
NCT02706405 (14) [back to overview] | Overall Survival |
NCT02706405 (14) [back to overview] | Objective Response Rate by Investigator Assessment Using Lugano Criteria |
NCT02706405 (14) [back to overview] | Maximum JCAR014 Cmax in Blood by Quantitative Polymerase Chain Reaction (qPCR) Analysis |
NCT02706405 (14) [back to overview] | Maximum JCAR014 Cmax by Flow Cytometry |
NCT02706405 (14) [back to overview] | Duration of Response |
NCT02706405 (14) [back to overview] | Dose Limiting Toxicity (DLT) Rates |
NCT02706405 (14) [back to overview] | Count of Participants Who Experienced Adverse Events |
NCT02706405 (14) [back to overview] | AUC of JCAR014 Cells by qPCR Analysis |
NCT02706405 (14) [back to overview] | Area Under the Curve (AUC) of JCAR014 by Flow Cytometry |
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 |
NCT02756572 (19) [back to overview] | Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - GENDER |
NCT02756572 (19) [back to overview] | Overall Survival (OS) Among Patients Who Received Early Transplant. |
NCT02756572 (19) [back to overview] | Treatment Related Mortality Among Patients Who Received Early Transplant vs Patients Who Did Not Receive Early Transplant |
NCT02756572 (19) [back to overview] | Relapse-free Survival (RFS) Among Patients Who Received Early Transplant |
NCT02756572 (19) [back to overview] | Relapse-free Survival (RFS) Among Patients Who Received Early Transplant |
NCT02756572 (19) [back to overview] | Overall Survival (OS) Among Patients Who Received Early Transplant. |
NCT02756572 (19) [back to overview] | Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant |
NCT02756572 (19) [back to overview] | Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant |
NCT02756572 (19) [back to overview] | Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - TREATMENT RELATED MORTALITY |
NCT02756572 (19) [back to overview] | Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants |
NCT02756572 (19) [back to overview] | Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - AGE |
NCT02756572 (19) [back to overview] | Event-free Survival (EFS) Among Patients Who Received Early Transplant |
NCT02756572 (19) [back to overview] | Event-free Survival (EFS) Among Patients Who Received Early Transplant |
NCT02756572 (19) [back to overview] | Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant |
NCT02756572 (19) [back to overview] | Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant |
NCT02756572 (19) [back to overview] | Acute Graft Versus Host Disease Among Patients Who Received Early Transplant |
NCT02756572 (19) [back to overview] | Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84 |
NCT02756572 (19) [back to overview] | Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 |
NCT02756572 (19) [back to overview] | Demonstrate the Feasibility of Collecting Resource Utilization Data for Trial Participants |
NCT02757885 (12) [back to overview] | Veno-occlusive Disease (VOD) Rate |
NCT02757885 (12) [back to overview] | Rate of Disease Recurrence |
NCT02757885 (12) [back to overview] | Primary Graft Rejection Rate |
NCT02757885 (12) [back to overview] | Overall Survival Rate |
NCT02757885 (12) [back to overview] | Late Graft Rejection Rate |
NCT02757885 (12) [back to overview] | Infection Rate |
NCT02757885 (12) [back to overview] | Frequency of Stroke |
NCT02757885 (12) [back to overview] | Frequency of Idiopathic Pneumonia Syndrome (IPS) |
NCT02757885 (12) [back to overview] | Rate of Central Nervous System (CNS) Toxicity |
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 |
NCT02761915 (7) [back to overview] | Assessment of Tumour Response From Baseline (RECIST) |
NCT02761915 (7) [back to overview] | Safety and Tolerability of 1RG-CART Therapy |
NCT02761915 (7) [back to overview] | To Determine Recommended Phase II Regimen by Assessing the Number of DLTs at Each Dose Level |
NCT02761915 (7) [back to overview] | 1RG-CART Counts in the Peripheral Blood |
NCT02761915 (7) [back to overview] | To Evaluate Anti-tumour Activity (Overall Survival) |
NCT02761915 (7) [back to overview] | To Evaluate Anti-tumour Activity (Progression Free Survival) |
NCT02761915 (7) [back to overview] | Assessment of Tumour Response From Baseline (irRC) |
NCT02771197 (2) [back to overview] | Number of Patients With 2-year Relapse Risk |
NCT02771197 (2) [back to overview] | Assess Safety of Pembrolizumab by Recording the Number of Participants With Treatment-related Adverse Events |
NCT02774291 (1) [back to overview] | Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0 |
NCT02833805 (12) [back to overview] | Number of Participants Who Experience Primary Graft Failure |
NCT02833805 (12) [back to overview] | Number of Participants Who Experience Grades III-IV Acute GVHD |
NCT02833805 (12) [back to overview] | Number of Participants Who Experience Grades II-IV Acute GVHD |
NCT02833805 (12) [back to overview] | Overall Survival at One Year |
NCT02833805 (12) [back to overview] | GVHD-free Relapse-free Survival (GRFS) |
NCT02833805 (12) [back to overview] | Probability of Neutrophil Recovery as Assessed by the Number of Participants Who Have Recovered Neutrophil Counts |
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] | Overall Survival and Engraftment at One Year |
NCT02833805 (12) [back to overview] | Number of Participants With Full Donor Chimerism |
NCT02833805 (12) [back to overview] | Number of Participants Who Experience Secondary Graft Failure |
NCT02833805 (12) [back to overview] | Transplant-related Mortality |
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 Neutrophil Recovery |
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 Graft-Failure-Free Survival |
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] | Percentage of Participants With Primary Graft Failure |
NCT02918292 (15) [back to overview] | Percentage of Participants With Secondary Graft Failure |
NCT02918292 (15) [back to overview] | Frequencies of Infections Categorized by Infection Type |
NCT02918292 (15) [back to overview] | Health Related Quality of Life (HR-QoL) - PedsQL Stem Cell Transplant Module |
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] | Participants With Grade 3-5 Toxicities by SOC |
NCT02918292 (15) [back to overview] | Health Related Quality of Life (HR-QoL) - Medical Outcomes Study Short Form (MOS SF-36) |
NCT02926833 (22) [back to overview] | Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |
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: 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 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: 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: 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: 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: 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: Objective Response Rate (ORR) |
NCT02926833 (22) [back to overview] | Phase 1 and 2: Overall Survival (OS) |
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: Peak Serum Levels of C-Reactive Protein (CRP) 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: Peak Serum Levels of Interleukin-2 Receptor Alpha (IL-2Rα) in Blood |
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: Percentage of Participants With Anti-Atezolizumab Antibodies |
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 Hematology Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Values |
NCT02926833 (22) [back to overview] | Phase 1 and 2: Progression-Free Survival (PFS) |
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] | Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794 |
NCT02992743 (22) [back to overview] | Change From Baseline in ECG Mean Heart Rate |
NCT02992743 (22) [back to overview] | Progression Free Survival (PFS) Assessed by Investigator |
NCT02992743 (22) [back to overview] | Time to Cmax (Tmax) |
NCT02992743 (22) [back to overview] | Time to Response (TTR) Assessed by Independent Reviewer |
NCT02992743 (22) [back to overview] | Duration of Response (DOR) Assessed by Independent Reviewer |
NCT02992743 (22) [back to overview] | Number of Participants With Insertional Oncogenesis |
NCT02992743 (22) [back to overview] | Duration of Response (DOR) Assessed by Investigator |
NCT02992743 (22) [back to overview] | Maximum Transgene Expansion (Cmax) of GSK3377794 |
NCT02992743 (22) [back to overview] | Progression Free Survival (PFS) Assessed by Independent Reviewer |
NCT02992743 (22) [back to overview] | Time to Response (TTR) Assessed by Investigator |
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] | Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment |
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 Adverse Event of Special Interest (AESI) |
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 Any Grade Increase in Hematology Results at Worst-case Post-baseline |
NCT02992743 (22) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs |
NCT02992743 (22) [back to overview] | Number of Participants With Positive Anti-drug Antibodies (ADAs) |
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 Investigator Assessment |
NCT03018223 (4) [back to overview] | Incidence of Chronic GVHD |
NCT03018223 (4) [back to overview] | Incidence of Grade II-IV Acute Graft vs. Host Disease (GVHD) |
NCT03018223 (4) [back to overview] | Progression Free Survival (PFS) |
NCT03018223 (4) [back to overview] | Overall Survival (OS) |
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 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] | 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] | 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 |
NCT03071276 (3) [back to overview] | The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response) |
NCT03071276 (3) [back to overview] | Complete Response |
NCT03071276 (3) [back to overview] | Complete Response or Complete Response With Incomplete Count Recovery |
NCT03096782 (3) [back to overview] | Time to Engraftment |
NCT03096782 (3) [back to overview] | Disease-free Survival |
NCT03096782 (3) [back to overview] | Overall Survival |
NCT03128359 (3) [back to overview] | Overall Survival (OS) 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 |
NCT03168438 (13) [back to overview] | Maximum Persistence (Cmax) of GSK3377794 |
NCT03168438 (13) [back to overview] | Duration of Response |
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] | 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] | 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] | Time to Maximum Persistence |
NCT03168438 (13) [back to overview] | Progression-free Survival |
NCT03168438 (13) [back to overview] | Overall Response Rate |
NCT03168438 (13) [back to overview] | Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings |
NCT03215810 (2) [back to overview] | Number of Participants With Objective Response |
NCT03215810 (2) [back to overview] | Rate of Dose Limiting Toxicity (DLT) |
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 |
NCT03303950 (8) [back to overview] | Number of Participants With Minimal Residual Disease (MRD) Response |
NCT03303950 (8) [back to overview] | Disease Free Survival at One Year |
NCT03303950 (8) [back to overview] | Incidence of Acute Graft Versus Host Disease (GVHD) |
NCT03303950 (8) [back to overview] | Incidence of Chronic GVHD |
NCT03303950 (8) [back to overview] | Non-relapse Mortality (NRM) at Day 100 |
NCT03303950 (8) [back to overview] | Non-relapse Mortality (NRM) at Day 365 |
NCT03303950 (8) [back to overview] | Overall 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] | 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] | Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
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] | Objective Response Rate (ORR) as Determined by Study Investigators According to the International Myeloma Working Group (IMWG) Consensus Panel 1 Criteria |
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] | 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] | Objective Response Rate (ORR) |
NCT03338972 (7) [back to overview] | Overall Survival (OS) |
NCT03338972 (7) [back to overview] | Progression-free Survival (PFS) |
NCT03504410 (1) [back to overview] | Complete Remission (CR) |
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 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] | Number of Participants at Each Dose Level Who Experience a Dose-Limiting Toxicity (DLT) |
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] | Objective Response Rate (ORR) Per Investigator Review Assessed by International Workshop on CLL (IWCLL) 2018 Criteria |
NCT03624036 (4) [back to overview] | Peak Level of Anti-CD19 CAR T-Cells in Blood |
NCT03624036 (4) [back to overview] | Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
NCT03624036 (4) [back to overview] | Number of Participants Experiencing Dose Limiting Toxicities (DLTs) |
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] | Duration of Response (DOR) Per the Lugano Classification |
NCT03761056 (15) [back to overview] | Event-Free Survival (EFS) |
NCT03761056 (15) [back to overview] | Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators |
NCT03761056 (15) [back to overview] | Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators |
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] | Overall Survival (OS) |
NCT03761056 (15) [back to overview] | Peak Serum Level of Granzyme B, Interferon-gamma (IFNg), Interleukin (IL)-2, IL-5, IL-6, IL-8 |
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] | Peak Serum Level of C-Reactive Protein (CRP) |
NCT03761056 (15) [back to overview] | Peak Serum Level of Ferritin |
NCT03761056 (15) [back to overview] | Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood |
NCT03761056 (15) [back to overview] | Progression-Free Survival (PFS) |
NCT03761056 (15) [back to overview] | Relapse With Central Nervous Disease (CNS) Disease |
NCT03813147 (8) [back to overview] | Elimination Half-life of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS |
NCT03813147 (8) [back to overview] | Maximum Time to Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS |
NCT03813147 (8) [back to overview] | Total Plasma Clearance of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS |
NCT03813147 (8) [back to overview] | Maximum Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS |
NCT03813147 (8) [back to overview] | Number of Participants With Adverse Events Attributable to MLN4924 (Pevonedistat) |
NCT03813147 (8) [back to overview] | Number of Participants With Antitumor Activity of MLN4924 (Pevonedistat) |
NCT03813147 (8) [back to overview] | Number of Participants With Dose Limiting Toxicities of MLN4924 (Pevonedistat) |
NCT03813147 (8) [back to overview] | Area Under the Plasma Concentration Versus Time Curve of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS |
NCT03860844 (13) [back to overview] | AML: AUC of Isatuximab |
NCT03860844 (13) [back to overview] | Percentage of Participants With Complete Response (CR) Rate |
NCT03860844 (13) [back to overview] | Overall Response Rate (ORR) |
NCT03860844 (13) [back to overview] | Number of Participants With Infusion Reactions (IRs) |
NCT03860844 (13) [back to overview] | CD38 Receptor Occupancy |
NCT03860844 (13) [back to overview] | AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough) |
NCT03860844 (13) [back to overview] | Cluster of Differentiation (CD)38 Receptor Density |
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] | CD38 Receptor Occupancy |
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] | B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab |
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: Ceoi of Isatuximab |
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) |
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) |
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 a Response |
NCT04002115 (7) [back to overview] | Severity of Chronic GVHD |
NCT04002115 (7) [back to overview] | Rate of Chronic GVHD |
NCT04002115 (7) [back to overview] | Severity of Acute Graft-versus-host Disease (GVHD) |
NCT04002115 (7) [back to overview] | Complete Remission (CR) Rate at Day 30 Post HSCT |
NCT04002115 (7) [back to overview] | Non-relapse Related Mortality |
NCT04002115 (7) [back to overview] | Rate of Acute Graft-versus-host Disease (GVHD) |
NCT04002115 (7) [back to overview] | Neutrophil Engraftment |
NCT04030195 (4) [back to overview] | Objective Response Rate |
NCT04030195 (4) [back to overview] | Maximum Tolerated Dose (MTD) |
NCT04030195 (4) [back to overview] | Number of Participants With Dose-Limiting Toxicities |
NCT04030195 (4) [back to overview] | Progression-free Survival (PFS) |
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] | Maximum Tolerated Dose (MTD) of 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] | Percentage of Peak Blood Chimeric Antigen Receptors (CAR) T Cells |
NCT04160195 (7) [back to overview] | Percentage of Peripheral Blood Mononuclear Cells (PBMC) of Chimeric Antigen Receptors (CAR) T Cells |
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 |
NCT04205240 (2) [back to overview] | Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD) |
NCT04205240 (2) [back to overview] | Number of Patients With a Partial Response |
NCT04339101 (3) [back to overview] | Progression Free Survival (PFS) |
NCT04339101 (3) [back to overview] | Cumulative Incidence of Grade II-IV Acute GVHD |
NCT04339101 (3) [back to overview] | Graft-versus-host Disease Free Relapse Free (GRFS) at 1 Year |
NCT04395222 (2) [back to overview] | Proportion of Failure of the Haplo-Graft |
NCT04395222 (2) [back to overview] | Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment |
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] | 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] | Objective Response Rates |
NCT05993299 (5) [back to overview] | Time to Cmax (Tmax) |
NCT05993299 (5) [back to overview] | Overall Response Rate (ORR) |
NCT05993299 (5) [back to overview] | Maximum Transgene Expansion (Cmax) |
NCT05993299 (5) [back to overview] | Disease Control Rate (DCR) |
NCT05993299 (5) [back to overview] | Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) |
Change in Gene Expression Post Chemo
Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells. (NCT00001586)
Timeframe: 6 hours post treatment, and 24 hours post treatment
Intervention | Percent change in cells (Number) |
---|
| 6 hours post treatment (e.g. ># cells) | 24 hours post treatment (e.g. > # cells) |
---|
Intermediate-high Risk B-Cell Pts | 30 | 50 |
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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. (NCT00001586)
Timeframe: 13 years, 10.5 months
Intervention | Participants (Number) |
---|
Intermediate-high Risk B-Cell Pts | 18 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
(NCT00027560)
Timeframe: 12 months post transplant
Intervention | participants (Number) |
---|
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES | 37 |
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Overall Survival
(NCT00027560)
Timeframe: 24 months post transplant
Intervention | participants (Number) |
---|
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES | 30 |
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Relapse Free Survival
Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of > 5% blasts after a documented complete remission. (NCT00036738)
Timeframe: Assessed up to 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Nonmyeloablative HSCT) | 3 |
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Overall Survival
Number of patients surviving up to five years post-transplant. (NCT00036738)
Timeframe: Assessed up to 5 years
Intervention | Participants (Count of Participants) |
---|
| 6 Months | 1 Year | 2 Years | 3 Years | 4 Years | 5 Years |
---|
Treatment (Allogeneic Nonmyeloablative HSCT) | 26 | 24 | 19 | 17 | 16 | 13 |
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Leukemia-free Survival
Number of patients surviving in CR up to five years post-transplant. (NCT00036738)
Timeframe: Assessed up to 5 years
Intervention | Participants (Count of Participants) |
---|
| 6 Months | 1 Year | 2 Years | 3 Years | 4 Years | 5 Years |
---|
Treatment (Allogeneic Nonmyeloablative HSCT) | 19 | 17 | 13 | 11 | 11 | 10 |
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Number of Participants With Absolute Neutrophil Count Engraftment
Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Baseline to Day 30 post transplant. (NCT00038857)
Timeframe: Day 0 up to Day 30
Intervention | participant (Number) |
---|
Melphalan + Thiotepa + Fludarabine + Rabbit ATG + CD34 PBPC | 21 |
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Evaluate the Risk for Disease Progression and Relapse
Percentage patients who relapsed/progressed within 1 year post-transplant. (NCT00040846)
Timeframe: 1 year after transplant
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 21.7 |
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Evaluate the Risk/Incidence of Infections
Percentage patients who experienced infections within 100 days post-transplant. (NCT00040846)
Timeframe: 100 days after transplant
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 91.7 |
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Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells. (NCT00040846)
Timeframe: 100 days after transplant
Intervention | percentage of participants (Number) |
---|
| CD3 - Graft rejection | CD3 - Mixed chimerism | CD3 - Full donor chimerism | CD3 - Unknown | CD33 - Graft Rejection | CD33 - Mixed chimerism | CD33 - Full donor chimerism | CD33 - Unknown |
---|
Dose Level 1 (No Campath) | 3.3 | 18.3 | 70 | 8.33 | 1.7 | 3.3 | 80 | 15 |
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Evaluate the Risk of Occurrence of Acute and Chronic GVHD
"Percentage patients who developed acute/chronic GVHD.~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" (NCT00040846)
Timeframe: 1 year after transplant
Intervention | percentage of participants (Number) |
---|
| Grade III-IV aGVHD | cGVHD |
---|
Dose Level 1 (No Campath) | 23.3 | 41.7 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Disease-free Survival-incidence of Survival Without Relapse
Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%. (NCT00045435)
Timeframe: By 1 year after transplant
Intervention | percentage of participants (Number) |
---|
Treatment (Nonmyeloablative Donor PBSC Transplant) | 47 |
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Incidence of Rejection
Percent patients who developed infections post-transplant. (NCT00045435)
Timeframe: By 1 year after transplant
Intervention | percentage of participants (Number) |
---|
Treatment (Nonmyeloablative Donor PBSC Transplant) | 0 |
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Incidence of Acute and Chronic GVHD
Percent patients with acute/chronic GVHD (NCT00045435)
Timeframe: aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.
Intervention | percentage of participants (Number) |
---|
| Grade II-IV aGVHD | cGVHD |
---|
Treatment (Nonmyeloablative Donor PBSC Transplant) | 35.3 | 35.3 |
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Overall Survival
Percent patients surviving. (NCT00045435)
Timeframe: By 1 year after transplant
Intervention | percentage of participants (Number) |
---|
Treatment (Nonmyeloablative Donor PBSC Transplant) | 70.6 |
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Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death
Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%. (NCT00045435)
Timeframe: 200 days after transplant
Intervention | percentage of participants (Number) |
---|
Treatment (Nonmyeloablative Donor PBSC Transplant) | 6 |
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Incidence of Relapse
Percent patients with relapsed disease post-transplant. (NCT00045435)
Timeframe: By 1 year after transplant
Intervention | percentage of participants (Number) |
---|
Treatment (Nonmyeloablative Donor PBSC Transplant) | 41.2 |
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Number of Participants That Remained Disease-free
Number of participants that remained Disease-free survival following stem cell transplant. Disease-free survival is defined as survival free of disease relapse or disease progression following stem cell transplant. (NCT00047060)
Timeframe: up to 100 days
Intervention | Participants (Count of Participants) |
---|
Stem Cell Transplant Therapy With Campath-1H | 4 |
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Number of Participants That Experienced Red Blood Cell Recovery
Number of participants that experienced red blood cell recovery following stem cell transplant. Red blood cell recovery is defined as achieving transfusion independence. (NCT00047060)
Timeframe: up to 100 days
Intervention | Participants (Count of Participants) |
---|
Stem Cell Transplant Therapy With Campath-1H | 5 |
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Efficacy of Nonmyeloablative Preparative Regimen
Proportion of subjects achieving a complete response. Complete response (CR) is defined as: disappearance of all signs and symptoms of cutaneous T-cell lymphomas (CTCL) for a period of at least one month. (NCT00047060)
Timeframe: 36 months
Intervention | Participants (Count of Participants) |
---|
Stem Cell Transplant Therapy With Campath-1H | 4 |
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Number of Participants That Experienced Platelet Recovery
Number of participants that experienced platelet recovery up to day 100 following stem cell transplant. Platelet recovery is defined as platelet count is greater than 50 x 10^9/l without platelet transfusion. (NCT00047060)
Timeframe: up to 100 days
Intervention | Participants (Count of Participants) |
---|
Stem Cell Transplant Therapy With Campath-1H | 5 |
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Number of Participants That Experienced Graft Failure
Number of participants that experienced graft failure. Graft failure is defined as: the failure to achieve sustained engraftment following stem cell transplantation. (NCT00047060)
Timeframe: up to 100 days
Intervention | Participants (Count of Participants) |
---|
Stem Cell Transplant Therapy With Campath-1H | 0 |
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Number of Participants That Experienced Engraftment
Number of participants that experienced engraftment following stem cell transplant. Engraftment is defined as neutrophil count is greater than 0.5 x10^9. (NCT00047060)
Timeframe: up to 100 days
Intervention | Participants (Count of Participants) |
---|
Stem Cell Transplant Therapy With Campath-1H | 5 |
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Number of Participants Overall Survival
Number of participants overall survival following stem cell transplant. Overall survival is defined as number participants alive following stem cell transplant (NCT00047060)
Timeframe: up to 5 years
Intervention | Participants (Count of Participants) |
---|
Stem Cell Transplant Therapy With Campath-1H | 3 |
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Number of Participants Who Experienced Acute GVHD Grades II-IV
"Number of participants who experienced acute GVHD grades II-IV~Acute-GVHD was graded and staged prospectively using criteria from the 1994 Consensus Conference on Acute- GVHD Grading.~Grades are defined as:~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 II GVHD as moderate, grade III as severe, and grade IV life-threatening." (NCT00047060)
Timeframe: up to 100 days
Intervention | Participants (Count of Participants) |
---|
| Grade II | Grade III-IV |
---|
Stem Cell Transplant Therapy With Campath-1H | 0 | 1 |
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Number of Participant Who Experienced Chronic Graft Versus Host Disease
"Number of participant who experienced chronic graft versus host disease (GVHD) following stem cell transplant The diagnosis of clinical features of chronic-GVHD was determined prospectively and classified retrospectively into limited or extensive based on the Revised Seattle Classification. Chronic GvHD severity categorized as limited is defined as: localized skin lesions with or without limited hepatic involvement and extensive is defined as: generalized skin involvement, major hepatic complications, or involvement of any other organ." (NCT00047060)
Timeframe: Day 100 up to 3 years
Intervention | Participants (Count of Participants) |
---|
| Limited | Extensive |
---|
Stem Cell Transplant Therapy With Campath-1H | 3 | 0 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Serious Adverse Events
Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9. (NCT00053014)
Timeframe: 9 months
Intervention | participants (Number) |
---|
Treatment | 0 |
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Overall Survival
measured from date of registration to study until death from any cause with patients still alive censored at date of last contact (NCT00053014)
Timeframe: 1 year
Intervention | participants (Number) |
---|
Treatment | 1 |
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Acute GvHD
overall grade II-IV acute GvHD (NCT00053989)
Timeframe: Day +100
Intervention | Participants (Count of Participants) |
---|
All Patients | 16 |
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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 |
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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 |
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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 |
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PFS
PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas. (NCT00054353)
Timeframe: At 1 year post-transplant
Intervention | Participants (Count of Participants) |
---|
Related Donor | 4 |
Unrelated Donor | 1 |
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Relapse Rate
Number of subjects who relapsed after achieving CR post-transplant. Relapse rate will be summarized using cumulative incidence estimates. (NCT00054353)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Related Donor | 1 |
Unrelated Donor | 1 |
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Response Rate
Number of subjects who achieved CR post-transplant. Response rate will be summarized using cumulative incidence estimates. (NCT00054353)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Related Donor | 2 |
Unrelated Donor | 1 |
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Engraftment
Number of subjects who engrafted post-transplant. Engraftment will be monitored in a sequential fashion. (NCT00054353)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Related Donor | 12 |
Unrelated Donor | 4 |
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Incidence of Acute GVHD (Grades III-IV)
Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion. (NCT00054353)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Related Donor | 2 |
Unrelated Donor | 0 |
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OS
Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated. (NCT00054353)
Timeframe: At 6 months and then every year thereafter, up to 5 years
Intervention | Participants (Count of Participants) |
---|
| 6 Months | 1 Year | 2 Years | 3 Years | 4 Years | 5 Years |
---|
Related Donor | 8 | 5 | 4 | 3 | 3 | 3 |
,Unrelated Donor | 3 | 2 | 0 | 0 | 0 | 0 |
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Non-relapse Mortality
Early NRM will be monitored in a sequential fashion. (NCT00054353)
Timeframe: At day 100
Intervention | Participants (Count of Participants) |
---|
Related Donor | 1 |
Unrelated Donor | 1 |
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Incidence of Chronic (Extensive) GVHD
Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion. (NCT00054353)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Related Donor | 4 |
Unrelated Donor | 1 |
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2-year Overall Survival
Overall survival (OS) was calculated from the time of transplant to death from any cause or censored at last follow-up. Survival data were analyzed by Kaplan-Meier method. (NCT00058825)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Stem Cell Transplant | 33.3 |
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Donor Chimerism Engraftment of Greater Than 50%
Number of patients that engrafted who showed a chimerism (donor cells) of greater than 50% in the first 30 days (NCT00058825)
Timeframe: 30 days
Intervention | participants (Number) |
---|
| Yes | No |
---|
Stem Cell Transplant | 20 | 2 |
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Number of Patients Who Engrafted With the Isolex/CLINIMACs System
Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days. (NCT00058825)
Timeframe: 30 days
Intervention | participants (Number) |
---|
Isolex | 15 |
CLINIMACs | 7 |
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Time in Days to ANC Engraftment
Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days. (NCT00058825)
Timeframe: 30 days
Intervention | days (Median) |
---|
Stem Cell Transplant | 12 |
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Acute Graft Versus Host Disease
Number of patients with Acute Graft Versus Host Disease within 100 days post-transplant (NCT00058825)
Timeframe: 100 days
Intervention | participants (Number) |
---|
| Grade 0 | Grade I | Grade II | Grade III | Grade IV |
---|
Stem Cell Transplant | 26 | 0 | 0 | 1 | 0 |
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Chronic Graft Versus Host Disease
Number of patients with Chronic Graft Versus Host Disease within 1 year post-transplant (NCT00058825)
Timeframe: 1 year
Intervention | participants (Number) |
---|
| Yes | No |
---|
Stem Cell Transplant | 1 | 26 |
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2-year Relapse-free Survival
Relapse-free survival (RFS) was calculated from the time of transplant to the date of relapse, death, or last follow-up, whichever occurred first. Survival data were analyzed by Kaplan-Meier method. (NCT00058825)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Stem Cell Transplant | 25.9 |
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Rate of Relapse
Number of patients with relapsed disease post-transplant. Relapse/progression is defined as 1) Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, 2) circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, or 3) lymph node Biopsy Richter's transformation. (NCT00060424)
Timeframe: 18 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis) | 8 |
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Acute Grade II-IV GVHD and Chronic (Extensive) GVHD
"Number of patients who developed acute/chronic 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 II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement 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" (NCT00060424)
Timeframe: aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.
Intervention | Participants (Count of Participants) |
---|
| Acute GVHD | Chronic extensive GVHD |
---|
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis) | 10 | 10 |
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Rate and Types of Infections
Number of infections patients experienced, by infection type. (NCT00060424)
Timeframe: 18 months
Intervention | infections (Number) |
---|
| Viral | Fungal | Fever of unknown origin | Bacterial | Other |
---|
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis) | 27 | 13 | 6 | 53 | 5 |
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Overall Survival
Number of patients surviving 18 months post-transplant. (NCT00060424)
Timeframe: At 18 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis) | 15 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Non-relapse Mortality (NRM)
Percentage of patients who died due to causes other than relapse (NCT00070135)
Timeframe: Up to 5 years
Intervention | percentage of patients (Number) |
---|
Treatment (Fludarabine, Busulfan, Allogeneic PBSC) | 16 |
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2 Year DFS for All Patients
Percentage of participants who were alive and relapse free at 2 years for all patients. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method. (NCT00070135)
Timeframe: Up to 2 years
Intervention | percentage of participants (Number) |
---|
Treatment (Fludarabine, Busulfan, Allogeneic PBSC) | 42 |
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Response as Measured at 12 Months Post Allografting
response (partial and complete) assessed by CT scan at 12 months post allografting (NCT00074269)
Timeframe: From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Intervention | Participants (Count of Participants) |
---|
Treatment | 3 |
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Progression-free Survival
Progression assessed by CT scan (NCT00074269)
Timeframe: From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Intervention | days (Median) |
---|
Treatment | 110 |
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Overall Survival
(NCT00074269)
Timeframe: 1 year from the time of transplant
Intervention | days (Median) |
---|
Treatment | 279.4 |
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Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes
Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes based on cell counts of ANC >1000 for 3 consecutive days and platelet count of >50,000 (NCT00074269)
Timeframe: 30 days post transplant
Intervention | Participants (Count of Participants) |
---|
Treatment | 5 |
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Number of Participants With Adverse Events
(NCT00074269)
Timeframe: 5 years post transplant
Intervention | Participants (Count of Participants) |
---|
Treatment | 5 |
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Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)
(NCT00074269)
Timeframe: 100 days post transplant
Intervention | Participants (Count of Participants) |
---|
Treatment | 3 |
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Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting
(NCT00074269)
Timeframe: 1 month post allografting
Intervention | Participants (Count of Participants) |
---|
Treatment | 5 |
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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 |
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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 |
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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 |
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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 |
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Incidence of Graft Rejection
Donor CD3 chimerism less than 5% (NCT00075478)
Timeframe: 1 year after transplant
Intervention | participants (Number) |
---|
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) | 0 |
Arm II (TBI, Transplant, GVHD Prophylaxis) | 2 |
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Incidence of Relapse/Progression
Percentage of relapse estimated by cumulative incidence methods (NCT00075478)
Timeframe: 3 years after transplant
Intervention | percentage of participants (Number) |
---|
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) | 40 |
Arm II (TBI, Transplant, GVHD Prophylaxis) | 55 |
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Incidence of Non-relapse Mortality
Percentage of NRM as estimated by cumulative incidence methods with competing risks (NCT00075478)
Timeframe: 3 years after transplant
Intervention | percentage of participants (Number) |
---|
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) | 7 |
Arm II (TBI, Transplant, GVHD Prophylaxis) | 9 |
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Incidence of Grades II-IV Acute GVHD
Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods (NCT00075478)
Timeframe: 120 days after transplant
Intervention | percentage of participants (Number) |
---|
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) | 46 |
Arm II (TBI, Transplant, GVHD Prophylaxis) | 32 |
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Incidence of Chronic Extensive GVHD
Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods (NCT00075478)
Timeframe: 3 years after transplant
Intervention | percentage of participants (Number) |
---|
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) | 72 |
Arm II (TBI, Transplant, GVHD Prophylaxis) | 48 |
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Progression-free Survival
Percentage of patients with progression-free survival, estimated by cumulative incidence methods (NCT00075478)
Timeframe: 3 years after transplant
Intervention | percentage of participants (Number) |
---|
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) | 53 |
Arm II (TBI, Transplant, GVHD Prophylaxis) | 36 |
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Overall Survival
Percentage of patients surviving as estimated by Kaplan-Meier. (NCT00075478)
Timeframe: 3 years after transplant
Intervention | percentage of participants (Number) |
---|
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis) | 65 |
Arm II (TBI, Transplant, GVHD Prophylaxis) | 54 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment
EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59). (NCT00086580)
Timeframe: up to month 6 (end of treatment)
Intervention | units on a scale (Mean) |
---|
Combination Arm (FluCAM) | 0.8049 |
Fludarabine Alone | 0.7749 |
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Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology. (NCT00086580)
Timeframe: Up to 9 months
Intervention | participants (Number) |
---|
| Overall Response (CR+PR) | Complete Response (CR) | Partial Response (PR) | Progressive Disease (PD) | Stable Disease (SD) | Not Evaluable (NE) |
---|
Combination Arm (FluCAM) | 137 | 21 | 116 | 6 | 12 | 13 |
,Fludarabine Alone | 126 | 7 | 119 | 9 | 21 | 11 |
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Total Volume of Distribution (Vss) of Fludarabine
The total volume of distribution (Vss) is the apparent volume in which fludarabine is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Total volume of distribution (Vss) of fludarabine is derived from plasma concentration versus time data. (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
Intervention | liters (Mean) |
---|
Combination Arm (FluCAM) | 117 |
Fludarabine Alone | 172 |
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Participants With Minimal Residual Disease (MRD)
MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome. (NCT00086580)
Timeframe: up to 9 months
Intervention | participants (Number) |
---|
Combination Arm (FluCAM) | 6 |
Fludarabine Alone | 0 |
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Mean Systemic Clearance (CL) of Fludarabine
Clearance of drug from plasma is affected by the absorption, distribution, metabolism and elimination of the drug. Mean systemic clearance of fludarabine is derived from plasma concentration versus time data. (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
Intervention | liters/hour (Mean) |
---|
Combination Arm (FluCAM) | 9.46 |
Fludarabine Alone | 9.54 |
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Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment
"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom." (NCT00086580)
Timeframe: up to month 6 (end of treatment)
Intervention | units on a scale (Mean) |
---|
Combination Arm (FluCAM) | 77.1 |
Fludarabine Alone | 75.7 |
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Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline
"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom." (NCT00086580)
Timeframe: Day 0 (baseline)
Intervention | units on a scale (Mean) |
---|
Combination Arm (FluCAM) | 70.9 |
Fludarabine Alone | 70.2 |
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Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)
AUC (0-tau) is the area under the plasma concentration curve for fludarabine over the dosage interval (tau). (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
Intervention | ng*h/mL (Mean) |
---|
Combination Arm (FluCAM) | 8203 |
Fludarabine Alone | 5669 |
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Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline
EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59). (NCT00086580)
Timeframe: Day 0 (baseline)
Intervention | units on a scale (Mean) |
---|
Combination Arm (FluCAM) | 0.7959 |
Fludarabine Alone | 0.7822 |
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Maximum Plasma Concentration (Cmax) of Fludarabine
Cmax is the maximum plasma concentration of fludarabine observed. (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
Intervention | ng/mL (Mean) |
---|
Combination Arm (FluCAM) | 4084 |
Fludarabine Alone | 1847 |
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Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II
Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage I or II. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | NA |
Fludarabine Alone | NA |
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Kaplan-Meier Estimates of Overall Survival Time
Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | NA |
Fludarabine Alone | 52.93 |
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Kaplan-Meier Estimates for Time to Alternative Therapy
Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | 25.43 |
Fludarabine Alone | 22.01 |
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Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV
Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage III or IV. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | 20.53 |
Fludarabine Alone | 11.51 |
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Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment
Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | 23.65 |
Fludarabine Alone | 16.48 |
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Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)
Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | 25.10 |
Fludarabine Alone | 19.14 |
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Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)
Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | 27.96 |
Fludarabine Alone | 18.68 |
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Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV
Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage III or IV. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | NA |
Fludarabine Alone | 23.52 |
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Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II
Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage I or II. (NCT00086580)
Timeframe: Up to 6 years
Intervention | months (Median) |
---|
Combination Arm (FluCAM) | 23.75 |
Fludarabine Alone | 20.76 |
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Summary of Participants With Adverse Experiences (AEs)
Number of participants with adverse events (AEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (4 point scale from 'not related' to 'definitely related'). Categories reported include participant counts for treatment-emergent AEs, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), and deaths. Related AEs for the combination arm can be related to either fludarabine or alemtuzumab. (NCT00086580)
Timeframe: Up to 6 years
Intervention | participants (Number) |
---|
| At least 1 treatment emergent AE | At least 1 related treatment emergent AE | At least 1 treatment-emergent infection | At least 1 drug-related infection | At least 1 serious AE | At least 1 related serious AE | Discontinuation of study drug due to AE | Discontinuation of study drug due to related AE | Deaths | Patients who died due to a related AE | Patients who died within 30 days of the last dose |
---|
Combination Arm (FluCAM) | 161 | 159 | 67 | 44 | 54 | 47 | 37 | 32 | 10 | 7 | 4 |
,Fludarabine Alone | 149 | 125 | 58 | 30 | 41 | 28 | 32 | 24 | 12 | 6 | 7 |
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Incidences of Grades II-IV Acute GVHD
"Number of patients who developed acute/chronic 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 II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement 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" (NCT00089011)
Timeframe: Day 180 post-transplantation
Intervention | Participants (Count of Participants) |
---|
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 26 |
Arm II (Nonmyeloablative Conditioning With TBI) | 14 |
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Incidence of Grade III/IV GVHD
"Number of patients who developed acute/chronic 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" (NCT00089011)
Timeframe: Day 180 post-transplantation
Intervention | Participants (Count of Participants) |
---|
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 2 |
Arm II (Nonmyeloablative Conditioning With TBI) | 4 |
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Incidences of Graft Rejection
Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT. (NCT00089011)
Timeframe: Day 180 post-transplantation
Intervention | Participants (Count of Participants) |
---|
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 0 |
Arm II (Nonmyeloablative Conditioning With TBI) | 0 |
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Overall Survival
Number of patients surviving post-transplant. (NCT00089011)
Timeframe: At 1 year after conditioning
Intervention | Participants (Count of Participants) |
---|
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 85 |
Arm II (Nonmyeloablative Conditioning With TBI) | 39 |
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Incidence of 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. (NCT00089011)
Timeframe: Day 180 post-transplantation
Intervention | Participants (Count of Participants) |
---|
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 15 |
Arm II (Nonmyeloablative Conditioning With TBI) | 6 |
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Rates of Disease Progression
"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL ≥1 of: Physical exam/imaging studies ≥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." (NCT00089011)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 41 |
Arm II (Nonmyeloablative Conditioning With TBI) | 33 |
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Rate and Duration of Steroid Use for the Treatment of Chronic GVHD
Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone. (NCT00089011)
Timeframe: Up to 5 years
Intervention | days (Median) |
---|
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) | 78 |
Arm II (Nonmyeloablative Conditioning With TBI) | 89 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Duration of Response
(NCT00096018)
Timeframe: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years
Intervention | months (Mean) |
---|
Phase I - Dose Escalation | 43.3 |
Phase II | 30.0 |
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Overall Responders (Complete and Partial Response)
Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.) (NCT00096018)
Timeframe: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years
Intervention | participants (Number) |
---|
Phase I - Dose Escalation | 8 |
Phase II | 18 |
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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 |
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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 |
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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 |
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Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab
"A complete response, as defined by the National Cancer Institute Working Group (NCIWG):~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy" (NCT00098670)
Timeframe: Duration of treatment (up to 13.5 months)
Intervention | participants (Number) |
---|
Alemtuzumab Consolidation | 38 |
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Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab
"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death." (NCT00098670)
Timeframe: 6 weeks beginning at study week 36
Intervention | participants (Number) |
---|
Alemtuzumab Consolidation | 23 |
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2 Year Survival
Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method. (NCT00098670)
Timeframe: 2 years from registration
Intervention | percentage of participants (Number) |
---|
Alemtuzumab Consolidation | 86 |
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2 Year Progression Free Survival
Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method. (NCT00098670)
Timeframe: 2 years from registration
Intervention | percentage of participants (Number) |
---|
Alemtuzumab Consolidation | 72 |
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Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab
"Response, as defined by the National Cancer Institute Working Group (NCIWG):~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/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions" (NCT00098670)
Timeframe: Up to 9 months
Intervention | participants (Number) |
---|
Alemtuzumab Consolidation | 92 |
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Number of Participants With Grade II-III and III-IV Acute GVHD and Chronic GVHD
"Number of patients who developed acute GVHD post-transplant. Grade I +1 to +2 skin rash, No gut or liver involvement Grade II +1 to +3 skin rash, +1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +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~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." (NCT00104858)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy and Rituximab Followed by HCT) | 46 |
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Rituxan Concentration
Median rituxan level at days 60, 84, 180, and 1 year. (NCT00104858)
Timeframe: Days 60, 84, 180, and 1 year
Intervention | ug/ml (Median) |
---|
| Day 60 | Day 84 | Day 180 | 1 year |
---|
Treatment (Chemotherapy and Rituximab Followed by HCT) | 109 | 51 | 1.3 | .03 |
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Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse
Number of participants without progressive disease and surviving at one year. Participants with FCgammaRIIIa receptor vs participants without FCgammaRIIIa receptor. (NCT00104858)
Timeframe: 1 Year
Intervention | Participants (Count of Participants) |
---|
| Surviving participants w/ FCgammaRIIIa receptor | Surviving participants w/o FCgammaRIIIa receptor | w/ FCgammaRIIIa receptor w/o progressive disease | w/o FCgammaRIIIa receptor w/o progressive disease |
---|
Treatment (Chemotherapy and Rituximab Followed by HCT) | 2 | 21 | 2 | 19 |
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Overall Survival
Number of participants surviving post-transplant (NCT00104858)
Timeframe: At 18 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy and Rituximab Followed by HCT) | 34 |
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Number of Patients Achieving Complete Response and Partial Response (Overall Response Rate)
"Complete Remission (CR):~Imaging studies (Xray, CT, MRI) (nodes, liver, and spleen): Normal Peripheral blood by flow cytometry: No clonal lymphocytes Bone marrow by morphology: No nodules; or if present, nodules are free from CLL cells by immunohistochemistry Duration: ≥2 months~CR with minimal residual disease Peripheral blood or bone marrow by flow cytometry: >0 - <1 CLL cells/1000 leukocytes (0.1%)~Partial Remission (PR):~Both criteria:~Absolute lymphocyte count in peripheral blood: ≥50% decrease Physical exam/Imaging studies (nodes, liver, and/or spleen): ≥50% decrease Duration: ≥2 months" (NCT00104858)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy and Rituximab Followed by HCT) | 35 |
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Number of Participants With Relapse/Progression
"Relapse/Progression criteria for CLL~Progressive disease:~≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~Relapsed disease:~Criteria of progression occurring 6 months after achievement of complete or partial remission." (NCT00104858)
Timeframe: Day 84
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy and Rituximab Followed by HCT) | 1 |
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Number of Participants Surviving Without Progression
"Number of patients with progression-free survival, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 2 Years post-transplant
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and Tacrolimus) | 28 |
Arm II (MMF and Tacrolimus Alternate Schedule) | 27 |
Arm III (MMF, Tacrolimus, and Sirolimus) | 26 |
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Number of Participants Utilizing High-Dose Corticosteroids
"Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 150 days after transplant
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and Tacrolimus) | 38 |
Arm II (MMF and Tacrolimus Alternate Schedule) | 35 |
Arm III (MMF, Tacrolimus, and Sirolimus) | 22 |
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Number of Non-Relapse Mortalities
"Percentage of NRM as estimated by cumulative incidence methods with competing risks.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 200 days after transplant
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and Tacrolimus) | 3 |
Arm II (MMF and Tacrolimus Alternate Schedule) | 6 |
Arm III (MMF, Tacrolimus, and Sirolimus) | 2 |
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Number of Participants Surviving Overall
"Number of patients surviving, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 1 Year post-transplant
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and Tacrolimus) | 48 |
Arm II (MMF and Tacrolimus Alternate Schedule) | 47 |
Arm III (MMF, Tacrolimus, and Sirolimus) | 40 |
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Number of Participants With Grades II-IV Acute GVHD
"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ 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 w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT00105001)
Timeframe: 150 days after transplant
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and Tacrolimus) | 44 |
Arm II (MMF and Tacrolimus Alternate Schedule) | 34 |
Arm III (MMF, Tacrolimus, and Sirolimus) | 32 |
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Progression of HIV
Count of participants with HIV progression. (NCT00112593)
Timeframe: Within 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) | 0 |
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Death From Regimen Toxicity or Opportunistic Infection
(NCT00112593)
Timeframe: Within the first 100 days
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) | 0 |
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Death From GVHD
(NCT00112593)
Timeframe: Within the first 360 days
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) | 0 |
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Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin
Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor. (NCT00112593)
Timeframe: Up to day 80
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) | 5 |
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Reconstitution of HIV-specific Immunity
(NCT00112593)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) | 2 |
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Overall Survival
Kaplan-Meier estimate assessed at 1 year. (NCT00112593)
Timeframe: Up to 1 year
Intervention | survival probability (Number) |
---|
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) | 0.40 |
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Delayed Pneumonia Toxicity Rate
Delayed pneumonia toxicity rate is the proportion of patients who experienced significant pneumonia toxicity defined as nocardia or pneumocystis jiroveci after completing therapy. (NCT00117156)
Timeframe: Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.
Intervention | proportion of patients (Number) |
---|
Fludarabine and Rituximab | 0.115 |
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Objective Response Rate
Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999). (NCT00117156)
Timeframe: Assessed after three- and six-cycles of therapy.
Intervention | proportion of patients (Number) |
---|
Fludarabine and Rituximab | .85 |
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Delayed Bone Marrow Toxicity Rate
Delayed bone marrow toxicity rate is the proportion of patients who experienced significant bone marrow toxicity defined as aplastic anemia or myelodysplastic syndromes (MDS) after completing therapy. (NCT00117156)
Timeframe: Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.
Intervention | proportion of patients (Number) |
---|
Fludarabine and Rituximab | 0.154 |
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3.1-Year Progression-Free Survival
3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999). (NCT00117156)
Timeframe: Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years
Intervention | probability (Number) |
---|
Fludarabine and Rituximab | 0.795 |
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3.1-Year Overall Survival
3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry. (NCT00117156)
Timeframe: Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years
Intervention | probability (Number) |
---|
Fludarabine and Rituximab | 0.874 |
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Incidence of Non-relapse Mortality
Percentage patient deaths due to non-relapse mortality (NCT00118352)
Timeframe: 100 days after transplant
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 8.3 |
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Disease Progression/Relapse
"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." (NCT00118352)
Timeframe: Up to 5 years
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 25 |
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Incidence of Infection
Percentage patients that experienced infection(s). (NCT00118352)
Timeframe: Up to 5 years post-transplant
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 100 |
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Incidence of Grade III-IV Acute GVHD
"Severity of Individual Organ Involvement~Liver:~Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin > 15mg/100ml~Gut:~Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 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~Severity of GVHD~Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 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" (NCT00118352)
Timeframe: 100 days after transplant
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 25 |
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Incidence of High-dose Corticosteroid Utilization.
Percentage patients requiring steroids greater than 1 mg/kg. (NCT00118352)
Timeframe: 100 days after transplant
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 83.3 |
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Incidence of Graft Rejection
Percentage patients that experienced graft rejection. (NCT00118352)
Timeframe: 84 days after transplant
Intervention | percentage of participants (Number) |
---|
Dose Level 1 (No Campath) | 0 |
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Participant Disease Response Within 4 Weeks After Transplant
"The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant.~Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.~Normalization of blood counts (no blasts, platelets >100,000/mm3, granulocytes >1,500/mm3).~No extramedullary disease.~Relapse is measured as follows:~After CR: >5% blasts in the bone marrow and/or peripheral blood.~Confirmation of relapse by bone marrow analysis with more than 10% blasts.~Extramedullary disease confirmed cytologically or histologically." (NCT00119366)
Timeframe: 4 weeks after transplant
Intervention | Participants (Count of Participants) |
---|
| Number of participants that are in CR 4 weeks after transplant | Number of participants that relapsed 4 weeks after transplant |
---|
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody | 0 | 1 |
,Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody | 6 | 2 |
,Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody | 2 | 0 |
,Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody | 3 | 0 |
,Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody | 1 | 1 |
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Number of Participants With 100% Donor Chimerism at Day 28 and Day 84
Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis (NCT00119366)
Timeframe: Day 28 and Day 80 after transplant
Intervention | Participants (Count of Participants) |
---|
| Day 28 Donor Chimerism | Day 84 Donor Chimerism |
---|
Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody | 0 | 0 |
,Dose Level 10: 28 Gy Iodine-131+ BC8 | 7 | 4 |
,Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody | 1 | 1 |
,Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody | 3 | 3 |
,Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody | 2 | 2 |
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Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen
"Survival and complete resolution of all signs of leukemia for 2 years after transplant with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.~Normalization of blood counts (no blasts, platelets >100,000/mm3, granulocytes >1,500/mm3).~No extramedullary disease." (NCT00119366)
Timeframe: 2 years post transplant
Intervention | Participants (Count of Participants) |
---|
Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody | 0 |
Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody | 2 |
Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody | 1 |
Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody | 0 |
Dose Level 10: 28 Gy Iodine-131+ BC8 | 2 |
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Overall and Progression-free Survival
Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years. (NCT00119392)
Timeframe: Up to 8 years
Intervention | percent (Number) |
---|
| Overall survival | Progression free survival |
---|
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant) | 54 | 31 |
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Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
(NCT00119392)
Timeframe: At day +84
Intervention | Participants (Count of Participants) |
---|
| Acute GVHD: Grade 1-2 | Acute GVHD: Grade 3 | Chronic extensive GVHD |
---|
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant) | 27 | 4 | 5 |
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Engraftment and Hematopoietic Toxicity
Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter. (NCT00119392)
Timeframe: At day +100
Intervention | days (Median) |
---|
| Neutrophils | Platelets |
---|
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant) | 17 | 11 |
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Response Rates
(NCT00119392)
Timeframe: Up to 8 years
Intervention | Participants (Count of Participants) |
---|
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant) | 25 |
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Overall Survival
OS rate at 1 year. (NCT00121186)
Timeframe: 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
Intervention | participants (Number) |
---|
Nonmyeloablative Allogeneic Stem Cell Transplant | 1 |
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Progression-free Survival
PFS rate at 1 year. (NCT00121186)
Timeframe: 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
Intervention | participants (Number) |
---|
Nonmyeloablative Allogeneic Stem Cell Transplant | 1 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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The Incidence of Grade II-IV Acute Graft vs. Host Disease.
Outcome was measured by incidence and severity of acute and chronic GVHD following donor stem cell infusion. (NCT00153985)
Timeframe: 3 years
Intervention | participants (Number) |
---|
Transplant for Severe Hemoglobinopathies | 2 |
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Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy.
Outcome was measured by ANC >500 for three consecutive days prior to day 30 after PBSC infusion, >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods prior to day 45 after PBSC infusion and >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods after day 180 after PBSC infusion. (NCT00153985)
Timeframe: 3 years
Intervention | participants (Number) |
---|
Transplant for Severe Hemoglobinopathies | 2 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Percentage of Donor Chimerism at 100 Days
The percent of recipient bone marrow and blood cells that are of donor origin. (NCT00176865)
Timeframe: Day 100
Intervention | percentage of donor cells (Mean) |
---|
Arm 1 - Matched Sibling Donor | 96.5 |
Arm 2 - Matched Unrelated Donor | 75.5 |
Arm 3 - Mismatched Double Cord Donors | 100 |
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Number of Subjects With Mixed Chimerism
>10% Donor Cells at Day 100 (NCT00176865)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Arm 1 - Matched Sibling Donor | 3 |
Arm 2 - Matched Unrelated Donor | 8 |
Arm 3 - Mismatched Double Cord Donors | 4 |
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Incidence of Chronic Graft Versus Host Disease (cGVHD)
Chronic graft versus host disease (cGVHD) is a reaction which typically develops 3 to 6 months after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. (NCT00176865)
Timeframe: 6 months and 1 year
Intervention | participants (Number) |
---|
Arm 1 - Matched Sibling Donor | 1 |
Arm 2 - Matched Unrelated Donor | 0 |
Arm 3 - Mismatched Double Cord Donors | 0 |
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Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)
Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease. (NCT00176865)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Arm 1 - Matched Sibling Donor | 1 |
Arm 2 - Matched Unrelated Donor | 3 |
Arm 3 - Mismatched Double Cord Donors | 0 |
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Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)
Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease. (NCT00176865)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Arm 1 - Matched Sibling Donor | 1 |
Arm 2 - Matched Unrelated Donor | 1 |
Arm 3 - Mismatched Double Cord Donors | 0 |
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Number of Subjects Alive at One Year
(NCT00176865)
Timeframe: Day 365
Intervention | participants (Number) |
---|
Arm 1 - Matched Sibling Donor | 3 |
Arm 2 - Matched Unrelated Donor | 7 |
Arm 3 - Mismatched Double Cord Donors | 3 |
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Number of Subjects Alive at 100 Days
(NCT00176865)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Arm 1 - Matched Sibling Donor | 3 |
Arm 2 - Matched Unrelated Donor | 8 |
Arm 3 - Mismatched Double Cord Donors | 4 |
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Percentage of Donor Chimerism at 365 Days
The percent of recipient bone marrow and blood cells that are of donor origin. (NCT00176865)
Timeframe: Day 365
Intervention | percentage of donor cells (Mean) |
---|
Arm 1 - Matched Sibling Donor | 81.9 |
Arm 2 - Matched Unrelated Donor | 78.6 |
Arm 3 - Mismatched Double Cord Donors | 91.7 |
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Percentage of Donor Chimerism at 180 Days
The percent of recipient bone marrow and blood cells that are of donor origin. (NCT00176865)
Timeframe: Day 180
Intervention | percentage of donor cells (Mean) |
---|
Arm 1 - Matched Sibling Donor | 88.9 |
Arm 2 - Matched Unrelated Donor | 73.3 |
Arm 3 - Mismatched Double Cord Donors | 90.5 |
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Number of Patients With Disease Recurrence
Number of patients who exhibited disease recurrence at 2 years. (NCT00176878)
Timeframe: 2 years
Intervention | Participants (Number) |
---|
Bone Marrow Failure Patients | 0 |
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Number of Patients With Grade 2-4 Acute Graft Versus Host Disease
Number of patients with Grade 2, 3 and 4 Acute (normally observed within the first 100 days) Graft Versus Host Disease. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of 1 to a high of 4. Patients with grade IV GVHD usually have a poor prognosis. Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. (NCT00176878)
Timeframe: 100 Days
Intervention | Participants (Number) |
---|
Bone Marrow Failure Patients | 5 |
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Number of Patients With Succcessful Engraftment After Transplantation
"Number of patients who received non-genotypic identical marrow or cord blood cells using a non-myeloablative preparative regimen and exhibited engraftment at Day 42." (NCT00176878)
Timeframe: 42 Days
Intervention | Participants (Number) |
---|
Bone Marrow Failure Patients | 10 |
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Number of Patients Alive at Three Years (Survival)
Number of subjects who survived 3 years post-transplant. (NCT00176878)
Timeframe: 3 years
Intervention | Participants (Number) |
---|
Bone Marrow Failure Patients | 6 |
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Number of Patients With Chronic Graft Versus Host Disease
Number of patients who exhibited chronic (normally occurs after 100 days) Graft Versus Host Disease at 2 years post transplant. Chronic graft-versus-host-disease, over its long-term course, can also cause damage to the connective tissue and exocrine glands. (NCT00176878)
Timeframe: 2 years
Intervention | Participants (Number) |
---|
Bone Marrow Failure Patients | 3 |
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Number of Patients Alive (Survival) at 2 Years
Calculated from day 1 of transplant to last contact. (NCT00176878)
Timeframe: 2 years
Intervention | Participants (Number) |
---|
Bone Marrow Failure Patients | 6 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Percentage of Participants With Overall Response at Different Observation Times
Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease. (NCT00206726)
Timeframe: from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier
Intervention | percentage of participants in response (Number) |
---|
| After 90 days | After 180 days | After 270 days |
---|
Alemtuzumab Plus Fludarabine | 76.5 | 64.7 | 29.4 |
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Complete Response (CR)
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular. (NCT00206726)
Timeframe: 28 days after last cycle with confirmation 2 months later
Intervention | Percentage of participants with CR (Number) |
---|
Alemtuzumab Plus Fludarabine | 8.3 |
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Overall Survival (OS)
Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year (NCT00206726)
Timeframe: 1 year after start of treatment
Intervention | Percentage of participants alive (Number) |
---|
Alemtuzumab Plus Fludarabine | 86.4 |
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Overall Response (OR)
Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease. (NCT00206726)
Timeframe: 28 days after last cycle with confirmation 2 months later
Intervention | Percentage of participants with CR or PR (Number) |
---|
Alemtuzumab Plus Fludarabine | 28.3 |
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Progression-free Survival (PFS)
Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year (NCT00206726)
Timeframe: 1 year after start of treatment
Intervention | percentage alive without progression (Number) |
---|
Alemtuzumab Plus Fludarabine | 48.8 |
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Number of Participants With Minimal Residual Disease (MRD)
Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples. (NCT00206726)
Timeframe: When CR is confirmed
Intervention | participants (Number) |
---|
| Positive | Negative | Not Assessed |
---|
Alemtuzumab Plus Fludarabine | 3 | 2 | 0 |
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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 |
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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 |
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Duration of Response
(NCT00230282)
Timeframe: 105 months
Intervention | months (Median) |
---|
Fludarabine and Cyclophosphamide, Followed by Alemtuzumab | 38 |
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Progression-Free Survival
"The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5.~Definition of Disease Progression:~MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%.~CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells.~AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate.~CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis.~MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence." (NCT00245037)
Timeframe: Years 1, 2, 3, and 5
Intervention | percentage of analyzed participants (Number) |
---|
| Year 1 | Year 2 | Year 3 | Year 5 |
---|
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 48 | 39 | 35 | 29 |
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Acute Graft-Versus-Host Disease (aGVHD) Outcome
"Grading of Acute GVHD:~Severity of Individual Organ Involvement:~Skin~1 a maculopapular eruption involving less than 25% of the body surface~2 a maculopapular eruption involving 25-50% of the body surface~3 generalized erythroderma~4 generalized erythroderma with bullous formation and/or with desquamation Liver~1 bilirubin 2.0-3.0mg/100mL~2 bilirubin 3-5.9mg/100mL~3 bilirubin 6-14.9mg/100mL~4 bilirubin >15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea~1 <1000mL of liquid stool/day~2 >1,000mL of stool/day~3 >1,500mL of stool/day~4 2,000mL of stool/day, severe abdominal pain, with or without ileus~Severity of GVHD:~Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver" (NCT00245037)
Timeframe: Day 100, Month 6
Intervention | percentage of analyzed participants (Number) |
---|
| Day 100 | Month 6 |
---|
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 55 | 60 |
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Chronic Graft-Versus-Host Disease (cGVHD) Outcome
"Grading of Chronic GVHD:~Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD~Extensive:~One or more of the following:~Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer's test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ~Chronic GVHD Severity:~Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy.~Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy.~Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy" (NCT00245037)
Timeframe: Years 1, 2 and 3
Intervention | percentage of analyzed participants (Number) |
---|
| Year 1 | Year 2 | Year 3 |
---|
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 64.6 | 66 | 67.3 |
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Non-relapse Mortality
Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease. (NCT00245037)
Timeframe: Two years post-transplant
Intervention | Participants (Count of Participants) |
---|
| Year 1 | Year 2 |
---|
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 27 | 33 |
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Overall Survival
The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5. (NCT00245037)
Timeframe: Years 1, 2, 3 and 5
Intervention | percentage of analyzed participants (Number) |
---|
| Year 1 | Year 2 | Year 3 | Year 5 |
---|
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 60 | 48 | 42 | 29 |
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Relapse Mortality
The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate. (NCT00245037)
Timeframe: Years 1 and 2
Intervention | percentage of analyzed participants (Number) |
---|
| Year 1 | Year 2 |
---|
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 13 | 20 |
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Number of Patients Experiencing Graft Failure
Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither. (NCT00253513)
Timeframe: 42 days
Intervention | participants (Number) |
---|
| acute graft vs. host disease (aGVHD) | chronic graft vs. host disease (cGVHD) |
---|
Treosulfan and Fludarabine Conditioning | 36 | 31 |
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Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival.
(NCT00253513)
Timeframe: One year
Intervention | participants (Number) |
---|
Treosulfan and Fludarabine Conditioning | 58 |
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Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)
NRM (Non relapse mortality) - death not attributed to the primary cancer. (NCT00253513)
Timeframe: 200 days
Intervention | percent of participants (Number) |
---|
Treosulfan and Fludarabine Conditioning | 5 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants Who Survived 100 Days or Longer
(NCT00255684)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Conditioning Therapy Followed by TBI | 13 |
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Number of Participants Who Developed Acute Graft Versus Host Disease
(NCT00255684)
Timeframe: 3 months
Intervention | participants (Number) |
---|
Conditioning Therapy Followed by TBI | 0 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Survival
Survival (NCT00278512)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Autologous Stem Cell Transplant | 6 |
Allogeneic Stem Cell Transplant | 0 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation
The percentage of participants with ≥90 percent donor-derived hematopoeisis was assessed around day +100 using peripheral blood chimerism. (NCT00282282)
Timeframe: 100 days
Intervention | percentage of participants (Number) |
---|
Tacrolimus and Sirolimus | 78 |
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Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus.
All participants received tacrolimus and sirolimus in this one arm study. There were no participants considered unevaluable for this measure (deceased prior to day 100). The total number of people who developed grade II-IV aGVHD before day 100 are reported here. (NCT00282282)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Tacrolimus and Sirolimus | 5 |
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Disease Response.
Disease response was assessed as 2 year progression-free survival. The median follow-up time was 1.84 years. The percentage of participants with who reached this timepoint with no disease progression are reported. (NCT00282282)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Tacrolimus and Sirolimus GVHD Prophylaxis | 48 |
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Survival
The number of participants who survived treatment (NCT00282412)
Timeframe: up to 5 years
Intervention | Participants (Count of Participants) |
---|
Hematopoietic Stem Cell Transplantation | 2 |
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Overall Survival
OS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact. Median Overall Survival was estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval. (NCT00290511)
Timeframe: up to 5 years
Intervention | months (Number) |
---|
R-FIND + Zevalin | 143 |
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Percentage of Participants With Overall Survival Rate at 10 Years
OS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact. Overall Survival Rate estimated by the method of Kaplan and Meier. (NCT00290511)
Timeframe: 10 years
Intervention | percentage of participants (Number) |
---|
R-FIND + Zevalin | 69 |
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Number of Participants With Time to Progression (TTP)
Regimen regarded as a success if median TTP can be prolonged to 36 months or greater. Time to Progression measured by the method of Kaplan and Meier, and accompanied by 95% confidence interval. Complete Response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays and Partial Response (PR) is defined as a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. av (NCT00290511)
Timeframe: baseline, 2 and 4 courses, approximately month 8, 9, and 12 months, then restaging every 4 months, then at 2 years every 4-6 months, then yearly until progressive disease or lost to follow up, average of 10 years
Intervention | Participants (Count of Participants) |
---|
| Complete Response (CR) | Partial Response (PR) |
---|
R-FIND + Zevalin | 42 | 4 |
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Tolerance and Efficacy of Maintenance Therapy With Rituximab
"To assess the tolerance and efficacy of maintenance therapy with rituximab. Participants proceeded to the rituximab maintenance program of 6 treatments comprising 1 every 2 months. CR: defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. CRu: defined as CR unconfirmed on the basis of minimal residual abnormalities on x-ray such as a residual mass <25% of original measurement, and or residual indeterminate bone marrow aggregates. PR: a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. Progressive disease (PD) is also defined by the appearance of new lymph nodes, of other new or worsening sites of disease, such as > 50% increase in the size of liver and/or spleen, or a > 50% increase in absolute number of circulating lymphocytes." (NCT00290511)
Timeframe: cycle 1 and every 2 weeks thereafter until completion of therapy, an average of 10 years
Intervention | Participants (Count of Participants) |
---|
| Complete Response (CR) | Progression Disease (PD) |
---|
R-FIND + Zevalin | 38 | 3 |
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Tolerance and Efficacy of Maintenance Therapy With Yttrium-90 Ibritumomab Tiuxetan (YIT)
"To assess the tolerance and efficacy of maintenance therapy with YIT. CR: defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. CRu: defined as CR unconfirmed on the basis of minimal residual abnormalities on x-ray such as a residual mass <25% of original measurement, and or residual indeterminate bone marrow aggregates. PR: a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. Progressive disease (PD) is also defined by the appearance of new lymph nodes, of other new or worsening sites of disease, such as > 50% increase in the size of liver and/or spleen, or a > 50% increase in absolute number of circulating lymphocytes." (NCT00290511)
Timeframe: cycle 1 and every 2 weeks thereafter until completion of therapy, an average of 10 years
Intervention | Participants (Count of Participants) |
---|
| Complete Response (CR) | Progressive Disease |
---|
R-FIND + Zevalin | 37 | 1 |
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Progression Free Survival at 10 Years
Progression-free survival time is defined as time from registration/randomization to the date of progression or death from any cause. PFS was estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval. (NCT00290511)
Timeframe: 10 years
Intervention | months (Number) |
---|
R-FIND + Zevalin | 49 |
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Disease-free Survival With Correction of Disease at One Year Post Transplantation
"Patients deemed alive and well at follow-up timepoint later than 1-year post-transplantation" (NCT00301834)
Timeframe: 1 year post-transplantation
Intervention | participants (Number) |
---|
Single Arm - Transplant Pre-conditioning Per Study Protocol | 22 |
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Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation
Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences (NCT00301834)
Timeframe: 6 weeks post-transplant
Intervention | participants (Number) |
---|
Single Arm - Transplant Pre-conditioning Per Study Protocol | 31 |
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Cytomegalovirus (CMV) Viral Infection and Disease Symptoms
polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) > 200 cells/mm3. Median time to T-cell reconstitution was 6 months. (NCT00301834)
Timeframe: Up to one year post-transplant
Intervention | participants (Number) |
---|
| Positive CMV Viral Load Assay | Symptomatic CMV disease |
---|
CMV Seronegative Participants | 1 | 0 |
,CMV Seropositive Participants | 12 | 0 |
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Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation
(NCT00301834)
Timeframe: 1 year post-transplantation
Intervention | participants (Number) |
---|
| Grade 3-4 acute Graft-Versus-Host Disease | Grade 3-4 mucositis |
---|
Single Arm | 2 | 16 |
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Treatment-related Mortality at 100 Days and 1 Year Post Transplantation
(NCT00301834)
Timeframe: 100 days and 1 year
Intervention | participants (Number) |
---|
| Transplantation-related mortality 0-100 days | Transplantation-related mortality 100-365 days |
---|
Single Arm - Transplant Pre-conditioning Per Study Protocol | 2 | 1 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
(NCT00303719)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
High Risk Patients | 8 |
Standard Risk Patients | 181 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Non-relapse Mortality
(NCT00322101)
Timeframe: At 100 days
Intervention | participants (Number) |
---|
Arm I (Nonmyeloablative Regimen) | 0 |
Arm II (Myeloablative Regimen) | 0 |
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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 |
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Overall Survival
(NCT00322101)
Timeframe: At 2 years
Intervention | participants (Number) |
---|
Arm I (Nonmyeloablative Regimen) | 6 |
Arm II (Myeloablative Regimen) | 6 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants Experiencing Infections by Day 365
(NCT00352976)
Timeframe: by day 365
Intervention | Participants (Count of Participants) |
---|
Treatment With TBI | 56 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants Experiencing Infections by Day 180
(NCT00352976)
Timeframe: by day 180
Intervention | Participants (Count of Participants) |
---|
Treatment With TBI | 55 |
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Number of Participants Experiencing Infections by Day 100
(NCT00352976)
Timeframe: by day 100
Intervention | Participants (Count of Participants) |
---|
Treatment With TBI | 53 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)
The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant. (NCT00361140)
Timeframe: 100 days
Intervention | participants (Number) |
---|
AUC 6000 | 0 |
AUC 7500 | 1 |
AUC 9000 | 2 |
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Non-relapse Mortality
The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant. (NCT00361140)
Timeframe: 100 days
Intervention | participants (Number) |
---|
AUC 6000 | 3 |
AUC 7500 | 4 |
AUC 9000 | 2 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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)=4x10^9/L, Hb>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:ALC=4x109/L + Hb>11 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 |
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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)=4x10^9/L, Hb>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:ALC=4x109/L + Hb>11 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 |
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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 |
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Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation
Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count >500/mm3 and platelets >20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.). (NCT00381550)
Timeframe: Up to 4 years
Intervention | participants (Number) |
---|
Arm I | 18 |
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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 |
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Incidence of Chronic Graft-versus-host Disease (GVHD)
"Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (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. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD." (NCT00392782)
Timeframe: 1 Year
Intervention | Participants (Number) |
---|
All Treated Patients | 4 |
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Incidence of Disease Relapse
Number of patients with disease at 1 year. (NCT00392782)
Timeframe: 1 Year
Intervention | Participants (Number) |
---|
All Treated Patients | 6 |
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Incidence of Disease-free Survival
Number of patients alive and without disease at 1 year after transplant. (NCT00392782)
Timeframe: 1 Year
Intervention | Participants (Number) |
---|
All Treated Patients | 18 |
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Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)
"Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (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. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening." (NCT00392782)
Timeframe: Day 100
Intervention | Participants (Number) |
---|
All Treated Patients | 6 |
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Incidence of Graft Failure
Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days. (NCT00392782)
Timeframe: Day 100
Intervention | Participants (Number) |
---|
All Treated Patients | 1 |
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Overall Survival
Number of patients who were deceased at 1 year post transplant. (NCT00392782)
Timeframe: 1 Year
Intervention | Participants (Number) |
---|
All Treated Patients | 10 |
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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 |
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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 |
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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 |
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Number of Patients Who Engrafted
Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%. (NCT00397813)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Arm A - Dose Level 1 | 35 |
Arm A - Dose Level 2 | 0 |
Arm A - Dose Level 3 | 0 |
Arm B - Dose Level 1 | 12 |
Arm B - Dose Level 2 | 4 |
Arm B - Dose Level 3 | 24 |
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Number of Patients Who Had Infections
Number of patients who experienced bacterial, fungal, or viral infections. (NCT00397813)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Arm A - Dose Level 1 | 24 |
Arm A - Dose Level 2 | 0 |
Arm A - Dose Level 3 | 0 |
Arm B - Dose Level 1 | 12 |
Arm B - Dose Level 2 | 4 |
Arm B - Dose Level 3 | 24 |
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Number of Patients With HCT Failure.
HCT failure will be defined as graft rejection (defined as < 5% donor T-cell chimerism) or disease progression within 200 days of transplant. (NCT00397813)
Timeframe: 200 days
Intervention | Participants (Count of Participants) |
---|
Arm A - Dose Level 1 | 4 |
Arm A - Dose Level 2 | 0 |
Arm A - Dose Level 3 | 0 |
Arm B - Dose Level 1 | 5 |
Arm B - Dose Level 2 | 3 |
Arm B - Dose Level 3 | 2 |
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Number of Patients With Relapse/Progression
Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia. (NCT00397813)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Arm A - Dose Level 1 | 6 |
Arm A - Dose Level 2 | 0 |
Arm A - Dose Level 3 | 0 |
Arm B - Dose Level 1 | 6 |
Arm B - Dose Level 2 | 3 |
Arm B - Dose Level 3 | 6 |
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Number of Patients With Progression-free Survival
Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia. (NCT00397813)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Arm A - Dose Level 1 | 24 |
Arm A - Dose Level 2 | 0 |
Arm A - Dose Level 3 | 0 |
Arm B - Dose Level 1 | 1 |
Arm B - Dose Level 2 | 2 |
Arm B - Dose Level 3 | 11 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Incidence of Chronic GVHD at 1 Year
(NCT00425802)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Treatment | 14 |
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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 |
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Overall Survival at 1 Year
(NCT00425802)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Treatment | 90 |
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Time to Neutrophil Engraftment
(NCT00425802)
Timeframe: 2 years
Intervention | days (Median) |
---|
Treatment | 15 |
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Immune Reconstruction/CD4+ Count at 3 Months
(NCT00425802)
Timeframe: 3 months
Intervention | cells/microliters (Median) |
---|
Treatment | 253 |
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Time to Platelet Engraftment
(NCT00425802)
Timeframe: 1 year
Intervention | days (Median) |
---|
Treatment | 12 |
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Immune Reconstruction/CD4+ Count at 6 Months
(NCT00425802)
Timeframe: 6 months
Intervention | cells/microliter (Median) |
---|
Treatment | 312 |
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Immune Reconstruction/CD4+ Count at 1 Year
(NCT00425802)
Timeframe: 1 year
Intervention | cells/microliter (Median) |
---|
Treatment | 333 |
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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 |
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Number of Participants With Engraftment
Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment. (NCT00427557)
Timeframe: Baseline to 100 days post-engraftment
Intervention | participants (Number) |
---|
Fludarabine + Melphalan + Umbilical Cord Blood Unit | 27 |
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Engraftment at 1 Year Post BMT.
Measurement of total PBMC chimerism (NCT00427661)
Timeframe: 1 year
Intervention | participants (Number) |
---|
AHSC in Severe SCD | 6 |
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Development of GVHD Within 1 Year of BMT
GVHD is assessed by physical exam, bloodwork and biopsy. (NCT00427661)
Timeframe: 1 year
Intervention | participants (Number) |
---|
AHSC in Severe SCD | 2 |
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Incidence of Grade 2-4 Acute GVHD.
(NCT00427661)
Timeframe: 100 days
Intervention | participants with grade 2-4 AGVHD (Number) |
---|
Experimental | 1 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Grade II-IV Toxicity
Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe). (NCT00429572)
Timeframe: Up to one year.
Intervention | Participants (Number) |
---|
| Cardiac | Pulmonary | Gastrointestinal | Renal | Neurological | Fever/Flu like symptoms | Infection | Genitourinary | Skin |
---|
Allogeneic Transplantation | 1 | 3 | 8 | 0 | 2 | 2 | 3 | 2 | 2 |
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Time to Progressive Disease
Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first. (NCT00429572)
Timeframe: Transplant to Progression.
Intervention | Days (Median) |
---|
Allogeneic Transplantation | 202 |
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Overall Survival
Survival duration was calculated from time of transplantation by number of days. (NCT00429572)
Timeframe: Transplant until death.
Intervention | Days (Median) |
---|
Allogeneic Transplantation | 643 |
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Number of Participants With Tumor Response
Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions. (NCT00429572)
Timeframe: Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.
Intervention | participants (Number) |
---|
| Complete Response | Stable Disease | Partial Response | Progressive Disease |
---|
Allogeneic Transplantation | 5 | 9 | 1 | 3 |
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Number of Participants With Acute or Chronic GVHD And Response to Therapy
"Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from Consensus conference on acute GVHD grading, Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy." (NCT00429572)
Timeframe: Transplant to 1 year post transplant
Intervention | participants (Number) |
---|
| aGVHD | aGVHD responded to therapy | cGVHD | cGVHD responded to therapy |
---|
Allogeneic Transplantation | 9 | 7 | 14 | 14 |
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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 |
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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 |
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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 |
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Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant
"Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC).~Chimerism was not tabulated on day 30." (NCT00448201)
Timeframe: Days 30, 60, and 90
Intervention | percentage of patients (Number) |
---|
| Complete Donor | Mixed Donor |
---|
Day 60 | 82 | 18 |
,Day 90 | 87 | 13 |
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Graft-vs-host Disease at 6 Months Post-transplant
"Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces~Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled.~Extensive chronic GVHD - Usually occurs at about three months post-transplant." (NCT00448201)
Timeframe: 6 Months
Intervention | percentage of participants (Number) |
---|
| Acute GVHD | Extensive Chronic GVHD |
---|
All Trial Participants | 13 | 30 |
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5-year Disease-free Survival
The length of time post-transplant that the patient survives without any signs or symptoms of that cancer. (NCT00448201)
Timeframe: Year 5
Intervention | percentage of participants (Number) |
---|
All Trial Participants | 31 |
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Incidence of DNA Chimerism in Patients Between One Month Post Transplant
Deoxyribonucleic acid (DNA) chimerism is a measure identifying the genetic profiles of the transplant recipient and of the donor and then evaluating the extent of mixture in the recipient's blood, bone marrow, or other tissue. (NCT00448357)
Timeframe: 30 days post transplant
Intervention | Participants (Count of Participants) |
---|
| Whole blood chimerism-Any | Whole blood chimerism->=95% donor | T Cell chimerism-Any | T Cell chimerism>=95% donor |
---|
Experimental: GVHD Prophylaxis | 49 | 47 | 46 | 30 |
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Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)
Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years (NCT00448357)
Timeframe: Three years post-transplant
Intervention | percentage of participants (Number) |
---|
Low Busulfan AUC Tertile | 22 |
Intermediate Busulfan AUC Tertile | 39 |
High Busulfan AUC Tertile | 43 |
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Overall Survival
Percentage of participants alive at 3 years post transplant (NCT00448357)
Timeframe: Three years post-transplant
Intervention | percentage of participants (Number) |
---|
Low Busulfan AUC Tertile (5078) | 28 |
Intermediate Busulfan AUC Tertile (6372) | 39 |
High Busulfan AUC Tertile (7605) | 55 |
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Number of Participants With Dose Limiting Toxicities (DLTs)
Dose limiting toxicity will be defined as any irreversible grade 3 or any grade 4 non-hematologic toxicity that is related to busulfan infusion and not graft vs host disease or late infection after recovery from the initial period of myelosuppression. The maximum tolerated dose (MTD) is defined as the dose with probability of dose limiting toxicity (DLT) of 0.25. The dose of continuous infusion IV busulfan based on blood levels derived from a test dose in conjunction with fludarabine and alemtuzumab plus tacrolimus for GVHD prophylaxis. (NCT00448357)
Timeframe: first 6 weeks or 42 days following stem cell infusion
Intervention | DLTs (Number) |
---|
Dose Level 1 | 1 |
Dose Level 2 | 1 |
Dose Level 3 | 1 |
Dose Level 4 | 2 |
Dose Level 5 | 2 |
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Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen
Test doses of busulfan were administered and plasma levels were measured to determine a targeted AUC dosing estimate. The capacity is reported as the precision with which these test dose goals predicted the actual 90-hour mean AUC levels.Dose targeting precision was estimated by root mean squared error. (NCT00448357)
Timeframe: Day -15 to Day -11
Intervention | percentage of error (Number) |
---|
Dose Level 1 | 11.7 |
Dose Level 2 | 4.9 |
Dose Level 3 | 10.2 |
Dose Level 4 | 11.1 |
Dose Level 5 | 15.9 |
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Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant
"GVHD can be mild, moderate or severe depending on the differences in tissue type between patient and donor. GVHD can be acute or chronic. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces" (NCT00448357)
Timeframe: 100 days post transplant
Intervention | Participants (Count of Participants) |
---|
| Acute GVHD grade >=II | Acute GVHD grades III and IV | Chronic GVHD; intermediate/severe |
---|
High Busulfan AUC Tertile | 11 | 3 | 2 |
,Intermediate Busulfan AUC Tertile | 10 | 4 | 6 |
,Low Busulfan AUC Tertile | 7 | 2 | 4 |
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Risk for Graft Failure
Count of participant that had graft failure. (NCT00450983)
Timeframe: Engraftment documented day +20
Intervention | Participants (Count of Participants) |
---|
Treatment | 0 |
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Risk for Mortality From Infection Before Day 180
Count of participant deaths from infection up to day 180. (NCT00450983)
Timeframe: Up to day 180
Intervention | Participants (Count of Participants) |
---|
Treatment | 0 |
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Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)
Count of participants with acute GVHD grades III-IV. (NCT00450983)
Timeframe: Up to day 100
Intervention | Participants (Count of Participants) |
---|
Treatment | 0 |
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Risk for Life-threatening Infections
Count of participants with life-threatening infections (NCT00450983)
Timeframe: Up to day 100
Intervention | Participants (Count of Participants) |
---|
Treatment | 1 |
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Number of Participants With a Complete Response or Partial Response
According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as > 50% decrease of clinical symptoms from baseline and recovery from blood counts. (NCT00452374)
Timeframe: Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days
Intervention | Participants (Number) |
---|
| Complete response (CR) | Partial response (PR) |
---|
Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 12 | 28 |
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Maximum Tolerated Dose (MTD) Oxaliplatin
MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale. (NCT00452374)
Timeframe: From treatment onset to end of each cycle of treatment (every 21 days)
Intervention | mg/m^2 (Number) |
---|
Oxaliplatin, Fludarabine, Cytarabine + Rituximab | 25 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Length of Survival
(NCT00462332)
Timeframe: At 2 years and a half from study entry
Intervention | years (Mean) |
---|
High Risk Patientes | 1.57 |
Low Risk Patients | 1.1 |
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Number of Patients With Complete Response
"Normal clinical or X-ray examination (lymph nodes, liver, spleen)~No symptoms~Lymphocytes higher or equal to 4.0 per 10^9/L~Neutrophils lower or equal to 1.5 per 10^9/L~Platelets >100 per 10^9/L~Hb >11.0 g/dL~Bone marrow lymphs according to age, lymphocytes <30%, no nodules." (NCT00462332)
Timeframe: At 2 years from study entry
Intervention | participants (Number) |
---|
Low Risk Patients | 14 |
High Risk Patients | 3 |
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3 Year Progression Free Survival
"PFS defined as length of time either due to disease recurrence or death, from the time of stem cell infusion (Bone marrow or PBPC) to 3 years.~Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response." (NCT00469144)
Timeframe: 3 years
Intervention | Days (Median) |
---|
Fixed-Dose Busulfan + Fludarabine | 42 |
Adjusted Dose Busulfan + Fludarabine | 56 |
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Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days)
Maximum dose levels for Phase I determined among three possible dose levels of Fludarabine and Cytarabine in combination with fixed doses of Oxaliplatin and Rituximab. Fludarabine and Cytarabine Dose Level 1: Days 2-3 (2 Days); Dose Level 2: Days 2-4 (3 Days); and Dose 3: Days 2-5 (4 Days). MTD is dose level at which less than 2/3 or 2/6 participants experience dose limiting toxicities (DLTs). The number of days of fludarabine and cytarabine administration increased simultaneously. Participants received a subsequent cycle of treatment with 1 additional day of fludarabine and cytarabine treatment no less than 4 weeks from the initiation of the previous cycle if no drug-related grade 3 or 4 non-hematologic life-threatening adverse events, and drug-related non-hematologic toxicity resolved to baseline or < grade 2. A maximum of 6 cycles were administered. (NCT00472849)
Timeframe: Up to 36 weeks (6 cycles each 4-6 weeks)
Intervention | mg/m^2 (Number) |
---|
| Fludarabine MTD (Total 3 Day Dose) | Cytarabine MTD (Total 3 Day Dose) |
---|
OFAR (Phase I) | 90 | 1500 |
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Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission
Overall Response includes Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) in high-risk, previously untreated participants with Chronic Lymphocytic Leukemia treated with CFAR using National Cancer Institute - Working Group 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. (NCT00472849)
Timeframe: Up to 36 weeks (6 cycles each 4-6 weeks)
Intervention | participants (Number) |
---|
| Complete Remission | Partial Remission | Nodular Partial Remission |
---|
OFAR MTD (Phase II) | 3 | 27 | 9 |
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Rate of Non-relapse Mortality at 100 Days Post-transplant
To evaluate the safety of Fludarabine/Busulfan as conditioned regimen for allogeneic stem cell transplantation in patients with myelofibrosis/myelodysplastic syndrome at 100 days post-transplant (NCT00475020)
Timeframe: Non-relapse mortality at 100 days post-transplant
Intervention | Participants (Count of Participants) |
---|
| Infections | Organ Failures | Sudden death: likely due to ischemic cardiac event |
---|
Participants With Myelofibrosis and Myelodysplastic Syndrome | 1 | 2 | 1 |
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Efficacy of This Therapy 3 Years Post-transplant
Efficacy Assessed as Number of Participants with Overall Survival, Leukemia Progression, Primary Graft Failure and Complete Hematological Response. Primary graft failure is defined as failure to achieve an ANC >/= 0.5 x 10 (9)/L for 3 consecutive days and evidence of donor chimerism by Day +28. Complete hematological response is defined by hemoglobin >/= 120 g/L; or achievement of transfusion independence, with stable Hb > 110 g/L, for RBC transfusion-dependent participants; Spleen not palpable; platelet count 150 x 10 (9)/L; White blood cell 4 x 10 (9)/L to 10 x 10(9)/L. (NCT00475020)
Timeframe: Up to 3 years post-transplant
Intervention | Participants (Count of Participants) |
---|
| Overall survival at 3 years | Leukemia progression | Primary graft failures | Complete hematological remission |
---|
Participants With Myelofibrosis and Myelodysplastic Syndrome | 25 | 27 | 0 | 44 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants With Objective Response
Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/Liters or more and platelet count of 100*10^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100*10^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts >/= 50% and not more than 6-25% abnormal cells in the marrow. (NCT00480987)
Timeframe: After 2 months
Intervention | Participants (Number) |
---|
| Complete response | Complete response with platelets | Partial response |
---|
Oxaliplatin + Cytarabine + Fludarabine | 3 | 2 | 0 |
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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 |
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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 |
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Number of Participants in Complete Molecular Remission at 1 Year
Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials). (NCT00499889)
Timeframe: Baseline to 1 year
Intervention | participants (Number) |
---|
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin | 21 |
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Participants' With mCR Response to Post Transplant DLI
Number of participants with response of molecular complete remission (mCR) to DLI as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests. (NCT00499889)
Timeframe: 1 year
Intervention | Participants (Number) |
---|
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin | 4 |
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Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy
Number of participants with response of molecular complete remission (mCR) to Imatinib Mesylate therapy as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests. (NCT00499889)
Timeframe: 1 Year
Intervention | Participants (Number) |
---|
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin | 10 |
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Number of Participants With Successful Engraftment
Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28. (NCT00502905)
Timeframe: Study period one week prior to transplant through post Day 28
Intervention | participants (Number) |
---|
Busulfan + Fludarabine | 192 |
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Number of Participants With Successful Engraftment at Day 100
(NCT00505895)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Fludarabine + Melphalan + Stem Cell Infusion | 27 |
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion | 23 |
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Acute Grade II-IV Graft Versus Host Disease (GVHD)
Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4. (NCT00505895)
Timeframe: GVHD grading weekly during first 100 days; Annual examinations for nine year study period
Intervention | percentage of participants (Number) |
---|
| Acute GVHD | Chronic GVHD |
---|
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion | 21 | 48 |
,Fludarabine + Melphalan + Stem Cell Infusion | 22 | 29 |
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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 |
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Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( > 90% to < 100%); only traces of disease remains; 2) Significant improvement ( > 75% to < 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( > 50% to < 75%); 4) Some improvement ( > 25% to < 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by > 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one. (NCT00506129)
Timeframe: Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.
Intervention | participants (Number) |
---|
| Complete Response (CR) Converted Post Transplant | CR Prior to Transplant | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) |
---|
Fludarabine + Melphalan With PBPC | 19 | 6 | 0 | 0 | 16 |
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Average Overall Survival (OS) Length
OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days. (NCT00506129)
Timeframe: Baseline to disease progression, followed up to 5 years post transplant
Intervention | Days (Mean) |
---|
Fludarabine + Melphalan With PBPC | 1207 |
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Maximum Tolerated Dose (MTD)
"Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where toxicity is defined as grade 3 or 4 conventional toxicity [National Cancer Institute Common Toxicity Criteria (NCI-CTC)]. Participant evaluation in a cohort with each modality is 30 days." (NCT00506857)
Timeframe: 1 month
Intervention | mg/kg (Number) |
---|
Busulfan + Fludarabine | 11.2 |
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Number of Participants With Graft Versus Host Disease (GVHD)
Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status. (NCT00506857)
Timeframe: 5 years
Intervention | Participants (Number) |
---|
| Grade 2 | Grade 3-4 |
---|
Tacrolimus + Methotrexate | 18 | 8 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants With Neuropathy, Any Grade
Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC). (NCT00510887)
Timeframe: up to 1 year
Intervention | participants (Number) |
---|
VR-FND | 6 |
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Percentage of Subjects Experiencing Progression Free Survival
Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment. (NCT00510887)
Timeframe: up to 2 years
Intervention | percentage of participants (Number) |
---|
VR-FND | 17 |
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Percentage of Subjects Experiencing Overall Survival
Overall survival is from the day of enrollment to date of death from any cause. (NCT00510887)
Timeframe: up to 2 years
Intervention | percentage of participants (Number) |
---|
VR-FND | 27 |
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Number of Participants With a Grade 3-4 Hematologic Toxicity.
Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC). (NCT00510887)
Timeframe: up to 1 year
Intervention | participants (Number) |
---|
VR-FND | 7 |
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Duration of Response
Duration of response is measured from time of treatment to time of disease progression (NCT00510887)
Timeframe: up to 4 years
Intervention | months (Mean) |
---|
VR-FND | 16.47143 |
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Complete and Partial Response
"Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma.~Partial Response requires the following:~greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses.~No increase in size of other nodes, liver, or spleen.~Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD).~Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported.~No new lesions." (NCT00510887)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
VR-FND | 64 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival (OS) for High Risk Patients
Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to death from any cause. Estimates were not stratified. Patients who did not experience this primary outcome had their survival times censored at their last follow-up. (NCT00513747)
Timeframe: Up to 72 months
Intervention | months (Median) |
---|
Arm A: High Risk Early Intervention | NA |
Arm B: High Risk Observation + Later Treatment | NA |
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Disease-Free Survival in High Risk Patients
"Kaplan-Meier analysis was conducted to estimate disease free survival defined as:>~Arm A: Time from randomization until Second Treatment (first relapse) or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.>~Arm B: Time from randomization until First Treatment (first relapse) or death whichever comes first. Events were defined as the start of first treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up." (NCT00513747)
Timeframe: Up to 72 months
Intervention | months (Median) |
---|
Arm A: High Risk Early Intervention | 62.7 |
Arm B: High Risk Observation + Later Treatment | 39.2 |
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Time to Second Treatment in High Risk Patients
Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to second treatment or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up. (NCT00513747)
Timeframe: Up to 72 months
Intervention | months (Median) |
---|
Arm A: High Risk Early Intervention | 62.7 |
Arm B: High Risk Observation + Later Treatment | 56.3 |
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Time to First Treatment Survival in Low Risk Patients
"Time to First Treatment Survival in low risk patients (registration to first treatment or death)>~• Events were defined as the start of first treatment or death from any cause. Patients who didn't receive their first treatment were censored at their last known follow-up." (NCT00513747)
Timeframe: Up to 72 months
Intervention | months (Median) |
---|
Arm C: Low Risk Observation + Later Treatment | 58.1 |
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Overall Survival in Low Risk Patients
"Overall survival in low risk patients (registration to first treatment or death)>~• Events were defined as death from any cause. Low risk Patients who were alive were censored at their last known follow-up." (NCT00513747)
Timeframe: Up to 72 months
Intervention | months (Median) |
---|
Arm C: Low Risk Observation + Later Treatment | 58.1 |
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Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD)
Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria. (NCT00520130)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 42 |
B - Cyclosporine (AC) Arm | 38 |
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Days to Engraftment of Platelets
Platelet recovery: designated by the first of 7 days where the platelet count remains above 20,000/mm(3) without transfusion support (NCT00520130)
Timeframe: 2 years
Intervention | Days (Median) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 19 |
B - Cyclosporine (AC Arm) | 14 |
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Overall Survival
Time between the first day of transplant to the day of death. (NCT00520130)
Timeframe: Patients were followed for an average of up to 5 years.
Intervention | Months (Median) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 41.7 |
B - Cyclosporine (AC) Arm | 18.8 |
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Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD)
Acute GVHD is assessed by the 1994 Consensus Conference on acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria. (NCT00520130)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 13 |
B - Cyclosporine (AC) Arm | 21 |
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Days to Engraftment of Neutrophils
Days to engraftment is defined as neutrophil recovery: designated by the first of 3 consecutive days with an absolute neutrophil count (ANC) above 500/mm(3). (NCT00520130)
Timeframe: 2 years
Intervention | Days to neutrophil engraftment (Median) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 11 |
B - Cyclosporine (AC Arm) | 9 |
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Toxicities
Here are the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00520130)
Timeframe: 103 months and 22 days
Intervention | participants (Number) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 43 |
B - Cyclosporine (AC) Arm | 42 |
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Changes in CD8 T Cell Receptor Vbeta Repertoire
Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison. (NCT00520130)
Timeframe: Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant
Intervention | Divergence index (Median) |
---|
| 1 month | 3 months | 6 mo (TMS=7; AC= 9) | 12 mo (TMS=7; AC= 9) | Donor CD8 cells (TMS=8; AC= 8) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 62 | 54 | 62 | 55 | 47 |
,B - Cyclosporine (AC) Arm | 78 | 81 | 84 | 89 | 43 |
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Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations
Cluster of Differentiation 3 (CD3)+CD4+ and CD3+Cluster of Differentiation 8 (CD8)+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. (NCT00520130)
Timeframe: 2 weeks, and 1, 3, 6, 12 and 24 months post transplant
Intervention | Cells/µl (Median) |
---|
| 2 weeks | 1 month | 3 months | 6 months | 12 months | 24 months |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 171 | 285 | 297 | 387 | 447 | 451 |
,B - Cyclosporine (AC) Arm | 0 | 21 | 61 | 121 | 132 | 373 |
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Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations
Cluster of differentiation 3 (CD3)+cluster of differentiation 4 (CD4)+ and CD3+CD8+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. (NCT00520130)
Timeframe: 2 weeks, 1, 3, 6, 12 and 24 months post transplant
Intervention | Cells/µl (Median) |
---|
| 2 weeks | 1 month | 3 months | 6 months | 12 months | 24 months |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 72 | 204 | 334 | 429 | 485 | 434 |
,B - Cyclosporine (AC) Arm | 1 | 6 | 54 | 158 | 243 | 502 |
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Immune Reconstitution of Normal Killer (NK) Cells
Cluster of differentiation 3 (CD3) - cluster of differentiation 56 (CD56) + Natural Killer (NK) cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. (NCT00520130)
Timeframe: 2 weeks, and 1, 3, 6, 12, and 24 months post transplant
Intervention | Cells/µl (Median) |
---|
| 2 weeks | 1 month | 3 months | 6 months | 12 months | 24 months |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 123 | 270 | 134 | 136 | 134 | 133 |
,B - Cyclosporine (AC) Arm | 15 | 31 | 124 | 202 | 150 | 307 |
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Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD)
Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. First the individual organ scoring is done, and then based on that the Global score is determined (mild-moderate-severe). See Citation: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (NCT00520130)
Timeframe: 2 years post transplant
Intervention | percentage of participants (Number) |
---|
| Moderate or Severe cGVHD | Severe cGVHD |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 50 | 28 |
,B - Cyclosporine (AC) Arm | 12 | 5 |
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Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells
The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry. (NCT00520130)
Timeframe: Recipient recovery at 6, 12 and 24 months post transplant
Intervention | % of naive (CCR7+CD45RA+) CD4 Cells (Median) |
---|
| 6 mo (TMS=28; AC= 28) | 12 mo (TMS=25; AC= 21) | 24 mo (TMS=18; AC= 13) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 24 | 22 | 20 |
,B - Cyclosporine (AC) Arm | 1 | 7 | 25 |
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Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells
The percentage of CCR7+CD45RA+ naïve T cells within the CD4 and CD8 T cell populations was determined by flow cytometry. (NCT00520130)
Timeframe: Recipient recovery at 6, 12 and 24 months post transplant
Intervention | % of naive (CCR7+CD45RA+) CD8 Cells (Median) |
---|
| 6 mo (TMS=28; AC= 28) | 12 mo (TMS=25; AC= 21) | 24 mo (TMS=18; AC= 13) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 20 | 17 | 16 |
,B - Cyclosporine (AC) Arm | 3 | 6 | 6 |
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Days to Engraftment of Lymphocytes
Lymphocyte recovery: designated by the first of 3 consecutive days with absolute lymphocyte count (ALC) above 500/mm(3). (NCT00520130)
Timeframe: 2 years
Intervention | Days (Median) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 16 |
B - Cyclosporine (AC Arm) | 76 |
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Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire
Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison. (NCT00520130)
Timeframe: Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant
Intervention | Divergence index (Median) |
---|
| 1 month | 3 months | 6 mo (TMS=7; AC= 9) | 12 mo (TMS=7; AC=9) | Donor CD4 cells (TMS=8; AC=8) |
---|
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 48 | 31 | 35 | 30 | 23 |
,B - Cyclosporine (AC) Arm | 90 | 66 | 75 | 67 | 22 |
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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 |
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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 |
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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 |
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Complete Response Rate
An improvement in complete response to at least 60% following treatment, assessed using CT scans, clinical/lab examinations, and bone marrow aspirations, as defined by National Cancer Institute Working Group Response Criteria. (NCT00536341)
Timeframe: At 12 weeks during treatment and 2 months post-treatment until disease progression, projected 8 months
Intervention | participants (Number) |
---|
Dose Level 1 | 4 |
Dose Level 2 | 9 |
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Overall Survival
Defined as the time from Day 1 of treatment administration to date of death from any cause, estimated using Kaplan-Meier methods. (NCT00536341)
Timeframe: Every 3 months until treatment discontinuation, expected average of 6 months and then every 6 months thereafter up to 5 years
Intervention | months (Median) |
---|
All Patients | NA |
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Number of Adverse Events as a Measure of Safety and Tolerability
Recorded from first treatment until 30 days after last treatment and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (NCT00536341)
Timeframe: 63 months
Intervention | participants (Number) |
---|
| Fatigue | Neutropenia | Anemia | Leukopenia | Thrombocytopenia | Rash | Nausea | Constipation | Anorexia | Fever | Hyperhidrosis | Arthralgia | Edema Limbs | Pruritus | Back pain | Headache | Chills | Insomnia | Vomiting | Dysgeusia | Abdominal Pain | Allergic Reaction | Diarrhea | Cough | Dizziness | Dyspnea | Hypotension | Myalgia |
---|
Dose Level 1 | 8 | 7 | 8 | 7 | 8 | 6 | 7 | 3 | 4 | 3 | 3 | 1 | 3 | 0 | 3 | 1 | 2 | 2 | 2 | 1 | 2 | 4 | 3 | 2 | 2 | 0 | 1 | 2 |
,Dose Level 2 | 40 | 41 | 34 | 34 | 30 | 27 | 25 | 15 | 12 | 13 | 13 | 14 | 12 | 15 | 11 | 13 | 11 | 11 | 11 | 11 | 9 | 7 | 8 | 8 | 8 | 10 | 9 | 8 |
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Progression-Free Survival
Measured from first treatment to disease progression and assessed using Kaplan-Meier methods. (NCT00536341)
Timeframe: Every 3 months during treatment until disease progression and every 6 months thereafter, up to 5 years
Intervention | months (Median) |
---|
All Patients | 24.64 |
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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 |
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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 |
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Overall Survival on Day 180 Days Post-transplant
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 180 days after transplant and Kaplan-Meier survival analysis was used to generate the Overall Survival estimate at 180 days. (NCT00544466)
Timeframe: Up to 180 days post-transplant
Intervention | Percent Probability (Number) |
---|
Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) | 81 |
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Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.
Toxicities (adverse events) were evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT00544466)
Timeframe: 100 days post treatment
Intervention | events (Number) |
---|
Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) | 793 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
Number of patients alive at 1 year (NCT00553098)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 19 |
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Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism
The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism. (NCT00553098)
Timeframe: At 1 year post transplant
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 13 |
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Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant
Number of patients who experienced a clinical significant infection, requiring treatment, within 100 days post transplant. (NCT00553098)
Timeframe: 100 days
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 21 |
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Immune Reconstitution by 1 Year Post Transplant
Number of patients with normal range CD3 at 1 year post transplant (NCT00553098)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 7 |
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Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD
Number of patients diagnosed with overall grade I or grade II acute GVHD by Day 100 post transplant (NCT00553098)
Timeframe: Day 100
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 12 |
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Number of Patients Diagnosed With Acute GVHD
Number of patients diagnosed with acute GVHD by Day 100 post transplant (NCT00553098)
Timeframe: Day 100
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 18 |
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Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD
Number of patients diagnosed with overall Grade III or Grade IV Acute GVHD by Day 100 post transplant (NCT00553098)
Timeframe: Day 100
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 6 |
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Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant
Number of patients who achieve greater than 50% CD33+ donor chimerisms at 1 year post transplant. (NCT00553098)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 8 |
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Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant
Number of Patients Who Achieve Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant (NCT00553098)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 16 |
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Disease Response by 1 Year Post Transplant
Number of patients at 1 year with disease response (defined as no clinical evidence of active disease and/or sufficient level of donor chimerisms to prevent disease recurrence) (NCT00553098)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 15 |
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Number of Patients Diagnosed With Chronic GVHD
Number of patients diagnosed with chronic GVHD within 1 year post transplant (NCT00553098)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy, Low Dose Radiation) | 8 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Response Outcomes
assessed according to the IWG Criteria (NCT00572897)
Timeframe: 180 days
Intervention | participants (Number) |
---|
| clinical complete response | clinical partial response | clinical improvement | stable disease | progressive disease |
---|
Sibling Donor | 7 | 8 | 11 | 2 | 0 |
,Unrelated Donor | 6 | 1 | 5 | 4 | 1 |
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The Primary Endpoint is Progression-free Survival.
Number of participants alive at 2 years who are progression-free (NCT00572897)
Timeframe: 2 years
Intervention | participants (Number) |
---|
Sibling Donor | 24 |
Unrelated Donor | 11 |
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PLT
Patients with PLT ≥20 × 109/L (NCT00572897)
Timeframe: 2 years
Intervention | participants (Number) |
---|
| yes | no |
---|
Sibling Donor | 28 | 4 |
,Unrelated Donor | 20 | 14 |
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Absolute Neutrophil Count (ANC)
Patients with ANC ≥0.5 × 10^9/L (NCT00572897)
Timeframe: 2 years
Intervention | participants (Number) |
---|
| yes | no |
---|
Sibling Donor | 31 | 1 |
,Unrelated Donor | 26 | 8 |
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Overall Survival
The number of patients alive at last follow-up. (NCT00572897)
Timeframe: 73 months
Intervention | participants (Number) |
---|
Sibling Donor | 25 |
Unrelated Donor | 11 |
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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 |
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Overall Survival
(NCT00574496)
Timeframe: up to 8 years
Intervention | months (Median) |
---|
High-Risk or Relapsed Hodgkin Lymphoma | 70.3 |
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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 |
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Overall Survival at Two Years
Overall survival (OS) was measured from initial treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. (NCT00577278)
Timeframe: From the initial treatment to the last disease assessment, up to two years
Intervention | percentage of survival probability (Number) |
---|
0.4 mCi 90Y-Ibritumomab Tiuxetan | 63 |
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Relapse/Progression Rate at Two Years
The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events. (NCT00577278)
Timeframe: From the initial treatment to the last disease assessment, up to two years
Intervention | percentage of cumulative incidence (Number) |
---|
0.4 mCi 90Y-Ibritumomab Tiuxetan | 20 |
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Progression-free Survival at Two Years
Progression-free survival (PFS) was measured from initial treatment to disease progression or death from any cause, whichever came first. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. (NCT00577278)
Timeframe: From the initial treatment to the last disease assessment, up to two years
Intervention | percentage of survival probability (Number) |
---|
0.4 mCi 90Y-Ibritumomab Tiuxetan | 61 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Patients With Successful Donor Engraftment
Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant. (NCT00579111)
Timeframe: 100 days
Intervention | participants (Number) |
---|
HLA-identical Sibling Transplant | 2 |
Unrelated Matched or Single Antigen Mismatched Transplant | 1 |
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Patients Alive at 1 Year
(NCT00579137)
Timeframe: 1 Year
Intervention | participants (Number) |
---|
Single Group | 3 |
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Number of Patients With Grade III to IV Acute GVHD
(NCT00579137)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Single Group | 0 |
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Number of Patients With Grade III or IV Toxicity
(NCT00579137)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Single Group | 0 |
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Number of Patients With Donor Engraftment
(NCT00579137)
Timeframe: 100 Days
Intervention | participants (Number) |
---|
Single Group | 1 |
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Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
(NCT00582894)
Timeframe: At time of study termination
Intervention | Participants (Number) |
---|
Reduced Intensity Regimen | 17 |
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Number of Participants Relapse-Free
(NCT00582894)
Timeframe: 100 days post-transplant
Intervention | Participants (Number) |
---|
Reduced Intensity Regimen | 5 |
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Number of Participants Overall Survival as a Function of Time.
(NCT00582894)
Timeframe: 100 days post transplant
Intervention | Participants (Number) |
---|
Reduced Intensity Regimen | 11 |
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Death From GVHD
To establish the early transplant-related severe morbidity and mortality and 3-the incidence and severity of GvHD. (NCT00582933)
Timeframe: 2 years
Intervention | participants (Number) |
---|
Transplant Patients | 4 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Patients With Limited Chronic GVHD From Day 100 to 365
Number of patients with limited chronic GVHD from day 100 to 365 (NCT00590460)
Timeframe: 365 days
Intervention | participants (Number) |
---|
Allogeneic Stem Cell Transplant | 0 |
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Patients With Grade III - IV Acute GVHD
Number of patients with Grade III-IV acute GVHD (NCT00590460)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Allogeneic Stem Cell Transplant | 0 |
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Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD)
Number of patients with grade II - IV acute Graft versus Host Disease (GVHD) (NCT00590460)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Allogeneic Stem Cell Transplant | 0 |
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Days to Absolute Neutrophil Count (ANC) of 500/mm3
Number of days to Absolute neutrophil count (ANC) of 500/mm3 (NCT00590460)
Timeframe: 30 Days
Intervention | days (Median) |
---|
Allogeneic Stem Cell Transplant | 15 |
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Patients With Extensive Chronic GVHD From Day 100 to 365
Number of patients with extensive chronic GVHD from day 100 to 365. (NCT00590460)
Timeframe: 365 days
Intervention | participants (Number) |
---|
Allogeneic Stem Cell Transplant | 0 |
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Number of Patients With Donor Engraftment
Number of patients with engraftment of at least 65% of donor cells 100 days after transplantation (NCT00590460)
Timeframe: 100 Days
Intervention | participants (Number) |
---|
Allogeneic Stem Cell Transplant | 2 |
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Number of Patients Alive at 1 Year Post Transplant
Number of patients alive at 1 year post allogeneic stem cell transplant (NCT00590460)
Timeframe: 1 year
Intervention | participants (Number) |
---|
Allogeneic Stem Cell Transplant | 5 |
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Number of Patients With Graft Failure
Graft failure is defined as engraftment of less than 65% of donor cells 100 days after transplantation. (NCT00590460)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Allogeneic Stem Cell Transplant | 3 |
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Days to Platelet Count of 20,000/mm3 Without Transfusions
Number of days to Platelet count of 20,000 / mm3 without transfusions (NCT00590460)
Timeframe: 30 Days
Intervention | days (Median) |
---|
Allogeneic Stem Cell Transplant | 16 |
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Time to Platelet Engraftment
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided. (NCT00593554)
Timeframe: Transplant (Day 0) up to 1 year
Intervention | days (Median) |
---|
Treatment Without Paliferim | 22.5 |
Treatment With Palifermin | 20 |
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Acute Graft vs. Host Disease (GvHD)
Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study. (NCT00593554)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment Without Paliferim | 0 |
Treatment With Palifermin | 0 |
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Chronic Graft vs. Host Disease (GvHD)
Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study. (NCT00593554)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment Without Paliferim | 0 |
Treatment With Palifermin | 0 |
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Frequency of Infection
Number of unique patients with bacterial and/or viral infections reported. (NCT00593554)
Timeframe: Day 0 through 1 year post transplantation
Intervention | Participants (Count of Participants) |
---|
Treatment Without Paliferim | 2 |
Treatment With Palifermin | 5 |
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Time to Neutrophil Engraftment
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided. (NCT00593554)
Timeframe: Transplant (Day 0) up to 1 year
Intervention | days (Median) |
---|
Treatment Without Paliferim | 15 |
Treatment With Palifermin | 14 |
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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 |
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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 |
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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 |
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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 |
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Incidence & Quality of Engraftment & Hematopoietic Reconstitution
Number of patients who engrafted (NCT00595127)
Timeframe: 8 years
Intervention | participants (Number) |
---|
Cyclophosphamide and Fludarabine | 19 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Quality and Timing of Immunologic Reconstitution: Concentration of ATG Levels
Analyses of ATG levels in order to assess the immune system recuperation (NCT00603954)
Timeframe: Day 0, Day 3 and Day 10
Intervention | mg/L (Median) |
---|
| Median ATG serum levels at day 0 | Median ATG serum levels at day 3 | Median ATG serum levels at day 10 |
---|
TLI-ATG | 4 | 2.2 | 0.95 |
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Percentage of 4-year Progression Free Survival in the 2 Groups
(NCT00603954)
Timeframe: 4 year after HCT
Intervention | percentage of participants (Number) |
---|
Flu-TBI | 54 |
TLI-ATG | 37 |
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Percentage of 5-year Overall Survival in the 2 Groups
(NCT00603954)
Timeframe: 5 year after HCT
Intervention | percentage of participants (Number) |
---|
Flu-TBI | 53 |
TLI-ATG | 55 |
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Percentage of Participants With Chronic GVHD in the 2 Groups
Comparaison of the number of Participants with chronic GVHD in the 2 groups (NCT00603954)
Timeframe: 2 years after HCT
Intervention | percentage of participants (Number) |
---|
Flu-TBI | 40.8 |
TLI-ATG | 18.8 |
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Percentage of 5-year Progression Free Survival in the 2 Groups
(NCT00603954)
Timeframe: 5 year after HCT
Intervention | percentage of participants (Number) |
---|
Flu-TBI | 50 |
TLI-ATG | 37 |
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Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism
graft rejection are reported in outcome measure data table (defined as ≤ 5% donor chimerism in T cells, total white blood cells and/or total bone marrow cells). (NCT00603954)
Timeframe: 1 year after HCT
Intervention | participants (Number) |
---|
Flu-TBI | 3 |
TLI-ATG | 4 |
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Percentage of 4-year Overall Survival in the 2 Groups
(NCT00603954)
Timeframe: 4 year after HCT
Intervention | percentage of participants (Number) |
---|
Flu-TBI | 53 |
TLI-ATG | 54 |
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Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups.
(NCT00603954)
Timeframe: D100 after HCT
Intervention | participants (Number) |
---|
| Bacterial infection | Fungal infection | CMV reactivation |
---|
Flu-TBI | 19 | 3 | 15 |
,TLI-ATG | 25 | 7 | 21 |
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Percentage of Non Relapse Mortality in the 2 Groups
(NCT00603954)
Timeframe: 1 year after HCT
Intervention | percentage of participants (Number) |
---|
Flu-TBI | 24 |
TLI-ATG | 13 |
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Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups
"Percentage of participants with aGVHD according grades:~Grade I: rash skin < 25 % area; bilirubin: 20-30 mg/ml; diarrhea: 500-1000 ml/day Grade II: rash skin 25-50 % area; bilirubin: 30-60 mg/ml; diarrhea: 10000-1500 ml/day Grade III:rash skin > 50 % area; bilirubin: 60-150 mg/ml; diarrhea: >1500 ml/day Grade IV: erythroderma; bilirubin: > 150 mg/ml; diarrhea: >2000 ml/day~Grade IV is the worst grade Patients given a second allogeneic HCT were censured for GVHD analyses." (NCT00603954)
Timeframe: 180 days after HCT
Intervention | percentage of participants with aGVHD (Number) |
---|
Flu-TBI | 12.2 |
TLI-ATG | 8.9 |
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Percentage of Relapse Rate in the 2 Groups
(NCT00603954)
Timeframe: 1 year after HCT
Intervention | percentage of Relapse (Number) |
---|
Flu-TBI | 22 |
TLI-ATG | 50 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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The Percentage of Patients Free From Progression at 1 Year
"One of the secondary outcomes that will be measured is progression free survival at 1 Year.~Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia." (NCT00615589)
Timeframe: 1 Year
Intervention | percentage of patients (Number) |
---|
Flu-Bu4 | 40 |
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Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years. (NCT00615589)
Timeframe: 3 years
Intervention | percentage of deaths (Number) |
---|
| NRM at 1 Year | NRM at 3 Years |
---|
Flu-Bu4 | 19 | 29 |
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The Percentage of Patients Alive 1 Year Post Transplant
The primary objective is overall survival, one year from the time of transplant. (NCT00615589)
Timeframe: 1 Year
Intervention | percentage of patients (Number) |
---|
Flu-Bu4 | 61 |
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Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
"Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.~Acute GVHD Grading:~Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus" (NCT00615589)
Timeframe: 100 days, 2 years
Intervention | percentage of participants (Number) |
---|
| Grade II-IV Acute GVHD | Grade III-IV Acute GVHD | Chronic GVHD |
---|
Flu-Bu4 | 48 | 23 | 55 |
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Overall Survival
Count of patients alive at 1 and 3 years. Deaths from any cause are events. Surviving patients are censored at the date of last contact. (NCT00618540)
Timeframe: Year 1, Year 3
Intervention | participants (Number) |
---|
Alemtuzumab Conditioning | 0 |
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Platelet Engraftment
Incidence of platelet recovery and donor chimerism at Day 100. (NCT00618540)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Alemtuzumab | 0 |
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Incidence of Chronic GVHD
Occurrence of symptoms in any organ system fulfilling the criteria of limited or extensive chronic GvHD (Appendix III), among patients surviving > 90 days with evidence of engraftment. Patients without chronic GvHD will be censored at time of death or last follow-up. (NCT00618540)
Timeframe: Day 100 and Month 6
Intervention | participants (Number) |
---|
Alemtuzumab Conditioning | 0 |
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Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant. (NCT00618540)
Timeframe: Day 100 and Month 6
Intervention | participants (Number) |
---|
Alemtuzumab Conditioning | 1 |
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Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD)
The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant. (NCT00618540)
Timeframe: Day 100 and Month 6
Intervention | participants (Number) |
---|
Alemtuzumab Conditioning | 0 |
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Neutrophil Engraftment
Incidence of neutrophil recovery and donor chimerism at Day 100. (NCT00618540)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Alemtuzumab Conditioning | 1 |
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Disease-free Survival at 12 Months Post Transplantation
"This outcome is defined as survival with resolution of LCH at 12 months post transplant.~Unresolved disease for over 12 months post-transplant, progressive disease after this time period, recurrence of disease and death from any cause are considered events.~Those who survive with resolution of disease are censored at the date of last contact." (NCT00618540)
Timeframe: Year 1
Intervention | participants (Number) |
---|
Alemtuzumab Conditioning | 0 |
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Number of Patients Alive 24 Months Post Day 100 Transplant
Patients will be followed for survival for 24 months post day 100 transplant. (NCT00619645)
Timeframe: 24 months post day 100 transplant
Intervention | Participants (Count of Participants) |
---|
RIST for Heme Malignancies | 3 |
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Skin Score
The skin score measure is a scale: the name of the scale is the modified Rodnan skin score (mRSS). Total score of mRSS is from 0 to 51. Higher values represents worse skin score. Highest value is 51, represents very hidebound tight thick skin. Lowest value is 0, represent normal skin, no tightness. (NCT00622895)
Timeframe: Up to 5 years post-transplant
Intervention | units on a scale (mRSS) (Number) |
---|
| Pre-transplant (baseline) skin score | 5 year post-transplant skin score |
---|
Treatment: Allogeneic HCT After Reduced Intensity Conditioning | 17 | 4 |
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Event-free Survival (EFS)
The events will be defined as any one of the following: death; respiratory failure; renal failure, as defined by chronic dialysis > or = 6 months or kidney transplantation; occurrence of cardiomyopathy, confirmed by clinical CHF (New York Class III or IV) or LVEF < 30% by echocardiogram, sustained for at least 3 months despite therapy; organ dysfunction specific events must be documented on at least two occasions > or = 3 months apart, or sustained for a 3-month period (documented from the first occurrence). (NCT00622895)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
Treatment: Allogeneic HCT After Reduced Intensity Conditioning | 1 |
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EFS
event-free survival after umbilical cord blood transplant (NCT00622895)
Timeframe: 5 years
Intervention | Participants (Count of Participants) |
---|
Treatment: Allogeneic UCB After Reduced Intensity Conditioning | 1 |
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Incidence of Graft Rejection
Engraftment is defined as achieving > 5% donor peripheral blood T cell chimerism by Day 56 after HCT. Primary graft failure is defined as a donor peripheral blood T cell chimerism peak of < 5% by Day 56 post-HCT. Methodological requirements for chimerism are as defined by institutional standard of practice. Secondary Graft Failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood T cell chimerism < 5% as demonstrated by a chimerism assay (NCT00622895)
Timeframe: Up to day +56
Intervention | Participants (Count of Participants) |
---|
Treatment: Allogeneic HCT After Reduced Intensity Conditioning | 0 |
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Overall Survival
Event is defined as death due to any cause. (NCT00622895)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Treatment: Allogeneic HCT After Reduced Intensity Conditioning | 1 |
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The Percent of Participants With Definite and Probable Viral, Fungal, and Bacterial Infections
The percent of participants with definite and probable viral, fungal, and bacterial infections after transplant (NCT00622895)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Treatment: Allogeneic HCT After Reduced Intensity Conditioning | 2 |
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Incidence and Severity of Graft-versus-host Disease (GVHD)
The grading of acute and chronic GVHD will follow previously published guidelines and according to institutional standard of practice 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 SSc involve the skin and the gastrointestinal tract, all diagnostic biopsies of these organs will be centrally reviewed by a study pathologist. (NCT00622895)
Timeframe: Up to 5 years post-transplant
Intervention | units on a scale (Number) |
---|
| acute GVHD severity maximum grade | chronic GVHD maximum grade |
---|
Treatment: Allogeneic HCT After Reduced Intensity Conditioning | 2 | 2 |
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Quality of Life as Assessed by the Modified Scleroderma Health Assessment Questionnaire (SHAQ)
The questionnaire includes measure of quality of life and measure of the scale of skin tightness, activity level and function specifically designed for patients with systemic sclerosis (NCT00622895)
Timeframe: Up to 5 years
Intervention | units on a scale (Number) |
---|
| pre-transplant SHAQ | 5 year post transplant | pre-transplant Raynaud symptoms | 5 year post transplant Raynaud symptoms | pre-transplant Finger ulcer symptoms | 5 year post-transplant Finger ulcer symptoms | pre-transplant Overall health symptoms | 5 year post-transplant overall health symptoms |
---|
Treatment: Allogeneic HCT After Reduced Intensity Conditioning | 1.125 | 0.125 | 3 | 0.5 | 3 | 0 | 2.5 | 0.2 |
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Percentage of Participants Alive at 1 Year
One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor. (NCT00623935)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Fludarabine Plus Busulfan | 58 |
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Percentage of Participants With Relapse Free Survival at 1 Year
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen. (NCT00623935)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Fludarabine Plus Busulfan | 56 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
(NCT00636155)
Timeframe: 5 years
Intervention | months (Median) |
---|
All Patients | 10.6 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Incidence of Chronic GVHD.
(NCT00691015)
Timeframe: Within 2 years after PBSCT
Intervention | percentage of participants (Number) |
---|
All Participants | 44.68 |
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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 |
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Overall Survival.
(NCT00691015)
Timeframe: At 2 years after PBSCT
Intervention | percentage of participants (Number) |
---|
All Participants | 57.4 |
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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 |
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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 |
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Composite Incidence of Acute and Chronic Graft Versus Host Disease
(NCT00714259)
Timeframe: Up to 100 days post transplant.
Intervention | participants (Number) |
---|
Single Arm Trial | 2 |
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Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient. (NCT00714259)
Timeframe: Post transplant up to 100 days post transplant
Intervention | participant (Number) |
---|
Single Arm Trial | 1 |
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Progression Free Survival Post Transplant
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology. (NCT00714259)
Timeframe: 2 years post transplant
Intervention | participants (Number) |
---|
Single Arm Trial | 2 |
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Progressive Free Survival Post Transplant
Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. (NCT00714259)
Timeframe: 180 days post transplant
Intervention | participants (Number) |
---|
Single Arm Trial | 4 |
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Progressive Free Survival Post Transplant
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. (NCT00714259)
Timeframe: 365 days post transplant
Intervention | participants (Number) |
---|
Single Arm Trial | 4 |
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Progressive Free Survival Post Transplant
subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. (NCT00714259)
Timeframe: 100 days post transplant
Intervention | participants (Number) |
---|
Single Arm Trial | 4 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants With Graft Failure/Rejection
descriptive (NCT00723099)
Timeframe: By day 55
Intervention | participants (Number) |
---|
Treatment (Chemotherapy, Transplant) | 3 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 = 15 Days | Engrafted 16-30 Days | Engrafted >30 Days |
---|
Study Treatment | 1 | 15 | 1 |
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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 |
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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 |
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To Describe the Incidence of Grade 3-4 Organ Toxicity
(NCT00744692)
Timeframe: 2 years post transplant
Intervention | participants (Number) |
---|
RIC Cord Blood Transplant | 0 |
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To Evaluate the Incidence of Late Graft Failures at 2 Years Post-transplant
(NCT00744692)
Timeframe: 2 years post transplant
Intervention | participants (Number) |
---|
RIC Cord Blood Transplant | 0 |
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To Evaluate Long-term Complications, Such as Sterility, Endocrinopathy, and Growth Failure
(NCT00744692)
Timeframe: at least 2 years post transplant
Intervention | percentage of patients (Number) |
---|
RIC Cord Blood Transplant | 0 |
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To Evaluate the Pace of Immune Reconstitution.
Immune reconstitution after RIC in UCBT was described. CD4 count is a standard measure of immune reconstitution and is described here. Additional data is available upon request. (NCT00744692)
Timeframe: 1 year post transplant
Intervention | cells/uL (Median) |
---|
RIC Cord Blood Transplant | 805 |
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To Describe the Pace of Neutrophil Recovery
Neutrophil recovery was defined as the first day of an absolute neutrophil count (ANC) more than 500/uL for 3 consecutive days not secondary to granulocyte infusions (NCT00744692)
Timeframe: 42 days post transplant
Intervention | days (Median) |
---|
RIC Cord Blood Transplant | 20 |
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Determine the Feasibility of Attaining Acceptable Rates of Donor Cell Engraftment (>25% Donor Cells at 180 Days) Following RIC Regimens in Children < 21 Years Receiving UCBT for Non-malignant Disorders.
Determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor cells at 180 days) following reduced intensity conditioning regimens in children < 21 years receiving cord blood transplant for non-malignant disorders. (NCT00744692)
Timeframe: 180 days post transplant
Intervention | % of participants (Number) |
---|
RIC Cord Blood Transplant | 88 |
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To Describe the Pace of Platelet Recovery
Platelet engraftment was defined as the first day of platelet counts more than 50,000/uL for 7 consecutive days without transfusions (NCT00744692)
Timeframe: 180 days post transplant
Intervention | days (Median) |
---|
RIC Cord Blood Transplant | 48 |
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To Determine the Overall Survival at day180 Post-transplant
To determine the overall survival at day180 post-transplant: determined by Kaplan Meier survival analysis (NCT00744692)
Timeframe: 180 days
Intervention | percentage of participants (Number) |
---|
RIC Cord Blood Transplant | 81.8 |
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To Describe Incidence of Acute Graft Versus Host Disease (GVHD) (II - IV)
To describe incidence of acute Graft Versus Host Disease (GVHD) (II - IV) : measured by cumulative incidence analysis (NCT00744692)
Timeframe: 100 days post transplant
Intervention | percentage of participants (Number) |
---|
RIC Cord Blood Transplant | 22.7 |
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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 |
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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 |
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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 |
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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 |
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Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
(NCT00782379)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Haploidentical Transplant | 2 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Patients Surviving Overall
Number of subjects surviving two years post autologous transplant. (NCT00793572)
Timeframe: At 2 years after the autograft
Intervention | Participants (Count of Participants) |
---|
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy | 21 |
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Number of Patients Surviving Progression-free
"Number of subjects surviving without progressive disease post-transplant.~Progressive disease criteria:~Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant.~Appearance of new lytic bone lesions or plasmacytomas." (NCT00793572)
Timeframe: At 2 years after the autograft
Intervention | Participants (Count of Participants) |
---|
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy | 14 |
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Number of Patients With Chronic GVHD
Number of subjects with classic chronic or chronic extensive GVHD post allogeneic transplant. (NCT00793572)
Timeframe: 1 year post allo
Intervention | Participants (Count of Participants) |
---|
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy | 10 |
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Number of Patients With Grade II-IV Acute GVHD
"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~- a maculopapular eruption involving < 25% BSA~- a maculopapular eruption involving 25 - 50% BSA~- generalized erythroderma~- generalized erythroderma w/ bullous formation and often w/ 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 II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT00793572)
Timeframe: 100 days post allo transplant
Intervention | Participants (Count of Participants) |
---|
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy | 14 |
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Number of Patients With Toxicities Related to Bortezomib Maintenance Therapy
Number of subjects with toxicities related to bortezomib maintenance therapy post-transplant. (NCT00793572)
Timeframe: Up to 100 days after the autograft or allograft
Intervention | Participants (Count of Participants) |
---|
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy | 1 |
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Number of Patients With Non-relapse Mortality
Number of subjects with non-relapse mortalities post allogeneic transplant. (NCT00793572)
Timeframe: 200 and 365 days after allo
Intervention | Participants (Count of Participants) |
---|
| 200 days post allo | 1 Year post allo |
---|
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy | 1 | 1 |
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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 |
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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 |
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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 |
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Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments
Assessed donor engraftment in very high risk pediatric patients. (NCT00795132)
Timeframe: 24 months
Intervention | participants (Number) |
---|
Related BM PBSC | 16 |
Unrelated BM PBSC | 18 |
Unrelated Cord Blood | 10 |
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Two Year Overall Survival
The probability that a given patient will be alive two years after transplantation. (NCT00795132)
Timeframe: 24 months
Intervention | probability (Mean) |
---|
Related BM PBSC | 0.501 |
Unrelated BM PBSC | 0.395 |
Unrelated Cord Blood | 0.438 |
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Non-relapse Mortality
Death of any cause other than relapse or disease progression was considered. (NCT00796068)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 8 |
Arm II (High Risk for Graft Failure) | 10 |
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Incidence of Clinically Significant Infections
Collected and graded according to the modified National Cancer Institute Common Toxicity Criteria. (NCT00796068)
Timeframe: At 6 months
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 53 |
Arm II (High Risk for Graft Failure) | 61 |
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Incidence of Acute or Chronic Graft-versus-host Disease (GVHD)
Overall GVHD is determined based on the organ stage, response to treatment and whether GVHD was a major cause of death. Chronic GVHD will be defined according to the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease. Described as mild, moderate, or severe as graded according to the attached Organ Scoring Sheet. Symptoms consistent with both chronic and acute GVHD occurring after day 100 will be considered overlap chronic GVHD syndrome. (NCT00796068)
Timeframe: At 1 year
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 7 |
Arm II (High Risk for Graft Failure) | 6 |
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Duration (Days) Until Participants Obtained Platelet Engraftment
Summarized using a range and median of measure in days until participants reached platelet engraftment. Platelet engraftment was defined as the first of 7 consecutive days when the platelet count exceeded 20 x 109/L (untransfused). (NCT00796068)
Timeframe: At 6 months
Intervention | days (Median) |
---|
Arm I (Low Risk for Graft Failure) | 31 |
Arm II (High Risk for Graft Failure) | 31 |
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The Number of Participants Alive at Two-years Follow up.
Overall survival of participants after two-years of follow up. (NCT00796068)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 50 |
Arm II (High Risk for Graft Failure) | 44 |
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Number of Patients With Non-relapse Mortality (NRM)
Defined as death from any cause without sign of disease progression or relapse. Loss to follow up are censored, whereas disease relapse or progression are considered competing risks. (NCT00796068)
Timeframe: At day -200
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 7 |
Arm II (High Risk for Graft Failure) | 6 |
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Number of Participants With Secondary Graft Failure
Secondary graft failure is defined as decline of neutrophil count to <500/ul with loss of donor chimerism after day 55 (NCT00796068)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 0 |
Arm II (High Risk for Graft Failure) | 0 |
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Number of Participants With Graft Failure/Rejection
"Patients will be considered primary graft failure provided they meet any criteria listed below, in the absence of documented disease persistence/recurrence or active bone marrow infection (ex. Cytomegalovirus (CMV)):~i. Absence of 3 consecutive days with neutrophils >500/u1 combined with host CD3+ peripheral blood chimerism ≥50% at day 42 ii. Absence of 3 consecutive days with neutrophils >500/u1 under any circumstances at day 55 iii. Death after day 28 with neutrophil count <100/u1 without any evidence of engraftment (< 5% donor CD3+) iv. Primary autologous count recovery with < 5% donor CD3+ peripheral blood chimerism at count recovery and without relapse" (NCT00796068)
Timeframe: Up to 100 days
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 2 |
Arm II (High Risk for Graft Failure) | 5 |
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Number of Participants With Acute Graft-versus-host Disease (GVHD) Grade II-IV by Day 100
Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. Diagnosing and grading acute GVHD is based on clinical findings (the organ stage, response to treatment and whether GVHD was a major cause of death) and frequently varies between transplant centers and independent reviewers. (NCT00796068)
Timeframe: Day 100
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 36 |
Arm II (High Risk for Graft Failure) | 37 |
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Number of Participants Surviving up to 2 Years Without Disease Progression
Progression-free survival is the time interval from start of treatment to documented evidence of disease progression. Disease progression was defined by European LeukemiaNet 2017 criteria and International Working Group (IWG) within 3 years of transplant. (NCT00796068)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 37 |
Arm II (High Risk for Graft Failure) | 41 |
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Incidence of Relapse or Disease Progression
Cumulative incidence estimates using non-relapse mortality as competitive event. (NCT00796068)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 17 |
Arm II (High Risk for Graft Failure) | 11 |
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Number of Participants Surviving by 1 Year
Overall survival was measured from the first day of CBT infusion until death from any cause. (NCT00796068)
Timeframe: At 1 year
Intervention | Participants (Count of Participants) |
---|
Arm I (Low Risk for Graft Failure) | 51 |
Arm II (High Risk for Graft Failure) | 47 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Time to Neutrophil Engraftment
Following MAC AutoSCT, the median time to neutrophil (PMN) recovery will be measured. (NCT00802113)
Timeframe: Up to 1 year post-transplantation
Intervention | days (Mean) |
---|
Arm A - Family Donor | 16 |
Arm B - Unrelated Cord Blood or Adult | 24 |
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Time to Platelet Engraftment
Following MAC AutoSCT, the median time to platelet recovery will be measured. (NCT00802113)
Timeframe: Up to 1 year post-transplantation
Intervention | days (Mean) |
---|
Arm A - Family Donor | 22 |
Arm B - Unrelated Cord Blood or Adult | 53 |
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Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT
Includes subjects with any measurable growth of disease in a previously affected site or detection of disease in a new site confirmed by biopsy. (NCT00802113)
Timeframe: Up to 1 year post-transplantation
Intervention | Participants (Count of Participants) |
---|
Arm A - Family Donor | 1 |
Arm B - Unrelated Cord Blood or Adult | 3 |
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Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT)
Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies. (NCT00802113)
Timeframe: Up to 1 year post-transplantation
Intervention | Participants (Count of Participants) |
---|
Arm A - Family Donor | 4 |
Arm B - Unrelated Cord Blood or Adult | 12 |
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Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD)
The criteria for grading is based on extent of organ involvement (i.e., Skin, Liver and Gut - rash on >50% of skin, bilirubin 2-3 mg/dl, diarrhea > 500 ml/day) with Grade II being better outcome and Grade IV being worse outcome. (NCT00802113)
Timeframe: Up to 1 year post-transplantation
Intervention | participants (Number) |
---|
Arm A - Family Donor | 0 |
Arm B - Unrelated Cord Blood or Adult | 7 |
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Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT
Total includes subjects with partial response and patients with stable disease, defined as <50% reduction in measurable disease or the uninterrupted persistence of B symptoms. (NCT00802113)
Timeframe: Up to 1 year post-transplantation
Intervention | Participants (Count of Participants) |
---|
Arm A - Family Donor | 4 |
Arm B - Unrelated Cord Blood or Adult | 9 |
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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 |
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Number of Participants With Molecular Response
Molecular Remission defined as two consecutive bone marrow samples done one month apart with negative PCR( polymerase chain reaction) tor CML. (NCT00813124)
Timeframe: 12 month post BMT
Intervention | Participants (Count of Participants) |
---|
| Complete Response | Partial Response | Progressive Disease |
---|
Azacytidine Maintenance After Allotx | 8 | 0 | 4 |
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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 |
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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 |
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Platelet Engraftment
The number of patients experiencing platelet engraftment post-transplant (NCT00818961)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Hematopoietic Stem Cell Transplantation | 35 |
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Number of Patients Experiencing Chronic Graft Versus Host Disease
(NCT00818961)
Timeframe: >100 days post-transplant
Intervention | participants (Number) |
---|
Hematopoietic Stem Cell Transplantation | 20 |
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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 |
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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 |
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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 |
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Neutrophil Recovery
The number of patients experiencing neutrophil recovery post transplant (NCT00818961)
Timeframe: Day 100
Intervention | participants (Number) |
---|
Hematopoietic Stem Cell Transplantation | 35 |
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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 |
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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 |
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Survival at Day 100
Survival at Day 100 (NCT00818961)
Timeframe: 100 day
Intervention | participants (Number) |
---|
Hematopoietic Stem Cell Transplantation | 35 |
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Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30
Number of participants with complete chimerism at day 30 where defined as: Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy. (NCT00822770)
Timeframe: 30 Days post engraftment
Intervention | Participants (Count of Participants) |
---|
Overall Study: Plerixafor + G-CSF | 32 |
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Number of Participants Alive With no Disease Progression at Time of Allo Transplant
In Phase II portion of study, number of participants with treatment failure defined as either disease recurrence or death, measured from start of treatment to allo transplant at Day 0. (NCT00822770)
Timeframe: Baseline till transplant, Day -9 to Day 0, to 10 days
Intervention | percentage of participants (Number) |
---|
| Participants in | Participants not in Complete Remission |
---|
Overall Study: Plerixafor + G-CSF | 16 | 16 |
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Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor
Phase I determination of MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant). (NCT00822770)
Timeframe: 28 day cycle (Plerixafor Day -7 to Day -4)
Intervention | participants (Number) |
---|
| 0 mcg/kg daily | 80 mcg/kg daily | 160 mcg/kg daily | 240 mcg/kg daily |
---|
Phase I Plerixafor + G-CSF | 1 | 4 | 7 | 4 |
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Number of Patients That Engrafted Blood Counts by 30 Days After Transplant
Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant (NCT00827099)
Timeframe: Day 30
Intervention | participants (Number) |
---|
Umbilical Cord Blood Transplant | 5 |
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Overall Response Rate
The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary. (NCT00850499)
Timeframe: Up to 8 cycles (1 cycle is 35 days: 280 days)
Intervention | participants (Number) |
---|
Velcade + Fludarabine | 3 |
Rituximab + Fludarabine | 6 |
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Complete Response Rate
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary. (NCT00850499)
Timeframe: Up to 8 cycles (1 cycle is 35 days: 280 days)
Intervention | participants (Number) |
---|
Velcade + Fludarabine | 2 |
Rituximab + Fludarabine | 3 |
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Rate of Complete Donor Chimerism - Blood
"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics." (NCT00856388)
Timeframe: Day 30
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 89 |
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1 yr Extenstive Chronic GVHD
"1 yr Extensive Chronic GVHD~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals." (NCT00856388)
Timeframe: Up to 4.5 years
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 60 |
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3 yr Overall Survival
3 yr Overall Survival estimated using the Kaplan-Meier method. (NCT00856388)
Timeframe: Up to 4.5 years
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 46.0 |
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Acute GVHD Grade III-IV
"Acute GVHD grade III-IV~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals." (NCT00856388)
Timeframe: Up to day 100
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 27 |
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Day 100 TRM
Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided. (NCT00856388)
Timeframe: First 100 days
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 8.44 |
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Rate of Complete Donor Chimerism - Blood
"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics." (NCT00856388)
Timeframe: Day 100
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 94 |
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Complete Response Rate
Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent. (NCT00860457)
Timeframe: 3 years
Intervention | percentage of patients (Number) |
---|
Chemotherapy | 36 |
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Incidence of Chronic GVHD
(NCT00860574)
Timeframe: at 6 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Transplantation) | 20 |
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Incidence of Grades II-IV Acute GVHD
(NCT00860574)
Timeframe: at 6 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Transplantation) | 57 |
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Non Relapse Mortality (NRM) Incidence
Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression. (NCT00860574)
Timeframe: At 6 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Transplantation) | 6 |
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Non Relapse Mortality Incidence
(NCT00860574)
Timeframe: 1 year after HCT
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Transplantation) | 6 |
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Relapse-free Survival
(NCT00860574)
Timeframe: at 2 years
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Transplantation) | 62 |
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Overall Survival (OS)
(NCT00860574)
Timeframe: at 2 years
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Transplantation) | 71 |
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Relapse Incidence
(NCT00860574)
Timeframe: At 6 months
Intervention | Participants (Count of Participants) |
---|
Treatment (Allogeneic Transplantation) | 18 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -10.9 |
Investigators Choice | -2.3 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Fatigue Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -4.9 |
Investigators Choice | -2.9 |
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Kaplan Meier Estimate of Time to Treatment Failure (TTF) as Assessed by the Investigator
Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From the date of the first treatment to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
Intervention | weeks (Median) |
---|
Lenalidomide | 24.4 |
Investigators Choice | 17.9 |
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Kaplan Meier Estimate of Time to Treatment Failure as Assessed by the Investigator at the Final Analysis
Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From date of first dose of treatment to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
Intervention | weeks (Median) |
---|
Lenalidomide | 24.4 |
Investigators Choice | 17.9 |
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Mean Change From Baseline in the EORTC QLQ-C30 Constipation
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 8.6 | -0.8 | 1.3 | 0.0 | 0.0 | 0.8 |
,Lenalidomide | 12.5 | 6.3 | 4.2 | 3.5 | -0.7 | 10.2 |
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Mean Change From Baseline in the EORTC QLQ-C30 Diarhoea
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarhoea Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 12.6 | -3.1 | 1.3 | -4.2 | 0.0 | 0.0 |
,Lenalidomide | 15.7 | -3.5 | -4.2 | 2.4 | -2.1 | 1.6 |
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Mean Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 21.2 | -0.8 | 0.0 | 4.2 | 5.6 | 0.8 |
,Lenalidomide | 26.5 | -1.6 | -1.4 | -2.9 | 1.4 | 6.0 |
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Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 78.5 | 1.3 | 1.3 | -3.1 | 1.4 | -1.5 |
,Lenalidomide | 73.7 | 3.4 | 3.6 | 8.1 | 4.5 | -1.3 |
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Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 39.2 | 2.1 | 3.4 | -6.9 | -7.4 | 2.6 |
,Lenalidomide | 40.2 | 0.1 | -3.2 | -1.0 | -3.9 | 5.2 |
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Mean Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 10.8 | -0.8 | -3.8 | -4.2 | -5.6 | 1.6 |
,Lenalidomide | 19.5 | -7.0 | -7.0 | -2.9 | -9.2 | -4.3 |
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Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 58.4 | 2.3 | 3.2 | 7.3 | 8.3 | -1.0 |
,Lenalidomide | 59.0 | -3.4 | -0.7 | 1.0 | 4.3 | -5.8 |
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Mean Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 25.7 | -4.7 | -6.4 | -16.7 | -16.7 | 0.8 |
,Lenalidomide | 29.4 | -7.6 | -5.2 | -1.8 | -7.1 | -3.2 |
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Mean Change From Baseline in the EORTC QLQ-C30 Nausea / Vomiting Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 3.8 | 0.4 | 5.8 | 2.1 | 2.8 | 6.6 |
,Lenalidomide | 4.9 | 2.5 | 2.6 | 5.3 | -0.7 | 0.5 |
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Mean Change From Baseline in the EORTC QLQ-C30 Pain Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Cycle 3 Day 1 | Cycle 5 Day 1 | Cycle 7 Day 1 | Cycle 9 Day 1 | Treatment Discontinuation |
---|
Investigators Choice | 13.7 | -1.2 | -2.6 | 0.0 | -2.8 | 3.5 |
,Lenalidomide | 22.6 | -2.2 | -0.2 | 3.2 | -3.2 | 4.6 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | 6.9 |
Investigators Choice | 3.7 |
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Mean Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 73.9 | 3.5 | -6.4 | 0.0 | 13.9 | -4.3 |
,Lenalidomide | 71.5 | -4.8 | 1.4 | 0.3 | 1.8 | -9.1 |
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Mean Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 78.4 | -1.2 | -4.5 | 2.1 | 0.0 | -2.7 |
,Lenalidomide | 74.9 | -1.0 | 1.6 | -1.5 | 4.3 | -5.1 |
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Number of Participants With Treatment Emergent Adverse Events
Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A Treatment Emergent Adverse event (TEAE) is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. (NCT00875667)
Timeframe: From the date of the first dose of study drug to 28 days after the last dose, up to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigators choice arm
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Any TEAE Grade 3 AE | Any TEAE Grade 4 AE | Any TEAE Grade 5 AE | Any TEAE Related to the IP | Any Grade 3 AE Related to IP | Any Grade 4 AE Related to IP | Any Grade 5 AE Related to IP | Any Serious Adverse Event (SAE) | Any SAE Related to IP | Any TEAE Leading to Stopping of IP | Any Treatment Related AE Leading to Stopping IP | TEAE Leading to Dose Reduction/Interruption | Related AE Leading to Dose Reduct/Interruption | TEAE Leading to Dose Reduction | Related AE Leading to Dose Reduction | TEAE Leading to Dose Interruption | Related AE Leading to Dose Interruption |
---|
Investigators Choice | 69 | 49 | 29 | 2 | 51 | 36 | 19 | 0 | 22 | 12 | 14 | 7 | 33 | 29 | 13 | 10 | 28 | 25 |
,Lenalidomide | 159 | 126 | 56 | 15 | 141 | 106 | 46 | 0 | 75 | 38 | 31 | 18 | 114 | 103 | 72 | 69 | 110 | 98 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -4.8 |
Investigators Choice | -4.1 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -7.3 |
Investigators Choice | -5.8 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Diarhoea Domain to Treatment Discontinuation Visit
"The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Diarhoea Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement." (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
Intervention | units on a scale (Least Squares Mean) |
---|
Lenalidomide | -7.2 |
Investigators Choice | -5.8 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | 3.2 |
Investigators Choice | 2.9 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Pain Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -5.8 |
Investigators Choice | -3.5 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | 3.4 |
Investigators Choice | -1.8 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Constipation Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -0.3 |
Investigators Choice | -3.5 |
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Kaplan Meier Estimate of Time to Progression According to the IRC Central Review
Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
Intervention | Weeks (Median) |
---|
Lenalidomide | 39.3 |
Investigators Choice | 24.7 |
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Kaplan Meier Estimate of Time to First Response as Assessed by the Investigator at the Final Analysis
Time to first response was defined as the time from first dose of study drug to the date of the first response (having at least a PR). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the subject was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
Intervention | Weeks (Median) |
---|
Lenalidomide | 23.9 |
Investigators Choice | 40.0 |
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Kaplan Meier Estimate of Time to First Response (TTFR) According to the IRC Central Review
Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants. ). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From randomization of study drug to time of first documented PR or better response; up to data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
Intervention | Weeks (Median) |
---|
Lenalidomide | 18.7 |
Investigators Choice | NA |
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Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis
Kaplan Meier estimates of PFS were defined as the time from randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last completed assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks
Intervention | weeks (Median) |
---|
Lenalidomide | 37.3 |
Investigators Choice | 23.6 |
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Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review
PFS was defined as time of randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks
Intervention | weeks (Median) |
---|
Lenalidomide | 37.6 |
Investigators Choice | 22.7 |
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Kaplan Meier Estimate for Overall Survival as Assessed by the Investigator at the Final Analysis
Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to the study discontinuation date of 09 October 2018; overall median follow-up time was 285 weeks
Intervention | weeks (Median) |
---|
Lenalidomide | 120.6 |
Investigators Choice | 91.7 |
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Kaplan Meier Estimate for Overall Survival (OS) According to the IRC Central Review
Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; overall median follow-up was 93.9 weeks
Intervention | weeks (Median) |
---|
Lenalidomide | 121.0 |
Investigators Choice | 91.7 |
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Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis
Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
Intervention | Weeks (Median) |
---|
Lenalidomide | 70.1 |
Investigators Choice | 91.7 |
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Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review
Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm
Intervention | Weeks (Median) |
---|
Lenalidomide | 69.6 |
Investigators Choice | 45.1 |
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Mean Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 83.6 | -2.3 | 1.3 | 4.2 | 5.6 | -2.3 |
,Lenalidomide | 84.6 | 0.0 | -1.9 | -3.2 | -2.5 | -5.1 |
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Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis
Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm
Intervention | Weeks (Median) |
---|
Lenalidomide | 39.3 |
Investigators Choice | 24.7 |
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Mean Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 16.2 | -0.8 | 5.1 | -12.5 | -11.1 | 5.4 |
,Lenalidomide | 18.1 | 2.5 | 1.9 | -2.3 | -4.3 | 4.8 |
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Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis
Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
Intervention | Percentage of participants (Number) |
---|
Lenalidomide | 70.0 |
Investigators Choice | 65.5 |
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Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review
Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
Intervention | Percentage of Participants (Number) |
---|
Lenalidomide | 69.4 |
Investigators Choice | 63.1 |
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Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm
Intervention | Percentage of Participants (Number) |
---|
Lenalidomide | 45.9 |
Investigators Choice | 22.6 |
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Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who discontinued before any response had been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm
Intervention | Percentage of Participants (Number) |
---|
Lenalidomide | 40.0 |
Investigators Choice | 10.7 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | 5.1 |
Investigators Choice | 3.8 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | 3.1 |
Investigators Choice | 5.0 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -2.3 |
Investigators Choice | -0.6 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Insomnia Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | -12.8 |
Investigators Choice | -7.6 |
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Maximum Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Discontinuation Visit
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Scale was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
Lenalidomide | 4.6 |
Investigators Choice | 5.6 |
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Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.
Intervention | units on a scale (Mean) |
---|
| Baseline | Change from Baseline to Cycle 3 Day 1 | Change from Baseline to Cycle 5 Day 1 | Change from Baseline to Cycle 7 Day 1 | Change from Baseline to Cycle 9 Day 1 | Change from Baseline to Treatment Discontinuation |
---|
Investigators Choice | 78.9 | -3.7 | -2.1 | 4.2 | 11.1 | -5.1 |
,Lenalidomide | 71.8 | -0.5 | 1.6 | 2.4 | 2.8 | -5.6 |
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Percentage of Participants With GVHD (Graft Versus Host Disease)
Acute grade 2 to 4 Graft versus host disease( GVHD )for patients who were able to be analyzed by measuring the T cell counts for increased CD3+ before and after lenalidomide. (NCT00899431)
Timeframe: Up to 6 months after allotransplant
Intervention | Participants (Count of Participants) |
---|
Group 1 | 0 |
Group 2 | 3 |
Group 3 | 1 |
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Number of Participants Who Did Not Engraft After Receiving a CD45RA+ T Cell Depleted PBSC Transplant
Graft failure is defined as either a failure to reach an ANC of >500/uL for 3 consecutive days by day 28 post-transplant, or an irreversible decrease in ANC <100 after an established donor graft, unless there is a reasonable explanation such as a viral infection or drug effect that may be responsible for a reversible decrease in ANC. (NCT00914940)
Timeframe: Up to 5 years post transplant
Intervention | Participants (Count of Participants) |
---|
Overall Study Participants | 0 |
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Number of Participants Who Have Relapsed Within 5 Years of CD45RA+ T Cell Depleted PBSC Transplant
Relapse is defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology. Testing for recurrent malignancy in the blood and bone marrow performed by monitoring the CBC and bone marrow at Day 28, 58, 80, 360, and as needed for suspected relapse. (NCT00914940)
Timeframe: Up to 5 years post transplant
Intervention | Participants (Count of Participants) |
---|
Overall Study Participants | 10 |
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Number of Participants With Chronic GVHD
Chronic GVHD measured by meeting NIH criteria and treated with immune suppression (NCT00914940)
Timeframe: Up to 5 years post transplant
Intervention | Participants (Count of Participants) |
---|
| Chronic GVHD that meets NIH criteria | No documented chronic GVHD |
---|
Overall Study Participants | 3 | 35 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants With Infections
Number of participants with clinically significant infections (bacterial, fungal, viral) requiring treatment within 100 days following transplant (NCT00919503)
Timeframe: 100 days post transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 57 |
Regimen B (UBCT) | 9 |
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Number of Patients With Grade II-IV Acute Graft-versus-host Disease
Number of patients diagnosed with overall grade II-IV acute GVHD by Day 100 post transplant (NCT00919503)
Timeframe: Day 100 post transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 44 |
Regimen B (UBCT) | 8 |
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Number of Patients With of Chronic Graft-versus-host Disease
Number of patients diagnosed with chronic GVHD and requiring systemic immunosuppression within 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 29 |
Regimen B (UBCT) | 5 |
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Overall Survival
Number of patients alive at 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 80 |
Regimen B (UBCT) | 9 |
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Preliminary Efficacy
Number of patients engrafted (>5% donor CD3+ peripheral blood chimerisms) at 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 83 |
Regimen B (UBCT) | 10 |
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Donor Chimerism CD3 at 100 Days Post Transplant
Number of patients with peripheral blood donor chimerism for CD3 less than 5%, 5-49%, 50-94% and greater than or equal to 95% at 100 days post transplant. (NCT00919503)
Timeframe: Day 100 post transplant
Intervention | Participants (Count of Participants) |
---|
| Greater than equal to 95% | 50 - 94% | 5-49% | Less than 5% |
---|
Regimen A (PBSCT and BMT) | 49 | 29 | 6 | 0 |
,Regimen B (UBCT) | 7 | 2 | 1 | 1 |
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Donor Chimerism CD33 at Day 100 Post Transplant
Number of patients with peripheral blood donor chimerism for CD33 less than 5%, 5-49%, 50-94% and greater than or equal to 95% at 100 days post transplant. (NCT00919503)
Timeframe: 100 days post transplant
Intervention | Participants (Count of Participants) |
---|
| Greater than equal to 95% | 50-94% | 5-49% | Less than 5% |
---|
Regimen A (PBSCT and BMT) | 72 | 8 | 4 | 0 |
,Regimen B (UBCT) | 7 | 2 | 2 | 1 |
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Immune Reconstitution Following Hematopoietic Cell Transplantation
Number of patients with immune reconstitution (defined by a normal range CD3) at 1 year post transplant (NCT00919503)
Timeframe: 1 year following transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 39 |
Regimen B (UBCT) | 4 |
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Disease Response at One Year Following Hematopoietic Cell Transplantation
Number of patients with no evidence of disease at one year following transplant (NCT00919503)
Timeframe: 1 year following transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 78 |
Regimen B (UBCT) | 8 |
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Non-relapse Mortality
Number of patients who experienced non-relapse mortality by 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant
Intervention | Participants (Count of Participants) |
---|
Regimen A (PBSCT and BMT) | 2 |
Regimen B (UBCT) | 5 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Maximum Tolerated Dose
Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L. (NCT00943319)
Timeframe: 5 years
Intervention | mmol-min/L (Number) |
---|
Busulfan and Fludarabine | 6800 |
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Overall Survival
Overall Survival measured as median survival in days (NCT00943319)
Timeframe: 5 years
Intervention | days (Median) |
---|
Busulfan and Fludarabine | 161 |
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Disease Free Survival
Disease Free Survival measured by median survival time in days (NCT00943319)
Timeframe: 5 years
Intervention | days (Median) |
---|
Busulfan and Fludarabine | 172 |
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Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(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 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+).~Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al)~The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported" (NCT00943800)
Timeframe: Up to 2 years
Intervention | percentage of patients (Number) |
---|
| Acute GVHD (grade II-IV) | Chronic GVHD |
---|
Treatment Group | 16.1 | 3.4 |
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Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years
We reported overall survival at 2 years and 5 years after transplant (NCT00943800)
Timeframe: up to 5 years
Intervention | percentage of patients (Number) |
---|
| Two-year overall survival | Five-year overall survival |
---|
Treatment Group | 43.7 | 32.9 |
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Percentage of Participants With Neutrophil Engraftment
Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC <500/mm3 and platelet count < 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity < 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to < 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection. (NCT00943800)
Timeframe: Transplant (Day 0) through Day +28
Intervention | percentage of patients (Number) |
---|
Treatment Group | 85.1 |
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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 |
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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 |
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Graft Failure
Percentage of participants who failed to engraft. (NCT00946023)
Timeframe: Day 60
Intervention | Participants (Count of Participants) |
---|
Transplant | 2 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival (OS) Rate
Overall survival in participants with multiple myeloma treated with Bortezomib (Velcade®) containing conditioning regimen and autologous as well as allogeneic transplantation. (NCT00948922)
Timeframe: End of 2 year, post transplant follow-up
Intervention | percentage (Number) |
---|
A: Allogeneic Stem Cell Transplant | 79.2 |
B: Autologous Stem Cell Transplant | 89.2 |
BE: Group B Expansion | 97.3 |
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Progression Free Survival (PFS)
PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: 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. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 10%; 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 that can be attributed solely to the plasma cell proliferative disorder. (NCT00948922)
Timeframe: End of 2 year, post transplant follow-up
Intervention | Participants (Count of Participants) |
---|
A: Allogeneic Stem Cell Transplant | 17 |
B: Autologous Stem Cell Transplant | 25 |
BE: Group B Expansion | 19 |
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Percentage of Participants With Acute or Chronic Graft-versus-host Disease (GVHD) Following Transplant
Percentage of participants with Acute or Chronic GVHD following transplant (NCT00948922)
Timeframe: End of 2 year, post transplant follow-up
Intervention | percentage of participants (Number) |
---|
A: Allogenic Stem Cell Transplant | 34 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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The Incidence of Acute GvHD
(NCT00987480)
Timeframe: 100 days
Intervention | percentage of participants (Number) |
---|
Chemotherapy-based Cytoreductive Regimen Plus a CD34+ Selected | 6.7 |
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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 |
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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 |
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Incidence of Disease Recurrence
(NCT01005576)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
Conditioning Regimen | 1 |
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Primary Objective: Event-free Survival at 1 Year.
(NCT01005576)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Conditioning Regimen | 17 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Participants With a Complete Response
Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks. (NCT01019317)
Timeframe: Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)
Intervention | Participants (Number) |
---|
Cytarabine + Fludarabine | 34 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Serious Infections
Serious infections are reported as the number of participants experienced serious infections. (NCT01050764)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT) | 6 |
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Overall Survival (OS), 1 Year
Assessed as subjects remaining alive 12 months after CD34+ cell infusion (ie, excludes death due to any cause) (NCT01050764)
Timeframe: 1 year
Intervention | Participants (Number) |
---|
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT) | 2 |
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Maximum-tolerated Dose (MTD) of Regulatory and Conventional T-cells
The maximum-tolerated dose (MTD) was to be determined based on the safety and feasibility observed for a pre-determined set of cellular dose level combinations of regulatory T-cells (T-reg) and conventional T-cells (T-con). (NCT01050764)
Timeframe: 30 days after HSCT infusion
Intervention | cells/kg (Number) |
---|
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT) | NA |
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To Measure the Incidence and Severity of Acute and Chronic GvHD
Population of participants that received HSCT and T-reg plus T-con, and developed actue, chronic, or any graft vs host disease (GvHD) (NCT01050764)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
| Acute GvHD | Chronic GvHD | Any GvHD (actue + chronic) |
---|
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT) | 1 | 2 | 3 |
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Acute Graft-versus-Host-Disease (aGvHD)
The primary outcome was incidence of grade 3 or 4 acute graft-vs-host-disease (aGvHD), reported as the number of participants developing grade 3 or 4 aGvHD. (NCT01050764)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT) | 1 |
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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 |
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Plasma Concentration of IDELA (Cohort 4)
(NCT01088048)
Timeframe: Predose at Week 0; predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 4; predose, 1.5 hours postdose at Week 12; and predose, 1.5 hours postdose at Week 24
Intervention | ng/mL (Mean) |
---|
| Pre-dose (Week 0) | Pre-dose (Week 4) | 0.5 hr post-dose (Week 4) | 1.0 hr post-dose (Week 4) | 1.5 hr post-dose (Week 4) | 2.0 hr post-dose (Week 4) | 3.0 hr post-dose (Week 4) | 4.0 hr post-dose (Week 4) | 6.0 hr post-dose (Week 4) | Pre-dose (Week 12) | 1.5 hr post-dose (Week 12) | Pre-dose (Week 24) | 1.5 hr post-dose (Week 24) |
---|
Idelalisib 150 mg (Cohort 4) | 0.0 | 0.0 | 1119.5 | 994.5 | 1758.2 | 737.0 | 605.0 | 547.0 | 524.0 | 401.9 | 2018.2 | 752.5 | 2251.1 |
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Plasma Concentration of IDELA (Cohort 6)
(NCT01088048)
Timeframe: Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24
Intervention | ng/mL (Mean) |
---|
| Pre-dose (Week 0) | 1.5 hr post-dose (Week 0) | Pre-dose (Week 4) | 1.5 hr post-dose (Week 4) | Pre-dose (Week 12) | 1.5 hr post-dose (Week 12) | Pre-dose (Week 24) | 1.5 hr post-dose (Week 24) |
---|
Idelalisib 150 mg (Cohort 6) | 0.0 | 1930.7 | 530.8 | 1869.8 | 677.9 | 1733.0 | 346.8 | 1710.7 |
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Plasma Concentration of IDELA (Cohort 7)
(NCT01088048)
Timeframe: Predose, 1.5 hours postdose at Weeks 0, 5 and 13
Intervention | ng/mL (Mean) |
---|
| Pre-dose (Week 0) | 1.5 hr post-dose (Week 0) | Pre-dose (Week 5) | 1.5 hr post-dose (Week 5) | Pre-dose (Week 13) | 1.5 hr post-dose (Week 13) |
---|
Idelalisib 150 mg (Cohort 7) | NA | 1603.1 | 20.7 | 1621.3 | 354.8 | 592.7 |
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Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5)
(NCT01088048)
Timeframe: Predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 0; predose, 1.5 hours postdose at Weeks 4, 12, and 24
Intervention | ng/mL (Mean) |
---|
| Pre-dose (Week 0) | 0.5 hr post-dose (Week 0) | 1.0 hr post-dose (Week 0) | 1.5 hr post-dose (Week 0) | 2.0 hr post-dose (Week 0) | 3.0 hr post-dose (Week 0) | 4.0 hr post-dose (Week 0) | 6.0 hr post-dose (Week 0) | Pre-dose (Week 4) | 1.5 hr post-dose (Week 4) | Pre-dose (Week 12) | 1.5 hr post-dose (Week 12) | Pre-dose (Week 24) | 1.5 hr post-dose (Week 24) |
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Idelalisib 100 mg (Cohort 1) | 0.4 | 437.6 | 1022.4 | 1434.0 | 1282.7 | 1001.0 | 788.4 | 523.7 | 416.5 | 1297.2 | 361.9 | 1309.5 | 369.9 | 1061.6 |
,Idelalisib 150 mg (Cohort 5) | 0.0 | 1380.0 | 1600.0 | 1564.7 | 1400.0 | 1170.0 | 795.0 | 517.0 | 408.0 | 1877.9 | 433.9 | 1426.8 | 549.1 | 885.6 |
,Idelalisib 150 mg (Cohorts 2 and 3) | 68.8 | 1231.4 | 1789.3 | 2017.3 | 1732.8 | 1296.1 | 910.0 | 486.0 | 364.1 | 1808.1 | 351.4 | 1883.0 | 419.7 | 1840.1 |
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Overall Survival
Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause. (NCT01088048)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Idelalisib + Rituximab | NA |
Idelalisib + Bendamustine | NA |
Idelalisib + Everolimus | NA |
Idelalisib + Bortezomib | NA |
Idelalisib + Rituximab + Bendamustine | NA |
Idelalisib + Ofatumumab | NA |
Idelalisib + Fludarabine | NA |
Idelalisib + Chlorambucil | NA |
Idelalisib + Rituximab + Chlorambucil | NA |
Idelalisib + Rituximab + Lenalidomide | NA |
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Progression-free Survival
"Progression free survival (PFS) was defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause.~The response definitions were based on the following standard criteria established for each indication:~CLL: International Workshop on chronic lymphocytic leukemia (IWCLL), 2008~iNHL & MCL: Cheson, 2007" (NCT01088048)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Idelalisib + Rituximab | NA |
Idelalisib + Bendamustine | NA |
Idelalisib + Everolimus | 4.3 |
Idelalisib + Bortezomib | 8.1 |
Idelalisib + Rituximab + Bendamustine | NA |
Idelalisib + Ofatumumab | NA |
Idelalisib + Fludarabine | NA |
Idelalisib + Chlorambucil | NA |
Idelalisib + Rituximab + Chlorambucil | NA |
Idelalisib + Rituximab + Lenalidomide | NA |
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Time to Response
Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR. (NCT01088048)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Idelalisib + Rituximab | 1.9 |
Idelalisib + Bendamustine | 1.9 |
Idelalisib + Everolimus | 1.9 |
Idelalisib + Bortezomib | 1.9 |
Idelalisib + Rituximab + Bendamustine | 1.9 |
Idelalisib + Ofatumumab | 1.9 |
Idelalisib + Fludarabine | 1.9 |
Idelalisib + Chlorambucil | 1.9 |
Idelalisib + Rituximab + Chlorambucil | 1.9 |
Idelalisib + Rituximab + Lenalidomide | 3.0 |
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Toxicity of Administration of IDELA
Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02 (NCT01088048)
Timeframe: First dose date up to 5 years
Intervention | percentage of participants (Number) |
---|
Idelalisib + Rituximab | 100.0 |
Idelalisib + Bendamustine | 100.0 |
Idelalisib + Everolimus | 100.0 |
Idelalisib + Bortezomib | 83.33 |
Idelalisib + Rituximab + Bendamustine | 100.0 |
Idelalisib + Ofatumumab | 100.0 |
Idelalisib + Fludarabine | 100.0 |
Idelalisib + Chlorambucil | 100.0 |
Idelalisib + Rituximab + Chlorambucil | 100.0 |
Idelalisib + Rituximab + Lenalidomide | 100.0 |
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Duration of Exposure to IDELA
Duration of exposure to IDELA was summarized using descriptive statistics. (NCT01088048)
Timeframe: First dose date up to 12 months
Intervention | months (Mean) |
---|
Idelalisib + Rituximab | 8.1 |
Idelalisib + Bendamustine | 7.6 |
Idelalisib + Everolimus | 4.2 |
Idelalisib + Bortezomib | 5.1 |
Idelalisib + Rituximab + Bendamustine | 8.0 |
Idelalisib + Ofatumumab | 8.3 |
Idelalisib + Fludarabine | 8.9 |
Idelalisib + Chlorambucil | 8.8 |
Idelalisib + Rituximab + Chlorambucil | 8.7 |
Idelalisib + Rituximab + Lenalidomide | 7.7 |
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Plasma Concentration of Lenalidomide
(NCT01088048)
Timeframe: Predose, 1.5 hours postdose at Week 1 and predose at Week 5
Intervention | ng/mL (Mean) |
---|
| Pre-dose (Week 1) | 1.5 hr post-dose (Week 1) | Pre-dose (Week 5) |
---|
Lenalidomide (Cohort 7a, 7b, 7c) | NA | 51.6 | NA |
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Sub-study: Plasma Concentration of IDELA (Cohorts 1-4)
(NCT01088048)
Timeframe: pre dose and 0.5, 1, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post dose
Intervention | ng/mL (Mean) |
---|
| Pre-dose | 0.5 hr post-dose | 1.0 hr post-dose | 1.5 hr post-dose | 2.0 hr post-dose | 3.0 hr post-dose | 4.0 hr post-dose | 6.0 hr post-dose |
---|
Idelalisib 100 mg (Cohort 1a, 1b) | 1.5 | 437.6 | 1022.4 | 1264.7 | 1282.7 | 1001.0 | 788.4 | 523.7 |
,Idelalisib 150 mg (Cohorts 2a, 2b, 3a, 3c, 3d, 3e, 3f, 3g, 4a, 4b) | 0.0 | 1222.1 | 1723.1 | 1599.2 | 1646.2 | 1238.5 | 879.8 | 489.3 |
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Plasma Concentration of Bendamustine
(NCT01088048)
Timeframe: Predose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 hours postdose at Week 0
Intervention | ng/mL (Mean) |
---|
| Pre-dose (Week 0) | 0.25 hr post-dose (Week 0) | 0.5 hr post-dose (Week 0) | 0.75 hr post-dose (Week 0) | 1.0 hr post-dose (Week 0) | 1.25 hr post-dose (Week 0) | 1.5 hr post-dose (Week 0) | 2.0 hr post-dose (Week 0) | 3.0 hr post-dose (Week 0) | 4.0 hr post-dose (Week 0) | 5.0 hr post-dose (Week 0) | 6.0 hr post-dose (Week 0) |
---|
Bendamustine (Cohorts 1b, 2b, 3a, 3b, 3f, 3g, 4b, 5c) | NA | 3484.1 | 4694.7 | 3433.2 | 2847.2 | 1916.4 | 1211.2 | 514.0 | 463.4 | 78.5 | 15.3 | 4.4 |
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Overall Response Rate
"Overall Response Rate (ORR) was defined as the percentage of participants achieving a complete response (CR) or partial response (PR).~The response definitions were based on the following standard criteria established for each indication:~CLL: International Workshop on chronic lymphocytic leukemia (IWCLL),2008~iNHL & MCL: Cheson, 2007" (NCT01088048)
Timeframe: Up to 5 years
Intervention | percentage of participants (Number) |
---|
Idelalisib + Rituximab | 78.4 |
Idelalisib + Bendamustine | 84.3 |
Idelalisib + Everolimus | 44.4 |
Idelalisib + Bortezomib | 61.1 |
Idelalisib + Rituximab + Bendamustine | 81.8 |
Idelalisib + Ofatumumab | 71.4 |
Idelalisib + Fludarabine | 91.7 |
Idelalisib + Chlorambucil | 66.7 |
Idelalisib + Rituximab + Chlorambucil | 93.3 |
Idelalisib + Rituximab + Lenalidomide | 71.4 |
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Plasma Concentration of Everolimus
(NCT01088048)
Timeframe: Predose, 1.5 hours postdose at Weeks 0 and 4
Intervention | ng/mL (Mean) |
---|
| Pre-dose (Week 0) | 1.5 hr post-dose (Week 0) | Pre-dose (Week 4) | 1.5 hr post-dose (Week 4) |
---|
Everolimus (Cohort 5a) | NA | 93.0 | 3.0 | 56.3 |
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Duration of Response
Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause. (NCT01088048)
Timeframe: Up to 5 years
Intervention | months (Median) |
---|
Idelalisib + Rituximab | NA |
Idelalisib + Bendamustine | NA |
Idelalisib + Everolimus | 5.6 |
Idelalisib + Bortezomib | 9.3 |
Idelalisib + Rituximab + Bendamustine | NA |
Idelalisib + Ofatumumab | NA |
Idelalisib + Fludarabine | NA |
Idelalisib + Chlorambucil | NA |
Idelalisib + Rituximab + Chlorambucil | NA |
Idelalisib + Rituximab + Lenalidomide | NA |
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Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
MTD defined as highest dose level in which 6 participants have been treated with = to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade >/= 3 non-hematologic toxicity. Hematologic toxicity grade >/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT. (NCT01096992)
Timeframe: After 4 week cycle
Intervention | mg/m^2 (Number) |
---|
Phase 1 | 30 |
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Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
Overall Response is Complete response (CR) + Partial response (PR). Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease. 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; positive or negative minimal residual disease (MRD); 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; (NCT01096992)
Timeframe: Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment.
Intervention | Participants (Count of Participants) |
---|
Phase 1 20 mg/m^2 | 5 |
Phase 1 30 mg/m^2 | 3 |
Phase 1 40 mg/m^2 | 5 |
Phase 1 50 mg/m^2 | 2 |
Phase 2 | 17 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS)
(NCT01131169)
Timeframe: 2 years
Intervention | Proportion of participants PFS (Number) |
---|
Relapsed Multiple Myeloma | 0.31 |
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Proportion of Participants With Relapsed Multiple Myeloma Alive at 2 Years
(NCT01131169)
Timeframe: 2 years
Intervention | Proportion of pts alive at 2 years (Number) |
---|
Relapsed Multiple Myeloma | 0.54 |
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Graft Failure
Percentage of participants who failed to engraft. (NCT01135329)
Timeframe: Day 60
Intervention | Participants (Count of Participants) |
---|
Transplant | 8 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Progression-free Survival
"Progression-free survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are alive and progression free at 2 and 5 years from date of transplantation respectively.~AML progression is defined as:~Reappearance of leukemia blast cells in peripheral blood and > 5% blasts in marrow~If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow >= 1 week later with > 5% blasts~Development of extramedullary leukemia MDS progression is defined as~For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts~For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts~Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate" (NCT01168219)
Timeframe: Up to 5 years
Intervention | percentage of patients (Number) |
---|
| PFS at 2 years | PFS at 5 years |
---|
Treatment (Chemotherapy and Transplant) | 41.2 | 26.9 |
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Overall Survival (OS)
Overall survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are still alive 2 and 5 years after date of transplantation respectively. Estimated using the Kaplan-Meier product limit estimator. (NCT01168219)
Timeframe: Up to 5 years
Intervention | percentage of patients (Number) |
---|
| OS at 2 years | OS at 5 years |
---|
Treatment (Chemotherapy and Transplant) | 45.7 | 31.2 |
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100-day Mortality
The number of death reported within the first 100 days after transplant. (NCT01168219)
Timeframe: Up to 100 days post-treatment
Intervention | Participants (Count of Participants) |
---|
Treatment (Chemotherapy and Transplant) | 10 |
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Toxicities
Dasatinib may enhance the myelosuppression expected from fludarabine. This toxicity will be monitored with frequent CBC's. If after Day 21 of a cycle there is a grade 4 cytopenia, a dose reduction will occur in the next cycle of treatment, and that cycle cannot start until the ANC > 1,000 and the platelets > 25,000. There is also a risk for pleural effusions with dasatinib, but the risk will be low, since there is a break from dasatinib dosing on days 15-28 of each cycle. Nevertheless, if a grade 2 pleural effusion occurs, there will be a dose reduction in the next cycle of treatment. (NCT01173679)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
| Platelets72308625 | Neutropenia72308625 | Fatigue72308625 | Dyspnea72308625 | Pleural effusion72308625 | Bleeding72308625 | Fever alone72308625 | Infection72308625 |
---|
| 3 | 4 | 5 | Did not have any |
---|
Dasatinib, Rituximab, Fludarabine | 4 |
Dasatinib, Rituximab, Fludarabine | 3 |
Dasatinib, Rituximab, Fludarabine | 1 |
Dasatinib, Rituximab, Fludarabine | 0 |
Dasatinib, Rituximab, Fludarabine | 9 |
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Progression-Free and Overall Survival
To describe the progression-free and overall surivial (NCT01173679)
Timeframe: 2 years
Intervention | months (Median) |
---|
| Progression-free survival | Overall survival |
---|
Dasatinib, Rituximab, Fludarabine | 8.75 | 24 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Estimated Two Year Overall Survival Rate for All Participants
(NCT01181271)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Autologous Then Allogeneic Transplant | 83 |
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Cumulative Incidence of Disease Relapse
(NCT01181271)
Timeframe: 2-years after allogeneic transplant
Intervention | percentage of participants (Number) |
---|
Autologous Then Allogeneic Transplant | 17.2 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Estimated Two Year Progression Free Survival Rate for All Participants
(NCT01181271)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Autologous Then Allogeneic Transplant | 64 |
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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 |
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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 |
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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 |
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Toxicity
To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented. (NCT01186458)
Timeframe: 6 months
Intervention | number of adverse events (Number) |
---|
| Total Adverse Events | Grade 1 Adverse Events | Grade 2 Adverse Events | Grade 3 Adverse Events | Grade 4 Adverse Events | Grade 5 Adverse Events |
---|
Fludarabine, Velcade and Rituximab | 122 | 77 | 35 | 9 | 1 | 0 |
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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 |
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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 |
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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 |
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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 |
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Rates of Acute and Chronic Graft Versus Host Disease (GVHD).
Count/Percentage rates of acute and chronic graft versus host disease (GVHD). (NCT01203020)
Timeframe: Day 100
Intervention | Participants (Count of Participants) |
---|
| Acute GVHD | Chronic GVHD |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 5 | 3 |
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Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year.
Percentage of participants NRM following RTC transplantation at 1-year. (NCT01203020)
Timeframe: At 1 year
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 17.1 |
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Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years.
Percentage of participants NRM following RTC transplantation at 2-year. (NCT01203020)
Timeframe: At 2 years
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 24.6 |
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Relapse Rate (RR) Following Transplantation at 2-year.
Percentage of participants Relapse Rates (RR) following transplantation at 2-year. (NCT01203020)
Timeframe: At 2 year
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 39.7 |
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Relapse Rate (RR) Following Transplantation at 1-year.
Percentage of participants Relapse Rates (RR) following transplantation at 1-year. (NCT01203020)
Timeframe: At 1 year
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 28.7 |
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Percentage of 1 Year Overall Survival (OS)
Percentage of participants--1 year overall survival (OS) following transplantation. (NCT01203020)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 63.6 |
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Percentage of 2-year Progression Free Survival (PFS)
Percentage of 2-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine. (NCT01203020)
Timeframe: At 2 year
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 45.5 |
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Percentage of 2 Year Overall Survival (OS)
Percentage of participants-- 2 Year Overall Survival (OS) post transplant (NCT01203020)
Timeframe: At 2nd year
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 59.1 |
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Percentage of 1-year Progression Free Survival (PFS)
Percentage of 1-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine. (NCT01203020)
Timeframe: At 1 year
Intervention | percentage of participants (Number) |
---|
Allogeneic Hematopoietic Progenitor Cell Transplant | 59.1 |
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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 |
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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 |
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Number of Non-Relapse Mortalities
Number of subjects expired without disease progression/relapse. (NCT01231412)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and CSP) | 12 |
Arm II (MMF, CSP, and Sirolimus) | 4 |
Arm 0 (CSP and Sirolimus) | 0 |
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Number of of Participants Surviving Overall
Number of subjects surviving overall post-transplant. (NCT01231412)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and CSP) | 53 |
Arm II (MMF, CSP, and Sirolimus) | 75 |
Arm 0 (CSP and Sirolimus) | 6 |
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Number of Participants With Relapse/Progression
"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL, MDS >5% blasts by morphologic or flow cytometric evaluation of the BMA or appearance of extramedullary disease CLL ≥1 of: Physical exam/imaging studies ≥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 numb" (NCT01231412)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and CSP) | 16 |
Arm II (MMF, CSP, and Sirolimus) | 16 |
Arm 0 (CSP and Sirolimus) | 1 |
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Number of Patients With 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. (NCT01231412)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and CSP) | 38 |
Arm II (MMF, CSP, and Sirolimus) | 43 |
Arm 0 (CSP and Sirolimus) | 3 |
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Number of Patients With Grades II-IV Acute GVHD
"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ 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 w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT01231412)
Timeframe: At day 100 post-transplant
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and CSP) | 39 |
Arm II (MMF, CSP, and Sirolimus) | 22 |
Arm 0 (CSP and Sirolimus) | 3 |
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Number of Patients With Grades III-IV Acute GVHD
"Number of patients with grades III-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ 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 w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT01231412)
Timeframe: Up to 100 days
Intervention | Participants (Count of Participants) |
---|
Arm I (MMF and CSP) | 8 |
Arm II (MMF, CSP, and Sirolimus) | 2 |
Arm 0 (CSP and Sirolimus) | 0 |
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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 = 1 of 6 patients experienced a DLT (i.e. grade 2 or greater allergic reaction)). (NCT01236573)
Timeframe: 4 years
Intervention | Cells (Number) |
---|
All Phase I Participants | 1,000,000,000 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Patients With Grade III-IV Acute GVHD
"Number of patients with grades III-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ 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 w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT01251575)
Timeframe: 100 days post-transplant
Intervention | Participants (Count of Participants) |
---|
Treatment (Fludarabine, Transplant, Immunosuppression) | 2 |
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Number of Non-Relapse Mortalities
Number of patients expired without disease progression/relapse. (NCT01251575)
Timeframe: 100 days post-transplant
Intervention | Participants (Count of Participants) |
---|
Treatment (Fludarabine, Transplant, Immunosuppression) | 3 |
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Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD)
"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ 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 w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT01251575)
Timeframe: 100 days post-transplant
Intervention | Participants (Count of Participants) |
---|
Class I Mismatch | 15 |
Class II Mismatch | 12 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Hospitalization Days
(NCT01263704)
Timeframe: Up to 53 months
Intervention | days (Median) |
---|
Rituximab Plus Fludarabine and Cyclophosphamide | 8 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT01289457)
Timeframe: up to 2 years
Intervention | Months (Median) |
---|
Group 1 CIA | 14.5 |
Group 2 FLAI | 15.1 |
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Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI)
NCI & Myelodysplastic syndromes (MDS) International Working Group (IWG) Definitions: Complete Response (CR): Neutrophil count ≥1.0 ×10^9/L, Platelet count ≥100 ×10^9/L, Bone marrow aspirate =5% blasts, No extramedullary leukemia; CRi: Response as in CR but platelets <100 ×10^9/L; Partial response (PR): Neutrophil count ≥ 1.0 ×10^9/L, Platelet count ≥100 ×10^9/L, ≥ 50% reduction in bone marrow blasts over baseline; Clinical benefit: In addition to IWG criteria, in AML, a decrease in bone marrow blasts to <5% is also considered clinical benefit; Stable Disease: In addition to IWG criteria and in absence any of above response criteria, stable disease considered if the bone marrow blast percent does not increase compared to pretreatment level; Relapse: Increase of bone marrow blasts to >10% after initial response. Response assessed Day 28 of every 2-3 cycles during treatment. (NCT01289457)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Group 1 CIA | 107 |
Group 2 FLAI | 76 |
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Event-Free Survival (EFS) at 2 Years
Comparison of the event-free survival (EFS) between treatment CIA and FLAI, where an event is defined to be resistance to treatment, relapse (after response) or death, whichever occurred first. (NCT01289457)
Timeframe: Up to 2 years or until relapse/death
Intervention | Months (Median) |
---|
Group 1 CIA | 7.1 |
Group 2 FLAI | 8.4 |
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Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine
MTD is highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicities (DLT). Toxicity defined as any treatment-related grade 3 or greater non-hematological toxicities. (NCT01289457)
Timeframe: 28 days
Intervention | mg/m^2 (Number) |
---|
Clofarabine + Idarubicin + Cytarabine | 15 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Rates of Non-relapse Mortality
Transplant-related deaths within 100 days after transplant (NCT01300572)
Timeframe: Within the first 100 days following transplant
Intervention | Participants (Count of Participants) |
---|
| Severe refractory GVHD | Bacterial infection |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 1 | 1 |
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Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor
The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight. (NCT01300572)
Timeframe: Approximately day -20 to day -12 prior to transplant
Intervention | Gy (Mean) |
---|
| Average absorbed dose to the marrow | Average absorbed dose to the liver | Average abosorbed dose total body | Average absorbed dose to the spleen |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 11.4 | 17.2 | 3.1 | 70 |
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The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.
The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached. (NCT01300572)
Timeframe: Within the first 30 days following transplant
Intervention | Gy (Number) |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 28 |
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Rates of Engraftment
Average number of days to ANC >= 500 after transplant (NCT01300572)
Timeframe: Up to 84 days post-transplant
Intervention | days (Mean) |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 16 |
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Rates of Donor Chimerism
Number of participants who has 100% donor chimerism within 100 days after transplant (NCT01300572)
Timeframe: Up to 100 days post-transplant
Intervention | Participants (Count of Participants) |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 14 |
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Achievement of Remission
"Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, > 15% erythropoiesis and > 25% granulocytopoiesis~Normalization of blood counts (no blasts, platelets > 100000/mm3, granulocytes >1500/mm3)~No extramedullary disease." (NCT01300572)
Timeframe: 4 weeks after transplant
Intervention | Participants (Count of Participants) |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 13 |
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Duration of Remission
"Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, > 15% erythropoiesis and > 25% granulocytopoiesis~Normalization of blood counts (no blasts, platelets > 100000/mm3, granulocytes >1500/mm3)~No extramedullary disease.~Relapse Criteria:~After CR: >5% blasts in the bone marrow and/or peripheral blood~After partial remission (PR): increase of blasts cells in the marrow to >50% of those during PR~Extramedullary disease confirmed cytologically or histologically." (NCT01300572)
Timeframe: 1 year
Intervention | days (Median) |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 213 |
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Disease-free Survival
Number of study participants who are alive and remains in complete remission after transplant. (NCT01300572)
Timeframe: 100 days after transplant
Intervention | participants (Number) |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 7 |
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Overall Survival
Number of participants who are still alive after transplant with or without disease. (NCT01300572)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | 7 |
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Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment
Number of participants who had the most frequently observed undesirable effects after exposure to study drug (NCT01310179)
Timeframe: Entry through Study Day 56
Intervention | participants (Number) |
---|
| injection site symptoms | fatigue | facial pain | nausea |
---|
Ad/PNP and Fludarabine Monophosphate | 12 | 8 | 8 | 5 |
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Treatment Outcome and Percent Change in Tumor Volume
Measurement of tumor response to study drug, as measured by the percentage of change in tumor volume as measured by a physicial measurement using a ruler (NCT01310179)
Timeframe: Entry through Study Day 56
Intervention | participants (Number) |
---|
| Progression (>+20%) | Stable (+20% to -30%) | Partial Response (>-30%) |
---|
Ad/PNP and Fludarabine Monophosphate | 2 | 5 | 5 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment
(NCT01366612)
Timeframe: 1 year
Intervention | Percent (Number) |
---|
Group 1 | 38.9 |
Group 2 | 18.8 |
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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 |
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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 |
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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 |
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Number of Participants With Molecular Complete Remission at 3 Month Post Transplant
Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion. (NCT01390402)
Timeframe: Baseline to up to 4 months post-transplant
Intervention | participants (Number) |
---|
NK Infusion + Chemotherapy | 3 |
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Relapse-free Survival
The percentage of participants that have not died or had disease progression by two years. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features. (NCT01408563)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Fludarabine/Melphalan/TBI | 49 |
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Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days
"Acute GVHD is assessed using Consensus Criteria:~Organ Classifications:~0: No rash due to GVHD; Bilirubin < 2 mg/dL; < 500 mL diarrhea/ day~1: Maculopapular rash < 25% of body surface; Bilirubin 2-3 mg/dL; 500 to 999 mL diarrhea/ day or persistent nausea with histologic evidence of GVHD in stomach/ duodenum~2: Maculopapular rash 25-50% of body surface; Bilirubin 3.1-6 mg/dL; 1,000 to 1,499 mL diarrhea/ day~3: Maculopapular rash > 50% of body surface; Bilirubin 6.1-15 mg/dL; 1,500 or more mL diarrhea/ day~4: Generalized erythroderma with bullous formation; Bilirubin > 15 mg/dL; Severe abdominal pain with or without ileus~Overall Clinical Grade:~0: No Stage 1-4 of any organ~I: Stage 1-2 rash and no liver or gut involvement~II: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gut involvement~III: None to Stage 3 skin rash with Stage 2-3 liver involvement, or Stage 2-4 gut involvement~IV: Stage 4 skin rash, or Stage 4 liver involvement" (NCT01408563)
Timeframe: 100 Days
Intervention | percentage of participants (Number) |
---|
Fludarabine/Melphalan/TBI | 16 |
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Rate of Post-transplant Lymphoma
The number of participants that were found to have lymphoma post-transplant. (NCT01408563)
Timeframe: 2.5 years
Intervention | Participants (Count of Participants) |
---|
Fludarabine/Melphalan/TBI | 0 |
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Overall Survival
The percentage of participants alive at two years (NCT01408563)
Timeframe: 2 years
Intervention | percentage of participants (Number) |
---|
Fludarabine/Melphalan/TBI | 55 |
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Number of Participants With Primary Graft Failure
Primary graft failure is defined as the failure to achieve an absolute neutrophil count (ANC) >500/ µL by day 42, in the absence of relapse. (NCT01408563)
Timeframe: From the time of transplantation until 42 days post transplantation
Intervention | Participants (Count of Participants) |
---|
Fludarabine/Melphalan/TBI | 8 |
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1 Year Relapse Rate
The percentage of participants that relapsed within 12 months. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features. (NCT01408563)
Timeframe: 1 year
Intervention | percentage (Number) |
---|
Fludarabine/Melphalan/TBI | 20 |
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The Rate of Chronic GVHD
Chronic Graft Versus Host Disease (GVHD) is assessed using the National Institutes of Health (NIH) consensus criteria. (NCT01408563)
Timeframe: From the time of transplantation until the time of chronic GVHD onset, up to 1 year
Intervention | percentage of participants (Number) |
---|
Fludarabine/Melphalan/TBI | 21 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Progression-free Survival
Based on a one-sample chi-square test with one-sided significance level of five percent. This study will be deemed successful if the 1 year progression-free survival of this highest-risk group of patients is 54% or greater. (NCT01434472)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT) | 11 |
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Overall Survival
(NCT01434472)
Timeframe: Up to 2 years post transplant
Intervention | Participants (Count of Participants) |
---|
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT) | 14 |
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Hematopoietic Toxicity
Clinical sequelae due to hematopoietic toxicity as defined by incidences of neutropenic fever and bleeding. (NCT01434472)
Timeframe: Up to day 100
Intervention | Incidences (Number) |
---|
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT) | 5 |
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Absolute Neutrophil Count (ANC) Engraftment
The median time in days to achieve ANC recovery defined as ANC>500uL. (NCT01434472)
Timeframe: Up to day 100
Intervention | Days (Median) |
---|
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT) | 16 |
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Platelet Engraftment
The median time in days to achieve platelet recovery as defined as platelet >20,000uL. (NCT01434472)
Timeframe: Up to day 100
Intervention | Days (Median) |
---|
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT) | 9 |
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Response Rates
Response is defined as having achieved a Partial Response or better. (NCT01434472)
Timeframe: Day 100
Intervention | Participants (Count of Participants) |
---|
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT) | 16 |
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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 |
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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 |
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Overall Response Rate
"Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.~International Myeloma Working Group Response Criteria for Multiple Myeloma:~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 SD: Not meeting criteria for CR, VGPR, PR, or progressive disease" (NCT01453101)
Timeframe: Up to 3 years
Intervention | Participants (Count of Participants) |
---|
Fludarabine, Melphalan, Bortezomib | 45 |
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Overall Survival (OS)
Overall survival (OS): Defined as time from the first dose of administration to death from any cause (NCT01453101)
Timeframe: Up to 3 years
Intervention | percentage (Number) |
---|
Fludarabine, Melphalan, Bortezomib | 42 |
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Progression Free Survival
The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur. (NCT01453101)
Timeframe: Subjects will be followed for progression-free survival for at least 36 months
Intervention | Months (Median) |
---|
Fludarabine, Melphalan, Bortezomib | 16.7 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Incidence of Acute Graft-Versus-Host Disease
(NCT01464359)
Timeframe: Day 60
Intervention | Participants (Count of Participants) |
---|
Patients With Acute Myelogenous Leukemia | 0 |
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Duration of Survival
(NCT01464359)
Timeframe: 6 months after Transplantation.
Intervention | Participants (Count of Participants) |
---|
Patients With Acute Myelogenous Leukemia | 1 |
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Duration of Survival
(NCT01464359)
Timeframe: 2 years after Transplantation.
Intervention | Participants (Count of Participants) |
---|
Patients With Acute Myelogenous Leukemia | 0 |
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Duration of Survival
(NCT01464359)
Timeframe: 1 year after Transplantation.
Intervention | Participants (Count of Participants) |
---|
Patients With Acute Myelogenous Leukemia | 0 |
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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 |
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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 |
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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 |
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Overall Survival (OS) Post Transplant at 1, 3 and 5 Years
Number of participants in the study who are alive and disease free at 1, 3 and 5 years post transplant. (NCT01471444)
Timeframe: Post transplant after 1, 3 and 5 years
Intervention | Participants (Count of Participants) |
---|
| 1 Year Post Transplant | 3 Year Post Transplant | 5 Year Post Transplant |
---|
Arm A (Flu+Bu) | 83 | 69 | 64 |
,Arm B (Flu+Clo+Bu) | 82 | 69 | 63 |
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Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant.
Number of participants in the study who are with no Grade 3 or 4 acute graft-versus-host disease at any time during the first 100 days post transplant. (NCT01471444)
Timeframe: 100 days post transplant
Intervention | Participants (Count of Participants) |
---|
Arm A (Flu+Bu) | 125 |
Arm B (Flu+Clo+Bu) | 115 |
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Number of Participants With Non Relapse Mortality at 100 Day Post Transplant
Number of participants expired from complications other than relapsed disease at 100 day Post Transplant. (NCT01471444)
Timeframe: 100 day Post Transplant
Intervention | Participants (Count of Participants) |
---|
Arm A (Flu+Bu) | 3 |
Arm B (Flu+Clo+Bu) | 6 |
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Progression-Free Survival (PFS)
Number of events with progression free survival. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.) or expired from treatment related mortality post transplant. (NCT01471444)
Timeframe: From day of transplant to disease of progression or death of any cause, whichever came first, assessed up to 5 years
Intervention | Number of events (Number) |
---|
Arm A (Flu+Bu) | 69 |
Arm B (Flu+Clo+Bu) | 61 |
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Overall Survival (OS)
Percentage of participants alive at 3 years. (NCT01490723)
Timeframe: From date of treatment to date of relapse or death, up to 3 years
Intervention | Participants (Count of Participants) |
---|
Yttrium-90 Ibritumomab + Chemo | 14 |
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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 |
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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 |
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Number of Participants With Engraftment.
Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant. (NCT01499147)
Timeframe: Up to 30 days post-transplant
Intervention | participants (Number) |
---|
Fludarabine/Busulfan + ATG | 18 |
Fludarabine/Melphalan + ATG | 12 |
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Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant. (NCT01499147)
Timeframe: Up to 100 days post-transplant (acute GVHD).
Intervention | participants (Number) |
---|
Fludarabine/Busulfan + ATG | 2 |
Fludarabine/Melphalan +ATG | 1 |
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Time to ANC and Platelet Engraftment
Days to ANC or platelet engraftment (NCT01499147)
Timeframe: Up to 30 days post-transplant
Intervention | days to ANC and platelet engraftment (Median) |
---|
Fludarabine/Busulfan + ATG | 15 |
Fludarabine/Melphalan + ATG | 12 |
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Overall Survival (OS)
Overall Survival is defined as the interval between day of transplant and day of death. (NCT01518153)
Timeframe: Every 3 months until day of death
Intervention | days (Median) |
---|
Stem Cell Transplant + Donor Lymphocyte Infusion | 246 |
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Success Rate
Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI). (NCT01518153)
Timeframe: 100 days
Intervention | participants (Number) |
---|
Low Dose Donor T-Cells | 1 |
High Dose Donor T-Cells | 3 |
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Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD)
"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ 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 II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT01527045)
Timeframe: 100 days post-transplant
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 15 |
Primary - Reg B (TBI Alone) | 2 |
Adjunct | 6 |
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Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy
Number of patients requiring systemic immunosuppressive therapy other than those used for prophylaxis and initial therapy. (NCT01527045)
Timeframe: 1 Year post-transplant
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 23 |
Primary - Reg B (TBI Alone) | 3 |
Adjunct | 4 |
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Number of Non-relapse Mortalities
Number of patients who died without relapsed/progressive disease. (NCT01527045)
Timeframe: 1 Year post-transplant
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 4 |
Primary - Reg B (TBI Alone) | 1 |
Adjunct | 0 |
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Number of Donors Discontinuing Atorvastatin Due to Toxicity
"The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events:~Musculoskeletal and connective tissue disorders: grade 2-5~Hepatobiliary disorders: grade 2-5~Other unexpected events thought related to the use of atorvastatin; grade 2-5~In cases where the NCI criteria do not apply, intensity will be defined as:~Mild: awareness of symptom or sign, but easily tolerated~Moderate: discomfort is enough to cause interference with normal activities~Severe: inability to perform normal daily activities~Life threatening: immediate risk of death from the reaction as it occurred" (NCT01527045)
Timeframe: Prior to stem cell collection
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 2 |
Primary - Reg B (TBI Alone) | 0 |
Adjunct | 1 |
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Number of Patients With Recurrent or Progressive Malignancy
"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, MDS >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." (NCT01527045)
Timeframe: 1 Year post-transplant
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 7 |
Primary - Reg B (TBI Alone) | 4 |
Adjunct | 3 |
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Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant
"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ 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 II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death" (NCT01527045)
Timeframe: 100 days post-transplant
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 2 |
Primary - Reg B (TBI Alone) | 0 |
Adjunct | 0 |
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Number of Patients With 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. Patients were evaluated as described in the National Institutes of Health (NIH) consensus project guidelines. (NCT01527045)
Timeframe: 1 Year post-transplant
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 8 |
Primary - Reg B (TBI Alone) | 1 |
Adjunct | 5 |
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Number of Patients Surviving Overall
Number of patients surviving overall post-transplant (NCT01527045)
Timeframe: 1 Year post-transplant
Intervention | Participants (Count of Participants) |
---|
Primary - Reg A (Flu/TBI) | 21 |
Primary - Reg B (TBI Alone) | 3 |
Adjunct | 9 |
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Progression Free Survival (PFS) at One Year
Assessed using Kaplan Meier and Proportional Hazards (NCT01529827)
Timeframe: day of transplant until progression up to 5 years
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic PBSCT) | 85 |
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Clinical Response
"Patients will be followed according to response criteria as referenced in BMT SOP Standards of Therapy last updated 2008. Clinical Response = CR + PR.~Complete Response Requires all of the following:~Serum and urine negative for monoclonal proteins by immunofixation~Normal free light chain ratio~Plasma cells in marrow < 5%~Partial Response (PR) Requires any of the following:~- ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL or urine light chain levels > 100 mg/day with a visible peak or free light chain levels > 10mg/dL~Progressive Disease (PD) Requires any of the following:~If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)~If progressive from PR or SD, ≥ 50% increase in the serum M protein to > 0.5 g/dL,or ≥ 50% increase in urine M protein to > 200mg/day with visible peak present.~Free light chain increase of ≥ 50% to" (NCT01529827)
Timeframe: In the first 100 days from day 0 of transplant
Intervention | percentage of participants (Number) |
---|
Treatment (Reduced Intensity Allogeneic PBSCT) | 45 |
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Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up. (NCT01564784)
Timeframe: Up to 2 years from randomization
Intervention | Months (Median) |
---|
Inotuzumab Ozogamicin | 5.4 |
Defined Investigator's Choice of Chemotherapy | 3.5 |
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Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations). (NCT01564784)
Timeframe: Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
Intervention | ng/mL (Mean) |
---|
| Cmax (Cycle 1 Day 1, 1 hour post-dose) (n=128) | Ctrough (Cycle 4 Day 1, pre-dose) (n=46) | Cmax (Cycle 4 Day 1, 1 hour post-dose) (n=37) |
---|
Inotuzumab Ozogamicin | 211 | 57.9 | 308 |
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms. (NCT01564784)
Timeframe: Day 1 of each cycle prior to dosing and EoT
Intervention | Score on a scale (Mean) |
---|
| Physical Functioning C2D1 | Physical Functioning C3D1 | Physical Functioning C4D1 | Physical Functioning C5D1 | Physical Functioning C6D1 | Physical Functioning EoT | Role Functioning C2D1 | Role Functioning C3D1 | Role Functioning C4D1 | Role Functioning C5D1 | Role Functioning C6D1 | Role Functioning EoT | Emotional Functioning C2D1 | Emotional Functioning C3D1 | Emotional Functioning C4D1 | Emotional Functioning C5D1 | Emotional Functioning C6D1 | Emotional Functioning EoT | Cognitive Functioning C2D1 | Cognitive Functioning C3D1 | Cognitive Functioning C4D1 | Cognitive Functioning C5D1 | Cognitive Functioning C6D1 | Cognitive Functioning EoT | Social Functioning C2D1 | Social Functioning C3D1 | Social Functioning C4D1 | Social Functioning C5D1 | Social Functioning C6D1 | Social Functioning EoT | Global Health Status C2D1 | Global Health Status C3D1 | Global Health Status C4D1 | Global Health Status C5D1 | Global Health Status C6D1 | Global Health Status EoT | Dyspnoea C2D1 | Dyspnoea C3D1 | Dyspnoea C4D1 | Dyspnoea C5D1 | Dyspnoea C6D1 | Dyspnoea EoT | Insomnia C2D1 | Insomnia C3D1 | Insomnia C4D1 | Insomnia C5D1 | Insomnia C6D1 | Insomnia EoT | Appetite Loss C2D1 | Appetite Loss C3D1 | Appetite Loss C4D1 | Appetite Loss C5D1 | Appetite Loss C6D1 | Appetite Loss EoT | Constipation C2D1 | Constipation C3D1 | Constipation C4D1 | Constipation C5D1 | Constipation C6D1 | Constipation EoT | Diarrhoea C2D1 | Diarrhoea C3D1 | Diarrhoea C4D1 | Diarrhoea C5D1 | Diarrhoea C6D1 | Diarrhoea EoT | Financial Difficulties C2D1 | Financial Difficulties C3D1 | Financial Difficulties C4D1 | Financial Difficulties C5D1 | Financial Difficulties C6D1 | Financial Difficulties EoT | Fatigue C2D1 | Fatigue C3D1 | Fatigue C4D1 | Fatigue C5D1 | Fatigue C6D1 | Fatigue Eot | Nausea and Vomiting C2D1 | Nausea and Vomiting C3D1 | Nausea and Vomiting C4D1 | Nausea and Vomiting C5D1 | Nausea and Vomiting C6D1 | Nausea and Vomiting EoT | Pain C2D1 | Pain C3D1 | Pain C4D1 | Pain C5D1 | Pain C6D1 | Pain EoT |
---|
Defined Investigator's Choice of Chemotherapy | 0.32 | -13.33 | 0.00 | NA | NA | -8.17 | -1.59 | -11.11 | 0.00 | NA | NA | -12.37 | 4.76 | -19.44 | 0.00 | NA | NA | 4.35 | 0.00 | -5.56 | 16.67 | NA | NA | 0.54 | -2.38 | -27.78 | 0.00 | NA | NA | -2.15 | 0.40 | -16.67 | 8.33 | NA | NA | -0.40 | -7.94 | 11.11 | 0.00 | NA | NA | 0.54 | 1.59 | 0.00 | 0.00 | NA | NA | 0.00 | 3.17 | 0.00 | 0.00 | NA | NA | 11.83 | 0.00 | 0.00 | 0.00 | NA | NA | -0.54 | -1.59 | -11.11 | 0.00 | NA | NA | 3.76 | 0.00 | 0.00 | 0.00 | NA | NA | 2.19 | 5.82 | 22.22 | -11.11 | NA | NA | 5.73 | -0.79 | 0.00 | -16.67 | NA | NA | 3.49 | -7.14 | -5.56 | -33.33 | NA | NA | -7.26 |
,Inotuzumab Ozogamicin | 0.48 | 3.15 | 5.33 | 11.52 | 7.22 | -3.38 | 5.45 | 11.81 | 16.67 | 12.88 | 16.67 | 1.32 | 5.21 | 7.41 | 5.69 | 6.82 | 2.78 | -0.91 | 4.05 | 5.79 | 4.58 | 0.76 | -8.33 | 0.83 | 4.20 | 5.56 | 10.42 | 12.88 | 16.67 | 1.82 | 3.98 | 9.38 | 11.25 | 8.71 | 0.69 | 0.00 | -5.41 | -7.41 | -12.50 | -3.03 | -2.78 | -2.31 | -2.40 | -9.26 | -7.50 | -4.55 | -11.11 | -2.31 | -4.20 | -8.33 | -11.67 | -6.06 | 2.78 | -1.32 | -1.21 | 0.47 | -2.50 | 0.00 | 5.56 | 2.64 | -3.30 | -5.09 | -0.83 | -9.52 | -2.78 | 2.31 | -1.80 | 0.47 | -1.67 | -3.03 | -5.56 | 0.33 | -4.10 | -8.33 | -9.17 | -7.32 | 0.00 | -0.33 | 0.15 | -4.63 | -3.33 | 2.27 | 0.00 | -0.17 | -8.86 | -8.56 | -4.17 | 0.76 | -2.78 | -1.98 |
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Change From Baseline in EQ-5D VAS
"The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting no problems, some problems, and extreme problems. The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state." (NCT01564784)
Timeframe: Day 1 of each cycle prior to dosing and EoT
Intervention | Score on a scale (Mean) |
---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6, Day 1 | EoT |
---|
Defined Investigator's Choice of Chemotherapy | 5.90 | 19.67 | 44.00 | NA | NA | -0.52 |
,Inotuzumab Ozogamicin | 5.81 | 8.13 | 7.13 | 7.62 | 15.09 | 4.62 |
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Progression-Free Survival (PFS)
PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method. (NCT01564784)
Timeframe: Up to 2 years from randomization
Intervention | Months (Median) |
---|
Inotuzumab Ozogamicin | 5.0 |
Defined Investigator's Choice of Chemotherapy | 1.7 |
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Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT
VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules. (NCT01564784)
Timeframe: Up to 2 years from randomization
Intervention | Percentage of Participants (Number) |
---|
Inotuzumab Ozogamicin | 22.8 |
Defined Investigator's Choice of Chemotherapy | 8.6 |
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Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL. (NCT01564784)
Timeframe: Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose
Intervention | Percentage of Participants (Number) |
---|
Inotuzumab Ozogamicin | 80.7 |
Defined Investigator's Choice of Chemotherapy | 29.4 |
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Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
"The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting no problems, some problems, and extreme problems. The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health)." (NCT01564784)
Timeframe: Day 1 of each cycle prior to dosing and EoT
Intervention | Score on a scale (Mean) |
---|
| Cycle 2, Day 1 | Cycle 3, Day 1 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6, Day 1 | EoT |
---|
Defined Investigator's Choice of Chemotherapy | 0.02 | -0.08 | 0.00 | NA | NA | -0.04 |
,Inotuzumab Ozogamicin | 0.00 | 0.01 | 0.04 | 0.04 | 0.03 | -0.01 |
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Overall Survival (OS)
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact. (NCT01564784)
Timeframe: Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
Intervention | Months (Median) |
---|
Inotuzumab Ozogamicin | 7.7 |
Defined Investigator's Choice of Chemotherapy | 6.2 |
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Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy. (NCT01564784)
Timeframe: Up to 19 weeks from last dose
Intervention | Percentage of Participants (Number) |
---|
Inotuzumab Ozogamicin | 42.7 |
Defined Investigator's Choice of Chemotherapy | 11.1 |
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Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening. (NCT01564784)
Timeframe: Up to approximately 4 weeks (EoT) from last dose of study drug
Intervention | Percentage of Participants (Number) |
---|
Inotuzumab Ozogamicin | 3.7 |
Defined Investigator's Choice of Chemotherapy | 18.2 |
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Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells. (NCT01564784)
Timeframe: Up to approximately 4 weeks (EoT) from last dose of study drug
Intervention | Percentage of Participants (Number) |
---|
Inotuzumab Ozogamicin | 78.4 |
Defined Investigator's Choice of Chemotherapy | 28.1 |
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Graft Failure
Primary graft failure occurs when a transplant recipient does not achieve donor chimerism following a bone marrow transplant. Secondary graft failure occurs when graft fails after donor chimerism had initially occurred. (NCT01565616)
Timeframe: 1 year after transplant
Intervention | Participants (Count of Participants) |
---|
| Primary graft failure | Secondary graft failure |
---|
Bone Marrow Transplant Recipients | 0 | 1 |
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Chronic Graft Versus Host Disease (GVHD)
Chronic GVHD was graded according to the National Institutes of Health (NIH) 2014 Consensus Criteria Diagnosis and scoring the severity of chronic GVHD is determined by evaluating symptoms of the skin, nails, hair, mouth, eyes, genitalia, gastrointestinal tract, liver, lungs, muscles, fascia and joints, immune function as well as other symptoms such as ascites and neuropathy. Chronic GVHD is graded as mild, moderate or severe based on the number of organ sites impacted and the severity of symptoms. (NCT01565616)
Timeframe: 1 year after transplant
Intervention | Participants (Count of Participants) |
---|
| Mild Chronic GVHD | Moderate Chronic GVHD | Severe Chronic GVHD |
---|
Bone Marrow Transplant Recipients | 3 | 2 | 1 |
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Time to Neutrophil and Platelet Engraftment
Time to neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of at least 500/µL after conditioning. Time to 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, without receiving a platelet transfusion in the previous 7 days. (NCT01565616)
Timeframe: 1 year after transplant
Intervention | Days (Median) |
---|
| Neutrophil engraftment | Platelet |
---|
Bone Marrow Transplant Recipients | 17 | 21 |
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Event -Free Survival Rate
Event-free survival is defined as stable donor erythropoiesis with no new clinical evidence of sickle cell disease. Primary or late graft rejection, disease recurrence, and death are considered events for this endpoint. (NCT01565616)
Timeframe: 1 year after transplant
Intervention | Participants (Count of Participants) |
---|
Bone Marrow Transplant Recipients | 19 |
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Acute Graft Versus Host Disease (GVHD)
"Acute GVHD was graded according to the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus criteria. Clinical manifestations of acute GVHD include skin, liver, and gastrointestinal symptoms. Grading of acute GVHD is determined by size of maculopapular rash, bilirubin and stool output. Acute GVHD grades range from 0 to 4 with 0 indicating no GVHD and 4 representing the most severe grade.~Grade II is defined as a maculopapular rash over 25-50% of body surface area (BSA), bilirubin of 3.1 to 6 mg/dL, and stool output of 1000-1500 mL/d (for adults).~Grade III is defined as a maculopapular rash over more than 50% of BSA, bilirubin of 6.1 to 15 mg/dL, and stool output of greater than 1500 mL/d (for adults).~Grade IV is defined as generalized erythroderma with bullous formation, bilirubin greater than 15 mg/dL, and severe abdominal pain with or without ileus." (NCT01565616)
Timeframe: 1 year after transplant
Intervention | Participants (Count of Participants) |
---|
| Grade II Acute GVHD | Grade III Acute GVHD | Grade IV Acute GVHD |
---|
Bone Marrow Transplant Recipients | 3 | 1 | 0 |
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Overall Survival
Overall survival is defined as survival with or without sickle cell disease after hematopoietic cell transplantation (HCT). (NCT01565616)
Timeframe: 1 year after transplant
Intervention | Participants (Count of Participants) |
---|
Bone Marrow Transplant Recipients | 20 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
Number of participants that were diseased free and alive 3 years post-transplant. (NCT01572662)
Timeframe: Up to 3 years post-transplant
Intervention | Participants (Count of Participants) |
---|
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l | 16 |
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | 47 |
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Overall Survival
Number of participants that are disease free and alive one year post transplant. (NCT01572662)
Timeframe: Up to 1 year post-transplant
Intervention | Participants (Count of Participants) |
---|
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l | 29 |
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | 93 |
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Non-Relapse Mortality Rate (NRM)
Number of participants expired within the first 100 days after transplant not due to relapsed disease. (NCT01572662)
Timeframe: 100 days
Intervention | Participants (Count of Participants) |
---|
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l | 2 |
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | 8 |
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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 |
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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 |
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Engraftment Rate of Patients With Non-malignant Diseases (Stratum A)
Engraftment will be defined as the development of an Absolute Neutrophil Count (ANC) >500 for 3 consecutive days plus donor CD14/15 cells >70%. The engraftment rate in the population used for historical control is 40%. If 3 patients in Stratum A experience graft rejection, this stratum will close early for failing to achieve superior engraftment compared to standard-of-care. (NCT01596699)
Timeframe: Participants will have engraftment blood studies starting approximately Day 30 post hematopoietic stem cell transplant and then monthly until stable. Average study participation is approximately 5 years.
Intervention | percentage of participants (Number) |
---|
Stratum A: Patients With Non-Malignancies | 66.67 |
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Mixed-donor Chimerism Rate of Patients With High-risk Myeloid Malignancies (Stratum B)
Full-donor chimerism will be defined by as ≥99% donor cells by Short Tandem Repeat (STR) analysis in all cell lines (CD3, CD14/15, and CD19) in peripheral blood. The historic control for Stratum B was determined using the 20 patients who were transplanted from 2005 - 2010 with Busulfan (BU)-based regimens and who retrospectively would have been eligible for the current trial. Of these 20 patients, at 100 days post-HCT, only 8 (40%) patients had full-donor chimerism. If 5 patients in Stratum B experienced mixed-donor chimerism at Day 100, we will close this stratum early for failing to achieve superior donor cell engraftment compared to standard-of-care. (NCT01596699)
Timeframe: Participants will have peripheral blood chimerism assessed at Day 100 post hematopoietic stem cell transplant and then monthly until stable.
Intervention | percentage of participants (Number) |
---|
Stratum B: Patients With Myeloid Malignancies | 66.67 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
(NCT01690520)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Standard of Care) | 52 |
Arm II (Experimental) | 57 |
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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 |
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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 |
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Non-relapse Mortality
(NCT01690520)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
Arm I (Standard of Care) | 16 |
Arm II (Experimental) | 16 |
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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 |
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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 |
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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 |
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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 |
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Progression Free Survival
(NCT01707004)
Timeframe: Up to 1 year
Intervention | days (Median) |
---|
Decitabine + Bone Marrow Transplant | 141 |
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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 |
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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 |
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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 |
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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 |
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Number of Participants With Complete Remission After Transplantation
(NCT01707004)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Decitabine + Bone Marrow Transplant | 14 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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18-Month Overall Survival
Assessment of overall survival at 18 months. Participants alive at last contact are censored at last contact. (NCT01773395)
Timeframe: 18 Month
Intervention | Percentage of participants (Number) |
---|
GVAX | 63 |
Placebo | 59 |
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Percentage of Participants Experiencing Grade 3 or Higher Non-Hematologic or Grade 4 or Higher Hematologic Adverse Events
Percentage of participants experiencing grade 3 or higher non-hematologic or grade or higher hematologic adverse events evaluated by CTCAE v5.0. (NCT01773395)
Timeframe: 18 Months
Intervention | Percentage of participants (Number) |
---|
GVAX | 3.33 |
Placebo | 0 |
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Percentage of Participants Experiencing Acute and Chronic Graft-Versus-Host Disease
"Percentage of participants with acute and chronic graft-versus-host disease (GVHD). The time frame for the acute incidence is 1 year and for chronic is 3 years.Grading of aGVHD was derived by consensus grading (Przepiorka 1995). The aGVHD algorithm calculates the grade based on the organ (skin, GI and liver) stage and etiology/biopsy reported. Skin staging: Stage 1. <25% rash; 2. 25-50%; 3. >50%; 4. generalized erythroderma with bullae. GI staging: Stage 1. Diarrhea>500ml/d or persistent nausea; 2. >1000ml/d; 3. >1500ml/d; 4. Large volume diarrhea and severe abdominal pain +- ileus. Liver staging: Stage 1. bilirubin 2-3mg/dl; 2. bili 3-6 mg/dl; 3. bili 6-15 mg/dl; 4. bili>15mg/dl. Grade 4 is the worst outcome.~Chronic GVHD is classified using the NIH Consensus Criteria. 8 organs will be scored on a 0-3 scale to reflect degree of cGVHD involvement 0 being none, 1 mild, 2 moderate 3 severe. Liver and pulmonary function test results will also be recorded. Severe is the worst outcome" (NCT01773395)
Timeframe: 1 and 3 years
Intervention | Percentage of participants (Number) |
---|
| Grade 2-4 aGVHD @1yr | Grade 3-4 aGVHD @1yr | Chronic GVHD @3yrs | Mod-severe cGVHD @3yrs |
---|
GVAX | 34 | 16 | 47 | 23 |
,Placebo | 12 | 0 | 59 | 33 |
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Percentage of Participants With Relapse and/or Non-Relapse Mortality
Percentage of participants with relapse and/or non-relapse mortality at 18 months from registration. (NCT01773395)
Timeframe: 18 Months
Intervention | Percentage of participants (Number) |
---|
| Non-relapse Mortality | Relapse |
---|
GVAX | 17 | 30 |
,Placebo | 7.7 | 37 |
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18-Month Progression Free Survival
"Progression-Free Survival (PFS) at 18 months after randomization. Progression-free survival is defined as time from randomization to progression of disease or death whichever occurs first. Patients with relapse/progressive disease who re-enter remission after vaccination or upon withdrawal of immune suppression alone will not be considered as having disease progression. The primary analysis will be performed using the modified intention-to-treat (ITT) principle, i.e., all transplanted and eligible patients who receive at least one vaccination will be included in the analysis according to the treatment arm they are randomized to. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free.~Progression is defined by either morphological evidence of acute leukemia or MDS consistent with pre-transplant features~is defined by either morphological evidence of acute leukemia or MDS consistent with pre-transplant features" (NCT01773395)
Timeframe: 18 months
Intervention | Percentage (Number) |
---|
GVAX | 53 |
Placebo | 55 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Overall Survival
Participants that survived between day of transplant and day of death on different dose levels. (NCT01823198)
Timeframe: Up to 2 years
Intervention | Participants (Count of Participants) |
---|
| Group A: NK cells from KIR mismatched haplo donors | Group B: NK cells from KIR mismatched cord blood donors | Group C: NK cells from matched related donors |
---|
Phase I: NK Cell Dose Level 1_10^6 | 2 | 1 | 2 |
,Phase I: NK Cell Dose Level 2_10^7 | 0 | 1 | 0 |
,Phase I: NK Cell Dose Level 3_ 3x10^7 | 0 | 0 | 3 |
,Phase I: NK Cell Dose Level 4_ 10^8 | 0 | 1 | 2 |
,Phase II: NK Cell Dose Level 3_3x10^7 | 0 | 1 | 0 |
,Phase II: NK Cell Dose Level 4_ 10^8 | 0 | 7 | 2 |
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Number of Participants With Grade 3 Toxicities
Number of participants that had grade 3 toxicities up to day 42. (NCT01823198)
Timeframe: Up to day 42
Intervention | Participants (Count of Participants) |
---|
| Group A: NK cells from KIR mismatched haplo donors | Group B: NK cells from KIR mismatched cord blood donors | Group C: NK cells from matched related donors |
---|
Phase I: NK Cell Dose Level 1_10^6 | 2 | 1 | 2 |
,Phase I: NK Cell Dose Level 2_10^7 | 1 | 2 | 2 |
,Phase I: NK Cell Dose Level 3_ 3x10^7 | 0 | 1 | 2 |
,Phase I: NK Cell Dose Level 4_ 10^8 | 0 | 1 | 2 |
,Phase II: NK Cell Dose Level 3_3x10^7 | 0 | 1 | 0 |
,Phase II: NK Cell Dose Level 4_ 10^8 | 0 | 11 | 6 |
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Number of Participants Who Experienced Dose-limiting Toxicities (DLT)
Participants that experienced DLT related to the NK Cells post transplant at different dose levels. (NCT01823198)
Timeframe: Up to 42 days
Intervention | Participants (Count of Participants) |
---|
| Group A: NK cells from KIR mismatched haplo donors | Group B: NK cells from KIR mismatched cord blood donors | Group C: NK cells from matched related donors |
---|
Phase I: NK Cell Dose Level 1_10^6 | 2 | 2 | 2 |
,Phase I: NK Cell Dose Level 2_10^7 | 1 | 2 | 3 |
,Phase I: NK Cell Dose Level 3_ 3x10^7 | 0 | 2 | 2 |
,Phase I: NK Cell Dose Level 4_ 10^8 | 0 | 2 | 2 |
,Phase II: NK Cell Dose Level 3_3x10^7 | 0 | 1 | 0 |
,Phase II: NK Cell Dose Level 4_ 10^8 | 0 | 12 | 9 |
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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 |
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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 |
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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 |
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Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
To evaluate the side effects of giving Azacytidine before and during chemotherapy using the standard drugs Fludarabine, Cytarabine, IT Cytarabine (AML patients) and IT methotrexate (ALL patients) (NCT01861002)
Timeframe: From Day 1 to Day 42 (Cycle 1)
Intervention | Participants (Count of Participants) |
---|
| # of patients with DLT | # of patients without DLT | # of patients not evaluable |
---|
Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL | 0 | 2 | 0 |
,Dose 75 mg/m2/Day Azacytidine Diagnosed With AML | 0 | 12 | 1 |
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To Assess the Proportions of GvHD Response Post-administration of AP1903.
To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903
Intervention | Participants (Count of Participants) |
---|
| Day 3 post-administration of AP190371985950 | Day 3 post-administration of AP190371985951 | Day 7 post-administration of AP190371985951 | Day 7 post-administration of AP190371985950 | Day 14 post-administration of AP190371985951 | Day 14 post-administration of AP190371985950 | Day 28 post-administration of AP190371985951 | Day 28 post-administration of AP190371985950 | Day 56 post-administration of AP190371985951 | Day 56 post-administration of AP190371985950 |
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| no response | complete response | progression | partial response |
---|
Transplat Plus DLI | 1 |
Transplat Plus DLI | 0 |
Transplant Only | 0 |
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To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD
To assess the proportion of patients developing grade I-IV acute GvHD by Day 28, 56, and 180 post DLI. (NCT01875237)
Timeframe: Day 28, 56, and 180 post DLI.
Intervention | Participants (Count of Participants) |
---|
| Day 28 | Day 56 | Day 180 |
---|
Transplant Only | 0 | 0 | 0 |
,Transplat Plus DLI | 1 | 1 | 0 |
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To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.
To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903.
Intervention | Participants (Count of Participants) |
---|
| Day 3 post-administration of AP1903. | Day 7 post-administration of AP1903. | Day 14 post-administration of AP1903. | Day 28 post-administration of AP1903. | Day 56 post-administration of AP1903. |
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Transplant Only | 0 | 0 | 0 | 0 | 0 |
,Transplat Plus DLI | 1 | 1 | 1 | 1 | 1 |
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To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.
To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events. (NCT01875237)
Timeframe: up to 3.5 years
Intervention | Participants (Count of Participants) |
---|
Transplant Only | 0 |
Transplat Plus DLI | 1 |
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To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism
To assess the number of Participants with 100% donor chimerism at 6 months post donor lymphocyte infusion (DLI) (NCT01875237)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Transplant Only | 0 |
Transplat Plus DLI | 1 |
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To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.
"To assess participants with incidence of acute GvHD flare after CR/PR requiring additional agent (including 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy before Day 56 post-administration of AP1903." (NCT01875237)
Timeframe: before Day 56 post AP1903
Intervention | Participants (Count of Participants) |
---|
Transplant Only | 0 |
Transplat Plus DLI | 1 |
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To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.
To assess the incidence of Epstein-Barr virus (EBV)-associated lymphoproliferative disorder or EBV reactivation requiring therapy post DLI. (NCT01875237)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Transplant Only | 0 |
Transplat Plus DLI | 1 |
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Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.
Participants to assess at 6 months post donor lymphocyte infusion (DLI): disease-free survival & non-relapse mortality, chimerism and GVHD (NCT01875237)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
| disease-free survivaI | chimerism post DLI | GVHD post DLI | non-relapse mortality |
---|
Transplant Only | 0 | 0 | 0 | 0 |
,Transplat Plus DLI | 1 | 1 | 1 | 0 |
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Overall Survival
"Secondary endpoints:~Overall survival: The distribution of time to death from any cause will be estimated by Kaplan- Meier product limit function and plotted. The overall survival will be measured from the time of transplant to any death and patients will be followed for 2 years." (NCT01877837)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
Patients With Sickle Cell Anemia | 23 |
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Number of Participants With Graft Failure
"Primary endpoint:~In each group, the Number of participants with Graft Failure at the 2 years endpoint will be estimated using the Kaplan Meier product limit estimator." (NCT01877837)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
Patients With Sickle Cell Anemia | 3 |
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Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
(NCT01894477)
Timeframe: Up to 84 days
Intervention | Participants (Count of Participants) |
---|
Arm A (Treosulfan, Fludarabine Phosphate) | 29 |
Arm B (Treosulfan, Fludarabine Phosphate, TBI) | 50 |
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Number of Participants That Did Not Progress Within 6 Months
Progression is defined as relapse (NCT01894477)
Timeframe: At 6 months post-transplant
Intervention | Participants (Count of Participants) |
---|
Arm A (Treosulfan, Fludarabine Phosphate) | 20 |
Arm B (Treosulfan, Fludarabine Phosphate, TBI) | 48 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Subjects Disease-free Survival
Percentage of patients without relapse of disease at 2 years (NCT01991457)
Timeframe: 2 years post-transplant
Intervention | percentage of participants (Number) |
---|
Treatment | 63.2 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Participants With Chronic GVHD at One Year
(NCT02224872)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Bone Marrow Transplant | 3 |
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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 |
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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 |
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Participants That Were GVHD Free, Relapse Free Survival (GRFS)
(NCT02224872)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Bone Marrow Transplant | 14 |
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Number of Patients That Have Survived at One Year
(NCT02224872)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Bone Marrow Transplant | 18 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Phase 2 (Safety Management Study): Cohort 6 | 35 | 45 | 0 | 0 | 0 | 0 | 25 | 18 | 8 | 5 | 3 | 15 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm
The CR/CRh rate was defined as the number of participants who achieved either CR or CRh at any of the postbaseline visits divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date 04 Aug 2017, the 142 patients included in the primary analysis of CR/CRh rate were followed up at least 112 days
Intervention | Percentage of participants (Number) |
---|
| CR/CRh rate | CR rate | CRh rate |
---|
Gilteritinib | 28.2 | 19.0 | 9.2 |
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Percentage of Participants Who Achieved Transfusion Conversion and Maintenance
Transfusion conversion & maintenance rate was defined for gilteritinib arm. Participants were classified as transfusion independent if there were no RBC or platelet transfusions within 28 days prior to the first dose to 28 days after the first dose; otherwise they were classified as transfusion dependent at baseline. Participants were considered independent postbaseline if they had 1 consecutive 8 week period without any RBC or platelet transfusion from 29 days after the first dose until the last dose date. For participants who were on treatment ≤ 4 weeks or > 4 weeks but < 12 weeks and there was no RBC or platelet transfusion within postbaseline period, they were considered not evaluable; otherwise, they were considered postbaseline transfusion dependent. Transfusion conversion rate was defined for participants who had evaluable postbaseline transfusion status. Transfusion status (independent vs. dependent) at baseline and postbaseline was reported in a 2 by 2 contingency table. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)
Intervention | Percentage of participants (Number) |
---|
| Baseline Independent/ Post baseline Independent | Baseline Independent/Post baseline Dependent | Baseline Independent/Post baseline Not Evaluable | Baseline Dependent/Post baseline Independent | Baseline Dependent/Post baseline Dependent | Baseline Dependent/Post baseline Not Evaluable |
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Gilteritinib | 59.2 | 24.5 | 16.3 | 34.5 | 55.8 | 9.6 |
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Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant
Transplantation rate is defined as the percentage of participants undergoing Hematopoietic stem cell transplant (HSCT) during the study period. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months
Intervention | Percentage of participants (Number) |
---|
Gilteritinib | 25.5 |
Salvage Chemotherapy | 15.3 |
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Change From Baseline in Brief Fatigue Inventory (BFI)
The Brief Fatigue Inventory (BFI) is a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions ask participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions ask participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A global fatigue score can be obtained by averaging all the items on the BFI. The global BFI score will be calculated only if at least 5 of the 9 items are answered. A higher BFI fatigue score indicates worse outcome. (NCT02421939)
Timeframe: Baseline and cycle 1, day 8 and cycle 2 day 1 (up to data cut off date of 17 Sep 2018)
Intervention | Units on a scale (Mean) |
---|
| Cycle 1 day 8 (C1D8) | Cycle 2 day 1 (C2D1) |
---|
Gilteritinib | -0.4 | 0.0 |
,Salvage Chemotherapy | 1.0 | 0.4 |
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Percentage of Participants With Composite Complete Remission (CRc Rate)
CRc rate was defined as the number of participants who achieved the best response of CRc (CR,complete remission with incomplete platelet recovery (CRp) or complete remission with incomplete hematologic recovery (CRi) divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months
Intervention | Percentage of participants (Number) |
---|
Gilteritinib | 54.3 |
Salvage Chemotherapy | 21.8 |
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Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh)
CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months
Intervention | Percentage of participants (Number) |
---|
Gilteritinib | 34.0 |
Salvage Chemotherapy | 15.3 |
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Percentage of Participants With Complete Remission (CR) Rate
The CR rate was defined as the number of participants who achieved the best response of CR divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, all participants included in the primary analysis of CR rate were followed up at least 6 months
Intervention | Percentage of participants (Number) |
---|
Gilteritinib | 21.1 |
Salvage Chemotherapy | 10.5 |
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Duration of Remission
Duration of remission included duration of composite complete remission (CRc), duration of complete remission (CR)/ complete remission with partial hematologic recovery (CRh), duration of CRh, duration of CR and duration of response (CRc + partial remission (PR). The duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse (i.e., the date of first NR after CRc or PR) for participants who achieved CRc or PR (relapse date - first CRc or PR disease assessment date + 1). Participants who died without report of relapse were considered nonevents and censored at their last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc or PR disease assessment date + 1). Other participants who did not relapse during the study were considered nonevents and censored at the last relapse-free assessment date. Duration of CR was only applicable to participants with best overall response of CR. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months
Intervention | Months (Median) |
---|
Gilteritinib | 14.8 |
Salvage Chemotherapy | 1.8 |
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Duration of Overall Survival (OS)
Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive by the cutoff date. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months
Intervention | Months (Median) |
---|
Gilteritinib | 9.3 |
Salvage Chemotherapy | 5.6 |
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Duration of Leukemia-Free Survival (LFS)
The LFS was defined as the time from the date of first CRc until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc (relapse date or death date - first CRc disease assessment date + 1). For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc disease assessment date + 1). For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc disease assessment date + 1). (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months
Intervention | Months (Median) |
---|
Gilteritinib | 4.4 |
Salvage Chemotherapy | 6.7 |
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Duration of Event-Free Survival (EFS)
"EFS was defined as the time from the date of randomization until the date of documented relapse (excluding relapse after PR), treatment failure or death from any cause within 30 days after the last dose of study drug, whichever occurred first (earliest of [relapse date, treatment failure date, death date] - randomization date + 1). If a participant experienced relapse or death within 30 days after the last dose of study drug, the participant was defined as having an EFS event related to either relapse or death, and the event date was the date of relapse or death. For a participant who was not known to have had a relapse or treatment failure or death event, EFS was censored at the date of last relapse-free disease assessment (last relapse-free disease assessment date - randomization date + 1). Data was estimated based on Kaplan-Meier estimates." (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months
Intervention | Months (Median) |
---|
Gilteritinib | 2.8 |
Salvage Chemotherapy | 0.7 |
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Number of Participants With Adverse Events
"A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the study drug (gilteritinib or salvage chemotherapy). If the AE occurred on day 1 and the onset check box was marked Onset after first dose of study drug or the onset check box was left blank, then the AE was considered treatment emergent. If the AE occurred on day 1 and the onset check box was marked Onset before first dose of study drug, then the AE was not considered treatment emergent. Majority of salvage chemotherapy participants finished the study by cycle 2 of treatment, the duration of exposure was longer in the gilteritinib arm compared with the salvage chemotherapy arm (126.00 [4.0, 885.0] days versus 28.0 [5.0, 217.0] days). The NCI-CTCAE is defined as National Cancer Institute-Common Terminology Criteria for Adverse Events." (NCT02421939)
Timeframe: From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)
Intervention | Participants (Count of Participants) |
---|
| Drug-related TEAE | Serious TEAE | Drug-related serious TEAE | TEAE leading to death | Drug-related TEAE leading to death | TEAE leading to withdrawal of treatment | Drug-related TEAE lead withdrawal of treatment | NCI-CTCAE Grade 3 or higher TEAE | Drug-related Grade 3 or higher TEAE | Death |
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Gilteritinib | 206 | 205 | 88 | 71 | 10 | 58 | 27 | 236 | 153 | 170 |
,Salvage Chemotherapy | 71 | 34 | 16 | 16 | 5 | 13 | 5 | 94 | 57 | 81 |
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Event Free Survival; Number of Participants Who Survived at 2 Years
29 participants will be evaluated for Event Free Survival. (NCT02435901)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
| Expired Secondary to Sepsis | Expired Secondary to GVHD | Survived Participants |
---|
Reduced Intensity Regimen | 1 | 2 | 26 |
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Number of Participants With Sustained Cell Engraftment of Donor Cells
Sustained stem cell engraftment of donor cells will be evaluated by chimerism (FISH fluorescence in situ hybridization OR VNTR (Variable Number of Tandem Repeats), based on recipient/donor gender, at 30 days, 100 days, 6 months and 1 year following the use of reduced intensity conditioning. (NCT02435901)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Reduced Intensity Regimen | 29 |
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Percentage of Participants With Infections Post-randomization by Infection Type
All Grade 2 and 3 infections are reported according to the BMT CTN MOP (Manual of Procedures) where a higher grade corresponds to more severe symptoms. The number of participants with post-randomization infections in each treatment arm is described by severity and type of infection. (NCT02440464)
Timeframe: 2 years post-randomization
Intervention | Participants (Count of Participants) |
---|
| Participants with Infections | Maximum Severity: Grade 2 | Maximum Severity: Grade 3 | Participants with Bacterial Infection | Participants with Viral Infection | Participants with Fungal Infection | Participants with Other Infection |
---|
Ixazomib Maintenance | 8 | 6 | 2 | 3 | 6 | 0 | 1 |
,Placebo | 11 | 10 | 1 | 2 | 11 | 1 | 0 |
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Percentage of Participants With Disease Progression
Disease progression was evaluated using the International Uniform Response Criteria. Participants in sCR/CR must meet at least one of the criteria for disease progression specified in the protocol for sCR/CR participants; those not in sCR/CR must meet at least one of the disease progression criteria specified in the protocol for those not in sCR/CR. The cumulative incidence of progression from randomization will be estimated for each treatment arm using the Aalen-Johansen estimator, with death in remission treated as a competing risk. Initiation of anti-myeloma therapy will be considered evidence of progression. Participants who were event-free at two years post-transplant are censored at that time. (NCT02440464)
Timeframe: 12 months and 21 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 12 Months Post-randomization | 21 Months Post-randomization |
---|
Ixazomib Maintenance | 34.7 | 44.7 |
,Placebo | 27.3 | 36.4 |
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Percentage of Participants With Overall Survival (OS)
Overall survival (OS) is defined as freedom from death from any cause. OS post-randomization is estimated for each arm using the Kaplan-Meier estimator and compared between arms using the log rank test. Participants who are alive at two years post-transplant are censored at that time. Confidence intervals for values of 100% were not calculated and are shown as 100%. (NCT02440464)
Timeframe: 12 months and 21 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 12 Months Post-randomization | 21 Months Post-randomization |
---|
Ixazomib Maintenance | 100.0 | 94.7 |
,Placebo | 90.9 | 86.4 |
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Percentage of Participants With Progression-Free Survival
The primary endpoint compares progression-free survival as a time to event endpoint from randomization between patients randomized to ixazomib and placebo maintenance in high risk multiple myeloma. Participants are considered a failure of the primary endpoint if they die or suffer from disease progression or if they initiate non-protocol anti-myeloma therapy. Disease progression was evaluated using the International Uniform Response Criteria. Participants must meet one of the criteria for disease progression specified in the protocol. The time to this event is the time from randomization to progression, death, or initiation of non-protocol anti myeloma therapy whichever comes first. The Kaplan-Meier estimator was used to estimate progression-free survival during the 2 year post-transplant follow-up period. Participants who were event-free at two years post-transplant are censored at that time. (NCT02440464)
Timeframe: 12 months and 21 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 12 Months Post-randomization | 21 Months Post-randomization |
---|
Ixazomib Maintenance | 65.3 | 55.3 |
,Placebo | 72.7 | 59.1 |
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Percentage of Participants With Toxicities Post-randomization by Toxicity Type
Toxicities are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Higher grades correspond to worse symptoms with the minimum grade being a 0 and the maximum grade being a 5. Toxicities post-randomization are described for each treatment arm by the type of toxicity as well as peak overall grade. (NCT02440464)
Timeframe: 2 years post-randomization
Intervention | Participants (Count of Participants) |
---|
| Maximum Toxicity Grade : 0 - 2 | Maximum Toxicity Grade : 3 | Maximum Toxicity Grade : 4 | Maximum Toxicity Grade : 5 | Abnormal Liver Symptoms | Dysgeusia | Encephalopathy | Grade 3-5 Allergic Reaction | Grade 3-5 Anaphylaxis | Grade 3-5 Blood/Lymphatic Toxicity | Grade 3-5 Cardiac Toxicity | Grade 3-5 Fatigue | Grade 3-5 Fever | Grade 3-5 GI Toxicity | Grade 3-5 Hearing Loss | Grade 3-5 Hemorrhage | Grade 3-5 Hepatobiliary/Pancreas | Grade 3-5 Hyperthyroidism | Grade 3-5 Hypothyroidism | Grade 3-5 Metabolic Toxicity | Grade 3-5 Musculoskeletal Toxicity | Grade 3-5 Nervous System Toxicity | Grade 3-5 Ocular Toxicity | Grade 3-5 Renal Toxicity | Grade 3-5 Respiratory Toxicity | Grade 3-5 Skin/Subcutaneous Tissue Toxicity | Grade 3-5 Vascular Toxicity | Hepatitis | Intestinal Obstruction | Liver Failure | Severe Muscle Weakness/Paralysis | Sudden Vision Loss | Tumor Lysis Syndrome |
---|
Ixazomib Maintenance | 8 | 13 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 5 | 6 | 3 | 0 | 6 | 0 | 0 | 1 | 0 | 0 | 4 | 1 | 4 | 0 | 0 | 2 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
,Placebo | 6 | 14 | 1 | 1 | 2 | 2 | 0 | 1 | 0 | 8 | 7 | 3 | 0 | 7 | 0 | 0 | 7 | 0 | 1 | 6 | 3 | 4 | 2 | 5 | 8 | 5 | 3 | 1 | 0 | 0 | 1 | 0 | 0 |
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Percentage of Participants With Best Response to Treatment After Randomization
Response was assessed using the International Uniform Response Criteria. Best response is the best of all the disease response status at each assessment time point after randomization. The order from best to worst is: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All disease classifications are relative to the patient's disease status prior to allogeneic transplant (i.e. study entry). This outcome was compared between treatment groups using all response data up to 2 years post-transplant. These response data were summarized separately for patients in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization. Within each group (in sCR/CR vs not in sCR/CR at randomization), best response to treatment was compared between treatment groups using a Fisher's Exact test instead of a chi-square test because of the small sample size. (NCT02440464)
Timeframe: 2 years post-transplant
Intervention | Participants (Count of Participants) |
---|
| Participants in sCR/CR at Randomization72551676 | Participants in sCR/CR at Randomization72551677 | Participants Not in sCR/CR at Randomization72551677 | Participants Not in sCR/CR at Randomization72551676 |
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| Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Stringent Complete Response (sCR) | Complete Response (CR) | Very Good Partial Response (VGPR) |
---|
Ixazomib Maintenance | 6 |
Placebo | 5 |
Ixazomib Maintenance | 2 |
Ixazomib Maintenance | 0 |
Placebo | 0 |
Placebo | 1 |
Ixazomib Maintenance | 3 |
Placebo | 4 |
Placebo | 3 |
Ixazomib Maintenance | 4 |
Ixazomib Maintenance | 1 |
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Percentage of Participants With Response to Treatment
Response was assessed using the International Uniform Response Criteria. All disease classifications are relative to the patient's disease status prior to allogeneic transplant (i.e. study entry). Response to treatment after randomization (sCR, CR, VGPR, or PR) is summarized in each arm post-transplant at 18 months and 24 months post-transplant. These response data were summarized separately for patients in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization. (NCT02440464)
Timeframe: 18 months and 24 months post-transplant
Intervention | Participants (Count of Participants) |
---|
| Response to Treatment at 18 Months Post-transplant for Participants in sCR/CR at Randomization72551676 | Response to Treatment at 18 Months Post-transplant for Participants in sCR/CR at Randomization72551677 | Response to Treatment at 18 Months Post-transplant for Participants Not in sCR/CR at Randomization72551676 | Response to Treatment at 18 Months Post-transplant for Participants Not in sCR/CR at Randomization72551677 | Response to Treatment at 24 Months Post-transplant for Participants in sCR/CR at Randomization72551676 | Response to Treatment at 24 Months Post-transplant for Participants in sCR/CR at Randomization72551677 | Response to Treatment at 24 Months Post-transplant for Participants Not in sCR/CR at Randomization72551677 | Response to Treatment at 24 Months Post-transplant for Participants Not in sCR/CR at Randomization72551676 |
---|
| Stringent Complete Response (sCR) | Complete Response (CR) | Very Good Partial Response (VGPR) | Not Evaluable | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Died Before Evaluation |
---|
Ixazomib Maintenance | 3 |
Placebo | 3 |
Placebo | 2 |
Placebo | 0 |
Ixazomib Maintenance | 2 |
Placebo | 4 |
Ixazomib Maintenance | 4 |
Placebo | 1 |
Placebo | 6 |
Ixazomib Maintenance | 0 |
Ixazomib Maintenance | 1 |
Ixazomib Maintenance | 5 |
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Percentage of Participants With Infections Post-randomization by Time Point
All Grade 2 and 3 infections are reported according to the BMT CTN MOP (Manual of Procedures) where a higher grade corresponds to more severe symptoms. The cumulative incidence of severe, life-threatening, or fatal infections (Grade 3), treating death as a competing event, are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between the two treatment arms was done using a Z test at fixed time points. (NCT02440464)
Timeframe: 6, 12 and 18 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 6 Months Post-randomization | 12 Months Post-randomization | 18 Months Post-randomization |
---|
Ixazomib Maintenance | 4.8 | 4.8 | 4.8 |
,Placebo | 0.0 | 0.0 | 0.2 |
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Percentage of Participants With Acute GVHD (Grades III-IV)
Cumulative incidences of grade III-IV acute GVHD were determined using the Aalen-Johansen estimator. Death prior to acute GVHD is treated as the competing risk. Cumulative incidences are compared between treatment arms using Gray's test. Grading of acute GVHD was derived by consensus grading per BMT Clinical Trials Network (CTN) 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. Grade I aGVHD is defined as Skin stage of 1-2 and stage 0 for both GI and liver organs. Grade II aGVHD is stage 3 of skin, or stage 1 of GI, or stage 1 of liver. Grade III is stage 2-4 for GI, or stage 2-3 of liver. Grade IV is stage 4 of skin, or stage 4 of liver. Grade 4 is the worst outcome. (NCT02440464)
Timeframe: 100 days post-randomization
Intervention | percentage of participants (Number) |
---|
Ixazomib Maintenance | 9.5 |
Placebo | 0.0 |
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Percentage of Participants With Chronic GVHD
Cumulative incidences of chronic GVHD were determined using the Aalen-Johansen estimator. Death prior to chronic GVHD is treated as the competing risk. Cumulative incidences are compared between treatment arms using Gray's test. Data of chronic GVHD were collected from providers and chart review according to the recommendations of the 2014 NIH Consensus Criteria. Eight organs are scored on a 0-3 scale to reflect degree of chronic GVHD involvement; 3 indicates the worst symptom. Liver and pulmonary function test results and use of systemic therapy for treatment of chronic GVHD are also recorded. (NCT02440464)
Timeframe: 12 months and 21 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 12 Months Post-randomization | 21 Months Post-randomization |
---|
Ixazomib Maintenance | 68.6 | 68.6 |
,Placebo | 63.6 | 63.6 |
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Functional Assessment of Cancer Therapy (FACT) - Bone Marrow Transplant (BMT) Total Score
The FACT-BMT version 4.0 instrument is comprised of the Functional Assessment of Cancer Therapy - General (FACT-G), which evaluates the health-related quality of life (HQL) of patients receiving treatment for cancer, and the BMT Concerns module, that addresses disease and treatment-related questions specific to bone marrow transplant. This scale goes from 0 to 196 where higher scores indicate better functioning. The FACT-BMT Total, which has all items in the FACT-G and BMT modules, was used as the outcome measure. This self-reported questionnaire was completed at transplant, randomization, 6 months following the start of maintenance therapy (which corresponds to 6 months post-randomization), and 24 months post-transplant. Comparisons between treatment groups were performed prior to maintenance, 6 months post-randomization and at 24 months after transplant. Only English and Spanish speaking patients were eligible to participate in the quality of life component of this trial. (NCT02440464)
Timeframe: Randomization, 6-months post-randomization, 24 months post-transplant
Intervention | score on a scale (Median) |
---|
| Randomization | 6 Months Post-randomization | 24 Months Post-transplant | Change from Randomization to 6 Months Post-randomization | Change from Randomization to 24 Months Post-transplant |
---|
Ixazomib Maintenance | 100.0 | 121.4 | 121.5 | 5.0 | 12.6 |
,Placebo | 110.0 | 114.0 | 109.0 | 7.0 | 3.0 |
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Percentage of Participants With Toxicities Post-randomization by Time Point
Toxicities are graded using NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Higher grades correspond to worse symptoms with the minimum grade being a 0 and the maximum grade being a 5. The cumulative incidence of Grade ≥ 3 toxicity was estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Death from a cause other than toxicity was treated as a competing risk. Comparison of cumulative incidence between the two treatment arms was done using a Z test at fixed time points. (NCT02440464)
Timeframe: 6, 12 and 18 months post-randomization
Intervention | percentage of participants (Number) |
---|
| 6 Months Post-randomization | 12 Months Post-randomization | 18 Months Post-randomization |
---|
Ixazomib Maintenance | 57.1 | 61.9 | 61.9 |
,Placebo | 63.6 | 68.2 | 72.7 |
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Acute Graft-versus-Host Disease (GVHD)
Number of patients who develop acute graft-versus-host disease of any grade. (NCT02497404)
Timeframe: 2 years post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 13 |
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Disease Free Survival at 1 Year Post-transplant
Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 1 year post-transplant. (NCT02497404)
Timeframe: 1 year post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 18 |
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Overall Survival at 6 Months Post-transplant
Number of participants alive at 6 months post-transplant (NCT02497404)
Timeframe: 6 months post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 35 |
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Disease Free Survival at 6 Months Post-transplant
Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 6 months post-transplant (NCT02497404)
Timeframe: 6 months post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 25 |
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Graft Failure
Number of patients who experience graft failure, defined as the absence of neutrophil engraftment by Day +21 or a drop in the absolute neutrophil count to <0.3 cells/microL for five consecutive days occurring after initial neutrophil engraftment within the first 3 weeks post-transplantation. (NCT02497404)
Timeframe: 21 days post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 1 |
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High-Risk Extensive Chronic Graft-versus-Host-Disease
Number of patients who develop high-risk extensive chronic graft-versus-host disease. Extensive chronic GVHD is defined as generalized skin or multiple organ involvement. High risk chronic GVHD is defined as platelet count of less than 100k/microL (NCT02497404)
Timeframe: 2 years post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 2 |
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Overall Survival at 1 Year Post-Transplant
Number of participants alive at 1 year post-transplant (NCT02497404)
Timeframe: 1 year post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 25 |
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Overall Survival at 2 Years Post-Transplant
Number of participants alive at 2 years post-transplant (NCT02497404)
Timeframe: 2 years post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 15 |
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Disease Free Survival at 2 Years Post-transplant
Number of participants without evidence of progression of underlying malignancy for which the transplant was performed, assessed at 2 years post-transplant. (NCT02497404)
Timeframe: 2 years post-transplant
Intervention | Participants (Count of Participants) |
---|
5 Azacytidine | 13 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Graft Rejection
Measurement of donor cells vs. recipient cells (NCT02581007)
Timeframe: 100 days
Intervention | Participants (Count of Participants) |
---|
Reduced-Intensity Mismatched Transplant | 3 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher 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. (NCT02614560)
Timeframe: Approximately 1 year
Intervention | Participants (Count of Participants) |
---|
| Any chemistry test | Amylase (iu/l) | Alanine aminotransferase (iu/l) | Aspartate aminotransferase (iu/l) | Total bilirubin (mg/dl) | Uric acid (mg/dl) | Lipase (iu/l) | Sodium (meq/l) | Any hematology test | Hemoglobin (g/dl) | Lymphocytes (x10^3/ul) | Neutrophils (x10^3/ul) | Platlets (x10^3/ul) | White blood cell count (x10^3/ul) |
---|
Post-allo (After Stem Cell Transplant) | 3 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 5 | 0 | 1 | 4 | 4 | 5 |
,Pre-allo (Before Stem Cell Transplant) | 4 | 3 | 1 | 1 | 3 | 1 | 0 | 0 | 6 | 3 | 6 | 6 | 6 | 6 |
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Rate of MRD Negativity
Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only) (NCT02614560)
Timeframe: 30 days
Intervention | Percentage of participants (Number) |
---|
| Day -1 Rate of MRD Negativity | Day 30 Rate of MRD Negativity |
---|
Pre-allo (Before Stem Cell Transplant) | NA | 75 |
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Best Response of CR or CRi
Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission) (NCT02614560)
Timeframe: 9 weeks
Intervention | Participants (Count of Participants) |
---|
Pre-allo (Before Stem Cell Transplant) | 4 |
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Duration of Response
Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause. (NCT02614560)
Timeframe: 9 weeks
Intervention | weeks (Median) |
---|
Pre-allo (Before Stem Cell Transplant) | 6.57 |
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Overall Survival
Defined as the time from the day of alloSCT to the date of death due to any cause. (NCT02614560)
Timeframe: Approximately 96 weeks
Intervention | weeks (Median) |
---|
Pre-allo (Before Stem Cell Transplant) | 11.07 |
Post-allo (After Stem Cell Transplant) | NA |
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Incidence of Adverse Events
AE: Adverse events; TEAE: Treatment-emergent adverse event. 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. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant. (NCT02614560)
Timeframe: Approximately 1 year
Intervention | Participants (Count of Participants) |
---|
| TEAEs | AEs Related to Vadatuximab Talirine | AEs Leading to Treatment Discontinuation | Grade 3 or Higher TEAEs | Serious AEs |
---|
Post-allo (After Stem Cell Transplant) | 8 | 7 | 1 | 6 | 2 |
,Pre-allo (Before Stem Cell Transplant) | 6 | 6 | 0 | 6 | 5 |
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1-year Survival Rate
1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT. (NCT02614560)
Timeframe: 12 months
Intervention | percentage of participants (Number) |
---|
Pre-allo (Before Stem Cell Transplant) | 0 |
Post-allo (After Stem Cell Transplant) | 75 |
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Clinical Response to Crenolanib With Standard Salvage Chemotherapy
To determine the response rate to crenolanib. Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L. CRi response included all CR criteria met, except participant did not have either platelet recovery or ANC recovery. CRh response included all CR criteria met, except subject only has partial platelet recovery and ANC recovery. Complete CR (CRc) response includes all subjects who achieve a CR, CRi and CRh. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but >5%. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy. (NCT02626338)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
| Composite complete remission (CR+CRh+CRi) | MLFS | Clinical benefit (CRc+PR+MLFS) |
---|
All Subjects | 7 | 3 | 7 |
,Arm A: HAM Chemotherapy | 3 | 2 | 3 |
,Arm B: FLAG-Ida Chemotherapy | 4 | 0 | 4 |
,Arm C: MEC Chemotherapy | 0 | 1 | 0 |
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Liposome-encapsulated Cytarabine Time of Maximum Concentration
Median liposome-encapsulated cytarabine time of maximum observed plasma concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | HOUR (Median) |
---|
Treatment (CPX-351 and FLAG) | 5 |
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Liposome-encapsulated Cytarabine Volume of Distribution
Geometric mean liposome-encapsulated cytarabine volume of distribution following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | MILLILITER (Geometric Mean) |
---|
Treatment (CPX-351 and FLAG) | 4158.0 |
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Liposome-encapsulated Daunorubicin Area Under the Curve
Geometric mean liposome-encapsulated daunorubicin area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | (NANOGRAM x HOUR) / MILLILITER (Geometric Mean) |
---|
Treatment (CPX-351 and FLAG) | 1288010.3 |
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Liposome-encapsulated Daunorubicin Clearance
Geometric mean liposome-encapsulated daunorubicin clearance following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | MILLILITER / HOUR (Geometric Mean) |
---|
Treatment (CPX-351 and FLAG) | 94.7 |
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Liposome-encapsulated Daunorubicin Volume of Distribution
Geometric mean liposome-encapsulated daunorubicin volume of distribution following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | MILLILITER (Geometric Mean) |
---|
Treatment (CPX-351 and FLAG) | 3827.7 |
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Number of Participants With a Dose-limiting Toxicity
Number of patients in the dose-finding phase with a dose-limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. (NCT02642965)
Timeframe: 28 days
Intervention | Participants (Count of Participants) |
---|
Treatment (CPX-351 and FLAG) | 1 |
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Percentage of Responders (Complete Response or Complete Remission With Partial or Incomplete Platelet Recovery) After First Cycle of Therapy
Response (complete response or complete remission with partial or incomplete platelet recovery) after first cycle of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated by the total of number of patients with complete response or complete remission with partial or incomplete platelet recovery divided by the number of patients evaluable for response after the first cycle. 95% confidence interval is determined using a binomial exact method. (NCT02642965)
Timeframe: Up to 4 weeks
Intervention | Percentage of responders (Number) |
---|
Treatment (CPX-351 and FLAG) | 75.68 |
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Percentage of Responders (Complete Response or Complete Remission With Partial Platelet Recovery) After up to 2 Cycles
Best response (complete response or complete remission with partial platelet recovery) after up to 2 cycles of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated using the methods of Jung and Kim. 90% confidence interval is determined using the methods of Koyama and Chen. (NCT02642965)
Timeframe: Up to 8 weeks
Intervention | Percantage of best responders (Number) |
---|
Treatment (CPX-351 and FLAG) | 68.30 |
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Liposome-encapsulated Daunorubicin Time of Maximum Concentration
Median liposome-encapsulated daunorubicin time of maximum observed plasma concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | HOUR (Median) |
---|
Treatment (CPX-351 and FLAG) | 2 |
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Liposome-encapsulated Cytarabine Area Under the Curve
Geometric mean liposome-encapsulated cytarabine area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | (NANOGRAM x HOUR) / MILLILITER (Geometric Mean) |
---|
Treatment (CPX-351 and FLAG) | 4418582.5 |
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Liposome-encapsulated Cytarabine Clearance
Geometric mean liposome-encapsulated cytarabine clearance following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1
Intervention | MILLILITER / HOUR (Geometric Mean) |
---|
Treatment (CPX-351 and FLAG) | 71.76 |
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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 |
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Overall Survival (OS)
(NCT02652468)
Timeframe: Median follow up of 1689 days
Intervention | days (Median) |
---|
Peripheral Blood Stem Cell Transplant | 352 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - GENDER
Patients who receive early transplant will be compared to those that don't using the Fisher's exact test for the categorical variables of gender. (NCT02756572)
Timeframe: From time of subject's study enrollment to time of subject's feasibility success assessment (i.e. when subject received transplant within 60 days or when it was determined subject would not proceed with transplant on study)
Intervention | Participants (Count of Participants) |
---|
| Female | Male |
---|
Did Not Receive Allogeneic HCT on Study | 10 | 11 |
,Received Allogeneic HCT on Study | 8 | 1 |
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Overall Survival (OS) Among Patients Who Received Early Transplant.
Overall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 100 days post-transplant
Intervention | Percentage of participants (Number) |
---|
Received Allogeneic HCT on Study | 91 |
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Relapse-free Survival (RFS) Among Patients Who Received Early Transplant
Relapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 6 months post-transplant
Intervention | Percentage of participants (Number) |
---|
Received Allogeneic HCT on Study | 82 |
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Relapse-free Survival (RFS) Among Patients Who Received Early Transplant
Relapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 100 days post-transplant
Intervention | Percentage of participants (Number) |
---|
Received Allogeneic HCT on Study | 91 |
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Overall Survival (OS) Among Patients Who Received Early Transplant.
Overall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 6 months post-transplant
Intervention | Percentage of participants (Number) |
---|
Received Allogeneic HCT on Study | 82 |
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Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
Overall survival among patients who did not receive early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 6 months after induction day 1
Intervention | Percentage of participants (Number) |
---|
Did Not Receive Allogeneic HCT on Study | 62 |
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Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
Overall survival among patients who did not receive early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 100 days after induction day 1
Intervention | Percentage of participants (Number) |
---|
Did Not Receive Allogeneic HCT on Study | 75 |
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Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
The amount of returned patient-reported outcome questionnaires will be summarized for each collection timepoint using percent collection from surviving patients for PRO timepoints. (NCT02756572)
Timeframe: Up to 12 months post-HCT
Intervention | Participants (Count of Participants) |
---|
| Enrollment PROs returned | Post G-CLAM PROs returned | Pre-HCT PROs returned | 6 months post-HCT PROs returned | 12 months post-HCT PROs returned |
---|
Treatment (Chemotherapy, HCT) | 27 | 23 | 8 | 4 | 3 |
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Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - AGE
Patients who receive early transplant will be compared to those that don't using the Wilcoxon rank sum test for the quantitative variable of age. (NCT02756572)
Timeframe: From time of subject's study enrollment to time of subject's feasibility success assessment (i.e. when subject received transplant within 60 days or when it was determined subject would not proceed with transplant on study)
Intervention | years (Median) |
---|
Received Allogeneic HCT on Study | 55 |
Did Not Receive Allogeneic HCT on Study | 57 |
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Event-free Survival (EFS) Among Patients Who Received Early Transplant
Event-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease. (NCT02756572)
Timeframe: Up to 6 months post-transplant
Intervention | Percentage of participants (Number) |
---|
Received Allogeneic HCT on Study | 82 |
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Event-free Survival (EFS) Among Patients Who Received Early Transplant
Event-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease. (NCT02756572)
Timeframe: Up to 100 days post-transplant
Intervention | Percentage of participants (Number) |
---|
Received Allogeneic HCT on Study | 91 |
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Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant
Success will be defined as observing a 40% of higher 6-month relapse-free survival among patients who received early transplant on study. (NCT02756572)
Timeframe: 6 months after early allogeneic HCT on study
Intervention | Participants (Count of Participants) |
---|
| No relapse within 6 months post-HCT (feasibility success) | Relapse within 6 months post-HCT (feasibility failure) |
---|
Received Early Allogeneic HCT on Study | 6 | 2 |
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Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant
Success will be defined as enrollment of at least 30 patients with transplants occurring in 15 of these 30 (50%) within 60 days of enrollment or start of induction chemotherapy with G-CLAM, whichever is earlier. (NCT02756572)
Timeframe: Up to 60 days after start of chemotherapy
Intervention | Participants (Count of Participants) |
---|
| Received allogeneic HCT on study within 60 days (feasibility success) | Did not receive allogeneic HCT on study within 60 days (feasibility failure) |
---|
Treatment (Chemotherapy, HCT) | 9 | 21 |
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Acute Graft Versus Host Disease Among Patients Who Received Early Transplant
Acute graft versus host disease (graded II, III, or IV) among patients who received early allogeneic HCT on study. (NCT02756572)
Timeframe: At day 100
Intervention | Participants (Count of Participants) |
---|
Received Allogeneic HCT on Study | 0 |
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Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
"Complete Remission (CR), defined as <5% blasts in bone marrow with hematologic recovery (ANC>1000/ul and platelets >100,000/ml).~CRi, defined as complete remission with insufficient hematologic recovery (ANC<1000/ul or platelets<100,000/ul).~CRp, defined as complete remission but platelets <100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria.~Morphologic leukemia-free state (MLFS), defined as <5% blasts in bone marrow with no hematologic recovery.~Relapse, defined as >5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease." (NCT02756572)
Timeframe: Approximately 84 days after early allogeneic HCT
Intervention | Participants (Count of Participants) |
---|
| CR with MRD | CR without MRD | CRi with MRD | CRi without MRD | MLFS with MRD | MLFS without MRD | Relapse |
---|
Received Allogeneic HCT on Study | 0 | 4 | 0 | 2 | 0 | 0 | 2 |
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Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
"Complete Remission (CR), defined as <5% blasts in bone marrow with hematologic recovery (ANC>1000/ul and platelets >100,000/ml).~CRi, defined as complete remission with insufficient hematologic recovery (ANC<1000/ul or platelets<100,000/ul).~CRp, defined as complete remission but platelets <100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria.~Morphologic leukemia-free state (MLFS), defined as <5% blasts in bone marrow with no hematologic recovery.~Relapse, defined as >5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease." (NCT02756572)
Timeframe: Approximately 28 days after early allogeneic HCT
Intervention | Participants (Count of Participants) |
---|
| CR with MRD | CR without MRD | CRi with MRD | CRi without MRD | MLFS with MRD | MLFS without MRD | Relapse |
---|
Received Allogeneic HCT on Study | 0 | 7 | 0 | 1 | 0 | 0 | 0 |
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Demonstrate the Feasibility of Collecting Resource Utilization Data for Trial Participants
The amount of days of hospitalization (the major driver of costs within the first year) will be collected for resource utilization. (NCT02756572)
Timeframe: Within the first year of induction chemotherapy on study
Intervention | days (Median) |
---|
Treatment (Chemotherapy, HCT) | 49 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Number of Patients With 2-year Relapse Risk
Hypothesis is that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse risk will decrease to ≤35% (NCT02771197)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
Lymphodepletion Plus Pembrolizumab | 10 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response)
Complete response or complete response with incomplete count recovery or partial response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study (NCT03071276)
Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)
Intervention | percentage of participants (Number) |
---|
Interventions: Selinexor, Fludarabine, and Cytarabine | 53.6 |
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Complete Response
Complete response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study (NCT03071276)
Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)
Intervention | percentage of participants (Number) |
---|
Interventions: Selinexor, Fludarabine, and Cytarabine | 46.4 |
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Complete Response or Complete Response With Incomplete Count Recovery
Complete response or complete response with incomplete count recovery, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study (NCT03071276)
Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)
Intervention | percentage of participants (Number) |
---|
Interventions: Selinexor, Fludarabine, and Cytarabine | 50.0 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Complete Remission (CR)
Complete disappearance of all clinical evidence of disease (NCT03504410)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
CPI-613 + HD Cytarabine and Mitoxantrone | 20 |
Control (HAM) and Control Sub-groups (MEC and FLAG) | 22 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Elimination Half-life of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
Median (Range) of the elimination half-life of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days
Intervention | Hour (Median) |
---|
Stratum 1 With 20 mg/m^2 | 4.7 |
PK With 20 mg/m^2 | 5.5 |
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Maximum Time to Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
Median (Range) of the maximum time to concentration of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days
Intervention | Hour (Median) |
---|
Stratum 1 With 20 mg/m^2 | 1.2 |
PK With 20 mg/m^2 | 1.1 |
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Total Plasma Clearance of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
Median (Range) of the total plasma clearance of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days
Intervention | L/h/m^2 (Median) |
---|
Stratum 1 With 20 mg/m^2 | 20.1 |
PK With 20 mg/m^2 | 19.2 |
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Maximum Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
Median (Range) of the maximum concentration of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days
Intervention | ng/mL (Median) |
---|
Stratum 1 With 20 mg/m^2 | 248.5 |
PK With 20 mg/m^2 | 213 |
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Number of Participants With Adverse Events Attributable to MLN4924 (Pevonedistat)
Frequency of patients with at least one grade 3 adverse event at least possibly attributable to MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level. (NCT03813147)
Timeframe: Up to 70 days
Intervention | Participants (Count of Participants) |
---|
Stratum 1 With 20 mg/m^2 | 6 |
PK With 20 mg/m^2 | 6 |
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Number of Participants With Antitumor Activity of MLN4924 (Pevonedistat)
Frequency of participants with best overall response by dose level of PR or CR for MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction Per Response Evaluation Criteria for CR (M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (ANC > 1000/uL and platelet count > 100,000/uL), CRp (M1 bone marrow (< 5% blasts) and no evidence of circulating blasts or extramedullary disease and with recovery of ANC > 1000/uL and platelet transfusion independence), CRi (M1 bone marrow (<5% blasts) and no evidence of circulating blasts or extramedullary disease and with ANC < 1000/uL or platelet count < 100,000/uL without platelet transfusion independence), or PR (M2 marrow status (> 5% or < 25% blasts cells) and at least 50% decrease in bone marrow blast percent from baseline. (NCT03813147)
Timeframe: Up to 1 year
Intervention | Participants (Count of Participants) |
---|
Stratum 1 With 20 mg/m^2 | 1 |
PK With 20 mg/m^2 | 2 |
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Number of Participants With Dose Limiting Toxicities of MLN4924 (Pevonedistat)
Frequency of patients with dose limiting toxicity in the first cycle of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level among patients in the dose escalation cohort. (NCT03813147)
Timeframe: Up to 35 days
Intervention | Participants (Count of Participants) |
---|
Stratum 1 With 20 mg/m^2 | 1 |
PK With 20 mg/m^2 | 2 |
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Area Under the Plasma Concentration Versus Time Curve of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
Median (Range) of the area under the plasma concentration versus time curve of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days
Intervention | hr*ng/mL (Median) |
---|
Stratum 1 With 20 mg/m^2 | 1004.9 |
PK With 20 mg/m^2 | 1047.4 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Progression Free Survival (PFS)
Kaplan-Meier curve will be generated for PFS. (NCT04339101)
Timeframe: From the date of stem cell infusion to the date of death, disease relapse/progression, or last follow-up, whichever occurs first, assessed at 1 year post transplant
Intervention | percentage of probability (Number) |
---|
Treatment (Itacitinib Adipate, Tacrolimus, Sirolimus) | 70 |
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Cumulative Incidence of Grade II-IV Acute GVHD
Acute GVHD will be graded and staged according to the Consensus Grading. (NCT04339101)
Timeframe: From day 0 (date of stem cell infusion) through 100 days post-transplant
Intervention | percentage of probability (Number) |
---|
Treatment (Itacitinib Adipate, Tacrolimus, Sirolimus) | 4 |
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Graft-versus-host Disease Free Relapse Free (GRFS) at 1 Year
GRFS is defined as time from the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first. Kaplan-Meier curve will be generated for GRFS. (NCT04339101)
Timeframe: From the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first, assessed at 1 year post transplant.
Intervention | percentage of probability (Number) |
---|
Treatment (Itacitinib Adipate, Tacrolimus, Sirolimus) | 56 |
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Proportion of Failure of the Haplo-Graft
Proportion of patients with a failed haplo-graft, defined as the absence of neutrophil engraftment by Day +21 or a drop in the absolute neutrophil count to <0.3 cells/microL for five consecutive days occurring after initial neutrophil engraftment within the first 3 weeks post-transplantation (second nadir) (NCT04395222)
Timeframe: 21 days post-transplant
Intervention | Participants (Count of Participants) |
---|
ATG Group I | 2 |
ATG Group II | 5 |
ATG Group III | 1 |
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Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment
"This is defined as:~Achieve an absolute neutrophil count (ANC) of 500 cells/microL for three consecutive days with the first on or prior to Day +21 post-transplant, AND~Absence of a second nadir - a drop in the ANC to <300 cells/microL for five consecutive days - after initial neutrophil recovery." (NCT04395222)
Timeframe: 21 days post-transplant
Intervention | percentage of participants (Number) |
---|
ATG Group I | 80 |
ATG Group II | 50 |
ATG Group III | 0 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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