| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Phase I/II Pilot Study of Ifosfamide, Carboplatin and Etoposide Therapy (ICE) and SGN-30 (NSC# 731636, IND#) in Children With CD30+ Recurrent Anaplastic Large Cell Lymphoma [NCT00354107] | Phase 1/Phase 2 | 5 participants (Actual) | Interventional | 2007-01-31 | Terminated |
| Single Centre, Subject and Observer Blinded, Placebo Controlled, Cross-over Study of the Effect of Oral Ibuprofen and Topical Hydrocortisone-21-acetate on Ultraviolet Radiation (UVR) Induced Pain and Inflammation in Healthy Volunteers [NCT01055249] | Phase 1 | 24 participants (Anticipated) | Interventional | 2010-01-31 | Completed |
| Monocentric, Double-blind Placebo-Controlled, Randomized Cross-Sectional Clinical Trial of Hydrocortisone (10 and 30 mg/d) in Outpatients With Posttraumatic-Stress-Disorder (PTSD) [NCT01108146] | | 30 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Imaging Corticotrophin-releasing Factor (CRF) X Nociceptive Opioid Peptide (NOP) Interactions in Cocaine Use Disorders (Aim 1) [NCT05008146] | Early Phase 1 | 80 participants (Anticipated) | Interventional | 2020-12-31 | Recruiting |
| The Role of Stress Neuromodulators in Decision Making Under Risk [NCT04359147] | | 167 participants (Actual) | Interventional | 2019-11-01 | Completed |
| 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 |
| Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia [NCT02096510] | Phase 1/Phase 2 | 10 participants (Anticipated) | Interventional | 2014-08-31 | Recruiting |
| Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. [NCT01941589] | Phase 4 | 149 participants (Actual) | Interventional | 2013-09-30 | Completed |
| A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse [NCT04546399] | Phase 2 | 550 participants (Anticipated) | Interventional | 2020-12-04 | Suspended(stopped due to Other - FDA Partial Clinical Hold) |
| Assessment of Application Order When Utilizing Locoid Lotion and Hylatopic Plus Cream in the Treatment of Atopic Dermatitis [NCT02153762] | | 41 participants (Actual) | Interventional | 2013-04-30 | Completed |
| A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma [NCT02043587] | Phase 2 | 31 participants (Actual) | Interventional | 2014-01-31 | Terminated(stopped due to Original investigator for the trial has left) |
| Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months) [NCT00096135] | | 168 participants (Actual) | Interventional | 2004-11-30 | Completed |
| A Multi-center, Randomized, Placebo-controlled, Double-blind, Adaptive Clinical Trial of Vitamin C, Thiamine and Steroids as Combination Therapy in Patients With Sepsis. [NCT03509350] | Phase 3 | 501 participants (Actual) | Interventional | 2018-08-22 | Completed |
| Phase IV Study to Evaluate the Neuropsychological Effects of Hydrocortisone Substitution in Patients With Partial Adrenal Insufficiency After Traumatic Brain Injury or Subarachnoidal Haemorrhage [NCT01089075] | Phase 4 | 32 participants (Actual) | Interventional | 2010-02-28 | Terminated(stopped due to Insufficient recruitment of suitable patients.) |
| A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations [NCT04293562] | Phase 3 | 1,400 participants (Anticipated) | Interventional | 2020-07-21 | Recruiting |
| Effectiveness Evaluation of Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Early Esophageal Cancer Invading More Than 2/3 Esophageal Perimeter [NCT03165344] | | 66 participants (Actual) | Interventional | 2017-02-10 | Completed |
| A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients With MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen [NCT02481310] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2015-10-28 | Active, not recruiting |
| Effect of Modified-release Compared to Conventional Hydrocortisone on Fatigue, Measured by Ecological Momentary Assessments; a Pilot Study. [NCT02282150] | Phase 4 | 30 participants (Anticipated) | Interventional | 2016-10-31 | Enrolling by invitation |
| Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone [NCT05716607] | | 16 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
| Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial [NCT03358082] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2017-10-01 | Recruiting |
| Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions [NCT02230930] | Phase 2 | 20 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
| A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy) [NCT02112916] | Phase 3 | 847 participants (Actual) | Interventional | 2014-10-04 | Active, not recruiting |
| International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147] | Phase 3 | 475 participants (Anticipated) | Interventional | 2017-08-08 | Recruiting |
| Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) [NCT02101853] | Phase 3 | 669 participants (Actual) | Interventional | 2014-12-17 | Active, not recruiting |
| Single-center, Double-masked, Placebo-controlled Parallel-group Study of Pregnancy-related Hormones Estradiol and Medroxyprogesterone, in Conjunction With Hydrocortisone and Growth Hormone to Stimulate C-peptide Secretion in Women With T1DM [NCT01265017] | Phase 1 | 0 participants (Actual) | Interventional | 2012-07-31 | Withdrawn(stopped due to Insufficient funding) |
| Intensive Treatment For T-CELL Acute Lymphoblastic Leukemia and Advanced Stage Lymphoblastic Non-Hodgkin's Lymphoma: A Pediatric Oncology Group Phase III Study [NCT01230983] | Phase 3 | 573 participants (Actual) | Interventional | 1996-06-30 | Completed |
| Stress Hydrocortisone In Pediatric Septic Shock [NCT03401398] | Phase 3 | 1,032 participants (Anticipated) | Interventional | 2019-03-11 | Recruiting |
| Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial [NCT04301479] | Phase 3 | 140 participants (Anticipated) | Interventional | 2020-03-31 | Not yet recruiting |
| Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis (Steroids in Paediatric Sepsis, StePS) - a Randomised Pilot Study [NCT00732277] | Phase 2 | 21 participants (Actual) | Interventional | 2008-04-30 | Completed |
| ASSESSMENT OF ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS USING CONCENTRATION OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL [NCT02859584] | | 111 participants (Actual) | Interventional | 2011-08-31 | Completed |
| A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC) [NCT03110198] | Phase 4 | 528 participants (Anticipated) | Interventional | 2017-05-31 | Recruiting |
| The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression [NCT02837432] | Early Phase 1 | 192 participants (Actual) | Interventional | 2016-07-31 | Completed |
| Open Label Randomised 3 Period Crossover Study to Evaluate Bioavailability of Modified Release Hydrocortisone (HC) Under Fasting & Fed Conditions & Immediate Release HC Tablets Under Fasting Conditions in Dexamethasone-suppressed Subjects [NCT02408068] | Phase 1 | 18 participants (Actual) | Interventional | 2015-01-31 | Completed |
| The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes [NCT02575001] | | 207 participants (Actual) | Observational | 2015-07-31 | Completed |
| A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer [NCT06136598] | Phase 1 | 14 participants (Anticipated) | Interventional | 2023-12-25 | Not yet recruiting |
| Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome [NCT05919121] | | 60 participants (Anticipated) | Interventional | 2023-05-01 | Recruiting |
| A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL) [NCT00098839] | Phase 1/Phase 2 | 134 participants (Actual) | Interventional | 2005-02-28 | Completed |
| A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811] | Phase 2 | 97 participants (Actual) | Interventional | 2004-06-30 | Completed |
| Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia [NCT02735707] | Phase 3 | 10,000 participants (Anticipated) | Interventional | 2016-04-11 | Recruiting |
| Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL) [NCT00900445] | | 0 participants (Actual) | Observational | 2008-03-24 | Withdrawn |
| A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy f [NCT00027859] | Phase 3 | 0 participants | Interventional | 2003-10-08 | Completed |
| A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids [NCT02689856] | Phase 2 | 211 participants (Actual) | Interventional | 2015-05-31 | Completed |
| A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis [NCT05324618] | Phase 4 | 200 participants (Actual) | Interventional | 2022-05-15 | Completed |
| Randomized, Open Label, Crossover Study Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Administered as a Suppository With the Sephure® Rectal Suppository Applicator Compared With Cortenema in Healthy Subjects [NCT02671058] | Phase 1 | 16 participants (Actual) | Interventional | 2016-03-31 | Completed |
| A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT00873093] | Phase 2 | 148 participants (Actual) | Interventional | 2009-03-31 | Completed |
| An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock [NCT00842933] | Phase 4 | 32 participants (Anticipated) | Interventional | 2007-05-31 | Terminated(stopped due to Unable to meet enrollment goal prior to PI transfer) |
| DFCI ALL Adult Consortium Protocol: Adult ALL Trial [NCT01005758] | Phase 2 | 180 participants (Anticipated) | Interventional | 2009-01-31 | Not yet recruiting |
| A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410] | Phase 3 | 1,875 participants (Anticipated) | Interventional | 2023-05-11 | Recruiting |
| A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625] | Phase 3 | 6,720 participants (Anticipated) | Interventional | 2019-07-03 | Recruiting |
| A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia [NCT05063994] | Phase 3 | 150 participants (Anticipated) | Interventional | 2021-12-13 | Active, not recruiting |
| Hair Cortisol and the Risk of Acute Myocardial Infarction [NCT00682487] | | 120 participants (Actual) | Observational | 2008-06-30 | Completed |
| Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient. [NCT04117919] | Phase 2 | 30 participants (Anticipated) | Interventional | 2019-10-05 | Recruiting |
| RESCUE - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency; A Multicentre, Randomised, Double Blinded, Placebo-controlled Clinical Trial on Health-related Quality of Life in Patients With Polymyalgia Rheumat [NCT05435781] | Phase 4 | 250 participants (Anticipated) | Interventional | 2022-06-07 | Recruiting |
| A Double Blind, Multicentre, Randomised, Parallel Group Study to Demonstrate the Equivalence of the Response to Vaccination of a Tacrolimus Ointment Regimen to a Steroid Ointment Regimen in Children With Moderate to Severe Atopic Dermatitis [NCT00801957] | Phase 2 | 260 participants (Actual) | Interventional | 2003-03-31 | Completed |
| Double Blinded, Randomized Trial, Comparing Intravenous Bolus of 50 mg of Hydrocortisone Every 6 Hours for 7 Days With a Continuous Infusion of 300 mg Per Day of Hydrocortisone 300-mg Group During 5 Days in the Treatment of Septic Shock. [NCT02768740] | Phase 4 | 120 participants (Actual) | Interventional | 2008-04-30 | Completed |
| A Phase I Study Evaluating the Safety, Tolerability and Biological Activity of EZN-3042, a Survivin mRNA Antagonist, Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) [NCT01186328] | Phase 1 | 6 participants (Actual) | Interventional | 2010-08-24 | Terminated(stopped due to Enzon Pharmaceuticals decided to end its development of EZN-3042.) |
| A Phase I, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability Profile of Topical Cream SNG100 for 14 Days of Treatment in Moderate Atopic Dermatitis Subjects. [NCT04615962] | Phase 1 | 66 participants (Anticipated) | Interventional | 2021-01-01 | Not yet recruiting |
| Interval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal Hyperplasia [NCT03718234] | Phase 1 | 11 participants (Actual) | Interventional | 2019-01-01 | Completed |
| Randomized, Placebo-Controlled Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids vs. Low-Potency Corticosteroid Mono-therapy [NCT00871208] | Phase 4 | 0 participants (Actual) | Interventional | 2009-05-31 | Withdrawn(stopped due to Funding withdrawn) |
| Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia [NCT01014364] | Phase 3 | 40 participants (Actual) | Interventional | 2010-03-31 | Terminated(stopped due to the H1N1 pandemic is now over, and fewer cases than expected were observed) |
| Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109] | Phase 2/Phase 3 | 63 participants (Actual) | Interventional | 2008-07-14 | Completed |
| Glucocorticoid Treatment in Addison's Disease [NCT01063569] | Phase 2/Phase 3 | 33 participants (Actual) | Interventional | 2010-02-28 | Completed |
| Phase II Trial to Assess the Activity of Ketoconazole Plus Lenalidomide in Patients With Prostate Cancer Progressive After Androgen Deprivation [NCT00460031] | Phase 2 | 34 participants (Actual) | Interventional | 2006-09-01 | Completed |
| Effect of Estrogen on the Stress Response for Postmenopausal Women [NCT00220454] | Phase 2 | 40 participants | Interventional | 2002-12-31 | Completed |
| Withholding Hydrocortisone vs Routine Use of Hydrocortisone During Peri-operation in Pituitary Adenoma Patients With Intact Hypothalamus-Pituitary-Adrenal Axis: Randomized Controlled Trial to Assess Safety and Complications [NCT04621565] | | 436 participants (Anticipated) | Interventional | 2020-11-01 | Recruiting |
| [NCT01608945] | | 60 participants (Actual) | Observational | 2008-04-30 | Suspended |
| Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis [NCT00693693] | Phase 4 | 26 participants (Actual) | Interventional | 2006-11-30 | Completed |
| A Phase I/II Study of Oral Calcitriol in Combination With Ketoconazole in Androgen Independent Prostate Cancer [NCT00536991] | Phase 1/Phase 2 | 51 participants (Actual) | Interventional | 2006-10-31 | Terminated(stopped due to difficult to recruit) |
| 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 I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for Children, Adolescents and Young Adults With High-Risk Hematologic Malignancies [NCT05292664] | Phase 1 | 92 participants (Anticipated) | Interventional | 2023-03-29 | Recruiting |
| A Phase 1 Study Of Palbociclib (IND#141416), A CDK 4/6 Inhibitor, In Combination With Chemotherapy In Children With Relapsed Acute Lymphoblastic Leukemia (ALL) Or Lymphoblastic Lymphoma (LL) [NCT03792256] | Phase 1 | 15 participants (Anticipated) | Interventional | 2019-04-11 | Active, not recruiting |
| Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression [NCT00673270] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 2008-05-31 | Terminated |
| A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation [NCT00694408] | Phase 3 | 15 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to Study terminated due to withdrawal from market of Daclizumab) |
| Gleevec (Imatinib) Plus Multi-Agent Chemotherapy For Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia [NCT00618501] | Phase 2 | 50 participants (Anticipated) | Interventional | 2005-10-31 | Completed |
| Treatment of Acute Lymphoblastic Leukemia in Children [NCT00400946] | Phase 3 | 800 participants (Actual) | Interventional | 2005-04-30 | Completed |
| International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia [NCT00550992] | | 445 participants (Anticipated) | Interventional | 2006-01-31 | Recruiting |
| A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement [NCT02828358] | Phase 2 | 78 participants (Actual) | Interventional | 2017-04-01 | Active, not recruiting |
| A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193] | Phase 3 | 218 participants (Actual) | Interventional | 2008-01-15 | Active, not recruiting |
| Early Prevention of Broncho-pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone: a Randomized Controlled Trial [NCT00623740] | Phase 3 | 523 participants (Actual) | Interventional | 2008-04-30 | Completed |
| 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) |
| Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer [NCT00559481] | | 0 participants (Actual) | Interventional | 2007-10-31 | Withdrawn(stopped due to Withdrawn due to low accrual) |
| An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hy [NCT03532022] | Phase 3 | 0 participants (Actual) | Interventional | 2018-10-04 | Withdrawn(stopped due to Protocol re-design required following EU Phase III results) |
| The Effects of Epinephrine and Cortisol on Emotion in Depression [NCT04148261] | Early Phase 1 | 0 participants (Actual) | Interventional | 2020-12-31 | Withdrawn(stopped due to Principal Investigator left lab before study start) |
| A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4) [NCT00002700] | Phase 3 | 392 participants (Anticipated) | Interventional | 1995-08-31 | Completed |
| A PHASE III TWO-ARM RANDOMIZED STUDY COMPARING ANTIANDROGEN WITHDRAWAL ALONE VERSUS ANTIANDROGEN WITHDRAWAL COMBINED WITH KETOCONAZOLE AND HYDROCORTISON IN PATIENTS WITH ADVANCED PROSTAGE CANCER [NCT00002760] | Phase 3 | 260 participants (Actual) | Interventional | 1996-08-31 | Completed |
| A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies-POG/CCG Intergroup Study [NCT00002970] | Phase 2 | 148 participants (Actual) | Interventional | 1997-06-30 | 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 |
| Hemophagocytic Lymphohistiocytosis [NCT00334672] | Phase 3 | 288 participants (Anticipated) | Interventional | 2006-03-31 | Active, not recruiting |
| Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery [NCT00490828] | Phase 4 | 120 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease [NCT00507832] | Phase 2 | 30 participants (Actual) | Interventional | 2007-04-30 | Completed |
| A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586] | Phase 3 | 244 participants (Anticipated) | Interventional | 2021-10-05 | Recruiting |
| The Safety of Proctofoam-HC in the Third Trimester of Pregnancy [NCT00405288] | | 408 participants (Actual) | Observational | 2006-11-30 | Completed |
| Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas [NCT00691002] | Phase 3 | 1,245 participants (Actual) | Interventional | 2008-05-31 | Completed |
| Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock [NCT00625209] | Phase 3 | 1,241 participants (Actual) | Interventional | 2008-03-31 | Completed |
| A, Randomised, Controlled, Two-armed, Two-period Cross-over, Multi-centre Phase II/III Study to Assess the Safety and Pharmacokinetics of Once-daily Oral Modified-release Hydrocortisone in Patients With Adrenal Insufficiency [NCT00915343] | Phase 2/Phase 3 | 64 participants (Actual) | Interventional | 2007-08-21 | Completed |
| Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia [NCT00002744] | Phase 3 | 1,970 participants (Actual) | Interventional | 1996-05-31 | Completed |
| Induction Intensification in Infant ALL: A Children's Oncology Group Study [NCT00002756] | Phase 2 | 221 participants (Actual) | Interventional | 1996-06-30 | Completed |
| "A Phase II Trial of Early Medical Adrenalectomy for D0.5 Prostate Cancer" [NCT00006371] | Phase 2 | 2 participants (Actual) | Interventional | 2000-05-31 | Terminated(stopped due to low accrual) |
| A Randomized Study of Two Methods of CNS Prophylaxis in Patients With Acute Lymphoblastic Leukemia [NCT00019409] | Phase 3 | 0 participants (Actual) | Interventional | 1999-10-31 | Withdrawn |
| Intensive Induction Therapy for Children With Acute Lymphoblastic Leukemia (ALL) Who Experience a Bone Marrow Relapse [NCT00049569] | | 126 participants (Anticipated) | Interventional | 2003-01-31 | Completed |
| The Effect of Glucocorticoid Pre-Treatment on the Systemic Cytokine Response to Endotoxin in Human Volunteers [NCT00396344] | | 36 participants (Anticipated) | Interventional | 2006-10-31 | Completed |
| Corticosteroid Therapy of Septic Shock - Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study [NCT00147004] | Phase 3 | 500 participants (Actual) | Interventional | 2002-03-31 | Completed |
| A Double-Blind, Double-Dummy, Two-Way Cross-Over, Randomised, Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® Versus Plenadren®, in Adrenal Insufficiency [NCT05222152] | Phase 2 | 67 participants (Anticipated) | Interventional | 2021-11-23 | Active, not recruiting |
| A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in the Treatment of Symptomatic Internal Hemorrhoids. [NCT03335774] | Phase 2 | 103 participants (Actual) | Interventional | 2019-02-12 | Completed |
| An Open-label, Single-arm, Single-center Study Evaluating the Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock [NCT06122987] | Phase 4 | 50 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache: a Randomized Double-blind Study [NCT02760862] | Phase 4 | 50 participants (Actual) | Interventional | 2014-10-31 | Completed |
| A Phase III Study of Efficacy, Safety and Tolerability of Chronocort® Compared With Standard Glucocorticoid Replacement Therapy in the Treatment of Congenital Adrenal Hyperplasia [NCT02716818] | Phase 3 | 122 participants (Actual) | Interventional | 2016-02-22 | Completed |
| An Open Label Pilot Study to Investigate the Effects of Two Preparations of Hydrocortisone (Hydrocortisone 100mg/ml and Solu-Cortef) Injected Intramuscularly Into the Deltoid and Upper Thigh Muscle During the State of Hypocortisolaemia [NCT05350020] | Phase 4 | 8 participants (Anticipated) | Interventional | 2022-03-14 | Recruiting |
| Phase II Trial to Assess the Activity of Ketoconazole Plus GM-CSF in Patients With Prostate Cancer Progressive After Androgen Deprivation [NCT00309894] | Phase 2 | 49 participants (Actual) | Interventional | 2004-04-30 | Completed |
| HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN [NCT00002494] | Phase 2 | 134 participants (Actual) | Interventional | 1992-05-31 | Completed |
| Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment [NCT03760835] | Phase 4 | 150 participants (Anticipated) | Interventional | 2016-08-11 | Recruiting |
| Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study. [NCT01817153] | Phase 2/Phase 3 | 10 participants (Actual) | Interventional | 2013-11-05 | Terminated(stopped due to not enough recruitment) |
| Continuous Subcutaneous Hydrocortisone Infusion In Addison's Disease and Type 1 Diabetes [NCT01840189] | Phase 2 | 2 participants (Actual) | Interventional | 2013-05-31 | Completed |
| A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma [NCT01700946] | Phase 2 | 80 participants (Actual) | Interventional | 2013-04-15 | Completed |
| FAB LMB 96 -- Treatment of Mature B-CELL Lymphoma/Leukemia: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study [NCT00002757] | Phase 3 | 1,148 participants (Actual) | Interventional | 2001-06-30 | Completed |
| A Phase I Trial of Temsirolimus (CCI-779, Pfizer, Inc.) in Combination With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma [NCT01614197] | Phase 1 | 16 participants (Actual) | Interventional | 2015-07-03 | Completed |
| Low-dose Cortisol in Chronic Posttraumatic Stress Disorder [NCT00362661] | | 20 participants (Anticipated) | Interventional | 2007-06-30 | Terminated(stopped due to Recruitment: Insufficient number of patients eligible for enrollment) |
| Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient [NCT00850720] | | 3 participants (Actual) | Observational | 2009-03-31 | Terminated(stopped due to Inability to recruit / logistic problems.) |
| TREATMENT OF ISOLATED CNS RELAPSE OF ACUTE LYMPHOBLASTIC LEUKEMIA -- A PEDIATRIC ONCOLOGY GROUP-WIDE PHASE II STUDY [NCT00002704] | Phase 2 | 156 participants (Actual) | Interventional | 1996-01-31 | Completed |
| Medical Research Council Working Party on Leukaemia in Childhood Acute Myeloid Leukaemia Trial 12 [NCT00003436] | Phase 3 | 2,000 participants (Anticipated) | Interventional | 1998-07-31 | Completed |
| A Phase 2, Open Label, Crossover Pharmacokinetic and Pharmacodynamic Study to Compare Chronocort Versus Cortef in Patients With CAH [NCT00519818] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2007-08-31 | Completed |
| ALL Adult Consortium Trial: Adult ALL Trial [NCT00476190] | Phase 2 | 112 participants (Anticipated) | Interventional | 2007-04-30 | Active, not recruiting |
| Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone [NCT05534334] | Phase 2/Phase 3 | 30 participants (Anticipated) | Interventional | 2022-05-01 | Recruiting |
| Randomized Controlled Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery [NCT01559675] | | 121 participants (Actual) | Interventional | 2010-09-30 | Completed |
| An Open Label, Partially Randomised, Single Dose, Crossover Study to Evaluate the PK, Oral Bioavailability and Relationship to Metabolic Parameters of Hydrocortisone and Infacort® in Healthy Adult Male Volunteers. [NCT01960530] | Phase 1 | 14 participants (Actual) | Interventional | 2013-10-31 | Completed |
| Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock [NCT00320099] | Phase 3 | 508 participants (Actual) | Interventional | 2006-01-31 | Completed |
| AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA [NCT00002552] | Phase 2 | 40 participants (Anticipated) | Interventional | 1993-10-31 | Completed |
| 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 |
| EXTRAMEDULLARY RELAPSE AND OCCULT BONE MARROW INVOLVEMENT IN CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA: A PHASE III GROUP-WIDE STUDY [NCT00002816] | Phase 3 | 120 participants (Anticipated) | Interventional | 1996-12-31 | Completed |
| Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Infants Less Than 1 Year of Age. [NCT00002785] | Phase 2 | 0 participants | Interventional | 1996-07-31 | Completed |
| The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenanc [NCT00003728] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 1998-12-31 | Active, not recruiting |
| PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER [NCT00002881] | Phase 3 | 0 participants | Interventional | 1996-10-31 | Completed |
| A Two-Part, Phase II Randomized Trial to Explore Topical Spironolactone to Prevent/Attenuate Rash From Epidermal Growth Factor Receptor Inhibitors (Panitumumab and Cetuximab) in Advanced Cancer Patients [NCT01867294] | Phase 2 | 19 participants (Actual) | Interventional | 2012-08-31 | Completed |
| Phase II Trial of Intensive, Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkin's Lymphoma [NCT00002471] | Phase 2 | 0 participants | Interventional | 1990-02-28 | Completed |
| Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II [NCT00002921] | Phase 2 | 13 participants (Actual) | Interventional | 1997-03-31 | Terminated(stopped due to Permanently Closed Due to Lack of Accrual) |
| HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome [NCT04591990] | Phase 3 | 380 participants (Anticipated) | Interventional | 2021-05-27 | Recruiting |
| Acute Myeloid Leukemia Salvage Therapy for Patients in First Relapse or Who Fail to Achieve an Initial Remission or Who Develop AML as a Second Malignant Neoplasm [NCT00002805] | Phase 2 | 115 participants (Actual) | Interventional | 1997-08-31 | Completed |
| HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN [NCT00002865] | Phase 2 | 25 participants (Actual) | Interventional | 1995-04-30 | Completed |
| The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts [NCT02084134] | | 43 participants (Actual) | Interventional | 2012-03-31 | Completed |
| A Phase II Study of Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children With Central Nervous System Atypical Teratoid/Rhabdoid Tumor (AT/RT) Tumor [NCT00084838] | Phase 2 | 25 participants (Actual) | Interventional | 2003-02-28 | Completed |
| Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency [NCT01450930] | Phase 2 | 12 participants (Actual) | Interventional | 2011-11-30 | Completed |
| Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies [NCT00185692] | Phase 2 | 16 participants (Actual) | Interventional | 2000-08-31 | Completed |
| 3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis [NCT04469686] | Phase 3 | 618 participants (Anticipated) | Interventional | 2020-12-10 | Recruiting |
| A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations [NCT02883049] | Phase 3 | 5,937 participants (Actual) | Interventional | 2012-02-29 | Active, not recruiting |
| A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intert [NCT00640822] | Phase 3 | 782 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement [NCT01782859] | | 40 participants (Actual) | Interventional | 2012-10-31 | Completed |
| A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy [NCT03959085] | Phase 3 | 4,772 participants (Anticipated) | Interventional | 2019-10-31 | Recruiting |
| A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia [NCT06124157] | Phase 3 | 680 participants (Anticipated) | Interventional | 2024-01-22 | Not yet recruiting |
| A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate [NCT00002855] | Phase 3 | 306 participants (Actual) | Interventional | 1996-08-31 | Completed |
| Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL) [NCT00003215] | Phase 3 | 400 participants (Anticipated) | Interventional | 1997-04-30 | Completed |
| Treatment of Children With Down Syndrome (DS) and Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Transient Myeloproliferative Disorder (TMD): A Phase III Group-Wide Study [NCT00003593] | Phase 3 | 254 participants (Actual) | Interventional | 1999-06-30 | Completed |
| Prospective Phase II Study of a High Dose, Short Course Regimen (R-CODOX-M/IVAC) Including CNS Penetration and Intensive IT Prophylaxis in HIV-Associated Burkitt's and Atypical Burkitt's Lymphoma [NCT00392834] | Phase 2 | 34 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Randomized, Controlled, Multi-Centre Trial on the Effects of Dual-release Hydrocortisone Preparations Versus Conventional Glucocorticoid Replacement Therapy in Patients Affected by Primary and Secondary Adrenal Insufficiency. DREAM Trial. [NCT02277587] | Phase 4 | 89 participants (Actual) | Interventional | 2014-03-31 | Completed |
| The Intra-Procedural Cortisol Assay During Adrenal Vein Sampling: Rationale andDesign of A Randomized Study (I-PADUA) [NCT03449797] | | 200 participants (Anticipated) | Interventional | 2018-04-01 | Not yet recruiting |
| International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma [NCT00006455] | Phase 3 | 885 participants (Actual) | Interventional | 1999-11-26 | Completed |
| Hormonal Mechanisms of Sleep Restriction [NCT02256865] | Early Phase 1 | 40 participants (Actual) | Interventional | 2014-10-31 | Completed |
| Difference in Mortality and Evolution in Septic Patients Treated With Vitamin C, Tiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone Treated at the ICU of General Hospital Zone 11 IMSS Piedras Negras Coahuila. [NCT04197115] | Phase 3 | 19 participants (Actual) | Interventional | 2019-09-01 | Completed |
| Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock [NCT03821714] | | 22 participants (Actual) | Interventional | 2019-02-01 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00057811 (4) [back to overview] | Response Rate |
| NCT00057811 (4) [back to overview] | Minimal Residual Disease |
| NCT00057811 (4) [back to overview] | Grade ≥ 3 Stomatitis |
| NCT00057811 (4) [back to overview] | Toxic Death |
| NCT00084838 (19) [back to overview] | Grade 3-4 Constitutional Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Cardiovascular Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Blood/Bone Marrow Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Auditory/Hearing Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Allergy/Immunology |
| NCT00084838 (19) [back to overview] | 2-yr Overall Survival |
| NCT00084838 (19) [back to overview] | Pre-Radiation Therapy Chemotherapeutic Response |
| NCT00084838 (19) [back to overview] | Grade 3/4 Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Renal/Genitourinary Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Pulmonary Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Pain Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Neurology Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Muscloskeletal Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Metabolic/Laboratory Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Infection/Febrile Neutropenia Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Hepatic Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Hemorrhage Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Gastrointestinal Events |
| NCT00084838 (19) [back to overview] | Grade 3-4 Dermatology Events |
| NCT00096135 (1) [back to overview] | Event-free Survival |
| NCT00098839 (4) [back to overview] | Event-free Survival Rate |
| NCT00098839 (4) [back to overview] | Pharmacokinetics |
| NCT00098839 (4) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% |
| NCT00098839 (4) [back to overview] | Remission Re-induction (CR2) Rate |
| NCT00185692 (2) [back to overview] | Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning |
| NCT00185692 (2) [back to overview] | Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant |
| NCT00354107 (1) [back to overview] | Response |
| NCT00392834 (1) [back to overview] | Overall Survival (OS) at 1 Year |
| NCT00400946 (10) [back to overview] | 5-Year Disease-Free Survival |
| NCT00400946 (10) [back to overview] | Post-Induction Nadir Serum Asparaginase Activity Level |
| NCT00400946 (10) [back to overview] | 5-Year Disease-Free Survival by Bone Marrow Day 18 Status |
| NCT00400946 (10) [back to overview] | 5-year Disease-Free Survival by CNS Directed Treatment Group |
| NCT00400946 (10) [back to overview] | 5-Year Disease-Free Survival by MRD Day 32 Status |
| NCT00400946 (10) [back to overview] | Asparaginase-Related Toxicity Rate |
| NCT00400946 (10) [back to overview] | Induction Infection Toxicity Rate |
| NCT00400946 (10) [back to overview] | Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate |
| NCT00400946 (10) [back to overview] | Induction Serum Asparaginase Activity Level |
| NCT00400946 (10) [back to overview] | Induction Therapeutic Nadir Serum Asparaginase Activity Rate |
| NCT00405288 (12) [back to overview] | Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth |
| NCT00405288 (12) [back to overview] | Fetal Distress |
| NCT00405288 (12) [back to overview] | Mode of Delivery |
| NCT00405288 (12) [back to overview] | Prematurity |
| NCT00405288 (12) [back to overview] | Respiratory Neonatal Health Concerns |
| NCT00405288 (12) [back to overview] | Skin Conditions in Neonatal Period |
| NCT00405288 (12) [back to overview] | Birth-weight |
| NCT00405288 (12) [back to overview] | Low Birth Weight at Birth |
| NCT00405288 (12) [back to overview] | Neonatal Health |
| NCT00405288 (12) [back to overview] | Neonatal Health Concerns-infections |
| NCT00405288 (12) [back to overview] | Other Neonatal Health Concerns |
| NCT00405288 (12) [back to overview] | Gestational Age at Delivery |
| NCT00460031 (5) [back to overview] | Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0 |
| NCT00460031 (5) [back to overview] | Time to Progression |
| NCT00460031 (5) [back to overview] | Change in Immune Response From Baseline |
| NCT00460031 (5) [back to overview] | Ratio of Change in Immune Response From Baseline |
| NCT00460031 (5) [back to overview] | Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease |
| NCT00519818 (2) [back to overview] | Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose). |
| NCT00519818 (2) [back to overview] | 17 Hydroxyprogesterone at 08.00 Hours |
| NCT00536991 (4) [back to overview] | Objective Tumor Response, Assessed by RECIST |
| NCT00536991 (4) [back to overview] | Incidence of Toxicity Graded According to the National Cancer Institute CTC Version 3.0 |
| NCT00536991 (4) [back to overview] | Determine the Maximum Tolerated Dose (MTD) |
| NCT00536991 (4) [back to overview] | PSA Response Rate |
| NCT00557193 (10) [back to overview] | Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2 |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2) |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm A |
| NCT00557193 (10) [back to overview] | Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT) |
| NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm |
| NCT00640822 (1) [back to overview] | Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 |
| NCT00691002 (5) [back to overview] | "Participants With Success According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase" |
| NCT00691002 (5) [back to overview] | "Participants With Success According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase" |
| NCT00691002 (5) [back to overview] | "Participants With Controlled Disease According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase" |
| NCT00691002 (5) [back to overview] | "Participants With Controlled Disease According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase" |
| NCT00691002 (5) [back to overview] | "Participants With Controlled Disease According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase" |
| NCT00693693 (1) [back to overview] | Adherence to Locoid |
| NCT00720109 (5) [back to overview] | Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib) |
| NCT00720109 (5) [back to overview] | Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation |
| NCT00720109 (5) [back to overview] | Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy |
| NCT00720109 (5) [back to overview] | Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy |
| NCT00720109 (5) [back to overview] | Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events |
| NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 |
| NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 |
| NCT00873093 (7) [back to overview] | Toxic Death Rate |
| NCT00873093 (7) [back to overview] | Severe Adverse Events (SAE) Rate. |
| NCT00873093 (7) [back to overview] | Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy |
| NCT00873093 (7) [back to overview] | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 |
| NCT00873093 (7) [back to overview] | Event Free Survival |
| NCT00915343 (40) [back to overview] | Percentage (%) of Participants With Change From Baseline in Patient Tolerability Questionnaire at Month 6, Assessed by Patient and Investigator - Part B |
| NCT00915343 (40) [back to overview] | Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Area Under the Concentration Time Curve From Zero to 24 Hours Adjusted by Dose (AUC0-24h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Change From Baseline to 6 Months in Diurnal Fatigue Questionnaire for Day Average- Part B |
| NCT00915343 (40) [back to overview] | Area Under the Concentration Time Curve From Zero to 4 Hours Adjusted by Dose (AUC0-4h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Area Under the Concentration Time Curve From Zero to 10 Hours Adjusted by Dose (AUC0-10h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Average Concentration of S-cortisol During the Dosing Interval at Steady State Adjusted by Dose (Css,av/Dose) in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Change From Baseline to 12 Weeks in Diurnal Fatigue Questionnaire for Day Average of Once Daily Therapy - Part A |
| NCT00915343 (40) [back to overview] | Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score - Part B |
| NCT00915343 (40) [back to overview] | Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores- Part B |
| NCT00915343 (40) [back to overview] | Comparison of Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score Between Once Daily and Thrice Daily Therapy - Part A |
| NCT00915343 (40) [back to overview] | Comparison of Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores Between Once Daily and Thrice Daily Therapy- Part A |
| NCT00915343 (40) [back to overview] | Comparison on 24-hour Urinary Free Cortisol Between Once Daily and Thrice Daily Therapy-Part A |
| NCT00915343 (40) [back to overview] | Comparison on Participant Compliance Between Once Daily and Thrice Daily Therapy - Part A |
| NCT00915343 (40) [back to overview] | Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Drug Concentration Half-Life From 5 to 14 Hours (t1/2[5-14h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Drug Concentration Half-Life From 5 to 24 Hours (t1/2[5-24h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | First Detectable Concentration Adjusted by Dose (Cfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Maximal Concentration Adjusted by Dose (Cmax1/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Participant Compliance- Part B |
| NCT00915343 (40) [back to overview] | Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A |
| NCT00915343 (40) [back to overview] | Accumulation Ratio (Rac) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Area Under the Concentration Time Curve During a Dosing Interval at Steady State (AUCtau) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Area Under the Concentration Time Curve During a Dosing Interval at Steady State Adjusted by Dose (AUCtau/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score - Part B |
| NCT00915343 (40) [back to overview] | Percentage (%) of Area Under the Concentration Time Curve (AUC) Extrapolation of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Percentage (%) of Fluctuation in Concentrations of S-cortisol at Steady State in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Time to First Detectable Concentration Adjusted by Dose (Tfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Time to Reach a Concentration of 200 Nanometers (nM) (T200) of S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Area Under the Concentration Time Curve (AUC) Between Specified Timepoints of Total S-cortisol in Plasma After Single and Multiple Dosing During Part A |
| NCT00915343 (40) [back to overview] | Comparison of Overall Patient Tolerability Score Between Once Daily and Thrice Daily Therapy, Assessed by Patient and Investigator - Part A |
| NCT00915343 (40) [back to overview] | Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score Between Once Daily and Thrice Daily Therapy- Part A |
| NCT00915343 (40) [back to overview] | Comparison on Participant Preference by Questionnaire Between Once Daily and Thrice Daily Therapy-Part A |
| NCT01559675 (1) [back to overview] | Orthostatic Hypotension |
| NCT01614197 (1) [back to overview] | Minimum Residual Disease (MRD) Levels Present at End of Cycle 1 Therapy in Patients |
| NCT01700946 (4) [back to overview] | 3-year Event-free Survival Rates in Patients With Relapsed ALL |
| NCT01700946 (4) [back to overview] | 3-year Overall Survival Rate of Patients With Relapsed ALL |
| NCT01700946 (4) [back to overview] | Median CD20 Expression Levels |
| NCT01700946 (4) [back to overview] | Mean of CD20 Expression Levels |
| NCT01782859 (4) [back to overview] | Serum Prothrombin Fragment 1 and 2 (PF 1.2) |
| NCT01782859 (4) [back to overview] | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) |
| NCT01782859 (4) [back to overview] | Pain at 3 Months Post-op |
| NCT01782859 (4) [back to overview] | Plasmin-a 2 Antiplasmin Complex (PAP) |
| NCT01867294 (4) [back to overview] | Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I) |
| NCT01867294 (4) [back to overview] | Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I) |
| NCT01867294 (4) [back to overview] | Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I) |
| NCT01867294 (4) [back to overview] | Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I) |
| NCT01960530 (6) [back to overview] | PK and Metabolism of Cortisol |
| NCT01960530 (6) [back to overview] | Maximum Serum Concentration (Cmax) |
| NCT01960530 (6) [back to overview] | Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone. |
| NCT01960530 (6) [back to overview] | Concentrations of Cortisol Binding Protein |
| NCT01960530 (6) [back to overview] | Adverse Events (AEs) |
| NCT01960530 (6) [back to overview] | AUC0-t |
| NCT02084134 (2) [back to overview] | Number of Participants With Adrenal Insufficiency |
| NCT02084134 (2) [back to overview] | Percentage of Patients Discharged on Glucocorticoids |
| NCT02101853 (4) [back to overview] | Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients |
| NCT02101853 (4) [back to overview] | Overall Survival (OS) of HR and IR Relapse Patients |
| NCT02101853 (4) [back to overview] | Overall Survival (OS) of LR Relapse Patients |
| NCT02101853 (4) [back to overview] | Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients |
| NCT02112916 (6) [back to overview] | Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients |
| NCT02112916 (6) [back to overview] | Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase |
| NCT02112916 (6) [back to overview] | Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) |
| NCT02112916 (6) [back to overview] | EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) |
| NCT02112916 (6) [back to overview] | EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 |
| NCT02112916 (6) [back to overview] | EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond |
| NCT02408068 (6) [back to overview] | Chronocort Cmax |
| NCT02408068 (6) [back to overview] | Comparison of Fed and Fasted Chronocort Tmax |
| NCT02408068 (6) [back to overview] | Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using AUC0-t |
| NCT02408068 (6) [back to overview] | Comparison of Fed and Fasted Chronocort AUC0-t |
| NCT02408068 (6) [back to overview] | Bioavailability of Chronocort® vs Hydrocortisone Tablets - Cmax |
| NCT02408068 (6) [back to overview] | Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using Tmax. |
| NCT02481310 (2) [back to overview] | 12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II) |
| NCT02481310 (2) [back to overview] | To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R. |
| NCT02716818 (6) [back to overview] | Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany. |
| NCT02716818 (6) [back to overview] | Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass) |
| NCT02716818 (6) [back to overview] | Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit |
| NCT02716818 (6) [back to overview] | 17-OHP and A4 by Individual Baseline Treatment Strata. |
| NCT02716818 (6) [back to overview] | Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP |
| NCT02716818 (6) [back to overview] | Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4 |
| NCT02760862 (1) [back to overview] | Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol. |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R) |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine |
| NCT03335774 (2) [back to overview] | Reduction in Swelling |
| NCT03335774 (2) [back to overview] | Reduction in Itching Severity |
| NCT03509350 (19) [back to overview] | Wechsler Memory Scale III - Delayed Recall Logical Memory Score |
| NCT03509350 (19) [back to overview] | Controlled Oral Word Association Test (COWAT) Score |
| NCT03509350 (19) [back to overview] | Posttraumatic Stress Disorder-8 (PTSD-8) Score |
| NCT03509350 (19) [back to overview] | Digit Span Test Score |
| NCT03509350 (19) [back to overview] | Vasopressor and Ventilator-free Days (VVFD) |
| NCT03509350 (19) [back to overview] | EuroQol, 5 Dimension (EQ-5D) Visual Analog Scale Score |
| NCT03509350 (19) [back to overview] | Functional Activities Questionnaire (FAQ) Score |
| NCT03509350 (19) [back to overview] | Hayling Test Score |
| NCT03509350 (19) [back to overview] | Intensive Care Unit (ICU) Mortality |
| NCT03509350 (19) [back to overview] | Katz Index of Independence in Activities of Daily Living (ADL) Score |
| NCT03509350 (19) [back to overview] | Length of Hospital Stay |
| NCT03509350 (19) [back to overview] | Length of ICU Stay |
| NCT03509350 (19) [back to overview] | Mortality at 180 Days |
| NCT03509350 (19) [back to overview] | Number of Participants Employed |
| NCT03509350 (19) [back to overview] | Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM) |
| NCT03509350 (19) [back to overview] | Mortality at 30 Days |
| NCT03509350 (19) [back to overview] | Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6 |
| NCT03509350 (19) [back to overview] | Telephone Interview for Cognitive Status (TICS) |
| NCT03509350 (19) [back to overview] | Wechsler Adult Intelligence Scale (WAIS)-IV Similarities Score |
| NCT03813147 (8) [back to overview] | Number of Participants With Dose Limiting Toxicities of MLN4924 (Pevonedistat) |
| 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] | 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] | 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 |
| 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 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] | Number of Participants With Adverse Events Attributable to MLN4924 (Pevonedistat) |
| NCT03813147 (8) [back to overview] | Number of Participants With Antitumor Activity of MLN4924 (Pevonedistat) |
Response Rate
Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years
| Intervention | percentage of participants analyzed (Number) |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 88 |
| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 83 |
Minimal Residual Disease
The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided
| Intervention | percentage of samples analyzed (Number) |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 22 |
| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 70 |
Grade ≥ 3 Stomatitis
The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year
| Intervention | participants (Number) |
|---|
| Incidence of grade ≥ 3 stomatitis | No incidence of grade ≥ 3 stomatitis |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 4 | 41 |
,| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 6 | 34 |
Toxic Death
Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year
| Intervention | participants (Number) |
|---|
| Toxic death | No toxic death |
|---|
| Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 0 | 45 |
,| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 2 | 38 |
Grade 3-4 Constitutional Events
All Grade 3-4 Constitutional events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 22 |
Grade 3-4 Cardiovascular Events
All Grade 3-4 Cardiovascular events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 6 |
Grade 3-4 Blood/Bone Marrow Events
"All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms.~Arm Name" (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 564 |
Grade 3-4 Auditory/Hearing Events
All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 8 |
Grade 3-4 Allergy/Immunology
All Grade 3-4 Allergy/Immunology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 1 |
2-yr Overall Survival
Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up. (NCT00084838)
Timeframe: Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.
| Intervention | probability (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Modified IRS | 0.70 |
Pre-Radiation Therapy Chemotherapeutic Response
"Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR.~Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): >/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): <50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): >/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples." (NCT00084838)
Timeframe: Assessed at study entry and pre-RT/post-CT at week 7.
| Intervention | proportion of evaluable patients (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Modified IRS | 0.58 |
Grade 3/4 Events
All Grade 3-4 events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 1021 |
Grade 3-4 Renal/Genitourinary Events
All Grade 3-4 Renal/Genitourinary events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 4 |
Grade 3-4 Pulmonary Events
All Grade 3-4 Pulmonary events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 4 |
Grade 3-4 Pain Events
All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 31 |
Grade 3-4 Neurology Events
All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 45 |
Grade 3-4 Muscloskeletal Events
All Grade 3-4 Muscloskeletal events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 8 |
Grade 3-4 Infection/Febrile Neutropenia Events
All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 49 |
Grade 3-4 Hepatic Events
All Grade 3-4 Hepatic events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 8 |
Grade 3-4 Hemorrhage Events
All Grade 3-4 Hemorrhage events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 1 |
Grade 3-4 Gastrointestinal Events
All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 139 |
Grade 3-4 Dermatology Events
All Grade 3-4 Dermatology events based on CTCAEv2 as reported on case report forms. (NCT00084838)
Timeframe: Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.
| Intervention | adverse events (Number) |
|---|
| Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III) | 3 |
Event-free Survival
Monitoring of efficacy results will be performed in comparison with historical results. (NCT00096135)
Timeframe: 3 years
| Intervention | percentage of participants (Number) |
|---|
| CNS Patients - Treatment (Combination Chemotherapy) | 64.9 |
| Testicular Relapse Patients (Combination Chemotherapy) | 70 |
Event-free Survival Rate
Proportion of patients who were event free at 4 months (NCT00098839)
Timeframe: At 4 months after enrollment
| Intervention | Proportion of participants (Number) |
|---|
| Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .604 |
| Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .640 |
Pharmacokinetics
Mean trough serum concentration measured before final dose of epratuzumab. (NCT00098839)
Timeframe: Up to day 36
| Intervention | ug/mL (Mean) |
|---|
| Twice Weekly Dosing Schedule | 501 |
Rate of Minimal Residual Disease (MRD) < 0.01%
Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)
| Intervention | Proportion of participants (Number) |
|---|
| Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .195 |
| Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .295 |
Remission Re-induction (CR2) Rate
The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)
| Intervention | proportion of participants (Number) |
|---|
| Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly | .646 |
| Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly | .660 |
Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning
number achieving donor cell engraftment (>95%) by day 90 after transplant. (NCT00185692)
Timeframe: 100 days
| Intervention | Participants (Count of Participants) |
|---|
| Transplantation of CD34+ Cells | 4 |
Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant
GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant. (NCT00185692)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| Transplantation of CD34+ Cells | 1 |
Response
Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive. (NCT00354107)
Timeframe: Week 4
| Intervention | percent (Number) |
|---|
| Treatment (Monoclonal Antibody Therapy, Chemotherapy) | 50 |
Overall Survival (OS) at 1 Year
(NCT00392834)
Timeframe: 1 year post treatment
| Intervention | Cumulative proportion surviving at 1 yr (Number) |
|---|
| Regimen A (R-CODOX-M Chemotherapy) | 1.0 |
| Regimen B (Rituximab and IVAC Chemotherapy) | 0.82 |
5-Year Disease-Free Survival
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| Intramuscular Native E Coli L-asparaginase (IM-EC) | .89 |
| Intravenous PEG-asparaginase (IV-PEG) | .90 |
Post-Induction Nadir Serum Asparaginase Activity Level
Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.
| Intervention | IU/mL (Mean) |
|---|
| Week 5 NSAA Level | Week 11 NSAA Level | Week 17 NSAA Level | Week 23 NSAA Level | Week 29 NSAA Level |
|---|
| Intramuscular Native E Coli L-asparaginase (IM-EC) | 0.129 | 0.143 | 0.159 | 0.180 | 0.123 |
,| Intravenous PEG-asparaginase (IV-PEG) | 0.726 | 0.773 | 0.787 | 0.757 | 0.806 |
5-Year Disease-Free Survival by Bone Marrow Day 18 Status
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| M1 Day 18 Bone Marrow Status | .89 |
| M2/M3 Day 18 Bone Marrow Status | .78 |
| Hypocellular Day 18 Bone Marrow Status | .88 |
5-year Disease-Free Survival by CNS Directed Treatment Group
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| CNS-1 | .89 |
| CNS-2 | .89 |
| CNS-3 | 1.00 |
| Traumatic Tap With Blasts | .84 |
| Traumatic Tap Without Blasts | .87 |
5-Year Disease-Free Survival by MRD Day 32 Status
Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.
| Intervention | probability (Number) |
|---|
| Low Day 32 MRD Level | .79 |
| High Day 32 MRD Level | .90 |
Induction Infection Toxicity Rate
Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy. (NCT00400946)
Timeframe: Assessed daily during remission induction days 4-32.
| Intervention | percentage of participants (Number) |
|---|
| Overall | 26 |
Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate
Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.
| Intervention | percentage of participants (Number) |
|---|
| Intramuscular Native E Coli L-asparaginase (IM-EC) | 71 |
| Intravenous PEG-asparaginase (IV-PEG) | 99 |
Induction Serum Asparaginase Activity Level
Serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.
| Intervention | IU/mL (Median) |
|---|
| Day 4 NSAA Level | Day 11 NSAA Level | Day 18 NSAA Level | Day 25 NSAA Level |
|---|
| Overall | .694 | .505 | .211 | .048 |
Induction Therapeutic Nadir Serum Asparaginase Activity Rate
Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.
| Intervention | percentage of participants (Number) |
|---|
| Day 4 NSAA Rate | Day 11 NSAA Rate | Day 18 NSAA Rate | Day 25 NSAA Rate |
|---|
| Overall | 97 | 96 | 87 | 12 |
Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth
Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth (NCT00405288)
Timeframe: neonatal period
| Intervention | participants (Number) |
|---|
| Cardiovascular anomalies | Heart murmur | Premature atrial contraction |
|---|
| Control | 0 | 4 | 2 |
,| Proctofoam-HC® | 2 | 6 | 0 |
Fetal Distress
Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid (NCT00405288)
Timeframe: at birth
| Intervention | participants (Number) |
|---|
| Fetal distress | No fetal distress |
|---|
| Control | 31 | 142 |
,| Proctofoam-HC® | 36 | 163 |
Mode of Delivery
Method of delivery for both groups: vaginal or caesarean section (NCT00405288)
Timeframe: at birth
| Intervention | participants (Number) |
|---|
| Vaginal delivery | Caesarean section | Unknown |
|---|
| Control | 146 | 55 | 3 |
,| Proctofoam-HC® | 173 | 31 | 0 |
Prematurity
birth at <37 gestational weeks (NCT00405288)
Timeframe: at birth
| Intervention | participants (Number) |
|---|
| yes | no |
|---|
| Control | 10 | 180 |
,| Proctofoam-HC® | 8 | 193 |
Respiratory Neonatal Health Concerns
(NCT00405288)
Timeframe: neonatal period
| Intervention | participants (Number) |
|---|
| Pulmonary aspiration | Mild asthma | Tachypnea |
|---|
| Control | 0 | 2 | 2 |
,| Proctofoam-HC® | 4 | 2 | 0 |
Skin Conditions in Neonatal Period
(NCT00405288)
Timeframe: neonatal period
| Intervention | participants (Number) |
|---|
| Rash | Eczema | Acne |
|---|
| Control | 2 | 2 | 2 |
,| Proctofoam-HC® | 2 | 0 | 0 |
Birth-weight
Weight of the baby measured in grams at time of birth. (NCT00405288)
Timeframe: until delivery
| Intervention | grams (Mean) |
|---|
| Proctofoam-HC® | 3406.9 |
| Control | 3487.7 |
Low Birth Weight at Birth
Low birth weight (birth weights <2500 grams) (NCT00405288)
Timeframe: at birth
| Intervention | participants (Number) |
|---|
| Yes | No |
|---|
| Control | 3 | 198 |
,| Proctofoam-HC® | 6 | 194 |
Neonatal Health
Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth (NCT00405288)
Timeframe: at birth
| Intervention | participants (Number) |
|---|
| Yes (present neonatal health concerns) | No (absent neonatal health concerns) |
|---|
| Control | 24 | 154 |
,| Proctofoam-HC® | 28 | 171 |
Neonatal Health Concerns-infections
Infections occuring in the neonatal period (NCT00405288)
Timeframe: neonatal period
| Intervention | participants (Number) |
|---|
| Urinary tract infections | Streptococcus B infection | Pneumonia | Leucocytosis |
|---|
| Control | 0 | 2 | 2 | 0 |
,| Proctofoam-HC® | 2 | 0 | 0 | 2 |
Other Neonatal Health Concerns
(NCT00405288)
Timeframe: neonatal period
| Intervention | participants (Number) |
|---|
| Conjuctivitis | Myopia | Colic | Milk allergy | Hypoglycemia | Poor feeding | Poor weight gain | Anemia | Renal calculi |
|---|
| Control | 0 | 2 | 4 | 2 | 0 | 0 | 2 | 2 | 2 |
,| Proctofoam-HC® | 4 | 0 | 0 | 0 | 4 | 2 | 2 | 0 | 0 |
Gestational Age at Delivery
Fetal gestational age at delivery (NCT00405288)
Timeframe: until delivery
| Intervention | gestational weeks (Mean) |
|---|
| Proctofoam-HC® | 39.4 |
| Control | 39.1 |
Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0
Patients will be evaluated for toxicity every 2 weeks during the first cycle. Thereafter, evaluations will be done every 28 days or more frequently if clinically indicated. (NCT00460031)
Timeframe: Up to 30 days after discontinuation of treatment
| Intervention | participants (Number) |
|---|
| Ketoconazole Plus Lenalidomide | 19 |
Time to Progression
Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease. (NCT00460031)
Timeframe: One year (12 months) after start of treatment
| Intervention | Months (Median) |
|---|
| Ketoconazole Plus Lenalidomide | 3 |
Change in Immune Response From Baseline
The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the levels of CD4+ FoxP3+ Regulatory T cells (NCT00460031)
Timeframe: Week 8
| Intervention | cells/ul (Mean) |
|---|
| Ketoconazole Plus Lenalidomide | 0.18 |
Ratio of Change in Immune Response From Baseline
The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the ratio of BDCA-2 to BDCA-1 cells (NCT00460031)
Timeframe: Week 8
| Intervention | ratio (Mean) |
|---|
| Ketoconazole Plus Lenalidomide | -0.39 |
Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease
Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease. (NCT00460031)
Timeframe: 28 days
| Intervention | participants (Number) |
|---|
| Partial Response | Progressive Disease | Stable Disease |
|---|
| Ketoconazole Plus Lenalidomide | 7 | 7 | 9 |
Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).
(NCT00519818)
Timeframe: Cortef after one week, Chronocort after one month
| Intervention | h*nmol/l (Mean) |
|---|
| Cortef | 5380 |
| Chronocort | 3973 |
17 Hydroxyprogesterone at 08.00 Hours
(NCT00519818)
Timeframe: Cortef after one week compared with Chronocort after one month
| Intervention | nmol/l (Mean) |
|---|
| Cortef | 16.4 |
| Chronocort | 86.9 |
Objective Tumor Response, Assessed by RECIST
Judged by monthly physical exam and radiographic evaluation. Patients will be considered evaluable for tumor response if they have at least two post-baseline tumor assessments at least 4 weeks apart, received study medication for 8 weeks or if they have evidence of disease progression. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00536991)
Timeframe: Up to 11 years
| Intervention | percentage of participants (Number) |
|---|
| Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone | 24 |
Incidence of Toxicity Graded According to the National Cancer Institute CTC Version 3.0
Count of participants with serious adverse event. Please refer to the adverse event reporting for more detail. (NCT00536991)
Timeframe: Up to 11 years
| Intervention | Participants (Count of Participants) |
|---|
| Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone | 14 |
Determine the Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose (MTD) of oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole (400 mg thrice daily [TID]) + oral hydrocortisone (20 mg AM, 10 mg PM) (NCT00536991)
Timeframe: up to 11 years
| Intervention | mcg (Number) |
|---|
| Treatment (Calcitriol, Ketoconazole, Hydrocortisone) | 10 |
PSA Response Rate
Patients will be considered evaluable for PSA response if they have at least two post-baseline PSA measurements at least 4 weeks apart, or if they have other evidence of disease progression. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. (NCT00536991)
Timeframe: Up to 11 years
| Intervention | percentage of participants (Number) |
|---|
| Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone | 35 |
Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction
| Intervention | Activity percentage (Mean) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 69.00 |
Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.
| Intervention | percent probability (Number) |
|---|
| Arm B (IR/HR MLL-R Chemotherapy) | 38.89 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 35.82 |
Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
| Intervention | percentage probability (Number) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 35.82 |
Percent Probability for Event-free Survival (EFS) for Patients on Arm A
EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
| Intervention | percentage probability (Number) |
|---|
| Arm A (Standard Risk MLL-G) | 86.67 |
Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction
| Intervention | Proportion of cells that are viable (Median) |
|---|
| Arm A (Standard Risk MLL-G) | 0.75 |
| Arm B (IR/HR MLL-R Chemotherapy) | 0.48 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.47 |
Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)
| Intervention | Proportion of cells that are viable (Mean) |
|---|
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.69 |
Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction
| Intervention | qPCR fold expression ratio (Mean) |
|---|
| Arm A (Standard Risk MLL-G) | 1.25 |
| Arm B (IR/HR MLL-R Chemotherapy) | 7.85 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 5.83 |
Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)
| Intervention | qPCR fold expression ratio (Mean) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 5.73 |
Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)
| Intervention | percent probability (Number) |
|---|
| Arm A (MRD Negative) | 86.05 |
| Arm A (MRD Positive) | 87.5 |
| Arm B (MRD Negative) | 47.37 |
| Arm B (MRD Positive) | 22.73 |
| Arm C (MRD Negative) | 51.85 |
| Arm C (MRD Positive) | 27.03 |
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
(NCT00640822)
Timeframe: Week 8
| Intervention | Participants (Number) |
|---|
| Calcipotriol Plus Hydrocortisone Ointment | 183 |
| Tacalcitol Ointment | 147 |
| Calcipotriol Plus Hydrocortisone Ointment Vehicle | 37 |
"Participants With Success According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase"
"Success was defined as a TSS score of 0 or 1.~For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below:~Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured)~The sum of the three scores constituted a TSS ranging from 0 to 12" (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)
| Intervention | Participants (Count of Participants) |
|---|
| LEO 80190 | 171 |
| Calcipotriol | 136 |
| Hydrocortisone | 131 |
| LEO 80190 Vehicle | 42 |
"Participants With Success According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase"
"The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face.~For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below:~Redness 0 = none~= mild~= moderate~= severe~= very severe~Thickness 0 = none~= mild~= moderate~= severe~= very severe~Scaliness 0 = none~= mild~= moderate~= severe~= very severe~A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS.~Success was defined as a TSS score of 0 or 1." (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)
| Intervention | Participants (Count of Participants) |
|---|
| LEO 80190 | 82 |
| Calcipotriol | 81 |
| Hydrocortisone | 59 |
| LEO 80190 Vehicle | 15 |
"Participants With Controlled Disease According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase"
"The (sub)investigator made an assessment of the disease severity of the intertriginous areas using the 6-category scale below.~Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit.~For subjects with a baseline severity of moderate or worse - controlled disease of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas.~For subjects with a baseline severity of mild - controlled disease of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas." (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)
| Intervention | Participants (Count of Participants) |
|---|
| LEO 80190 | 80 |
| Calcipotriol | 55 |
| Hydrocortisone | 48 |
| LEO 80190 Vehicle | 14 |
"Participants With Controlled Disease According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase"
"The assessment of the disease severity of the face was made using the 6-category scale below.~Clear Almost clear Mild Moderate Severe Very severe~The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit.~For subjects with a baseline severity of moderate or worse - controlled disease of the face was defined as clear or almost clear according to the IGA of disease severity of the face.~For subjects with a baseline severity of mild - controlled disease of the face was defined as clear according to the IGA of disease severity of the face." (NCT00691002)
Timeframe: At Week 4
| Intervention | Participants (Count of Participants) |
|---|
| LEO 80190 | 101 |
| Calcipotriol | 66 |
| Hydrocortisone | 61 |
| LEO 80190 Vehicle | 14 |
"Participants With Controlled Disease According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase"
"The (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below.~Clear, Almost clear, Mild, Moderate, Severe, Very severe~The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit.~For subjects with a baseline (Visit 1) severity of moderate or worse - controlled disease of the face was defined as clear or almost clear according to the IGA of disease severity of the face.~For subjects with a baseline (Visit 1) severity of mild - controlled disease of the face was defined as clear according to the IGA of disease severity of the face." (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)
| Intervention | Participants (Count of Participants) |
|---|
| LEO 80190 | 158 |
| Calcipotriol | 135 |
| Hydrocortisone | 115 |
| LEO 80190 Vehicle | 41 |
Adherence to Locoid
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied (NCT00693693)
Timeframe: 2 weeks
| Intervention | percentage of days (Mean) |
|---|
| Cream | .55 |
| Ointment | .60 |
| Lipocream | .50 |
Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years
| Intervention | percentage of patients (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
| Standard-risk | 83.2 |
| High-risk | 66.7 |
Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 10.5 |
| Standard-risk | 0 |
| High-risk | 66.7 |
Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 40.7 |
| Standard-risk | 29.2 |
| High-risk | 100.0 |
Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years
| Intervention | Percent probability (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
| Standard-risk | 83.2 |
| High-risk | 66.7 |
Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
| Intervention | Pts with DLTs (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 1 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2. (NCT00873093)
Timeframe: End of Block 2 (Day 36 of Block 2) of re-induction therapy
| Intervention | percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 66.7 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 42.1 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1. (NCT00873093)
Timeframe: End of Block 1 (Day 36 of Block 1) of re-induction therapy
| Intervention | percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 35.4 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 25 |
Toxic Death Rate
The proportion of toxic death rate among all eligible patients. (NCT00873093)
Timeframe: 4 months
| Intervention | percentage of participants (Number) |
|---|
| Overall | 2.1 |
Severe Adverse Events (SAE) Rate.
The proportion of SAE rate among all eligible patients (NCT00873093)
Timeframe: 4 months
| Intervention | percentage of participants (Number) |
|---|
| Overall | 8.2 |
Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy
The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. (NCT00873093)
Timeframe: The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.
| Intervention | Percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 72.2 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 63 |
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3. (NCT00873093)
Timeframe: End of Block 3 (Day 36 of Block 3) of re-induction therapy
| Intervention | Percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 80 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 63.6 |
Event Free Survival
Percentage of patients who were event free at 4 months (NCT00873093)
Timeframe: 4 months after enrollment
| Intervention | Percentage of participants (Number) |
|---|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 68.5 |
| Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 37.8 |
Percentage (%) of Participants With Change From Baseline in Patient Tolerability Questionnaire at Month 6, Assessed by Patient and Investigator - Part B
Patient tolerability questionnaire was assessed by both patient and investigator, the responses were as follows: improvement, no change, worsening and were reported. (NCT00915343)
Timeframe: Baseline (week 0), month 6
| Intervention | percentage of participants (Number) |
|---|
| Improvement (Patient) | Improvement (Investigator) | No change (Patient) | No change (Investigator) | Worsening (Patient) | Worsening (Investigator) |
|---|
| Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 10.7 | 14.0 | 73.2 | 70.0 | 16.1 | 16.0 |
Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A
Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | nanomoles per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 165.1 |
| Hydrocortisone Tablet TID - Part A | 203.3 |
Area Under the Concentration Time Curve From Zero to 24 Hours Adjusted by Dose (AUC0-24h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hour per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.047 |
| Hydrocortisone Tablet TID - Part A | 0.060 |
Change From Baseline to 6 Months in Diurnal Fatigue Questionnaire for Day Average- Part B
Diurnal fatigue scores (Visual Analog Scale [VAS] scores of energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: Baseline (week 0), month 6
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part B (All 6 Months) | -0.180 |
Area Under the Concentration Time Curve From Zero to 4 Hours Adjusted by Dose (AUC0-4h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hour per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.025 |
| Hydrocortisone Tablet TID - Part A | 0.024 |
Area Under the Concentration Time Curve From Zero to 10 Hours Adjusted by Dose (AUC0-10h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hour per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.041 |
| Hydrocortisone Tablet TID - Part A | 0.046 |
Average Concentration of S-cortisol During the Dosing Interval at Steady State Adjusted by Dose (Css,av/Dose) in Plasma After Single and Multiple Dosing During Part A
Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.002 |
| Hydrocortisone Tablet TID - Part A | 0.003 |
Change From Baseline to 12 Weeks in Diurnal Fatigue Questionnaire for Day Average of Once Daily Therapy - Part A
Diurnal fatigue was assessed at 8 ante meridian (AM), at 12 AM and at 4 post meridian (PM) by a visual analogue scale (VAS) based on 8 domains (energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity). Mean values were calculated for the morning (8 AM), the day (12 AM), the evening (4 PM) and mean per day (mean of 8 AM, 12 AM and 4 PM) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: Baseline (week 0), Week 12
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | -3.1 |
Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score - Part B
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: Baseline (week 0), month 6
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part B (All 6 Months) | -1.09 |
Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores- Part B
The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being. (NCT00915343)
Timeframe: Baseline (week 0), month 6
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part B (All 6 Months) | -0.739 |
Comparison of Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score Between Once Daily and Thrice Daily Therapy - Part A
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being. (NCT00915343)
Timeframe: 12 weeks
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 22.6 |
| Hydrocortisone Tablet TID - Part A | 26.4 |
Comparison of Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores Between Once Daily and Thrice Daily Therapy- Part A
The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being. (NCT00915343)
Timeframe: 12 weeks
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 110.5 |
| Hydrocortisone Tablet TID - Part A | 107.7 |
Comparison on 24-hour Urinary Free Cortisol Between Once Daily and Thrice Daily Therapy-Part A
(NCT00915343)
Timeframe: 12 weeks
| Intervention | nanomoles per 24 hours (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 385.7 |
| Hydrocortisone Tablet TID - Part A | 425.9 |
Comparison on Participant Compliance Between Once Daily and Thrice Daily Therapy - Part A
Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets - Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose). (NCT00915343)
Timeframe: Weeks 4 up to 28
| Intervention | percentage use (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 104.8 |
| Hydrocortisone Tablet TID - Part A | 103.1 |
Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | nanomoles per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 278.5 |
| Hydrocortisone Tablet TID - Part A | 426.7 |
Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | nanomoles per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 214.1 |
| Hydrocortisone Tablet TID - Part A | 322.4 |
Drug Concentration Half-Life From 5 to 14 Hours (t1/2[5-14h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
t1/2[5-14h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 14 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hours (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 4.60 |
| Hydrocortisone Tablet TID - Part A | 18.4 |
Drug Concentration Half-Life From 5 to 24 Hours (t1/2[5-24h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
t1/2[5-24h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 24 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hours (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 7.32 |
| Hydrocortisone Tablet TID - Part A | 1.84 |
First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | nanomoles per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 229.0 |
| Hydrocortisone Tablet TID - Part A | 295.1 |
First Detectable Concentration Adjusted by Dose (Cfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.003 |
| Hydrocortisone Tablet TID - Part A | 0.004 |
Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | nanomoles per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 690.7 |
| Hydrocortisone Tablet TID - Part A | 802.8 |
Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax2 is the Cmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | nanomoles per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 553.8 |
| Hydrocortisone Tablet TID - Part A | 446.9 |
Maximal Concentration Adjusted by Dose (Cmax1/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.008 |
| Hydrocortisone Tablet TID - Part A | 0.010 |
Participant Compliance- Part B
Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets - Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose). (NCT00915343)
Timeframe: Up to Month 6 follow-up
| Intervention | percentage use (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 102.3 |
Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hour*nanomole per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 3962.0 |
| Hydrocortisone Tablet TID - Part A | 4879.6 |
Accumulation Ratio (Rac) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
The Rac was calculated as area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) on Day 28 divided by AUC0-24h on Day 1. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | ratio (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 1.11 |
| Hydrocortisone Tablet TID - Part A | 1.03 |
Area Under the Concentration Time Curve During a Dosing Interval at Steady State (AUCtau) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUCtau is defined as AUC during a dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hour*nanomole per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 3962.0 |
| Hydrocortisone Tablet TID - Part A | 4879.6 |
Area Under the Concentration Time Curve During a Dosing Interval at Steady State Adjusted by Dose (AUCtau/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 14 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hour per liter (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.048 |
| Hydrocortisone Tablet TID - Part A | 0.061 |
Percentage (%) of Area Under the Concentration Time Curve (AUC) Extrapolation of S-cortisol in Plasma After Single and Multiple Dosing During Part A
The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) was calculated by using the formula AUC%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter was to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t). Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | percentage of AUC (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 10.1 |
| Hydrocortisone Tablet TID - Part A | 9.26 |
Percentage (%) of Fluctuation in Concentrations of S-cortisol at Steady State in Plasma After Single and Multiple Dosing During Part A
Percentage of fluctuation was calculated by using formula 100*(Cmax-minimum plasma concentration [Cmin])/Cavg,ss. It was peak trough fluctuation within one dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | percentage of fluctuation (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 429.7 |
| Hydrocortisone Tablet TID - Part A | 396.2 |
Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hours (Median) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.229 |
| Hydrocortisone Tablet TID - Part A | 0.208 |
Time to First Detectable Concentration Adjusted by Dose (Tfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | (hour per nanomole)*10^6 (Mean) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 2.26 |
| Hydrocortisone Tablet TID - Part A | 2.32 |
Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax1 is the Tmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hours (Median) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 1.00 |
| Hydrocortisone Tablet TID - Part A | 0.750 |
Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax2 is the Tmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hours (Median) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 5.00 |
| Hydrocortisone Tablet TID - Part A | 6.00 |
Time to Reach a Concentration of 200 Nanometers (nM) (T200) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hours (Median) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 0.250 |
| Hydrocortisone Tablet TID - Part A | 0.167 |
Area Under the Concentration Time Curve (AUC) Between Specified Timepoints of Total S-cortisol in Plasma After Single and Multiple Dosing During Part A
"AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUC between specified timepoints included AUC0-4h, AUC4-12h, AUC6-12h, AUC12-24h, AUC0-10h, AUC4-10h, AUC6-10h, AUC10-24h, AUC(0-inf), AUC(24h-inf). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. Here, Nsignifies the number of participants evaluable for this outcome." (NCT00915343)
Timeframe: Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
| Intervention | hour*nanomole per liter (Mean) |
|---|
| AUC0-4h (N=61, 61) | AUC4-12h (N=61, 61) | AUC6-12h (N=61, 61) | AUC12-24h (N=61, 61) | AUC0-10h (N=61, 61) | AUC4-10h (N=61, 61) | AUC6-10h (N=61, 61) | AUC10-24h (N=61, 61) | AUC(0-inf) (N=52, 52) | AUC(24h-inf) (N=52, 52) |
|---|
| Hydrocortisone MR Tablet OD - Part A | 2053.7 | 1491.8 | 808.2 | 306.2 | 3388.4 | 1334.7 | 651.1 | 465.0 | 3972.6 | 195.3 |
,| Hydrocortisone Tablet TID - Part A | 1929.7 | 2302.5 | 1607.6 | 576.6 | 3768.7 | 1839.0 | 1144.1 | 1058.0 | 5162.8 | 410.4 |
Comparison of Overall Patient Tolerability Score Between Once Daily and Thrice Daily Therapy, Assessed by Patient and Investigator - Part A
"Overall patient tolerability score assessed by patient and investigator, ranged from 1 (feeling poor on treatment) to 5 (feeling very well on treatment). The average total score ranges from 1 to 5 with a higher score representing better tolerability of the treatment. Questionnaire assessed by patient were I have been very poorly on the treatment, I haven't been very well (or less well) on the treatment, I have been acceptably well on the treatment, I have been well on the treatment and I have been very well on the treatment. Questionnaire assessed by investigator were The patient has been feeling very poorly on the treatment, The patient has not tolerated the treatment well, The patient has tolerated the treatment less well, The patient has tolerated the treatment well and The patient has tolerated the treatment very well." (NCT00915343)
Timeframe: 12 weeks
| Intervention | scores on a scale (Mean) |
|---|
| Patient | Investigator |
|---|
| Hydrocortisone MR Tablet OD - Part A | 4.28 | 4.26 |
,| Hydrocortisone Tablet TID - Part A | 4.36 | 4.33 |
Comparison on Participant Preference by Questionnaire Between Once Daily and Thrice Daily Therapy-Part A
Participant Preference Questionnaire consisted of the following set of questions: 1. How large was the benefit with OD compared to TID and the responses were recorded as considerably poorer, somewhat poorer, comparable, large, very large; 2. How strongly concur with the following statement: I prefer novel OD to conventional TID and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly; 3. How strongly concur with the following statement: I prefer conventional TID to novel OD and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly. (NCT00915343)
Timeframe: Weeks 16 up to 28
| Intervention | percentage of preference (Number) |
|---|
| Benefit compared OD to TID: Considerably poorer | Benefit compared OD to TID: Somewhat poorer | Benefit compared OD to TID: Comparable | Benefit compared OD to TID: Large | Benefit compared OD to TID: Very large | Prefer OD to TID: Strongly disagree | Prefer OD to TID: Disagree | Prefer OD to TID: Neutral | Prefer OD to TID: Strongly | Prefer OD to TID: Very strongly | Prefer TID to OD: Strongly disagree | Prefer TID to OD: Disagree | Prefer TID to OD: Neutral | Prefer TID to OD: Strongly | Prefer TID to OD: Very strongly |
|---|
| Hydrocortisone OD Versus TID | 3.8 | 5.7 | 5.7 | 20.8 | 64.2 | 3.7 | 3.7 | 5.6 | 25.9 | 61.1 | 39.6 | 35.4 | 12.5 | 4.2 | 8.3 |
Orthostatic Hypotension
(NCT01559675)
Timeframe: Postoperative Day 1
| Intervention | participants (Number) |
|---|
| High Dose Steroid | 2 |
| Low Dose Steroid | 2 |
Minimum Residual Disease (MRD) Levels Present at End of Cycle 1 Therapy in Patients
"MRD positive is defined as > or = to 0.1% MRD MRD negative is define as < 0.1% MRD~All these analyses will be descriptive and exploratory and hypotheses generating in nature." (NCT01614197)
Timeframe: Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| MRD positive | MRD negative |
|---|
| Dose Level 1 | 3 | 0 |
,| Dose Level 2 | 2 | 1 |
,| Dose Level 3 | 5 | 1 |
,| Dose Level 4 | 2 | 1 |
3-year Event-free Survival Rates in Patients With Relapsed ALL
Estimate the 3-year event-free survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy. (NCT01700946)
Timeframe: 3 years of follow-up since the on-study date
| Intervention | percentage of participants (Number) |
|---|
| STANDARD RISK | 83.3 |
| HIGH RISK | 55.7 |
| All Patients Enrolled on the Study | 67.83 |
3-year Overall Survival Rate of Patients With Relapsed ALL
Estimate the 3-year survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy. (NCT01700946)
Timeframe: 3 years of follow-up since the on-study date
| Intervention | percentage of participants (Number) |
|---|
| STANDARD RISK | 94.4 |
| HIGH RISK | 55.5 |
| All Patients Enrolled on the Study | 72.63 |
Mean of CD20 Expression Levels
To estimate mean levels of CD20 expression at baseline, during treatment with dexamethasone-containing chemotherapy and following rituximab treatment in Block I of remission induction therapy for relapsed precursor B-cell ALL. (NCT01700946)
Timeframe: Baseline and at the end of Block I (approximately 5 weeks after the on-study date)
| Intervention | percentage of CD20 Antigen (Mean) |
|---|
| At Baseline | At Block I |
|---|
| All Patients Enrolled on the Study | 36.23 | 19.43 |
,| HIGH RISK | 39.82 | 20.10 |
,| STANDARD RISK | 31.10 | 18.54 |
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
(NCT01782859)
Timeframe: First 24 hours after surgery
| Intervention | pmol/mL (Mean) |
|---|
| Baseline | Wound Closure | 4 hours postoperatively | 6 hours postoperatively | 24 hours postoperatively |
|---|
| Placebo | 334.15 | 778.33 | 1306.76 | 1175.71 | 356.79 |
,| Prednisone/Hydrocortisone | 298.12 | 619.21 | 1138.65 | 1032.52 | 422.61 |
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. (NCT01782859)
Timeframe: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
| Intervention | picograms/milliliter (Mean) |
|---|
| Baseline | Wound closure | 4 hours postoperatively | 6 hours postoperatively | 24 hours postoperatively |
|---|
| Placebo | 2.98 | 4.46 | 89.21 | 115.17 | 176.79 |
,| Prednisone/Hydrocortisone | 5.69 | 4.47 | 56.72 | 64.4 | 68.51 |
Pain at 3 Months Post-op
At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain. (NCT01782859)
Timeframe: 3 months postoperatively
| Intervention | units on a scale (Mean) |
|---|
| Placebo | 0.92 |
| Prednisone/Hydrocortisone | 0.54 |
Plasmin-a 2 Antiplasmin Complex (PAP)
(NCT01782859)
Timeframe: First 24 hours after surgery
| Intervention | mcg/L (Mean) |
|---|
| Baseline | Wound Closure | 4 hours postoperatively | 6 hours postoperatively | 24 hours postoperatively |
|---|
| Placebo | 924.67 | 1361.23 | 2251.33 | 2283.18 | 996.39 |
,| Prednisone/Hydrocortisone | 1011.17 | 2251.33 | 2455.71 | 2379.57 | 914.16 |
Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)
Adverse events were collected at the end of each 4-week cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a truncal/extremity adverse event is reported here. The treatment will be considered feasible if at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks. (NCT01867294)
Timeframe: At 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Study I: Spironolactone | 6 |
| Study I: Placebo | 6 |
Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
Adverse events were collected at the end of one 4-week cycle and one 4-week observation period according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a grade 2+ adverse event attributed to spironolactone is reported here. (NCT01867294)
Timeframe: At 8 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Study I: Spironolactone | 0 |
| Study I: Placebo | 0 |
Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)
The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported. (NCT01867294)
Timeframe: At 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Study I: Spironolactone | 4 |
| Study I: Placebo | 0 |
Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)
Patients will be dichotomously categorized as a success if no rash is reported and a failure if rash exists at the end of 4 weeks. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported. (NCT01867294)
Timeframe: At 4 weeks
| Intervention | participants (Number) |
|---|
| Study I: Spironolactone | 1 |
| Study I: Placebo | 2 |
Maximum Serum Concentration (Cmax)
Derived PK for Serum Cortisol: Maximum serum concentration (Cmax) (NCT01960530)
Timeframe: Hourly from 0 to 24 hours
| Intervention | nmol/L (Geometric Mean) |
|---|
| Infacort® | 940.012 |
| Hydrocortisone Tablet | 896.489 |
| i.v Hydrocortisone Injection | 1563.479 |
Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.
A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance. (NCT01960530)
Timeframe: Blood samples on Day 1 and/or Day 2 of each Study Period
| Intervention | uIU/mL (Mean) |
|---|
| Endogenous Cortisol | 70.529 |
| Dexamethasone | 80.668 |
| Infacort® | 77.575 |
| Hydrocortisone Tablet | 70.650 |
| i.v Hydrocortisone Injection | 70.121 |
Concentrations of Cortisol Binding Protein
Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone. (NCT01960530)
Timeframe: Blood samples on Day 1 and/or Day 2 of each Study Period
| Intervention | ug/mL (Mean) |
|---|
| Endogenous Cortisol | 22.950 |
| Dexamethasone | 23.441 |
| Infacort® | 22.386 |
| Hydrocortisone Tablet | 21.757 |
| i.v Hydrocortisone Injection | 21.482 |
Adverse Events (AEs)
Number of subjects with adverse events throughout the study. (NCT01960530)
Timeframe: Days 1-2 during each Study Period
| Intervention | participants (Number) |
|---|
| Endogenous Cortisol | 3 |
| Dexamethasone | 3 |
| Infacort® | 0 |
| Hydrocortisone Tablet | 1 |
| i.v Hydrocortisone Injection | 2 |
AUC0-t
Derived PK for Serum Cortisol: Area under the curve from 0-24 hours (NCT01960530)
Timeframe: Hourly from 0 to 24 hours
| Intervention | nmol*h/L (Geometric Mean) |
|---|
| Infacort® | 2543.24 |
| Hydrocortisone Tablet | 2896.73 |
| i.v Hydrocortisone Injection | 2923.46 |
Number of Participants With Adrenal Insufficiency
Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test (NCT02084134)
Timeframe: 6 weeks following surgery
| Intervention | Participants (Count of Participants) |
|---|
| Steroid Treatment Arm | 2 |
| Non-steroid Treatment | 1 |
Percentage of Patients Discharged on Glucocorticoids
Patient charts were reviewed to identify patients who were discharged on prednisone (NCT02084134)
Timeframe: 1 day (Day of hospital discharge)
| Intervention | Participants (Count of Participants) |
|---|
| Steroid Treatment Arm | 8 |
| Non-steroid Treatment | 2 |
Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm C (LR Control) | 58.94 |
| Arm D (LR Blinatumomab) | 67.00 |
Overall Survival (OS) of HR and IR Relapse Patients
OS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Two-year OS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 2 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm A (HR and IR Control) | 58.40 |
| Arm B (HR and IR Blinatumomab) | 71.33 |
Overall Survival (OS) of LR Relapse Patients
OS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Three-year OS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm C (LR Control) | 88.29 |
| Arm D (LR Blinatumomab) | 90.37 |
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| Arm A (Combination Chemotherapy) | 81.7 |
| Arm B (Combination Chemotherapy, Bortezomib) | 85.1 |
Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase
Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (NCT02112916)
Timeframe: 3 years from start of therapy by patient
| Intervention | Percentage of participants (Number) |
|---|
| Total Patients | 78.0 |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| Isolated CNS Relapse | Isolated Bone Marrow Relapse | Combined Bone Marrow Relapse |
|---|
| AALL0434 T-ALL Patients | 2.2 | 3.0 | 1.8 |
,| AALL1231 T-ALL Patients | 3.6 | 1.4 | 1.3 |
EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3
EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| VHR T-ALL MRD Undetectable | 25.0 |
| VHR T-ALL MRD Detectable | 88.9 |
EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond
EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| VHR T-LLy (CR/PR) | 0 |
Chronocort Cmax
Comparison of fed and fasted Chronocort Cmax for serum cortisol. (NCT02408068)
Timeframe: 24 hours
| Intervention | nmol/L (Geometric Least Squares Mean) |
|---|
| Chronocort Fed | 549.49 |
| Chronocort Fasted | 708.46 |
| Immediate-Release Hydrocortisone | 856.36 |
Comparison of Fed and Fasted Chronocort Tmax
Comparison of Fed and Fasted Chronocort based on the time to achive the maximum concentration of serum cortisol (NCT02408068)
Timeframe: 24 hours
| Intervention | hours (Median) |
|---|
| Chronocort Fed | 6.75 |
| Chronocort Fasted | 4.5 |
| Immediate-Release Hydrocortisone | 0.87 |
Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using AUC0-t
To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using area under the curve (NCT02408068)
Timeframe: 24 hours
| Intervention | h*nmol/L (Geometric Mean) |
|---|
| Chronocort Fasted | 2980.85 |
| Immediate-Release Hydrocortisone | 2466.90 |
| Chronocort Fed | 3229.26 |
Comparison of Fed and Fasted Chronocort AUC0-t
"Area under the curve from 0 to 24 hours for serum cortisol. Please note that the AUC0-t will be presented as a single figure (geometric mean) to represent exposure over time.~N.B., the sampling points for Hydrocortisone are as follows: 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h and 12h post-dose. However, the results for Hydrocortisone will not be incorporated into the analysis for this outcome measure." (NCT02408068)
Timeframe: 24 hours (at 0h, then 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h, 13h, 14h, 15h, 16h, 18h, 20h, 22h and 24h post-dose.)
| Intervention | h*nmol/L (Geometric Mean) |
|---|
| Chronocort Fed | 3229.26 |
| Chronocort Fasted | 2980.85 |
| Immediate-Release Hydrocortisone | 2466.90 |
Bioavailability of Chronocort® vs Hydrocortisone Tablets - Cmax
Evaluation of the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state by Cmax (NCT02408068)
Timeframe: 24 hours
| Intervention | nmol/L (Geometric Mean) |
|---|
| Chronocort Fasted | 708.45 |
| Immediate-Release Hydrocortisone | 856.36 |
| Chronocort Fed | 549.49 |
Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using Tmax.
To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using Tmax. (NCT02408068)
Timeframe: 24 hours
| Intervention | hours (Median) |
|---|
| Chronocort Fasted | 4.5 |
| Immediate-Release Hydrocortisone | 0.87 |
| Chronocort Fed | 6.75 |
12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)
12-month PFS will be defined as the percentage of patients alive and progression free 12 months from start of therapy. Patients lost to follow up will be censored from last point of contact. PFS was calculated using a Kplan-meier estimation with the probability of patients being progression free at 12 months, presented as the percentage based on this probability. (NCT02481310)
Timeframe: Up to 12 months from initiation of treatment
| Intervention | probability (%) of patients alive (Number) |
|---|
| Treatment (Combination Chemotherapy, Rituximab, Ixazomib) | 75.84 |
To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R.
"The RP2D will be determined by the evaluation of dose-limiting toxicities (DLT) to find the Maximum Tolerated Dose (MTD) which will constitute the RP2D. DLTs will be defined as the occurrence of ≥ Grade 3 toxicity experienced during the first cycle (3 weeks or 21 days) of study treatment, will be determined, except for cytopenias.~The dose of ixazomib will start at 2.3 mg weekly (for phase I patients) when given concurrently with DA-EPOCH-R. Single-subject cohorts (escalating in ixazomib dose) will be enrolled until the MTD is encountered, after which expansion to 3-subject cohorts will be undertaken. The MTD from phase I will equate the RP2D for ixazomib given in conjunction with DA-EPOCH-R." (NCT02481310)
Timeframe: The first 21 days of treatment
| Intervention | mg (Number) |
|---|
| Treatment (Combination Chemotherapy, Rituximab, Ixazomib) | 3 |
Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany.
Changes relative to Standard glucocorticoid therapy in body composition (DEXA - bone mineral density only) - measured at all sites except Germany. (NCT02716818)
Timeframe: Baseline and 24 weeks
| Intervention | g/cm^2 (Mean) |
|---|
| Chronocort - DEXA - Bone Mineral Density | -0.001 |
| Standard Glucocorticoid Therapy - DEXA - Bone Mineral Density | -0.008 |
Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)
Changes relative to Standard glucocorticoid therapy in body composition (DEXA) (fat mass and lean mass) - measured at all sites except Germany. (NCT02716818)
Timeframe: Baseline and 24 weeks
| Intervention | kilograms (Mean) |
|---|
| Chronocort - DEXA - Fat Mass | -0.575 |
| Standard Glucocorticoid Therapy - DEXA - Fat Mass | 0.445 |
| Chronocort - DEXA - Lean Mass | 0.640 |
| Standard Glucocorticoid Therapy - DEXA - Lean Mass | 0.234 |
Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit
"17-OHP and A4 levels at 09:00 at the week 24 visit, as a responder analysis (i.e. the number of participants achieving results in the optimal range).~Optimal range for 17-OHP (male) = 1.2* - 6.7 nmol/L (female) = 1.2* - 8.6 Optimal range for A4 (male) = 1.4 - 5.2 nmol/L (female) = 1.0 - 7.0 nmol/L~* = There is no lower reference range available for 17-OHP, hence the lower limit of the optimal range was used in the derivation of the average Standard Deviation Score. This enabled calculation of an 'unsigned' SDS score which was used to assess potential over-treatment as well as under-treatment." (NCT02716818)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Chronocort - 09:00h Response - 17-OHP | 30 |
| Chronocort - 09:00h Response - A4 | 25 |
| Standard Glucocorticoid Therapy - 09:00h Response - 17-OHP | 30 |
| Standard Glucocorticoid Therapy - 09:00h Response - A4 | 30 |
17-OHP and A4 by Individual Baseline Treatment Strata.
17-OHP and A4 by individual baseline treatment strata presented in the same manner as the primary endpoint (using 24-hour SDS profile at 24 weeks). Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP and A4. This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP and A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP and A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP and A4 when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks
| Intervention | Z-score (Mean) |
|---|
| Pre-Baseline - Hydrocortisone - 17-OHP | -0.248 |
| Pre-Baseline - Prednisone/Prednisolone - 17-OHP | -0.061 |
| Pre-Baseline - Dexamethasone - 17-OHP | -0.245 |
| Pre-Baseline - Chronocort vs. Hydrocortisone - 17-OHP | -0.431 |
| Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - 17-OHP | -0.320 |
| Pre-Baseline - Chronocort vs. Dexamethasone - 17-OHP | -0.565 |
| Pre-Baseline - Hydrocortisone - A4 | -0.211 |
| Pre-Baseline - Prednisone/Prednisolone - A4 | 0.100 |
| Pre-Baseline - Dexamethasone - A4 | 0.368 |
| Pre-Baseline - Chronocort vs. Hydrocortisone - A4 | 0.015 |
| Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - A4 | 0.328 |
| Pre-Baseline - Chronocort vs. Dexamethasone - A4 | -0.092 |
Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP
Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP (17-Hydroxyprogesterone). The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks
| Intervention | Z-score (Mean) |
|---|
| Chronocort® | -0.403 |
| Standard Glucocorticoid Therapy | -0.172 |
Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4
Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for A4 (androstenedione). This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of A4 when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks
| Intervention | Z-score (Mean) |
|---|
| Chronocort® | 0.113 |
| Standard Glucocorticoid Therapy | -0.041 |
Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.
(NCT02760862)
Timeframe: within 48 hours after starting of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Group (I) (N=25) | 25 |
| Group (II) (N=25) | 25 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 75.54 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 74.52 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 78.17 |
Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration. (NCT02828358)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|
| KMT2A-Rearranged | 6.45 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 76.5 |
Reduction in Swelling
"Reduction in the swelling of internal hemorrhoid was measured by anoscopy. Visual assessment of hemorrhoids was performed at end of treatment. Video of the procedure will be recorded for blinded central reading and assessment. Swelling was graded on a scale from 0 - None to 4 - Very Severe.~Numeric grades and their changes from baseline are summarized descriptively by visit and treatment group. Changes from baseline will be compared between the treatment groups. Mean difference between the groups and its 95% confidence interval will be displayed at Visit 4, along with the p-value from the two-sample t-test." (NCT03335774)
Timeframe: Day 15
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone Acetate Suppository, 25 mg | 2.3 |
| Placebo (Vehicle) Suppository | 2.0 |
Reduction in Itching Severity
"Patient-reported outcome (PRO) was collated and analyzed by deploying the Internal Hemorrhoid Sign and Symptom Assessment (IHSSA) questionnaire. The patients updated the questionnaire on a daily basis between visits 1-5. Responses to each item were averaged across each period.~The mean score from the Screening period was considered the baseline score.~Mean scores and their changes from baseline were summarized.~Itching was scored from on 0-4 scale (0 =No itching, 1 = A little itching, 2 =Moderate itching, 3 = A lot of itching, 4 = Worst itching that you could imagine" (NCT03335774)
Timeframe: Day 15
| Intervention | scores on a scale (Mean) |
|---|
| Hydrocortisone Acetate Suppository, 25 mg | 0.74 |
| Placebo (Vehicle) Suppository | 0.71 |
Wechsler Memory Scale III - Delayed Recall Logical Memory Score
Memory is assessed with the Logical Memory subtest from the Wechsler Memory Scale III. Participants listened to two short paragraphs and were asked to recall details from each story after 30 minutes. Scores represent the number of correctly remembered details. Total scores range from 0 to 25 with higher scores reflecting better memory. (NCT03509350)
Timeframe: Day 180
| Intervention | correct story details (Mean) |
|---|
| Treatment Protocol | 6.9 |
| Control Protocol | 8.1 |
Controlled Oral Word Association Test (COWAT) Score
Language is assessed with the Controlled Oral Word Association Test (COWAT). Participants generate words beginning with selected letters within 60 seconds. Generating a higher number of words indicates greater language skills. (NCT03509350)
Timeframe: Day 180
| Intervention | words (Mean) |
|---|
| Treatment Protocol | 40 |
| Control Protocol | 40 |
Posttraumatic Stress Disorder-8 (PTSD-8) Score
Posttraumatic Stress Disorder (PTSD) is assessed with the Posttraumatic Stress Disorder - 8 instrument. The PTSD-8 includes 8 items which are answered on a 4 point scale where 01 = not at all and 3 = all of the time. Total scores range from 0 to 24 where higher scores indicate greater symptoms of PTSD. (NCT03509350)
Timeframe: Day 180
| Intervention | score on a scale (Mean) |
|---|
| Treatment Protocol | 5.7 |
| Control Protocol | 5.2 |
Digit Span Test Score
The Digit Span Test is used to assesses attention. In the Digit Span Test, participants are read a series of numbers and are asked to repeat them back in the same order. The Digit Span test is scored by the number of digits the participant is able to remember in each test. Higher scores indicate greater ability to pay attention and to remember sequences. The average adult can remember about 7 numbers, plus or minus two, without making an error. (NCT03509350)
Timeframe: Day 180
| Intervention | numbers recalled (Mean) |
|---|
| Treatment Protocol | 8.3 |
| Control Protocol | 9.5 |
Vasopressor and Ventilator-free Days (VVFD)
The primary outcome measure is VVFD in the first 30 days after the start of treatment. The endpoint was recorded to the nearest day. Participants who died are scored zero days, even if there was a period during which the participant was alive and free of vasopressors and mechanical ventilation. Participants who must return to ventilation and/or vasopressors had their counters reset at zero days. (NCT03509350)
Timeframe: Up to Day 30
| Intervention | days (Median) |
|---|
| Treatment Protocol | 25 |
| Control Protocol | 26 |
EuroQol, 5 Dimension (EQ-5D) Visual Analog Scale Score
Quality of life is assessed with the Visual Analog Scale of the EuroQol, 5 dimension (EQ-5D) questionnaire. The EQ-5D asks about 5 dimensions of health (mobility, self-care, usual activities, pain, and depression). The questionnaire includes a visual analog scale where respondents rate their current health where 0 = worst health imaginable and 100 = best health imaginable. (NCT03509350)
Timeframe: Day 180
| Intervention | units on a scale (Mean) |
|---|
| Treatment Protocol | 66 |
| Control Protocol | 67 |
Functional Activities Questionnaire (FAQ) Score
Instrumental activities of daily living is assessed with the Functional Activities Questionnaire (FAQ). The FAQ includes 10 items which are scored on a scale from 0 to 3 where 0 = normal and 3 = dependent. Total scores range from 0 to 30 and lower scores indicate that the respondent is able to perform daily activities. A score of 9 (where the person is dependent in 3 activities) is used as a cut-point indicating impairments with functioning. (NCT03509350)
Timeframe: Day 180
| Intervention | score on a scale (Mean) |
|---|
| Treatment Protocol | 9.5 |
| Control Protocol | 7.7 |
Hayling Test Score
Executive function is assessed with the Hayling Test. The Hayling Test includes two parts of 15 items each where participants complete sentences by providing the missing word. The test is scored as the amount of time it takes, in seconds, to recite a correct response and the appropriateness of the response (in Part 2). Scaled scores range from 1 to 10 where 1 = impaired, 6 = average, and 10 = very superior. (NCT03509350)
Timeframe: Day 180
| Intervention | units on a scale (Mean) |
|---|
| Treatment Protocol | 4.2 |
| Control Protocol | 4.2 |
Intensive Care Unit (ICU) Mortality
The number of participants who died while in the ICU is compared between study arms. (NCT03509350)
Timeframe: Day 30
| Intervention | Participants (Count of Participants) |
|---|
| Treatment Protocol | 52 |
| Control Protocol | 49 |
Katz Index of Independence in Activities of Daily Living (ADL) Score
Activities of daily living is assessed with the Katz ADL instrument. The Katz ADL has 6 items asking if participants can perform daily tasks independently. Responses are scored as 1 = yes and 0 = no. Total scores range from 0 to 6 with higher scores indicating greater independence. (NCT03509350)
Timeframe: Day 180
| Intervention | score on a scale (Mean) |
|---|
| Treatment Protocol | 2.8 |
| Control Protocol | 2.4 |
Length of Hospital Stay
The number of days that participants were in the hospital is compared between study arms. (NCT03509350)
Timeframe: Day 30
| Intervention | days (Mean) |
|---|
| Treatment Protocol | 12.6 |
| Control Protocol | 13.5 |
Length of ICU Stay
The number of days that participants were in the ICU is compared between study arms. (NCT03509350)
Timeframe: Day 30
| Intervention | days (Mean) |
|---|
| Treatment Protocol | 6.7 |
| Control Protocol | 6.4 |
Mortality at 180 Days
The number of participants who did not survive until Day 180 is compared between study arms. (NCT03509350)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| Treatment Protocol | 102 |
| Control Protocol | 94 |
Number of Participants Employed
The Employment Questionnaire is a brief measure of the participant's employment history and ability or capacity to work. The number of participants who indicated being employed are presented here. (NCT03509350)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| Treatment Protocol | 17 |
| Control Protocol | 25 |
Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM)
The Telephone CAM evaluates dementia with 9-items, where additional questions are asked if symptoms are present. Rather than providing a summary score, if participants exhibit signs of a change in mental status which fluctuates and they experience inattention, along with disorganized thinking or altered level of consciousness, delirium is suggested. (NCT03509350)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| Treatment Protocol | 0 |
| Control Protocol | 0 |
Mortality at 30 Days
The number of participants who did not survive until Day 30 is compared between study arms. (NCT03509350)
Timeframe: Day 30
| Intervention | Participants (Count of Participants) |
|---|
| Treatment Protocol | 56 |
| Control Protocol | 60 |
Telephone Interview for Cognitive Status (TICS)
The Telephone Interview for Cognitive Status (TICS) is an 11-item instrument assessing orientation. Correct responses to the items are scored in a variety of ways, depending on how much of the response is correct. Total scores range from 0 to 41 with higher scores indicating increased cognitive orientation. (NCT03509350)
Timeframe: Day 180
| Intervention | score on a scale (Mean) |
|---|
| Treatment Protocol | 30.6 |
| Control Protocol | 31.2 |
Wechsler Adult Intelligence Scale (WAIS)-IV Similarities Score
Reasoning is assessed with the WAIS-IV Similarities instrument. Participants were asked to explain how two words are alike. Responses are scored according to how correct they are, with a score of 0 for incorrect answers. After 3 consecutive scores of 0 the survey is stopped. Total raw scores vary depending on the number of word pairs presented. Higher scores indicate better performance. Scores will be compared between study arms. (NCT03509350)
Timeframe: Day 180
| Intervention | score on a scale (Mean) |
|---|
| Treatment Protocol | 7.7 |
| Control Protocol | 8.2 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |