Trial · NCT03112603
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit | Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | percentage of participants | NUMBER |
| SECONDARY | Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score | Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | percentage of participants | NUMBER |
| SECONDARY | Rate of Failure-free Survival (FFS) | Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | months | MEDIAN |
| SECONDARY | Rate of FFS at Study Completion | From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years) | FAS | months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) at Cycle 7 Day 1 | up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | percentage of participants | NUMBER |
| SECONDARY | BOR During Cross-over Treatment With Ruxolitinib | from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | Cross-over Analysis Set | percentage of participants | NUMBER |
| SECONDARY | ORR at the End of Cycle 3 | Cycle 4 Day 1 (each cycle was comprised of 4 weeks) | FAS | percentage of participants | NUMBER |
| SECONDARY | Duration of Response Through Study Completion | from first response to LPLV (approximately 5 years) | FAS. Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years) | FAS | months | MEDIAN |
| SECONDARY | Cumulative Incidence of Non-relapse Mortality (NRM) | Months 3, 6, 12, 18, 24, 30, and 36 | FAS. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose | from Day 15 up to Day 182 | Safety Set: all participants who received at least one dose of study treatment. Participants were to have been analyzed according to the study treatment received, where treatment received was defined as the randomized treatment if the participant took at least one dose of that treatment or the first treatment received if the randomized treatment was never received. Six participants in the BAT arm discontinued before receiving the first dose. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Successfully Tapered Off of All Corticosteroids | up to Day 179 | FAS. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Malignancy Relapse/Recurrence (MR) | Months 3, 6, 12, 18, 24, 30, and 36 | FAS. Cumulative incidence was calculated for participants with underlying hematologic malignant disease. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) | Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks) | FAS. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in EQ-5D-5L | Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks) | FAS. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | from Baseline to LPLV (approximately 5 years) | Safety Set. Six participants in the BAT arm discontinued before receiving the first dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose | Pharmacokinetic Analysis Set (PAS): all participants who provided at least one evaluable pharmacokinetic (PK) concentration. Only participants with available data were analyzed. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose | PAS. Only participants with available data were analyzed. | ng*hour/mL | GEOMETRIC_MEAN |
| SECONDARY | AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose | PAS. Only participants with available data were analyzed. | ng*hour/mL | GEOMETRIC_MEAN |
| SECONDARY | CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses | Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose | PAS. Only participants with available data were analyzed. | Liters/hour | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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