Trial · NCT03112174
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in) | After at least 3 months of treatment, with an overall median treatment duration of 20.0 months | All treated safety run-in participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | After at least 3 months of treatment, with an overall median treatment duration of 20.0 months | All treated safety run-in participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Safety Run-in) | From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 20.0 months | All treated safety run-in participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (PFS) (Randomization Phase) | For an overall median time on study of 61.34 months | All randomized participants | months | MEDIAN |
| PRIMARY | Complete Response (CR) Rate (Treatment-Naive Arm) | For an overall median time on study of 40.51 months | All Enrolled Treatment-Naïve Participants | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) (Safety Run-in) | For an overall median time on study of 74.78 months | All Enrolled Safety Run-in participants | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) (Safety Run-in) | For an overall median time on study of 74.78 months | All Enrolled Safety Run-in participants | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) (Safety Run-in) | For an overall median time on study of 74.78 months | All Enrolled Safety Run-in Subjects Achieving Response (Partial Response or Better) | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) (Safety Run-in) | For an overall median time on study of 74.78 months | All enrolled Safety Run-in participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Complete Response (CR) (Randomization Phase) | For an overall median time on study of 61.34 months | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) (Randomization Phase and Treatment-Naive Arm) | For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm) | All randomized participants and all treatment-naive open-label arm participants. | percentage of participants | NUMBER |
| SECONDARY | MRD-negative Remission Rate in Participants Who Achieve CR Per Investigator Assessment (Randomization Phase and Treatment-Naive Arm) | For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm) | All enrolled treatment-naïve participants achieving CR who were evaluable for MRD (those who had positive MRD status at screening). Participants with a given post-screening sample. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) (Randomization Phase and Treatment-Naive Arm) | For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm) | All randomized and all enrolled treatment-naïve participants | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) (Randomization Phase and Treatment-Naive Arm) | For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm) | All randomized participants and all enrolled treatment-naïve participants achieving response (partial response or better) | months | MEDIAN |
| SECONDARY | Time to Next Treatment (TTNT) (Randomization Phase and Treatment-Naive Arm) | For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm) | All randomized and all enrolled treatment-naïve participants | months | MEDIAN |
| SECONDARY | Number of Participants With TEAEs (Randomization Phase) | From first dose of study drug until the end of treatment + 30 days, with an overall median treatment duration of 19.5 months | All randomized and treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TLS TEAEs (Randomization Phase) | From first dose of study drug until the end of treatment + 7 days, with an overall median treatment duration 19.5 months | All randomized and treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Steady-State Pharmacokinetics (PK) of Ibrutinib: Maximum Observed Plasma Concentration (Cmax) (Randomization Phase) | Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose | Participants with an evaluable PK assessment at given time point. | ng/mL | MEAN |
| SECONDARY | Steady-State PK of Ibrutinib: Time to Cmax (Tmax) (Randomization Phase) | Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose | Participants with an evaluable PK assessment at given time point. | hours | MEDIAN |
| SECONDARY | Steady-State PK of Ibrutinib: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) (Randomization Phase) | Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose | Participants with an evaluable PK assessment at given time point. | ng·h/mL | 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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