Trial · NCT03112174
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | TLS events are defined as follows: * Clinical TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) with the following exceptions: * For the purpose of TLS assessment during the Safety Run-in Period, only those increases in serum creatinine \> 1.0 mg/dL from pre-treatment baseline will be considered clinical TLS. * In participants with renal dysfunction at baseline (CrCl \< 60 mL/min), clinical TLS is defined as the presence of laboratory TLS plus either seizures, cardiac dysrhythmia, or death. * Laboratory TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) for laboratory TLS, that does not resolve within 72 hours despite protocol required management. |
| 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 | DLT: any Grade (Gr) 3 or higher non-TLS adverse event (AE) at least possibly related to study drug occurring during the DLT assessment period with the following clarifications: Non-Hematologic DLTs: Gr ≥3 nausea, vomiting or diarrhea uncontrolled despite maximum medical supportive care and persisting \>5 days; Gr 3 fatigue persisting \>7 days; Gr 3 infection is not a DLT, however an infection with lifethreatening consequences or requiring urgent intervention (Gr 4) was considered a DLT; Treatment delay of any study drug \>7 days for toxicity. Hematologic DLTs: Gr 3 neutropenia is not a DLT, however, Gr 4 neutropenia (ANC \<500/mm\^3) lasting for \> 7 days is a DLT; Gr 3 or 4 neutropenia complicated by fever ≥38.5°C or infection; Gr 4 thrombocytopenia (\<25,000/mm\^3) that persists for \> 7 days; Gr 3 or 4 thrombocytopenia associated with Gr 2 or greater bleeding; Gr 3 anemia is not a DLT, however, Gr 4 anemia is a DLT; Treatment delay of any study drug \>7 days for hematologic toxicity. |
| 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 | AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with treatment. The investigator assesses the relationship of each event to the use of study. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug. Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5). |
| Primary | Progression-free Survival (PFS) (Randomization Phase) | For an overall median time on study of 61.34 months | PFS is defined as the time from the date of randomization to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first. |
| Primary | Complete Response (CR) Rate (Treatment-Naive Arm) | For an overall median time on study of 40.51 months | CR rate is defined as the percentage of participants with a CR according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014). |
| Secondary | Overall Survival (OS) (Safety Run-in) | For an overall median time on study of 74.78 months | OS is defined as the time from the date of the first dose of study treatment to death from any cause. |
| Secondary | Progression-free Survival (PFS) (Safety Run-in) | For an overall median time on study of 74.78 months | PFS is defined as the time from the date of the first dose of study treatment to the date of disease progression using the Revised Response Criteria for Malignant Lymphoma (Cheson 2014), or death from any cause, whichever occurs first. |
| Secondary | Duration of Response (DOR) (Safety Run-in) | For an overall median time on study of 74.78 months | DOR is defined for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014\]) to disease progression or death, whichever occurs first. |
| Secondary | Overall Response Rate (ORR) (Safety Run-in) | For an overall median time on study of 74.78 months | ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014). |
| Secondary | Percentage of Participants With a Complete Response (CR) (Randomization Phase) | For an overall median time on study of 61.34 months | Complete response rate (CR) based on the best overall response per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014). |
| 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) | ORR is defined as the percentage of participants with CR or PR per investigator assessment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014). |
| 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) | MRD-negative remission rate is defined as the percentage of participants with undetectable MRD at documented CR in participants who were MRD positive at screening as assessed by flow cytometry in bone marrow and/or peripheral blood, with requirement of confirmation of MRD negativity in the subsequent peripheral blood 12 weeks later. |
| 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) | OS is defined as the time from the date of randomization (Randomization Phase) or the first dose of study treatment (Treatment-Naïve arm) to death from any cause. |
| 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) | DOR is defined as the time frame for participants who achieve an overall response as the time from the first occurrence of response (CR or PR according to the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014\]) to disease progression or death, whichever occurs first. |
| 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) | TTNT is defined as the duration from the date of randomization (Randomization Phase) or date of first dose of study treatment (Treatment-Naive Arm) to the start date of any anti-lymphoma treatment subsequent to study treatment. Post-treatment stem cell transplantation, chimeric antigen receptor (CAR) T-cell therapy, or other cellular therapies were not considered subsequent anti-cancer treatments for participants responding to the study treatment (CR or PR). |
| 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 | AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with treatment. The investigator assesses the relationship of each event to the use of study. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug. Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5). |
| 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 | Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs): any event that began or worsened in severity on or after the first dose of study drug (SD). Event severity is graded as mild (1), moderate (2), severe (3), life threatening (4), death (5). |
| 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 | Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters. |
| 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 | Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters. |
| 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 | Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters. |
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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