Trial · NCT03112174
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
NCT03112174, Phase 3, Completed, Pharmacyclics LLC.; results first posted 2025-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL). Trials, record NCT03112174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03112174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
- NCT number
- NCT03112174
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 366 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Mantle-Cell Lymphoma
- Interventions
- Ibrutinib, Venetoclax, Placebo Oral tablet to match Venetoclax
- First posted
- 2017-04-13
- Last updated
- 2025-07-22
- Other registries' IDs
- eudract:2017-000129-12
- Results first posted
- 2025-07-22
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group193
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in) | Safety Run-in: Increased TLS Risk at Baseline | 1 | Participants | ||
| Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in) | Safety Run-in: Low TLS Risk at Baseline | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Increased TLS Risk at Baseline | Any TEAE/Any Grade | 3 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Low TLS Risk at Baseline | Any TEAE/Any Grade | 0 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Increased TLS Risk at Baseline | Any TEAE/ Grade 3+4 | 3 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Low TLS Risk at Baseline | Any TEAE/ Grade 3+4 | 0 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Increased TLS Risk at Baseline | Any TEAE/Grade 5 | 0 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Low TLS Risk at Baseline | Any TEAE/Grade 5 | 0 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Increased TLS Risk at Baseline | Atrial fibrillation/Any Grade | 1 | Participants | |
| Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in) | Safety Run-in: Low TLS Risk at Baseline | Atrial fibrillation/Any Grade | 0 | Participants |
1 to 10 of 193Source ClinicalTrials.gov
See all 193 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Run-in: Increased TLS Risk at Baseline | 15 | |
| Overall Study | STARTED | Safety Run-in: Low TLS Risk at Baseline | 6 | |
| Overall Study | STARTED | Randomization Phase: Ibrutinb + Venetoclax | 134 | |
| Overall Study | STARTED | Randomization Phase: Ibrutinib + Placebo | 133 | |
| Overall Study | STARTED | Treatment-naive Open-label Arm | 78 | |
| Overall Study | On Study Treatment at Study Closure | Safety Run-in: Increased TLS Risk at Baseline | 0 | |
| Overall Study | On Study Treatment at Study Closure | Safety Run-in: Low TLS Risk at Baseline | 2 | |
| Overall Study | On Study Treatment at Study Closure | Randomization Phase: Ibrutinb + Venetoclax | 31 | |
| Overall Study | On Study Treatment at Study Closure | Randomization Phase: Ibrutinib + Placebo | 21 | |
| Overall Study | On Study Treatment at Study Closure | Treatment-naive Open-label Arm | 26 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events2,365
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Safety Run-in: Increased TLS Risk at Baseline | 4 | 15 | 20 |
| other | ANAEMIA | Blood and lymphatic system disorders | Safety Run-in: Low TLS Risk at Baseline | 2 | 6 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Randomization Phase: Ibrutinb + Venetoclax | 27 | 134 | 40 |
| other | ANAEMIA | Blood and lymphatic system disorders | Randomization Phase: Ibrutinib + Placebo | 17 | 132 | 32 |
| other | ANAEMIA | Blood and lymphatic system disorders | Treatment-naive Open-label Arm | 17 | 78 | 27 |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Safety Run-in: Increased TLS Risk at Baseline | 3 | 15 | 4 |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Safety Run-in: Low TLS Risk at Baseline | 3 | 6 | 4 |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Randomization Phase: Ibrutinb + Venetoclax | 12 | 134 | 17 |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Randomization Phase: Ibrutinib + Placebo | 10 | 132 | 12 |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Treatment-naive Open-label Arm | 17 | 78 | 25 |
1 to 10 of 2,365Source ClinicalTrials.gov
See all 2,365 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Run-in: Increased TLS Risk at Baseline | 8 | 15 |
| Total, all-cause mortality | Safety Run-in: Low TLS Risk at Baseline | 3 | 6 |
| Total, all-cause mortality | Randomization Phase: Ibrutinb + Venetoclax | 70 | 134 |
| Total, all-cause mortality | Randomization Phase: Ibrutinib + Placebo | 78 | 132 |
| Total, all-cause mortality | Treatment-naive Open-label Arm | 20 | 78 |
| Total, other adverse events | Safety Run-in: Increased TLS Risk at Baseline | 15 | 15 |
| Total, other adverse events | Safety Run-in: Low TLS Risk at Baseline | 6 | 6 |
| Total, other adverse events | Randomization Phase: Ibrutinb + Venetoclax | 131 | 134 |
| Total, other adverse events | Randomization Phase: Ibrutinib + Placebo | 127 | 132 |
| Total, other adverse events | Treatment-naive Open-label Arm | 77 | 78 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Safety Run-in: Increased TLS Risk at Baseline vs Safety Run-in: Low TLS Risk at Baseline: Number of Participants With Tumor Lysis Syndrome (TLS) Events (Safety Run-in) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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Read this trial from software.
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