Trial · NCT01776840
A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
NCT01776840, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2022-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma. Trials, record NCT01776840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01776840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
- NCT number
- NCT01776840
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 523 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Bendamustine, Rituximab, Ibrutinib, Placebo
- First posted
- 2013-01-28
- Last updated
- 2025-07-08
- Other registries' IDs
- eudract:2012-004056-11
- Results first posted
- 2022-07-26
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 97 months | Progression-free survival (PFS) was defined as the interval between the date of randomization to the date of disease progression (PD) or relapse from complete response (CR) or death, whichever was first reported. Disease assessments were based on the 2007 Revised Response Criteria for Malignant Lymphoma. PD was defined as any new lesion or increase by 50 percent (%) of previously involved sites from nadir (PD criteria: Appearance of new nodal lesion 1.5 centimeters \[cm\] in any axis, 50% increase in sum of product of diameters \[SPD\] of greater than \[\>\] 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis). |
| Secondary | Overall Survival | From randomization (Day -3) up to 121 months | Overall survival was defined as the time from the date of randomization to the date of the participant's death. Kaplan-Meier estimate was used. |
| Secondary | Complete Response Rate | Up to 97 months | Complete response (CR) rate was defined as the percentage of participants who achieve CR (based on investigator assessment) on or prior to the initiation of subsequent anticancer therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on computed tomography (CT); spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. |
| Secondary | Time-to-Next Treatment | Up to 97 months | Time-to-next treatment was measured from the date of randomization to the start date of any anti-mantle cell lymphoma (anti-MCL) treatment subsequent to the study treatment. |
| Secondary | Percentage of Participants With Overall Response | Up to 97 months | Percentage of participants with overall response was defined as the portion of participants who achieved CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. Criteria for PR: greater than or equal to (\>=) 50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. |
| Secondary | Minimal Residual Disease (MRD)-Negative Response Rate | Up to 97 months | Minimal residual disease negative rate was defined as the percentage of participants with a best overall response of CR with MRD-negative disease status (that is, \<5 mantle cell lymphoma \[MCL\] cell per 10,000 leukocytes for detection using the MRD assay), as assessed by flow cytometry of a bone marrow and/or peripheral blood sample. |
| Secondary | Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Questionnaire | Up to 97 months | Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline, death, or a missing assessment due to being "too ill", whichever occurred first. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score was the total of reverse scores, ranged 0 to 60. Higher scores indicated a better quality of life. |
| Secondary | Duration of Response (DoR) | Up to 97 months | Duration of Response (DoR) was defined as the interval between the date of initial documentation of a response including PR and the date of first documented evidence of PD or death |
| Secondary | Duration of Complete Response (DoCR) | Up to 97 months | Duration of complete response (DoCR) was defined as the interval between the date of initial documentation of a CR and the date of first documented evidence of PD or death whichever occurs first. |
| Secondary | Time to Response | Up to 97 months | Time to response was defined as the interval between the date of randomization and the date of initial documentation of a response. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Up to 97 months | Intent-to-treat (ITT) analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Here, N (overall number of participants analyzed) signifies number of participants that were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization (Day -3) up to 121 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Complete Response Rate | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. | percentage of participants | NUMBER |
| SECONDARY | Time-to-Next Treatment | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Overall Response | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. | percentage of participants | NUMBER |
| SECONDARY | Minimal Residual Disease (MRD)-Negative Response Rate | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. CR participants with missing MRD data and participants who did not achieve a CR were considered nonresponders. | percentage of participants | NUMBER |
| SECONDARY | Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Questionnaire | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Participants who achieved a PR or better were included in the analysis of duration of response. | months | MEDIAN |
| SECONDARY | Duration of Complete Response (DoCR) | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Participants who achieved a CR or better were included in the analysis of duration of complete response. | months | MEDIAN |
| SECONDARY | Time to Response | Up to 97 months | ITT analysis set included all randomized participants and classified according to the assigned treatment group, regardless of the actual treatment received. Participants who achieved a PR or better were included in the analysis of time to response. | months | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 52.9 | 95% Confidence Interval 43.7 to 71.0 | months | |
| Progression-free Survival (PFS) | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 80.6 | 95% Confidence Interval 61.9 to NA | months | |
| Overall Survival | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 95.9 | 95% Confidence Interval 86.1 to 115.3 | months | |
| Overall Survival | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 104.3 | 95% Confidence Interval 81.1 to NA | months | |
| Complete Response Rate | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 57.6 | percentage of participants | ||
| Complete Response Rate | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 65.5 | percentage of participants | ||
| Time-to-Next Treatment | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 92.0 | 95% Confidence Interval 71.5 to NA | months | |
| Time-to-Next Treatment | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | NA | 95% Confidence Interval NA to NA | months | |
| Percentage of Participants With Overall Response | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 88.5 | percentage of participants | ||
| Percentage of Participants With Overall Response | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 89.7 | percentage of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 262 | |
| Overall Study | STARTED | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 261 | |
| Overall Study | Safety Analysis Set (Treated) | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 260 | |
| Overall Study | Safety Analysis Set (Treated) | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 259 | |
| Overall Study | COMPLETED | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 129 | |
| Overall Study | COMPLETED | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 119 | |
| Overall Study | NOT COMPLETED | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 133 | |
| Overall Study | NOT COMPLETED | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 142 |
Source ClinicalTrials.gov
Adverse events916
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 | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 60 | 260 | |
| other | Anaemia | Blood and lymphatic system disorders | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 83 | 259 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 14 | 260 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 27 | 259 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 14 | 260 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 18 | 259 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 104 | 260 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 109 | 259 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 43 | 260 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 62 | 259 |
1 to 10 of 916Source ClinicalTrials.gov
See all 916 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 129 | 262 |
| Total, all-cause mortality | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 120 | 261 |
| Total, other adverse events | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 255 | 260 |
| Total, other adverse events | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 256 | 259 |
| Total, serious adverse events | Placebo + Bendamustine and Rituximab (BR) (Treatment A) | 157 | 260 |
| Total, serious adverse events | Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B) | 201 | 259 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35657079 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Bendamustine and Rituximab (BR) (Treatment A) vs Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Placebo + Bendamustine and Rituximab (BR) (Treatment A) vs Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B): deaths from any cause | Trial comparisons |
| Placebo + Bendamustine and Rituximab (BR) (Treatment A) vs Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B): serious adverse events | 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.
For software
Read this trial from software.
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