Trial · NCT01974440
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
NCT01974440, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2023-04-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma. Trials, record NCT01974440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01974440
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
- NCT number
- NCT01974440
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 403 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Lymphoma
- Interventions
- Bendamustine, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, PCI-32765 (Ibrutinib), Placebo
- First posted
- 2013-11-01
- Last updated
- 2025-05-25
- Other registries' IDs
- eudract:2013-003093-27
- Results first posted
- 2023-04-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Analysis: Progression Free Survival (PFS): Stratified Analysis | Up to 8 years | PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir disease progression 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. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. |
| Primary | Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) | Up to 8 years | PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by \>=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. |
| Secondary | Primary Analysis: Overall Survival (OS): Stratified Analysis | Up to 8 years | OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. |
| Secondary | Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL | Up to 8 years | OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. |
| Secondary | Primary Analysis: Complete Response Rate (CRR): Stratified Analysis | Up to 8 years | CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma 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 CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. |
| Secondary | Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL | Up to 8 years | CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. 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 and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. |
| Secondary | Primary Analysis: Overall Response Rate (ORR): Stratified Analysis | Up to 8 years | ORR was defined as the percentage of participants who achieved a CR or partial response (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 and no new sites of disease detected during assessment. Criteria for PR: \>=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. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. |
| Secondary | Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL | Up to 8 years | ORR in MZL participants was defined as the percentage of participants who achieved a 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 and no new sites of disease detected during assessment. Criteria for PR: \>=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. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. |
| Secondary | Primary Analysis: Duration of Response (DOR): Stratified Analysis | Up to 8 years | DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. 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 and no new sites of disease detected during assessment. Criteria for PR: \>=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. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. |
| Secondary | Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL | Up to 8 years | DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. 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 and no new sites of disease detected during assessment. Criteria for PR: \>=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. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Analysis: Progression Free Survival (PFS): Stratified Analysis | Up to 8 years | Intent-to-treat (ITT) population included all randomized participants who were enrolled with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and were analyzed according to the treatment to which they were randomized. | months | MEDIAN |
| PRIMARY | Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) | Up to 8 years | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | months | MEDIAN |
| SECONDARY | Primary Analysis: Overall Survival (OS): Stratified Analysis | Up to 8 years | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. | months | MEDIAN |
| SECONDARY | Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL | Up to 8 years | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | months | MEDIAN |
| SECONDARY | Primary Analysis: Complete Response Rate (CRR): Stratified Analysis | Up to 8 years | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL | Up to 8 years | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Primary Analysis: Overall Response Rate (ORR): Stratified Analysis | Up to 8 years | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL | Up to 8 years | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Primary Analysis: Duration of Response (DOR): Stratified Analysis | Up to 8 years | ITT population included all randomized participants who were enrolled with FL or MZL and were analyzed according to the treatment to which they were randomized. Participants who achieved a PR or better were included in the analysis of duration of response. | months | MEDIAN |
| SECONDARY | Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL | Up to 8 years | All randomized participants who were enrolled with MZL and were analyzed according to the treatment to which they were randomized. Participants who achieved a PR or better were included in the analysis of duration of response. | months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Analysis: Progression Free Survival (PFS): Stratified Analysis | Placebo + Chemoimmunotherapy (CIT) | 23.75 | 95% Confidence Interval 20.11 to 31.18 | months | |
| Primary Analysis: Progression Free Survival (PFS): Stratified Analysis | Ibrutinib + CIT | 40.51 | 95% Confidence Interval 32.62 to 52.80 | months | |
| Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) | Placebo + Chemoimmunotherapy (CIT) | 91.63 | 95% Confidence Interval 9.23 to NA | months | |
| Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) | Ibrutinib + CIT | NA | 95% Confidence Interval 49.25 to NA | months | |
| Primary Analysis: Overall Survival (OS): Stratified Analysis | Placebo + Chemoimmunotherapy (CIT) | NA | 95% Confidence Interval 94.19 to NA | months | |
| Primary Analysis: Overall Survival (OS): Stratified Analysis | Ibrutinib + CIT | NA | 95% Confidence Interval NA to NA | months | |
| Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL | Placebo + Chemoimmunotherapy (CIT) | NA | 95% Confidence Interval 75.86 to NA | months | |
| Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL | Ibrutinib + CIT | NA | 95% Confidence Interval NA to NA | months | |
| Primary Analysis: Complete Response Rate (CRR): Stratified Analysis | Placebo + Chemoimmunotherapy (CIT) | 50.2 | percentage of participants | ||
| Primary Analysis: Complete Response Rate (CRR): Stratified Analysis | Ibrutinib + CIT | 55 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Chemoimmunotherapy (CIT) | 201 | |
| Overall Study | STARTED | Ibrutinib + CIT | 202 | |
| Overall Study | Safety Analysis Set | Placebo + Chemoimmunotherapy (CIT) | 199 | |
| Overall Study | Safety Analysis Set | Ibrutinib + CIT | 201 | |
| Overall Study | Participants With Marginal Zone Lymphoma (MZL) | Placebo + Chemoimmunotherapy (CIT) | 28 | |
| Overall Study | Participants With Marginal Zone Lymphoma (MZL) | Ibrutinib + CIT | 28 | |
| Overall Study | Participants With Follicular Lymphoma (FL) | Placebo + Chemoimmunotherapy (CIT) | 173 | |
| Overall Study | Participants With Follicular Lymphoma (FL) | Ibrutinib + CIT | 174 | |
| Overall Study | COMPLETED | Placebo + Chemoimmunotherapy (CIT) | 61 | |
| Overall Study | COMPLETED | Ibrutinib + CIT | 65 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events610
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 + Chemoimmunotherapy (CIT) | 39 | 199 | |
| other | Anaemia | Blood and lymphatic system disorders | Ibrutinib + CIT | 50 | 201 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Chemoimmunotherapy (CIT) | 26 | 199 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ibrutinib + CIT | 27 | 201 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + Chemoimmunotherapy (CIT) | 23 | 199 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Ibrutinib + CIT | 18 | 201 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Chemoimmunotherapy (CIT) | 69 | 199 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ibrutinib + CIT | 75 | 201 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Chemoimmunotherapy (CIT) | 28 | 199 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib + CIT | 46 | 201 |
1 to 10 of 610Source ClinicalTrials.gov
See all 610 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Chemoimmunotherapy (CIT) | 61 | 201 |
| Total, all-cause mortality | Ibrutinib + CIT | 65 | 202 |
| Total, other adverse events | Placebo + Chemoimmunotherapy (CIT) | 196 | 199 |
| Total, other adverse events | Ibrutinib + CIT | 198 | 201 |
| Total, serious adverse events | Placebo + Chemoimmunotherapy (CIT) | 76 | 199 |
| Total, serious adverse events | Ibrutinib + CIT | 113 | 201 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37722354 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Chemoimmunotherapy (CIT) vs Ibrutinib + CIT: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Placebo + Chemoimmunotherapy (CIT) vs Ibrutinib + CIT: deaths from any cause | Trial comparisons |
| Placebo + Chemoimmunotherapy (CIT) vs Ibrutinib + CIT: Number of Participants With TEAEs: Participants With MZL | Trial comparisons |
| Placebo + Chemoimmunotherapy (CIT) vs Ibrutinib + CIT: 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01974440
GET https://conductscience.org/api/trials/v1/NCT01974440/results?page=2