Trial · NCT01855750
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
NCT01855750, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2019-03-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma. Trials, record NCT01855750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01855750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
- NCT number
- NCT01855750
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 838 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Lymphoma
- Interventions
- Ibrutinib, Placebo, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (or equivalent)
- First posted
- 2013-05-16
- Last updated
- 2025-02-04
- Other registries' IDs
- eudract:2013-000959-40
- Results first posted
- 2019-03-19
- Limitations and caveats
- Sponsor decided to stop the study as all participants had concluded study treatment and outcomes were not expected to change and study was considered as completed.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population | Up to 5.5 years | EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; 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. |
| Primary | Event-Free Survival (EFS) - Activated B-Cell (ABC) Population | Up to approximately 4.5 years | EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD 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. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; 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. |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 4.5 years | PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (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. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; 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. |
| Secondary | Percentage of Participants Who Achieved Complete Response (CR) | Up to approximately 4.5 years | Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to \[\<=\]1.5 cm in greatest transverse diameter \[GTD\] for nodes greater than \[\>\]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (\>)1.0 cm in short axis before treatment decreased to \<=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. |
| Secondary | Overall Survival | Up to 5.5 years | Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method. |
| Secondary | Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) | Up to approximately 4.5 years | 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. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population | Up to 5.5 years | Intent-to-Treat (ITT) population included all randomized participants, enrolled with non-germinal center B-cell (GCB) of diffuse large B-cell lymphoma (DLBCL) subtype by immunohistochemistry (IHC), and were analyzed according to treatment to which they were randomized. | Months | MEDIAN |
| PRIMARY | Event-Free Survival (EFS) - Activated B-Cell (ABC) Population | Up to approximately 4.5 years | ABC population included ITT population (all randomized participants, enrolled with non-GCB of DLBCL subtype by IHC) having ABC subtype determined by gene expression profiling (GEP) (retrospectively determined from available formalin-fixed paraffin-embedded \[FFPE\] tissue specimens). Participants were analyzed according to randomized treatment. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to approximately 4.5 years | ITT population included all randomized participants, enrolled with non-GCB of DLBCL subtype by IHC, and were analyzed according to treatment to which they were randomized. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved Complete Response (CR) | Up to approximately 4.5 years | ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Up to 5.5 years | ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) | Up to approximately 4.5 years | ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population | Treatment Arm B: Ibrutinib+R-CHOP | 49.64 | 95% Confidence Interval 47.47 to NA | Months | |
| Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population | Treatment Arm A: Placebo+R-CHOP | 54.77 | 95% Confidence Interval 48.16 to 54.77 | Months | |
| Event-Free Survival (EFS) - Activated B-Cell (ABC) Population | Treatment Arm B: Ibrutinib+R-CHOP | 48.56 | 95% Confidence Interval 48.56 to NA | Months | |
| Event-Free Survival (EFS) - Activated B-Cell (ABC) Population | Treatment Arm A: Placebo+R-CHOP | 48.16 | 95% Confidence Interval 48.16 to NA | Months | |
| Progression-Free Survival (PFS) | Treatment Arm B: Ibrutinib+R-CHOP | 48.56 | 95% Confidence Interval 48.56 to NA | Months | |
| Progression-Free Survival (PFS) | Treatment Arm A: Placebo+R-CHOP | NA | 95% Confidence Interval 48.16 to NA | Months | |
| Percentage of Participants Who Achieved Complete Response (CR) | Treatment Arm B: Ibrutinib+R-CHOP | 67.3 | Percentage of participants | ||
| Percentage of Participants Who Achieved Complete Response (CR) | Treatment Arm A: Placebo+R-CHOP | 68.0 | Percentage of participants | ||
| Overall Survival | Treatment Arm B: Ibrutinib+R-CHOP | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival | Treatment Arm A: Placebo+R-CHOP | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm B: Ibrutinib+R-CHOP | 419 | |
| Overall Study | STARTED | Treatment Arm A: Placebo+R-CHOP | 419 | |
| Overall Study | Treated | Treatment Arm B: Ibrutinib+R-CHOP | 416 | |
| Overall Study | Treated | Treatment Arm A: Placebo+R-CHOP | 418 | |
| Overall Study | COMPLETED | Treatment Arm B: Ibrutinib+R-CHOP | 0 | |
| Overall Study | COMPLETED | Treatment Arm A: Placebo+R-CHOP | 0 | |
| Overall Study | NOT COMPLETED | Treatment Arm B: Ibrutinib+R-CHOP | 419 | |
| Overall Study | NOT COMPLETED | Treatment Arm A: Placebo+R-CHOP | 419 |
Source ClinicalTrials.gov
Adverse events566
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 | Treatment Arm B: Ibrutinib+R-CHOP | 173 | 416 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Arm A: Placebo+R-CHOP | 116 | 418 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Treatment Arm B: Ibrutinib+R-CHOP | 41 | 416 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Treatment Arm A: Placebo+R-CHOP | 22 | 418 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Arm B: Ibrutinib+R-CHOP | 70 | 416 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Arm A: Placebo+R-CHOP | 74 | 418 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment Arm B: Ibrutinib+R-CHOP | 23 | 416 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment Arm A: Placebo+R-CHOP | 36 | 418 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment Arm B: Ibrutinib+R-CHOP | 213 | 416 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment Arm A: Placebo+R-CHOP | 248 | 418 |
1 to 10 of 566Source ClinicalTrials.gov
See all 566 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm B: Ibrutinib+R-CHOP | 78 | 416 |
| Total, all-cause mortality | Treatment Arm A: Placebo+R-CHOP | 78 | 418 |
| Total, other adverse events | Treatment Arm B: Ibrutinib+R-CHOP | 411 | 416 |
| Total, other adverse events | Treatment Arm A: Placebo+R-CHOP | 411 | 418 |
| Total, serious adverse events | Treatment Arm B: Ibrutinib+R-CHOP | 221 | 416 |
| Total, serious adverse events | Treatment Arm A: Placebo+R-CHOP | 143 | 418 |
Source ClinicalTrials.gov
Papers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP vs Treatment Arm A: Placebo+R-CHOP: deaths from any cause | Trial comparisons |
| Treatment Arm B: Ibrutinib+R-CHOP vs Treatment Arm A: Placebo+R-CHOP: 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/NCT01855750
GET https://conductscience.org/api/trials/v1/NCT01855750/events?page=2