NCT01855750|CompletedPhase 3ResultsDMC

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

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Janssen Research & Development, LLC ClinicalTrials.gov

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4 other identifiers

CR102118PCI-32765DBL3001U1111-1139-62222013-000959-40

Study Type

interventional

Target

838

Locations

27 countries

Sites

201

Timeline

RegisteredMay 2013

StartedSep 2013

CompletionApr 2019

Brief Summary

The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

838

participants targeted

Target at P75+ for phase_3 lymphoma

Timeline

Completed

Started Sep 2013

Geographic Reach

27 countries

201 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

First Submitted

Initial submission to the registry

May 14, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed

4 months until next milestone

Study Start

First participant enrolled

September 3, 2013

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 19, 2019

Completed

17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed

Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

4.5 years

First QC Date

May 14, 2013

Results QC Date

February 22, 2019

Last Update Submit

January 31, 2025

Conditions

Lymphoma

Keywords

LymphomaB-cell lymphomaNon-germinal center B-cell subtypeDiffuse large B-cell lymphomaBruton's tyrosine kinase inhibitorPCI-32765JNJ-54179060IbrutinibRituximabCyclophosphamideDoxorubicinVincristinePrednisone

Outcome Measures

Primary Outcomes (2)

Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
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.
Up to 5.5 years
Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
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.
Up to approximately 4.5 years

Secondary Outcomes (4)

Progression-Free Survival (PFS)
Up to approximately 4.5 years
Percentage of Participants Who Achieved Complete Response (CR)
Up to approximately 4.5 years
Overall Survival
Up to 5.5 years
Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Up to approximately 4.5 years

Study Arms (2)

Treatment Arm A: placebo + R-CHOP

PLACEBO COMPARATOR

Treatment Arm A = placebo + R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone)

Drug: PlaceboDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: Prednisone (or equivalent)

Treatment Arm B: ibrutinib + R-CHOP

EXPERIMENTAL

Treatment Arm B = ibrutinib + R-CHOP

Drug: IbrutinibDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: Prednisone (or equivalent)

Interventions

IbrutinibDRUG

560 mg capsules administered by mouth once daily (21-day cycles)

Treatment Arm B: ibrutinib + R-CHOP

PlaceboDRUG

4 matched capsules administered by mouth once daily (21-day cycles)

Treatment Arm A: placebo + R-CHOP

RituximabDRUG

375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)