CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 838 enrolled
Drug / intervention
Ibrutinib +6 moredrug
Likely dose
Ibrutinib 560 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01855750
NCT01855750Phase 3Completed
CompareCT.gov

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·interventional·Posted May 16, 2013·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating Ibrutinib, Placebo, and 5 other interventions for Lymphoma. Completed, enrolled 838 participants across 201 sites in 27 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Japan, Mexico, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsPharmacyclics LLC.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 16, 2013
Enrollment StartSep 3, 2013
Primary CompletionFeb 26, 2018
Study CompletionApr 5, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.1 years ago

Interventions

Ibrutinibdrug

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

Placebodrug

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

Rituximabdrug

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

Cyclophosphamidedrug

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

Doxorubicindrug

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

Vincristinedrug

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

Prednisone (or equivalent)drug

100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle