At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)
In Brief
A Phase 3 clinical trial evaluating Bendamustine, Rituximab, and 6 other interventions for Lymphoma. Completed, enrolled 403 participants across 135 sites in 19 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.
Study Details
Timeline
Interventions
90 milligram per meter square (mg/m\^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.
375 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.
750 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.
50 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.
1.4 mg/m\^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.
100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.
560 mg (4\*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.
Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.