A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination with Acalabrutinib (ACP-196) in Subjects with Previously Untreated Mantle Cell Lymphoma
This clinical trial is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating acalabrutinib plus BR compared with placebo plus BR in subjects with previously untreated MCL. Approximately 546 subjects meeting the eligibility criteria for the study will be randomized 1:1 (DLBCL, Diffus großzellige B-Zell-Lyphom, Lymphozyten, B-Lymphozyten, Lymphom, follikuläres Lymphom, Mantelzell-Lyphom, Non-Hodgkin-Lymphom)
Arm 1: Acalabrutinib administered 100 mg twice per day (BID) orally (PO) plus bendamustine 90 mg/m2 intravenously (IV) on Days 1 and 2 and rituximab 375 mg/m2 IV on Day 1; cycles are repeated every 28 days.
Arm 2: Matching placebo administered BID PO plus bendamustine 90 mg/m2 IV on Days 1 and 2 and rituximab 375 mg/m2 IV on Day 1; cycles are repeated every 28 days.
