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
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.