A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicentre Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

Summary:

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

Trial Description

Primary Outcome:

• Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2

Secondary Outcome:

• Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
• Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
• IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
• Overall survival in Arm 1 compared to Arm 2
• IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
• IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2

To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).

View this trial on ClinicalTrials.gov