NCT02972840

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 635 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Lymphoma, Mantle Cell

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Administered orally (PO)
DRUG	Bendamustine	Administered intravenously (IV)
DRUG	Rituximab	Administered intravenously (IV)
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2017-04-05
• Primary completion: 2027-02-15
• Completion: 2027-02-15
• First posted: 2016-11-25
• Last updated: 2026-02-18

Locations

228 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, Vietnam

Regulatory

• FDA-regulated drug study