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

Lymphoma, Mantle Cell Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02972840
Study type	Interventional
Source	Acerta Pharma BV
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	April 5, 2017
Completion date	October 28, 2025

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See also
	Status	Clinical Trial	Phase
	Completed	`NCT00114738` - EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma	Phase 2
	Completed	`NCT00005780` - Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma	Phase 2