A study of BR alone versus in combination with acalabrutinib in subjects with previously untreated MCL

Study identifier:ACE-LY-308

ClinicalTrials.gov identifier:NCT02972840

EudraCT identifier:2015-005220-26

CTIS identifier:2023-509354-58-00

Recruitment Complete

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

Medical condition

Lymphoma, Mantle Cell

Phase

Phase 3

Healthy volunteers

No

Study drug

Acalabrutinib, Bendamustine, Rituximab, Placebo

Sex

All

Actual Enrollment

635

Study type

Interventional

Age

65 Years - n/a

Date

Study Start Date: 05 Apr 2017
Estimated Primary Completion Date: 28 Oct 2025
Estimated Study Completion Date: 28 Oct 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2024 by AcertaPharma

Sponsors

AcertaPharma

Collaborators

AstraZeneca

Inclusion and exclusion criteria