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

Phase 3 Active not recruiting 635 enrolled Acerta Pharma BV AstraZeneca · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2017-04-05
Primary completion: 2027-02-15
Completion: 2027-02-15

Publications

Wang M, Salek D, Belada D, Song Y, Jurczak W, Kahl BS, Paludo J, Chu MP, Kryachok I, Fogliatto L, Cheah CY, Morawska M, Sancho JM, Li Y, Patti C, Forsyth C, Zhang J, Lesley R, Ramadan S, Rule S, Dreyling M; ECHO investigators; ECHO Investigators. Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma. J Clin Oncol. 2025 Jul 10;43(20):2276-2284. doi: 10.1200/JCO-25-00690. Epub 2025 May 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acalabrutinib	Small molecule	100 mg	Oral
Background	Bendamustine	Small molecule	90 mg/m2	Intravenous
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications