drugset / Trial / NCT02972840

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

Outcome

Met primary endpoint

paper the median PFS was 66.4 months in the acalabrutinib arm and 49.6 months in the placebo arm PMID 40311141 ↗

paper hazard ratio [HR], 0.73 [95% CI, 0.57 to 0.94]; P = .0160 PMID 40311141 ↗

release “ECHO Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival” astrazeneca.com ↗

release “Results from the ECHO trial showed Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy” astrazeneca.com ↗

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