drugset
drugset / Trial / NCT04529772

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

NCT04529772 ↗

Phase 3 Active not recruiting 611 enrolled Acerta Pharma BV AstraZeneca · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

Timeline

Start
2020-10-08
Primary completion
2027-02-22
Completion
2027-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule — —
Background Cyclophosphamide Other / unclassified — —
Background Doxorubicin Other / unclassified — —
Background Prednisone Other / unclassified — —
Background Rituximab Monoclonal antibody — —
Background Vincristine Small molecule — —

Indications

diffuse large B-cell lymphoma