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

Official Title

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤70 Years With Previously Untreated Non-GCB DLBCL

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 ≤70 years of age with previously untreated non-germinal centre diffuse large B-cell lymphoma.

Trial Description

Primary Outcome:

• Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B

Secondary Outcome:

• Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B
• Overall survival in Arm A compared to Arm B
• Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification at the end of study treatment

Phase 3 randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as compared with placebo plus R-CHOP in subjects ≤70 years of age with previously untreated non-germinal centre diffuse large B-cell lymphoma (activated B-cell (ABC) and unclassified).

View this trial on ClinicalTrials.gov