A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB Subtype 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 in Subjects ≤65 Years With Previously Untreated Non-Germinal Centre 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 ≤65 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 ≤65 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

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Resources

Canadian Cancer Society

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