NCT04529772

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

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma (activated B-cell (ABC) and unclassified).

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	acalabrutinib	Investigational Product
DRUG	placebo	Placebo comparator
DRUG	Prednisone	Investigational Product
DRUG	Rituximab	Investigational Product
DRUG	Cyclophosphamide	Investigational Product
DRUG	Vincristine	Investigational Product
DRUG	Doxorubicin	Investigational Product

Timeline

• Start date: 2020-10-08
• Primary completion: 2027-02-22
• Completion: 2027-02-22
• First posted: 2020-08-28
• Last updated: 2026-03-31

Locations

243 sites across 23 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study