Phase 2 Study of Acalabrutinib Plus DA-EPOCH-R or R-CHOP in Adults With Untreated Aggressive Diffuse Large B-Cell Lymphoma

What this Trial Is About

Diffuse large B-cell lymphoma DLBCL is the most common type of non-Hodgkin lymphoma, and while many people can be cured, those who are not have a poor outlook. Researchers are studying whether adding the drug acalabrutinib to standard treatments like rituximab combined with chemotherapy can improve the cure rates for aggressive B-cell lymphomas, including DLBCL. This phase 2 study focuses on untreated patients with different molecular and genetic subtypes of DLBCL to better understand responses to treatment. Participants begin with a 14-day period taking acalabrutinib pills twice daily. After this initial treatment, scans assess tumor response. Depending on the reduction in tumor size, participants receive either standard chemotherapy with rituximab alone or combined with acalabrutinib for up to six 21-day cycles. Chemotherapy regimens include DA-EPOCH-R or R-CHOP, administered intravenously. Some participants may also receive up to four doses of a drug injected into their spinal fluid. Throughout treatment, participants undergo repeated tests and scans to monitor progress. During the study, participants attend regular visits for blood and urine tests, physical exams, tumor biopsies, and imaging scans. Follow-up visits occur 30 days after the last treatment, then every 3 months for 2 years, every 6 months for 3 years, and yearly thereafter. Researchers measure response rates every two cycles, monitor safety and tolerability, and assess progression-free, event-free, and overall survival over several years. The study aims to gather detailed information about treatment effects and long-term outcomes.

Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma