A Phase 3 Study of Acalabrutinib Combined With Rituximab and Reduced Dose CHOP R-miniCHOP in Older Adults Treating Untreated Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating whether adding Acalabrutinib to the standard R-miniCHOP chemotherapy can improve progression-free survival in older adults with untreated diffuse large B-cell lymphoma DLBCL. This phase 3, randomized trial compares outcomes of patients receiving R-miniCHOP alone with those receiving R-miniCHOP plus Acalabrutinib. The study focuses on individuals 61 years and older who are ineligible for full-dose R-CHOP treatment. Participants will be randomly assigned to one of two groups one receiving 6 cycles of R-miniCHOP plus 2 doses of Rituximab, and the other receiving the same regimen combined with Acalabrutinib taken orally twice daily for 8 cycles. The chemotherapy cycles are repeated every 3 weeks, and the study is open-label, meaning both participants and researchers know which treatment is given. During the trial, participants will undergo regular assessments to monitor disease progression, survival, remission rates, and adverse events for up to 5 years. Researchers will evaluate blood tests, physical exams, and other health parameters to measure outcomes such as progression-free survival, overall survival, event-free survival, and treatment safety. The study aims to provide detailed information on long-term effects and treatment tolerability in this older patient population.

Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma