Evaluation of Acalabrutinib Combined With R-CHOP Chemotherapy for Untreated Mantle Cell Lymphoma in Spain

What this Trial Is About

Researchers are evaluating the combination of acalabrutinib with the standard chemotherapy regimen R-CHOP for the initial treatment of mantle cell lymphoma MCL in adults in Spain. This phase II, open-label, single-arm study aims to describe the safety and efficacy of this treatment approach for previously untreated MCL patients. The trial includes a safety run-in for older patients and an efficacy assessment after six cycles of induction therapy. Participants receive acalabrutinib orally twice daily along with up to six 21-day cycles of R-CHOP chemotherapy during the induction phase. After completing induction, patients who tolerate treatment and do not have disease progression continue acalabrutinib monotherapy. Those achieving a response will also receive maintenance rituximab every other 28-day cycle for up to twelve doses. Following maintenance, acalabrutinib monotherapy is continued until disease progression or treatment discontinuation. Throughout the study, participants are monitored regularly with clinical evaluations, safety assessments, and response measurements up to 30 months after the last participant is enrolled. Researchers will measure outcomes such as overall response rate, time to response, duration of response, progression-free survival, and overall survival. Safety and tolerability are also closely tracked from enrollment until 30 days after the last dose or disease progression.

A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain