Study of Acalabrutinib With Rituximab to Treat Elderly or Younger Patients With Untreated Mantle Cell Lymphoma at Low to Intermediate Risk

What this Trial Is About

Researchers are evaluating Acalabrutinib combined with Rituximab for treating elderly patients or younger individuals with low- to intermediate-risk untreated mantle cell lymphoma. This phase II, single-arm, open-label, multicenter study aims to assess the effectiveness and safety of this treatment approach. The study focuses on patients with confirmed CD20 mantle cell lymphoma who have not received prior anti-lymphoma therapy. Participants will receive Acalabrutinib orally at 100 mg twice daily and continue this treatment until disease progression, intolerable side effects, or completion of 24 months. Alongside, Rituximab is given intravenously at 375 mgm2 once weekly during the first cycle, then once monthly for 12 months, followed by infusions every two months, for a maximum of 24 months. The treatment duration and dosing schedules are carefully structured to monitor response. During the study, participants will undergo regular assessments to evaluate their response to treatment, including measuring the complete response rate after 12 months. Additional outcome measures include objective response rate, duration of response, progression-free survival, and overall survival, with follow-up extending up to five years. Safety and organ function will be closely monitored, and participants must comply with all study procedures and provide informed consent. The study is sponsored by Sun Yat-sen University and started in April 2025, with completion anticipated by February 2033.

Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma