A Randomized Phase 3 Trial Comparing Continuous Versus Intermittent Zanubrutinib Maintenance Therapy for Older Patients With Previously Untreated Mantle Cell Lymphoma

What this Trial Is About

Researchers are evaluating zanubrutinib treatment approaches for older adults with mantle cell lymphoma MCL who have not been treated before. This phase III trial compares continuous versus intermittent zanubrutinib after patients achieve complete remission with initial zanubrutinib plus rituximab therapy. The study aims to find out if stopping zanubrutinib until disease progression is as safe and effective as continuing it indefinitely, which could reduce treatment and financial burdens for older patients. Participants first receive induction therapy combining oral zanubrutinib and intravenous rituximab, along with bone marrow biopsies and imaging scans such as PETCT or CT. Those who achieve complete remission are then randomly assigned to one of two maintenance treatments continuous zanubrutinib until disease progression, or observation until progression followed by zanubrutinib restarted until second progression. Optional blood sample collection and additional procedures like endoscopy may be performed when needed. Throughout the trial, patients undergo regular imaging CT, MRI, or PETCT and laboratory assessments to monitor their response and safety. Researchers measure progression-free survival, overall survival, response rates, adverse events, and quality of life using validated questionnaires. After treatment ends, participants are followed for up to 10 years with visits every six months to assess long-term outcomes and health status.

Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma