Study of Orelabrutinib Alone or With CD20 Antibody in Adults With Untreated Marginal Zone Lymphoma

What this Trial Is About

Researchers are evaluating treatments for patients newly diagnosed with marginal zone lymphoma MZL, focusing on the effectiveness and safety of orelabrutinib alone or combined with a CD20 monoclonal antibody. This study addresses the lack of a standard first-line therapy for MZL and aims to explore chemotherapy-free options with fewer side effects. Orelabrutinib is a newer BTK inhibitor known for its selectivity and safety, and it may work well with CD20 antibodies. The trial includes patients at different disease stages and monitors tumor response and side effects closely. Participants receive orelabrutinib treatment in all study groups but are divided based on disease stage. Those with Stage I MZL receive orelabrutinib monotherapy, taking 150mg orally once daily for 21 days per cycle, over six cycles. Patients with Stages II to IV MZL receive orelabrutinib combined with either rituximab or obinutuzumab, given through intravenous infusions on specific days during the same six treatment cycles. A maintenance phase with orelabrutinib may follow the initial treatment cycles for the combination group. Throughout the study, participants undergo regular imaging and lab tests to evaluate tumor changes and overall response. Safety is assessed by recording all adverse reactions in detail. Long-term follow-up tracks progression-free and overall survival rates up to two years and beyond. The primary outcome is the overall response rate by the end of 21 weeks of treatment, with additional measures including complete response rate and safety monitoring over approximately 2.5 years.

Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma