Study of Orelabrutinib with Rituximab and Optional Lenalidomide for Untreated Marginal Zone Lymphoma Phase II, Response-Adapted Stratified Therapy

What this Trial Is About

Researchers are evaluating a combination of orelabrutinib with rituximab, with or without lenalidomide, in a response-adapted treatment approach for patients newly diagnosed with marginal zone lymphoma MZL. This single-arm, phase II study aims to assess the safety and effectiveness of this combination by measuring the complete response rate after treatment. MZL is a type of lymphoma that includes several subtypes and represents about 7.8% of all non-Hodgkin lymphomas, with some patients experiencing relapse or disease progression despite generally favorable outcomes. Participants will receive orelabrutinib and rituximab for six cycles, each cycle lasting 21 days. After these initial cycles, patients who achieve a complete response will continue with the same combination for another six cycles. Those with partial response or stable disease will receive an additional six cycles that include lenalidomide alongside orelabrutinib and rituximab. Patients whose disease progresses during treatment will discontinue the study therapy. Throughout the study, participants will be closely monitored with assessments to measure their response to treatment, including the complete response rate at the end of 12 cycles. Additional outcomes include overall response rate, progression-free survival, and overall survival over two years. The trial involves regular clinical evaluations and safety monitoring to track participant health and treatment effects, lasting until disease progression, death, or study completion.

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL