Phase II Study Comparing Orelabrutinib Plus Rituximab to R-CVP for Newly Diagnosed Marginal Zone Lymphoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of combining orelabrutinib with rituximab compared to the R-CVP regimen in patients with previously untreated marginal zone lymphoma MZL. This randomized, open-label, multicenter, phase II clinical trial focuses on patients with advanced-stage MZL who require treatment. The study aims to explore a chemotherapy-free option using orelabrutinib, a second-generation BTK inhibitor that has shown promise in relapsed or refractory MZL, followed by maintenance therapy. Participants are assigned to one of two treatment groups. One group receives oral orelabrutinib 150mg once daily for 24 cycles each cycle lasting 4 weeks combined with intravenous rituximab 375mgm2 on day 1 of each of the first 6 cycles. The other group receives the R-CVP regimen, consisting of intravenous rituximab, cyclophosphamide, vincristine, and oral prednisone over 8 cycles each cycle lasting 3 weeks, followed by rituximab maintenance therapy for up to two years or until intolerable toxicity. Throughout the study, participants will undergo regular assessments including imaging scans such as enhanced CT or MRI to measure lesions, laboratory tests, and safety monitoring for up to three years. Researchers will track response rates, progression-free survival, and safety parameters. The primary outcome is the complete response rate assessed up to two years. Participants will be monitored closely to evaluate treatment effects and ensure compliance with study procedures during this period.

Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial