Study of Orelabrutinib with Rituximab as First Treatment for Marginal Zone Lymphoma

What this Trial Is About

Marginal zone lymphoma MZL is a common type of B-cell non-Hodgkin lymphoma. Researchers are evaluating the efficacy and safety of combining orelabrutinib with rituximab as a first-line systemic treatment for MZL. This is a single-arm, prospective clinical trial aiming to explore a chemotherapy-free regimen that may offer a safer alternative to intensive immunochemotherapy, which has high rates of serious side effects. The study focuses on patients with newly diagnosed MZL who need systemic therapy. All participants will receive induction treatment with orelabrutinib and rituximab over six 28-day cycles. In the first cycle, rituximab is given on Day 1. From the second to the sixth cycle, participants take oral orelabrutinib daily and receive rituximab on Day 1 of each cycle. Patients who respond partially or better will then enter a 2-year maintenance period taking orelabrutinib alone. This treatment plan is designed to assess the combined impact of these drugs over extended time. Participants will undergo various assessments during the study, including measuring overall response rate up to 6 months and monitoring complete response, duration of response, progression-free survival, and overall survival for up to 2 years. Safety and tolerability will also be evaluated throughout. The trial involves regular clinical evaluations and laboratory tests to track treatment effects and health status. Total participation may last over 2 years, including induction and maintenance phases.

Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma