Study of Risk-Adapted Targeted Therapy Based on MZL-IPI in Untreated Marginal Zone B-cell Lymphoma Patients

What this Trial Is About

Marginal zone lymphoma MZL is a common slow-growing lymphoma that arises from the marginal zone of lymphoid follicles. Researchers are evaluating targeted therapies tailored to the risk level of MZL-IPI in newly diagnosed patients who need systemic treatment. This study aims to establish a precision treatment approach based on prognostic risk stratification for untreated MZL cases. Participants receive treatment based on their risk group low-risk patients MZL-IPI 0-2 points receive the Obinutuzumab and Orelabrutinib O2 regimen, while high-risk patients MZL-IPI 3-5 points receive the Obinutuzumab, Orelabrutinib, and Lenalidomide O2R regimen. Induction therapy includes Obinutuzumab given on specific days across 6 cycles, Orelabrutinib taken daily, and Lenalidomide for high-risk patients. After induction, maintenance treatment consists of daily Orelabrutinib monotherapy for up to 24 months. Throughout the study, participants will be monitored for 2-year progression-free survival, response rates at 6 cycles, 12 months, and 24 months, and treatment-related side effects. Assessments include evaluating response duration, histological transformation, and overall survival over approximately 24 months. Participants must comply with study procedures and will have regular evaluations of bone marrow, liver, and kidney function as well as performance status during the trial.

MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL