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drugset / Trial / NCT06504940

Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)

NCT06504940 ↗

Phase 2 Recruiting 69 enrolled First Affiliated Hospital of Zhejiang University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.

Timeline

Start
2024-06-28
Primary completion
2027-07-08
Completion
2029-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 70 mg/m2 —
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Subject Orelabrutinib Small molecule 150 mg —
Subject Rituximab Monoclonal antibody 375 mg/m2 —

Indications

marginal zone lymphoma