drugset / Trial / NCT06700798

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

NCT06700798

Phase 2 Recruiting 90 enrolled Fei Li
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL

Timeline

Start
2024-12-01
Primary completion
2026-05-04
Completion
2027-12-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Subject Orelabrutinib Small molecule 150 mg Oral
Comparator Prednisone Other / unclassified 60 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous