drugset / Trial / NCT05051891

A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

NCT05051891

Phase 3 Completed 3 enrolled Beijing InnoCare Pharma Tech Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.

Timeline

Start
2021-12-22
Primary completion
2025-06-30
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Orelabrutinib Small molecule
Background Cyclophosphamide Other / unclassified
Background Doxorubicin Other / unclassified
Background Prednisone Other / unclassified
Background Rituximab Monoclonal antibody
Background Vincristine Small molecule

Indications