Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Status:
RECRUITING
Trial end date:
2027-07-10
Target enrollment:
Participant gender:
Summary
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.
Phase:
PHASE3
Details
Lead Sponsor:
Ruijin Hospital
Collaborators:
Anhui Provincial Cancer Hospital Fujian Cancer Hospital Fujian Medical University Union Hospital Huadong Hospital Affiliated with Fudan University, Shanghai Jiangxi Provincial Cancer Hospital The First Affiliated Hospital of Anhui Medical University Third Xiangya Hospital of Central South University Yantai Yuhuangding Hospital