Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

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.

NCT Number	NCT06496308
Lead Sponsor	Ruijin Hospital Collaborators: The Third Xiangya Hospital of Central South University, Anhui Provincial Cancer Hospital, Fujian Medical University Union Hospital, Yantai Yuhuangding Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Anhui Medical University, Jiangxi Provincial Cancer Hospital, Fujian Cancer Hospital
Conditions	Mantle Cell Lymphoma (MCL)
Enrollment	78 participants
Start Date	2024-07-10
Primary Completion	2027-07-10 (estimated)
Study Completion	2027-07-10 (estimated)
Updated on ClinicalTrials.gov	2024-07-11