Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease

This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib plus lisaftoclax and rituximab in patients with high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal 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	NCT07272499
Lead Sponsor	Ruijin Hospital Collaborators: Fujian Medical University Union Hospital, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Anhui Medical University, The Third Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Shanghai Minhang Central Hospital, Yangpu District Central Hospital Affiliated to Tongji University, Xuhui Central Hospital, Shanghai, Jiujiang No.1 People's Hospital, Shanghai 411 hospital
Conditions	Mantle Cell Lymphoma (MCL)
Enrollment	25 participants
Start Date	2025-09-10
Primary Completion	2028-09-10 (estimated)
Study Completion	2028-09-10 (estimated)
Updated on ClinicalTrials.gov	2026-07-28