Overview

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

Status:
RECRUITING
Trial end date:
2028-09-10
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE2
Details
Lead Sponsor:
Ruijin Hospital
Collaborators:
First Affiliated Hospital of Wenzhou Medical University
Fujian Medical University Union Hospital
Huadong Hospital
Qilu Hospital of Shandong University
Shanghai Minhang Central Hospital
The First Affiliated Hospital of Anhui Medical University
The Third Xiangya Hospital of Central South University
Yangpu District Central Hospital Affiliated to Tongji University
Treatments:
Lisaftoclax
orelabrutinib
Rituximab