Clinical Research Directory
Browse clinical research sites, groups, and studies.
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
Sponsor: Ruijin Hospital
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.
Official title: A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib Plus Lisaftoclax and Rituximab in Treatment-Naive, High-Risk Mantle Cell Lymphoma (MCL)
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2025-09-10
Completion Date
2028-09-10
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Orelabrutinib
150mg/day PO once daily
Rituximab (R)
375 mg/m² IV on day 1/cycle
Lisaftoclax (APG-2575)
Cycle1(100mg day1, 200mg day2, 400mg day3, 600mg/day day4-28), Cycle2-6 600mg/day, PO once daily.
Lisaftoclax (APG-2575)
600mg/day, PO once daily
Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China