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RECRUITING
NCT07272499
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Orelabrutinib

150mg/day PO once daily

DRUG

Rituximab (R)

375 mg/m² IV on day 1/cycle

DRUG

Lisaftoclax (APG-2575)

Cycle1(100mg day1, 200mg day2, 400mg day3, 600mg/day day4-28), Cycle2-6 600mg/day, PO once daily.

DRUG

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