RecruitingPhase 2NCT07272499

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

A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib Plus Lisaftoclax and Rituximab in Treatment-Naive, High-Risk Mantle Cell Lymphoma (MCL)


Sponsor

Ruijin Hospital

Enrollment

25 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — orelabrutinib, lisaftoclax, and rituximab — as a first treatment for patients with high-risk mantle cell lymphoma (MCL), a type of blood cancer. All three drugs target different pathways cancer cells rely on to survive. **You may be eligible if...** - You are over 14 years old - You have a confirmed new diagnosis of mantle cell lymphoma and have not yet received any treatment - Your cancer is stage II–IV - Your lymphoma has at least one high-risk feature: a high MIPI score, rapidly dividing cells (Ki67 above 30%), a TP53 mutation, or the blastic or pleomorphic (aggressive) cell type **You may NOT be eligible if...** - You have already started any treatment for MCL - Your cancer lacks any high-risk features - You have significant organ dysfunction - You are pregnant or breastfeeding - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

150mg/day PO once daily

DRUGRituximab (R)

375 mg/m² IV on day 1/cycle

DRUGLisaftoclax (APG-2575)

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

DRUGLisaftoclax (APG-2575)

600mg/day, PO once daily


Locations(1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT07272499


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