MedTrace Logo

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

NCT07272499 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-09

No results posted yet for this study

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.

Conditions

  • Mantle Cell Lymphoma (MCL)

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

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Shanghai Minhang Central Hospital

    collaborator OTHER

  • Huadong Hospital

    collaborator OTHER

  • Yangpu District Central Hospital Affiliated to Tongji University

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2028-09-10
Completion
2028-09-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272499 on ClinicalTrials.gov