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.
Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
Age > 14 years of age, both genders are eligible.
Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
At least one measurable lesion.
Patients who have previously received treatment with BTK inhibitors.
Patients with severe complications or serious infections.
Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
Single group
Orelabrutinib
Drug150mg/day PO once daily
Rituximab (R)
Drug375 mg/m² IV on day 1/cycle
Lisaftoclax (APG-2575)
DrugCycle1(100mg day1, 200mg day2, 400mg day3, 600mg/day day4-28), Cycle2-6 600mg/day, PO once daily.
Lisaftoclax (APG-2575)
Drug600mg/day, PO once daily
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Overall Response Rate
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Overall survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
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Ruijin Hospital
Lead sponsor
Fujian Medical University Union Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Shanghai Minhang Central Hospital
Collaborator
Yangpu District Central Hospital Affiliated to Tongji University
Collaborator
Xuhui Central Hospital, Shanghai
Collaborator
Jiujiang No.1 People's Hospital
Collaborator
Shanghai 411 hospital
Collaborator
