This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-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.
Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 > 30%, TP53 abnormality, blastic or pleomorphic variation.
Patients with severe complications or serious infections.
Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
Single group
Orelabrutinib
Drugorelabrutinib 150mg/day PO once daily
Rituximab (R)
Drugrituximab 375 mg/m² IV on day 1, 8, 15, 22 in Cycle 1, then day 1/cycle
BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)
Drugthe reference doses are as follows (each center may adjust them as appropriate based on actual conditions): carmustine 300mg/m² IV d-1; etoposide 200mg/m² IV d-6-(-3); cytarabine 200mg/m² IV d-6-(-3); melphalan 140mg/m² IV d-2.
orelabrutinib maintenance
Drugorelabrutinib 150mg/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
The First Affiliated Hospital of Anhui Medical University
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Huadong Hospital
Collaborator
