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.
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