Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Status:
RECRUITING
Trial end date:
2028-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE2
Details
Lead Sponsor:
Ruijin Hospital
Collaborators:
First Affiliated Hospital of Wenzhou Medical University Fujian Medical University Union Hospital Huadong Hospital Qilu Hospital of Shandong University The First Affiliated Hospital of Anhui Medical University The Third Xiangya Hospital of Central South University