Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment

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.

NCT Number	NCT07199296
Lead Sponsor	Ruijin Hospital Collaborators: Fujian Medical University Union Hospital, The First Affiliated Hospital of Anhui Medical University, The Third Xiangya Hospital of Central South University, First Affiliated Hospital of Wenzhou Medical University, Qilu Hospital of Shandong University, Huadong Hospital
Conditions	Mantle Cell Lymphoma (MCL)
Enrollment	45 participants
Start Date	2025-07-01
Primary Completion	2028-07-01 (estimated)
Study Completion	2028-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-30