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Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Sponsor: Ruijin Hospital
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.
Official title: A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib in Combination With Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in Treatment-Naive, Non-High-Risk Mantle Cell Lymphoma (MCL)
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-07-01
Completion Date
2028-07-01
Last Updated
2025-09-30
Healthy Volunteers
No
Conditions
Interventions
Orelabrutinib
orelabrutinib 150mg/day PO once daily
Rituximab (R)
rituximab 375 mg/m² IV on day 1, 8, 15, 22 in Cycle 1, then day 1/cycle
BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)
the 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
orelabrutinib 150mg/day PO once daily
Locations (1)
Ruijin Hospital
Shanghai, China