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Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Sponsor: Ruijin Hospital
Summary
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the 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 Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2024-07-10
Completion Date
2027-07-10
Last Updated
2024-07-11
Healthy Volunteers
No
Conditions
Interventions
Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Bendamustine
Bendamustine IV will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV will be administered as per the schedule specified in the respective arm.
Venetoclax
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Locations (1)
Ruijin Hospital
Shanghai, China