Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
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)
Ruijin Hospital
78 participants
Jul 10, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Bendamustine IV will be administered as per the schedule specified in the respective arm.
Rituximab IV will be administered as per the schedule specified in the respective arm.
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Locations(1)
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NCT06496308