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RECRUITING
NCT06496308
PHASE3

Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Orelabrutinib

Orelabrutinib PO will be administered as per the schedule specified in the respective arm.

DRUG

Bendamustine

Bendamustine IV will be administered as per the schedule specified in the respective arm.

DRUG

Rituximab

Rituximab IV will be administered as per the schedule specified in the respective arm.

DRUG

Venetoclax

Venetoclax PO will be administered as per the schedule specified in the respective arm.

Locations (1)

Ruijin Hospital

Shanghai, China