NCT06496308

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mantle Cell Lymphoma (MCL)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-10
• Primary completion: 2027-07-10
• Completion: 2027-07-10
• First posted: 2024-07-11
• Last updated: 2024-07-11

Locations

1 site across 1 country: China