NCT06363994

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (estimated)
• Sponsor: InnoCare Pharma Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Orelabrutinib	Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
DRUG	Bendamustine Injection	Eligible patients will receive Bendamustine by injection as per the protocol
DRUG	Rituximab	Eligible patients will receive Rituximab by injection as per the protocol
DRUG	Orelabrutinib Placebo	Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Timeline

• Start date: 2024-05-29
• Primary completion: 2031-06-25
• Completion: 2032-06-25
• First posted: 2024-04-12
• Last updated: 2024-12-27

Locations

39 sites across 1 country: China

Regulatory

• FDA-regulated drug study