Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Complete response rate — End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruijin Hospital | Shanghai | China | Recruiting |
More Ruijin Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06496308 on ClinicalTrials.gov ↗ ← All trials in China