drugset / Trial / NCT06496308
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Phase 3
Recruiting
78 enrolled
Ruijin Hospital
Anhui Provincial Cancer Hospital · collabFujian Cancer Hospital · collabFujian Medical University Union Hospital · collabHuadong Hospital Affiliated with Fudan University, Shanghai · collabJiangxi Provincial Cancer Hospital · collabThe First Affiliated Hospital of Anhui Medical University · collabThe Third Xiangya Hospital of Central South University · collabYantai Yuhuangding Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-07-10
- Primary completion
- 2027-07-10
- Completion
- 2027-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Background | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |