drugset / Trial / NCT07272499
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
Phase 2
Recruiting
25 enrolled
Ruijin Hospital
First Affiliated Hospital of Wenzhou Medical University · collabFujian Medical University Union Hospital · collabHuadong Hospital · collabQilu Hospital of Shandong University · collabShanghai Minhang Central Hospital · collabThe First Affiliated Hospital of Anhui Medical University · collabThe Third Xiangya Hospital of Central South University · collabYangpu District Central Hospital Affiliated to Tongji University · collab
NaSingle-groupOpen-labelTreatment
Summary
This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib plus lisaftoclax and rituximab in patients with high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal 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
- 2025-09-10
- Primary completion
- 2028-09-10
- Completion
- 2028-09-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APG-2575 | Small molecule | 600 mg | Oral |
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |