drugset / Trial / NCT07410520
PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, single-arm, prospective clinical study of PD-1 inhibitor combined with rituximab, methotrexate, and orelabrutinib (PD-1i+RMO) in the treatment of newly diagnosed primary central nervous system lymphoma (ND-PCNSL) and secondary central nervous system lymphoma (SCNSL). The primary endpoint is 1-year progression-free survival (PFS).
Timeline
- Start
- 2026-02-07
- Primary completion
- 2028-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 3.5 g | Intravenous |
| Subject | Orelabrutinib | Small molecule | 150 mg | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |