drugset / Trial / NCT07604987
R-PMDT Regimen in Newly Diagnosed PCNSL
NaSingle-groupOpen-labelTreatment
Summary
A total of six cycles of the R-PMDT regimen (rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, and thiotepa) will be administered to patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluating the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.
Timeline
- Start
- 2026-05-20
- Primary completion
- 2028-05-20
- Completion
- 2030-05-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Subject | Methotrexate | Small molecule | 3.5 g | Intravenous |
| Subject | Pirtobrutinib | Small molecule | 200 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Thiotepa | Other / unclassified | 30 mg/m2 | Intravenous |