drugset / Trial / NCT07604987

R-PMDT Regimen in Newly Diagnosed PCNSL

NCT07604987

Phase 2 Recruiting 33 enrolled Zou Dehui
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

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Intravenous
Subject Methotrexate Small molecule 3.5 g Intravenous
Subject Pirtobrutinib Other / unclassified 200 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Thiotepa Other / unclassified 30 mg/m2 Intravenous