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RECRUITING
NCT07604987
PHASE2

R-PMDT Regimen in Newly Diagnosed PCNSL

Sponsor: Zou Dehui

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multicenter, Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Rituximab, Pirtobrutinib, High-Dose Methotrexate, Dexamethasone, and Thiotepa (R-PMDT) in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-05-20

Completion Date

2030-05-20

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

R-PMDT

Rituximab (375 mg/m², IV infusion) is given on day 0; methotrexate (3.5 g/m², IV infusion over 3 hours) on day 1; dexamethasone (20 mg, IV infusion) on days 1-4; thiotepa (30 mg/m², IV infusion) on day 1; and pirtobrutinib (200 mg, oral) on days 4-21 or until the day prior to methotrexate administration in the next cycle.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China