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Clinical Trials in China / NCT07604987
Recruiting Phase 2

R-PMDT Regimen in Newly Diagnosed PCNSL

NCT07604987 · tracked via the Priya Life Science China tracker
Sponsor
Zou Dehui
Phase
Phase 2
Started
2026-05-20
Last updated
2026-05-22

Condition(s) studied

Primary Central Nervous System (CNS) Lymphoma

Investigational drug(s) / intervention(s)

R-PMDT

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Newly diagnosed primary central nervous system diffuse large B-cell lymphoma * Adequate hematologic function: ANC ≥1.0×10⁹/L, PLT ≥75×10⁹/L * Adequate hepatic function: ALT/AST ≤3×ULN; total bilirubin ≤1.5×ULN * Adequate renal function: serum creatinine ≤2×ULN or CrCl ≥40 mL/min * LVEF ≥55% by echocardiography * Baseline oxygen saturation \>92% on room air * Expected survival ≥3 months Exclusion Criteria: * Prior anti-lymphoma therapy other than corticosteroids. * Uncontrolled significant cardiovascular or cerebrovascular disease. * Uncontrolled active systemic bacterial, fungal, or viral infection. * Active hepatitis B and/or active hepatitis C (HCV RNA positive). Patients with positive hepatitis B surface antigen and/or core antibody but HBV-DNA \< 1000 IU/mL may be included and should receive concurrent oral antiviral prophylaxis against HBV reactivation. * Hypersensitivity to any study drug or its components. * Other active malignancy, except for adequately controlled non-melanoma skin cancer, in situ carcinoma, or malignancy that has been in complete remission for ≥5 years. * Pregnant or lactating women. Fertile patients unwilling to use effective contraception. * Other conditions deemed inappropriate by the investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital Tianjin China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07604987 on ClinicalTrials.gov ↗ ← All trials in China