R-PMDT Regimen for Newly Diagnosed PCNSL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, single-arm Phase 2 trial evaluating six cycles of the R-PMDT regimen (rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, thiotepa) in newly diagnosed PCNSL patients. The primary goal is to determine the overall response rate, with secondary goals including complete response rate, progression-free survival, overall survival, and safety. After six cycles, consolidation or maintenance therapy may be given at the investigator’s discretion. Eligible participants should have newly diagnosed PCNSL with adequate organ function and performance status, and should not have active uncontrolled infections or other active malignancies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Wei Liu, Docter
• Email: liuwei@ihcams.ac.cn
• Phone: 86-022-23608461

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.