R-PMDT Regimen in Newly Diagnosed PCNSL

NCT07604987 | Recruiting Phase 2

• 1 other identifier: LBCL-RPMDT1.0
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Central Nervous System (CNS) Lymphoma

Keywords

R-PMDT; PCNSL

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  The proportion of subjects achieving either a complete response (CR) or partial response (PR) after treatment with R-PMDT, as assessed by the Lugano criteria.

  up to 2 years

Secondary Outcomes (3)

• Complete response rate (CRR)

  up to 2 years

• Progression-Free-Survival (PFS)

  up to 2 years

• Overall survival (OS)

  up to 2 years

Study Arms (1)

R-PMDT

EXPERIMENTAL

Eligible patients will receive six cycles of the R-PMDT regimen.

Drug: R-PMDT

Interventions

R-PMDT DRUG

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.

R-PMDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zou Dehui: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, 022, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wei Liu, Docter

CONTACT

86-022-23608461; liuwei@ihcams.ac.cn

Dehui Zou, Docter

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Lymphoma Center Transplantation and Cellular Therapy Unit

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): May 20, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)