R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma

Official record

Identifier

NCT07764601

Recruiting locations

country

China

Interventions studied

PenpulimabRituximabMethotrexateCytarabine

Lead sponsor

WEI XU

Target enrolment

58 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Not yet recruiting

First posted

Aug 14, 2026

Last updated on the registry

Aug 14, 2026

Age

18 Years – 80 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. Fully understands the study and voluntarily signs informed consent.
2. Age 18 to 80 years.
3. Treatment-naive, pathologically (immunophenotypically) confirmed PCNSL (per 2016 WHO classification).
4. Diffuse large B-cell lymphoma originating in the CNS without other organ involvement, confirmed by PET-CT or contrast-enhanced CT.
5. Expected survival more than 3 months.
6. Laboratory: creatinine clearance ≥50 mL/min (Cockcroft-Gault); INR ≤1.5 x ULN or aPTT ≤1.5 x ULN (INR 2-3 allowed if on warfarin); LVEF ≥50%.
7. GFR ≥60 mL/min.
8. Participants of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose.

Exclusion Criteria:

1. Contraindication to any study drug.
2. Clinically significant liver disease, including viral or other hepatitis or cirrhosis (active HBV or active hepatitis C as defined).
3. HIV infection.
4. History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of penpulimab.
5. Prior anti-PD-1/PD-L1/PD-L2, anti-CTLA-4 antibody, CAR-T, or any other agent targeting T-cell co-stimulation or checkpoint pathways.
6. Congestive heart failure (NYHA \>2); acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months.
7. Congenital long QT syndrome or QTcF \>480 ms.
8. Other malignancy within the past 5 years (except adequately treated in situ cervical carcinoma, basal cell skin carcinoma, in situ breast carcinoma, or a second primary cancer cured and recurrence-free for 5 years).
9. Pregnant or lactating women, or intending to become pregnant during the study.
10. History of clinically significant neurological or psychiatric disorder, or substance/drug abuse.
11. Clinically significant active infection.

Indexed under

Lymphoma