Adding penpulimab to chemotherapy for new primary CNS lymphoma
Tests adding penpulimab to chemotherapy in adults with new primary CNS lymphoma.
Plain-language title generated from the registry record
Registry title: R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma
Key facts
- Where
- Changzhou, Huai'an, Nanjing, Wuxi, and Yixing, ChinaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07764601, who can take part
Where in China
- The First People's Hospital Of ChangzhouChangzhou, ChinaNo longer taking part
- The First People's Hospital of Huai'anHuai'an, ChinaNo longer taking part
- The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaNo longer taking part
- Wuxi People's HospitalWuxi, ChinaNo longer taking part
- Yixing People's HospitalYixing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- WEI XU
- Trial code
- NCT07764601
- Record updated
- 14 August 2026
- Original description
This is a prospective, open-label, multicenter, randomized controlled study in treatment-naive patients with primary central nervous system lymphoma (PCNSL, DLBCL type). Eligible participants are randomized 1:1 to the experimental arm (R-MA-PD-1: rituximab, methotrexate, cytarabine plus penpulimab) or the control arm (R-MA: rituximab, methotrexate, cytarabine). Induction is administered every 21 days for 6 cycles, followed by risk- and response-adapted consolidation (ASCT or whole-brain radiotherapy) and penpulimab maintenance. The primary objective is to compare the 2-year progression-free survival rate between the two arms.Read full original descriptionShow less
A Prospective, Open-label, Randomized Controlled Study Comparing Rituximab, Methotrexate, Cytarabine, and Penpulimab (R-MA-PD-1) Versus Rituximab, Methotrexate, and Cytarabine (R-MA) in Treatment-naive Patients With Primary Central Nervous System Lymphoma
This is a prospective, open-label, multicenter, randomized controlled study in treatment-naive patients with primary central nervous system lymphoma (PCNSL, DLBCL type). Eligible participants are randomized 1:1 to the experimental arm (R-MA-PD-1: rituximab, methotrexate, cytarabine plus penpulimab) or the control arm (R-MA: rituximab, methotrexate, cytarabine). Induction is administered every 21 days for 6 cycles, followed by risk- and response-adapted consolidation (ASCT or whole-brain radiotherapy) and penpulimab maintenance. The primary objective is to compare the 2-year progression-free survival rate between the two arms.
Inclusion: Fully understands the study and voluntarily signs informed consent; Age 18 to 80 years; Treatment-naive, pathologically (immunophenotypically) confirmed PCNSL (per 2016 WHO classification); Diffuse large B-cell lymphoma originating in the CNS without other organ involvement, confirmed by PET-CT or contrast-enhanced CT; Expected survival more than 3 months; 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%; GFR ≥60 mL/min; Participants of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose.
Exclusion: Contraindication to any study drug; 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; Clinically significant liver disease, including viral or other hepatitis or cirrhosis (active HBV or active hepatitis C as defined); HIV infection; History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of penpulimab; Congestive heart failure (NYHA >2); acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months; 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); History of clinically significant neurological or psychiatric disorder, or substance/drug abuse; Clinically significant active infection; Congenital long QT syndrome or QTcF >480 ms; Pregnant or lactating women, or intending to become pregnant during the study.