NCT07764601Not yet recruiting
R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 6 Aug 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- WEI XU
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07764601
What you commit to
- Study type: Interventional
- Planned participants: 58
- From 1 Aug 2026 to the primary completion date, 31 Aug 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Congenital long QT syndrome or QTcF \>480 ms.
Other
- Pregnant or lactating women, or intending to become pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital Of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| The First People's Hospital of Huai'an Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Yixing People's Hospital Coordinator of this site? Confirm its status | Yixing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.