Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Penpulimab | Biological | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- R-MA-PD-1 (Experimental)
- description
- Rituximab 375 mg/m2 (D0), methotrexate 3.5 g/m2 (D1), cytarabine (D2-3 or D2 by age/ECOG), plus penpulimab 200 mg (D5), every 21 days for 6 induction cycles, followed by response- and age-adapted consolidation and penpulimab maintenance.
- interventionNames
- Biological: Penpulimab
- Drug: Rituximab
- Drug: Methotrexate
- Drug: Cytarabine
- type
- ACTIVE_COMPARATOR
- label
- R-MA (Active Comparator)
- description
- Rituximab 375 mg/m2 (D0), methotrexate 3.5 g/m2 (D1), and cytarabine (D2-3 or D2 by age/ECOG), every 21 days for 6 induction cycles, followed by response- and age-adapted consolidation (ASCT or WBRT).
- interventionNames
- Drug: Rituximab
- Drug: Methotrexate
- Drug: Cytarabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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