R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Penpulimab: Anti-PD-1 monoclonal antibody, 200 mg intravenously on Day 5 of each induction cycle; continued as maintenance in responders.
Rituximab: 375 mg/m2 intravenously on Day 0 of each induction cycle.
Methotrexate: 3.5 g/m2 intravenously on Day 1 of each induction cycle.
Cytarabine: Age \<60 or ECOG ≤2: 2 g/m2 q12h on Days 2-3; age ≥60 or ECOG \>2: 1 g/m2 q12h on Day 2 (from cycle 2).
Study summary
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.
Eligibility
Primary outcome measure(s)
- 2-year progression-free survival (PFS) rate — 2 years from randomization
PFS is defined as the time from randomization to first documented disease progression or relapse (per 2014 Lugano response criteria) or death from any cause, whichever occurs first, as determined by the investigator.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | |
| The First People's Hospital of Huai'an | Huai'an | Jiangsu | |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | |
| Wuxi People's Hospital | Wuxi | Jiangsu | |
| Yixing People's Hospital | Yixing | Jiangsu |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07764601 on ClinicalTrials.gov ↗ ← All trials in China