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R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma
Sponsor: WEI XU
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2026-08
Completion Date
2029-08
Last Updated
2026-08-14
Healthy Volunteers
No
Interventions
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).
Locations (5)
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The First People's Hospital of Huai'an
Huai'an, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Yixing People's Hospital
Yixing, Jiangsu, China