Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07764601
NA

R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma

Sponsor: WEI XU

View on ClinicalTrials.gov

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

BIOLOGICAL

Penpulimab

Anti-PD-1 monoclonal antibody, 200 mg intravenously on Day 5 of each induction cycle; continued as maintenance in responders.

DRUG

Rituximab

375 mg/m2 intravenously on Day 0 of each induction cycle.

DRUG

Methotrexate

3.5 g/m2 intravenously on Day 1 of each induction cycle.

DRUG

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