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

NCT07764601 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-08-14

No results posted yet for this 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.

Conditions

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).

Sponsors & Collaborators

  • WEI XU

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2029-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764601 on ClinicalTrials.gov