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

Sponsor
WEI XU
Study ID
NCT07764601
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Penpulimab — BIOLOGICAL
    Anti-PD-1 monoclonal antibody, 200 mg intravenously on Day 5 of each induction cycle; continued as maintenance in responders.
  • Rituximab — DRUG
    375 mg/m2 intravenously on Day 0 of each induction cycle.
  • Methotrexate — DRUG
    3.5 g/m2 intravenously on Day 1 of each induction cycle.
  • Cytarabine — DRUG
    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 Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R-MA-PD-1 (Experimental)
    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.
  • Active Comparator: R-MA (Active Comparator)
    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).

Primary Outcome Measure

2-year progression-free survival (PFS) rate [ Time Frame: 2 years from randomization ]

Central Contacts

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