PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07410520
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Central Nervous System Lymphoma (PCNSL)
  • Secondary Central Nervous System Lymphoma (SCNSL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PD -1/PD-L1 monoclonal antibody — DRUG
    Induction Phase: Intravenous infusion, day2, cycle1-8(Cycles: every 3 weeks) Maintenance Phase: continued every 2 months for 2 years.
  • Rituximab (R) — DRUG
    Induction Phase: 375mg/m2, Intravenous infusion, day0, cycle1-8(Cycles: every 3 weeks)
  • Methotrexate — DRUG
    Induction Phase: 3.5g/m2, Intravenous infusion, day1, cycle1-8(Cycles: every 3 weeks)
  • Orelabrutinib — DRUG
    Induction Phase: 150mg qd(after methotrexate levels are cleared to \< 0.1 μmol/L.), cycle1-8(Cycles: every 3 weeks) Maintenance Phase: 150mg qd for 2 years.
  • ASCT/WBRT — PROCEDURE
    Patients with PR, SD, or PD after 8 cycles will discontinue the study, while those achieving CR will be evaluated by investigators for autologous stem cell transplantation (ASCT) or whole-brain radiotherapy (WBRT).

Study Details

This is a multicenter, open-label, single-arm, prospective clinical study of PD-1 inhibitor combined with rituximab, methotrexate, and orelabrutinib (PD-1i+RMO) in the treatment of newly diagnosed primary central nervous system lymphoma (ND-PCNSL) and secondary central nervous system lymphoma (SCNSL). The primary endpoint is 1-year progression-free survival (PFS).

Key Dates

Start date
Feb 7, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PD-1 Inhibitor Combined with Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO)

Primary Outcome Measure

1 year Progression free survival (PFS) [ Time Frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year ]

Central Contacts

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