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

NCT07410520 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-13

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DRUG

Methotrexate

Induction Phase: 3.5g/m2, Intravenous infusion, day1, cycle1-8(Cycles: every 3 weeks)

DRUG

PD -1/PD-L1 monoclonal antibody

Induction Phase: Intravenous infusion, day2, cycle1-8(Cycles: every 3 weeks) Maintenance Phase: continued every 2 months for 2 years.

DRUG

Rituximab (R)

Induction Phase: 375mg/m2, Intravenous infusion, day0, cycle1-8(Cycles: every 3 weeks)

DRUG

Orelabrutinib

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.

PROCEDURE

ASCT/WBRT

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).

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-07
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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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 NCT07410520 on ClinicalTrials.gov