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

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).

Trial Details

NCT ID
NCT07410520
Phase
PHASE2
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • PD -1/PD-L1 monoclonal antibody
  • Rituximab (R)
  • Methotrexate
  • Orelabrutinib
  • ASCT/WBRT
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • \[1\] Newly diagnosed PCNSL confirmed by histopathology, or independently relapsed SCNSL (diffuse large B-cell lymphoma), diagnosed according to th…
  • \[2\] Signed written informed consent, and ability to comply with protocol-specified visits and related procedures.
  • \[3\] Cranial MRI (non-contrast + contrast) performed within 28 days prior to study enrollment must show at least one measurable lesion in two perp…
  • \[4\] ECOG performance status of 0-4. \[5\] Adequate organ and bone marrow function, defined as follows:

For full eligibility, visit ClinicalTrials.gov.

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