eligibility_summary
Inclusion: ≥18, primary CNS lymphoma (incl vitreoretinal or CSF+ with CNS MRI), ineligible for HDCT/ASCT but fit for MTX+ibrutinib+rituximab, radiologic or suspected residual disease, ≤1 cycle MTX±RTX ≤4 wks allowed, intrathecal OK, steroids ≤8 mg dex then stop, ECOG 0–2 (or 3 from PCNSL), adequate organs. Exclusion: secondary CNS NHL, undrained effusions, active infection, major cardiac disease, pregnancy, concurrent anticancer therapy, warfarin/strong CYP3A drugs/>8 mg steroids, live vaccine <30 d, prior allo BMT.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm trial in transplant-ineligible newly diagnosed primary CNS lymphoma testing high-dose methotrexate + ibrutinib ± rituximab, then ibrutinib maintenance. Drugs and mechanisms: • Ibrutinib—oral small-molecule Brutons tyrosine kinase (BTK) inhibitor, blocks B-cell receptor (BCR) signaling and NF-κB survival pathways, CNS-penetrant. • Methotrexate—IV antimetabolite (antifolate), inhibits DHFR and thymidylate/purine synthesis, suppressing DNA replication in rapidly dividing cells, high-dose reaches CNS. • Rituximab—anti-CD20 monoclonal antibody, depletes CD20+ B cells via CDC/ADCC/apoptosis. Targets: malignant CNS B cells, BCR/BTK pathway, CD20+ B cells, nucleotide synthesis in proliferating lymphoma cells.