eligibility_summary
Include: ≥18, CD20+ MZL needing treatment (MALT/SMZL/NMZL), relapsed/progressed or unfit after local Rx, ECOG 0–2, measurable disease (SMZL ok with marrow), HBV‑DNA− if HBV+, adequate organs, survival ≥3 mo. Exclude: CNS/transformed, HIV+ or active HCV, recent DVT/PE, bleeding or anticoagulants, strong CYP3A inducers/inhibitors, uncontrolled infection, recent cancer, major CV disease/QTc↑/refractory HTN, GI malabsorption/gastrectomy, recent surgery, substance abuse, pregnancy, prior BTK/BCR/BCL‑2 inhibitors.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06478472 tests orelabrutinib plus rituximab in primary marginal zone lymphoma (MALT/SMZL/NMZL) unsuitable for or relapsed after local therapy. Drugs/mechanisms: • Orelabrutinib: oral, covalent small‑molecule Bruton tyrosine kinase (BTK) inhibitor, blocks B‑cell receptor (BCR) signaling to suppress survival/proliferation of malignant B cells. • Rituximab: intravenous anti‑CD20 monoclonal antibody, depletes CD20+ B cells via ADCC, complement‑dependent cytotoxicity, and direct apoptosis. Cells/pathways targeted: CD20+ malignant B cells, BCR/BTK signaling pathway, immune effector mechanisms (ADCC/CDC). Design: single‑arm induction with orelabrutinib + rituximab, then orelabrutinib maintenance.