eligibility_summary
Inclusion: Confirmed MALT lymphoma, stage III–IV or relapsed after local therapy, no prior systemic therapy (except H. pylori eradication in gastric MALT), no transformation, measurable disease, age ≥18, ECOG 0–2, >12‑mo survival, adequate organs, consent. Exclusion: stroke/ICH/warfarin <6 mo, CNS disease, prior allo‑HSCT, BTKi or anti‑CD20, infection, potent CYP inhibitors, serious CV disease, organ/absorption issues, pregnancy, therapy <4 wks, active HBV/HCV, steroids/immunosuppression <14d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm, open-label, multicenter phase II first-line study in MALT (extranodal marginal zone) lymphoma testing zanubrutinib plus rituximab. Interventions and mechanisms: • Zanubrutinib – small-molecule, second‑generation covalent BTK inhibitor that selectively blocks B‑cell receptor (BCR) signaling, suppressing downstream NF‑κB, PI3K/AKT, and MAPK pathways to reduce malignant B‑cell survival and proliferation. • Rituximab – chimeric anti‑CD20 IgG1 monoclonal antibody that depletes B cells via ADCC, complement‑dependent cytotoxicity, and direct apoptosis. Targets: CD20+ malignant marginal zone B cells. Pathways: BCR/BTK axis and its downstream survival signaling, immune effector mechanisms via Fc‑mediated cytotoxicity and complement. Primary endpoint: complete remission rate.