eligibility_summary
Adults (≥18) with untreated, confirmed SMZL needing therapy (ESMO), measurable disease, ECOG 0–2, adequate counts/organ function (allow if lymphoma-related), able to swallow. Include post–HCV eradication, splenomegaly/nodes. Exclude prior splenectomy/systemic SMZL therapy, CNS disease, recent other cancers, major CV/bleeding risks, warfarin/VKA or dual antiplatelets, malabsorption, uncontrolled infection, HIV, active COVID-19/HBV/HCV, autoimmune on >20 mg prednisone, strong CYP3A drugs, pregnancy/breastfeeding, or other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 RITZ trial in untreated symptomatic splenic marginal zone lymphoma compares rituximab + zanubrutinib vs rituximab alone. Drugs/interventions: Rituximab – anti-CD20 IgG1 monoclonal antibody (biosimilar Truxima), depletes CD20+ B cells via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis. Zanubrutinib – covalent small-molecule Brutons tyrosine kinase (BTK) inhibitor (Brukinsa), blocks B-cell receptor signaling (BTK→PLCγ2) to suppress downstream NF-kB/MAPK/PI3K-AKT pathways, reducing proliferation, survival, and trafficking. Cells/pathways targeted: malignant splenic marginal zone B cells and normal CD20+ B cells, CD20 surface antigen, BCR/BTK signaling cascade with downstream NF-kB/MAPK/AKT. Aim: determine if B-cell depletion plus BCR blockade improves progression-free survival vs rituximab alone.