eligibility_summary
Include: ≥18, life expectancy ≥6 mo, indolent, confirmed MCL (stage II–IV) with t(11,14) or cyclin D overexpression, measurable disease, ECOG 0–2, adequate counts/organ function, able to swallow, neg pregnancy test/contraception. Exclude: prior MCL therapy, CNS disease, uncontrolled infection, active HBV/HCV, no progression needing treatment, recent live vaccine/major surgery, other active cancer, need CYP3A inducers or warfarin, bleeding disorder, major CV disease/stroke, GI malabsorption, pregnancy/breastfeeding, severe allergy, severe lung disease, concurrent trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05635162 tests early, fixed-duration zanubrutinib plus rituximab vs observation in previously untreated indolent mantle cell lymphoma. Interventions: (1) Zanubrutinib—an oral, covalent small‑molecule Bruton tyrosine kinase (BTK) inhibitor—blocks B‑cell receptor signaling (BTK→NF‑κB/PI3K‑AKT/MAPK), reducing B‑cell survival, proliferation, and trafficking. (2) Rituximab—a chimeric anti‑CD20 IgG1 monoclonal antibody—targets CD20+ B cells, inducing complement‑dependent cytotoxicity, antibody‑dependent cellular cytotoxicity, and apoptosis. Targets: malignant CD20+ mantle cell B cells, pathways: BCR/BTK signaling and CD20‑mediated immune clearance. Experimental arm: 6×28‑day cycles, control: active observation. Phase II, randomized, open‑label.