eligibility_summary
Inclusion: ≥18, consent, untreated CLL/SLL per IWCLL with treatment indications, ECOG ≤2, contraception and negative pregnancy test if applicable. Exclusion: prior CLL therapy, active HIV/HBV/HCV, inadequate organ function (eGFR≤30, low ANC/platelets, high AST/ALT/bilirubin), bleeding diathesis, major CV dz/recent MI/stroke/ICH, warfarin/strong CYP3A, active infection, pregnancy/lactation, recent trial drug/surgery, CNS involvement, other recent malignancy (exceptions), AIHA/ITP, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 randomized trial in untreated CLL/SLL tests two schedules of combining: 1) Zanubrutinib (oral, small‑molecule, covalent Bruton tyrosine kinase inhibitor [BTKi]) and 2) Obinutuzumab (IV, glycoengineered type II anti‑CD20 monoclonal antibody, humanized IgG1). Mechanisms: Zanubrutinib inhibits BTK within the B‑cell receptor (BCR) signaling pathway, reducing survival, proliferation, and trafficking of malignant B cells. Obinutuzumab binds CD20 on B cells, driving direct cell death and immune effector killing (ADCC/ADCP, some CDC). Arms compare early (cycle 2) vs late (after 12 cycles) obinutuzumab added to continuous zanubrutinib. Targets: CD20+ malignant B cells, BTK/BCR pathway, engagement of NK cells and macrophages via Fc-mediated cytotoxicity. Primary endpoint: CR with undetectable MRD enabling BTKi discontinuation.