eligibility_summary
CLL/SLL needing therapy, relapsed/refractory ≥1 line, ≥1 disease marker, ECOG 0–2, life ≥3 mo, adequate organs, meets contraception/pregnancy rules. HBV/HCV/HIV allowed if controlled. Part 2 needs Del(17p)/TP53/IGHV results. Exclude: active HBV/HCV/infection, other recent cancer, Richter/CNS, CV disease, severe bleeding, study-drug allergy, recent therapy/radiation/BCL2i, strong CYP3A/P‑gp meds, recent live vaccine/investigational, psych/substance disorder, not recovered from surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 3, R/R CLL/SLL comparing nemtabrutinib + venetoclax vs venetoclax + rituximab. Interventions and mechanisms: - Nemtabrutinib (ARQ 531/MK-1026): oral small‑molecule, reversible/noncovalent Bruton tyrosine kinase (BTK) inhibitor designed to inhibit both wild‑type and C481‑mutant BTK, suppressing B‑cell receptor (BCR) signaling, survival, and trafficking of CLL cells. - Venetoclax (ABT‑199): oral small‑molecule BCL‑2 inhibitor (BH3‑mimetic) that restores mitochondrial apoptosis in BCL‑2–dependent CLL cells. - Rituximab: intravenous chimeric monoclonal antibody against CD20, depleting B cells via ADCC, complement‑dependent cytotoxicity, and direct apoptosis. Target cells/pathways: malignant CD20+ B cells in CLL/SLL, BCR/BTK signaling axis, intrinsic (mitochondrial) apoptosis pathway regulated by BCL‑2, immune‑mediated B‑cell clearance via CD20. Primary endpoint: PFS.