eligibility_summary
Adults ≥18, ECOG 0–2, CD20+ CLL with iwCLL treatment need (cytopenias, bulky/progressive nodes/spleen, rapid lymphocytosis/LDT<6 mo, steroid‑refractory AIHA/ITP, B symptoms). Labs: ANC ≥750 (≥500 BM+), Plt ≥50k (≥30k BM+), AST/ALT ≤3×ULN, Tbili ≤1.5×, CrCl ≥30. Contraception. Exclude: prior CLL therapy, Richter/PLL, uncontrolled AIHA/ITP or >20 mg steroids, serious CV/neuro, HIV or active HBV/HCV, PML, bleeding/warfarin, strong CYP3A drugs or PPIs, malabsorption, pregnancy, unsafe comorbidity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05950997 tests acalabrutinib plus obinutuzumab in treatment‑naive CLL. Acalabrutinib is a second‑generation, covalent small‑molecule Bruton’s tyrosine kinase (BTK) inhibitor that blocks B‑cell receptor (BCR) signaling, reducing proliferation, survival, and trafficking of malignant B cells. Obinutuzumab is a glycoengineered, humanized type II anti‑CD20 IgG1 monoclonal antibody that depletes CD20+ B cells via direct cell death and enhanced antibody‑dependent cellular cytotoxicity and phagocytosis. Targets/pathways: BTK within BCR signaling in CLL B cells, CD20 on mature/CLL B cells, engagement of innate effector mechanisms (NK cells/macrophages).