eligibility_summary
Inclusion: CLL/SLL (CD20+), age ≥65 or 18–65 with severe illness, ECOG 0–2, survival ≥12 wks, treatment indicated (IWCLL/China 2022), measurable disease or ALC >5000/µL, no prior systemic therapy, adequate organ function, contraception and consent. Exclusion: 17p−/TP53, Richter, active autoimmune cytopenias, CNS disease, recent high-dose steroids, other active cancer, major cardiac disease, bleeding/anticoag issues, recent thrombosis/surgery, malabsorption, active infection or HBV/HCV, psych/substance issues, recent trials, strong CYP3A4 modulators, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single‑arm trial in untreated/unfit CLL/SLL without del(17p)/TP53, testing Orelabrutinib + bendamustine + obinutuzumab (OBG). Mechanisms: - Orelabrutinib: oral covalent Bruton’s tyrosine kinase (BTK) inhibitor, blocks B‑cell receptor signaling, dampening NF‑kB/PI3K‑AKT/MAPK to impair survival, proliferation, and trafficking of malignant B cells. - Bendamustine: IV alkylating (nitrogen mustard) chemotherapeutic, induces DNA cross‑links and damage, triggering apoptosis. - Obinutuzumab: glycoengineered type II anti‑CD20 monoclonal antibody, depletes B cells via direct cell death and antibody‑dependent cytotoxicity/phagocytosis (ADCC/ADCP). Targets/pathways: BTK/BCR signaling, CD20 on CLL/SLL B cells, DNA replication/repair, engages NK cells/macrophages. Primary endpoints: CR and undetectable MRD.