eligibility_summary
Eligibility: ≥18, untreated classical HCL with BRAF V600E, cytopenias (ANC ≤1.0, Hgb ≤10, PLT ≤100K), ECOG 0–2, adequate organs (bili ≤1.5×ULN, AST/ALT ≤2.5×, Cr ≤1.5×), ECG acceptable, QTc <480 ms, contraception per protocol, negative pregnancy test. Exclude: prior HCL therapy, hypersensitivity, long QT/electrolyte issues, liver disease, active HBV/HCV (occult HBV ok with prophylaxis), HIV/HTLV‑1, uncontrolled infection, live vaccine <28d, active malignancy, malabsorption, HCL‑variant, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II randomized trial in untreated classical HCL (BRAF V600E+). Experimental: vemurafenib (oral small‑molecule targeted kinase inhibitor, selective BRAF V600E inhibitor that blocks MAPK/ERK signaling) plus obinutuzumab (glycoengineered type II anti‑CD20 IgG1 monoclonal antibody, induces potent ADCC and direct cell death). Comparator: cladribine (purine analog antimetabolite chemotherapy, incorporates into DNA and inhibits ribonucleotide reductase, triggering apoptosis of lymphocytes) plus rituximab (type I anti‑CD20 monoclonal antibody, mediates ADCC and complement‑dependent cytotoxicity). Cells/pathways targeted: malignant CD20+ B cells (“hairy cells”), mutant BRAF‑driven MAPK pathway, immune‑mediated B‑cell depletion via CD20, DNA damage–mediated cytotoxicity to lymphocytes (cladribine).