eligibility_summary
Eligibility: ≥60, poor-prognosis AML (first-line ELN 2022 int/adv, or any ELN if relapsed), ECOG ≤2, fit for intensive chemo, consent, AST/ALT <3×ULN, bilirubin <1.5×ULN, CrCl >60, LVEF ≥50%. Exclude: FLT3-mutated, TB, active COVID-19, HFI, uncontrolled infection, HBV/HCV/HIV, no French social security, pregnancy, breastfeeding or inadequate contraception, minors/legally protected adults, hypersensitivity, major CV disease, recent systemic immunosuppression (≥10 mg/d prednisone eq in 4 wks)
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm dose-escalation in ≥60-year-old adverse-risk AML tests daratumumab (DARZALEX), an anti‑CD38 IgG1 monoclonal antibody, added to induction chemotherapy (idarubicin + cytarabine). Mechanisms: Daratumumab binds CD38 on AML cells, triggering ADCC, CDC, ADCP, and apoptosis, it may also deplete CD38+ immunosuppressive cells (e.g., Tregs/Bregs/MDSCs), enhancing T/NK activity. Idarubicin is an anthracycline topoisomerase II inhibitor that intercalates DNA and generates free radicals, cytarabine is a cytidine analog antimetabolite that inhibits DNA polymerase and DNA synthesis (S-phase). Targets/pathways: CD38+ AML blasts/progenitors, immune effector pathways (NK/complement/macrophages), DNA replication/repair (topo II, DNA polymerase). MTD of SC daratumumab sought (D1 ± D8 ± D15).