eligibility_summary
Eligibility: Adults ≥18 with R/R CD33+ AML and FLT3‑ITD (AR≥0.05) or TKD mutation, prior chemo/HMA and non‑gilteritinib FLT3i allowed, ECOG ≤2, adequate liver/renal function, no contraindication to GO, cytarabine, gilteritinib, consent, French insurance. Exclude: APL/BCR‑ABL1 or sAML (from MDS/MPN), CNS leukemia, allo‑HSCT <6 mo/GVHD>1, GO <3 mo, active other cancer, major cardiac/QT issues, uncontrolled infection, HBV/HCV/HIV, recent trials/cytotoxics (except HU±dex), interacting drugs, malabsorption, severe comorbidity, pregnancy/breastfeeding, legal incapacity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: • Gemtuzumab ozogamicin (GO): antibody–drug conjugate (anti‑CD33 IgG) delivering calicheamicin, causing DNA double‑strand breaks and apoptosis in CD33+ AML blasts. • Gilteritinib: oral type I small‑molecule FLT3 tyrosine kinase inhibitor (also inhibits AXL), blocking FLT3‑driven survival/proliferation. • Cytarabine: antimetabolite nucleoside analog, converted to ara‑CTP, inhibits DNA polymerase and DNA synthesis. Targets/cellular pathways: • Cells: CD33‑expressing, FLT3‑mutant (primarily ITD, TKD allowed) AML blasts. • Pathways: FLT3→STAT5/PI3K‑AKT/MAPK signaling, DNA synthesis (cytarabine), DNA integrity via calicheamicin‑induced damage.