A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

Inclusion Criteria: * Patients aged 18 years old or more * Confirmed diagnosis of R/R AML positive for CD33 antigen as determined locally by immunophenotyping according to routine practice, defined as: * AML refractory to 1 or 2 intensive chemotherapy courses or a treatment by hypomethylating agents (HMAs) * Or AML in first hematologic relapse or progression after front-line therapy, including intensive chemotherapy or hypomethylating agents (HMAs). * Previous treatments with FLT3 inhibitors (other than gilteritinib) are allowed * R/R AML secondary to a prior chemotherapy or radiotherapy for another cancer (tAML) could be included. * Presence of a FLT3-ITD mutation (allelic ratio ≥0.05 at last evaluation)\* or a FLT3 TKD mutation * Patient with no contraindication to gemtuzumab ozogamicin (GO), cytarabine and gilteritinib * ECOG performance status ≤2 * AST and ALT ≤ 2.5 x upper the limit of normal (ULN) and/or total and direct serum bilirubin ≤ 1.5 x ULN unless considered due to leukemia * Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the formula usually used by the investigator * Written informed consent obtained prior to any screening procedures * Eligible for National Health Insurance in France Exclusion Criteria: * Acute promyelocytic leukemia or AML with BCR-ABL1 gene fusion * Secondary AML (sAML) defined by a history of prior myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPN) including chronic myelomonocytic leukemia (C…