MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.
Signed written informed consent according to ICH/EU/GCP and national/local laws
Patients aged between 18 and 60 years
Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of ≥ 6 months duration)
Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
Acute promyelocytic leukemia
Blast crisis of chronic myeloid leukemia
FLT3-ITD/TKD positive AML
Single group
Gemtuzumab Ozogamicin
DrugPatients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine
Activity of GO in combination with chemotherapy in terms of MRD negativity achievement
Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO
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