Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

Inclusion Criteria:

1. Signed written informed consent according to ICH/EU/GCP and national/local laws

2. Patients aged between 18 and 60 years

3. Patients previously untreated for their AML by other chemotherapeutic agents (exceptfor no more than 7 days HU) or radiotherapy

4. Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documentedby bone marrow aspiration (or biopsy in case of dry tap) (not supervening afterother myeloproliferative disease or myelodysplastic syndromes of ≥ 6 monthsduration)

5. Patients with favorable-intermediate AML according to ELN 2017 (except forFLT3-ITD/TKD positive AML)

6. WHO performance status 0-3

7. Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serumbilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered dueto organ leukemic involvement

8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram

9. Absence of severe concomitant neurological or psychiatric diseases and congestiveheart failure or active uncontrolled infection

10. Absence of any psychological, familial, sociological and geographical conditionpotentially hampering compliance with the study protocol and the follow-up schedule.

Exclusion Criteria:

1. Patients already treated for their AML by other chemotherapeutic agents (except forno more than 7 days HU) or radiotherapy

2. Acute promyelocytic leukemia

3. Blast crisis of chronic myeloid leukemia

4. FLT3-ITD/TKD positive AML

5. AML supervening after other myeloproliferative disease

6. AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration

7. Therapy-related AML

8. Other active or progressive malignant diseases.

9. Inadequate renal or liver function (metabolic abnormalities > 2-2.5 times the normalupper limit)

10. Severe heart failure requiring diuretics

11. Ejection fraction < 50%

12. Uncontrolled infections

13. Severe concomitant neurological or psychiatric diseases

14. Patients who are pregnant or adults of reproductive potential not employing aneffective method of birth control. Women of childbearing potential must have anegative serum pregnancy test within 48 hours prior to administration ofchemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to beconsidered of non-childbearing potential. Male and female patients must agree toemploy an effective barrier method of birth control throughout the study and for atleast 6 months following discontinuation of study drug.