This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.

Trial is based on:

• INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).

• CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)

• INTENSIFICATION: Allo-BMT, ASCT

• MAINTENANCE: AraC

  a) Primary endpoints:

• Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.

• RFS, DFS and OS.

  b) Secondary endpoints:

• Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.

• Evaluation of prognostic clinical relevance of biological features at onset.

• Feasibility and outcome of consolidation with BMT.

Inclusion Criteria:

• Age 18-65 years.
• WHO PS grade 0-2 (Appendix B) or Karnofsky > 70.
• AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy
• All FAB subtypes except M3.
• CD33 positivity (> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.
• Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS).
• Adequate renal and liver function, i.e., creatinine < 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
• Written informed consent

Exclusion Criteria:

• Blast crisis of chronic myeloid leukemia.
• AML supervening after other myeloproliferative diseases.
• AML de novo or secondary previously pretreated.
• Concomitant malignant disease.
• Active central nervous system (CNS) leukemia.
• Active uncontrolled infection [NB severe systemic infection should be excluded].
• Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease.
• Cardiac ejection fraction of 50% or less.
• Severe pulmonary dysfunction (CTC grade 3-4).
• Severe concomitant neurological or psychiatric disease.
• History of alcohol abuse.
• HIV positivity.
• Pregnancy.
• Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.
• Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.