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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5 ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5 IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5 GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6
University Hospital, Udine
Udine, Italy, Italy
Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
Time frame: one year
RFS, DFS and OS.
Time frame: one year
Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
Time frame: one year
Evaluation of prognostic clinical relevance of biological features at onset.
Time frame: one year
Feasibility and outcome of consolidation with BMT.
Time frame: one year
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