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
- 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
- Evaluation of prognostic clinical relevance of biological features at onset.
- Feasibility and outcome of consolidation with BMT.