Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

Inclusion Criteria

• •Patient between 18 and 60 years old (less than 61 years old)
• •With newly diagnosed with AML according to WHO classification:
• •With 20% or more blasts in the bone marrow
• •Patients with history of tumors other than myeloproliferative disorders or myelodysplastic syndromes, having received chemotherapy and/or radiotherapy without previous history of myelodysplastic syndromes are eligible for the present study
• •High-risk cytogenetics defined as one the following abnormalities : 5/5q-, 7/7q-, t(6,9), 11q23 abnormality excluding t(9;11), 3q abnormality,complex karyotype (\>3 abnormalites)
• •Left ventricular ejection fraction (LVEF) \> 50% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan.
• •Adequate liver function (all of the following) except if secondary to the leukemia:
• •Total bilirubin below 1.5 x upper limit of normal (ULN), AST and ALT below 2.5 x ULN , gamma-GT below 2.5 x ULN,
• •Adequate kidney function (all of the following): Serum creatinine below 1.5 x ULN, Creatinine clearance above 50 mL/min (Cockroft and Gault formula)
• •ECOG performance status \< or = 2.
• •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• •The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient.
• •Affiliated to the French Social Security (Health Insurance).