pilot study efficacy and tolerance fish oil emulsion daunorubicin and cytarabine treatment of aml younger patients

Conditions: Acute Myeloid Leukemia (AML)

Summary: pilot study of the efficacy and tolerance of the adjunction of a fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of acute myeloblastic leukemia of younger patients (under 61 years) with high-risk cytogenetics.

adjunction of a fish oil emulsion omegaven to daunorubicin and cytarabine chemotherapy for the treatment of acute myeloblastic leukemia of younger patients.

Eligibility criteria:
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). exclusion criteria: * previous allogeneic stem cell transplantation. * pre-existing aplastic anemia * presence of favourable cytogenetics with t(8;21), t(15;17), or inv(16) * previous history of mds or myeloproliferative neoplasm * uncontrolled active infection. * history of arrythmia. * cardiac toxicity induced by another anthracycline administration * maximum cumulative dose reached for any anthracyclin * allergy to cytarabine, daunorubicin, fish or egg proteins10. significant neurologic (grade \> 2) or psychiatric disorder, dementia or seizures. * clinical symptoms suggesting active central nervous system leukemia. * degenerative or toxic encephalopathy * severe complications of leukemia such as:uncontrolled bleeding, pneumonia with hypoxia or shock * prior total body irradiation \> 10 gy. * known active hiv, hepatitis b or c infection * pregnancy or breastfeeding * concomitant anti-amarile vaccination (yellow fever) * concurrent treatment with any other anti-cancer therapy except hydroxyurea

Keywords: aml high-risk cytogenetics younger patients induction treatment omegaven