Phase 3 study comparing systematic sequential induction chemotherapy to conditional sequential induction chemotherapy in patients with CBF group Acute Myeloid Leukemia - CBF 2006

INTERVENTION: Trade Name: CERUBIDINE Product Name: CERUBIDINE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN Daunorubicine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Trade Name: ARACYTINE Product Name: ARACYTINE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN Cytarabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: AMSALYO Product Name: AMSALYO Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN Amsacrine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Trade Name: GRANOCYTE 34 Product Name: GRANOCYTE 34 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN Lénograstim Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 263‐ Trade Name: METHOTREXATE Product Name: METHOTREXATE Pharmaceutical Form: Solution for injection INN or Proposed INN methotrexate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2,5‐ Trade Name: DEPO‐MEDROL Product Name: DEPO‐MEDROL Pharmaceutical Form: Suspension for injection INN or Proposed INN Acétate de méthylprednisolone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40‐ Trade Name: ARACYTINE Product Name: ARACYTINE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN Cytarabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: CERUBIDINE Product Name: CERUBIDINE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN Daunorubicine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Trade Name: ARACYTINE Product Name: ARACYTINE Pharmaceutical Form: Powder and solvent for solu CONDITION: Adult Acute Myeloid Leukemia with a favorable prognosis in the CBF group. MedDRA version: 8.1 Level: PT Classification code 10000880 Term: Acute Myeloid Leukemia PRIMARY OUTCOME: Main Objective: Increase in Event-Free Survival (EFS) in patients with CBF group AML by administering systematic sequential induction (ALFA arm) compared to conditional sequential induction (GOELAMS arm). Primary end point(s): - Event-Free Survival (EFS): Time between the date of inclusion in the protocol and the date of occurrence of one of the following events: Refractory disease, relapse (cytological), molecular relapse on MRD3 assessment, death from any cause. - CR (Complete Remission): PMN > 1000/mm3, platelets > 100,000/mm3, red blood cell transfusion independence, bone marrow blasts < 5% regardless of cell density, absence of Auer bodies, absence of extracellular leukemic infiltration; - CRc: Patients in CR, disappearance of the initial cytogenetic abnormality assessed with the same technique as the initial diagnosis; - CRm: Patients in CRc, reduction > 3 log (compared to the value obtained at diagnosis) of the bone marrow fusion/abl transcript ratio; Secondary Objective: - Study of CR rates, cumulative relapse incidence, RFS, and survival, as well as the level of minimal residual disease in the two groups; - Comparative toxicity of the two induction strategies. - Study of prognostic factors: Leukocytosis at induction, mutational status (FLT3, c-Kit and Ras), evaluation of the impact of minimal residual disease on outcome (CR, cumulative relapse incidence, EFS, RFS and overall survival); - Evaluation within the CBF group of AMLs of the value of defining subgroups based on the study of gene expression profiles; - Impact on prognosis of the study of polymorphisms of genes involved in the metabolism of cytarabine and anthracyclines (pharmacogenetic study). INCLUSION CRITERIA: - Patients aged 18 to 60 years - Presenting with CBF group AML, de novo or secondary, defined as follows: * CBFalpha subgroup: Presence of t(8;21)(q22;q22) and/or AML1-ETO fusion transcript. * CBFbet subgroup: Presence of inv(16)(p13;q22) or t(16;16)(p13;q22) and/or CBFbet-MYH11 fusion transcript. * Patients with hyperleukocytic AML (WBC > 30,000/mm3) classified as M4eo (FAB) pending confirmation by the above criteria. - Previously untreated. - No metastatic or progressive cancer, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix. - Good general condition (WHO performance status ≤ 2). - No severe uncontrolled infection. - No cardiac contraindication to the use of anthracyclines (decompensated or uncontrolled coronary insufficiency, recent myocardial infarction, etc.).