Study: NCT02416388

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Idarubicin
Description: Induction chemotherapy :~Idarubicin 9mg/m² /day, from D1 to D5 (IV, 30min)~+ cytarabine 200mg/m²/day from D1 to D7 (IV 24 h)~Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Daunorubicin
Description: Induction chemotherapy :~Daunorubicin 90mg/m²/day, from D1 to D3 (IV, 30min)~+ cytarabine 200mg/m² /day from D1 to D7 (IV 24 h)~Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: HD Cytarabine
Description: Consolidation chemotherapy course (s) :~-High dose cytarabine: 3g/m² /12h on D1, D3 and D5~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)~Up to 3 consolidation courses, depending on the patient AML risk group

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HD Cytarabine
Description: Consolidation chemotherapy course (s) :~-High dose cytarabine: 3g/m² /12h on D1, D3 and D5~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)~Up to 3 consolidation courses, depending on the patient AML risk group

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: HD Cytarabine
Description: Consolidation chemotherapy course (s) :~-High dose cytarabine: 3g/m² /12h on D1, D3 and D5~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)~Up to 3 consolidation courses, depending on the patient AML risk group

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporine
Description: GvHD prophylaxis post allogeneic SCT :~-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclosporine
Description: GvHD prophylaxis post allogeneic SCT :~-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporine
Description: GvHD prophylaxis post allogeneic SCT :~-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate
Description: GvHD prophylaxis post allogeneic SCT :~-15 mg/m² on D+1 then 10 mg/m² on D+3, D+6 and D+11

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolic acid (MPA)
Description: GvHD prophylaxis post allogeneic SCT :~* 720 mg BID from D0 to D+28 for HLA-identical siblings~* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mycophenolic acid (MPA)
Description: GvHD prophylaxis post allogeneic SCT :~* 720 mg BID from D0 to D+28 for HLA-identical siblings~* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolic acid (MPA)
Description: GvHD prophylaxis post allogeneic SCT :~* 720 mg BID from D0 to D+28 for HLA-identical siblings~* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vosaroxin
Description: Consolidation chemotherapy course (s) :~-70 mg/m² on D1 and D4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ID cytarabine
Description: Consolidation chemotherapy course (s) :~-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)~Up to 3 consolidation courses, depending on the patient AML risk group