Study: NCT01180322

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cytarabine
Description: Induction therapy:100 mg/m2/day by continuous intravenous (IV) infusion on days 1-7 (total dose 700 mg/m2)~Consolidation therapy:~Younger adults (18 to 65 years): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2).~Elderly patients (\>65 years): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Induction therapy:100 mg/m2/day by continuous intravenous (IV) infusion on days 1-7 (total dose 700 mg/m2)~Consolidation therapy:~Younger adults (18 to 65 years): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2).~Elderly patients (\>65 years): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Induction therapy:100 mg/m2/day by continuous intravenous (IV) infusion on days 1-7 (total dose 700 mg/m2)~Consolidation therapy:~Younger adults (18 to 65 years): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2).~Elderly patients (\>65 years): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Induction therapy:100 mg/m2/day by continuous intravenous (IV) infusion on days 1-7 (total dose 700 mg/m2)~Consolidation therapy:~Younger adults (18 to 65 years): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2).~Elderly patients (\>65 years): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Idarubicin
Description: First induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 1+3.~Arm B:~12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 6+8.~Second induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups)~Arm B:~12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Idarubicin
Description: First induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 1+3.~Arm B:~12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 6+8.~Second induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups)~Arm B:~12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Idarubicin
Description: First induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 1+3.~Arm B:~12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 6+8.~Second induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups)~Arm B:~12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Idarubicin
Description: First induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 1+3.~Arm B:~12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (\>65 yrs) patients only two doses of idarubicin are foreseen on days 6+8.~Second induction therapy:~Arm A, C, D:~12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups)~Arm B:~12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Etoposide
Description: Induction therapy:~Arm A, C, D:~100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 1+3.~Arm B:~100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 6 and 8 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 6+8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Induction therapy:~Arm A, C, D:~100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 1+3.~Arm B:~100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 6 and 8 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 6+8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Induction therapy:~Arm A, C, D:~100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 1+3.~Arm B:~100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 6 and 8 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 6+8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Induction therapy:~Arm A, C, D:~100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 1+3.~Arm B:~100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 6 and 8 start after idarubicin push. For elderly (\>65 yrs) patients only two doses of etoposide are foreseen on days 6+8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Induction therapy:~Arm B and C:~100 mg/m2/day by subcutaneous (SC) injection or 15-minute IV infusion on day 1 to day 5 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.~Arm D:~100 mg/m2/day by SC injection or 15-minute IV infusion on days 4-8 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.~Maintenance therapy:~Arm B, C, D:~50 mg/m2/day by SC injection on days 1-5 (total dose 250 mg/m2) every 4 weeks. (Maintenance therapy is scheduled for a total duration of 2 years in patients with continuous CR)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Induction therapy:~Arm B and C:~100 mg/m2/day by subcutaneous (SC) injection or 15-minute IV infusion on day 1 to day 5 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.~Arm D:~100 mg/m2/day by SC injection or 15-minute IV infusion on days 4-8 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.~Maintenance therapy:~Arm B, C, D:~50 mg/m2/day by SC injection on days 1-5 (total dose 250 mg/m2) every 4 weeks. (Maintenance therapy is scheduled for a total duration of 2 years in patients with continuous CR)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Induction therapy:~Arm B and C:~100 mg/m2/day by subcutaneous (SC) injection or 15-minute IV infusion on day 1 to day 5 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.~Arm D:~100 mg/m2/day by SC injection or 15-minute IV infusion on days 4-8 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.~Maintenance therapy:~Arm B, C, D:~50 mg/m2/day by SC injection on days 1-5 (total dose 250 mg/m2) every 4 weeks. (Maintenance therapy is scheduled for a total duration of 2 years in patients with continuous CR)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lenograstim
Description: Consolidation therapy:~subcutaneously daily beginning on day 10 until neutrophil count \> 0.5 x 109/l.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenograstim
Description: Consolidation therapy:~subcutaneously daily beginning on day 10 until neutrophil count \> 0.5 x 109/l.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenograstim
Description: Consolidation therapy:~subcutaneously daily beginning on day 10 until neutrophil count \> 0.5 x 109/l.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenograstim
Description: Consolidation therapy:~subcutaneously daily beginning on day 10 until neutrophil count \> 0.5 x 109/l.