Treatment according to randomization arm and age
. | Arm A, “3+7” induction . | Arm B, double induction . | Arm C, timed-sequential induction . |
|---|---|---|---|
| Induction therapy | |||
| DNR | 80 mg/m2 IV days 1-3 | 80 mg/m2 IV days 1-3 | 80 mg/m2 IV days 1-3 |
| AraC | 200 mg/m2 Cl days 1-7 | 200 mg/m2 Cl days 1-7 | 500 mg/m2 Cl days 1-3 |
| MTZ | — | 12 mg/m2 IV days 20-21 | 12 mg/m2 IV days 8-9 |
| AraC | — | 500 mg/m2/12 h IV days 20-22 | 500 mg/m2/12 h IV days 8-10 |
| Salvage therapy | |||
| Amsa | 100 mg/m2 IV days 5-7 | 100 mg/m2 IV days 5-7 | 100 mg/m2 IV days 5-7 |
| AraC | 3 g/m2/12 h IV days 1-6 | 3 g/m2/12 h IV days 1-6 | 3 g/m2/12 h IV days 1-6 |
| Consolidation: course 1 | |||
| Amsa | 90 mg/m2 IV day 1 | 90 mg/m2 IV day 1 | 90 mg/m2 IV day 1 |
| AraC | 60 mg/m2/12 h SC days 1-5 | 60 mg/m2/12 h SC days 1-5 | 60 mg/m2/12 h SC days 1-5 |
| Consolidation: EMA course | |||
| MTZ | 12 mg/m2 IV days 1-3 | 12 mg/m2 IV days 1-3 | 12 mg/m2 IV days 1-3 |
| AraC* | 500 mg/m2 Cl days 1-3 | 500 mg/m2 Cl days 1-3 | 500 mg/m2 Cl days 1-3 |
| AraC* | 500 mg/m2 Cl days 8-10 | 500 mg/m2 Cl days 8-10 | 500 mg/m2 Cl days 8-10 |
| VP16* | 200 mg/m2 Cl days 8-10 | 200 mg/m2 Cl days 8-10 | 200 mg/m2 Cl days 8-10 |
. | Arm A, “3+7” induction . | Arm B, double induction . | Arm C, timed-sequential induction . |
|---|---|---|---|
| Induction therapy | |||
| DNR | 80 mg/m2 IV days 1-3 | 80 mg/m2 IV days 1-3 | 80 mg/m2 IV days 1-3 |
| AraC | 200 mg/m2 Cl days 1-7 | 200 mg/m2 Cl days 1-7 | 500 mg/m2 Cl days 1-3 |
| MTZ | — | 12 mg/m2 IV days 20-21 | 12 mg/m2 IV days 8-9 |
| AraC | — | 500 mg/m2/12 h IV days 20-22 | 500 mg/m2/12 h IV days 8-10 |
| Salvage therapy | |||
| Amsa | 100 mg/m2 IV days 5-7 | 100 mg/m2 IV days 5-7 | 100 mg/m2 IV days 5-7 |
| AraC | 3 g/m2/12 h IV days 1-6 | 3 g/m2/12 h IV days 1-6 | 3 g/m2/12 h IV days 1-6 |
| Consolidation: course 1 | |||
| Amsa | 90 mg/m2 IV day 1 | 90 mg/m2 IV day 1 | 90 mg/m2 IV day 1 |
| AraC | 60 mg/m2/12 h SC days 1-5 | 60 mg/m2/12 h SC days 1-5 | 60 mg/m2/12 h SC days 1-5 |
| Consolidation: EMA course | |||
| MTZ | 12 mg/m2 IV days 1-3 | 12 mg/m2 IV days 1-3 | 12 mg/m2 IV days 1-3 |
| AraC* | 500 mg/m2 Cl days 1-3 | 500 mg/m2 Cl days 1-3 | 500 mg/m2 Cl days 1-3 |
| AraC* | 500 mg/m2 Cl days 8-10 | 500 mg/m2 Cl days 8-10 | 500 mg/m2 Cl days 8-10 |
| VP16* | 200 mg/m2 Cl days 8-10 | 200 mg/m2 Cl days 8-10 | 200 mg/m2 Cl days 8-10 |
Of note, central nervous system (CNS) prophylaxis, which was randomly evaluated in patients at high risk of CNS relapse, is not indicated in this Table. DNR indicates daunorubicine; AraC, cytosine arabinoside; Amsa, amsacrine: MTZ, mitoxantrone; VP16, etoposide; EMA, etoposide/mitoxantrone/AraC; IV, intravenously; Cl, continuous IV infusion; SC, subcutaneously.
Half daily dosage in patients 50 years or older.