Components of the APML4 protocol
| Induction | ||
| ATRA | 45 mg/m2/d PO | Days 1-36 in divided doses |
| Idarubicin | 12 mg/m2/d IV (ages 1-60) | Days 2, 4, 6, and 8 |
| 9 mg/m2/d IV (ages 61-70) | ||
| 6 mg/m2/d IV (ages > 70) | ||
| ATO | 0.15 mg/kg/d IV | Days 9-36 as a 2-hour IV infusion Supplemental potassium and magnesium as required to maintain serum levels in the upper half of the respective normal ranges |
| Prednisone | 1 mg/kg/d PO | Days 1-10 or until WBC count falls below 1 × 109/L or until resolution of differentiation syndrome (whichever occurs last) |
| Hemostatic support | Products administered once or twice daily as required to achieve specified targets | Platelets > 30 × 109/L Normal prothrombin time Normal activated partial thromboplastin time Fibrinogen > 1.5 g/L |
| Consolidation cycle 1 (3-4 wks after the end of induction) | ||
| ATRA | 45 mg/m2/d PO | Days 1-28 |
| ATO | 0.15 mg/kg/d IV | Days 1-28 |
| Consolidation cycle 2 (3-4 wks after the end of consolidation cycle 1) | ||
| ATRA | 45 mg/m2/d PO | Days 1-7, 15-21, 29-35 |
| ATO | 0.15 mg/kg/d IV | Days 1-5, 8-12, 15-19, 22-26, 29-33 |
| Maintenance: 8 cycles (3-4 wks after the end of consolidation cycle 2) | ||
| ATRA | 45 mg/m2/d PO | Days 1-14 |
| MTX | 5-15 mg/m2/wk PO | Days 15-90 |
| 6MP | 50-90 mg/m2/d PO | Days 15-90 |
| Induction | ||
| ATRA | 45 mg/m2/d PO | Days 1-36 in divided doses |
| Idarubicin | 12 mg/m2/d IV (ages 1-60) | Days 2, 4, 6, and 8 |
| 9 mg/m2/d IV (ages 61-70) | ||
| 6 mg/m2/d IV (ages > 70) | ||
| ATO | 0.15 mg/kg/d IV | Days 9-36 as a 2-hour IV infusion Supplemental potassium and magnesium as required to maintain serum levels in the upper half of the respective normal ranges |
| Prednisone | 1 mg/kg/d PO | Days 1-10 or until WBC count falls below 1 × 109/L or until resolution of differentiation syndrome (whichever occurs last) |
| Hemostatic support | Products administered once or twice daily as required to achieve specified targets | Platelets > 30 × 109/L Normal prothrombin time Normal activated partial thromboplastin time Fibrinogen > 1.5 g/L |
| Consolidation cycle 1 (3-4 wks after the end of induction) | ||
| ATRA | 45 mg/m2/d PO | Days 1-28 |
| ATO | 0.15 mg/kg/d IV | Days 1-28 |
| Consolidation cycle 2 (3-4 wks after the end of consolidation cycle 1) | ||
| ATRA | 45 mg/m2/d PO | Days 1-7, 15-21, 29-35 |
| ATO | 0.15 mg/kg/d IV | Days 1-5, 8-12, 15-19, 22-26, 29-33 |
| Maintenance: 8 cycles (3-4 wks after the end of consolidation cycle 2) | ||
| ATRA | 45 mg/m2/d PO | Days 1-14 |
| MTX | 5-15 mg/m2/wk PO | Days 15-90 |
| 6MP | 50-90 mg/m2/d PO | Days 15-90 |
PO indicates oral administration.