Treatment plan for infant ALL with a germline MLL gene
Phase and drug . | Site, duration . | Dosage . | Time of dose(s) . |
|---|---|---|---|
| Induction | |||
| DEX | Intravenous | 10 mg/m2 | Days 1-14 |
| PSL | By mouth or intravenous | 60 mg/m2 | Days 15-28 |
| VCR | Intravenous | 0.05 mg/kg | Days 1, 8, 15, 22 |
| CPA | Intravenous, 1-2 h | 1200 mg/m2 | Day 2 |
| DXR | Intravenous, 1 h | 25 mg/m2 | Days 3, 5 |
| ASP | Intravenous, 3-4 h | 10 000 U/m2 | Days 16, 18, 20, 23, 25, 27 |
| TIT | Intrathecal | Age-adjusted† | Days 1, 15, 29 |
| VP-16 | Intravenous, 1-2 h | 100 mg/m2 | Days 29-32 |
| Ara-C | Intravenous, 4 h | 500 mg/m2 | Days 29-32 |
| Consolidation and CNS prophylaxis | |||
| MTX | Intravenous, 24 h | 3 g/m2 | Days 1, 15, 29 |
| TIT | Intrathecal | Age-adjusted† | Days 1, 15, 29 |
| CPA | Intravenous, 1-2 h | 500 mg/m2 | Days 2, 16, 30 |
| ASP | Intravenous or intramuscular | 10 000 U/m2 | Days 2, 16, 30 |
| PSL | By mouth or intravenous | 60 mg/m2 | Days 1-3 |
| Intensification | |||
| VCR | Intravenous | 0.05 mg/kg | Days 1, 8, 15 |
| DNR | Intravenous | 25 mg/m2 | Days 1, 8, 15 |
| Ara-C | Intravenous, 1 h | 60 mg/m2 | Days 2-7, 9-14 |
| 6-MP | By mouth | 75 mg/m2 | Days 1-14 |
| TIT | Intrathecal | Age-adjusted† | Days 1, 15 |
| Maintenance* | |||
| Regimen A | |||
| 6-MP | By mouth | 75 mg/m2 | Days 1-14 |
| MTX | By mouth | 30 mg/m2 | Days 1, 8 |
| VP-16 | Intravenous, 1-2 h | 150 mg/m2 | Day 14 |
| Ara-C | Intravenous, 4 h | 200 mg/m2 | Day 14 |
| Regimen B | |||
| 6-MP | By mouth | 75 mg/m2 | Days 1-14 |
| MTX | By mouth | 30 mg/m2 | Days 1, 8 |
| PSL | By mouth | 60 mg/m2 | Days 15-28 |
| VCR | Intravenous | 0.05 mg/kg | Days 15, 22, 29 |
| MTX | Intravenous, 5 h | 300 mg/m2 | Day 15 |
| TIT | Intrathecal | Age-adjusted† | Every 6 weeks |
Phase and drug . | Site, duration . | Dosage . | Time of dose(s) . |
|---|---|---|---|
| Induction | |||
| DEX | Intravenous | 10 mg/m2 | Days 1-14 |
| PSL | By mouth or intravenous | 60 mg/m2 | Days 15-28 |
| VCR | Intravenous | 0.05 mg/kg | Days 1, 8, 15, 22 |
| CPA | Intravenous, 1-2 h | 1200 mg/m2 | Day 2 |
| DXR | Intravenous, 1 h | 25 mg/m2 | Days 3, 5 |
| ASP | Intravenous, 3-4 h | 10 000 U/m2 | Days 16, 18, 20, 23, 25, 27 |
| TIT | Intrathecal | Age-adjusted† | Days 1, 15, 29 |
| VP-16 | Intravenous, 1-2 h | 100 mg/m2 | Days 29-32 |
| Ara-C | Intravenous, 4 h | 500 mg/m2 | Days 29-32 |
| Consolidation and CNS prophylaxis | |||
| MTX | Intravenous, 24 h | 3 g/m2 | Days 1, 15, 29 |
| TIT | Intrathecal | Age-adjusted† | Days 1, 15, 29 |
| CPA | Intravenous, 1-2 h | 500 mg/m2 | Days 2, 16, 30 |
| ASP | Intravenous or intramuscular | 10 000 U/m2 | Days 2, 16, 30 |
| PSL | By mouth or intravenous | 60 mg/m2 | Days 1-3 |
| Intensification | |||
| VCR | Intravenous | 0.05 mg/kg | Days 1, 8, 15 |
| DNR | Intravenous | 25 mg/m2 | Days 1, 8, 15 |
| Ara-C | Intravenous, 1 h | 60 mg/m2 | Days 2-7, 9-14 |
| 6-MP | By mouth | 75 mg/m2 | Days 1-14 |
| TIT | Intrathecal | Age-adjusted† | Days 1, 15 |
| Maintenance* | |||
| Regimen A | |||
| 6-MP | By mouth | 75 mg/m2 | Days 1-14 |
| MTX | By mouth | 30 mg/m2 | Days 1, 8 |
| VP-16 | Intravenous, 1-2 h | 150 mg/m2 | Day 14 |
| Ara-C | Intravenous, 4 h | 200 mg/m2 | Day 14 |
| Regimen B | |||
| 6-MP | By mouth | 75 mg/m2 | Days 1-14 |
| MTX | By mouth | 30 mg/m2 | Days 1, 8 |
| PSL | By mouth | 60 mg/m2 | Days 15-28 |
| VCR | Intravenous | 0.05 mg/kg | Days 15, 22, 29 |
| MTX | Intravenous, 5 h | 300 mg/m2 | Day 15 |
| TIT | Intrathecal | Age-adjusted† | Every 6 weeks |
Reinduction regimen is the same as that for induction.
DEX indicates dexamethasone; PSL, prednisolone; VCR, vincristine; CPA, cyclophosphamide; DXR, doxorubicin; ASP, L-asparaginase; TIT, triple intrathecal therapy; VP-16, etoposide; Ara-C, cytarabine; MTX, methotrexate; DNR, daunorubicin; 6-MP, 6-mercaptopurine. The dose of each drug except VCR was reduced by one third in patients younger than 2 months and by one fourth in those 2 to 4 months of age.
Each cycle consisted of two courses of regimen A, followed by regimen B. Each regimen was given over 2 weeks. The 12-week course was repeated 4 times. The total period of maintenance therapy becomes almost 56 weeks.
Doses were adjusted according to the patient's age at administration as follows: 90 days old or younger, MTX 3 mg, hydrocortisone (HDC) 10 mg, Ara-C 6 mg; younger than 1 year old, MTX 6 mg, HDC 10 mg, Ara-C 12 mg; 1 year and older, MTX 8 mg, HDC 15 mg, Ara-C 20 mg.