Table I.
| Induction | PDN | 40mg/m2/day PO TID days 1–21, no taper |
| DXM+ | 10 mg/m2/day PO TID days 1–21 no taper (Cohort 1+2) | |
| (Week 1–3) | VCR | 0.05 mg/kg days 0, 14, 0.03 mg/kg day 7 |
| DNM | 2mg/kg/day IV push Day 1+2 age < 6 months | |
| 2.5mg/kg/day IV push Day 1+2 age ≥6–<9 months | ||
| 3mg/kg/day IV push Day 1+2 age ≥9 months | ||
| DNM+ | 45 mg/m2/IV over 48 hours Days 1–2 (Cohort 1) | |
| 4 mg/kg IV over 48 hours (<6 months) (Cohort 2) | ||
| 5 mg/kg IV over 48 hours (≥6–<9 months) (Cohort 2) | ||
| 6 mg/kg IV over 48 hours (≥9 months) (Cohort 2) | ||
| CPM | 250 mg/m2 q 12 h × 4 doses, days 3 and 4 | |
| L-ASP | 6000 IU/m2 × 8 doses 3 × week IM | |
| ITT | Days 1, 8, 15 | |
| G-CSF | 5 ug/kg/day beginning Day 5 through count recovery | |
| Induction | MTX | 4 gm/m2 × 2, Days 22/29 |
| Intensification | CF | 10 mg/m2 PO or IV q 6 h × ≥ 5 doses, start 18 h after MTX |
| (Week 4–7) | VP-16 | 100 mg/m2 × 5 days, Days 36–40 |
| CPM | 300 mg/m2 × 5 days, Days 36–40 | |
| G-CSF | 5 ug/kg/day beginning Day 41 until count recovery | |
| ITT | Days 22, 28 | |
| Re-Induction | PDN | 40mg/m2/day PO TID days 1–21, no taper |
| (Week 8–10) | VCR | 0.05 mg/kg days 0, 14, 0.03 mg/kg day 7 |
| DNM | 2mg/kg/day IV push Day 1+2 age < 6 months | |
| 2.5mg/kg/day IV push Day 1+2 age ≥6–<9 months | ||
| 3mg/kg/day IV push Day 1+2 age ≥9 months | ||
| DNM+ | 45 mg/m2/IV over 48 hours Days 1–2 (Cohort 1) | |
| 4 mg/kg IV over 48 hours (, 6 months) (Cohort 2) | ||
| 5 mg/kg IV over 48 hours (≥6–<9 months) (Cohort 2) | ||
| 6 mg/kg IV over 48 hours (≥9 months) (Cohort 2) | ||
| CPM | 250 mg/m2 q 12 h × 4 doses, days 3 and 4 | |
| L-ASP | 6000 IU/m2 × 8 doses 3 × week IM | |
| G-CSF | 5 ug/kg/day beginning Day 5 through count recovery | |
| ITT | Days 1, 15 | |
| Consolidation | MTX | 4 gm/m2 × 2, Days 1, 8 |
| (Week 11–17) | VP-16 | 100 mg/m2 × 5 days, Days 15–19 |
| CPM | 300 mg/m2 × 5 days, Days 15–19 | |
| G-CSF | 5 ug/kg/day beginning Day 20 until count recovery | |
| AraC | 3 gm/m2 dose q 12 hours × 4 doses Day 29, 30 | |
| L-asparaginase 6000 units/m2 IM Days 31 | ||
| G-CSF | 5 ug/kg/day beginning Day 232 until count recovery | |
| ITT | Day 1 | |
| Maintenance | VCR | 0.05 mg/kg IV days Week 18, 22, 28, 32, 38, 42 |
| (Week 18–46) | DXM+ | 10 mg/m2 divided PO TID × 5 days with VCR (Cohort 1+2) |
| PDN | 40mg/m2 divided PO TID × 5 days with VCR (Cohort 3) | |
| VP-16 | 100 mg/m2/day × 5 days Week 25, 35 | |
| CPM | 300 mg/m2/day IV × 5 days Week 25, 35 | |
| G-CSF | 5 ug/kg/day beginning at completion VP-16/CPM until recovery | |
| 6MP | 75 mg/m2 PO daily and MTX 20 mg/m2 IM weekly | |
| Weeks 19–21; 23–24; 29–31; 33–34; 39–41; 43–46 | ||
| ITT Weeks 18, 22, 28, 32, 38, 42 | ||
*
ALL DOSES IDENTICAL REGARDLESS OF AGE UNLESS OTHERWISE SPECIFIED (DNM; ITT);
+
Specific to Cohort 1 & 2 and in italics; PDN, prednisone; VCR, vincristine; DNM, daunomycin; L-ASP, L-asparaginase; 6-MP, mercaptopurine; CPM, cyclophosphamide; ARA-C, cytarabine; DXM, dexamethasone; MTX, methotrexate; CF, citrovorum factor (leucovorin); IT, intrathecal; ITT, intrathecal triple therapy (MTX-methotrexate; HC-hydrocortisone; ARA-C-cytosine arabinoside); VP-16, etoposide; IV ARA-C, cytosine arabinoside; G-CSF, colony stimulating factor. ITT Cohort 3: Age < 1 year: MTX – 7.5mg; HC 7.5 mg; AraC – 15 mg, Age≥ 1 year: MTX – 8mg; HC – 8 mg; AraC – 16 mg; ITT Cohort 1+2: All ages: MTX – 7.5mg; HC 7.5mg; AraC 15 mg