Table 1.

Chemotherapy Regimen for ALL in Adults

Course I: Induction (4 wk) 
 Cyclophosphamide* IV 1,200 mg/m2 Day 1 
 Daunorubicin* IV 45 mg/m2 Days 1, 2, 3 
 Vincristine IV 2 mg Days 1, 8, 15, 22 
 Prednisone* PO/IV 60 mg/m2/d Days 1-21 
 L-Asparaginase (E coli) SC/IM 6,000 IU/m2 Days 5, 8, 11, 15,  18, 22 
*For patients ≥60 years old: 
 Cyclophosphamide  800 mg/m2 Day 1 
 Daunorubicin  30 mg/m2 Days 1, 2, 3 
 Prednisone  60 mg/m2/d Days 1-7 
Course IIA: Early Intensification (4 wk; repeat once for Course IIB) 
 Intrathecal methotrexate  15 mg Day 1 
 Cyclophosphamide IV 1,000 mg/m2 Day 1 
 6-Mercaptopurine PO 60 mg/m2/d Days 1-14 
 Cytarabine SC 75 mg/m2/d Days 1-4, 8-11 
 Vincristine IV 2 mg Days 15, 22 
 L-Asparaginase (E coli) SC/IM 6,000 IU/m2 Days 15, 18, 22, 25 
Course III: CNS Prophylaxis and Interim Maintenance (12 wk) 
 Cranial irradiation  2,400 cGy Days 1-12 
 Intrathecal methotrexate  15 mg Days 1, 8, 15,  22, 29 
 6-Mercaptopurine PO 60 mg/m2/d Days 1-70 
 Methotrexate PO 20 mg/m2 Days 36, 43, 50,  57, 64 
Course IV: Late Intensification (8 wk) 
 Doxorubicin IV 30 mg/m2 Days 1, 8, 15 
 Vincristine IV 2 mg Days 1, 8, 15 
 Dexamethasone PO 10 mg/m2/d Days 1-14 
 Cyclophosphamide IV 1,000 mg/m2 Day 29 
 6-Thioguanine PO 60 mg/m2/d Days 29-42 
 Cytarabine SC 75 mg/m2/d Days 29-32,  36-39 
Course V: Prolonged Maintenance (until 24 mo from diagnosis) 
 Vincristine IV 2 mg Day 1 of every  4 wk 
 Prednisone PO 60 mg/m2/d Days 1-5 of every  4 wk 
 6-Mercaptopurine PO 60 mg/m2/d Days 1-28 
 Methotrexate PO 20 mg/m2 Days 1, 8, 15, 22 
Course I: Induction (4 wk) 
 Cyclophosphamide* IV 1,200 mg/m2 Day 1 
 Daunorubicin* IV 45 mg/m2 Days 1, 2, 3 
 Vincristine IV 2 mg Days 1, 8, 15, 22 
 Prednisone* PO/IV 60 mg/m2/d Days 1-21 
 L-Asparaginase (E coli) SC/IM 6,000 IU/m2 Days 5, 8, 11, 15,  18, 22 
*For patients ≥60 years old: 
 Cyclophosphamide  800 mg/m2 Day 1 
 Daunorubicin  30 mg/m2 Days 1, 2, 3 
 Prednisone  60 mg/m2/d Days 1-7 
Course IIA: Early Intensification (4 wk; repeat once for Course IIB) 
 Intrathecal methotrexate  15 mg Day 1 
 Cyclophosphamide IV 1,000 mg/m2 Day 1 
 6-Mercaptopurine PO 60 mg/m2/d Days 1-14 
 Cytarabine SC 75 mg/m2/d Days 1-4, 8-11 
 Vincristine IV 2 mg Days 15, 22 
 L-Asparaginase (E coli) SC/IM 6,000 IU/m2 Days 15, 18, 22, 25 
Course III: CNS Prophylaxis and Interim Maintenance (12 wk) 
 Cranial irradiation  2,400 cGy Days 1-12 
 Intrathecal methotrexate  15 mg Days 1, 8, 15,  22, 29 
 6-Mercaptopurine PO 60 mg/m2/d Days 1-70 
 Methotrexate PO 20 mg/m2 Days 36, 43, 50,  57, 64 
Course IV: Late Intensification (8 wk) 
 Doxorubicin IV 30 mg/m2 Days 1, 8, 15 
 Vincristine IV 2 mg Days 1, 8, 15 
 Dexamethasone PO 10 mg/m2/d Days 1-14 
 Cyclophosphamide IV 1,000 mg/m2 Day 29 
 6-Thioguanine PO 60 mg/m2/d Days 29-42 
 Cytarabine SC 75 mg/m2/d Days 29-32,  36-39 
Course V: Prolonged Maintenance (until 24 mo from diagnosis) 
 Vincristine IV 2 mg Day 1 of every  4 wk 
 Prednisone PO 60 mg/m2/d Days 1-5 of every  4 wk 
 6-Mercaptopurine PO 60 mg/m2/d Days 1-28 
 Methotrexate PO 20 mg/m2 Days 1, 8, 15, 22 

Course I: Patients received study drug (G-CSF 5 μg/kg or placebo) in a double-blinded fashion subcutaneously once per day starting on Day 4 and continuing until the ANC was ≥1,000/μL on two consecutive determinations >24 hours apart. Course IIA: Patients who had been assigned to G-CSF received G-CSF in an open-label fashion at 5 μg/kg subcutaneously daily, starting on day 2 and continuing for at least 14 days and until the ANC was ≥5,000/μL (see text). Patients who had been assigned to placebo received no further study drug.

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