Table 1.

Therapy on DFCI ALL Consortium Protocol 95-01


Type of therapy, duration, and regimen
Induction therapy, 4 wk 
    Vincristine 1.5 mg/m2 intravenously every week for 4 weeks  
    Prednisone 40 mg/m2 by mouth every day for 28 days  
    Doxorubicin 30 mg/m2 intravenously on days 0 and 1* 
    Methotrexate 4 g/m2 intravenously on day 2  
    Leucovorin 200 mg/m2 intravenous push hour 36, then 24 mg/m2 intravenously every 6 hours until methotrexate level < 0.1 μM  
    Asparaginase 25 000 IU/m2 intramuscularly on day 4 
    IT-Ara-C at diagnosis, dosed by age 
    ITT on day 16 and 30, dosed by age§ 
CNS treatment, 3 wk 
    Vincristine 2 mg/m2 intravenously for 1 dose  
    6-mercaptopurine 50 mg/m2 by mouth for 14 days  
    Doxorubicin 30 mg/m2 intravenously for 1 dose (HR only)* 
    SR: 1800 cGy cranial x-ray therapy (XRT) with IT every 18 weeks vs no XRT and intensive ITT every 9 weeks for 6 doses, then every 18 weeks  
    HR: IT every 18 weeks with 1800 cGy cranial XRT  
Intensification therapy, 5-6 mo 
    Vincristine 2 mg/m2 intravenously every 3 weeks  
    Prednisone 40 mg/m2 by mouth for 5 days every 3 weeks (SR)  
    Prednisone 120 mg/m2 by mouth for 5 days every 3 weeks (HR)  
    6-mercaptopurine 50 mg/m2 by mouth for 14 days every 3 weeks  
    Asparaginase every week for 20 doses 
    Methotrexate 30 mg/m2 intramuscularly every week (SR only)  
    Doxorubicin 30 mg/m2 intravenously every 3 weeks (HR only)* 
Continuation therapy, 2 y of CCR 
    Vincristine as intensification  
    Prednisone as intensification  
    6-mercaptopurine as intensification  
    Methotrexate as intensification
 

Type of therapy, duration, and regimen
Induction therapy, 4 wk 
    Vincristine 1.5 mg/m2 intravenously every week for 4 weeks  
    Prednisone 40 mg/m2 by mouth every day for 28 days  
    Doxorubicin 30 mg/m2 intravenously on days 0 and 1* 
    Methotrexate 4 g/m2 intravenously on day 2  
    Leucovorin 200 mg/m2 intravenous push hour 36, then 24 mg/m2 intravenously every 6 hours until methotrexate level < 0.1 μM  
    Asparaginase 25 000 IU/m2 intramuscularly on day 4 
    IT-Ara-C at diagnosis, dosed by age 
    ITT on day 16 and 30, dosed by age§ 
CNS treatment, 3 wk 
    Vincristine 2 mg/m2 intravenously for 1 dose  
    6-mercaptopurine 50 mg/m2 by mouth for 14 days  
    Doxorubicin 30 mg/m2 intravenously for 1 dose (HR only)* 
    SR: 1800 cGy cranial x-ray therapy (XRT) with IT every 18 weeks vs no XRT and intensive ITT every 9 weeks for 6 doses, then every 18 weeks  
    HR: IT every 18 weeks with 1800 cGy cranial XRT  
Intensification therapy, 5-6 mo 
    Vincristine 2 mg/m2 intravenously every 3 weeks  
    Prednisone 40 mg/m2 by mouth for 5 days every 3 weeks (SR)  
    Prednisone 120 mg/m2 by mouth for 5 days every 3 weeks (HR)  
    6-mercaptopurine 50 mg/m2 by mouth for 14 days every 3 weeks  
    Asparaginase every week for 20 doses 
    Methotrexate 30 mg/m2 intramuscularly every week (SR only)  
    Doxorubicin 30 mg/m2 intravenously every 3 weeks (HR only)* 
Continuation therapy, 2 y of CCR 
    Vincristine as intensification  
    Prednisone as intensification  
    6-mercaptopurine as intensification  
    Methotrexate as intensification
 

Infants were treated as HR patients but received additional chemotherapy, including high-dose methotrexate and high-dose Ara-C.

*

HR patients: doxorubicin given with or without dexrazoxane 300 mg/m2. Total cumulative dose of doxorubicin was 300 mg/m2 for HR and 60 mg/m2 for SR patients.

Asparaginase type randomized: E coli or Erwinia each at 25 000 IU/m2 intramuscularly.

IT-Ara-C dosed by age: younger than 1 year, 15 mg; 1-1.99 years, 20 mg; 2-2.99 years, 30 mg; older than 3 years, 40 mg.

§

ITT: triple intrathecal chemotherapy dosed per age: Ara-C dosing above, younger than 1 year, methotrexate 6 mg and hydrocortisone 6 mg; 1-1.99 years, methotrexate 8 mg and hydrocortisone 9 mg; 2-2.99 years, methotrexate 10 mg and hydrocortisone 12 mg; older than 3 years, methotrexate 12 mg and hydrocortisone 15 mg.

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