Table 1.

Treatment Elements for High-Risk ALL in GMALL Studies 03/87 and 04/89

Induction  
 Phase I  
  Prednisolone 3 × 20 mg/m2 PO  Days 1-28 
  Vincristine  2 mg  IV  Days 1, 8, 15, and 22 
  Daunorubicin  45 mg/m2 IV  Days 1, 8, 15, and 22  
  L-Asparaginase  5,000 E/m2 IV Days 15-28  
  Methotrexate  15 mg  IT Day 1  
 Phase II  
  Cyclophospha   mide  650 mg/m2 IV  Days 29, 43*, and 57  
  Cytarabine 75 mg/m2 IV  Days 31-34, 38-41, 45-48, and 52-55 
  6-Mercaptopu   rine  60 mg/m2 PO  Days 29-57  
  Methotrexate  15 mg  IT  Days 31, 38, 45, and 52 
Reinduction  
 Phase I  
  Prednisolone 3 × 20 mg/m2 PO  Days 1-28 
  Vincristine  2 mg  IV  Days 1, 8, 15, and 22 
  Doxorubicin  25 mg/m2 IV  Days 1, 8, 15, and 22  
  Methotrexate  15 mg  IT  Day 1 
  Cytarabine  40 mg  IT  Day 1  
  Dexamethasone 4 mg  IT  Day 1  
 Phase II 
  Cyclophospha   mide  650 mg/m2 IV  Day 29  
  Cytarabine  75 mg/m2 IV  Days 31-34, and 38-41  
  Thioguanine  60 mg/m2 PO  Days 29-42  
  Methotrexate  15 mg  IT  Day 29 
  Cytarabine  40 mg  IT  Day 29  
  Dexamethasone 4 mg  IT  Day 29  
Consolidation cycles  
 HD cytarabine/   mitoxantrone   (week 13) 
  Cytarabine  3 g/m2 (03/87)  IV  Days 1-4 (12 hourly)  
 1 g/m2 (04/89)  IV  Days 1-4 (12 hourly)  
  Mitoxantrone  10 mg/m2 (03/87)  IV Days 2-6  
 10 mg/m2 (04/89)  IV  Days 2-5 
 HD methotrexate/   L-asparaginase   (weeks 13, 15,   and 17)  
  HD-Methotrexate  1500 mg/m2 IV Day 1  
 1/10 within 30 min and 9/10 within 23.5 hours 
  L-Asparaginase  10,000 IU/m2 IV  Day 2 
 Teniposide/   cytarabine   (weeks 31   and 35)  
  Teniposide  60 mg/m2 IV  Days 1-5  
  Cytarabine  75 mg/m2 IV  Days 1-5 
Induction  
 Phase I  
  Prednisolone 3 × 20 mg/m2 PO  Days 1-28 
  Vincristine  2 mg  IV  Days 1, 8, 15, and 22 
  Daunorubicin  45 mg/m2 IV  Days 1, 8, 15, and 22  
  L-Asparaginase  5,000 E/m2 IV Days 15-28  
  Methotrexate  15 mg  IT Day 1  
 Phase II  
  Cyclophospha   mide  650 mg/m2 IV  Days 29, 43*, and 57  
  Cytarabine 75 mg/m2 IV  Days 31-34, 38-41, 45-48, and 52-55 
  6-Mercaptopu   rine  60 mg/m2 PO  Days 29-57  
  Methotrexate  15 mg  IT  Days 31, 38, 45, and 52 
Reinduction  
 Phase I  
  Prednisolone 3 × 20 mg/m2 PO  Days 1-28 
  Vincristine  2 mg  IV  Days 1, 8, 15, and 22 
  Doxorubicin  25 mg/m2 IV  Days 1, 8, 15, and 22  
  Methotrexate  15 mg  IT  Day 1 
  Cytarabine  40 mg  IT  Day 1  
  Dexamethasone 4 mg  IT  Day 1  
 Phase II 
  Cyclophospha   mide  650 mg/m2 IV  Day 29  
  Cytarabine  75 mg/m2 IV  Days 31-34, and 38-41  
  Thioguanine  60 mg/m2 PO  Days 29-42  
  Methotrexate  15 mg  IT  Day 29 
  Cytarabine  40 mg  IT  Day 29  
  Dexamethasone 4 mg  IT  Day 29  
Consolidation cycles  
 HD cytarabine/   mitoxantrone   (week 13) 
  Cytarabine  3 g/m2 (03/87)  IV  Days 1-4 (12 hourly)  
 1 g/m2 (04/89)  IV  Days 1-4 (12 hourly)  
  Mitoxantrone  10 mg/m2 (03/87)  IV Days 2-6  
 10 mg/m2 (04/89)  IV  Days 2-5 
 HD methotrexate/   L-asparaginase   (weeks 13, 15,   and 17)  
  HD-Methotrexate  1500 mg/m2 IV Day 1  
 1/10 within 30 min and 9/10 within 23.5 hours 
  L-Asparaginase  10,000 IU/m2 IV  Day 2 
 Teniposide/   cytarabine   (weeks 31   and 35)  
  Teniposide  60 mg/m2 IV  Days 1-5  
  Cytarabine  75 mg/m2 IV  Days 1-5 

*Only administered in GMALL study 04/89 (see treatment schedules).

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