ival (OS) constantly exceeded 1 year and were superior to historical control (DFS p<0.001; OS p<0.0001) in two studies (AJP01 and AUS01).
Table 5 Chemotherapy regimen used in combination with imatinib
Study ADE10
Prephase
DEX 10 mg/m2 oral, days 1-5;
CP 200 mg/m2 i.v., days 3, 4, 5;
MTX 12 mg intrathecal, day 1
Remission induction
DEX 10 mg/m2 oral, days 6-7, 13-16;
VCR 1 mg i.v., days 7, 14;
IDA 8 mg/m2 i.v. (0.5 h), days 7, 8, 14, 15;
CP 500 mg/m2 i.v.(1 h) day 1;
Ara-C 60 mg/m2 i.v., days 22-25, 29-32
Consolidation therapy I, III, V
MTX 500 mg/m2 i.v. (24 h), days 1, 15;
6-MP 25 mg/m2 oral, days 1-20
Consolidation therapy II, IV
Ara-C 75 mg/m2 i.v. (1 h), days 1-5;
VM26 60 mg/m2 i.v. (1 h), days 1-5
Study AAU02
Induction therapy (de novo Ph+ ALL)
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
VCR 2 mg total dose i.v., days 1, 8, 15, 22;
CP 750 mg/m2 i.v., days 1, 8;
Prednisone 60 mg/m2 oral, days 1-7, 15-21;
IDA 9 mg/m2 oral, days 1-28;
MTX 15 mg intrathecal, days 1, 8, 15, 22;
Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Consolidation (de novo Ph+ ALL)
Ara-C 1,000 mg/m2/12 h i.v.(3 h), days 1-4;
Mitoxantrone 10 mg/m2 i.v. days 3-5;
MTX 15 mg intrathecal, day 1;
Methylprednisolone 40 mg intrathecal, day 1
Study ADE04
Prephase
DEX 10 mg/m2 oral, days 1-5;
CP 200 mg/m2 i.v., days 3-5;
MTX 15 mg intrathecal, day 1
Induction therapy I
DEX 10 mg/m2 oral, days 1-5;
VCR 2 mg i.v., days 6, 13, 20;
Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Induction therapy II
CP 1 g/m2 i.v. (1 h), days 26, 46;
Ara-C 75 mg/m2 i.v. (1 h), days 28-31, 35-38, 42-45;
6-MP 60 mg/m2 oral, days 26-46
Consolidation therapy
DEX 10 mg/m2 oral, days 1-5;
Vindesine 3 mg/m2 i.v., day 1;
MTX 1.5 g/m2 i.v. (24 h), day 1;
Etoposide 250 mg/m2 i.v. (1 h) days 4-5;
Ara-C 2x 2 g/m2 i.v. (3 h, q 12 h), day 5
Study AJP01
Induction therapy
CP 1.2 g/m2 i.v. (3 h), day 1;
Daunorubicin 60 mg/m2 i.v. (1 h), days 1-3;
Vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21;
Prednisolone 60 mg/m2/day oral
Consolidation therapy
Alternating chemotherapy course: high dose chemotherapy with MTX 1 g/m2 i.v. (24 h), day 1, and Ara-C 2 g/m2 i.v. (q 12 h), days 2-3, for 4 cycles
Maintenance
VCR 1.3 g/m2 i.v., day 1;
Prednisolone 60 mg/m2 oral, days 1-5
Study AUS01
Induction-consolidation therapy
Hyper-CVAD regimen: CP 300 mg/m2 i.v. (3 h, q 12 h), days 1-3; Vincristine 2 mg i.v., days 4, 11;
Doxorubicine 50 mg/m2 i.v. (24 h), day 4;
DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 i.v. (24 h), day 1, Ara-C 1 g/m2 i.v. (2 h, q 12 h), days 2-3 (total of 8 courses)
Maintenance
VCR 2 mg i.v. monthly for 13 months;
Prednisolone 200 mg oral, 5 days per month for 13 months
All treatment regimens include administration of steroids for CNS prophylaxis.
Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.: intravenous
Paediatric p