Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

2,039

Participants

Timeline

Start Date

September 30, 2000

Primary Completion Date

July 31, 2006

Study Completion Date

July 31, 2006

Conditions
Leukemia
Interventions
DRUG

dexamethasone

10 mg/sqm/day from for 21 days

DRUG

asparaginase

native E-coli Asparaginase 5,000 IU/sqm x 8 doses

DRUG

Asparaginase

native E-Coli Asparaginase 10,000 IU/sqm x 4 doses

DRUG

cyclophosphamide

1,000 mg/sqm i.v. 2 doses in Induction phase 1000 mg/sqm i.v. 1 dose in Protocoll II 500 mg/sqm i.v. 1 dose in protocol III

DRUG

cytarabine

75 mg/sqm i.v.or s.c. 4 doses/week for 4 weeks in Induction phase 75 mg/sqm i.v.or s.c. 4 doses/week for 2 weeks in Protocol II and III

DRUG

daunorubicin

30 mg/sqm i.v. 4 doses in Induction phase

DRUG

doxorubicin

30 mg/sqm i.v. x 4 doses in Protocol II and III

DRUG

Etoposide

100 mg/sqm i.v. for 3 doses in HR block 3

DRUG

Ifosfamide

800 mg/sqm i.v.q12h x 5 in HR block 2

DRUG

mercaptopurine

60 mg/sqm p.o. c 28 days in Induction phase 60 mg/sqm p.o. x 56 days in Protocol M 50 mg/sqm daily in Maintenance phase

DRUG

Methotrexate

by age i.t. in Induction/Protocol M/Protocol II/Protocol III/HR Blocks and maintenance

DRUG

prednisone

60 mg/sqm daily p.o. for 28 days then tapered in Induction phase

DRUG

thioguanine

60 mg/sqm p.o. x 14 days in Protocol II and Protocol III

DRUG

Vincristine

1.5 mg/sqm i.v. x 4 doses in Induction phase and Protocol II 1.5 mg/sqm i.v. x 2 doses in Protocol III and HR block 1

DRUG

Vindesine

3 mg/sqm i.v. x 2 doses in HR block 2

All Listed Sponsors
lead

Associazione Italiana Ematologia Oncologia Pediatrica

OTHER

NCT00613457 - Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter