LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

PHASE4CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Prednisolone

Induction: 60 mg/m2/day, oral or i.v x 21 days and 30 mg/m2/day oral or iv x 7 days Reinduction-Intensification Treatment: 60 mg/m2/d x 14 days and 30 mg/m2/day oral x 7 days

DRUG

Daunorubicin

Induction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1

DRUG

Vincristine

Induction: 1,5 mg/m2 iv, days 1, 8, 15, 22 Consolidation (Bloc I):1,5 mg/m2 iv, days 1, 8 Consolidation (Bloc II):1,5 mg/m2 iv, days 1, 8 Reinduction: 1,5 mg/m2 iv, days 1, 8 Maintenance:1,5 mg/m2 iv, day 22

DRUG

L-Asparaginase

Induction: 10.000 U/m2 im or iv, days 9,11,13,16,18,20,23,25,27 Consolidation (Bloc II): 20.000 U/m2 im or iv, day 7 Maintenance: 20.000 U/m2 im or iv, day 22

DRUG

Cyclophosphamide

Induction: 500 mg/m2 iv, days 1, 2, 29 Consolidation (Bloc I): 500 mg/m2 iv, day 8 Reinduction:500 mg/m2 iv, day 15

DRUG

Methotrexate

Consolidation (Bloc I): 5 g/m2 24 hours infusion Consolidation (Bloc II): 5 g/m2 24 hours infusion Reinduction: 3 g/m2 24 hours infusion Maintenance: 20 mg/m2/d, IM/week x 3 (1, 7, 14)

DRUG

Cytosine Arabinoside

Consolidation (Bloc I): 1 g/m2/12 h iv, days 5, 6 Consolidation (Bloc II): 1 g/m2/12 h iv, days 5, 6 Reinduction: 1 g/m2/12 h iv, days 43, 44

Trial Locations (4)

Unknown

Hospital materno Infantil vall d'Hebrón, Barcelona

Hospital Niño Jesús, Madrid

Hospital Infantil Carlos Haya, Málaga

Hospital Virgen de la Arrixaca, Murcia

All Listed Sponsors
lead

PETHEMA Foundation

OTHER

NCT00526409 - LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter