Comparison of Consolidation Strategies for Pediatric Patients With Acute Myeloid Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

August 1, 2007

Primary Completion Date

March 15, 2015

Study Completion Date

December 21, 2015

Conditions
AMLPediatric AML
Interventions
DRUG

ARM A: Active Comparator Drug

Consolidation 6-thioguanine 60 mg/m2/d, 1 to 43 po; prednisone 40 mg/m2/d, on days 1-28 orally; vincristine 1.5 mg/m2/d, days 1, 8, 15, 22; idarubicin 7 mg/m2/d, on days 1, 8, 15, 22; cytarabine 75 mg/m2/d, on days 3-6, 10-13, 17-20, 24-27, 31-34, 38-41; intrathecal cytarabine on days 1, 15, 29, 43; cyclophosphamide 500 mg/m2/d, days 29, 43.

DRUG

ARM B: Blocks Therapy Drug

"Blocks AI Cytarabine 500 mg/m2 as 24 infusion infusion x 4 d; Idarubicin 7 mg/m2 on days 3 and 5; Intrathecal cytarabine on days 0 and 6.~haM Cytarabine 1 g/m2 every 12 hours for 3 days; Mitoxantrone 10 mg/m2 days 4 and 5; Intrathecal cytarabine days 6 and 15."

All Listed Sponsors
lead

Grupo Argentino de Tratamiento de la Leucemia Aguda

OTHER

NCT06211452 - Comparison of Consolidation Strategies for Pediatric Patients With Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter