drugset / Trial / NCT00137111

Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

NCT00137111

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective is to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy and to monitor the molecular remission induction rate.

Timeline

Start
2000-07-08
Primary completion
2010-11
Completion
2014-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Asparaginase Erwinia chrysanthemi Protein / enzyme biologic
Subject Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Subject Cytarabine Small molecule 75 mg/m2 Intravenous
Subject Cytarabine Small molecule 300 mg/m2 Intravenous
Subject Cytarabine Small molecule 2000 mg/m2 Intravenous
Subject Daunorubicin Small molecule 25 mg/m2 Intravenous
Subject Dexamethasone Small molecule 8 mg/m2 Oral
Subject Dexamethasone Small molecule 12 mg/m2 Oral
Subject Dexamethasone Small molecule 20 mg/m2 Oral
Subject Doxorubicin Other / unclassified 30 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Imatinib Small molecule 40 mg/m2 Oral
Subject MERCAPTOPURINE ANHYDROUS Small molecule 50 mg/m2 Oral
Subject MERCAPTOPURINE ANHYDROUS Small molecule 60 mg/m2 Oral
Subject MERCAPTOPURINE ANHYDROUS Small molecule 75 mg/m2 Oral
Subject Methotrexate Small molecule 40 mg/m2 Intravenous
Subject Methotrexate Small molecule 1000 mg/m2 Intravenous
Subject Pegaspargase Protein / enzyme biologic
Subject Prednisone Other / unclassified 40 mg/m2 Oral
Subject Vincristine Small molecule 1.5 mg/m2 Intravenous
Subject Vincristine Small molecule 2 mg/m2 Intravenous
Subject asparaginase Protein / enzyme biologic 10000 unknown Intramuscular
Subject asparaginase Protein / enzyme biologic 25000 unknown Intramuscular