drugset
drugset / Trial / NCT00187083

A Study of Children With Refractory or Relapsed ALL

NCT00187083 ↗

Phase 3 Completed 40 enrolled St. Jude Children's Research Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to find out which form of asparaginase (the native E. coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is resistant to treatment (refractory)

Timeline

Start
1997-02
Primary completion
2003-12
Completion
2003-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Asparaginase Erwinia chrysanthemi Protein / enzyme biologic — Intramuscular
Subject Etoposide Small molecule 50 mg/m2 Oral
Subject Pegaspargase Protein / enzyme biologic 2500 iu Intramuscular
Subject Topotecan Small molecule 2.4 mg/m2 Intravenous
Subject asparaginase Protein / enzyme biologic 10000 iu Intramuscular
Background Cytarabine Small molecule 300 mg/m2 Intravenous
Background Cytarabine Small molecule 2 g Intravenous
Background Dexamethasone Small molecule 6 mg/m2 Oral
Background Fludarabine Small molecule 15 mg/m2 Intravenous
Background Idarubicin Small molecule 12 mg/m2 Intravenous
Background MERCAPTOPURINE ANHYDROUS Small molecule 75 mg/m2 Oral
Background Methotrexate Small molecule 40 mg/m2 Intravenous
Background Methotrexate Small molecule 5 g Intravenous
Background Teniposide Small molecule 200 mg/m2 Intravenous
Background Vincristine Small molecule 1.5 mg/m2 Intravenous

Indications

acute lymphoblastic leukemia