drugset / Trial / NCT00991133

A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)

NCT00991133

Phase 1 Completed 8 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric patients with first relapse Acute Lymphoblastic Leukemia (ALL).

Timeline

Start
2009-10
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 40 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Pegaspargase Protein / enzyme biologic Intravenous
Background Vincristine Small molecule Intravenous