drugset / Trial / NCT00784017

Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

NCT00784017

Phase 3 Completed 199 enrolled medac GmbH
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL

Timeline

Start
2008-10
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject asparaginase Protein / enzyme biologic 5000 unknown Intravenous
Subject recombinant Escherichia coli-asparaginase Unknown 5000 unknown Intravenous