drugset / Trial / NCT00983138

Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)

NCT00983138 ↗

Phase 2 Completed 12 enrolled medac GmbH
NaSingle-groupOpen-labelTreatment

Summary

This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (\< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia

Timeline

Start
2009-07
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject recombinant asparaginase Unknown 10000 unknown Intravenous