NCT00983138

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

Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 364 Days
• Healthy volunteers: Not accepted

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

Conditions

• Acute Lymphoid Leukemia

Interventions

Type	Name	Description
DRUG	recombinant asparaginase	10 000 Units/m² adjusted to age, 6 i.v. infusions (day 15, day 18, day 22, day 25, day 29, day 33) during the induction therapy

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-09-23
• Last updated: 2011-03-01

Locations

17 sites across 2 countries: Germany, Netherlands