Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is

1. to determine the correct dose for intramuscular administration

2. to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Society for Pediatric Hematology and Oncology
• Collaborators: Danish Child Cancer Foundation; Medac, Hamburg, Germany
• Treatments: Asparaginase; Pegaspargase

Criteria

Inclusion Criteria:

• 1-17 years

• Newly diagnosed ALL (high intensive)

• Treated according to the NOPHO-2000 protocol

• Treated at one of the Nordic pediatric oncology centers

Exclusion Criteria:

• <1 year and >18 years

• Newly diagnosed ALL other than high intensive

• Not treated according to the NOPHO-2000 protocol

• Not treated at one of the Nordic pediatric oncology centers

• Allergy to the contents

• Pancreatitis (Active or earlier)