Status:
UNKNOWN
Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
Lead Sponsor:
Nordic Society for Pediatric Hematology and Oncology
Collaborating Sponsors:
Medac, Hamburg, Germany
Danish Child Cancer Foundation
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-14 years
Phase:
PHASE4
Brief 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 as...
Detailed Description
Asparaginase is used in the treatment of childhood lymphoblastic leukemia. Approximately 1/3 of the patients develops blocking antibodies against native E.coli asparaginase during the second exposure,...
Eligibility Criteria
Inclusion
- 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
- \<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)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00192673
Start Date
June 1 2005
End Date
December 1 2013
Last Update
September 30 2009
Active Locations (1)
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1
Department of Pediatrics, Skejby Hospital
Aarhus, Aarhus N, Denmark, 8200