Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
NCT00192673 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2009-09-30
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
Conditions
Interventions
- DRUG
-
PEG-asparaginase
Sponsors & Collaborators
-
Medac, Hamburg, Germany
collaborator UNKNOWN -
Danish Child Cancer Foundation
collaborator OTHER -
Nordic Society for Pediatric Hematology and Oncology
lead OTHER
Principal Investigators
-
Henrik Schrøder, M.D. PhD · Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Completion
- 2013-12-31
Countries
- Denmark
Study Locations
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