Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
NCT ID: NCT00192673
Last Updated: 2009-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
85 participants
INTERVENTIONAL
2005-06-30
2013-12-31
Brief Summary
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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
Detailed Description
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PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure.
There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses.
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose.
The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native E.coli asparaginase and PEG-asparaginase.
Other side effects than antibodies will be registered during treatment with PEG-asparaginase. Finally comparison of the 5-year EFS between the groups (native E.coli asparaginase and PEG-asparaginase as well as patients who have and have not developed antibodies) will be evaluated.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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PEG-asparaginase
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed ALL (high intensive)
* Treated according to the NOPHO-2000 protocol
* Treated at one of the Nordic pediatric oncology centers
Exclusion Criteria
* 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)
1 Year
14 Years
ALL
No
Sponsors
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Medac, Hamburg, Germany
UNKNOWN
Danish Child Cancer Foundation
OTHER
Nordic Society for Pediatric Hematology and Oncology
OTHER
Principal Investigators
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Henrik Schrøder, M.D. PhD
Role: STUDY_DIRECTOR
Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO
Locations
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Department of Pediatrics, Skejby Hospital
Aarhus, Aarhus N, Denmark
Countries
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Central Contacts
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Facility Contacts
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Birgitte K Albertsen, M.D. PhD
Role: primary
Henrik Schrøder, M.D. PhD
Role: backup
References
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Albenberg L, Brensinger CM, Wu Q, Gilroy E, Kappelman MD, Sandler RS, Lewis JD. A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn's Disease Flares. Gastroenterology. 2019 Jul;157(1):128-136.e5. doi: 10.1053/j.gastro.2019.03.015. Epub 2019 Mar 11.
Other Identifiers
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20040177
Identifier Type: -
Identifier Source: secondary_id
2004-41-4276
Identifier Type: -
Identifier Source: secondary_id
2005-000658-56
Identifier Type: -
Identifier Source: org_study_id