A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
NCT ID: NCT01272440
Last Updated: 2013-11-13
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
200 participants
OBSERVATIONAL
2011-01-31
2015-12-31
Brief Summary
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The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.
Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged PEG-asparaginase treatment: A NOPHO ALL-2008 study
Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study
Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated according to the NOPHO ALL 2008 protocol
Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which may lead to improved future therapy
Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Louise Tram Henriksen
MD
Principal Investigators
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Louise T Henriksen, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Paediatric department, Skejby University hospital
Aarhus, Denmark, Denmark
Countries
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Central Contacts
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Other Identifiers
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LTH-1
Identifier Type: -
Identifier Source: org_study_id
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