Spots Global Cancer Trial Database for A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
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Trial Identification
Brief Title: A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
Official Title: PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.
Study ID: NCT01272440
Conditions
Interventions
Study Description
Brief Summary: Asparaginase is an important drug i the treatment of childhood leukaemia. 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
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Paediatric department, Skejby University hospital, Aarhus, , Denmark
Contact Details
Name: Louise T Henriksen, MD
Affiliation: Aarhus University Hospital
Role: PRINCIPAL_INVESTIGATOR
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