A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
Recruitment status was Recruiting
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 during continuous versus intermittent PEG-asparaginase treatment. Clinical adverse effects are registered focusing especially on allergy.
The primary hypothesis is that allergic reactions during treatment with PEG-asparaginase are related to the development of IgE-asparaginase antibodies.
Perspectives are new knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which hopefully leads to improvement of future therapy
Study group: Children diagnosed acute lymphoblastic leukaemia in the Nordic Countries
Acute Lymphoblastic Leukaemia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.|
- Asparagine depletion [ Time Frame: Up to 30 weeks of treatment ] [ Designated as safety issue: No ]Bloodsamples and cerebrospinalfluidsamples are collected at certain timepoints during 30 weeks of treatment with PEG-asparaginase. They are analysed for asparagine, asparaginase-enzymeactivity and asparaginase-antibodies.These measures tell about the effect of the drug, PEG-asparaginase.
Biospecimen Retention: Samples With DNA
Blood, Cerebrospinal fluid
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Contact: Louise T Henriksen, MD||+45 89496771||LOUISE.TRAM.HENRIKSEN@KI.AU.DK|
|Paediatric department, Skejby University hospital||Recruiting|
|Aarhus, Denmark, 8200|
|Principal Investigator: Louise T Henriksen, MD|
|Principal Investigator:||Louise T Henriksen, MD||Aarhus University Hospital|