A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
|ClinicalTrials.gov Identifier: NCT01272440|
Recruitment Status : Unknown
Verified November 2013 by Louise Tram Henriksen, Aarhus University Hospital.
Recruitment status was: Recruiting
First Posted : January 7, 2011
Last Update Posted : November 13, 2013
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
|Condition or disease|
|Acute Lymphoblastic Leukaemia|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
U.S. FDA Resources
- Asparagine depletion [ Time Frame: Up to 30 weeks of treatment ]Blood samples and cerebrospinal fluid samples are collected at certain timepoints during 30 weeks of treatment with PEG-asparaginase. They are analyzed for asparagine, asparaginase-enzyme activity and asparaginase-antibodies.These measures tell about the effect of the drug, PEG-asparaginase.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272440
|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|