A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|