A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia

This study is currently recruiting participants.
Verified November 2013 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Louise Tram Henriksen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01272440
First received: January 5, 2011
Last updated: November 12, 2013
Last verified: November 2013

January 5, 2011
November 12, 2013
January 2011
December 2015   (final data collection date for primary outcome measure)
Asparagine depletion [ Time Frame: Up to 30 weeks of treatment ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01272440 on ClinicalTrials.gov Archive Site
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A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.

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

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood, Cerebrospinal fluid

Non-Probability Sample

Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol

Acute Lymphoblastic Leukaemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol and who have accepted to participate in this study

Exclusion Criteria:

Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment

Both
1 Year to 18 Years
No
Contact: Louise T Henriksen, MD +45 89496771 LOUISE.TRAM.HENRIKSEN@KI.AU.DK
Denmark
 
NCT01272440
LTH-1
Yes
Louise Tram Henriksen, Aarhus University Hospital
Aarhus University Hospital
Not Provided
Principal Investigator: Louise T Henriksen, MD Aarhus University Hospital
Aarhus University Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP