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.
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 13, 2013
November 1, 2013
4.9 years
January 5, 2011
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asparagine depletion
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.
Up to 30 weeks of treatment
Eligibility Criteria
Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol
You may qualify if:
- 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
You may not qualify if:
- Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paediatric department, Skejby University hospital
Aarhus, Denmark, 8200, Denmark
Biospecimen
Blood, Cerebrospinal fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise T Henriksen, MD
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 7, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
November 13, 2013
Record last verified: 2013-11