A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
Recruitment status was Recruiting
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Purpose
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
| Condition |
|---|
|
Acute Lymphoblastic Leukaemia |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 200 |
| 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) |
Eligibility| Ages Eligible for Study: | 1 Year to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol
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
Contacts and Locations| Contact: Louise T Henriksen, MD | +45 89496771 | LOUISE.TRAM.HENRIKSEN@KI.AU.DK |
| Denmark | |
| Paediatric department, Skejby University hospital | Recruiting |
| Aarhus, Denmark, 8200 | |
| Principal Investigator: Louise T Henriksen, MD | |
| Principal Investigator: | Louise T Henriksen, MD | Aarhus University Hospital |
More Information
No publications provided
| Responsible Party: | Louise Tram Henriksen, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT01272440 History of Changes |
| Other Study ID Numbers: | LTH-1 |
| Study First Received: | January 5, 2011 |
| Last Updated: | January 18, 2011 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by Aarhus University Hospital:
|
PEG-asparaginase children pharmacokinetics |
antibodies acute lymphoblastic leukaemia adverse effects |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Pegaspargase Asparaginase Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013