A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
| Tracking Information | |||||
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| First Received Date ICMJE | January 5, 2011 | ||||
| Last Updated Date | November 12, 2013 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01272440 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia | ||||
| Official Title ICMJE | PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects. | ||||
| 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 |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood, Cerebrospinal fluid |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol |
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| Condition ICMJE | Acute Lymphoblastic Leukaemia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 1 Year to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Denmark | ||||
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| Administrative Information | |||||
| NCT Number ICMJE | NCT01272440 | ||||
| Other Study ID Numbers ICMJE | LTH-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Louise Tram Henriksen, Aarhus University Hospital | ||||
| Study Sponsor ICMJE | Aarhus University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Aarhus University Hospital | ||||
| Verification Date | November 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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