A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
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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
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Tracking Information | ||||
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First Submitted Date | January 5, 2011 | |||
First Posted Date | January 7, 2011 | |||
Last Update Posted Date | November 13, 2013 | |||
Study Start Date | January 2011 | |||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures |
Asparagine depletion [ Time Frame: Up to 30 weeks of treatment ] 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 | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia | |||
Official Title | 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 | Observational | |||
Study Design | 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 | |||
Condition | Acute Lymphoblastic Leukaemia | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* 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 | Unknown status | |||
Estimated Enrollment |
200 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | December 2015 | |||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | 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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Sex/Gender |
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Ages | 1 Year to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01272440 | |||
Other Study ID Numbers | LTH-1 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Louise Tram Henriksen, Aarhus University Hospital | |||
Study Sponsor | Aarhus University Hospital | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Aarhus University Hospital | |||
Verification Date | November 2013 |