IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia
Recruitment status was: Recruiting
| Tracking Information | ||||
|---|---|---|---|---|
| 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 ] 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. |
|||
| Original Primary Outcome Measures ICMJE |
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. |
|||
| 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 |
|||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
|||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Retention: Samples With DNA Description: Blood, Cerebrospinal fluid |
|||
| 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 ICMJE | Acute Lymphoblastic Leukaemia | |||
| Intervention ICMJE | 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. |
||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Unknown status | |||
| 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 |
|||
| Sex/Gender |
|
|||
| Ages | 1 Year to 18 Years (Child, Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Denmark | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01272440 | |||
| Other Study ID Numbers ICMJE | 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 ICMJE | Aarhus University Hospital | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
|
|||
| PRS Account | Aarhus University Hospital | |||
| Verification Date | November 2013 | |||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||