A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia

Tracking Information
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; (submitted: November 12, 2013)	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; (submitted: January 6, 2011)	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	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
Detailed Description	Not Provided
Study Type	Observational
Study Design	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	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.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: January 6, 2011)	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
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Louise T Henriksen, MD Aarhus University Hospital
PRS Account	Aarhus University Hospital
Verification Date	November 2013