Acute Lymphoblastic Leukaemia Clinical Trial
Official title:
PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.
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
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 18 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Paediatric department, Skejby University hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asparagine depletion | 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. | Up to 30 weeks of treatment | No |
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