Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
The purpose of this study is
- to determine the correct dose for intramuscular administration
- to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia|
- Determination of the dose that secures sufficient treatment during 14 days
- Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
- Comparison of 5-year EFS between groups
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||December 2013|
Asparaginase is used in the treatment of childhood lymphoblastic leukemia. Approximately 1/3 of the patients develops blocking antibodies against native E.coli asparaginase during the second exposure, so that they do not benefit from treatment and thus may have a worse prognosis.
PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure.
There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses.
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose.
The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native E.coli asparaginase and PEG-asparaginase.
Other side effects than antibodies will be registered during treatment with PEG-asparaginase. Finally comparison of the 5-year EFS between the groups (native E.coli asparaginase and PEG-asparaginase as well as patients who have and have not developed antibodies) will be evaluated.
|Contact: Birgitte K Albertsen, M.D., PhD||+45 89495566 ext firstname.lastname@example.org|
|Department of Pediatrics, Skejby Hospital||Recruiting|
|Aarhus, Aarhus N, Denmark, 8200|
|Contact: Birgitte K Albertsen, M.D. PhD +45 89495566 ext 6732 email@example.com|
|Contact: Henrik Schrøder, M.D. PhD +45 89496712 firstname.lastname@example.org|
|Principal Investigator: Henrik Schrøder, M.D. PhD|
|Study Director:||Henrik Schrøder, M.D. PhD||Department of Pediatrics, Skejby Hospital, Denmark and member of the Scientific Commmittee in NOPHO|