Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
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|ClinicalTrials.gov Identifier: NCT00192673|
Recruitment Status : Unknown
Verified September 2009 by Nordic Society for Pediatric Hematology and Oncology.
Recruitment status was: Recruiting
First Posted : September 19, 2005
Last Update Posted : September 30, 2009
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: PEG-asparaginase||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia|
|Study Start Date :||June 2005|
|Estimated Study Completion Date :||December 2013|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192673
|Contact: Birgitte K Albertsen, M.D., PhD||+45 89495566 ext email@example.com|
|Department of Pediatrics, Skejby Hospital||Recruiting|
|Aarhus, Aarhus N, Denmark, 8200|
|Contact: Birgitte K Albertsen, M.D. PhD +45 89495566 ext 6732 firstname.lastname@example.org|
|Contact: Henrik Schrøder, M.D. PhD +45 89496712 email@example.com|
|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|