Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192673
|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|