Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: PEG-asparaginase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-17 years Newly diagnosed ALL (high intensive) Treated according to the NOPHO-2000 protocol Treated at one of the Nordic pediatric oncology centers Exclusion Criteria: <1 year and >18 years Newly diagnosed ALL other than high intensive Not treated according to the NOPHO-2000 protocol Not treated at one of the Nordic pediatric oncology centers Allergy to the contents Pancreatitis (Active or earlier)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PEG-asparaginase|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of 5-year EFS between groups |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asparaginase, intramuscular administration, Silent antibodies, Childhood acute lymphoblastic leukemia, Side effects, 5-year EFS