PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL

Study Overview
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Brief Summary
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The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.

Detailed Description
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Leukemia is the leading cause of cancer in children in Europe and the U.S. with an annual incidence of appoximately 3,5 cases per 100.000 children 0-14,9 years. Although the rate of cure has increased significantly, treatment is still unsuccesfull in appoximately 20 % of the patients. There is great variation in the how the individual patient processes the different chemotherapeutic agents. Furthermore there is a signifikant difference regarding the severity of sideeffects and toxicities. So far it has not been possible to predict which patients are at speciel risk of developing toxicities. Acute pancreatitis is a severe sideffect/toxicity when treating ALL. Patients are at risk of developing pancreatitis, because of the drug Asparaginase. The condition can not be prevented and in severe cases, e.g. hemorhaggic pancreatitis the only solution is to discontinue the drug, in spite of the fact that Asparaginase is on of the most important drugs when treating leukemia. In the current study we will map the occurence of pancreatitis, hepatotoxicity and hyperlipidemia among approximately 1000 children and adolescents with leukemia. This study is unique because it is the largest study of its kind regarding Asparaginase associated pancreatitis. Among other things it will involve extensive genetic analysis. We believe that this study will improve the possibilities, not only, for individualized treatmentVi mener at dette studie vil forbedre mulighederne for individ orienteret behandling, but also for other studies like this regarding other toxicities in patients with cancer.

Official Title
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PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL

Conditions
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Acute Lymphoblastic Leukemia, Pancreatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IR- or SR- type ALL, and treatment with Peg-Asparaginase Exclusion Criteria: HR ALL, and changing subgroup from IR or SR to HR

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALL, Asparaginase, pancreatitis<br>Patients that have been scanned and have had blood tests | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of pancreatitis | Risk of pancreatitis in relation to host genomic variants, inflammatory markers and ultrasound changes in the weeks prior to clinical pancreatitia | During asparaginase therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of pancreatitis | Risk of complications, specifically cysts, pain and diabetes in the months following pancratitis. Risk of 2nd episode of pancreatitis if reexposed to asparaginase | In the months following pancreatitis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, Pediatric, Asparaginase, Pancreatitis