Trial Information

Prediction and Prevention of PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With Acute Lymphoblastic Leukemia

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.