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Brief Title: The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
Official Title: The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
Study ID: NCT04187248
Brief Summary: Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.
Detailed Description: Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis. In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively. This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Aarhus University Hospital, Department of Pediatrics Skejby Hospital, Aarhus, Aarhus N, Denmark