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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,248
Aarhus University Hospital, Department of Pediatrics Skejby Hospital
Aarhus, Aarhus N, Denmark
Number of participants with hypersensitivity
Clinical allergy / silent inactivation.
Time frame: July 2008 - February 2016
Number of participants with asparaginase associated pancreatitis
Time frame: July 2008 - February 2016
Number of participants with tromboembolism
Time frame: July 2008 - February 2016
Number of participants with osteonecrosis
Time frame: July 2008 - February 2016
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