NCT04187248

The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,248 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Asparaginase

Timeline

• Start date: 2008-07-01
• Primary completion: 2016-02-28
• Completion: 2017-03-01
• First posted: 2019-12-05
• Last updated: 2023-08-25

Locations

1 site across 1 country: Denmark