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

Aarhus University Hospital

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Asparaginase

Study type: Observational

Funder types: Other

Identifiers

NCT04187248

NOPHOALL2008_asp-tox

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,248 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ALL, standard or intermediate risk
• Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)
• Children (1-17,9 years at diagnosis)

Exclusion criteria

• ALL: high risk disease, ph-, genetic predisposition, bilinear ALL
• < 2 samples for asparaginase enzyme activity measurements