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

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT04187248
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study Start: 2008-07-01
• Primary Completion: 2016-02-28
• Study Completion: 2017-03-01
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1248

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with asparaginase associated pancreatitis	July 2008 - February 2016
Number of participants with tromboembolism	July 2008 - February 2016
Number of participants with hypersensitivity	July 2008 - February 2016	Clinical allergy / silent inactivation.
Number of participants with osteonecrosis	July 2008 - February 2016

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Pediatrics Skejby Hospital; 🇩🇰 Aarhus, Aarhus N, Denmark