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NCT04187248 Clinical Trial

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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04187248
Other study ID # NOPHOALL2008_asp-tox
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2008
Est. completion date March 1, 2017

Study information
Verified date August 2023
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1248
Est. completion date March 1, 2017
Est. primary completion date February 28, 2016
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Asparaginase

Locations
Country Name City State
Denmark Aarhus University Hospital, Department of Pediatrics Skejby Hospital Aarhus Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with hypersensitivity Clinical allergy / silent inactivation. July 2008 - February 2016
Primary Number of participants with asparaginase associated pancreatitis July 2008 - February 2016
Primary Number of participants with tromboembolism July 2008 - February 2016
Primary Number of participants with osteonecrosis July 2008 - February 2016
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