- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187248
The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Aarhus N
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Aarhus, Aarhus N, Denmark, 8200
- Aarhus University Hospital, Department of Pediatrics Skejby Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with hypersensitivity
Time Frame: July 2008 - February 2016
|
Clinical allergy / silent inactivation.
|
July 2008 - February 2016
|
Number of participants with asparaginase associated pancreatitis
Time Frame: July 2008 - February 2016
|
July 2008 - February 2016
|
|
Number of participants with tromboembolism
Time Frame: July 2008 - February 2016
|
July 2008 - February 2016
|
|
Number of participants with osteonecrosis
Time Frame: July 2008 - February 2016
|
July 2008 - February 2016
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOPHOALL2008_asp-tox
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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