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

NCT ID: NCT04187248

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-01

Study Completion Date

2017-03-01

Brief Summary

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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

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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

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Asparaginase

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Birgitte Klug Albertsen

M.D., PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital, Department of Pediatrics Skejby Hospital

Aarhus, Aarhus N, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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NOPHOALL2008_asp-tox

Identifier Type: -

Identifier Source: org_study_id

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