Skip to main content
OpenTrials
Completed

NCT Number: NCT04187248

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Department of Pediatrics Skejby Hospital

Aarhus, Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

asparaginase

Drug

Primary outcomes

  1. Number of participants with hypersensitivity

    Time frame: July 2008 - February 2016

    Clinical allergy / silent inactivation.

  2. Number of participants with asparaginase associated pancreatitis

    Time frame: July 2008 - February 2016

  3. Number of participants with tromboembolism

    Time frame: July 2008 - February 2016

  4. Number of participants with osteonecrosis

    Time frame: July 2008 - February 2016

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2016
Study completion
2017
First posted
Dec 5, 2019
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.