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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04187248

Enrollment

1248

Registered

2019-12-05

Start date

2008-07-01

Completion date

2017-03-01

Last updated

2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

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.

Interventions

DRUGAsparaginase

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026