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NCT Number: NCT06367725

Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density

The goal of this observational study is to learn about systemic and central nervous system (CNS) exposure to dexamethasone in childhood acute lymphoblastic leukaemia (ALL). The main questions it aims to answer are:

* How does the intake of dexamethasone correlate with systemic exposure to dexamethasone in blood? * How does systemic exposure to dexamethasone correlate with dexamethasone concentrations in cerebrospinal fluid (CSF)? * Is dexamethasone exposure in blood and CSF associated with clearance of leukemic CNS infiltration? * Does systemic and/or CNS exposure to dexamethasone correlate with neurotoxicity as assessed by questionnaires? * Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?

Participants will:

* Continue to receive the best available therapy for ALL in Western Europe. * Have blood samples taken from their central line to measure dexamethasone levels. * When standard lumbar punctures are performed as part of treatment, an additional sample of cerebrospinal fluid will be collected to analyse dexamethasone concentrations and assess leukemic CNS involvement when applicable. * Visit the clinic four times for DXA scans to measure bone density and perform vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. * Complete validated questionnaires to monitor neurotoxicity and to track daily physical activity levels during treatment.

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of acute lymphoblastic leukaemia
  • Age 1-17.9 years

Exclusion criteria

  • Down syndrome

Treatment and study plan

Primary outcomes

  1. Area Under the Plasma Concentration Curve (AUC) of Dexamethasone

    Time frame: Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours

    Blood samples

Secondary outcomes

  1. Mineral bone density by DXA-scan

    Time frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.

    DXA-scan

  2. Vertebral fracture assessment (VFA) by DXA-scan

    Time frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.

    DXA-scan

  3. Dexamethasone in cerebrospinal fluid

    Time frame: When lumbar punctures are performed according to standard treatment during induction

    Comparing measurements of dexamethasone in blood and cerebrospinal fluid

  4. Neurotoxicity

    Time frame: On day 15 and day 29 of induction treatment

    Questionnaire

Other outcomes

  1. Physical activity questionnaire

    Time frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.

  2. Biomarkers of bone metabolism

    Time frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Birgitte K Albertsen, Professor

CONTACT

[email protected]

+45 2022 4643

Karen S Jensen, phd

CONTACT

[email protected]

+45 61718432

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Apr 16, 2024
Registry last updated
Feb 27, 2026

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.

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