Actively Recruiting

Age: 1Year - 17Years
All Genders
NCT06367725

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

Led by University of Aarhus · Updated on 2026-02-27

100

Participants Needed

4

Research Sites

350 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of acute lymphoblastic leukemia
  • Age between 1 and 17.9 years
Not Eligible

You will not qualify if you...

  • Diagnosis of Down syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, Denmark, 9000

Actively Recruiting

2

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus N, Aarhus N, Denmark, 8200

Actively Recruiting

3

Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet

Copenhagen, København Ø, Denmark, 2100

Actively Recruiting

4

Department of Paediatrics and Adolescent Medicine, Odense University Hospital

Odense, Odense C, Denmark, 5000

Actively Recruiting

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Research Team

B

Birgitte K Albertsen, Professor

CONTACT

K

Karen S Jensen, phd

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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