Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute lymphoblastic leukemia
- Age between 1 and 17.9 years
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
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here