Studies how dexamethasone moves through the body in children with leukemia
Observes dexamethasone levels in blood and spinal fluid in children with leukemia.
Plain-language title generated from the registry record
Registry title: Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
Key facts
- Where
- Aalborg, Aarhus N, Copenhagen, and Odense, DenmarkSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 17 years old?
Source: NCT06367725, who can take part
Where in Denmark
- Department of Paediatrics and Adolescent Medicine, Aalborg University HospitalAalborg, DenmarkTaking people
- Department of Paediatrics and Adolescent Medicine, Aarhus University HospitalAarhus N, DenmarkTaking people
- Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital RigshospitaletCopenhagen, DenmarkTaking people
- Department of Paediatrics and Adolescent Medicine, Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT06367725
- Record updated
- 26 October 2026
- Original description
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:Read full original descriptionShow less
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.
Inclusion: A diagnosis of acute lymphoblastic leukaemia; Age 1-17.9 years.
Exclusion: Down syndrome.