RecruitingNCT06367725

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


Sponsor

University of Aarhus

Enrollment

100 participants

Start Date

Apr 11, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how the steroid medication dexamethasone is absorbed and processed in children with acute lymphoblastic leukemia (ALL, a type of blood cancer), and whether differences in how the body handles this drug are linked to loss of bone density — a known side effect of steroid treatment in this population. **You may be eligible if...** - Your child has been diagnosed with acute lymphoblastic leukemia (ALL) - Your child is between 1 and 17.9 years old - Your child is currently receiving or scheduled to receive dexamethasone as part of their treatment **You may NOT be eligible if...** - Your child has Down syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(4)

Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, Denmark

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus N, Aarhus N, Denmark

Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet

Copenhagen, København Ø, Denmark

Department of Paediatrics and Adolescent Medicine, Odense University Hospital

Odense, Odense C, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06367725


Related Trials