Leukemia Clinical Trials

Find Leukemia Clinical Trials Near You

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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• A diagnosis of acute lymphoblastic leukaemia

• Age 1-17.9 years

Locations
Other Locations
Denmark
Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital
RECRUITING
Aalborg
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
RECRUITING
Aarhus N
Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet
RECRUITING
Copenhagen
Department of Paediatrics and Adolescent Medicine, Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Birgitte K Albertsen, Professor
biralber@rm.dk
+45 2022 4643
Backup
Karen S Jensen, phd
kascje@rm.dk
+45 61718432
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 100
Sponsors
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov