Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: 1 year — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Area Under the Plasma Concentration Curve (AUC) of Dexamethasone [Time frame: Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours]
Secondary outcome measures (4)
- Mineral bone density by DXA-scan [Time frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.]
- Vertebral fracture assessment (VFA) by DXA-scan [Time frame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.]
- Dexamethasone in cerebrospinal fluid [Time frame: When lumbar punctures are performed according to standard treatment during induction]
- Neurotoxicity [Time frame: On day 15 and day 29 of induction treatment]
Eligibility criteria
Inclusion criteria
- A diagnosis of acute lymphoblastic leukaemia
- Age 1-17.9 years
Exclusion criteria
- Down syndrome
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 4 centers
- Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital — Aalborg
- Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital — Aarhus N
- Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshosp — Copenhagen
- Department of Paediatrics and Adolescent Medicine, Odense University Hospital — Odense
Identifiers
NCT: NCT06367725 · 1-10-72-122-23