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NCT06367725

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

Recruiting now Last updated 27 February 2026
What this trial tests

trial in Acute Lymphoblastic Leukemia in 100 participants. Currently enrolling.

Timeline
11 April 2024
Primary endpoint
30 December 2027
30 December 2030

Quick facts

Lead sponsorUniversity of Aarhus
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment100
Start date11 April 2024
Primary completion30 December 2027
Estimated completion30 December 2030
Sites4 locations across Denmark

Conditions studied

Sponsor

University of Aarhus

Who can join

Adults 1 to 17, any sex, with Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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: * 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

Other University of Aarhus trials

Trials by the same sponsor.

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Data sources for this page

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