Clinical trial NCT06367725: Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
Official title: Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents diagnosed with ALL and treated according to the established and approved treatment protocol in Denmark

Brief summary: The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:

* How does the intake of dexamethasone correlate with systemic exposure to dexamethason?
* 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 done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.
* Visit the clinic four times for a DXA scans to measure bone density and 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. Additionally, participants will fill out questionnaires to track their daily physical activity levels.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of acute lymphoblastic leukaemia
* Age 1-17.9 years

Exclusion Criteria:

* Down syndrome

Primary outcomes:
measure: Area Under the Plasma Concentration Curve (AUC) of Dexamethasone
timeFrame: 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 outcomes:
measure: Mineral bone density by DXA-scan
timeFrame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
measure: Vertebral fracture assessment (VFA) by DXA-scan
timeFrame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
measure: Dexamethasone in cerebrospinal fluid
timeFrame: When lumbar punctures are performed according to standard treatment during induction
Other outcomes:
measure: Physical activity questionnaire
timeFrame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
measure: Biomarkers of bone metabolism
timeFrame: Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Locations:
city: Copenhagen
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet
state: København Ø
city: Odense
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Odense University Hospital
state: Odense C
city: Aalborg
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital
city: Aarhus N
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Study officials:
affiliation: Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
name: Birgitte K Albertsen, Professor
role: PRINCIPAL_INVESTIGATOR
References: