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

NCT06367725 | Recruiting

• 1 other identifier: 1-10-72-122-23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Area Under the Plasma Concentration Curve (AUC) of Dexamethasone

  Blood samples

  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 (4)

• Mineral bone density by DXA-scan

  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

  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

  When lumbar punctures are performed according to standard treatment during induction

• Neurotoxicity

  On day 15 and day 29 of induction treatment

Other Outcomes (2)

• Physical activity questionnaire

  Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.

• Biomarkers of bone metabolism

  Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• Down syndrome

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (4)

Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, 9000, Denmark

RECRUITING

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus N, Aarhus N, 8200, Denmark

RECRUITING

Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

RECRUITING

Department of Paediatrics and Adolescent Medicine, Odense University Hospital

Odense, Odense C, 5000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Birgitte K Albertsen, Professor

  Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitte K Albertsen, Professor

CONTACT

+45 2022 4643; biralber@rm.dk

Karen S Jensen, phd

CONTACT

+45 61718432; kascje@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 11, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)