Acute Lymphoblastic LeukemiaNCT06367725
Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
An observational study of Acute Lymphoblastic Leukemia, run by University of Aarhus at 4 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 100 participants
- Where
- 4 sitesDenmark
- Study dates
- 11 Apr 2024to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents diagnosed with ALL and treated according to the established and approved treatment protocol in Denmark
Who may be able to join
- A diagnosis of acute lymphoblastic leukaemia
- Age 1-17.9 years
Who cannot join
- Down syndrome
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Recruiting
Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital
Aalborg, Aalborg, 9000
Nina M B Wischmann, phd, n.wischmann@rn.dk
- Recruiting
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus N, Aarhus N, 8200
Karen S Jensen, phd, kascje@rm.dk
Birgitte K Albertsen, Professor
- Recruiting
Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet
Copenhagen, København Ø, 2100
Peter EL Pontoppidan, phd, peter.erik.lotko.pontoppidan@regionh.dk
- Recruiting
Department of Paediatrics and Adolescent Medicine, Odense University Hospital
Odense, Odense C, 5000
Mathias Rathe, phd, Mathias.Rathe@rsyd.dk
About this study
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?
Read more
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
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Curve (AUC) of Dexamethasone
Blood samples
Measured: 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
DXA-scan
Measured: 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
DXA-scan
Measured: 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
Comparing measurements of dexamethasone in blood and cerebrospinal fluid
Measured: When lumbar punctures are performed according to standard treatment during induction
Neurotoxicity
Questionnaire
Measured: On day 15 and day 29 of induction treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start11 Apr 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgitte K Albertsen, Professor, Principal investigator, Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367725
- Sponsor's protocol ID
- 1-10-72-122-23
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
- ClinicalTrials.gov ID
- NCT06367725
- Acronym / sponsor ID
- 1-10-72-122-23
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents diagnosed with ALL and treated according to the established and approved treatment protocol in Denmark
Key inclusion criteria (2 listed)
- A diagnosis of acute lymphoblastic leukaemia
- Age 1-17.9 years
Key exclusion criteria (1 listed)
- Down syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Blood samples
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgitte K Albertsen, Professor principal investigator
Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by University of Aarhus at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgitte K Albertsen, Professor (+45 2022 4643, biralber@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.