Adrenal InsufficiencyLeukemiaCortNCT06861530
A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children
An observational study of Adrenal Insufficiency and Leukemia, Lymphoblastic, Acute, Pediatric, run by University Children's Hospital Basel at 2 sites in Switzerland.
Trial summary
Plain Language Summary: Background Glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. Cortisol is the most well-known example of a glucocorticoid. These stress hormones are essential for the bodys healthy functioning. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Adrenal Insufficiency, Leukemia, Lymphoblastic, Acute, Pediatric, Lymphoma, Lymphoblastic
- How many people
- 40 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 13 Aug 2024to 31 Dec 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 0-17 years who are: Diagnosed with ALL or LBL, and who are treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau
Who may be able to join
- diagnosed with ALL or LBL
- treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau
- lnformed consent can be obtained from the patient\'s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids
Who cannot join
- Contraindication to the administration of intravenous synthetical ACTH (Synacthen®): extremely rare cases of known or suspected hypersensitivity to Synacthen®.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
KSA
Aarau
Pascal Gächter, Physician, +41 704 22 80, pascal.gaechter@ukbb.ch
- Recruiting
UKBB
Basel
Pascal Gächter, Physician, +41 704 22 80, pascal.gaechter@ukbb.ch
About this study
Official title: A Swiss Prospective Multicenter Longitudinal Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children: An Explorative Study
Plain Language Summary:
Background Glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. Cortisol is the most well-known example of a glucocorticoid. These stress hormones are essential for the bodys healthy functioning.
Read more
To treat certain types of cancer, such as leukemia (blood cancer) in children, glucocorticoids are administered as medications in large quantities. This helps rapidly reduce the number of cancer cells in the body but also leads to the suppression of the body's natural glucocorticoid production, causing a deficiency.
This deficiency can be particularly dangerous for children with leukemia, as their immune defenses are already weakened by chemotherapy, leading to an increased risk of infections. Moreover, the signs of glucocorticoid deficiency in children with leukemia are often indistinguishable from the side effects of chemotherapy, making the deficiency harder to detect.
Objectives The aim of the study is to understand how frequently and for how long the body's natural glucocorticoid production is impaired in children treated for lymphoblastic leukemia and lymphoblastic lymphoma. Additionally, the goal is to identify which children are at particularly high risk.
By gaining a better understanding, this study may help to improve the detection and treatment of glucocorticoid deficiency in children with blood cancer.
Methods Regular low-dose ACTH tests will be conducted to assess the bodys natural glucocorticoid production during and after treatment. To avoid placing additional burden on children who are already heavily affected by the disease, these tests will only be performed when there is already a venous access established and the children are in the hospital for treatment reasons.
- Keywords
- Adrenal insufficiency, leukemia, leukaemia, childhood, pediatric, paediatric, glucocorticoid
- Medical subject headings
- Adrenal Insufficiency, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observed Cohort | Observed Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Adrenal Insufficiency
The primary outcome of this study is he measurement of the occurrence of HPA axis suppression. The outcome is binary (yes/no) and is considered yes, if a HPA axis suppression occurs at 1 test or more. HPA axis suppression is commonly defined as stimulated cortisol levels below 500nmol/l (below 18μg/dl) in the low-dose ACTH stimulation test, i.e. a measurement of cortisol 30 minutes and 60 minutes after the stimulation with 1 μg of synthetical ACTH (Synacthen®).
For further analyses the following subgroups may be considered:
- Morning cortisol according to current norm values from our laboratory: suppressed if below 66nmol/l (1-11 years) / below 100nmol/l (12-18 years)
- Stimulated peak cortisol 300-500nmol/l = partially suppressed; below 300nmol/l = suppressed
- Increment of cortisol after stimulation (basal to peak): below 100nmol/l = suppressed, 100-200nmol/l = partially suppressed, above 200nmol/l = normal
Measured: Study enrollment until 3 months after the last dose of glucocorticoid treatment
Secondary outcomes (1)
Duration of Adrenal Insufficiency
The measurement of the duration of HPA axis suppression. The outcome is continuous (in weeks). lf there is no occurrence of HPA axis suppression (primary outcome, then this secondary outcome is 0 weeks.
The cut-off values are specified under the primary outcome section.
Measured: Study enrollment until 3 months after the last dose of glucocorticoid treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start13 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861530
- Sponsor's protocol ID
- 2024-00736
- Acronym
- LeukemiaCort
- Status last verified
- May 2026
- First submitted
- 24 Feb 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Individual data sharing
- No: not specified in approval by ethics comittee
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Swiss Prospective Multicenter Longitudinal Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children: An Explorative Study
- ClinicalTrials.gov ID
- NCT06861530
- Acronym / sponsor ID
- LeukemiaCort / 2024-00736
- Keywords
- Adrenal insufficiency, leukemia, leukaemia, childhood, pediatric, paediatric, glucocorticoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Collaborators
- Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2025 (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.
Plain Language Summary:
Background Glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. Cortisol is the most well-known example of a glucocorticoid. These stress hormones are essential for the bodys healthy functioning.
To treat certain types of cancer, such as leukemia (blood cancer) in children, glucocorticoids are administered as medications in large quantities. This helps rapidly reduce the number of cancer cells in the body but also leads to the suppression of the body's natural glucocorticoid production, causing a deficiency.
This deficiency can be particularly dangerous for children with leukemia, as their immune defenses are already weakened by chemotherapy, leading to an increased risk of infections. Moreover, the signs of glucocorticoid deficiency in children with leukemia are often indistinguishable from the side effects of chemotherapy, making the deficiency harder to detect.
Objectives The aim of the study is to understand how frequently and for how long the body's natural glucocorticoid production is impaired in children treated for lymphoblastic leukemia and lymphoblastic lymphoma. Additionally, the goal is to identify which children are at particularly high risk.
By gaining a better understanding, this study may help to improve the detection and treatment of glucocorticoid deficiency in children with blood cancer.
Methods Regular low-dose ACTH tests will be conducted to assess the bodys natural glucocorticoid production during and after treatment. To avoid placing additional burden on children who are already heavily affected by the disease, these tests will only be performed when there is already a venous access established and the children are in the hospital for treatment reasons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed Cohort | – | –Observed Cohort |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 0-17 years who are: Diagnosed with ALL or LBL, and who are treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau
Key inclusion criteria (3 listed)
- diagnosed with ALL or LBL
- treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau
- lnformed consent can be obtained from the patient\'s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids
Key exclusion criteria (1 listed)
- Contraindication to the administration of intravenous synthetical ACTH (Synacthen®): extremely rare cases of known or suspected hypersensitivity to Synacthen®.
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
Occurence of Adrenal Insufficiency
Time frame: Study enrollment until 3 months after the last dose of glucocorticoid treatment
The primary outcome of this study is he measurement of the occurrence of HPA axis suppression. The outcome is binary (yes/no) and is considered yes, if a HPA axis suppression occurs at 1 test or more. HPA axis suppression is commonly defined as stimulated cortisol levels below 500nmol/l (below 18μg/dl) in the low-dose ACTH stimulation test, i.e. a measurement of cortisol 30 minutes and 60 minutes after the stimulation with 1 μg of synthetical ACTH (Synacthen®). For further analyses the following subgroups may be considered: - Morning cortisol according to current norm values from our laboratory: suppressed if below 66nmol/l (1-11 years) / below 100nmol/l (12-18 years) * Stimulated peak cortisol 300-500nmol/l = partially suppressed; below 300nmol/l = suppressed * Increment of cortisol after stimulation (basal to peak): below 100nmol/l = suppressed, 100-200nmol/l = partially suppressed, above 200nmol/l = normal
1 secondary outcome
Duration of Adrenal Insufficiency
Time frame: Study enrollment until 3 months after the last dose of glucocorticoid 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 8 May 2026.
- Individual participant dataSharing planned: No. not specified in approval by ethics comittee
Related trials for Adrenal Insufficiency
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Not yet recruiting
IT and IV Lentiviral Gene Therapy for X-ALD
X-linked Adrenoleukodystrophy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency and Leukemia, Lymphoblastic, Acute, Pediatric, run by University Children's Hospital Basel at 2 sites in Switzerland.
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 3 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Adrenal Insufficiency (time frame: Study enrollment until 3 months after the last dose of glucocorticoid treatment). 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 8 May 2026.