Clinical trial NCT06861530: A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenal Insufficiency
Leukemia, Lymphoblastic, Acute, Pediatric
Lymphoma, Lymphoblastic
Keywords: Adrenal insufficiency
leukemia
leukaemia
childhood
pediatric
paediatric
glucocorticoid
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
Collaborators: name: Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
First posted: 2025-03-06
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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, we will only perform these tests when there is already a venous access established and the children are in the hospital for treatment reasons.


Eligibility criteria: Inclusion Criteria:

* 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\&#39;s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids

Exclusion Criteria:

- Contraindication to the administration of intravenous synthetical ACTH (Synacthen®): extremely rare cases of known or suspected hypersensitivity to Synacthen®.

Primary outcomes:
measure: Occurence of Adrenal Insufficiency
timeFrame: Study enrollment until 3 months after the last dose of glucocorticoid treatment
Secondary outcomes:
measure: Duration of Adrenal Insufficiency
timeFrame: Study enrollment until 3 months after the last dose of glucocorticoid treatment
Other outcomes:
measure: Number of infections
timeFrame: Study enrollment until 3 months after the last dose of glucocorticoid treatment
measure: Total days of hospitalization
timeFrame: Study enrollment until 3 months after the last dose of glucocorticoid treatment
measure: Total dose of glucocorticoid substitution
timeFrame: Study enrollment until 3 months after the last dose of glucocorticoid treatment
measure: Number of ICU admissions
timeFrame: Study enrollment until 3 months after the last dose of glucocorticoid treatment
Locations:
city: Aarau
country: Switzerland
facility: KSA
city: Basel
country: Switzerland
facility: UKBB
Study officials:
References: