A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children

NCT06861530 | Recruiting

• 1 other identifier: 2024-00736
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Adrenal Insufficiency; Leukemia, Lymphoblastic, Acute, Pediatric; Lymphoma, Lymphoblastic

Keywords

Adrenal insufficiency; leukemia; leukaemia; childhood; pediatric; paediatric; glucocorticoid

Outcome Measures

Primary Outcomes (1)

• 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

  Study enrollment until 3 months after the last dose of glucocorticoid treatment

Secondary Outcomes (1)

• Duration of Adrenal Insufficiency

  Study enrollment until 3 months after the last dose of glucocorticoid treatment

Other Outcomes (4)

• Number of infections

  Study enrollment until 3 months after the last dose of glucocorticoid treatment

• Total days of hospitalization

  Study enrollment until 3 months after the last dose of glucocorticoid treatment

• Total dose of glucocorticoid substitution

  Study enrollment until 3 months after the last dose of glucocorticoid treatment

Study Arms (1)

Observed Cohort

Observed Cohort

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Children's Hospital Basel: lead
• Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel: collaborator

Study Sites (2)

KSA

Aarau, Switzerland

RECRUITING

UKBB

Basel, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (Serum, EDTA)

MeSH Terms

Conditions

Adrenal Insufficiency; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: August 13, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)