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

Last updated: March 5, 2025
Sponsor: University Children's Hospital Basel
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Female Hormonal Deficiencies/abnormalities

Hormone Deficiencies

Treatment

N/A

Clinical Study ID

NCT06861530
2024-00736
  • Ages < 18
  • All Genders

Study 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

Inclusion Criteria:

  • diagnosed with ALL or LBL

  • treated for at least 21 sequential days with glucocorticoids between the 01.07.2024and the 30.06.2027 at the Childrens University Hospital of Basel or at the ChildrensHospital of Aarau

  • lnformed consent can be obtained from the patient&#39;s legal representatives (andthe patient if at least 14 years of age) within week 2 of treatment withglucocorticoids

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 40
Study Start date:
August 13, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • KSA

    Aarau,
    Switzerland

    Active - Recruiting

  • UKBB

    Basel,
    Switzerland

    Active - Recruiting

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