Actively Recruiting

Age: 0 - 18Years
All Genders
NCT06861530

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

Led by University Children's Hospital Basel · Updated on 2026-05-08

40

Participants Needed

2

Research Sites

124 weeks

Total Duration

On this page

Sponsors

U

University Children's Hospital Basel

Lead Sponsor

G

Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)
  • Treated with glucocorticoids for at least 21 consecutive days between 01.07.2024 and 30.06.2027 at the Children's University Hospital of Basel or the Children's Hospital of Aarau
  • Informed consent obtained from legal representatives (and the patient if at least 14 years old) within the second week of glucocorticoid treatment
Not Eligible

You will not qualify if you...

  • Known or suspected hypersensitivity to intravenous synthetic ACTH (Synacthen®)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

KSA

Aarau, Switzerland

Actively Recruiting

2

UKBB

Basel, Switzerland

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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