Actively Recruiting

Age: 0 - 18Years
All Genders
ID06861530

A Swiss Prospective Multicenter Longitudinal 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

N/A

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

Glucocorticoids are hormones that help control inflammation and regulate the immune system. In children with blood cancers like acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), these hormones are given as medications to quickly reduce cancer cells. However, this treatment can suppress the body's natural glucocorticoid production, leading to a deficiency that increases infection risks and is hard to detect due to overlapping chemotherapy side effects. This study aims to understand how often and for how long this deficiency occurs in children with these cancers and to identify those at higher risk. The study observes children diagnosed with ALL or LBL who are treated with glucocorticoids for at least 21 consecutive days. Regular low-dose ACTH tests will be performed during and after treatment to assess the body's natural glucocorticoid production. These tests are done only when children already have venous access and are hospitalized for treatment, minimizing extra burden. The study follows participants from enrollment until three months after their last glucocorticoid dose. Participants will be monitored through these ACTH tests to detect adrenal insufficiency and its duration. The main outcome measured is the occurrence of adrenal insufficiency, with a secondary focus on how long it lasts. The study involves children up to 18 years old and takes place at two children's hospitals. The goal is to improve understanding and management of glucocorticoid deficiency during and after cancer treatment, with careful attention to the safety and comfort of the children involved.

CONDITIONS

Brief 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 the patient's legal representatives (and from the patient if at least 14 years old) within week 2 of glucocorticoid treatment
Not Eligible

You will not qualify if you...

  • Known or suspected hypersensitivity to intravenous synthetic ACTH (Synacthen�), which is a contraindication for its administration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - Up to 2 weeks after starting glucocorticoid treatment

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility confirmation

Monitoring

Duration - From enrollment until 3 months after the last dose of glucocorticoid treatment

Participants who undergo glucocorticoid therapy are observed for adrenal insufficiency and hypothalamic-pituitary-adrenal axis suppression.

Visits scheduled as per routine clinical care; additional assessments may occur depending on cohort assignment

Trial Site Locations

Total: 2 locations

1

KSA

Aarau, Switzerland

Actively Recruiting

2

UKBB

Basel, Switzerland

Actively Recruiting

Loading map...

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

Similar Trials

A Block-and-Replace Therapy With Osilodrostat and Concomitan...

Endogenous Cushing Syndrome

Actively Recruiting

1 location

A Study to Evaluate Safety, Efficacy, and Pharmacokinetics o...

Acute Lymphocytic Leukemia Refractory

Actively Recruiting

8 locations

Molecular Mechanisms in Childhood B-acute Lymphoblastic Leuk...

Leukemia, Lymphoblastic, Acute, Pediatric

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here