Using oral prednisone to treat bone Langerhans cell histiocytosis in children and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of oral prednisone for treating Langerhans cell histiocytosis (LCH) of bone in children and adolescents. It is a multi-center, open-label, randomized-controlled Phase II study where participants will be assigned to either receive oral prednisone or undergo regular observation. The study aims to provide a standardized therapeutic approach for a condition that currently lacks widely accepted treatment options. The trial will focus on patients with single-system involvement of LCH, specifically targeting the skeletal system.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathological diagnosis of Langerhans cell histiocytosis (LCH) of bone;
* Single-system involvement (skeletal system);
* No need of surgical intervention;
* Must be able to swallow tablets;
* Signing informed consent form.

Exclusion Criteria:

* Multi-system involvements (≥2 systems, including bone, liver, spleen, hematologic system, central nerve system);
* Need of surgical intervention (e.g. pathological fracture and/or spinal cord compression)
* Glucocorticoid allergy;
* Immunodeficiency;
* Severe infection;
* Insulin dependent/independent Diabetes;
* Having taken glucocorticoid in the past two weeks;
* Not capable of swallowing tablets;
* Without signed informed consent inform.

Where it's running

• Shanghai Changzheng Hospital
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.