Using oral prednisone to treat bone Langerhans cell histiocytosis in children and adolescents
The Efficacy of Oral Prednisone in Treating Langerhans Cell Histiocytosis of Bone in Childhood and Adolescence: A Multi-center, Open-label, Randomized-controlled, Phase II Study
This study is testing if giving oral prednisone can help children and teenagers with bone Langerhans cell histiocytosis feel better compared to just watching their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06078969 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents diagnosed with LCH of bone who do not require surgical intervention.
Not a fit: Patients with multi-system involvement of LCH or those requiring surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved quality of life for children and adolescents suffering from LCH of bone.
How similar studies have performed: Previous clinical experiences have shown that some patients with LCH have achieved pain relief with prednisone, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.