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Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

Study Purpose

Langerhans cell histiocytosis (LCH) of bone is a benign-tumor-like osteolytic lesion in childhood and adolescence, which is characterized by the aberrant activation of antigen presenting cells. Rather than the multi-system involvements of LCH, no standard or widely-accepted therapeutic regimens were established for LCH of bone. In the previous clinical practice, several LCH patients obtained remarkable pain relief after taking prednisone. Therefore, the investigators aim to conducting a multi-center, open-labelled, randomized-controlled, Phase II study to investigate the efficacy and safety of oral prednisone in treating LCH of bone in children and adolescents. The enrolled patients will be randomly recruited to the following groups:

(1) Oral prednisone [Test group); (2) Regular observation [Control group].

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 17 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06078969
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Changzheng Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Langerhans Cell Histiocytosis of Bone

Arms & Interventions

Arms

Experimental: Oral prednisone

Oral prednisone, 0.5mg/kg/day, first 5 days/month, 6months

No Intervention: Regular observation

Regular observation and follow up without medication

Interventions

Drug: - Prednisone

For the experimental group, the patient will be administrated oral prednisone (0.5mg/kg/day, first 5 days per month, 6 months)

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