Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence
Recruiting now · Phase 2
Conditions studied: Langerhans Cell Histiocytosis of Bone
In brief
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 \[Control group\].
Key facts
- Study ID
- NCT06078969
- Run by
- Shanghai Changzheng Hospital
- People needed
- 118
- Starts
- 2023-11-04
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2024-02-01
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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