Status:
RECRUITING
Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence
Lead Sponsor:
Shanghai Changzheng Hospital
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
Peking University Third Hospital
Conditions:
Langerhans Cell Histiocytosis of Bone
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06078969
Start Date
November 4 2023
End Date
September 30 2027
Last Update
February 1 2024
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003