Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

• Status: Recruiting
• Trial end date: 2027-09-30
• Target enrollment: 0
• Participant gender: All

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 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].

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Collaborators: Beijing Children's Hospital; First Affiliated Hospital of Zhejiang University; First Affiliated Hospital, Sun Yat-Sen University; Henan Cancer Hospital; Jinling hospital Nanjing, Jiangsu, China; National Sun Yat-sen University; Peking University People's Hospital; Peking University Third Hospital; Second Hospital of Jilin University; The First Affiliated Hospital of Nanchang University; The Third Affiliated Hospital of Southern Medical University; Tianjin Hospital
• Treatments: Prednisone

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.