Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

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 \[Control group\].

NCT Number	NCT06078969
Lead Sponsor	Shanghai Changzheng Hospital Collaborators: First Affiliated Hospital of Zhejiang University, Peking University Third Hospital, National Sun Yat-sen University, Beijing Children's Hospital, Henan Cancer Hospital, Tianjin Hospital, First Affiliated Hospital, Sun Yat-Sen University, Second Hospital of Jilin University, Peking University People's Hospital, Jinling Hospital, China, The First Affiliated Hospital of Nanchang University, The Third Affiliated Hospital of Southern Medical University
Conditions	Langerhans Cell Histiocytosis of Bone
Enrollment	118 participants
Start Date	2023-11-04
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2024-02-01