Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence
Status:
Recruiting
Trial end date:
2027-09-30
Target enrollment:
Participant gender:
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
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