Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

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 \[Control group\].

Conditions

• Langerhans Cell Histiocytosis of Bone

Interventions

DRUG

Prednisone

For the experimental group, the patient will be administrated oral prednisone (0.5mg/kg/day, first 5 days per month, 6 months)

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• National Sun Yat-sen University

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Tianjin Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Jinling Hospital, China

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The Third Affiliated Hospital of Southern Medical University

  collaborator OTHER_GOV

• Shanghai Changzheng Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

2 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-04

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• China

Study Locations