The Efficacy of Oral Prednisone in Treating Langerhans Cell Histiocytosis of Bone in Childhood and Adolescence: A Multi-center, Open-label, Randomized-controlled, Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 \[Control group\].

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2023-11-04
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 118
Treatments
Experimental: Oral prednisone
Oral prednisone, 0.5mg/kg/day, first 5 days/month, 6months
No_intervention: Regular observation
Regular observation and follow up without medication
Sponsors
Collaborators: Tianjin Hospital, Second Hospital of Jilin University, Jinling Hospital, China, The First Affiliated Hospital of Nanchang University, Beijing Children's Hospital, First Affiliated Hospital of Zhejiang University, Peking University Third Hospital, Henan Cancer Hospital, National Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen University, The Third Affiliated Hospital of Southern Medical University, Peking University People's Hospital
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov

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