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Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

Sponsor
Shanghai Changzheng Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06078969
Collaborator
First Affiliated Hospital of Zhejiang University (Other), Peking University Third Hospital (Other), National Sun Yat-sen University (Other), Beijing Children's Hospital (Other), Henan Cancer Hospital (Other), Tianjin Hospital (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), Second Hospital of Jilin University (Other), Peking University People's Hospital (Other), Jinling hospital Nanjing, Jiangsu, China (Other), The First Affiliated Hospital of Nanchang University (Other), The Third Affiliated Hospital of Southern Medical University (Other)
118
Enrollment
1
Location
2
Arms
46.9
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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].

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
If the diseae progression in the control group is confirmed, the patient is allowed to transferred to the test group (Oral prednisone).If the diseae progression in the control group is confirmed, the patient is allowed to transferred to the test group (Oral prednisone).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Sep 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oral prednisone

Oral prednisone, 0.5mg/kg/day, first 5 days/month, 6months

Drug: Prednisone
For the experimental group, the patient will be administrated oral prednisone (0.5mg/kg/day, first 5 days per month, 6 months)
No Intervention: Regular observation

Regular observation and follow up without medication

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [2 years]

    Any evidence proving the disease progression

Secondary Outcome Measures

  1. Local control rate [2 years]

    radiological examinations of local lesion status

  2. Pain relief [2 years]

    The Visual Analogue Scale (Minimum: 0; Maximum: 10 scores), is used to evaluate the degree of pain relief. The higher scores mean a worse outcome.

  3. Adverse effect rate [2 years]

    side effects related to the prednisone

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Changzheng Hospital Shanghai Shanghai China 200003

Sponsors and Collaborators

  • Shanghai Changzheng Hospital
  • 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 Nanjing, Jiangsu, China
  • The First Affiliated Hospital of Nanchang University
  • The Third Affiliated Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jianru Xiao, Professor, Chief Surgeon, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT06078969
Other Study ID Numbers:
  • 2023SL049
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jianru Xiao, Professor, Chief Surgeon, Shanghai Changzheng Hospital
Langerhans cell histiocytosis
Bone
Single-system
Children
Adolescents
Additional relevant MeSH terms:
Histiocytosis, Langerhans-Cell
Histiocytosis
Prednisone

Study Results

No Results Posted as of Oct 17, 2023