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NCT Number: NCT06078969

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].

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Key information

Conditions

Langerhans Cell Histiocytosis of Bone Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Langerhans-Cell Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Respiratory Tract Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location status: Recruiting

Location contact

Chen Ye, MD

CONTACT

[email protected]

086+17621628515

Shaohui He, MD;PhD

CONTACT

[email protected]

086+18221376577

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisone

Drug

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

Primary outcomes

  1. Progression-free survival

    Time frame: 2 years

    Any evidence proving the disease progression

Secondary outcomes

  1. Local control rate

    Time frame: 2 years

    radiological examinations of local lesion status

  2. Pain relief

    Time frame: 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

    Time frame: 2 years

    side effects related to the prednisone

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Collaborators

  • Beijing Children's Hospital
  • First Affiliated Hospital of Zhejiang University
  • First Affiliated Hospital, Sun Yat-Sen University
  • Henan Cancer Hospital
  • Jinling Hospital, 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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 12, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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