RecruitingPhase 2NCT06078969

Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

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


Sponsor

Shanghai Changzheng Hospital

Enrollment

118 participants

Start Date

Nov 4, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 YearsMax Age: 17 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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.

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Interventions

DRUGPrednisone

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


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT06078969