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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 \[Control group\].

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form. Who Should NOT Join This Trial: - 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; - weakened immune system; - Severe infection; - Insulin dependent/independent Diabetes; - Having taken glucocorticoid in the past two weeks; - Not capable of swallowing tablets; - Without signed willing to sign a consent form inform. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Prednisone

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