Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

Naval Military Medical University (Second Military Medical University)

Status and phase

Enrolling

Phase 2

Conditions

Langerhans Cell Histiocytosis of Bone

Treatments

Drug: Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT06078969

2023SL049

Details and patient eligibility

About

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].

Enrollment

118 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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.