ClinicalTrials.gov record NCT06078969

Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Feb 1, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age2 years old to 17 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase II, randomized, open-label study compares oral prednisone with regular observation for children and adolescents who have single-system Langerhans cell histiocytosis of bone. Enrolled participants are assigned to either a prednisone group (monthly short courses for 6 months) or a regular follow-up group without medication. The study measures progression, local lesion status on imaging, pain, and side effects over two years.

What it is studying. The study is testing whether a planned course of oral prednisone given to children and adolescents with single-system bone LCH affects disease outcomes and safety. Key outcomes listed in the record include progression-free survival, radiologic local control, pain levels, and rates of prednisone-related side effects.

What the researchers hope to learn. To gather evidence on the efficacy and safety of oral prednisone for treating LCH of bone in children and adolescents, including effects on disease progression, local lesion control on imaging, pain relief, and frequency of side effects.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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].

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Prednisone

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After random assignment, participants will either take oral prednisone (0.5 mg/kg/day for the first 5 days of each month for 6 months) or be followed with regular observation and follow-up without medication. Participants will attend follow-up visits over about two years that include radiological exams to check the local bone lesion, pain assessments using the Visual Analogue Scale, and monitoring for side effects related to prednisone. The study is open-label and uses a randomized crossover design, so group assignments are not masked and participants may cross over as defined by the study. The registry record does not describe additional procedures (for example, biopsies or blood draws).

How the study is structured. Randomized, open-label Phase II trial with two main groups: an experimental group receiving oral prednisone (0.5 mg/kg/day for the first 5 days each month for 6 months) and a control group receiving regular observation and follow-up without medication. The registry lists a crossover model: if disease progression is confirmed in the control group, those patients may be transferred to the prednisone group. Outcomes are followed for up to two years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Langerhans cell histiocytosis

Clinical trials20 trials listed for Langerhans cell histiocytosisEvery trial the registry lists for Langerhans cell histiocytosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Langerhans cell histiocytosis researchLatest monthly update: September 2026. Includes: Adult routine care. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 4, 2023
Primary completion
Sep 30, 2027 (estimated)
Study completion
Sep 30, 2027 (estimated)
Target enrollment
118 participants (estimated)
Last updated on registry
Feb 1, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Shanghai Changzheng Hospital
Principal investigator
Jianru Xiao, Professor, Chief Surgeon
Shanghai Changzheng Hospital
Collaborators
  • 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, China
  • The First Affiliated Hospital of Nanchang University
  • The Third Affiliated Hospital of Southern Medical University

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

prednisone
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
Control group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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