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New pill could spare kids with rare bone disease from chemo

NCT ID NCT07371182

Disease control Sponsor: West China Second University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new daily oral drug called luvometinib in children aged 0-18 with Langerhans cell histiocytosis (LCH) that affects certain bones. LCH is a rare condition where immune cells build up and can cause bone damage. The drug targets a faulty cell signal found in nearly all cases. Researchers want to see if this pill can keep the disease from coming back and improve quality of life, with fewer side effects than standard chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children aged 0-18 years, both sexes. 2. Pathologically confirmed diagnosis of LCH (CD1a+ and/or CD207+), with no prior treatment specific to LCH. 3. Patients assessed as having single-system multifocal bone involvement, single-site bone involvement at central nervous system risk sites (central nervous system risk sites include craniofacial region \[excluding parietal, occipital, and frontal bones\], orbital, ear, and oral regions), or single-site vertebral bone involvement with intraspinal space-occupying lesion compressing the spinal cord. 4. Signed informed consent, willing to receive treatment according to this protocol and undergo follow-up. Exclusion Criteria: 1. Patients with other underlying diseases, such as primary immunodeficiency, heart failure, renal insufficiency, hepatitis virus infection, HIV infection, post-organ transplantation, etc. 2. Secondary malignancy. 3. QTcF \> 0.47 seconds on electrocardiogram prior to enrollment. 4. Ophthalmologic screening prior to enrollment reveals retinal vein occlusion, retinal pigment epithelial detachment, or other ocular diseases. 5. Patients with LCH carrying category 3 MEK mutations, specifically the following mutation sites: L98\_I103del, L98\_K104del, P105\_A106del, P105\_I107delinsL, L101\_I103delinsF, E102\_I103delinsF, E102\_I103del, E102\_I103delinsV, E102\_I103delinsVN, E102\_K104delinsQ, I103\_A106del. 6. Refusal to sign the informed consent form.

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Conditions

The condition(s) this trial relates to.

Histiocytosis, Langerhans-Cell Langerhans cell histiocytosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Langerhans cell histiocytosis (LCH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, China

  • Anhui Provincial Children's Hospital

    RECRUITING

    Hefei, China

  • Jiangxi Provincial Children's Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Kunming Children's Hospital

    RECRUITING

    Kunming, Yunan, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The Second Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, China

  • West China Second Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xi'an Children's Hospital

    RECRUITING

    Xi'an, Shaanxi, China

  • Xi'an Northwest Women's and Children's Hospital

    RECRUITING

    Xi'an, Shaanxi, China

  • Zunyi Medical University Affiliated Hospital, Guizhou Provincial Children's Hospital

    RECRUITING

    Zunyi, Guizhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.