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New targeted drug combo aims to curb relapse in kids with rare immune disorder

NCT ID NCT07431060

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether adding the targeted drug luvometinib to standard chemotherapy improves outcomes for children with multisystem Langerhans cell histiocytosis (LCH), a rare immune cell disorder. About 120 children aged 0-18 with newly diagnosed, untreated LCH will be randomly assigned to receive either standard chemo alone or chemo plus luvometinib. The goal is to see if the combination reduces disease reactivation and improves survival without major side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Luvometinib (a targeted cancer drug) plus chemotherapy (prednisone, vincristine, mercaptopurine)
What this could lead to
If successful, this combination could offer better disease control and fewer relapses for children with severe multisystem LCH.
What could go wrong
This is an early-stage trial with only 120 participants, so results may not apply to all children. Adding a targeted drug may also increase side effects like skin issues or high triglycerides.

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 120 people

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

Expected to start

Feb 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, of either sex. 2. Pathologically confirmed diagnosis of Langerhans cell histiocytosis (LCH) with positive staining for CD1a and/or CD207 (Langerin), and no prior treatment specifically directed against LCH. 3. Multisystem involvement of LCH, as determined by clinical and imaging evaluation. 4. Provision of written informed consent (by parent/legal guardian and, where appropriate, assent from the child), with willingness to comply with the study treatment regimen and follow-up assessments. Exclusion Criteria: 1. Presence of any other significant underlying medical condition, including but not limited to primary immunodeficiency disorders, congestive heart failure, renal insufficiency, chronic viral hepatitis, HIV infection, or status post solid organ transplantation. 2. History of a second (secondary) malignancy. 3. QTcF interval \> 0.47 seconds on electrocardiogram performed prior to enrollment. 4. Ophthalmologic screening prior to enrollment revealing retinal vein occlusion, retinal pigment epithelial detachment, or other clinically significant ocular abnormalities that, in the opinion of the investigator, contraindicate participation. 5. LCH harboring Class 3 MEK pathway mutations, specifically the following alterations: L98\_I103del, L98\_K104del, P105\_A106del, P105\_I107delinsL, L101\_I103delinsF, E102\_I103delinsF, E102\_I103del, E102\_I103delinsV, E102\_I103delinsVN, E102\_K104delinsQ, or I103\_A106del. 6. Refusal or inability to provide written informed consent (or assent, as applicable).

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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, China

  • Anhui Provincial Children's Hospital

    RECRUITING

    Hefei, China

  • Jiangxi Provincial Children's Hospital

    RECRUITING

    Jiangxi, China

  • Kunming Children's Hospital

    RECRUITING

    Kunming, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The Second Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, China

  • West China Second Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Xi'an Children's Hospital

    RECRUITING

    Xi'an, China

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

    RECRUITING

    Xi'an, China

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

    RECRUITING

    Zunyi, China

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