Luvometinib for children with single-system multifocal or special-site bone LCH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol enrolls children aged 0–18 with pathologically confirmed LCH limited to single-system multifocal bone disease or single-site bone lesions at central nervous system risk locations who have not received LCH-specific treatment. Enrolled patients will receive luvometinib and be followed for clinical response, recurrence rates, and safety outcomes including neurologic and ophthalmologic monitoring. The trial targets lesions in craniofacial, orbital, temporal, ear, oral regions, and vertebral lesions with intraspinal compression. Sites for enrollment are multiple tertiary hospitals in China and participants will undergo regular imaging and clinical assessments during and after therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• The Second Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Recruiting
• Zunyi Medical University Affiliated Hospital, Guizhou Provincial Children's Hospital
  Zunyi, Guizhou, China Recruiting
• Jiangxi Provincial Children's Hospital
  Nanchang, Jiangxi, China Recruiting
• Xi'an Children's Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Xue Tang
• Email: txily0912@126.com
• Phone: 86+18280145819

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.