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Luvometinib in Pediatric SS-LCH With Special-site Single/Multifocal Bone Lesions

RecruitingNAAges 0 Years - 18 YearsAllWest China Second University Hospital
NCT07371182 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Langerhans cell histiocytosis (LCH) is the most common type of histiocytic disorder in children, affecting about 2.6 to 8.9 out of every million kids each year. It can look very different from one child to another-some cases get better on their own-but when it affects special bones (like the base of the skull, temporal bone, eye socket, or spine) or when there are multiple bone lesions in one system, children often face a higher risk of long-term complications and the disease coming back.Current guidelines in China and around the world recommend treating these children with whole-body therapy, usually a chemotherapy combination of vinblastine and prednisone. However, even with longer treatment courses, about 27.6% of children with multiple bone lesions still have the disease return, and less than 70% stay free of events after 5 years. Some even develop lasting nerve system problems. In

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📋 Eligibility rules (as published)
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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What it tests

  • Luvometinib
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Where

11 sites
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Affiliated Hospital of Guizhou Medical University
Guiyang, China
Zunyi Medical University Affiliated Hospital, Guizhou Provincial Children's Hospital
Zunyi, China
Jiangxi Provincial Children's Hospital
Nanchang, China
Xi'an Children's Hospital
Xi'an, China
Xi'an Northwest Women's and Children's Hospital
Xi'an, China
West China Second Hospital, Sichuan University
Chengdu, China

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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