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New treatment option for Langerhans Cell Histiocytosis (LCH)
Official title Luvometinib in Pediatric SS-LCH With Special-site Single/Multifocal Bone Lesions
ClinicalTrials.gov ID: NCT07371182
What this study is testing
What is Luvometinib?
Luvometinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for langerhans cell histiocytosis (lch).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18
You may be able to join if
- Children aged 0-18 years, both sexes.
- Pathologically confirmed diagnosis of LCH (CD1a+ and/or CD207+), with no prior treatment specific to LCH.
- Patients assessed as having single-system multifocal bone involvement, single-site bone involvement at central nervous system risk sites (central...
- Signed informed consent, willing to receive treatment according to this protocol and undergo follow-up.
You likely can't join if
- Patients with other underlying diseases, such as primary immunodeficiency, heart failure, renal insufficiency, hepatitis virus infection, HIV...
- Secondary malignancy.
- QTcF \> 0.47 seconds on electrocardiogram prior to enrollment.
- Ophthalmologic screening prior to enrollment reveals retinal vein occlusion, retinal pigment epithelial detachment, or other ocular diseases.
- Patients with LCH carrying category 3 MEK mutations, specifically the following mutation sites: L98\_I103del, L98\_K104del, P105\_A106del...
- Refusal to sign the informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Zunyi, Guizhou, China
- Nanchang, Jiangxi, China
- Xi'an, Shaanxi, China
- Chengdu, Sichuan, China
- Ürümqi, Xinjiang, China
- Kunming, Yunan, China
- Hefei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Nanning, Guangxi, China; Guiyang, Guizhou, China; Zunyi, Guizhou, China; Nanchang, Jiangxi, China; Xi'an, Shaanxi, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.