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New treatment option for Langerhans Cell Histiocytosis (LCH)
Official title Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis
ClinicalTrials.gov ID: NCT07431060
What this study is testing
What is Prednisone?
Prednisone is an investigational medicine, given as a pill taken by mouth, 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 histiocytic disorder in children, caused by excessive proliferation and accumulation of Langerhans cells (a type of immune cell) in various body tissues. The annual incidence is about 2.6-8.9 cases per million children.Clinical presentation varies widely.
- Which group you join is decided by chance.
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, of either sex.
- Pathologically confirmed diagnosis of Langerhans cell histiocytosis (LCH) with positive staining for CD1a and/or CD207 (Langerin), and no prior...
- Multisystem involvement of LCH, as determined by clinical and imaging evaluation.
- Provision of written informed consent (by parent/legal guardian and, where appropriate, assent from the child), with willingness to comply with the...
You likely can't join if
- Presence of any other significant underlying medical condition, including but not limited to primary immunodeficiency disorders, congestive heart...
- History of a second (secondary) malignancy.
- QTcF interval \> 0.47 seconds on electrocardiogram performed prior to enrollment.
- Ophthalmologic screening prior to enrollment revealing retinal vein occlusion, retinal pigment epithelial detachment, or other clinically significant...
- LCH harboring Class 3 MEK pathway mutations, specifically the following alterations: L98\_I103del, L98\_K104del, P105\_A106del, P105\_I107delinsL...
- Refusal or inability to provide written informed consent (or assent, as applicable).
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, China
- Guiyang, China
- Hefei, China
- Jiangxi, China
- Kunming, China
- Nanning, China
- Ürümqi, China
- Xi'an, China
- Zunyi, 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 Chengdu, China; Guiyang, China; Hefei, China; Jiangxi, China; Kunming, China; Nanning, China and 3 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.