[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626086":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":47,"responsibleParty":189,"collaborators":28,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":28,"eligibilityCriteria":199,"healthyVolunteers":195,"sex":200,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":28,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":50,"whyStopped":28,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"West China Second University Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Modified LCH-III Chemotherapy + Luvometinib (Experimental Arm)","EXPERIMENTAL","Participants receive the same modified LCH-III chemotherapy regimen (prednisone, vinblastine, mercaptopurine) combined with oral luvometinib throughout the treatment period",[13,14,15,16],"Drug: Prednisone","Drug: Vincristine","Drug: Mercaptopurine","Drug: Luvometinib",{"label":18,"type":19,"description":20,"interventionNames":21},"Modified LCH-III Chemotherapy Alone (Control Arm)","ACTIVE_COMPARATOR","Participants receive the modified standard LCH-III chemotherapy regimen consisting of prednisone and vincristine.",[13,14,15],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Prednisone","Corticosteroid administered orally as part of the modified LCH-III regimen",[9,18],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Vincristine","Intravenous vinca alkaloid chemotherapy agent used in the modified LCH-III regimen",[9,18],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Mercaptopurine","Oral purine analog antimetabolite used in the maintenance phase of therapy for multisystem LCH",[9,18],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Luvometinib","Oral selective MEK1\u002F2 inhibitor added to the experimental arm. Administered daily in combination with modified LCH-III chemotherapy for multisystem Langerhans cell histiocytosis.",[9],[42],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Xue Tang","CONTACT","86+18280145819","txily0912@126.com",[48,65,78,91,101,114,127,140,153,166,176],{"facility":49,"status":50,"city":51,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"West China Second Hospital, Sichuan University","RECRUITING","Chengdu","China","CN",{"type":55,"coordinates":56},"Point",[57,58],104.06667,30.66667,{"lat":58,"lon":57},[61],{"name":62,"role":44,"phone":63,"phoneExt":28,"email":64},"XIa Guo","86+1818609112","guoxkl@163.com",{"facility":66,"status":50,"city":67,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Affiliated Hospital of Guizhou Medical University","Guiyang",{"type":55,"coordinates":69},[70,71],106.71667,26.58333,{"lat":71,"lon":70},[74],{"name":75,"role":44,"phone":76,"phoneExt":28,"email":77},"Xiao Yan Yang","86+18786635712","469389553@qq.com",{"facility":79,"status":50,"city":80,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Anhui Provincial Children's Hospital","Hefei",{"type":55,"coordinates":82},[83,84],117.28083,31.86389,{"lat":84,"lon":83},[87],{"name":88,"role":44,"phone":89,"phoneExt":28,"email":90},"Hong Jun Liu","86+13515657759","13515657759@126.com",{"facility":92,"status":50,"city":80,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"The Second Affiliated Hospital of Anhui Medical University",{"type":55,"coordinates":94},[83,84],{"lat":84,"lon":83},[97],{"name":98,"role":44,"phone":99,"phoneExt":28,"email":100},"Jin Hua Chu","86+15805602655","997222161@qq.com",{"facility":102,"status":50,"city":103,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Jiangxi Provincial Children's Hospital","Jiangxi",{"type":55,"coordinates":105},[106,107],105.19994,33.99934,{"lat":107,"lon":106},[110],{"name":111,"role":44,"phone":112,"phoneExt":28,"email":113},"Chong Jun Wu","86+13699560860","wuchongjunmed@163.com",{"facility":115,"status":50,"city":116,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Kunming Children's Hospital","Kunming",{"type":55,"coordinates":118},[119,120],102.71833,25.03889,{"lat":120,"lon":119},[123],{"name":124,"role":44,"phone":125,"phoneExt":28,"email":126},"Xin Tian","86+13668757522","tianxin999@aliyun.com",{"facility":128,"status":50,"city":129,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"The Second Affiliated Hospital of Guangxi Medical University","Nanning",{"type":55,"coordinates":131},[132,133],108.31667,22.81667,{"lat":133,"lon":132},[136],{"name":137,"role":44,"phone":138,"phoneExt":28,"email":139},"Hong Ying Wei","86+15977767103","whylhr@qq.com",{"facility":141,"status":50,"city":142,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"The First Affiliated Hospital of Xinjiang Medical University","Ürümqi",{"type":55,"coordinates":144},[145,146],87.60046,43.80096,{"lat":146,"lon":145},[149],{"name":150,"role":44,"phone":151,"phoneExt":28,"email":152},"MAIMAITI GULIBAHA","86+13070423745","156510283@qq.com",{"facility":154,"status":50,"city":155,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Xi'an Children's Hospital","Xi'an",{"type":55,"coordinates":157},[158,159],108.92861,34.25833,{"lat":159,"lon":158},[162],{"name":163,"role":44,"phone":164,"phoneExt":28,"email":165},"Hua Wang","86+18991236496","luoshake0219@163.com",{"facility":167,"status":50,"city":155,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":168,"geoPoint":170,"contacts":171},"Xi'an Northwest Women's and Children's Hospital",{"type":55,"coordinates":169},[158,159],{"lat":159,"lon":158},[172],{"name":173,"role":44,"phone":174,"phoneExt":28,"email":175},"Hui Liu","86+15829655607","15829655607@139.com",{"facility":177,"status":50,"city":178,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Zunyi Medical University Affiliated Hospital, Guizhou Provincial Children's Hospital","Zunyi",{"type":55,"coordinates":180},[181,182],106.90722,27.68667,{"lat":182,"lon":181},[185],{"name":186,"role":44,"phone":187,"phoneExt":28,"email":188},"Yan Chen","86+13985261758","cyz600@163.com",{"type":190,"investigatorFullName":191,"investigatorTitle":192,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Xia Guo","Professor of Pediatrics","100626086","modified-lch-iii-regimen-with-or-without-luvometinib-for-multisystem-pediatric-langerhans-cell-histiocytosis-100626086",false,"NCT07431060","Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis","Modified LCH-III Regimen Versus Modified LCH-III Regimen Combined With Luvometinib in the Treatment of Multisystem Pediatric Langerhans Cell Histiocytosis: A Multicenter, Open-Label, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Children aged 0-18 years, of either sex.\n2. Pathologically confirmed diagnosis of Langerhans cell histiocytosis (LCH) with positive staining for CD1a and\u002For CD207 (Langerin), and no prior treatment specifically directed against LCH.\n3. Multisystem involvement of LCH, as determined by clinical and imaging evaluation.\n4. Provision of written informed consent (by parent\u002Flegal guardian and, where appropriate, assent from the child), with willingness to comply with the study treatment regimen and follow-up assessments.\n\nExclusion Criteria:\n\n1. 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.\n2. History of a second (secondary) malignancy.\n3. QTcF interval \\> 0.47 seconds on electrocardiogram performed prior to enrollment.\n4. 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.\n5. 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.\n6. Refusal or inability to provide written informed consent (or assent, as applicable).","ALL","0 Years","18 Years",{"count":204,"type":205},120,"ESTIMATED","INTERVENTIONAL",[208],"NA","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.\n\nMild (low-risk) cases may resolve spontaneously or cause minimal issues with excellent outcomes. Severe multisystem LCH involves multiple organs, particularly high-risk sites such as liver, spleen, or bone marrow, leading to poorer prognosis and potential life-threatening complications without appropriate treatment.Standard first-line therapy for many children is prednisone (a corticosteroid) plus vinblastine (chemotherapy). Trials like LCH-III show near-100% survival in low-risk disease, but long-term survival drops to \\~80% in high-risk cases. Reactivation occurs in \\~37% of low-risk patients post-treatment, and \\~50% of children eventually develop resistance, resulting in progression or relapse. Treatment failure heightens risks of long-term sequelae, including growth retardation, endocrine dysfunction, and neurological damage, severely impacting quality of life.\n\nMore than half of LCH cases harbor the BRAF V600E mutation, activating the MAPK pathway abnormally. This has driven development of targeted MAPK inhibitors (e.g., vemurafenib, dabrafenib, trametinib), which demonstrate strong efficacy and acceptable safety (mainly manageable skin rash) in relapsed\u002Frefractory pediatric cases, with no reported secondary malignancies to date. These agents provide rapid symptom relief and durable control, though monotherapy often fails to eradicate abnormal cells in multisystem disease, leading to relapse after discontinuation.\n\nNo MAPK inhibitors were previously approved specifically for LCH. In 2025, luvometinib (developed by Fosun Pharma, China; a selective MEK1\u002F2 inhibitor) received approval in China for adult LCH and histiocytic neoplasms. Adult studies showed \\~83% objective response rate and \\~74% progression-free at ≥12 months, with mostly mild side effects (skin issues, hypertriglyceridemia) and no discontinuations due to serious toxicity.\n\nLaboratory evidence indicates MAPK overactivation confers apoptosis resistance to LCH cells; combining MAPK inhibitors with chemotherapy may enhance cell killing and leverage chemotherapy-induced immune microenvironment changes for better clearance.\n\nSmall studies and real-world data in refractory LCH support this: combination regimens yielded low relapse rates (especially with prolonged therapy), 100% responses in some pediatric cohorts with sustained remission and no added severe toxicity, and notably lower relapse (20% vs 75% with inhibitor alone) in our center's early experience with LCH-III backbone plus MAPK inhibitor.\n\nThis multicenter randomized trial will enroll children with multisystem LCH, assigning them to modified standard LCH-III chemotherapy alone or the same regimen combined with luvometinib, to evaluate whether adding this targeted agent improves outcomes.",[211],"Langerhans Cell Histiocytosis (LCH)",[213,38],"Langerhans Cell Histiocytosis","2026-02-20",{"date":216,"type":217},"2026-02-24","ACTUAL",{"date":219,"type":205},"2026-02-13",{"date":221,"type":205},"2030-12-31",{"name":5,"class":6},11]