[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607333":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":55,"collaborators":21,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":21,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":21,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":21,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Newly diagnosed LCH patients","EXPERIMENTAL","(1) The histopathological diagnosis of LCH is confirmed; (2) Multi-system involvement or single-system with multiple lesions; (3) No prior systemic treatment (patients who have only received local radiotherapy or surgery are eligible);",[13,14],"Drug: Cytarabine (Ara-C)","Drug: Thalidomide (100mg)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Cytarabine (Ara-C)","The treatment regimen consists of Ara-C administered at a dose of 100 mg\u002Fm² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Thalidomide (100mg)","The treatment regimen consists of AraC administered at a dose of 100 mg\u002Fm² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.",[9],[27],{"name":28,"affiliation":29,"role":30},"Xinxin XX Cao, doctor","NCC, CICAMS","STUDY_CHAIR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","+86-18618315968","caoxinxin@126.com",{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},"Huilei HL Miao, doctor","+86-18801317695","miaohl13@163.com",[41],{"facility":42,"status":43,"city":44,"state":21,"zip":21,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Medical Oncology, National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Beijing","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},{"type":56,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100607333","phase-2-efficacy-and-safety-of-low-dose-cytarabine-combined-with-thalidomide-in-adult-patients-with-untreated-lch-100607333",false,"NCT07187193","Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH","Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in the Treatment of Adult Patients With Untreated Langerhans Cell Histiocytosis: A Prospective, Multicenter, Single-Arm Study.","Inclusion Criteria:\n\n* Clearly diagnose and treat adult patients with multisystem or single-system multifocal LCH;\n* Aged between 18 and 70 years;\n* Multisystem involvement or single-system multifocal disease;\n* No prior systemic treatment (patients who have only received local radiotherapy or surgery may be enrolled);\n* ECOG performance status score ≤ 2;\n* Judged by clinicians as suitable for treatment with this protocol;\n* Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent.\n\nExclusion Criteria:\n\n* Patients with LCH involving the central nervous system;\n* Single-system single-lesion LCH;\n* Subjects who have undergone major surgery within 4 weeks prior to the first dose in the study;\n* Subjects who have received radiotherapy within 4 weeks prior to the first dose in the study; subjects with a history of myocardial infarction within the past year;\n* Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or a history of NYHA class 3 or 4 congestive heart failure;\n* Pregnant or lactating women;\n* Abnormal liver and kidney function: creatinine level ≥176.8μmol\u002Fl (2mg\u002Fdl), transaminase and bilirubin levels more than 2 times the upper limit of normal (for LCH patients with liver involvement, bilirubin levels more than 10 times the upper limit of normal);\n* Abnormal blood counts: absolute neutrophil count less than 1×10\\^9\u002FL, platelet count less than 50×10\\^9\u002FL;\n* Patients or their families unable to understand the conditions and objectives of this study;\n* Any other circumstances in which the investigator deems the patient unsuitable to participate in this trial.","ALL","18 Years","70 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.",[75],"Langerhans Cell Histiocytosis","2025-09-16",{"date":78,"type":79},"2025-09-22","ACTUAL",{"date":81,"type":79},"2025-04-12",{"date":83,"type":69},"2027-04-13",{"name":5,"class":6},1]