[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421866":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":62,"centralContacts":66,"locations":76,"responsibleParty":93,"collaborators":36,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":36,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":36,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":78,"whyStopped":36,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Shanghai Children's Medical Center","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Multisystem patients (≥2 organs\u002Fsystems) with involvement of one or more \"Risk\" organs, i.e. hematopoietic system, liver or spleen.\n\nAll patients in this group receive an initial therapy (Week 1\\~6) followed by a consolidation continuation therapy (Week 7\\~22) and maintenance continuation therapy (Week 25\\~52).",[13,14],"Drug: Prednisone+Cytarabine+vincristine","Drug: Prednisone+Cytarabine+vincristine+Mercaptopurine",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2","Multisystem patients, but without involvement of \"Risk\" organs.\n\nAll patients in this group receive an initial therapy (Week 1\\~6) followed by continuation therapy (Week 7\\~52).",[13,19],"Drug: Prednisone+vincristine+Mercaptopurine",{"label":21,"type":10,"description":22,"interventionNames":23},"Group 3","Includes patients with single system, multifocal or with single system, unifocal and special site (Isolated lesion of special site) or with single system, unifocal and CNS risk or with single system, unifocal i.e. thyroid, lung, thymus, hypothalamic-pituitary or with single system, unifocal and other functionally critical anatomical sites.\n\nAll patients in this group receive an initial therapy (Week 1\\~6) followed by continuation therapy (Week 7\\~52).",[24],"Drug: Prednisone+vincristine",{"label":26,"type":10,"description":27,"interventionNames":28},"Group 4","Patients with single system, unifocal i.e. bone, skin or lymph node (not the draining lymph node of another LCH lesion).\n\nAll patients in this group enter into observation after local therapy. Chemotherapy only apply to patients with disease reactivation during observation.",[29],"Other: Local therapy",[31,37,41,44,47,51,55,58],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Prednisone+Cytarabine+vincristine","Group 1 initial treatment (W1\\~W6). Prednisone 40mg\u002Fm2×4w, taper 2w; Vincristine 1.5mg\u002Fm2 iv d1 of w1,2,3,4,5,6; Cytarabine 100mg\u002Fm2 iv\u002FIH d1-4 q2w (w1,3,5)",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Prednisone+Cytarabine+vincristine+Mercaptopurine","Group 1 Consolidation continuation treatment (W7\\~W22) . Prednisone 40mg\u002Fm2 d1-5 q3w (w7,10,13,16,19,22); VCR 1.5\u002Fm2 iv d1 q3w (w7,10,13,16,19,22); Cytarabine 100mg\u002Fm2 iv\u002FIH d1-4 q3w (w7,10,13,16,19,22); 6-MP 50mg\u002Fm2\u002Fd,po,qn",[9],{"type":32,"name":38,"description":42,"armGroupLabels":43,"otherNames":36},"Group 1 Maintenance continuation treatment (W25\\~52) . Prednisone 40mg\u002Fm2 d1-5 q3w; Vincristine 1.5\u002Fm2 iv d1 q3w; Cytarabine 100mg\u002Fm2 iv\u002FIH d1-4 q6w ×3 times (w25,31,37); 6-MP 50mg\u002Fm2\u002Fd,po,qn",[9],{"type":32,"name":33,"description":45,"armGroupLabels":46,"otherNames":36},"Group 2 Initial treatment (W1\\~W6) . Prednisone 40mg\u002Fm2×4w, taper 2w; Vincristine 1.5mg\u002Fm2 iv d1 of w1,2,3,4,5,6; Cytarabine 100mg\u002Fm2 iv\u002FIH d1-4 q2w (w1,3,5)",[16],{"type":32,"name":48,"description":49,"armGroupLabels":50,"otherNames":36},"Prednisone+vincristine+Mercaptopurine","Group 2 continuation treatment (W7\\~W52) . Prednisone 40mg\u002Fm2 d1-5 q3w; VCR 1.5\u002Fm2 iv d1 q3w; 6-MP 50mg\u002Fm2\u002Fd,po,qn",[16],{"type":32,"name":52,"description":53,"armGroupLabels":54,"otherNames":36},"Prednisone+vincristine","Group 3 Initial treatment (W1\\~W6) . Prednisone 40mg\u002Fm2×4w, taper 2w; Vincristine 1.5mg\u002Fm2 iv d1 of w1,2,3,4,5,6",[21],{"type":32,"name":52,"description":56,"armGroupLabels":57,"otherNames":36},". Group 3 Continuation treatment (W7\\~W52)Prednisone 40mg\u002Fm2 d1-5 q3w; Vincristine 1.5\u002Fm2 iv d1 q3w",[21],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":36},"Local therapy","Local therapy\u002Fwait and see. Group 4",[26],[63],{"name":64,"affiliation":5,"role":65},"Yi-Jin Gao, MD","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":36,"email":71},"Meng Su, MD","CONTACT","0086-18817821853","sumeng@scmc.com.cn",{"name":73,"role":69,"phone":74,"phoneExt":36,"email":75},"Ya-Li Han, MD","0086-21-38626288","hanyali@scmc.com.cn",[77],{"facility":5,"status":78,"city":79,"state":36,"zip":36,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"RECRUITING","Shanghai","China","CN",{"type":83,"coordinates":84},"Point",[85,86],121.45806,31.22222,{"lat":86,"lon":85},[89],{"name":90,"role":69,"phone":91,"phoneExt":36,"email":92},"Yi-Jin Gao","021-38626161","gaoyijin@scmc.com.cn",{"type":94,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100421866","phase-3-a-prospective-study-for-the-treatment-of-children-with-newly-diagnosed-lch-using-a-cytarabine-contained-protocol-100421866",false,"NCT04773366","A Prospective Study for the Treatment of Children With Newly Diagnosed LCH Using a Cytarabine Contained Protocol","A Prospective Institutional Study for the Treatment of Children With Newly Diagnosed Langerhans Cell Histiocytosis Using a Cytarabine Contained Protocol","Inclusion Criteria:\n\n1. Age under 18 years\n2. Newly diagnosed LCH：Morphologic identification of the characteristic LCH cells, positive staining of the lesional cells with CD1α and\u002For Langerin\n3. No congenital immunodeficiency, HIV infection, or prior organ transplant\n4. No previous chemotherapy\u002Ftarget therapy\u002Fradiation, if any steroid applied, total prior steroids dosage \\\u003C prednisone 280 mg\u002Fm2\n\nExclusion Criteria:\n\n* Patients have overwhelming infection, and a life expectancy of \\\u003C 2 weeks","ALL","1 Day","18 Years",{"count":106,"type":107},200,"ESTIMATED","INTERVENTIONAL",[110],"PHASE3","From January 2010 to December 2014, 150 children with MS-LCH were treated in our hospital following a LCH II (Arm B) based protocol. Treatment was based on a modification of the LCH-II (Arm B) based protocol. However, the continuation treatment was extended to 56 weeks and etoposide was omitted from the continuation treatment.\n\nFor the 59 patients with RO involvement (RO+) (the lungs are not considered a RO in the current study), the rapid response rate (week 6) was 61.0% and the 3-year overall survival (OS) 73.4±5.9%. Rapid responders had a better 3-year survival rate than poor responders (90.9±5.0% vs. 45.7±11.0%, P\\\u003C0.001). The 3-year OS in the current study is 10\\~20% lower than the rates reported by Gadner et al. and Morimoto et al.. We have not yet adopted effective salvage therapies for RO+ patients with recurrent disease. During the time of this study, cladribine was unavailable. Second-line therapy for non-responders or patients with disease reactivation was individualized treatment based on the physician's experience. An effective salvage therapy is essential for this high-risk group.\n\nFor 91without RO involvement (RO-), 78 patients (85.7%) were rapid responders at week 6. The 3-year cumulative reactivation rate was 10.7% for RO- patients. No death occurred in this subgroup, with a 3-year OS of 100% in RO- patients. Compared to the LCH II and LCH III trials, the current study had a more intensive initial treatment regimen for RO- patients. However, the addition of etoposide to prednisone and vincristine in the initial therapy did not increase the 6-week response rate for RO- patients (85.7% in this study compared to 83% in the LCH II study and 86% in the LCH III study). Surprisingly, with a relatively intense initial treatment, a relatively low 3-year cumulative reactivation rate was observed in RO- patients in the current study. This result suggests that the initial treatment intensity and duration of continuation therapy both impact disease reactivation. The intensity of induction can affect the degree of disease resolution. Insufficient treatment intensity might lead to late relapse. Similarity to that observed has been in other childhood hematological malignancies. This finding deserves to be tested in prospective clinical trials with long-term follow-up. Cytarabine has been applied for patients with LCH but has never been evaluated in our hospital prospectively. In this study, we administer a cytarabine contained protocol to patients with multisystem involvement with or without risk organs involvement. The treatment results will be compared with our historical studies.",[113],"Langerhans Cell Histiocytosis",[115,116,117,118],"Langerhans cell histiocytosis","pediatric patients","cytarabine","treatment outcome","2022-07-23",{"date":121,"type":122},"2022-07-26","ACTUAL",{"date":124,"type":122},"2018-07-01",{"date":126,"type":107},"2026-06-30",{"name":5,"class":6},1]