[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562765":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":101,"collaborators":104,"id":127,"slug":19,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":19,"studyType":139,"phases":140,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":66,"whyStopped":19,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Blinatumomab","EXPERIMENTAL","Patients in this group should receive Blinatumomab",[13],"Drug: Blinatumomab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Shuhong Shen, PhD\u002FMD","CONTACT","86-18930830638","shenshuhong@scmc.com.cn",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Wenting Hu, MD","13524836748","huwenting@scmc.com.cn",[31,49,64,86],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Anhui Provincial Children's Hospital","NOT_YET_RECRUITING","Hefei","Anhui","230051","China",{"type":39,"coordinates":40},"Point",[41,42],117.28083,31.86389,{"lat":42,"lon":41},[45],{"name":46,"role":23,"phone":47,"phoneExt":19,"email":48},"Hongjun Liu, MD","13515657759","13515657759@126.com",{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":37,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Fujian Children's Hospital","Fuzhou","Fujian","350011",{"type":39,"coordinates":55},[56,57],119.30611,26.06139,{"lat":57,"lon":56},[60],{"name":61,"role":23,"phone":62,"phoneExt":19,"email":63},"Hui Zhang, PhD\u002FMD","15821333007","zhanghui@scmc.com.cn",{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":37,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Shanghai Children's Medical center","RECRUITING","Shanghai","Shanghai Municipality","200127",{"type":39,"coordinates":71},[72,73],121.45806,31.22222,{"lat":73,"lon":72},[76,79,80,82,84],{"name":22,"role":23,"phone":77,"phoneExt":78,"email":25},"86-21-38626161","82077",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":81,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"name":27,"role":83,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"name":85,"role":83,"phone":19,"phoneExt":19,"email":19},"Changcheng Chen, MD",{"facility":87,"status":66,"city":88,"state":89,"zip":90,"country":37,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Ningbo Women and Children's Hospital","Ningbo","Zhejiang","315012",{"type":39,"coordinates":92},[93,94],121.54945,29.87819,{"lat":94,"lon":93},[97],{"name":98,"role":23,"phone":99,"phoneExt":19,"email":100},"Binfei Hu, MD","13777028360","hbfdkc@sina.com",{"type":81,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Shuhong Shen","Chair of hematology oncology department of SCMC",[105,107,109,111,113,116,118,120,122,123,125],{"name":106,"class":6},"Fujian Maternity and Child Health Hospital",{"name":108,"class":6},"Zhangzhou Affiliated Hospital of Fujian Medical University",{"name":110,"class":6},"Guizhou Provincial People's Hospital",{"name":112,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":114,"class":115},"Dalian Women and Children's Medical Center","UNKNOWN",{"name":117,"class":6},"The Third Xiangya Hospital of Central South University",{"name":119,"class":6},"Hunan Provincial People's Hospital",{"name":121,"class":6},"Ningbo Women & Children's Hospital",{"name":32,"class":6},{"name":124,"class":6},"Jiangxi Province Children's Hospital",{"name":126,"class":6},"Yuying Children's Hospital of Wenzhou Medical University","100562765",false,"NCT06607419","Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia","BBClean","Inclusion Criteria:\n\n* Age older than 1 month to younger than 18 years.\n* Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n* Immunophenotyping: acute B-lymphoblastic leukemia;\n* Meet one of the following situations:\n\nA. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;\n\n* Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee\n\nExclusion Criteria:\n\n* sIgM+;\n* ALL evolved from chronic myeloid leukemia (CML);\n* Down's syndrome, or major congenital or hereditary disease with organ dysfunction;\n* Other secondary leukemias;\n* CNS involvement;\n* History of epilepsy; or convulsions within the last month;\n* Known underlying congenital immunodeficiency or metabolic disease;\n* Congenital heart disease with cardiac insufficiency;\n* Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \\> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);\n* Initial diagnosis of high risk;\n* D46MRD ≥1%.","ALL","1 Month","18 Years",{"count":137,"type":138},90,"ESTIMATED","INTERVENTIONAL",[141,142],"PHASE2","PHASE3","The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:\n\n• If the flow cytometric MRD negative (\\\u003C0.01%) rate and the NGS- MRD negative (\\\u003C0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol).\n\nParticipants will:\n\n* Take 14 days full dose Blinatumomab;\n* With bone marrow evaluated before and after Blinatumomab treatment.",[145],"B-Cell Lymphoblastic Leukemia",[147,145,9],"Children","2024-09-20",{"date":150,"type":151},"2024-09-23","ACTUAL",{"date":153,"type":151},"2024-05-21",{"date":155,"type":138},"2030-05-31",{"name":5,"class":6},4]