[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562765":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":102,"collaborators":105,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":19,"studyType":141,"phases":142,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"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",[31,50,65,87],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Anhui Provincial Children's Hospital","NOT_YET_RECRUITING","Hefei","Anhui","230051","China","CN",{"type":40,"coordinates":41},"Point",[42,43],117.28083,31.86389,{"lat":43,"lon":42},[46],{"name":47,"role":23,"phone":48,"phoneExt":19,"email":49},"Hongjun Liu, MD","13515657759","13515657759@126.com",{"facility":51,"status":33,"city":52,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Fujian Children's Hospital","Fuzhou","Fujian","350011",{"type":40,"coordinates":56},[57,58],119.30611,26.06139,{"lat":58,"lon":57},[61],{"name":62,"role":23,"phone":63,"phoneExt":19,"email":64},"Hui Zhang, PhD\u002FMD","15821333007","zhanghui@scmc.com.cn",{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":37,"countryCode":38,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Shanghai Children's Medical center","RECRUITING","Shanghai","Shanghai Municipality","200127",{"type":40,"coordinates":72},[73,74],121.45806,31.22222,{"lat":74,"lon":73},[77,80,81,83,85],{"name":22,"role":23,"phone":78,"phoneExt":79,"email":25},"86-21-38626161","82077",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":82,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"name":27,"role":84,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"name":86,"role":84,"phone":19,"phoneExt":19,"email":19},"Changcheng Chen, MD",{"facility":88,"status":67,"city":89,"state":90,"zip":91,"country":37,"countryCode":38,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Ningbo Women and Children's Hospital","Ningbo","Zhejiang","315012",{"type":40,"coordinates":93},[94,95],121.54945,29.87819,{"lat":95,"lon":94},[98],{"name":99,"role":23,"phone":100,"phoneExt":19,"email":101},"Binfei Hu, MD","13777028360","hbfdkc@sina.com",{"type":82,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Shuhong Shen","Chair of hematology oncology department of SCMC",[106,108,110,112,114,117,119,121,123,124,126],{"name":107,"class":6},"Fujian Maternity and Child Health Hospital",{"name":109,"class":6},"Zhangzhou Affiliated Hospital of Fujian Medical University",{"name":111,"class":6},"Guizhou Provincial People's Hospital",{"name":113,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":115,"class":116},"Dalian Women and Children's Medical Center","UNKNOWN",{"name":118,"class":6},"The Third Xiangya Hospital of Central South University",{"name":120,"class":6},"Hunan Provincial People's Hospital",{"name":122,"class":6},"Ningbo Women & Children's Hospital",{"name":32,"class":6},{"name":125,"class":6},"Jiangxi Province Children's Hospital",{"name":127,"class":6},"Yuying Children's Hospital of Wenzhou Medical University","100562765","phase-2-efficacy-study-of-blinatumomab-clean-up-early-residual-disease-for-newly-diagnosed-pediatric-b-lymphoblastic-leukemia-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":139,"type":140},90,"ESTIMATED","INTERVENTIONAL",[143,144],"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.",[147],"B-Cell Lymphoblastic Leukemia",[149,147,9],"Children","2024-09-20",{"date":152,"type":153},"2024-09-23","ACTUAL",{"date":155,"type":153},"2024-05-21",{"date":157,"type":140},"2030-05-31",{"name":5,"class":6},4]