[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491669":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":66,"collaborators":68,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":33,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":33,"overallStatus":52,"whyStopped":33,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR","Oral placebo was added to conventional chemotherapy",[13],"Combination Product: Conventional chemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental Group","EXPERIMENTAL","Oral RIF was added to conventional chemotherapy",[19,13],"Drug: Realgar Indigo naturalis formula",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Realgar Indigo naturalis formula","Realgar Indigo naturalis formula was used in the induction, consolidation and intensive treatment of patients in intermediate or high risk",[15],[27],"RIF",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"COMBINATION_PRODUCT","Conventional chemotherapy","conventional chemotherapy",[9,15],null,[35],{"name":36,"affiliation":37,"role":38},"Xin Y Chen, Doctoral","Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University","STUDY_CHAIR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},"Pei J Fang, Doctoral","CONTACT","13682290830","jpfang2005@163.com",{"name":46,"role":42,"phone":47,"phoneExt":33,"email":48},"Jian Wang, Master's","18588935208","459283765@qq.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510120","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},{"type":67,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[69,71,73,75,77,79,81,83,85,87,89,91,93],{"name":70,"class":6},"First Affiliated Hospital, Sun Yat-Sen University",{"name":72,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University",{"name":74,"class":6},"Zhujiang Hospital",{"name":76,"class":6},"The First Affiliated Hospital of Guangzhou Medical University",{"name":78,"class":6},"Guangzhou First People's Hospital",{"name":80,"class":6},"Huizhou Municipal Central Hospital",{"name":82,"class":6},"First Affiliated Hospital of Shantou University Medical College",{"name":84,"class":6},"Zhongshan People's Hospital, Guangdong, China",{"name":86,"class":6},"Zhongshan Bo Ai Hospital",{"name":88,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":90,"class":6},"LiuZhou People's Hospital",{"name":92,"class":6},"Second Xiangya Hospital of Central South University",{"name":94,"class":6},"Hainan People's Hospital","100491669","phase-4-south-china-children-cancer-group---relapsed-acute-lymphoblastic-leukemia-2022-protocol-100491669",false,"NCT05682131","South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol","SCCCG-R-ALL","Inclusion Criteria:\n\n* B or T cell type;\n* the first recurrence;\n* the risk stratification was medium or high risk.\n\nExclusion Criteria:\n\n* mature B cell leukemia;\n* acute mixed phenotype leukemia;\n* patients with positive BCR\u002FABL fusion gene;\n* the second tumor\n* definite CML blast crisis;\n* ALL with Down's syndrome.","ALL","1 Year","14 Years",{"count":106,"type":107},210,"ESTIMATED","INTERVENTIONAL",[110],"PHASE4","In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the 5-year OS of patients with first recurrence is still less than 50%. A number of in vitro studies have shown that arsenic trioxide (ATO) can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can produce similar pharmacological effects to ATO. Based on the R3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL children, in order to improve the MRD negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed ALL.",[113,114],"Arsenic Trioxide","Childhood ALL","2023-01-10",{"date":117,"type":118},"2023-01-12","ACTUAL",{"date":120,"type":118},"2022-09-27",{"date":122,"type":107},"2030-09-27",{"name":5,"class":6},1]