[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583878":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":410,"collaborators":17,"id":412,"slug":413,"hasResults":414,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":414,"sex":420,"minAge":421,"maxAge":422,"enrollmentInfo":423,"targetDuration":17,"studyType":426,"phases":427,"briefSummary":430,"conditions":431,"keywords":435,"overallStatus":385,"whyStopped":17,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"NGS MRD46 ≥ 10^-6","EXPERIMENTAL","All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\\>0.1% in the 2020 protocol). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment. Reinduction-2 and Maintenance-2 will be given in full doses",[13],"Drug: Blinatumomab",{"label":15,"type":10,"description":16,"interventionNames":17},"MRD19≥ 0.01% and NGS MRD46 \u003C 10^-6","All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\\>0.1% in the 2020 protocol). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment. Reinduction-2 will be omitted, but Maintenance-2 will be given in full doses",null,{"label":19,"type":10,"description":20,"interventionNames":21},"MRD19 \u003C 0.01% and NGS MRD46 \u003C 10^-6","All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\\>0.1% in the 2020 protocol). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment. Reinduction-2 will be omitted, and 5 cycles of Maintenance-2 will be omitted",[13,22,23],"Drug: Reinduction-2 omission","Drug: Chemo-light Maintenance 2",[25,40,45],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Blinatumomab","All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\\>0.1% in the 2020 protocol). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment.",[19,9],[31,32,33,34,35,36,37,38,39],"Dexamethasone","Prednisone","Asparaginase","Vincristine","Cyclophosphomide","Cytarabine","6-MP","Methotrexate","Daunorubicin",{"type":26,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Reinduction-2 omission","Reinduction-2 will be omitted for patients with NGS-MRD46\\\u003C10\\^-6 who have receive the two courses of Blina-14.",[19],[31,32,39,33,34,35,36,37,38],{"type":26,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Chemo-light Maintenance 2","Patients with FCM-MRD19\\\u003C0.01% and IgH rearrangement NGS MRD 46\\\u003C10\\^-6 will receive chemo-light maintenance-2 with 4 cyles of 8-week course of MTX + 6MP (totally 32 weeks).",[19],[31,32,39,33,34,35,36,37,38],[51],{"name":52,"affiliation":53,"role":54},"Xiaofan Zhu, MD","Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC","PRINCIPAL_INVESTIGATOR",[56,60],{"name":52,"role":57,"phone":58,"phoneExt":17,"email":59},"CONTACT","+ 86 22 23909001","xfzhu@ihcams.ac.cn",{"name":61,"role":57,"phone":62,"phoneExt":17,"email":63},"Jingliao Zhang, MD","+86 22 23909196","zhangjingliao@ihcams.ac.cn",[65,83,93,107,121,135,145,159,173,187,197,207,221,231,241,255,268,282,296,309,323,333,343,357,370,384,396],{"facility":66,"status":67,"city":68,"state":69,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Anhui Medical University Second Affiliated Hospital","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":73,"coordinates":74},"Point",[75,76],117.28083,31.86389,{"lat":76,"lon":75},[79],{"name":80,"role":57,"phone":81,"phoneExt":17,"email":82},"Ningling Wang, MD","0551-63869302","zwnltt@126.com",{"facility":84,"status":67,"city":68,"state":69,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Anhui Provincial Children's Hospital",{"type":73,"coordinates":86},[75,76],{"lat":76,"lon":75},[89],{"name":90,"role":57,"phone":91,"phoneExt":17,"email":92},"Xuhan Zhang, MD","0551-62284005","taidousx@163.com",{"facility":94,"status":67,"city":95,"state":96,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Chongqing Medical University Affiliated Children's Hospital","Chongqing","Chongqing Municipality",{"type":73,"coordinates":98},[99,100],106.55771,29.56026,{"lat":100,"lon":99},[103],{"name":104,"role":57,"phone":105,"phoneExt":17,"email":106},"Jie Yu, MD","023-63632756","1808106657@qq.com",{"facility":108,"status":67,"city":109,"state":110,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Fujian Medical University Union Hospital","Fuzhou","Fujian",{"type":73,"coordinates":112},[113,114],119.30611,26.06139,{"lat":114,"lon":113},[117],{"name":118,"role":57,"phone":119,"phoneExt":17,"email":120},"Jian Li, MD","0591-83357896","1354113723@qq.com",{"facility":122,"status":67,"city":123,"state":124,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Guangzhou Women and Children's Medical Center","Guangzhou","Guangdong",{"type":73,"coordinates":126},[127,128],113.25,23.11667,{"lat":128,"lon":127},[131],{"name":132,"role":57,"phone":133,"phoneExt":17,"email":134},"Hua Jiang, MD","020-81886332","jiang_hua18@sina.cn",{"facility":136,"status":67,"city":123,"state":124,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":137,"geoPoint":139,"contacts":140},"Nanfang Hospital, Southern Medical University",{"type":73,"coordinates":138},[127,128],{"lat":128,"lon":127},[141],{"name":142,"role":57,"phone":143,"phoneExt":17,"email":144},"Xuedong Wu, MD","020-61641114","xuedongwu@163.com",{"facility":146,"status":67,"city":147,"state":148,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"The People's Hospital of Guangxi Zhuang Autonomous Region","Nanning","Guangxi",{"type":73,"coordinates":150},[151,152],108.31667,22.81667,{"lat":152,"lon":151},[155],{"name":156,"role":57,"phone":157,"phoneExt":17,"email":158},"Yan Dai, MD","0771-2635268","3677458@qq.com",{"facility":160,"status":67,"city":161,"state":162,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"The Affiliated Hospital of Guizhou Medical University","Guiyang","Guizhou",{"type":73,"coordinates":164},[165,166],106.71667,26.58333,{"lat":166,"lon":165},[169],{"name":170,"role":57,"phone":171,"phoneExt":17,"email":172},"Jiao Jin, MD","0851-86772025","jinjiao999@gmc.edu.cn",{"facility":174,"status":67,"city":175,"state":176,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei",{"type":73,"coordinates":178},[179,180],114.26667,30.58333,{"lat":180,"lon":179},[183],{"name":184,"role":57,"phone":185,"phoneExt":17,"email":186},"Aiguo Liu, PhD","027-83663131","aiguoliu309@163.com",{"facility":188,"status":67,"city":175,"state":176,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":189,"geoPoint":191,"contacts":192},"Union Hospital of Tongji Medical College, Huazhong University of Science and Technology",{"type":73,"coordinates":190},[179,180],{"lat":180,"lon":179},[193],{"name":194,"role":57,"phone":195,"phoneExt":17,"email":196},"Xiaoyan Wu, PhD","027-85726114","xiaoyanw8016@163.com",{"facility":198,"status":67,"city":175,"state":176,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":199,"geoPoint":201,"contacts":202},"Wuhan Children's Hospital",{"type":73,"coordinates":200},[179,180],{"lat":180,"lon":179},[203],{"name":204,"role":57,"phone":205,"phoneExt":17,"email":206},"Hao Xiong, MD","13006107360","22587481@qq.com",{"facility":208,"status":67,"city":209,"state":210,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Hunan Children's Hospital","Changsha","Hunan",{"type":73,"coordinates":212},[213,214],112.97087,28.19874,{"lat":214,"lon":213},[217],{"name":218,"role":57,"phone":219,"phoneExt":17,"email":220},"Wenyong Kuang, PhD","0731-85356114","kathy5460@sina.com",{"facility":222,"status":67,"city":209,"state":210,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":223,"geoPoint":225,"contacts":226},"The Third Xiangya Hospital of the Central South University",{"type":73,"coordinates":224},[213,214],{"lat":214,"lon":213},[227],{"name":228,"role":57,"phone":229,"phoneExt":17,"email":230},"Minghua Yang, MD","0731-88618576","yangminghua@csu.edu.cn",{"facility":232,"status":67,"city":209,"state":210,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":233,"geoPoint":235,"contacts":236},"Xiangya Hospital Central South University",{"type":73,"coordinates":234},[213,214],{"lat":214,"lon":213},[237],{"name":238,"role":57,"phone":239,"phoneExt":17,"email":240},"Liangchun Yang, MD","0731-89753999","yangliangchung@163.com",{"facility":242,"status":67,"city":243,"state":244,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Nanjing Children's Hospital Affiliated to Nanjing Medical University","Nanjing","Jiangsu",{"type":73,"coordinates":246},[247,248],118.77778,32.06167,{"lat":248,"lon":247},[251],{"name":252,"role":57,"phone":253,"phoneExt":17,"email":254},"Yongjun Fang, MD","025-83117500","fyj322@189.cn",{"facility":256,"status":67,"city":257,"state":244,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Children's Hospital of Soochow University","Suzhou",{"type":73,"coordinates":259},[260,261],120.59538,31.30408,{"lat":261,"lon":260},[264],{"name":265,"role":57,"phone":266,"phoneExt":17,"email":267},"Shaoyan Hu, MD","0512-80695102","hsyl39@126.com",{"facility":269,"status":67,"city":270,"state":271,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Jiangxi Provincial Children's Hospital","Nanchang","Jiangxi",{"type":73,"coordinates":273},[274,275],115.85306,28.68396,{"lat":275,"lon":274},[278],{"name":279,"role":57,"phone":280,"phoneExt":17,"email":281},"Fei He, MD","0791-86802382","hefei1944@163.com",{"facility":283,"status":67,"city":284,"state":285,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":73,"coordinates":287},[288,289],116.99722,36.66833,{"lat":289,"lon":288},[292],{"name":293,"role":57,"phone":294,"phoneExt":17,"email":295},"Xiul Ju, MD","0531-82169114","shellysdcn@hotmail.com",{"facility":297,"status":67,"city":298,"state":285,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Affiliated Hospital of Qingdao University","Qingdao",{"type":73,"coordinates":300},[301,302],120.38042,36.06488,{"lat":302,"lon":301},[305],{"name":306,"role":57,"phone":307,"phoneExt":17,"email":308},"Lingzhen Lingzhen, MD","0532-96166","hopewang2006@163.com",{"facility":310,"status":67,"city":311,"state":312,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Children's Hospital of Fudan University","Shanghai","Shanghai Municipality",{"type":73,"coordinates":314},[315,316],121.45806,31.22222,{"lat":316,"lon":315},[319],{"name":320,"role":57,"phone":321,"phoneExt":17,"email":322},"Xiaowen Zhai, MD","021-64931990","zhaixiaowendy@163.com",{"facility":324,"status":67,"city":311,"state":312,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":325,"geoPoint":327,"contacts":328},"Shanghai Children's Hospital",{"type":73,"coordinates":326},[315,316],{"lat":316,"lon":315},[329],{"name":330,"role":57,"phone":331,"phoneExt":17,"email":332},"Hui Jiang, MD","021-62474880","jhui0111@126.com",{"facility":334,"status":67,"city":311,"state":312,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":335,"geoPoint":337,"contacts":338},"Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine",{"type":73,"coordinates":336},[315,316],{"lat":316,"lon":315},[339],{"name":340,"role":57,"phone":341,"phoneExt":17,"email":342},"Shuhong Shen, MD","021-3862616","shenshuhong@scmc.com.cn",{"facility":344,"status":67,"city":345,"state":346,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Xi'an Northwest Women and Children Hospital","Xi’an","Shanxi",{"type":73,"coordinates":348},[349,350],113.52486,35.99785,{"lat":350,"lon":349},[353],{"name":354,"role":57,"phone":355,"phoneExt":17,"email":356},"Jian Zhang, MD","029-89550001","kailipan@fmmu.edu.cn",{"facility":358,"status":67,"city":359,"state":359,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":360,"geoPoint":364,"contacts":365},"Shenzhen Children's Hospita","Shenzhen",{"type":73,"coordinates":361},[362,363],114.0683,22.54554,{"lat":363,"lon":362},[366],{"name":367,"role":57,"phone":368,"phoneExt":17,"email":369},"Sixi Liu, MD","83936101","tiger647@126.com",{"facility":371,"status":67,"city":372,"state":373,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"West China Second University Hospital","Chengdu","Sichuan",{"type":73,"coordinates":375},[376,377],104.06667,30.66667,{"lat":377,"lon":376},[380],{"name":381,"role":57,"phone":382,"phoneExt":17,"email":383},"Ju Gao, MD","028-88570307","gaoju651220@126.com",{"facility":53,"status":385,"city":386,"state":387,"zip":17,"country":70,"countryCode":71,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"RECRUITING","Tianjin","Tianjin Municipality",{"type":73,"coordinates":389},[390,391],117.17667,39.14222,{"lat":391,"lon":390},[394],{"name":52,"role":57,"phone":395,"phoneExt":17,"email":59},"+86 022 23909001",{"facility":397,"status":67,"city":398,"state":398,"zip":17,"country":398,"countryCode":399,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"Hong Kong Children's Hospital","Hong Kong","HK",{"type":73,"coordinates":401},[402,403],114.17469,22.27832,{"lat":403,"lon":402},[406],{"name":407,"role":57,"phone":408,"phoneExt":17,"email":409},"Chi-kong Li, MD","(852) 3505-2849","ckli@cuhk.edu.hk",{"type":411,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100583878","phase-2-newly-diagnosed-low-risk-pediatric-b-cell-all-protocol-100583878",false,"NCT06882057","Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol","Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia","CCCG-LR-B-ALL","Inclusion Criteria:\n\nMust meet all items below:\n\n1. Age older than 1 year and younger than 18 years.\n2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n3. Diagnosis of B-ALL by immunophenotyping.\n4. Low risk group\n\nExclusion Criteria:\n\nShould be excluded in the presence of any item below:\n\n1. T-ALL\n2. I\u002FHR B-ALL group\n3. sIgM+\n4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.\n5. Philadelphia chromosome positive ALL (Ph-ALL)\n6. ALL evolved from chronic myeloid leukemia (CML).\n7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction\n8. Secondary leukemia\n9. Known underlying congenital immunodeficiency or metabolic disease\n10. Congenital heart disease with cardiac insufficiency.\n11. Glucocorticoid treatment 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)","ALL","1 Year","18 Years",{"count":424,"type":425},3000,"ESTIMATED","INTERVENTIONAL",[428,429],"PHASE2","PHASE3","CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).",[432,433,434],"Acute Lymphoblastic Leukemia ALL","Childhood Leukemia, Acute Lymphoblastic","B Cell Acute Lymphoblastic Leukemia (B-ALL)",[436,437],"blinatumomab","chemo-light","2025-08-23",{"date":440,"type":441},"2025-08-26","ACTUAL",{"date":443,"type":441},"2025-03-03",{"date":445,"type":425},"2033-06",{"name":5,"class":6},27]