[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604632":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":355,"collaborators":40,"id":357,"slug":358,"hasResults":359,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":359,"sex":365,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":40,"studyType":371,"phases":372,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":318,"whyStopped":40,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OVB+Blina+VEN+Chemo-light regimen","EXPERIMENTAL","All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen. Cyclophosphamide and asparaginase are totally omitted from the entire treatment to mitigate toxicities.\n\nOVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol.\n\nPatients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity.\n\nAll patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase. The dosage of AraC will be reduced to 1 g\u002Fm2 in the consolidation 2 phase.\n\nThroughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP.",[13],"Drug: olverembatinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","olverembatinib","All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen.\n\nOVB is combined with Vincristine and Prednisone (VP) during the first 2 weeks and with blinatumomab during the last 4 weeks of remission induction in this protocol.\n\nPatients will receive blinatumomab for 28 days as induction instead of CAT to improve induction response and avoid toxicity.\n\nAll patients will receive two cycles of HDMTX+Blina-14 and 4 times of triple intrathecal therapy (TIT) throughout the consolidation 1 phase.\n\nTo decrease the toxicities of high-dose AraC, the dosage will be reduced to 1 g\u002Fm2 in the consolidation 2 phase in contrast to 2 g\u002Fm2 in 2020 protocol.\n\nThroughout the early Maintenance Therapy, dexamethasone and vincristine combination will be added with either venetoclax or daunorubicin alternatively for five cycles, given after MTX and 6-MP.",[9],[21,22,23,24,25,26,27,28,29],"vincristine","prednisone","blinatumomab","Methotrexate","Cytarabine","Daunorubicin","venetoclax","Dexamethasone","6-MP",[31],{"name":32,"affiliation":33,"role":34},"Xiaofan Zhu, MD","Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Jingliao Zhang, MD","CONTACT","+86 22 23909196",null,"zhangjingliao@ihcams.ac.cn",{"name":32,"role":38,"phone":43,"phoneExt":40,"email":44},"+ 86 22 23909001","xfzhu@ihcams.ac.cn",[46,64,78,92,106,116,126,140,154,164,174,188,198,212,225,239,253,266,280,290,303,317,332,341],{"facility":47,"status":48,"city":49,"state":50,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Anhui Medical University Second Affiliated Hospita","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":54,"coordinates":55},"Point",[56,57],117.28083,31.86389,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":40,"email":63},"Ningling Wang, MD","0551-63869302","zwnltt@126.com",{"facility":65,"status":48,"city":66,"state":67,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Chongqing Medical University Affiliated Children's Hospital","Chongqing","Chongqing Municipality",{"type":54,"coordinates":69},[70,71],106.55771,29.56026,{"lat":71,"lon":70},[74],{"name":75,"role":38,"phone":76,"phoneExt":40,"email":77},"Jie Yu, MD","023-63632756","1808106657@qq.com",{"facility":79,"status":48,"city":80,"state":81,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Fujian Medical University Union Hospital","Fuzhou","Fujian",{"type":54,"coordinates":83},[84,85],119.30611,26.06139,{"lat":85,"lon":84},[88],{"name":89,"role":38,"phone":90,"phoneExt":40,"email":91},"Jian Li, MD","0591-83357896","1354113723@qq.com",{"facility":93,"status":48,"city":94,"state":95,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Guangzhou Women and Children's Medical Center","Guangzhou","Guangdong",{"type":54,"coordinates":97},[98,99],113.25,23.11667,{"lat":99,"lon":98},[102],{"name":103,"role":38,"phone":104,"phoneExt":40,"email":105},"Hua Jiang, MD","020-81886332","jiang_hua18@sina.cn",{"facility":107,"status":48,"city":94,"state":95,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"Nanfang Hospital, Southern Medical University",{"type":54,"coordinates":109},[98,99],{"lat":99,"lon":98},[112],{"name":113,"role":38,"phone":114,"phoneExt":40,"email":115},"Xuedong Wu, MD","020-61641114","xuedongwu@163.com",{"facility":117,"status":48,"city":94,"state":95,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"The First Affiliated Hospital, Sun Yat-sen University",{"type":54,"coordinates":119},[98,99],{"lat":99,"lon":98},[122],{"name":123,"role":38,"phone":124,"phoneExt":40,"email":125},"Xuequn Luo, MD","020-87755766","l-xuequn@126.com",{"facility":127,"status":48,"city":128,"state":129,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"The Affiliated Hospital of Guizhou Medical University","Guiyang","Guizhou",{"type":54,"coordinates":131},[132,133],106.71667,26.58333,{"lat":133,"lon":132},[136],{"name":137,"role":38,"phone":138,"phoneExt":40,"email":139},"Jiao Jin, MD","0851-86772025","jinjiao999@gmc.edu.cn",{"facility":141,"status":48,"city":142,"state":143,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei",{"type":54,"coordinates":145},[146,147],114.26667,30.58333,{"lat":147,"lon":146},[150],{"name":151,"role":38,"phone":152,"phoneExt":40,"email":153},"Aiguo Liu, MD","027-83663131","aiguoliu309@163.com",{"facility":155,"status":48,"city":142,"state":143,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Union Hospital of Tongji Medical College, Huazhong University of Science and Technology",{"type":54,"coordinates":157},[146,147],{"lat":147,"lon":146},[160],{"name":161,"role":38,"phone":162,"phoneExt":40,"email":163},"Xiaoyan Wu, MD","027-85726114","xiaoyanw8016@163.com",{"facility":165,"status":48,"city":142,"state":143,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":166,"geoPoint":168,"contacts":169},"Wuhan Children's Hospital",{"type":54,"coordinates":167},[146,147],{"lat":147,"lon":146},[170],{"name":171,"role":38,"phone":172,"phoneExt":40,"email":173},"Hao Xiong, MD","13006107360","22587481@qq.com",{"facility":175,"status":48,"city":176,"state":177,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Hunan Children's Hospital","Changsha","Hunan",{"type":54,"coordinates":179},[180,181],112.97087,28.19874,{"lat":181,"lon":180},[184],{"name":185,"role":38,"phone":186,"phoneExt":40,"email":187},"Wenyong Kuang, MD","0731-85356114","kathy5460@sina.com",{"facility":189,"status":48,"city":176,"state":177,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":190,"geoPoint":192,"contacts":193},"The Third Xiangya Hospital of the Central South University",{"type":54,"coordinates":191},[180,181],{"lat":181,"lon":180},[194],{"name":195,"role":38,"phone":196,"phoneExt":40,"email":197},"Minghua Yang, MD","0731-88618576","yangminghua@csu.edu.cn",{"facility":199,"status":48,"city":200,"state":201,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Nanjing Children's Hospital Affiliated to Nanjing Medical University","Nanjin","Jiangsu",{"type":54,"coordinates":203},[204,205],121.74055,31.75772,{"lat":205,"lon":204},[208],{"name":209,"role":38,"phone":210,"phoneExt":40,"email":211},"Yongjun Fang, MD","025-83117500","fyj322@189.cn",{"facility":213,"status":48,"city":214,"state":201,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Children's Hospital of Soochow University","Suzhou",{"type":54,"coordinates":216},[217,218],120.59538,31.30408,{"lat":218,"lon":217},[221],{"name":222,"role":38,"phone":223,"phoneExt":40,"email":224},"Shaoyan Hu, MD","0512-80695102","hsyl39@126.com",{"facility":226,"status":48,"city":227,"state":228,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Jiangxi Provincial Children's Hospital","Nanchang","Jiangxi",{"type":54,"coordinates":230},[231,232],115.85306,28.68396,{"lat":232,"lon":231},[235],{"name":236,"role":38,"phone":237,"phoneExt":40,"email":238},"Fei He, MD","0791-86802382","hefei1944@163.com",{"facility":240,"status":48,"city":241,"state":242,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":54,"coordinates":244},[245,246],116.99722,36.66833,{"lat":246,"lon":245},[249],{"name":250,"role":38,"phone":251,"phoneExt":40,"email":252},"Xiuli Ju, MD","0531-82169114","shellysdcn@hotmail.com",{"facility":254,"status":48,"city":255,"state":242,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Affiliated Hospital of Qingdao University","Qingdao",{"type":54,"coordinates":257},[258,259],120.38042,36.06488,{"lat":259,"lon":258},[262],{"name":263,"role":38,"phone":264,"phoneExt":40,"email":265},"Lingzhen Wang, MD","0532-96166","hopewang2006@163.com",{"facility":267,"status":48,"city":268,"state":269,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Children's Hospital of Fudan University","Shanghai","Shanghai Municipality",{"type":54,"coordinates":271},[272,273],121.45806,31.22222,{"lat":273,"lon":272},[276],{"name":277,"role":38,"phone":278,"phoneExt":40,"email":279},"Xiaowen Zhai, MD","021-64931990","zhaixiaowendy@163.com",{"facility":281,"status":48,"city":268,"state":269,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":282,"geoPoint":284,"contacts":285},"Shanghai Children's Hospital",{"type":54,"coordinates":283},[272,273],{"lat":273,"lon":272},[286],{"name":287,"role":38,"phone":288,"phoneExt":40,"email":289},"Hui Jiang, MD","021-62474880","jhui0111@126.com",{"facility":291,"status":48,"city":292,"state":292,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"Shenzhen Children's Hospital","Shenzhen",{"type":54,"coordinates":294},[295,296],114.0683,22.54554,{"lat":296,"lon":295},[299],{"name":300,"role":38,"phone":301,"phoneExt":40,"email":302},"Sixi Liu","83936101","tiger647@126.com",{"facility":304,"status":48,"city":305,"state":306,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"West China Second University Hospita","Chengdu","Sichuan",{"type":54,"coordinates":308},[309,310],104.06667,30.66667,{"lat":310,"lon":309},[313],{"name":314,"role":38,"phone":315,"phoneExt":40,"email":316},"Ju Gao, MD","028-88570307","gaoju651220@126.com",{"facility":33,"status":318,"city":319,"state":320,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"RECRUITING","Tianjin","Tianjin Municipality",{"type":54,"coordinates":322},[323,324],117.17667,39.14222,{"lat":324,"lon":323},[327,329,330],{"name":32,"role":38,"phone":328,"phoneExt":40,"email":44},"+86 022 23909001",{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},{"name":37,"role":331,"phone":40,"phoneExt":40,"email":40},"SUB_INVESTIGATOR",{"facility":33,"status":48,"city":319,"state":320,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":333,"geoPoint":335,"contacts":336},{"type":54,"coordinates":334},[323,324],{"lat":324,"lon":323},[337],{"name":338,"role":38,"phone":339,"phoneExt":40,"email":340},"Wenyu Yang, MD","022-23909138","yangwenyu@ihcams.ac.cn",{"facility":342,"status":48,"city":343,"state":40,"zip":40,"country":343,"countryCode":344,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Hong Kong Children's Hospital, The Chinese University of Hong Kong","Hong Kong","HK",{"type":54,"coordinates":346},[347,348],114.17469,22.27832,{"lat":348,"lon":347},[351],{"name":352,"role":38,"phone":353,"phoneExt":40,"email":354},"Chi-kong Li, MD","(852) 3505-2849","ckli@cuhk.edu.hk",{"type":356,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100604632","phase-3-newly-diagnosed-pediatric-ph-positive-b-all-protocol-100604632",false,"NCT07152041","Newly-diagnosed Pediatric Ph-positive B-ALL Protocol","A Phase 3, Multicenter Trial for Pediatric Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia -2025 Project","CAMS-Ph+ B-ALL","Inclusion Criteria:\n\nMust meet all items below:\n\n1. Age older than 1 month to younger 18 years.\n2. Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.\n3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.\n\nExclusion Criteria:\n\nShould be excluded if had any item below:\n\n1. ALL evolved from CML.\n2. Known underlying congenital immunodeficiency or metabolic disease.\n3. Congenital heart disease with cardiac insufficiency.\n4. Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.\n5. Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.\n6. Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).\n7. Treated with glucocorticoids for ≥14 days, or targeted inhibitor for \\> 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression).\n8. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.","ALL","1 Month","18 Years",{"count":369,"type":370},150,"ESTIMATED","INTERVENTIONAL",[373],"PHASE3","This prospective clinical trial evaluates the effectiveness and safety of \"chemotherapy-light\" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3\u002FCD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric\u002Fadolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol",[376,377],"Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)","Childhood Leukemia, Acute Lymphoblastic",[17,379,27],"Blinatumomab","2025-08-28",{"date":382,"type":383},"2025-09-03","ACTUAL",{"date":385,"type":383},"2025-03-28",{"date":387,"type":370},"2030-06",{"name":5,"class":6},24]