[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535866":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":167,"collaborators":170,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":185,"sex":191,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":24,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"[Arm A, Dasatinib(Sprycel) Arm]","EXPERIMENTAL","▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)\n\n* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n  1. If MRD \\& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance\n  2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT\n* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT\n\n  1. If MRD \\& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine\n  2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab\n\n     * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.",[13],"Drug: Dasatinib(Sprycel) arm",{"label":15,"type":10,"description":16,"interventionNames":17},"[Arm B, Non-Dasatinib(Sprycel) Arm]","▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction\n\n* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n  1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT\n  2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT\n* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT\n\n  1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine\n  2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab",[18],"Drug: Non-Dasatinib(Sprycel) arm",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Dasatinib(Sprycel) arm",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Non-Dasatinib(Sprycel) arm","▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction\n\n* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3\n\n  1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT\n  2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT\n* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT\n\n  1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine\n  2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Hyoung Jin Kang, Ph.D","CONTACT","+82-2-2072-3452","kanghj@snu.ac.kr",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":34},"Hyoung Jin Kang","+82220723452",[39,56,70,84,98,109,120,131,142,153],{"facility":40,"status":41,"city":42,"state":24,"zip":43,"country":44,"countryCode":24,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Kyungpook National University Chilgok-Hospital","RECRUITING","Daegu","41404","South Korea",{"type":46,"coordinates":47},"Point",[48,49],128.59111,35.87028,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":54,"phoneExt":24,"email":55},"Ji Yoon Kim, Professor","+82-53-200-5704","phojyk@knu.ac.kr",{"facility":57,"status":41,"city":58,"state":24,"zip":59,"country":44,"countryCode":24,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Chungnam National University Hospital","Daejeon","35015",{"type":46,"coordinates":61},[62,63],127.38493,36.34913,{"lat":63,"lon":62},[66],{"name":67,"role":32,"phone":68,"phoneExt":24,"email":69},"Yeon Jung Lim, Professor","+82-10-2705-1743","heagori@daum.net",{"facility":71,"status":41,"city":72,"state":24,"zip":73,"country":44,"countryCode":24,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Chonnam National University Hwasun Hospital","Hwasun","58128",{"type":46,"coordinates":75},[76,77],126.98746,35.06125,{"lat":77,"lon":76},[80],{"name":81,"role":32,"phone":82,"phoneExt":24,"email":83},"Hee Jo Baek, Professor","+82-61-379-8060","swan93@naver.com",{"facility":85,"status":41,"city":86,"state":24,"zip":87,"country":44,"countryCode":24,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Jeju National University Hospital","Jeju City","63241",{"type":46,"coordinates":89},[90,91],126.52194,33.50972,{"lat":91,"lon":90},[94],{"name":95,"role":32,"phone":96,"phoneExt":24,"email":97},"Hyun Sik Kang, Professor","+82-64-717-1528","medyapsb@naver.com",{"facility":5,"status":41,"city":99,"state":24,"zip":100,"country":44,"countryCode":24,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Seoul","03080",{"type":46,"coordinates":102},[103,104],126.9784,37.566,{"lat":104,"lon":103},[107],{"name":108,"role":32,"phone":33,"phoneExt":24,"email":34},"Hyoung Jin Kang, Professor",{"facility":110,"status":41,"city":99,"state":24,"zip":111,"country":44,"countryCode":24,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Severance Hospital","03722",{"type":46,"coordinates":113},[103,104],{"lat":104,"lon":103},[116],{"name":117,"role":32,"phone":118,"phoneExt":24,"email":119},"Seung-min Hahn, Professor","+82-2-2258-9943","bluenile88@yuhs.ac",{"facility":121,"status":41,"city":99,"state":24,"zip":122,"country":44,"countryCode":24,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Asan Medical Center","05505",{"type":46,"coordinates":124},[103,104],{"lat":104,"lon":103},[127],{"name":128,"role":32,"phone":129,"phoneExt":24,"email":130},"Ho Joon Im, Professor","8201062311573","hojim@amc.seoul.kr",{"facility":132,"status":41,"city":99,"state":24,"zip":133,"country":44,"countryCode":24,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"Samsung Medical Center","06351",{"type":46,"coordinates":135},[103,104],{"lat":104,"lon":103},[138],{"name":139,"role":32,"phone":140,"phoneExt":24,"email":141},"Hee Young Ju, Professor","+82-2-3410-0865","hyju320@gmail.com",{"facility":143,"status":41,"city":99,"state":24,"zip":144,"country":44,"countryCode":24,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Seoul saint Mary's Hospital","06591",{"type":46,"coordinates":146},[103,104],{"lat":104,"lon":103},[149],{"name":150,"role":32,"phone":151,"phoneExt":24,"email":152},"Jae Won Yoo, Professor","+82-2-2258-6763","hoiring0209@gmail.com",{"facility":154,"status":41,"city":155,"state":24,"zip":156,"country":44,"countryCode":24,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Pusan National University Yangsan Hospital","Yangsan","50612",{"type":46,"coordinates":158},[159,160],129.03358,35.34199,{"lat":160,"lon":159},[163],{"name":164,"role":32,"phone":165,"phoneExt":24,"email":166},"Eu Jeen Yang, Professor","+82-10-6478-8489","41sirius@hanmail.net",{"type":168,"investigatorFullName":36,"investigatorTitle":169,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Professor",[171,172,173,174,175,177,179,180,182],{"name":121,"class":6},{"name":132,"class":6},{"name":110,"class":6},{"name":154,"class":6},{"name":176,"class":6},"Seoul St. Mary's Hospital",{"name":178,"class":6},"Chonnam National University Hospital",{"name":57,"class":6},{"name":181,"class":6},"Kyungpook National University Chilgok Hospital",{"name":85,"class":6},"100535866","phase-2-treatment-of-pediatric-very-high-risk-acute-lymphoblastic-leukemia-in-korea-100535866",false,"NCT06257394","Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea","Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea","VHR ALL","Inclusion Criteria:\n\n* Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:\n\n  * Philadelphia chromosome-positive t(9;22)(q34;q11) or\n  * Patients with failed remission who had blast \\> 5% on bone marrow test after initial remission induction therapy or\n  * Hypodiploidy (Number of chromosomes \\< 44 (less than 44)) or\n  * E2A-HLF(Hepatic Leukemia Factor) translocation-positive or\n  * When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy\n\nExclusion Criteria:\n\n* Participants with contraindications to medications\n* When the study participant or their legal representative withdraws consent\n* Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)\n* Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol","ALL","1 Year","19 Years",{"count":195,"type":196},74,"ESTIMATED","INTERVENTIONAL",[199],"PHASE2","Very high-risk acute lymphoblastic leukemia",[202],"Acute Lymphoblastic Leukemia, Pediatric",[189,204],"NGS-MRD","2026-07-28",{"date":207,"type":208},"2026-07-29","ACTUAL",{"date":210,"type":208},"2024-10-20",{"date":212,"type":196},"2034-12-31",{"name":36,"class":6},10]