[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535866":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":112,"collaborators":115,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":24,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"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",[39,53,64,75,86,97],{"facility":5,"status":40,"city":41,"state":24,"zip":42,"country":43,"countryCode":24,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Seoul","03080","South Korea",{"type":45,"coordinates":46},"Point",[47,48],126.9784,37.566,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":33,"phoneExt":24,"email":34},"Hyoung Jin Kang, Professor",{"facility":54,"status":40,"city":41,"state":24,"zip":55,"country":43,"countryCode":24,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Severance Hospital","03722",{"type":45,"coordinates":57},[47,48],{"lat":48,"lon":47},[60],{"name":61,"role":32,"phone":62,"phoneExt":24,"email":63},"Seung-min Hahn, Professor","+82-2-2258-9943","bluenile88@yuhs.ac",{"facility":65,"status":40,"city":41,"state":24,"zip":66,"country":43,"countryCode":24,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Asan Medical Center","05505",{"type":45,"coordinates":68},[47,48],{"lat":48,"lon":47},[71],{"name":72,"role":32,"phone":73,"phoneExt":24,"email":74},"Ho Joon Im, Professor","8201062311573","hojim@amc.seoul.kr",{"facility":76,"status":40,"city":41,"state":24,"zip":77,"country":43,"countryCode":24,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Samsung Medical Center","06351",{"type":45,"coordinates":79},[47,48],{"lat":48,"lon":47},[82],{"name":83,"role":32,"phone":84,"phoneExt":24,"email":85},"Hee Young Ju, Professor","+82-2-3410-0865","hyju320@gmail.com",{"facility":87,"status":40,"city":41,"state":24,"zip":88,"country":43,"countryCode":24,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Seoul saint Mary's Hospital","06591",{"type":45,"coordinates":90},[47,48],{"lat":48,"lon":47},[93],{"name":94,"role":32,"phone":95,"phoneExt":24,"email":96},"Jae Won Yoo, Professor","+82-2-2258-6763","hoiring0209@gmail.com",{"facility":98,"status":99,"city":100,"state":24,"zip":101,"country":43,"countryCode":24,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Pusan National University Yangsan Hospital","NOT_YET_RECRUITING","Yangsan","50612",{"type":45,"coordinates":103},[104,105],129.03358,35.34199,{"lat":105,"lon":104},[108],{"name":109,"role":32,"phone":110,"phoneExt":24,"email":111},"Eu Jeen Yang, Professor","+82-10-6478-8489","41sirius@hanmail.net",{"type":113,"investigatorFullName":36,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Professor",[116,117,118,119,120],{"name":65,"class":6},{"name":76,"class":6},{"name":54,"class":6},{"name":98,"class":6},{"name":121,"class":6},"Seoul St. Mary's Hospital","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":134,"type":135},74,"ESTIMATED","INTERVENTIONAL",[138],"PHASE2","Very high-risk acute lymphoblastic leukemia",[141],"Acute Lymphoblastic Leukemia, Pediatric",[128,143],"NGS-MRD","2025-06-04",{"date":146,"type":147},"2025-06-08","ACTUAL",{"date":149,"type":147},"2024-10-20",{"date":151,"type":135},"2034-12-31",{"name":36,"class":6},6]