[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555791":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":39,"responsibleParty":163,"collaborators":30,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":30,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":30,"maxAge":173,"enrollmentInfo":174,"targetDuration":30,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":30,"overallStatus":72,"whyStopped":30,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Yonsei University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low risk group","EXPERIMENTAL","KMT2A wild type \\& minimal residual disease(MRD) (-) after consolidation 1",[13],"Drug: Consolidation #4(without daunorubicin)",{"label":15,"type":10,"description":16,"interventionNames":17},"Intermediate risk group","ntermediate risk (If one of the two cases below applies)\n\n* KMT2A: MLL mutation (+) \\& minimal residual disease (MRD) (-) after consolidation 1\n\n  * KMT2A: wild type \\& minimal residual disease (MRD) (+) after consolidation 1",[18],"Drug: Consolidation #4(with daunorubicin)",{"label":20,"type":10,"description":21,"interventionNames":22},"High risk group","Somatic KMT2A mutation (+) \\& minimal residual disease (MRD) (+) after consolidation 1",[23],"Drug: Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Consolidation #4(without daunorubicin)","1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate\n2. Low Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, intrathecal methotrexate\n3. Low Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate\n4. Low Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate\n5. Low Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate\n6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Consolidation #4(with daunorubicin)","1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate\n2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate\n3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate\n4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate\n5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate\n6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)","1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate\n2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate\n3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate\n4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate\n5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate\n6. Allogeneic hematopoietic stem cell transplantation",[20],[40,57,70,84,97,110,123,133,143,153],{"facility":41,"status":42,"city":43,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Kyungpook National University Chilgok-Hospital","NOT_YET_RECRUITING","Daegu","South Korea",{"type":46,"coordinates":47},"Point",[48,49],128.59111,35.87028,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":30,"phoneExt":55,"email":56},"Ji Yoon Kim, Professor","CONTACT","82-53-200-5704","phojyk@knu.ac.kr",{"facility":58,"status":42,"city":59,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Chungnam National University Hospital","Daejeon",{"type":46,"coordinates":61},[62,63],127.38493,36.34913,{"lat":63,"lon":62},[66],{"name":67,"role":54,"phone":68,"phoneExt":30,"email":69},"Yeon Jung Lim, Professor","82-10-2705-1743","heagori@daum.net",{"facility":71,"status":72,"city":73,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Chonnam National University Hwasun Hospital","RECRUITING","Hwasun",{"type":46,"coordinates":75},[76,77],126.98746,35.06125,{"lat":77,"lon":76},[80],{"name":81,"role":54,"phone":82,"phoneExt":30,"email":83},"Hee Jo Baek","+82-61-379-8060","swan93@naver.com",{"facility":85,"status":72,"city":86,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Jeju National University Hospital","Jeju City",{"type":46,"coordinates":88},[89,90],126.52194,33.50972,{"lat":90,"lon":89},[93],{"name":94,"role":54,"phone":95,"phoneExt":30,"email":96},"Hyun Sik Kang","+82-64-717-1528","medyapsb@naver.com",{"facility":98,"status":72,"city":99,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Pusan National University Yangsan Hospital","Pusan",{"type":46,"coordinates":101},[102,103],128.02524,35.70128,{"lat":103,"lon":102},[106],{"name":107,"role":54,"phone":108,"phoneExt":30,"email":109},"Eu Jeen Yang","+82-10-6478-8489","41sirius@hanmail.net",{"facility":111,"status":72,"city":112,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Asan Medical Center","Seoul",{"type":46,"coordinates":114},[115,116],126.9784,37.566,{"lat":116,"lon":115},[119],{"name":120,"role":54,"phone":121,"phoneExt":30,"email":122},"Ho Joon Im, MD","+82-2-3010-3371","hojim@amc.seoul.kr",{"facility":124,"status":72,"city":112,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":125,"geoPoint":127,"contacts":128},"Samsung Medical Cente",{"type":46,"coordinates":126},[115,116],{"lat":116,"lon":115},[129],{"name":130,"role":54,"phone":131,"phoneExt":30,"email":132},"Hee Young Ju, MD","+82-2-3410-0865","heeyoung.ju@samsung.com",{"facility":134,"status":72,"city":112,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"Seoul National University Hospital",{"type":46,"coordinates":136},[115,116],{"lat":116,"lon":115},[139],{"name":140,"role":54,"phone":141,"phoneExt":30,"email":142},"Hyoung Jin Kang, MD","+82-2-2072-3452","kanghj@snu.ac.kr",{"facility":144,"status":72,"city":112,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Seoul saint Mary's Hospital",{"type":46,"coordinates":146},[115,116],{"lat":116,"lon":115},[149],{"name":150,"role":54,"phone":151,"phoneExt":30,"email":152},"Jae Wook Lee, MD","+82-2-2258-6192","dashwood@catholic.ac.kr",{"facility":154,"status":72,"city":112,"state":30,"zip":30,"country":44,"countryCode":30,"cosmosGeoPoint":155,"geoPoint":157,"contacts":158},"Severance Hospital",{"type":46,"coordinates":156},[115,116],{"lat":116,"lon":115},[159],{"name":160,"role":54,"phone":161,"phoneExt":30,"email":162},"seung min Hahn, MD","+82-2-2228-2050","bluenile88@yuhs.ac",{"type":164,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100555791","phase-2-efficacy-of-risk-stratified-treatment-in-newly-diagnosed-infant-leukemia-100555791",false,"NCT06516679","Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia","Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study","Inclusion Criteria:\n\n* The age of diagnosis is less than 1 year old\n* The disgnosisi of ALL or ALAL(lymphoid predominant)\n* Informed consent of the parents(guardians) before participation in this study\n\nExclusion Criteria:\n\n* Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation\n* Relapsed infant leukemia\n* Participants with contraindication to medication\n* Administered systemic steroid therapy within 4 weeks prior to this study (However, steroid administration is allowable in oncologic emergencies only after the subject's disease diagnosis and risk group classification are completed.)\n* Participants in other interventional studies other than this protocol","ALL","2 Years",{"count":175,"type":176},40,"ESTIMATED","INTERVENTIONAL",[179],"PHASE2","This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment.\n\nIn addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.",[182],"Leukemia, Lymphoid","2026-07-28",{"date":185,"type":186},"2026-07-29","ACTUAL",{"date":188,"type":186},"2024-12-11",{"date":190,"type":176},"2032-12-31",{"name":5,"class":6},10]