[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502845":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":79,"centralContacts":83,"locations":88,"responsibleParty":172,"collaborators":175,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":186,"sex":191,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":41,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":91,"whyStopped":41,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,18,25,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Risk group with B-ALL","EXPERIMENTAL","Reinduction -\\> Consolidation 1st -\\> Consolidation 2nd -\\> Repeat the Intensification course in parentheses 3 times(Intensification 1st -\\> Intensification 2nd -\\> Intensification 3rd -\\> Intensification 4th) -\\> Maintenance",[13,14,15,16,17],"Drug: Reinduction(4weeks)","Drug: Cosolodation 1st(3weeks)","Drug: Consolidation 2nd(3weeks)","Drug: Intensification course","Drug: Maintenance(12 Weeks\u002FCycle)",{"label":19,"type":10,"description":20,"interventionNames":21},"High Risk group with B-ALL","Reinduction -\\> Consolidation 1st -\\> Consolidation 2nd -\\> Blinatumomab 1st -\\> Blinatumomab 2nd -\\> HSCT",[13,14,15,22,23,24],"Drug: Blinatumomab 1st(High Risk Group)_4 Weeks","Drug: Blinatumomab 2nd (High Risk Group)_4 Weeks","Procedure: Stem Cell Transplantation",{"label":26,"type":10,"description":27,"interventionNames":28},"Very high Risk with B-ALL","Reinduction -\\> Blinatumomab-Salvage 1st -\\> Blinatumomab-Salvage 2nd -\\> HSCT",[13,29,30,16],"Drug: Blinatumomab-Salvage 1st (Very High Risk Group)_4 Weeks","Drug: Blinatumomab-Salvage 2nd (Very High Risk Group)_4 Weeks",{"label":32,"type":10,"description":33,"interventionNames":34},"T-ALL","Reinduction -\\> Consolidation 1st -\\> Consolidation 2nd -\\> HSCT",[13,14,15,24],[36,42,46,50,54,58,62,66,70,74],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Reinduction(4weeks)","Prednisolone 60 mg\u002Fm2\u002Fday tid days 1-28, Vincristine 1.5 mg\u002Fm2 on days 1, 8, 15, 22, L-asparaginase 6,000 IU\u002Fm2(days 2-4 start, total 9 doses for 3 weeks), Idarubicin 10 mg\u002Fm2 on days 1, 8, (15\\~17), IT Ara-C on days 1, IT MTX on days 8, 29",[19,9,32,26],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Cosolodation 1st(3weeks)","Ifosfamide: 1.8 g\u002Fm2 (days 1, 2, 3, 4, 5), Etoposide: 100 mg\u002Fm2 (days 1, 2, 3, 4, 5), IT MTX on day 1",[19,9,32],{"type":37,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"Consolidation 2nd(3weeks)","MTX: 500 mg\u002Fm2 over 30 min followed by 1,000 mg\u002Fm2 over 23.5 hr (day 1), Ara-C: 3,000 mg\u002Fm2\u002Fdose (day 2, 3), IT MTX on day 1",[19,9,32],{"type":37,"name":51,"description":52,"armGroupLabels":53,"otherNames":41},"Blinatumomab 1st(High Risk Group)_4 Weeks","Blinatumomab 15 mcg\u002Fm²\u002Fday(Days: 1-28), Dexamethasone 5 mg\u002Fm2\u002Fdose on Day 1, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)",[19],{"type":37,"name":55,"description":56,"armGroupLabels":57,"otherNames":41},"Blinatumomab 2nd (High Risk Group)_4 Weeks","Blinatumomab 15 mcg\u002Fm²\u002Fday(Days: 1-28), IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)",[19],{"type":37,"name":59,"description":60,"armGroupLabels":61,"otherNames":41},"Blinatumomab-Salvage 1st (Very High Risk Group)_4 Weeks","Blinatumomab 9 mcg\u002Fday(Weight ≥ 45kg) or 5 mcg\u002Fm²\u002Fday(Weight \\\u003C 45kg) on 1-7 days, 28 mcg\u002Fday(Weight ≥ 45kg) or 15 mcg\u002Fm²\u002Fday(Weight \\\u003C 45kg) on 8-28 days, Dexamethasone 5 mg\u002Fm2\u002Fdose on day 1 and day 8, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)",[26],{"type":37,"name":63,"description":64,"armGroupLabels":65,"otherNames":41},"Blinatumomab-Salvage 2nd (Very High Risk Group)_4 Weeks","Blinatumomab 28 mcg\u002Fday(Weight ≥ 45kg) or 15 mcg\u002Fm²\u002Fday(Weight \\\u003C 45kg) on 1-28 days, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)",[26],{"type":37,"name":67,"description":68,"armGroupLabels":69,"otherNames":41},"Intensification course","\\\u003CIntensification 1st(3 Weeks)\\> Etoposide: 100 mg\u002Fm2 on day 1, 2, 3, Ifosfamide 3.4 g\u002Fm2 on day 1, 2, 3\n\n\\\u003CIntensification 2nd(2 Weeks)\\> Oral 6-mercaptopurine 50 mg\u002Fm2\u002Fday PO (days 1-14), Methotrexate: 25 mg\u002Fm2 on day 1, 8, TIT on day 1\n\n\\\u003CIntensification 3rd(3 Weeks)\\> Ara-C 1.0 g\u002Fm2 (days 1-3), Idarubicin: 5mg\u002Fm2 (days 1- 3)\n\n\\\u003CIntensification 4th(2 Weeks)\\> Dexamethasone 8 mg\u002Fm2\u002Fday on days 1-14, Vincristine 2 mg\u002Fm2 on days 1 and 8, L-asparaginase 10,000 IU\u002Fm2 on days 1 and 8",[9,26],{"type":37,"name":71,"description":72,"armGroupLabels":73,"otherNames":41},"Maintenance(12 Weeks\u002FCycle)","Prednisolone: 15 mg\u002Fm²\u002Fdose(Days 1-5, 29-33, 57-61), Vincristine: 1.5 mg\u002Fm²\u002Fdose(Day 1, 29, 57), Oral 6-mercaptopurine: 50 mg\u002Fm²\u002Fdose (Days 1-84), Methotrexate: 20 mg\u002Fm²\u002Fdose (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78), Intrathecal methotrexate (Day 1)",[9],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":41},"PROCEDURE","Stem Cell Transplantation","All matters related to hematopoietic stem cell transplantation are subject to each institution's practice.",[19,32],[80],{"name":81,"affiliation":5,"role":82},"Ho Joon Im","STUDY_CHAIR",[84],{"name":81,"role":85,"phone":86,"phoneExt":41,"email":87},"CONTACT","+82-10-6231-1573","hojim@amc.seoul.kr",[89,106,118,129,138,147,158],{"facility":90,"status":91,"city":92,"state":41,"zip":93,"country":94,"countryCode":41,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Chonnam National University Hwasun Hospital","RECRUITING","Hwasun","58128","South Korea",{"type":96,"coordinates":97},"Point",[98,99],126.98746,35.06125,{"lat":99,"lon":98},[102],{"name":103,"role":85,"phone":104,"phoneExt":41,"email":105},"Hee Jo Baek, Ph.D","+82-10-4607-1784","swan93@naver.com",{"facility":107,"status":91,"city":108,"state":41,"zip":109,"country":94,"countryCode":41,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Seoul National University Hospital","Seoul","03080",{"type":96,"coordinates":111},[112,113],126.9784,37.566,{"lat":113,"lon":112},[116],{"name":117,"role":85,"phone":41,"phoneExt":41,"email":41},"Hyoung Jin Kang, Professor",{"facility":119,"status":91,"city":108,"state":41,"zip":120,"country":94,"countryCode":41,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"Severance Hospital","03722",{"type":96,"coordinates":122},[112,113],{"lat":113,"lon":112},[125],{"name":126,"role":85,"phone":127,"phoneExt":41,"email":128},"Seung Min Hahn, Professor","+82-10-8821-5201","bluenile88@yuhs.ac",{"facility":5,"status":91,"city":108,"state":41,"zip":130,"country":94,"countryCode":41,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"05505",{"type":96,"coordinates":132},[112,113],{"lat":113,"lon":112},[135],{"name":136,"role":85,"phone":137,"phoneExt":41,"email":87},"Ho Joon Im, Professor","8201062311573",{"facility":139,"status":91,"city":108,"state":41,"zip":140,"country":94,"countryCode":41,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"Samsung Medical Center","06351",{"type":96,"coordinates":142},[112,113],{"lat":113,"lon":112},[145],{"name":146,"role":85,"phone":41,"phoneExt":41,"email":41},"Hee Young Ju, Professor",{"facility":148,"status":91,"city":108,"state":41,"zip":149,"country":94,"countryCode":41,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"Seoul saint Mary's Hospital","06591",{"type":96,"coordinates":151},[112,113],{"lat":113,"lon":112},[154],{"name":155,"role":85,"phone":156,"phoneExt":41,"email":157},"Jae Wook Lee, Professor","+821026460668","dashwood@catholic.ac.kr",{"facility":159,"status":91,"city":160,"state":41,"zip":161,"country":94,"countryCode":41,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Pusan National University Yangsan Hospital","Yangsan","50612",{"type":96,"coordinates":163},[164,165],129.03358,35.34199,{"lat":165,"lon":164},[168],{"name":169,"role":85,"phone":170,"phoneExt":41,"email":171},"Eu Jeen Yang, Professor","+82-10-6478-8489","41sirius@hanmail.net",{"type":173,"investigatorFullName":81,"investigatorTitle":174,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Professor",[176,177,178,179,181,182],{"name":139,"class":6},{"name":107,"class":6},{"name":119,"class":6},{"name":180,"class":6},"Chonnam National University Hospital",{"name":159,"class":6},{"name":183,"class":6},"Seoul St. Mary's Hospital","100502845","phase-2-evaluation-of-treatment-efficacy-according-to-risk-group-in-relapsed-childhood-acute-lymphoblastic-leukemia-100502845",false,"NCT05827549","Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia","ReCALL","Inclusion Criteria:\n\n* Patients \\\u003C= 1 year and \\>22 years of age at the time of relapse will be eligible\n* Participants must have a histologic diagnosis of acute lymphoblastic leukemia:\n\n  * B-ALL: Precursor B-cell acute lymphoblastic leukemia\n  * T-ALL: Precursor T-cell acute lymphoblastic leukemia\n* 1st recurred acute lymphoblastic leukemia patients, recurred parts including marrow. Enrolling patients with combined extra medullary relapse including bone marrow is acceptable. (No limits for extra medullary site) Additionally, subjects whose blast cells in bone marrow are less than 5% (ALL whether type M2 or M3 must be definite)\n* Patients who have never received allogeneic stem cell transplant\n* Patients who have never received blinatumomab before\n* Adequate Renal Function\n\n  -A serum creatinine based on age\u002Fgender as follows:\n\n  1 to \\< 2 years - Male (0.6) Female (0.6) 2 to \\< 6 years - Male (0.8) Female (0.8) 6 to \\< 10 years - Male (1) Female (1) 10 to \\< 13 years - Male (1.2) Female (1.2) 13 to \\< 16 years - Male (1.5) Female (1.4)\n\n  ≥ 16 years - Male (1.7) Female (1.4)\n* Adequate Liver Function defined as a direct bilirubin \\<3.0 mg\u002FdL\n* Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram\n* Lansky (age \\< 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60% at screening\n* Patients with a life expectancy of 1 or more year\n* Patients who are expected to comply with all required study procedures and follow the study protocol in the opinion of the investigator\n* Signed written informed consent and assent forms must be obtained prior to any study procedures\n\nExclusion Criteria:\n\n* Patients with Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Patients with Philadelphia chromosome positive (Ph+) ALL\n* Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia (non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are not eligible for administration of Blinatumomab\n* In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study\n* Patients with mixed phenotype leukemia\n* patient who was relapsed within 1 month after the end of induction therapy with the same 4-drug regimen to be used in this study.\n* Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome\n* Patients with known HIV\n* Female patients who are not proved as infertile or pregnant (Evidence of infertility: History taking of possibilities of pregnancy or urine human chorionic gonadotrophin test negative, amenorrhea more than a year, Natural or artificial (Ex.hormone therapy) menopause status more than a year, surgical sterilization(Ex.Hysterectomy or ovariotomy etc)\n* Currently receiving treatment in another investigational drug study or clinical trial\n* Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients\\' compliance\n* Patients with clinically relevant central nervous system (CNS) pathology or active CNS involvement including: unstable epilepsy, uncontrolled seizure, paralysis, aphasia, history of severe brain injury, cerebellar disease, organic brain syndrome, psychosis, coordination\u002Fmovement disorder\n* Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab","ALL","1 Year","22 Years",{"count":195,"type":196},90,"ESTIMATED","INTERVENTIONAL",[199],"PHASE2","This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.",[202],"Acute Lymphoid Leukemia",[204],"combination chemotherapy","2025-06-04",{"date":207,"type":208},"2025-06-06","ACTUAL",{"date":210,"type":208},"2024-04-04",{"date":212,"type":196},"2032-12-31",{"name":81,"class":6},7]