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Professor","+82-2-2258-6763","hoiring0209@gmail.com",{"type":194,"investigatorFullName":195,"investigatorTitle":196,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","Hee Young Ju","Clinical Professor",[198,199,200,202,203,204,205,207],{"name":80,"class":6},{"name":161,"class":6},{"name":201,"class":6},"Seoul St. Mary's Hospital",{"name":172,"class":6},{"name":106,"class":6},{"name":150,"class":6},{"name":206,"class":6},"Chonnam National University Hospital",{"name":136,"class":6},"100523720","phase-2-treatment-of-newly-diagnosed-standard-risk-acute-lymphoblastic-leukemia-in-children-100523720",false,"NCT06099366","Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children","Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in","SR ALL","\\\u003CInclusion Criteria\\>\n\n* Newly diagnosed pediatric\u002Fadolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following\n\n  1. 1 year old ≤ Age \\\u003C 10 years old\n  2. white blood cell at initial diagnosis \\\u003C 5x10\\^10\u002FL (50,000uL)\n  3. No testis involvement\n  4. Satisfaction of following organ functions\n\nA. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL\u002Fmin\u002F1.73m2 ii. Creatinine value according to age\u002Fsec satisfies the following:\n\n1 to \\\u003C 2 years: Male: 0.6 \u002F Female: 0.6, 2 to \\\u003C 6 years: Male: 0.8 \u002F Female: 0.8, 6 to \\\u003C 10 years: Male: 1 \u002F Female: 1, 10 to \\\u003C 13 years: Male: 1.2 \u002F Female: 1.2, 13 to \\\u003C 16 years: Male: 1.5 \u002F Female: 1.4, ≥ 16 years: Male: 1.7 \u002F Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.\n\nB. Liver function i. Direct bilirubin \\\u003C 3.0mg\u002FdL\n\n\\\u003CExclusion Criteria\\>\n\n1. Steroid administration within 2 weeks before the registration\n2. t(9;22) or t(4;11)(q11;q23) or chromosome \\\u003C 44 or iAMP21 or t(17;19)\u002FTCF3-HLF\n3. Newly diagnosed T cell ALL\n4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome\n5. Burkitt leukemia\u002Flymphoma\n6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome\n7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent","ALL","1 Year","9 Years",{"count":220,"type":221},116,"ESTIMATED","INTERVENTIONAL",[224],"PHASE2","Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.",[227],"Lymphoblastic Leukemia in Children",[229,230],"Standard Risk ALL","NGS MRD","2025-06-04",{"date":233,"type":234},"2025-06-08","ACTUAL",{"date":236,"type":234},"2024-03-05",{"date":238,"type":221},"2033-12-31",{"name":195,"class":6},9]