[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540447":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":57,"centralContacts":62,"locations":72,"responsibleParty":254,"collaborators":66,"id":257,"slug":258,"hasResults":259,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":66,"eligibilityCriteria":263,"healthyVolunteers":259,"sex":264,"minAge":66,"maxAge":265,"enrollmentInfo":266,"targetDuration":66,"studyType":269,"phases":270,"briefSummary":272,"conditions":273,"keywords":279,"overallStatus":188,"whyStopped":66,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},{"fullName":5,"class":6},"Children's Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Relapsed\u002FRefractory CBF-AML with KIT mutation","EXPERIMENTAL","The relapsed\u002Frefractory patients will receive a combination treatment of decitabine\u002Fazacitidine+ IdAG (idarubicine + cytarabine + granulocyte stimulating factor)regimen along with avapritinib. CBF-AML with KIT mutated patients with molecular relapse after hematopoietic stem cell transplantation may receive avapritinib combined with demethylating agents or interferon or donor lymphocyte infusion without low-dose chemotherapy. The dose of avapritinib will start at 50mg\u002Fm2\u002Fd, and if platelets stabilize at 50 ×10\\^9\u002FL and neutrophils stabilize above 1.0 ×10\\^9\u002FL after one week, the dose can be increased to 100mg\u002Fm2\u002Fd, with a maximum daily dose of 100mg. Avapritinib should be discontinued in the presence of febrile neutropenia or active infection, and avapritinib can be resumed once the infection is controlled, with each treatment cycle not exceeding 28 days.",[13,14,15,16,17,18],"Drug: Avapritinib","Drug: Azacitidine Injection","Drug: Decitabine Injection","Drug: Idarubicin Hydrochloride","Drug: Cytarabine","Drug: Granulocyte Colony-Stimulating Factor",[20,27,33,39,45,51],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Avapritinib","50mg\u002Fm2\u002Fday for weighing bodyweight \\>10kg, 1.65mg\u002Fkg\u002Fday for weighing ≤ 10kg, po, qd, d1-28.",[9],[26],"AYVAKIT",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Azacitidine Injection","75mg\u002Fm2\u002Fd for weighing \\>10kg, 2.5mg\u002Fkg\u002Fd for weighing ≤ 10kg, d1-7, ivgtt, qd, more than 3 hours. Azacitidine and decitabine cannot be used simultaneously.",[9],[32],"Azacitidine",{"type":21,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Decitabine Injection","20mg\u002Fm2\u002Fd for weighing \\>10kg, 0.67mg\u002Fkg\u002Fd for weighing ≤ 10kg, d1-5, ivgtt, qd, more than 3 hours. Azacitidine and decitabine cannot be used simultaneously.",[9],[38],"Decitabine",{"type":21,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Idarubicin Hydrochloride","5mg\u002Fm2\u002Fday for weighing \\>10kg, 0.17mg\u002Fkg\u002Fday for weighing ≤ 10kg, d 6, 8, 10 (d 8, 10, 12 for azacitidine) ivgtt, qod, more than 1 hour at 10 am.",[9],[44],"Idarubicine",{"type":21,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Cytarabine","10mg\u002Fm2\u002Fday for weighing \\>10kg, 0.33mg\u002Fkg\u002Fday for weighing ≤ 10kg, d6-15 （d8-17 for azacitidine ）, s.c., q12h.",[9],[50],"CYTOSAR",{"type":21,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Granulocyte Colony-Stimulating Factor","300ug\u002Fday for weighing \\>10kg, 10ug\u002Fkg\u002Fday for weighing ≤10kg, d0-5, s.c., qd.",[9],[56],"Recombinant Human Granulocyte Colony-Stimulating Factor Injection",[58],{"name":59,"affiliation":60,"role":61},"Shaoyan Hu, MD, PhD","Children 's Hospital of Soochow University","PRINCIPAL_INVESTIGATOR",[63,68],{"name":59,"role":64,"phone":65,"phoneExt":66,"email":67},"CONTACT","+86-13771870462",null,"hsy139@126.com",{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},"Li Gao, MD","+86-15821963190","joygaoli@163.com",[73,92,102,117,132,147,161,176,187,210,224,239],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"First Affiliated Hospital Of University of Science and Technology of China","NOT_YET_RECRUITING","Hefei","Anhui","230000","China","CN",{"type":82,"coordinates":83},"Point",[84,85],117.28083,31.86389,{"lat":85,"lon":84},[88],{"name":89,"role":64,"phone":90,"phoneExt":66,"email":91},"Chun Li, MD,PhD","+86-13865992676","lichun1230@sohu.com",{"facility":93,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"The Second Hospital of Anhui Medical University",{"type":82,"coordinates":95},[84,85],{"lat":85,"lon":84},[98],{"name":99,"role":64,"phone":100,"phoneExt":66,"email":101},"Ninglin Wang, MD","+86-13721113063","zwnltt@126.com",{"facility":103,"status":75,"city":104,"state":105,"zip":106,"country":79,"countryCode":80,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Guangzhou Women and Children Medical Center","Guangzhou","Guangdong","510000",{"type":82,"coordinates":108},[109,110],113.25,23.11667,{"lat":110,"lon":109},[113],{"name":114,"role":64,"phone":115,"phoneExt":66,"email":116},"Hua Jiang, MD, PhD","+86-13533330985","jiang_hua18@sina.cn",{"facility":118,"status":75,"city":119,"state":120,"zip":121,"country":79,"countryCode":80,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530000",{"type":82,"coordinates":123},[124,125],108.31667,22.81667,{"lat":125,"lon":124},[128],{"name":129,"role":64,"phone":130,"phoneExt":66,"email":131},"Ning Liao, MD","+86-13978812808","ln12808@163.com",{"facility":133,"status":75,"city":134,"state":135,"zip":136,"country":79,"countryCode":80,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Kaifeng Children's Hospital","Kaifeng","Henan","475000",{"type":82,"coordinates":138},[139,140],114.30742,34.7986,{"lat":140,"lon":139},[143],{"name":144,"role":64,"phone":145,"phoneExt":66,"email":146},"Jixia Luo, MD","+86-13592146539","luojixia@163.com",{"facility":148,"status":75,"city":149,"state":135,"zip":150,"country":79,"countryCode":80,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","450052",{"type":82,"coordinates":152},[153,154],113.64861,34.75778,{"lat":154,"lon":153},[157],{"name":158,"role":64,"phone":159,"phoneExt":66,"email":160},"Yufeng Liu, MD,PhD","+86-13673666608","lyf6012@126.com",{"facility":162,"status":75,"city":163,"state":164,"zip":165,"country":79,"countryCode":80,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Third Xiangya Hospital of Central South University","Changsha","Hunan","410000",{"type":82,"coordinates":167},[168,169],112.97087,28.19874,{"lat":169,"lon":168},[172],{"name":173,"role":64,"phone":174,"phoneExt":66,"email":175},"Minghua Yang, MD","+86-13973135843","yamahua123@163.com",{"facility":177,"status":75,"city":163,"state":164,"zip":178,"country":79,"countryCode":80,"cosmosGeoPoint":179,"geoPoint":181,"contacts":182},"XiangYa Hospital Central South University","410008",{"type":82,"coordinates":180},[168,169],{"lat":169,"lon":168},[183],{"name":184,"role":64,"phone":185,"phoneExt":66,"email":186},"Liangchun Yang, MD,PhD","+86-13974927514","yangliangchung@163.com",{"facility":5,"status":188,"city":189,"state":190,"zip":191,"country":79,"countryCode":80,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"RECRUITING","Suzhou","Jiangsu","215000",{"type":82,"coordinates":193},[194,195],120.59538,31.30408,{"lat":195,"lon":194},[198,200,201,202,204,206,208],{"name":59,"role":64,"phone":199,"phoneExt":66,"email":67},"+86-13771835430",{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},{"name":59,"role":61,"phone":66,"phoneExt":66,"email":66},{"name":203,"role":61,"phone":66,"phoneExt":66,"email":66},"Peifang Xiao, MD",{"name":69,"role":205,"phone":66,"phoneExt":66,"email":66},"SUB_INVESTIGATOR",{"name":207,"role":205,"phone":66,"phoneExt":66,"email":66},"Jun Lu, MD",{"name":209,"role":205,"phone":66,"phoneExt":66,"email":66},"Jie Li, MD",{"facility":211,"status":75,"city":212,"state":190,"zip":213,"country":79,"countryCode":80,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Xuzhou Children's Hospital","Xuzhou","221000",{"type":82,"coordinates":215},[216,217],117.28386,34.20442,{"lat":217,"lon":216},[220],{"name":221,"role":64,"phone":222,"phoneExt":66,"email":223},"Qi An, MD","+86-13814422329","anqi1974@sina.com",{"facility":225,"status":75,"city":226,"state":227,"zip":228,"country":79,"countryCode":80,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Qilu Hospital of Shandong University","Jinan","Shandong","250000",{"type":82,"coordinates":230},[231,232],116.99722,36.66833,{"lat":232,"lon":231},[235],{"name":236,"role":64,"phone":237,"phoneExt":66,"email":238},"Xiuli Ju, MD,PhD","+86-13869192944","shellysdcn@hotmail.com",{"facility":240,"status":75,"city":241,"state":242,"zip":243,"country":79,"countryCode":80,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Children's Hospital Of Fudan University","Shanghai","Shanghai Municipality","200000",{"type":82,"coordinates":245},[246,247],121.45806,31.22222,{"lat":247,"lon":246},[250],{"name":251,"role":64,"phone":252,"phoneExt":66,"email":253},"Xiaowen Zhai, MD, PhD","+86-18017590808","zhaixiaowendy@163.com",{"type":61,"investigatorFullName":255,"investigatorTitle":256,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"Shaoyan Hu","Study Chair","100540447","phase-2-safety-and-efficacy-of-avapritinib-in-relapsed-or-refractory-pediatric-cbf-aml-with-kit-mutation-100540447",false,"NCT06316960","Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation","A Prospective, Multicenter Clinical Study on The Safety and Efficacy of Avapritinib in The Treatment of Relapsed\u002FRefractory Pediatric Core Binding Factor Acute Myeloid Leukemia (CBF-AML) With KIT Mutation","Inclusion Criteria:\n\n1. Gender unlimited;\n2. Under 18 years;\n3. Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).\n4. Presence of t(8;21)\u002FRUNX1::RUNX1T1 or inv(16)\u002Ft(16;16)\u002FCBFβ::MYH11;\n5. KIT mutation;\n6. Refractory AML: AML patients who do not achieve CR or CRi after induction therapy;\n7. Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration;\n8. No active infections;\n9. Liver function: Tbil ≤2×ULN, ALT\u002FAST ≤3×ULN, creatinine clearance ≥50ml\u002Fmin;\n10. ECOG score \\\u003C2;\n11. Expected survival time \\>12 weeks;\n12. Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form.\n\nExclusion Criteria:\n\n1. Have received prior treatment with avapritinib;\n2. Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;\n3. Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);\n4. Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；\n5. With other malignancies requiring treatment；\n6. Already enrolled in another interventional clinical study；\n7. The researchers determined that the individual is not suitable to participate in this trial.","ALL","18 Years",{"count":267,"type":268},50,"ESTIMATED","INTERVENTIONAL",[271],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.",[274,275,276,277,278],"AML, Childhood","Relapse\u002FRecurrence","Refractory AML","Core Binding Factor Acute Myeloid Leukemia","C-KIT Mutation",[22,280,281,282,283],"KIT","CBF AML","Childhood","Relapsed\u002FRefractory","2024-08-21",{"date":286,"type":287},"2024-08-22","ACTUAL",{"date":289,"type":287},"2024-03-01",{"date":291,"type":268},"2027-03",{"name":5,"class":6},12]