[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484287":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":57,"centralContacts":62,"locations":68,"responsibleParty":86,"collaborators":41,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":41,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":41,"enrollmentInfo":97,"targetDuration":41,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":41,"overallStatus":71,"whyStopped":41,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Sunshine Lake Pharma Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clifutinib","EXPERIMENTAL","Subjects received 40 mg dose orally once a day in continuous 28-day cycles, at least 2 hours before and after food. Clifutinib treatment continued until sujects met one of the treatment discontinuation criteria.",[13],"Drug: Clifutinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Salvage Chemotherapy","ACTIVE_COMPARATOR","Subjects received chemotherapy in 28-day cycles. Subjects on Low-Dose Cytarabine (LoDAC) received 10 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10\\~14 days. Subjects on azacitidine received 75 mg\u002Fm\\^2 daily by SC for 7 days. Subjects on decitabine received 20 mg\u002Fm\\^2 daily by IV injection for 5 days. Subjects on LoDAC or azacitidine or decitabine treatment continued until they met discontinuation criteria. Subjects on Ara-C±IDA chemotherapy received cytarabine 1\\~3 g\u002Fm\\^2 daily by IV for 3 days and idarubicin 10 mg\u002Fm\\^2 daily by IV for 3 days. Participants on FLAG-IDA chemotherapy received G-CSF 300 μg\u002Fm\\^2 daily by SC for 6 days (days 1-6), fludarabine 30 mg\u002Fm\\^2 daily by IV for 5 days (days 2-6), cytarabine 1\\~2 g\u002Fm\\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg\u002Fm\\^2 daily by IV for 3 days (days 2-4). Subjects receiving Ara-C±IDA or FLAG-IDA received 1 cycle of therapy and were assessed for response on day 28+\u002F-2 days.",[19,20,21,22,23],"Drug: LoDAC","Drug: Azacitidine","Drug: Decitabine","Drug: Ara-C±IDA","Drug: FLAG-IDA",[25,31,37,42,46,52],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","tablet, oral",[9],[30],"HEC73543",{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"LoDAC","subcutaneous (SC) or intravenous (IV) injection",[15],[36],"Low Dose Cytarabine",{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Azacitidine","SC or IV",[15],null,{"type":26,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Decitabine","IV",[15],{"type":26,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Ara-C±IDA","SC and IV",[15],[51],"Cytarabine, Idarubicin",{"type":26,"name":53,"description":48,"armGroupLabels":54,"otherNames":55},"FLAG-IDA",[15],[56],"Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin",[58],{"name":59,"affiliation":60,"role":61},"Jie Jin, MD, PhD","First Affiliated Hospital of Zhejiang University","PRINCIPAL_INVESTIGATOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":41,"email":67},"Yingzhi Jiang, MSc","CONTACT","86 13692244182","jiangyingzhi@hec.cn",[69],{"facility":70,"status":71,"city":72,"state":41,"zip":41,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"the First Affiliated Hospital,College of Medicine,Zhejiang University","RECRUITING","Hanzhou","China","CN",{"type":76,"coordinates":77},"Point",[78,79],99.437,26.4965,{"lat":79,"lon":78},[82],{"name":83,"role":65,"phone":84,"phoneExt":41,"email":85},"Jie Jin, Doctor","0571-87236685","jiej0503@163.com",{"type":87,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100484287","phase-3-hec73543-versus-salvage-chemotherapy-in-rr-flt3-itd-aml-100484287",false,"NCT05586074","HEC73543 Versus Salvage Chemotherapy in R\u002FR FLT3-ITD AML","HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age at the time of obtaining informed consent.\n* Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification;\n* Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant )\n* Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab\n* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion\n\nExclusion Criteria:\n\n* Subject has received prior treatment with other FLT3 inhibitors\n* Subject has AML that has relapsed after or is refractory to more than 1 line of therapy\n* Subject has an active uncontrolled infection\n* Subject is known to have human immunodeficiency virus infection\n* Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation","ALL","18 Years",{"count":98,"type":99},324,"ESTIMATED","INTERVENTIONAL",[102],"PHASE3","A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed\u002F refractory (R\u002FR) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR\u002FCRh rate in these subjects.",[105],"Leukemia, Acute Myeloid (AML)","2026-04-27",{"date":108,"type":109},"2026-04-28","ACTUAL",{"date":111,"type":109},"2023-03-03",{"date":113,"type":99},"2028-05-30",{"name":5,"class":6},1]