[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574948":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":32,"responsibleParty":45,"collaborators":22,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":22,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":22,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":72,"whyStopped":22,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Allo-HSCT recipients will begin maintenance therapy with oral Avapritinib tablets at a dose of 100 mg\u002Fday, starting 2-4 months post-transplantation. Each treatment cycle lasts 28 days, and therapy will continue for up to 2 years or until disease progression or unacceptable toxicity occurs.",[13],"Drug: Avapritinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Avapritinib","After allo-HSCT, CBF-AML patients who have kit mutation would receive avapritinib for maintenance therapy.",[9],[21],"KIT inhibitor",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Xiaoxia HU, Doctor","CONTACT","02164370045","hxx12276@rjh.com.cn",{"name":30,"role":26,"phone":27,"phoneExt":22,"email":31},"Xiaoxia HU","hu_xiaoxia@126.com",[33],{"facility":34,"status":22,"city":35,"state":36,"zip":22,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":22},"Ruijin Hospital of Shanghai Jiaotong University","Shanghai","Shanghai Municipality","China","CN",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Hu Xiaoxia","Principal Investigator","100574948","phase-2-avapritinib-maintenance-for-aml-with-kit-mutations-100574948",false,"NCT06765915","Avapritinib Maintenance for AML With KIT Mutations","Avapritinib Maintenance Following Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia With KIT Mutations","Inclusion Criteria:\n\n* Age≥ 14 years old;\n* First allo-HSCT for AML (including secondary AML) ;\n* KIT mutation at diagnosis (no restriction on locus for kit mutation\n* CR and negative MFC-MRD prior to initiation of maintenance therapy;\n* Absolute neutrophil count ≥ 1.0 x 109 \u002FL, platelets ≥ 75 x 109 \u002FL, hemoglobin ≥ 80 g\u002FL before maintenance;\n* Normal functioning of major organs and laboratory findings in accordance with the following criteria:AST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g\u002FL (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\\^9\u002FL (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\\^9\u002FL (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL\u002Fmin; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%;\n* ECOG PS 0-2 points;\n* Expected survival ≥ 3 months;\n* Patient consent\n\nExclusion Criteria:\n\n* concurrently receiving other targeted therapies for AML;\n* Prior treatment with a TKI inhibitor that proved ineffective;\n* with concurrent FLT3-ITD mutations at enrollment;\n* Acute\u002Fchronic graft-versus-host disease requiring systemic immunosuppressive therapy prior to maintenance therapy;\n* Accompanied by other malignant tumors requiring treatment;\n* Have important organ-based diseases: e.g., myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal failure;\n* Active, uncontrolled infection;\n* HIV-positive, active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy;\n* Other interventional clinical studies have been enrolled;\n* Men and women of childbearing potential are unwilling to use contraception during and for 12 months after treatment;\n* The investigator believes that there are other conditions that make the patient unsuitable for participation in this study.","ALL","14 Years","70 Years",{"count":60,"type":61},47,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","A multicenter, single-arm clinical study of evaluate the efficacy and safety of avapritinib as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients with KIT mutation.",[67],"AML, Adult",[69,70,71],"AML","KIT mutation","avapritinib","NOT_YET_RECRUITING","2025-01-05",{"date":75,"type":76},"2025-01-09","ACTUAL",{"date":78,"type":61},"2025-02-01",{"date":80,"type":61},"2028-02-01",{"name":5,"class":6},1]