[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-with-t1616p13q22\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-with-t1616p13q22":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100595101","phase-1-a-new-treatment-of-newly-diagnosed-kit-mutation-cbf-acute-myeloid-leukemia-100595101",false,"NCT07028073","A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia","Avapritinib Combined With Standard Therapy for the Treatment of Newly Diagnosed KIT Mutation Acute Myeloid Leukemia With t(8;21)(q22;q22.1); Inv(16)(p13.1q22) or t(16;16)(p13.1;q22): a Prospective, Multi-center, Single-arm, Two-cohorts Study","Inclusion Criteria:\n\n* Age ≥18 years, both genders\n* Diagnosis of acute myeloid leukemia according to WHO 2022 criteria\n* Treatment-naive patients (hydroxyurea or low-dose cytarabine \\\u003C0.5g cumulative dose allowed)\n* Bone marrow detection of KIT mutations with concurrent t(8;21)(q22;q22.1) or RUNX1::RUNX1T1 fusion gene; or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) or CBFβ::MYH11 fusion gene\n* Life expectancy \\>12 weeks Group A: ≥18 and \\\u003C65 years with ECOG 0-1; Group B: ≥65 years or ≥18 and \\\u003C65 years with comorbidities (ECOG ≥2, cardiac disease, creatinine clearance 30-50ml\u002Fmin, or mild hepatic impairment)\n* Adequate organ function: bilirubin ≤2×ULN, ALT\u002FAST ≤3×ULN (≤5×ULN if leukemic infiltration), creatinine clearance ≥30ml\u002Fmin, left ventricular ejection fraction \\>45%\n\nExclusion Criteria:\n\n* Known hypersensitivity to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine or similar agents\n* Concurrent use of other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin)\n* Intracranial hemorrhage on imaging or unresolved prior intracranial bleeding\n* Active uncontrolled infection\n* Significant organ dysfunction: myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":19,"type":20},78,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn if avapritinib combined with standard induction therapy works to treat newly diagnosed adult acute myeloid leukemia (AML) patients with KIT mutations and t(8;21)(q22;q22.1); inv(16)(p13.1q22) or t(16;16)(p13.1;q22). It will also investigate the safety and tolerability of this combination therapy. The main questions it aims to answer are:\n\nTo determine the maximum tolerated dose (MTD) and\u002For recommended Phase II dose (RP2D) of avapritinib combined with chemotherapy by Dose-limiting toxicity (DLT).\n\nDoes this combination therapy improve the rates of minimal residual disease (MRD) negativity and long-term survival outcomes?",[27,28,29,30],"Acute Myeloid Leukemia With T(8;21)(Q22;Q22)","Acute Myeloid Leukemia With T(16;16)(P13;Q22)","KIT Gene Mutation","Avapritinib","RECRUITING","2025-06-11",{"date":34,"type":35},"2025-06-19","ACTUAL",{"date":37,"type":35},"2025-05-15",{"date":39,"type":20},"2027-12-31",{"name":41,"class":42},"The First Affiliated Hospital of Soochow University","OTHER"]