[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-idh1-mutation-positive-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-idh1-mutation-positive-acute-myeloid-leukemia":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":5},"100639605",false,"NCT07604064","A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia","A Phase II Clinical Trial of Olutasidenib in Patients With Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Japanese patients who personally provide written informed consent to participate in this clinical trial\n* Patients with a confirmed diagnosis of AML based on WHO classification (2022 edition) (except acute promyelocytic leukemia with t (15:17) translocation)\n* Patients with relapsed or refractory AML who may or may not have undergone allogeneic hematopoietic stem cell transplantation.\n* Patients with IDH1 gene mutation confirmed by central confirmation after relapse or refractoriness\n\nExclusion Criteria:\n\n* Patients with IDH2 mutations or patients with a history of IDH2 inhibitor treatment\n* Patients who are intolerant to IDH1 inhibitors\n* Patients who are deemed inappropriate for the clinical trial by the investigator or sub-investigator","ALL","18 Years",{"count":18,"type":19},3,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of 28 days in at least 3 Japanese patients with relapsed or refractory IDH1 mutation-positive AML.",[25],"Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia","RECRUITING","2026-05-22",{"date":29,"type":30},"2026-05-27","ACTUAL",{"date":32,"type":19},"2026-06",{"date":34,"type":19},"2030-09",{"name":36,"class":37},"Kissei Pharmaceutical Co., Ltd.","INDUSTRY",""]