[{"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":26},{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100639605","phase-2-a-clinical-trial-of-olutasidenib-in-patients-with-acute-myeloid-leukemia-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":19,"type":20},3,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia","RECRUITING","2026-05-22",{"date":30,"type":31},"2026-05-27","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2030-09",{"name":37,"class":38},"Kissei Pharmaceutical Co., Ltd.","INDUSTRY"]