[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639605":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":44,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":66,"collaborators":30,"id":68,"slug":30,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":30,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":30,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":30,"overallStatus":62,"whyStopped":30,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Kissei Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of adverse events and adverse drug reactions","The number of events, number of patients, and incidence will be presented for all events, Grade 3 or higher events, Grade 4 or higher events, events resulting in death, serious events excluding death, events resulting in drug withdrawal, and events resulting in drug interruption.","From the start of IMP administration to 28 days after the final dose of the IMP",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"CR\u002FCRh rate","The number and proportion of patients who achieve CR or CRh","Through study completion, approximately up to 3 years",{"measure":19,"description":20,"timeFrame":17},"Duration of CR\u002FCRh","The duration from the achievement of the first CR or CRh to relapse or death, whichever occurs first",{"measure":22,"description":23,"timeFrame":17},"Time to CR\u002FCRh","The duration from the start of IMP administration to the achievement of CR or CRh",{"measure":25,"description":26,"timeFrame":17},"Transfusion independence","The number and proportion of patients who have been transfusion-free for 28 days and 56 days after the start of IMP",{"measure":28,"description":29,"timeFrame":17},"Overall survival (OS)","The duration from the start of IMP administration to death for any reason",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NA","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Olutasidenib","EXPERIMENTAL","Olutasidenib will be administered orally twice daily under fasting condition.",[43],"Drug: Olutasidenib",[45],{"type":46,"name":39,"description":47,"armGroupLabels":48,"otherNames":30},"DRUG","Olutasidenib: Oral administration",[39],[50],{"name":51,"affiliation":5,"role":52},"Yumi Ikezaki","STUDY_DIRECTOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":30,"email":58},"Kissei Pharmaceutical Co., Ltd","CONTACT","Email only","rinsyousiken@pharm.kissei.co.jp",[60],{"facility":61,"status":62,"city":63,"state":30,"zip":30,"country":64,"countryCode":65,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Research Site","RECRUITING","Tokyo and Other Japanese Cities","Japan","JP",{"type":67,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":77,"type":78},3,"ESTIMATED","INTERVENTIONAL",[81],"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.",[84],"Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia","2026-05-22",{"date":87,"type":88},"2026-05-27","ACTUAL",{"date":90,"type":78},"2026-06",{"date":92,"type":78},"2030-09",{"name":5,"class":6},1]