[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypomethylating-agent-hma-naive-myelodysplastic-syndromes-mds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypomethylating-agent-hma-naive-myelodysplastic-syndromes-mds":27},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100551889","phase-3-ivosidenib-ivo-monotherapy-and-azacitidine-aza-monotherapy-in-patients-with-hypomethylating-agent-hma-naive-myelodysplastic-syndromes-mds-with-an-idh1-mutation-100551889",false,"NCT06465953","Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation","A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)","PyramIDH","Inclusion Criteria:\n\n* Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):\n* Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%.\n* Low and moderate low-risk MDS per IPSS-M score must:\n* Have cytopenias related to MDS, defined as: \\\u003C100 platelets\u002Fmicroliter, or absolute neutrophil count (ANC) \\\u003C1000\u002Fmm3, or hemoglobin \\\u003C10g\u002FdL AND\n* Have a blast count between 5-19% AND\n* Be eligible for HMA therapy (very low risk participants are to be excluded)\n* Locally or centrally confirmed IDH1 R132 C\u002FG\u002FH\u002FL\u002FS mutation\n\nExclusion Criteria:\n\n* Received prior anticancer\u002Fdisease modifying treatment for MDS (including HMA's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.\n* \\>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate\u002Fbiopsy","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.",[27,28],"Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS)","Myelodysplastic Syndromes (MDS)","RECRUITING","2026-05-08",{"date":32,"type":33},"2026-05-11","ACTUAL",{"date":35,"type":33},"2024-12-03",{"date":37,"type":21},"2028-12-01",{"name":39,"class":40},"Institut de Recherches Internationales Servier","OTHER",62]