[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551889":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":583,"collaborators":585,"id":588,"slug":589,"hasResults":590,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":590,"sex":596,"minAge":597,"maxAge":11,"enrollmentInfo":598,"targetDuration":11,"studyType":601,"phases":602,"briefSummary":604,"conditions":605,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":619},{"fullName":5,"class":6},"Servier","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ivosidenib monotherapy","EXPERIMENTAL",null,[13],"Drug: Ivosidenib",{"label":15,"type":10,"description":11,"interventionNames":16},"Azacitidine monotherapy",[17],"Drug: Azacitidine",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Ivosidenib","Two 250 mg tablets, totaling 500 mg, administered orally once daily until disease relapse or progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death, withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs first.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Azacitidine","Azacitidine 75mg\u002Fm\\^2\u002Fday administered by subcutaneous (SC) or intravenous (IV) injection for 1 week (7 days) of each 4-week (28 day) treatment cycle until disease relapse or progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death, withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs first.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department","CONTACT","+33 1 55 72 60 00","scientificinformation@servier.com",[35,49,60,75,84,94,104,114,124,133,144,153,162,171,180,189,200,209,215,221,227,233,239,245,256,265,274,283,292,301,312,321,330,339,348,359,368,377,386,395,404,413,420,424,428,432,436,445,456,465,476,485,494,503,512,521,530,541,551,560,565,574],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Presbyterian \u002F St. Luke'S Medical Center","NOT_YET_RECRUITING","Denver","Colorado","80218","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-104.9847,39.73915,{"lat":47,"lon":46},{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":59,"contacts":11},"University of Chicago, Duchossois Center for Advanced Medicine (DCAM)","RECRUITING","Chicago","Illinois","60637",{"type":44,"coordinates":56},[57,58],-87.65005,41.85003,{"lat":58,"lon":57},{"facility":61,"status":51,"city":62,"state":63,"zip":64,"country":41,"countryCode":42,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":44,"coordinates":66},[67,68],-71.05977,42.35843,{"lat":68,"lon":67},[71],{"name":72,"role":31,"phone":73,"phoneExt":11,"email":74},"Andrew Brunner","617-724-1124","abrunner@mgb.org",{"facility":76,"status":51,"city":77,"state":77,"zip":78,"country":41,"countryCode":42,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"MSKCC","New York","10065",{"type":44,"coordinates":80},[81,82],-74.00597,40.71427,{"lat":82,"lon":81},{"facility":85,"status":51,"city":86,"state":87,"zip":88,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"Unc Lineberger Comprehensive Cancer Center","Chapel Hill","North Carolina","27514",{"type":44,"coordinates":90},[91,92],-79.05584,35.9132,{"lat":92,"lon":91},{"facility":95,"status":51,"city":96,"state":97,"zip":98,"country":41,"countryCode":42,"cosmosGeoPoint":99,"geoPoint":103,"contacts":11},"Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":44,"coordinates":100},[101,102],-82.99879,39.96118,{"lat":102,"lon":101},{"facility":105,"status":51,"city":106,"state":107,"zip":108,"country":41,"countryCode":42,"cosmosGeoPoint":109,"geoPoint":113,"contacts":11},"Oncology Associates of Oregon","Eugene","Oregon","97401",{"type":44,"coordinates":110},[111,112],-123.08675,44.05207,{"lat":112,"lon":111},{"facility":115,"status":37,"city":116,"state":117,"zip":118,"country":41,"countryCode":42,"cosmosGeoPoint":119,"geoPoint":123,"contacts":11},"University of Texas UT Southwestern Comprehensive Cancer Center","Dallas","Texas","75235",{"type":44,"coordinates":120},[121,122],-96.80667,32.78306,{"lat":122,"lon":121},{"facility":125,"status":51,"city":126,"state":117,"zip":127,"country":41,"countryCode":42,"cosmosGeoPoint":128,"geoPoint":132,"contacts":11},"MD Anderson Cancer Centre","Houston","77030",{"type":44,"coordinates":129},[130,131],-95.36327,29.76328,{"lat":131,"lon":130},{"facility":134,"status":37,"city":135,"state":11,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":11},"Royal Adelaide Hospital","Adelaide","5000","Australia","AU",{"type":44,"coordinates":140},[141,142],138.59863,-34.92866,{"lat":142,"lon":141},{"facility":145,"status":51,"city":146,"state":11,"zip":147,"country":137,"countryCode":138,"cosmosGeoPoint":148,"geoPoint":152,"contacts":11},"Monash Health","Clayton","3168",{"type":44,"coordinates":149},[150,151],145.11667,-37.91667,{"lat":151,"lon":150},{"facility":154,"status":51,"city":155,"state":11,"zip":156,"country":137,"countryCode":138,"cosmosGeoPoint":157,"geoPoint":161,"contacts":11},"Northern Health","Epping","3076",{"type":44,"coordinates":158},[159,160],145.03333,-37.65,{"lat":160,"lon":159},{"facility":163,"status":37,"city":164,"state":11,"zip":165,"country":137,"countryCode":138,"cosmosGeoPoint":166,"geoPoint":170,"contacts":11},"Liverpool Hospital","Liverpool","2170",{"type":44,"coordinates":167},[168,169],150.92588,-33.91938,{"lat":169,"lon":168},{"facility":172,"status":51,"city":173,"state":11,"zip":174,"country":137,"countryCode":138,"cosmosGeoPoint":175,"geoPoint":179,"contacts":11},"Sir Charles Gairdner Hospital","Nedlands","6009",{"type":44,"coordinates":176},[177,178],115.8073,-31.98184,{"lat":178,"lon":177},{"facility":181,"status":51,"city":182,"state":11,"zip":183,"country":137,"countryCode":138,"cosmosGeoPoint":184,"geoPoint":188,"contacts":11},"Calvary Mater Newcastle","Waratah","2298",{"type":44,"coordinates":185},[186,187],151.72647,-32.90667,{"lat":187,"lon":186},{"facility":190,"status":51,"city":191,"state":11,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":11},"Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner","Curitiba","81520-060","Brazil","BR",{"type":44,"coordinates":196},[197,198],-49.27306,-25.42778,{"lat":198,"lon":197},{"facility":201,"status":51,"city":202,"state":11,"zip":203,"country":193,"countryCode":194,"cosmosGeoPoint":204,"geoPoint":208,"contacts":11},"Centro de Pesquisa Clínica - Hospital Nove de Julho","São Paulo","01308-070",{"type":44,"coordinates":205},[206,207],-46.63611,-23.5475,{"lat":207,"lon":206},{"facility":210,"status":51,"city":202,"state":11,"zip":211,"country":193,"countryCode":194,"cosmosGeoPoint":212,"geoPoint":214,"contacts":11},"Real E Benemérita Associação Portuguesa de São Paulo","01321-001",{"type":44,"coordinates":213},[206,207],{"lat":207,"lon":206},{"facility":216,"status":37,"city":202,"state":11,"zip":217,"country":193,"countryCode":194,"cosmosGeoPoint":218,"geoPoint":220,"contacts":11},"Hospital das Clínicas da Faculdade de Medicina da USP","05403-010",{"type":44,"coordinates":219},[206,207],{"lat":207,"lon":206},{"facility":222,"status":51,"city":202,"state":11,"zip":223,"country":193,"countryCode":194,"cosmosGeoPoint":224,"geoPoint":226,"contacts":11},"Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein","05652-900",{"type":44,"coordinates":225},[206,207],{"lat":207,"lon":206},{"facility":228,"status":37,"city":202,"state":11,"zip":229,"country":193,"countryCode":194,"cosmosGeoPoint":230,"geoPoint":232,"contacts":11},"Casa de Saúde Santa Marcelina","08270-120",{"type":44,"coordinates":231},[206,207],{"lat":207,"lon":206},{"facility":234,"status":37,"city":202,"state":11,"zip":235,"country":193,"countryCode":194,"cosmosGeoPoint":236,"geoPoint":238,"contacts":11},"Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho","17210-190",{"type":44,"coordinates":237},[206,207],{"lat":207,"lon":206},{"facility":240,"status":37,"city":202,"state":11,"zip":241,"country":193,"countryCode":194,"cosmosGeoPoint":242,"geoPoint":244,"contacts":11},"Instituto Nacional do Câncer","20231-050",{"type":44,"coordinates":243},[206,207],{"lat":207,"lon":206},{"facility":246,"status":51,"city":247,"state":11,"zip":248,"country":249,"countryCode":250,"cosmosGeoPoint":251,"geoPoint":255,"contacts":11},"Chu Nantes-Hotel Dieu","Nantes","44093","France","FR",{"type":44,"coordinates":252},[253,254],-1.55336,47.21725,{"lat":254,"lon":253},{"facility":257,"status":51,"city":258,"state":11,"zip":259,"country":249,"countryCode":250,"cosmosGeoPoint":260,"geoPoint":264,"contacts":11},"Chu de Nice - Hôpital L'Archet 1","Nice","062000",{"type":44,"coordinates":261},[262,263],7.26608,43.70313,{"lat":263,"lon":262},{"facility":266,"status":51,"city":267,"state":11,"zip":268,"country":249,"countryCode":250,"cosmosGeoPoint":269,"geoPoint":273,"contacts":11},"Hopital Saint Louis","Paris","75010",{"type":44,"coordinates":270},[271,272],2.3488,48.85341,{"lat":272,"lon":271},{"facility":275,"status":51,"city":276,"state":11,"zip":277,"country":249,"countryCode":250,"cosmosGeoPoint":278,"geoPoint":282,"contacts":11},"Chu Bordeaux, Hopital Du Haut Leveque","Pessac","33600",{"type":44,"coordinates":279},[280,281],-0.6324,44.80565,{"lat":281,"lon":280},{"facility":284,"status":51,"city":285,"state":11,"zip":286,"country":249,"countryCode":250,"cosmosGeoPoint":287,"geoPoint":291,"contacts":11},"Institut Universitaire Du Cancer Toulouse-Oncopole","Toulouse","31059",{"type":44,"coordinates":288},[289,290],1.44367,43.60426,{"lat":290,"lon":289},{"facility":293,"status":51,"city":294,"state":11,"zip":295,"country":249,"countryCode":250,"cosmosGeoPoint":296,"geoPoint":300,"contacts":11},"Chu Brabois","Vandœuvre-lès-Nancy","54500",{"type":44,"coordinates":297},[298,299],6.17114,48.66115,{"lat":299,"lon":298},{"facility":302,"status":51,"city":303,"state":11,"zip":304,"country":305,"countryCode":306,"cosmosGeoPoint":307,"geoPoint":311,"contacts":11},"Universitatsklinikum Dresden Carl Gustav Carus","Dresden","01307","Germany","DE",{"type":44,"coordinates":308},[309,310],13.73832,51.05089,{"lat":310,"lon":309},{"facility":313,"status":51,"city":314,"state":11,"zip":315,"country":305,"countryCode":306,"cosmosGeoPoint":316,"geoPoint":320,"contacts":11},"Marien Hospital Duesseldorf","Düsseldorf","40477",{"type":44,"coordinates":317},[318,319],6.77927,51.22319,{"lat":319,"lon":318},{"facility":322,"status":51,"city":323,"state":11,"zip":324,"country":305,"countryCode":306,"cosmosGeoPoint":325,"geoPoint":329,"contacts":11},"Universitaetsmedizin Goettingen (Umg)","Göttingen","37075",{"type":44,"coordinates":326},[327,328],9.93228,51.53443,{"lat":328,"lon":327},{"facility":331,"status":51,"city":332,"state":11,"zip":333,"country":305,"countryCode":306,"cosmosGeoPoint":334,"geoPoint":338,"contacts":11},"Universitaetsklinikum Leipzig","Leipzig","04103",{"type":44,"coordinates":335},[336,337],12.37129,51.33962,{"lat":337,"lon":336},{"facility":340,"status":51,"city":341,"state":11,"zip":342,"country":305,"countryCode":306,"cosmosGeoPoint":343,"geoPoint":347,"contacts":11},"Tum Klinikum Rechts Der Isar","Munich","81675",{"type":44,"coordinates":344},[345,346],11.57549,48.13743,{"lat":346,"lon":345},{"facility":349,"status":51,"city":350,"state":11,"zip":351,"country":352,"countryCode":353,"cosmosGeoPoint":354,"geoPoint":358,"contacts":11},"Azienda Ospedaliero Universitaria Delle Marche","Ancona","60126","Italy","IT",{"type":44,"coordinates":355},[356,357],13.5103,43.60717,{"lat":357,"lon":356},{"facility":360,"status":51,"city":361,"state":11,"zip":362,"country":352,"countryCode":353,"cosmosGeoPoint":363,"geoPoint":367,"contacts":11},"Istituto Di Ematologia \"Lorenzo E Ariosto Seragnoli\" - Policlinico Di S. Orsola","Bologna","40138",{"type":44,"coordinates":364},[365,366],11.33875,44.49381,{"lat":366,"lon":365},{"facility":369,"status":51,"city":370,"state":11,"zip":371,"country":352,"countryCode":353,"cosmosGeoPoint":372,"geoPoint":376,"contacts":11},"Azienda Ospedaliero-Universitaria Careggi","Florence","50139",{"type":44,"coordinates":373},[374,375],11.24626,43.77925,{"lat":375,"lon":374},{"facility":378,"status":51,"city":379,"state":11,"zip":380,"country":352,"countryCode":353,"cosmosGeoPoint":381,"geoPoint":385,"contacts":11},"Humanitas Research Hospital (Istituto Clinico Humanitas)","Milan","20089",{"type":44,"coordinates":382},[383,384],12.59836,42.78235,{"lat":384,"lon":383},{"facility":387,"status":51,"city":388,"state":11,"zip":389,"country":352,"countryCode":353,"cosmosGeoPoint":390,"geoPoint":394,"contacts":11},"Fondazione I.R.C.C.S. Policlinico San Matteo","Pavia","27100",{"type":44,"coordinates":391},[392,393],9.15917,45.19205,{"lat":393,"lon":392},{"facility":396,"status":51,"city":397,"state":11,"zip":398,"country":352,"countryCode":353,"cosmosGeoPoint":399,"geoPoint":403,"contacts":11},"Dipartimento Di Biomedicina E Prevenzione - Universita Degli Studi Di Roma \"Tor Vergata\"","Roma","00133",{"type":44,"coordinates":400},[401,402],11.10642,44.99364,{"lat":402,"lon":401},{"facility":405,"status":51,"city":406,"state":11,"zip":407,"country":352,"countryCode":353,"cosmosGeoPoint":408,"geoPoint":412,"contacts":11},"Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino - Presidio Molinette","Torino","10126",{"type":44,"coordinates":409},[410,411],11.99138,44.88856,{"lat":411,"lon":410},{"facility":414,"status":51,"city":415,"state":416,"zip":417,"country":418,"countryCode":419,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"University of Fukui Hospital","Yoshida-gun","Eiheiji-cho 670-8540 Himeji","910-1193","Japan","JP",{"facility":421,"status":51,"city":422,"state":11,"zip":423,"country":418,"countryCode":419,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Kyushu University Hospital","Higashi-ku, Fukuoka-city, Fukuoka","8128582",{"facility":425,"status":51,"city":426,"state":11,"zip":427,"country":418,"countryCode":419,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Japanese Red Cross Society Himeji Hospital","Himeji-city, Hyogo","6708540",{"facility":429,"status":51,"city":430,"state":11,"zip":431,"country":418,"countryCode":419,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Tokai University Hospital","Isehara-city, Kanagawa","2591193",{"facility":433,"status":51,"city":434,"state":11,"zip":435,"country":418,"countryCode":419,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Japanese Red Cross Musashino Hospital","Musashino-city, Tokyo","1808610",{"facility":437,"status":37,"city":438,"state":11,"zip":439,"country":418,"countryCode":419,"cosmosGeoPoint":440,"geoPoint":444,"contacts":11},"Kitasato University Hospital","Sagamihara","252-0375",{"type":44,"coordinates":441},[442,443],139.24167,35.56707,{"lat":443,"lon":442},{"facility":446,"status":51,"city":447,"state":11,"zip":448,"country":449,"countryCode":450,"cosmosGeoPoint":451,"geoPoint":455,"contacts":11},"Umc Amsterdam - Vumc","Amsterdam","1081HV","Netherlands","NL",{"type":44,"coordinates":452},[453,454],4.88969,52.37403,{"lat":454,"lon":453},{"facility":457,"status":51,"city":458,"state":11,"zip":459,"country":449,"countryCode":450,"cosmosGeoPoint":460,"geoPoint":464,"contacts":11},"Umc Groningen","Groningen","9713GZ",{"type":44,"coordinates":461},[462,463],6.56667,53.21917,{"lat":463,"lon":462},{"facility":466,"status":51,"city":467,"state":11,"zip":468,"country":469,"countryCode":470,"cosmosGeoPoint":471,"geoPoint":475,"contacts":11},"Institut Catala D' Oncologia","Badalona","8916","Spain","ES",{"type":44,"coordinates":472},[473,474],2.24741,41.45004,{"lat":474,"lon":473},{"facility":477,"status":51,"city":478,"state":11,"zip":479,"country":469,"countryCode":470,"cosmosGeoPoint":480,"geoPoint":484,"contacts":11},"H. Valle de Hebron","Barcelona","8035",{"type":44,"coordinates":481},[482,483],2.15899,41.38879,{"lat":483,"lon":482},{"facility":486,"status":51,"city":487,"state":11,"zip":488,"country":469,"countryCode":470,"cosmosGeoPoint":489,"geoPoint":493,"contacts":11},"Clinica Universitaria de Navarra (Madrid)","Madrid","28027",{"type":44,"coordinates":490},[491,492],-3.70256,40.4165,{"lat":492,"lon":491},{"facility":495,"status":51,"city":496,"state":11,"zip":497,"country":469,"countryCode":470,"cosmosGeoPoint":498,"geoPoint":502,"contacts":11},"Clinica Universitaria de Navarra (Pamplona)","Pamplona","31008",{"type":44,"coordinates":499},[500,501],-1.64323,42.81687,{"lat":501,"lon":500},{"facility":504,"status":51,"city":505,"state":11,"zip":506,"country":469,"countryCode":470,"cosmosGeoPoint":507,"geoPoint":511,"contacts":11},"Hospital Clinico Universitario de Salamanca","Salamanca","37007",{"type":44,"coordinates":508},[509,510],-5.66388,40.96882,{"lat":510,"lon":509},{"facility":513,"status":51,"city":514,"state":11,"zip":515,"country":469,"countryCode":470,"cosmosGeoPoint":516,"geoPoint":520,"contacts":11},"Hospital Universitario Virgen de La Macarena","Seville","41009",{"type":44,"coordinates":517},[518,519],-5.97317,37.38283,{"lat":519,"lon":518},{"facility":522,"status":51,"city":523,"state":11,"zip":524,"country":469,"countryCode":470,"cosmosGeoPoint":525,"geoPoint":529,"contacts":11},"H. Universitario La Fe","Valencia","46026",{"type":44,"coordinates":526},[527,528],-0.37966,39.47391,{"lat":528,"lon":527},{"facility":531,"status":51,"city":532,"state":11,"zip":533,"country":534,"countryCode":535,"cosmosGeoPoint":536,"geoPoint":540,"contacts":11},"Western General Hospital","Edinburgh","EH4 2XU","United Kingdom","UK",{"type":44,"coordinates":537},[538,539],-3.19648,55.95206,{"lat":539,"lon":538},{"facility":542,"status":543,"city":544,"state":11,"zip":545,"country":534,"countryCode":535,"cosmosGeoPoint":546,"geoPoint":550,"contacts":11},"St James' University Hospital","WITHDRAWN","Leeds","LS9 7TF",{"type":44,"coordinates":547},[548,549],-1.54785,53.79648,{"lat":549,"lon":548},{"facility":552,"status":51,"city":553,"state":11,"zip":554,"country":534,"countryCode":535,"cosmosGeoPoint":555,"geoPoint":559,"contacts":11},"University College London Hospital","London","NW1 2PG",{"type":44,"coordinates":556},[557,558],-0.12574,51.50853,{"lat":558,"lon":557},{"facility":561,"status":51,"city":553,"state":11,"zip":11,"country":534,"countryCode":535,"cosmosGeoPoint":562,"geoPoint":564,"contacts":11},"Kings College Hospital",{"type":44,"coordinates":563},[557,558],{"lat":558,"lon":557},{"facility":566,"status":51,"city":567,"state":11,"zip":568,"country":534,"countryCode":535,"cosmosGeoPoint":569,"geoPoint":573,"contacts":11},"Churchill Hospital","Oxford","OX3 7LE",{"type":44,"coordinates":570},[571,572],-1.25596,51.75222,{"lat":572,"lon":571},{"facility":575,"status":51,"city":576,"state":11,"zip":577,"country":534,"countryCode":535,"cosmosGeoPoint":578,"geoPoint":582,"contacts":11},"Torbay Hospital","Torquay","TQ2 7AA",{"type":44,"coordinates":579},[580,581],-3.52522,50.46198,{"lat":581,"lon":580},{"type":584,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[586],{"name":587,"class":6},"Servier Bio-Innovation LLC","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":599,"type":600},48,"ESTIMATED","INTERVENTIONAL",[603],"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.",[606,607],"Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS)","Myelodysplastic Syndromes (MDS)","2026-05-08",{"date":610,"type":611},"2026-05-11","ACTUAL",{"date":613,"type":611},"2024-12-03",{"date":615,"type":600},"2028-12-01",{"name":617,"class":618},"Institut de Recherches Internationales Servier","OTHER",62]