[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100367524":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":81,"studyPopulation":73,"armGroups":82,"interventions":90,"overallOfficials":102,"centralContacts":106,"locations":111,"responsibleParty":887,"collaborators":73,"id":889,"slug":890,"hasResults":891,"nctId":892,"briefTitle":893,"officialTitle":894,"acronym":895,"eligibilityCriteria":896,"healthyVolunteers":891,"sex":897,"minAge":898,"maxAge":73,"enrollmentInfo":899,"targetDuration":73,"studyType":902,"phases":903,"briefSummary":906,"conditions":907,"keywords":913,"overallStatus":147,"whyStopped":73,"lastUpdateSubmitDate":923,"lastUpdatePostDateStruct":924,"startDateStruct":927,"completionDateStruct":929,"leadSponsor":931,"locationsCount":932},{"fullName":5,"class":6},"Syndax Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":73},[9,13,15,18,21,24,28,31,34],{"measure":10,"description":11,"timeFrame":12},"Number of participants with dose-limiting toxicities (DLTs) (Phase 1)","Assessed by the NCI CTCAE version 5.0 (Phase 1)","Approximately 1 year",{"measure":14,"description":11,"timeFrame":12},"Number of participants with treatment-emergent adverse events (TEAEs) (Phase 1)",{"measure":16,"description":17,"timeFrame":12},"Cmax (Phase 1)","Maximum plasma concentration (Cmax) of revumenib and relevant metabolites (Phase 1)",{"measure":19,"description":20,"timeFrame":12},"Tmax (Phase 1)","Time to observed maximum plasma concentration of revumenib and relevant metabolites (Phase 1)",{"measure":22,"description":23,"timeFrame":12},"AUC0-t (Phase 1)","Area under the plasma concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of revumenib and relevant metabolites (Phase 1)",{"measure":25,"description":26,"timeFrame":27},"CR+CRh rate (Phase 2 [Cohorts 2A-2C])","To assess the complete remission (CR) and complete remission with partial hematologic recovery (CRh) rate (Phase 2 \\[Cohorts 2A-2C\\])","Approximately 3 years",{"measure":29,"description":30,"timeFrame":27},"Number of participants with TEAEs (Phase 2 [Cohorts 2A-2C])","Assessed by the NCI CTCAE version 5.0 (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":32,"description":33,"timeFrame":27},"Cmax (Phase 2 [Cohort 2D])","Cmax of revumenib (Phase 2 \\[Cohort 2D\\])",{"measure":35,"description":36,"timeFrame":27},"AUC0-tau (Phase 2 [Cohort 2D])","Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau) of revumenib (Phase 2 \\[Cohort 2D\\])",[38,41,44,47,51,54,57,61,64,67,70],{"measure":39,"description":40,"timeFrame":27},"Transfusion independence (Phase 2 [Cohorts 2A-2C])","Transfusion independence is defined as any transfusion-free period lasting for at least 56 consecutive days",{"measure":42,"description":43,"timeFrame":27},"CRc rate (Phase 2 [Cohorts 2A-2C])","To assess the composite definition of complete remission (CRc) rate (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":45,"description":46,"timeFrame":27},"ORR (CRc+ morphological leukemia-free state [MLFS] + partial remission [PR]) (Phase 2 [Cohorts 2A-2C])","To assess the overall response rate (ORR) of revumenib (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":48,"description":49,"timeFrame":50},"TTR (Phase 2 [Cohorts 2A-2C])","To assess the time to response (TTR) of revumenib (Phase 2 \\[Cohorts 2A-2C\\])","Approximately 34 months",{"measure":52,"description":53,"timeFrame":27},"DOR (Phase 2 [Cohorts 2A-2C])","To assess the duration of response (DOR) of revumenib (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":55,"description":56,"timeFrame":27},"EFS (Phase 2 [Cohorts 2A-2C])","To assess the event free survival (EFS) of revumenib (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":58,"description":59,"timeFrame":60},"OS (Phase 2 [Cohorts 2A-2C])","To assess overall survival (OS) of revumenib (Phase 2 \\[Cohorts 2A-2C\\])","Approximately 5 years",{"measure":62,"description":63,"timeFrame":27},"Cmax (Phase 2 [Cohorts 2A-2C])","Cmax of revumenib and relevant metabolites (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":65,"description":66,"timeFrame":27},"Tmax (Phase 2 [Cohorts 2A-2C])","Tmax of revumenib and relevant metabolites (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":68,"description":69,"timeFrame":27},"AUC0-t (Phase 2 [Cohorts 2A-2C])","AUC0-t of revumenib and relevant metabolites (Phase 2 \\[Cohorts 2A-2C\\])",{"measure":71,"description":72,"timeFrame":27},"Number of participants with TEAEs (Phase 2 [Cohort 2D])","Assessed by the NCI CTCAE version 5.0 (Phase 2 \\[Cohort 2D\\]))",null,{"allocation":75,"interventionModel":76,"interventionModelDescription":77,"primaryPurpose":78,"observationalModel":73,"timePerspective":73,"maskingInfo":79},"NA","SEQUENTIAL","Phase 1 will employ an accelerated titration design. The dose escalation will follow a modified Fibonacci sequence.","TREATMENT",{"masking":80,"maskingDescription":73,"whoMasked":73},"NONE","Phase 1: Oral revumenib; sequential cohorts of escalating dose levels of revumenib to identify the MTD and RP2D. Participants will be enrolled in one of six dose-escalation arms:\n\nArm A: Participants not receiving any strong cytochrome P450 3A4 (CYP3A4) inhibitor\u002Finducers or fluconazole.\n\nArm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis.\n\nArm C: Participants receiving revumenib and cobicistat.\n\nArm D: Participants receiving fluconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis.\n\nArm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors\u002Finducers.\n\nArm F: Participants receiving isavuconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis.\n\nIn Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib:\n\n* Cohort 2A: Participants with KMT2Ar acute lymphoblastic leukemia (ALL)\u002Fmixed phenotype acute leukemia (MPAL)\n* Cohort 2B: Participants with KMT2A AML\n* Cohort 2C: Participants with NPM1m AML\n* Cohort 2D: Participants with acute leukemia (including KMT2Ar, NPM1m, NUP98r and other acute leukemias expected to have HOX\u002FMEIS upregulation)",[83],{"label":84,"type":85,"description":86,"interventionNames":87},"Revumenib","EXPERIMENTAL","Phase 1: Oral revumenib; sequential cohorts of escalating dose levels of revumenib. Participants will be enrolled in 1 of 6 dose-escalation arms:\n\n* Arm A: Participants not receiving any strong CYP3A4 inhibitor\u002Finducers or fluconazole\n* Arm B: Participants receiving any strong CYP3A4 inhibitors for antifungal prophylaxis\n* Arm C: Participants receiving revumenib and cobicistat\n* Arm D: Participants receiving fluconazole for antifungal prophylaxis\n* Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors\u002Finducers\n* Arm F: Participants receiving isavuconazole for antifungal prophylaxis\n\nPhase 2: Oral revumenib; 4 indication-specific expansion cohorts will be enrolled:\n\n* Cohort 2A: Participants with KMT2Ar ALL\u002FMPAL\n* Cohort 2B: Participants with KMT2Ar AML\n* Cohort 2C: Participants with NPM1m AML\n* Cohort 2D: Participants with acute leukemia (including KMT2Ar, NPM1m, NUP98r and other acute leukemias expected to have HOX\u002FMEIS upregulation)",[88,89],"Drug: revumenib","Drug: cobicistat",[91,98],{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"DRUG","revumenib","revumenib orally",[84],[97],"SNDX-5613",{"type":92,"name":99,"description":100,"armGroupLabels":101,"otherNames":73},"cobicistat","Phase 1 Arm C participants will receive 150 mg cobicistat daily.",[84],[103],{"name":104,"affiliation":5,"role":105},"Angela R Smith, M.D.","STUDY_DIRECTOR",[107],{"name":5,"role":108,"phone":109,"phoneExt":73,"email":110},"CONTACT","781-419-1400","clinicaltrials@syndax.com",[112,126,136,145,163,173,182,198,204,221,238,248,264,274,283,295,311,321,337,354,374,384,394,406,415,424,436,448,465,470,487,502,517,532,551,561,570,582,597,612,621,638,653,666,681,696,711,728,743,758,773,788,805,823,840,857,872],{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":73},"City of Hope Comprehensive Cancer Center","ACTIVE_NOT_RECRUITING","Duarte","California","91010","United States","US",{"type":121,"coordinates":122},"Point",[123,124],-117.97729,34.13945,{"lat":124,"lon":123},{"facility":127,"status":128,"city":129,"state":116,"zip":130,"country":118,"countryCode":119,"cosmosGeoPoint":131,"geoPoint":135,"contacts":73},"University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital","COMPLETED","Los Angeles","90033",{"type":121,"coordinates":132},[133,134],-118.24368,34.05223,{"lat":134,"lon":133},{"facility":137,"status":114,"city":138,"state":116,"zip":139,"country":118,"countryCode":119,"cosmosGeoPoint":140,"geoPoint":144,"contacts":73},"Stanford Cancer Institute","Palo Alto","94305",{"type":121,"coordinates":141},[142,143],-122.14302,37.44188,{"lat":143,"lon":142},{"facility":146,"status":147,"city":148,"state":149,"zip":150,"country":118,"countryCode":119,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"University of Colorado","RECRUITING","Aurora","Colorado","80045",{"type":121,"coordinates":152},[153,154],-104.83192,39.72943,{"lat":154,"lon":153},[157,160],{"name":158,"role":108,"phone":73,"phoneExt":73,"email":159},"Katelyn Anttila","Katelyn.Anttila@ucdenver.edu",{"name":161,"role":162,"phone":73,"phoneExt":73,"email":73},"Christine McMahon","PRINCIPAL_INVESTIGATOR",{"facility":164,"status":114,"city":165,"state":166,"zip":167,"country":118,"countryCode":119,"cosmosGeoPoint":168,"geoPoint":172,"contacts":73},"Florida Cancer Specialists and Research Institute","Sarasota","Florida","34232",{"type":121,"coordinates":169},[170,171],-82.53065,27.33643,{"lat":171,"lon":170},{"facility":174,"status":128,"city":175,"state":166,"zip":176,"country":118,"countryCode":119,"cosmosGeoPoint":177,"geoPoint":181,"contacts":73},"Moffitt Cancer Center","Tampa","33162",{"type":121,"coordinates":178},[179,180],-82.45843,27.94752,{"lat":180,"lon":179},{"facility":183,"status":147,"city":184,"state":185,"zip":186,"country":118,"countryCode":119,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Emory Winship Cancer Institute","Atlanta","Georgia","30322",{"type":121,"coordinates":188},[189,190],-84.38798,33.749,{"lat":190,"lon":189},[193,196],{"name":194,"role":108,"phone":73,"phoneExt":73,"email":195},"Feranmi Arowolo","feranmi.arowolo@emory.edu",{"name":197,"role":162,"phone":73,"phoneExt":73,"email":73},"Martha Arellano",{"facility":199,"status":128,"city":184,"state":185,"zip":200,"country":118,"countryCode":119,"cosmosGeoPoint":201,"geoPoint":203,"contacts":73},"Children's Healthcare of Atlanta","30329",{"type":121,"coordinates":202},[189,190],{"lat":190,"lon":189},{"facility":205,"status":147,"city":206,"state":207,"zip":208,"country":118,"countryCode":119,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"The University of Chicago Medical Center","Chicago","Illinois","60637",{"type":121,"coordinates":210},[211,212],-87.65005,41.85003,{"lat":212,"lon":211},[215,219],{"name":216,"role":108,"phone":217,"phoneExt":73,"email":218},"Bukola Rinola","773-795-2430","Bukola.Rinola@bsd.uchicago.edu",{"name":220,"role":162,"phone":73,"phoneExt":73,"email":73},"Michael Thirman",{"facility":222,"status":147,"city":223,"state":224,"zip":225,"country":118,"countryCode":119,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"University of Iowa Hospital","Iowa City","Iowa","52246",{"type":121,"coordinates":227},[228,229],-91.53017,41.66113,{"lat":229,"lon":228},[232,236],{"name":233,"role":108,"phone":234,"phoneExt":73,"email":235},"Chris Stamy","319-467-5320","chris-stamy@uiowa.edu",{"name":237,"role":162,"phone":73,"phoneExt":73,"email":73},"Michael Halyko",{"facility":239,"status":114,"city":240,"state":241,"zip":242,"country":118,"countryCode":119,"cosmosGeoPoint":243,"geoPoint":247,"contacts":73},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":121,"coordinates":244},[245,246],-71.05977,42.35843,{"lat":246,"lon":245},{"facility":249,"status":147,"city":250,"state":251,"zip":252,"country":118,"countryCode":119,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Washington University in St. Louis School of Medicine","St Louis","Missouri","63110",{"type":121,"coordinates":254},[255,256],-90.19789,38.62727,{"lat":256,"lon":255},[259,262],{"name":260,"role":108,"phone":73,"phoneExt":73,"email":261},"Morgan Swanner","swanner@wustl.edu",{"name":263,"role":162,"phone":73,"phoneExt":73,"email":73},"John DiPersio",{"facility":265,"status":128,"city":266,"state":267,"zip":268,"country":118,"countryCode":119,"cosmosGeoPoint":269,"geoPoint":273,"contacts":73},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":121,"coordinates":270},[271,272],-74.04347,40.88593,{"lat":272,"lon":271},{"facility":275,"status":114,"city":276,"state":276,"zip":277,"country":118,"countryCode":119,"cosmosGeoPoint":278,"geoPoint":282,"contacts":73},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":121,"coordinates":279},[280,281],-74.00597,40.71427,{"lat":281,"lon":280},{"facility":284,"status":147,"city":276,"state":276,"zip":285,"country":118,"countryCode":119,"cosmosGeoPoint":286,"geoPoint":288,"contacts":289},"Montefiore Medical Center","10467",{"type":121,"coordinates":287},[280,281],{"lat":281,"lon":280},[290,293],{"name":291,"role":108,"phone":73,"phoneExt":73,"email":292},"Aradhika Dhawan","aradhika.dhawan@einsteinmed.edu",{"name":294,"role":162,"phone":73,"phoneExt":73,"email":73},"Ioannis Mantzaris",{"facility":296,"status":147,"city":297,"state":298,"zip":299,"country":118,"countryCode":119,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"Duke University Medical Center","Durham","North Carolina","27110",{"type":121,"coordinates":301},[302,303],-78.89862,35.99403,{"lat":303,"lon":302},[306,309],{"name":307,"role":108,"phone":73,"phoneExt":73,"email":308},"Linda Brown","linda.brown@duke.edu",{"name":310,"role":162,"phone":73,"phoneExt":73,"email":73},"Brittany DePriest",{"facility":312,"status":128,"city":313,"state":314,"zip":315,"country":118,"countryCode":119,"cosmosGeoPoint":316,"geoPoint":320,"contacts":73},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":121,"coordinates":317},[318,319],-84.51439,39.12711,{"lat":319,"lon":318},{"facility":322,"status":147,"city":323,"state":314,"zip":324,"country":118,"countryCode":119,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"Ohio State University","Columbus","43201",{"type":121,"coordinates":326},[327,328],-82.99879,39.96118,{"lat":328,"lon":327},[331,335],{"name":332,"role":108,"phone":333,"phoneExt":73,"email":334},"Mandana Moghaddam","614-685-2932","Mandana.Moghaddam@osumc.edu",{"name":336,"role":162,"phone":73,"phoneExt":73,"email":73},"James Blachly",{"facility":338,"status":147,"city":339,"state":340,"zip":341,"country":118,"countryCode":119,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"Oregon Health & Science University","Portland","Oregon","97239",{"type":121,"coordinates":343},[344,345],-122.67621,45.52345,{"lat":345,"lon":344},[348,352],{"name":349,"role":108,"phone":350,"phoneExt":73,"email":351},"Tess Messan","503-494-5466","Allentes@ohsu.edu",{"name":353,"role":162,"phone":73,"phoneExt":73,"email":73},"Elie Traer, MD",{"facility":355,"status":147,"city":356,"state":357,"zip":358,"country":118,"countryCode":119,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":121,"coordinates":360},[361,362],-75.16362,39.95238,{"lat":362,"lon":361},[365,369,372],{"name":366,"role":108,"phone":367,"phoneExt":73,"email":368},"Robin E Blauser, BSN RN","215-662-2870","Robin.Blauser@pennmedicine.upenn.edu",{"name":370,"role":108,"phone":73,"phoneExt":73,"email":371},"Thomas Greenwood","Thomas.Greenwood@Pennmedicine.upenn.edu",{"name":373,"role":162,"phone":73,"phoneExt":73,"email":73},"Alexander Perl",{"facility":375,"status":114,"city":376,"state":377,"zip":378,"country":118,"countryCode":119,"cosmosGeoPoint":379,"geoPoint":383,"contacts":73},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":121,"coordinates":380},[381,382],-95.36327,29.76328,{"lat":382,"lon":381},{"facility":385,"status":128,"city":386,"state":387,"zip":388,"country":118,"countryCode":119,"cosmosGeoPoint":389,"geoPoint":393,"contacts":73},"Huntsman Cancer Institute at the University of Utah","Salt Lake City","Utah","84112",{"type":121,"coordinates":390},[391,392],-111.89105,40.76078,{"lat":392,"lon":391},{"facility":395,"status":114,"city":396,"state":397,"zip":398,"country":399,"countryCode":400,"cosmosGeoPoint":401,"geoPoint":405,"contacts":73},"Peter MacCallum Cancer Centre (PMCC)","Melbourne","Victoria","3000","Australia","AU",{"type":121,"coordinates":402},[403,404],144.96332,-37.814,{"lat":404,"lon":403},{"facility":407,"status":114,"city":408,"state":397,"zip":409,"country":399,"countryCode":400,"cosmosGeoPoint":410,"geoPoint":414,"contacts":73},"Royal Melbourne Hospital (RMH)","Parkville","3050",{"type":121,"coordinates":411},[412,413],144.95,-37.78333,{"lat":413,"lon":412},{"facility":416,"status":147,"city":396,"state":73,"zip":417,"country":399,"countryCode":400,"cosmosGeoPoint":418,"geoPoint":420,"contacts":421},"Alfred Hospital","3004",{"type":121,"coordinates":419},[403,404],{"lat":404,"lon":403},[422],{"name":423,"role":162,"phone":73,"phoneExt":73,"email":73},"Shaun Fleming, MD",{"facility":425,"status":147,"city":426,"state":73,"zip":427,"country":399,"countryCode":400,"cosmosGeoPoint":428,"geoPoint":432,"contacts":433},"Sir Charles Gairdner Hospital","Nedlands","6009",{"type":121,"coordinates":429},[430,431],115.8073,-31.98184,{"lat":431,"lon":430},[434],{"name":435,"role":162,"phone":73,"phoneExt":73,"email":73},"Carolyn Grove, MD",{"facility":437,"status":147,"city":438,"state":73,"zip":439,"country":399,"countryCode":400,"cosmosGeoPoint":440,"geoPoint":444,"contacts":445},"Royal North Shore Hospital","Saint Leonards","2065",{"type":121,"coordinates":441},[442,443],144.71803,-38.17051,{"lat":443,"lon":442},[446],{"name":447,"role":162,"phone":73,"phoneExt":73,"email":73},"Matthew Greenwood, MD",{"facility":449,"status":147,"city":450,"state":73,"zip":451,"country":452,"countryCode":453,"cosmosGeoPoint":454,"geoPoint":458,"contacts":459},"University Health Network","Toronto","M5G 2M9","Canada","CA",{"type":121,"coordinates":455},[456,457],-79.39864,43.70643,{"lat":457,"lon":456},[460,463],{"name":461,"role":108,"phone":73,"phoneExt":73,"email":462},"Allison Mahon","Allison.Mahon@uhn.ca",{"name":464,"role":162,"phone":73,"phoneExt":73,"email":73},"Andre Schuh, MD",{"facility":466,"status":114,"city":450,"state":73,"zip":73,"country":452,"countryCode":453,"cosmosGeoPoint":467,"geoPoint":469,"contacts":73},"The Hospital for Sick Children",{"type":121,"coordinates":468},[456,457],{"lat":457,"lon":456},{"facility":471,"status":147,"city":472,"state":73,"zip":473,"country":474,"countryCode":475,"cosmosGeoPoint":476,"geoPoint":480,"contacts":481},"Hospital Saint-Louis - APHP","Paris","75010","France","FR",{"type":121,"coordinates":477},[478,479],2.3488,48.85341,{"lat":479,"lon":478},[482,485],{"name":483,"role":108,"phone":73,"phoneExt":73,"email":484},"Marion Le Duff","marion.leduff@aphp.fr",{"name":486,"role":162,"phone":73,"phoneExt":73,"email":73},"Emmanuel Raffoux",{"facility":488,"status":147,"city":489,"state":73,"zip":490,"country":474,"countryCode":475,"cosmosGeoPoint":491,"geoPoint":495,"contacts":496},"Centre Hospitalier Universitaire (CHU) de Bordeaux","Pessac","33604",{"type":121,"coordinates":492},[493,494],-0.6324,44.80565,{"lat":494,"lon":493},[497,500],{"name":498,"role":108,"phone":73,"phoneExt":73,"email":499},"Thomas Grenier","thomas.grenier@chu-bordeaux.fr",{"name":501,"role":162,"phone":73,"phoneExt":73,"email":73},"Arnaud Pigneux",{"facility":503,"status":147,"city":504,"state":73,"zip":505,"country":474,"countryCode":475,"cosmosGeoPoint":506,"geoPoint":510,"contacts":511},"Centre Hospitalier Lyon Sud","Pierre-Bénite","69495",{"type":121,"coordinates":507},[508,509],4.82424,45.70359,{"lat":509,"lon":508},[512,515],{"name":513,"role":108,"phone":73,"phoneExt":73,"email":514},"James EAV","ext-james.eav@chu-lyon.fr",{"name":516,"role":162,"phone":73,"phoneExt":73,"email":73},"Mael Heiblig",{"facility":518,"status":147,"city":519,"state":73,"zip":520,"country":474,"countryCode":475,"cosmosGeoPoint":521,"geoPoint":525,"contacts":526},"Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP","Villejuif","94805",{"type":121,"coordinates":522},[523,524],2.35992,48.7939,{"lat":524,"lon":523},[527,530],{"name":528,"role":108,"phone":73,"phoneExt":73,"email":529},"Laetitia PIREYRE","Laetitia.PIREYRE@gustaveroussy.fr",{"name":531,"role":162,"phone":73,"phoneExt":73,"email":73},"Stephanie De Botton",{"facility":533,"status":147,"city":534,"state":535,"zip":536,"country":537,"countryCode":538,"cosmosGeoPoint":539,"geoPoint":543,"contacts":544},"University Hospital Of Ulm, Universitatsklinikum Ulm","Ulm","Baden-Wurttemberg","89081","Germany","DE",{"type":121,"coordinates":540},[541,542],9.99155,48.39841,{"lat":542,"lon":541},[545,549],{"name":546,"role":108,"phone":547,"phoneExt":73,"email":548},"Christiane Rudolph","+49 (0)731 500 45903","Christiane.Rudolph@uniklinik-ulm.de",{"name":550,"role":162,"phone":73,"phoneExt":73,"email":73},"Hartmut Doehner",{"facility":552,"status":553,"city":554,"state":73,"zip":555,"country":537,"countryCode":538,"cosmosGeoPoint":556,"geoPoint":560,"contacts":73},"Universitaetsklinikum Essen (AoR)","WITHDRAWN","Essen","45147",{"type":121,"coordinates":557},[558,559],7.01228,51.45657,{"lat":559,"lon":558},{"facility":562,"status":128,"city":563,"state":73,"zip":564,"country":537,"countryCode":538,"cosmosGeoPoint":565,"geoPoint":569,"contacts":73},"Universitaetsmedizin Greifswald","Greifswald","17475",{"type":121,"coordinates":566},[567,568],13.40244,54.08905,{"lat":568,"lon":567},{"facility":571,"status":147,"city":572,"state":73,"zip":573,"country":537,"countryCode":538,"cosmosGeoPoint":574,"geoPoint":578,"contacts":579},"Universitaetsmedizin Der Johannes","Gutenberg","55131",{"type":121,"coordinates":575},[576,577],11.97181,51.5471,{"lat":577,"lon":576},[580],{"name":73,"role":108,"phone":73,"phoneExt":73,"email":581},"m3.uct-studien@unimedizin-mainz.de",{"facility":583,"status":147,"city":584,"state":73,"zip":585,"country":537,"countryCode":538,"cosmosGeoPoint":586,"geoPoint":590,"contacts":591},"Universitaetsklinikum Hamburg-Eppendorf","Hamburg","20246",{"type":121,"coordinates":587},[588,589],9.99302,53.55073,{"lat":589,"lon":588},[592,595],{"name":593,"role":108,"phone":73,"phoneExt":73,"email":594},"Petra Kuehne","p.kuehne@uke.de",{"name":596,"role":162,"phone":73,"phoneExt":73,"email":73},"Franziska Westendorf",{"facility":598,"status":147,"city":599,"state":73,"zip":600,"country":537,"countryCode":538,"cosmosGeoPoint":601,"geoPoint":605,"contacts":606},"University of Leipzig","Leipzig","04103",{"type":121,"coordinates":602},[603,604],12.37129,51.33962,{"lat":604,"lon":603},[607,610],{"name":608,"role":108,"phone":73,"phoneExt":73,"email":609},"Karolin Neelsen","karolin.neelsen@medizin.uni-leipzig.de",{"name":611,"role":162,"phone":73,"phoneExt":73,"email":73},"Madlen Jentzsch",{"facility":613,"status":128,"city":614,"state":73,"zip":615,"country":537,"countryCode":538,"cosmosGeoPoint":616,"geoPoint":620,"contacts":73},"Klinikum Nuernberg Nord","Nuremberg","90419",{"type":121,"coordinates":617},[618,619],11.07752,49.45421,{"lat":619,"lon":618},{"facility":622,"status":147,"city":623,"state":73,"zip":624,"country":625,"countryCode":626,"cosmosGeoPoint":627,"geoPoint":631,"contacts":632},"Rambam Health Care Campus 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Kerem","9112001",{"type":121,"coordinates":657},[644,645],{"lat":645,"lon":644},[660,662,664],{"name":661,"role":108,"phone":73,"phoneExt":73,"email":73},"Leah Greenfeld",{"name":73,"role":108,"phone":73,"phoneExt":73,"email":663},"leahgr@hadassah.org.il",{"name":665,"role":162,"phone":73,"phoneExt":73,"email":73},"Boaz Nachmias",{"facility":667,"status":147,"city":668,"state":73,"zip":669,"country":625,"countryCode":626,"cosmosGeoPoint":670,"geoPoint":674,"contacts":675},"Galilee Medical Center","Nahariya","2210010",{"type":121,"coordinates":671},[672,673],35.09814,33.00892,{"lat":673,"lon":672},[676,679],{"name":677,"role":108,"phone":73,"phoneExt":73,"email":678},"Lana Saada","LanaS@gmc.gov.il",{"name":680,"role":162,"phone":73,"phoneExt":73,"email":73},"Galia Stemer",{"facility":682,"status":147,"city":683,"state":73,"zip":684,"country":625,"countryCode":626,"cosmosGeoPoint":685,"geoPoint":689,"contacts":690},"Rabin Medical Center","Petah Tikva","4941492",{"type":121,"coordinates":686},[687,688],34.88666,32.0888,{"lat":688,"lon":687},[691,694],{"name":692,"role":108,"phone":73,"phoneExt":73,"email":693},"Shani Gillows","shanigil@clalit.org.il",{"name":695,"role":162,"phone":73,"phoneExt":73,"email":73},"Ofir Wolach",{"facility":697,"status":147,"city":698,"state":73,"zip":699,"country":625,"countryCode":626,"cosmosGeoPoint":700,"geoPoint":704,"contacts":705},"Sheba Medical Center","Ramat Gan","52621",{"type":121,"coordinates":701},[702,703],34.81065,32.08227,{"lat":703,"lon":702},[706,709],{"name":707,"role":108,"phone":73,"phoneExt":73,"email":708},"Yuval Carmel","Yuval.Carmel@sheba.health.gov.il",{"name":710,"role":162,"phone":73,"phoneExt":73,"email":73},"Irina Armitai",{"facility":712,"status":147,"city":713,"state":73,"zip":714,"country":715,"countryCode":716,"cosmosGeoPoint":717,"geoPoint":721,"contacts":722},"IRCCS Azienda Ospedaliero Universitaria di Bologna","Bologna","40138","Italy","IT",{"type":121,"coordinates":718},[719,720],11.33875,44.49381,{"lat":720,"lon":719},[723,726],{"name":724,"role":108,"phone":73,"phoneExt":73,"email":725},"Riccardo Mennuti","riccardo.mennuti@aosp.bo.it",{"name":727,"role":162,"phone":73,"phoneExt":73,"email":73},"Cristina Papayannidis",{"facility":729,"status":147,"city":730,"state":73,"zip":731,"country":715,"countryCode":716,"cosmosGeoPoint":732,"geoPoint":736,"contacts":737},"Istituto Romagnolo Per Lo Studio dei tumori Dino Amadori","Meldola","47014",{"type":121,"coordinates":733},[734,735],12.0626,44.12775,{"lat":735,"lon":734},[738,741],{"name":739,"role":108,"phone":73,"phoneExt":73,"email":740},"Fabiana Mammoli","fabiana.mammoli@irst.emr.it",{"name":742,"role":162,"phone":73,"phoneExt":73,"email":73},"Maria Giannini",{"facility":744,"status":147,"city":745,"state":73,"zip":746,"country":715,"countryCode":716,"cosmosGeoPoint":747,"geoPoint":751,"contacts":752},"IRCCS-Istituto Europeo di Oncologia","Milan","20141",{"type":121,"coordinates":748},[749,750],9.18951,45.46427,{"lat":750,"lon":749},[753,756],{"name":754,"role":108,"phone":73,"phoneExt":73,"email":755},"Marialuisa Catalano","Marialuisa.Catalano@ieo.it",{"name":757,"role":162,"phone":73,"phoneExt":73,"email":73},"Enrico Derenzini",{"facility":759,"status":147,"city":760,"state":73,"zip":761,"country":715,"countryCode":716,"cosmosGeoPoint":762,"geoPoint":766,"contacts":767},"Universita Cattolica Fondazione Policlinico Agostino Gemelli","Roma","00168",{"type":121,"coordinates":763},[764,765],11.10642,44.99364,{"lat":765,"lon":764},[768,771],{"name":769,"role":108,"phone":73,"phoneExt":73,"email":770},"Gulia De Santis","giulia.desantis@policlinicogemelli.it",{"name":772,"role":162,"phone":73,"phoneExt":73,"email":73},"Patrizia Chiusolo",{"facility":774,"status":147,"city":775,"state":73,"zip":776,"country":715,"countryCode":716,"cosmosGeoPoint":777,"geoPoint":781,"contacts":782},"S Bortolo Hospital AULSS 8 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More","lauramorahuvr@gmail.com",{"name":871,"role":162,"phone":73,"phoneExt":73,"email":73},"Eduardo Rodriguez-Arboli",{"facility":873,"status":147,"city":874,"state":73,"zip":875,"country":844,"countryCode":845,"cosmosGeoPoint":876,"geoPoint":880,"contacts":881},"Hospital Universitari i Politecnic La Fe de Valencia","Valencia","46026",{"type":121,"coordinates":877},[878,879],-0.37966,39.47391,{"lat":879,"lon":878},[882,885],{"name":883,"role":108,"phone":73,"phoneExt":73,"email":884},"Alvaro Fernandez-Pardo","alvaro_fernandez@iislafe.es",{"name":886,"role":162,"phone":73,"phoneExt":73,"email":73},"Pau Montesinos Fernandez",{"type":888,"investigatorFullName":73,"investigatorTitle":73,"investigatorAffiliation":73,"oldNameTitle":73,"oldOrganization":73},"SPONSOR","100367524","phase-1-a-study-of-revumenib-in-rr-leukemias-including-those-with-an-mllkmt2a-gene-rearrangement-or-npm1-mutation-100367524",false,"NCT04065399","A Study of Revumenib in R\u002FR Leukemias Including Those With an MLL\u002FKMT2A Gene Rearrangement or NPM1 Mutation","A Phase 1\u002F2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed\u002FRefractory Leukemias, Including Those Harboring an MLL\u002FKMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation","AUGMENT-101","Key Inclusion Criteria:\n\nParticipants must have active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020), or acute leukemia harboring KMT2A rearrangement, NUP98 rearrangement, or NPM1 mutation that have detectable disease in the bone marrow.\n\n1. Phase 1:\n\n   * Arm A: Participants not receiving any strong CYP3A4 inhibitor\u002Finducers or fluconazole.\n   * Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis.\n   * Arm C: Participants receiving revumenib in combination with cobicistat.\n   * Arm D: Participants receiving fluconazole (moderate CYP3A4 inhibitor).\n   * Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors\u002Finducers.\n   * Arm F: Participants receiving isavuconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis.\n2. Phase 2:\n\n   Documented R\u002FR active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the NCCN Guidelines® for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020).\n   * Cohort 2A: Documented R\u002FR ALL\u002FMPAL with KMT2A rearrangement.\n   * Cohort 2B: Documented R\u002FR AML with KMT2A rearrangement.\n   * Cohort 2C: Documented R\u002FR AML with NPM1m.\n   * Cohort 2D: Documented R\u002FR acute leukemia with a genetic mutation expected to lead to HOX\u002FMEIS upregulation (for example, KMT2Ar, NPM1m, and NUP98r), including participants who are MRD-positive by multiparametric flow cytometry or molecular methods only, and including participants with isolated extramedullary disease.\n3. White blood cell count below 25,000\u002F microliter at time of enrollment. Participants may receive cytoreduction prior to enrollment per protocol-specified criteria.\n4. Male or female participants aged ≥30 days old. Participants intended to receive SNDX-5613 in combination with cobicistat must weigh ≥35 kilograms (kg). Participants in Cohort 2D must be ≥18 years of age and have a body weight ≥40 kg.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 or Karnofsky\u002FLansky score ≥50.\n6. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 neuropathy or alopecia.\n\n   Phase 1 and Phase 2 Cohorts 2A-2C only:\n7. Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n8. Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant and at least 4 weeks must have elapsed from donor lymphocyte infusion.\n9. Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T or NK cell therapy.\n10. Antileukemia Therapy: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy.\n11. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n12. Biologics: At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent.\n13. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing or cytoreductive therapy.\n\n    Phase 2 Cohort 2D only:\n\n    At least 14 days since any other investigational or commercially available antileukemic therapy, with the following exceptions:\n    1. Cytoreductive therapy with hydroxyurea, low-dose cytarabine (20 mg\u002Fsquare meter (m\\^2)\u002Fday subcutaneously \\[SC\\] for 10 days) or low-dose etoposide (up to 200 mg\u002Fday orally for 10 days) may be administered concurrently with SNDX-5613.\n    2. Intrathecal chemotherapy for CNS prophylaxis is permitted at the treating physician's discretion.\n    3. Steroids at physiologic dosing (equivalent to ≤10 mg prednisone daily for participants ≥18 years or ≤10 mg\u002Fm\\^2\u002Fday for participants \\\u003C18 years) or for cytoreductive therapy.\n14. Adequate organ function.\n15. If of childbearing potential, willing to use a highly effective method of contraception from the time of enrollment through 120 days following the last study drug dose.\n\nKey Exclusion Criteria:\n\nParticipants meeting any of the following criteria are not eligible for study participation:\n\n1. Diagnosis of active acute promyelocytic leukemia.\n2. Isolated extramedullary relapse (Phase 2 Cohorts 2A-2C only).\n3. Active central nervous system disease (cytologic, such as any blasts on cytospin, or radiographic).\n4. Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Participants with a known history of HIV 1\u002F2 antibodies must have viral load testing prior to study enrollment.\n5. Hepatitis B or C.\n6. Pregnant or nursing women.\n7. Cardiac Disease:\n\n   * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n   * Corrected QT interval (QTc) \\>450 milliseconds.\n8. Gastrointestinal Disease:\n\n   * any gastrointestinal issue of the upper GI tract that might affect oral drug absorption or ingestion (that is, gastric bypass and gastroparesis).\n   * Cirrhosis with a Child-Pugh score of B or C.\n9. Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD \\>Grade 0 within 4 weeks of enrollment. All transplant participants must have been off all systemic immunosuppressive therapy and calcineurin inhibitors for at least 4 weeks prior to enrollment. Participants may be on physiological doses of steroids.\n10. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (for example, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy, or concurrent low-grade lymphoma, that is asymptomatic and lacks bulky disease and shows no evidence of progression, and for which the participant is not receiving any systemic therapy or radiation.\n11. In Phase 1 and Phase 2: Participants requiring the concurrent use of medications known or suspected to prolong the QT\u002FQTc interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard supportive therapies (for example, diphenhydramine, famotidine, ondansetron, Bactrim) and the azoles permitted in the relevant arms of Phase 1 and in Phase 2.\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria may apply.","ALL","30 Days",{"count":900,"type":901},447,"ESTIMATED","INTERVENTIONAL",[904,905],"PHASE1","PHASE2","Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia.\n\nIn Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.",[908,909,910,911,912],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Mixed Lineage Acute Leukemia","Mixed Phenotype Acute Leukemia","Acute Leukemia of Ambiguous Lineage",[914,897,915,916,917,918,919,920,921,922],"AML","MPAL","MLAL","ALAL","relapsed leukemia","refractory leukemia","acute leukemia","KMT2A","NPM1","2026-10-07",{"date":925,"type":926},"2026-10-09","ACTUAL",{"date":928,"type":926},"2019-11-05",{"date":930,"type":901},"2027-12-15",{"name":5,"class":6},57]