[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06852222":3,"trial-entities:NCT06852222":1877,"trial-summary:NCT06852222":1883},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":50,"secondary_outcomes":58,"sex":86,"minimum_age":87,"maximum_age":17,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":107,"locations":110,"central_contacts":1865,"overall_officials":1871,"references":1875,"see_also_links":1876},"NCT06852222","75276617AML3001","A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy","RECRUITING","2029-08-15","2026-08","2026-08-28","2025-06-04","Janssen Research & Development, LLC","INDUSTRY",true,"The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.",null,[19],"Leukemia, Myeloid, Acute",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},600,"ESTIMATED",[29,37,42,46],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Bleximenib","Bleximenib will be administered orally.",[34],"Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)",[36],"JNJ-75276617",{"type":30,"name":38,"description":39,"armGroupLabels":40},"Venetoclax (VEN)","VEN will be administered orally.",[34,41],"Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)",{"type":30,"name":43,"description":44,"armGroupLabels":45},"Azacitidine (AZA)","AZA will be administered intravenously or subcutaneously.",[34,41],{"type":30,"name":47,"description":48,"armGroupLabels":49},"Placebo","Placebo will be administered orally.",[41],[51,55],{"measure":52,"description":53,"timeFrame":54},"Percentage of Participants who Achieve Complete Remission (CR)","CR is defined as Bone marrow blasts less than (\\\u003C) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (\\>=) 1.0 \\* 10\\^9\u002FLiter (1,000\u002Fmicroliter \\[mcL\\]); Platelet count \\>= 100 \\* 10\\^9\u002FL (100,000\u002FmcL).","Up to 4 years and 1 month",{"measure":56,"description":57,"timeFrame":54},"Overall Survival (OS)","Overall survival time is defined as the time duration from the date of randomization to death due to any cause.",[59,62,65,68,71,74,77,80,83],{"measure":60,"description":61,"timeFrame":54},"Event-free survival (EFS)","EFS is defined as the time from randomization to treatment failure, relapse, or death due to any cause, whichever occurs first.",{"measure":63,"description":64,"timeFrame":54},"Duration of CR","Duration of CR will be estimated among responders from the date of initial documentation of CR, to the date of first documented evidence of relapse, or death due to any cause, whichever occurs first, respectively.",{"measure":66,"description":67,"timeFrame":54},"Time to CR","Time to CR is defined as time from randomization to first documented response.",{"measure":69,"description":70,"timeFrame":54},"Rate of CR Without Measurable Residual Disease (MRD-)","Rate of CR MRD- is defined as percentage of participants who have achieved CR without MRD.",{"measure":72,"description":73,"timeFrame":54},"Percentage of Participants who Achieved Transfusion Independence","Transfusion independence is defined as lack of requirement for red blood cell (RBC) and platelet transfusions during any 56-day period.",{"measure":75,"description":76,"timeFrame":54},"Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)","Allo-HSCT rate is defined as the percentage of participants who have undergone allo-HSCT after randomization.",{"measure":78,"description":79,"timeFrame":54},"Number of Participants with Adverse Events (AEs)","An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical\u002Fbiological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.",{"measure":81,"description":82,"timeFrame":54},"Number of Participants with Abnormalities in Clinical Laboratory Parameters","Participants with abnormalities in clinical laboratory parameters will be reported.",{"measure":84,"description":85,"timeFrame":54},"Serum Concentration of Bleximenib","Serum samples will be analyzed to determine concentrations of bleximenib.","ALL","18 Years",false,{"inclusion":90,"exclusion":98,"raw_text":106},[91,92,93,94,95,96,97],"Be 18 years of age or older at the time of informed consent","Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria","Ineligible for intensive chemotherapy based on the following criteria: a) \\>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \\>=18 to \\\u003C75 years of age with \\>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care","Participants must have adequate hepatic and renal function","A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment","A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment","Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study",[99,100,101,102,103,104,105],"Diagnosis of acute promyelocytic leukemia (APL)","Known active leukemic involvement of the central nervous system (CNS)","Recipient of solid organ transplant","Any cardiac disorders such as heart attack, uncontrolled\u002Funstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization","Active infectious hepatitis","Live, attenuated vaccine within 4 weeks of randomization","Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients","Inclusion criteria:\n\n* Be 18 years of age or older at the time of informed consent\n* Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria\n* Ineligible for intensive chemotherapy based on the following criteria: a) \\>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \\>=18 to \\\u003C75 years of age with \\>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care\n* Participants must have adequate hepatic and renal function\n* A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment\n* A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment\n* Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n\nExclusion criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL)\n* Known active leukemic involvement of the central nervous system (CNS)\n* Recipient of solid organ transplant\n* Any cardiac disorders such as heart attack, uncontrolled\u002Funstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization\n* Active infectious hepatitis\n* Live, attenuated vaccine within 4 weeks of randomization\n* Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax 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of Alabama at Birmingham","Birmingham","Alabama","35294","United States",{"lat":118,"lon":119},33.52066,-86.80249,{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":116,"geoPoint":125},"Cancer Treatment Center of America Phoenix","Goodyear","Arizona","85338",{"lat":126,"lon":127},33.43532,-112.35821,{"facility":129,"status":8,"city":130,"state":123,"zip":131,"country":116,"geoPoint":132},"The University of Arizona Cancer Center","Tucson","85724",{"lat":133,"lon":134},32.22174,-110.92648,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":116,"geoPoint":140},"University of Arkansas at Little Rock","Little Rock","Arkansas","72204",{"lat":141,"lon":142},34.74648,-92.28959,{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":116,"geoPoint":148},"City of Hope","Duarte","California","91010",{"lat":149,"lon":150},34.13945,-117.97729,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":116,"geoPoint":156},"Rocky Mountain 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Specialists","Niles","60714",{"lat":227,"lon":228},42.01892,-87.80284,{"facility":230,"status":8,"city":231,"state":232,"zip":233,"country":116,"geoPoint":234},"University of Kentucky Markey Cancer Center","Lexington","Kentucky","40536",{"lat":235,"lon":236},37.98869,-84.47772,{"facility":238,"status":8,"city":239,"state":232,"zip":240,"country":116,"geoPoint":241},"UofL Health Brown Cancer Center","Louisville","40202",{"lat":242,"lon":243},38.25424,-85.75941,{"facility":245,"status":8,"city":239,"state":232,"zip":246,"country":116,"geoPoint":247},"Norton Cancer Institute","40207",{"lat":242,"lon":243},{"facility":249,"status":8,"city":250,"state":251,"zip":252,"country":116,"geoPoint":253},"Mary Bird Perkins Cancer Center","Baton Rouge","Louisiana","70809",{"lat":254,"lon":255},30.44332,-91.18747,{"facility":257,"status":8,"city":258,"state":259,"zip":260,"country":116,"geoPoint":261},"Center for Cancer and Blood Disorders","Bethesda","Maryland","20817",{"lat":262,"lon":263},38.98067,-77.10026,{"facility":265,"status":8,"city":266,"state":267,"zip":268,"country":116,"geoPoint":269},"Dana Farber Cancer Institute","Boston","Massachusetts","02115",{"lat":270,"lon":271},42.35843,-71.05977,{"facility":273,"status":8,"city":274,"state":275,"zip":276,"country":116,"geoPoint":277},"Henry Ford Health System","Detroit","Michigan","48202",{"lat":278,"lon":279},42.33143,-83.04575,{"facility":281,"status":8,"city":282,"state":275,"zip":283,"country":116,"geoPoint":284},"Trinity Health Michigan Heart - Ann Arbor Campus","Ypsilanti","48106",{"lat":285,"lon":286},42.24115,-83.61299,{"facility":288,"status":8,"city":289,"state":290,"zip":291,"country":116,"geoPoint":292},"Washington University in St Louis","St Louis","Missouri","63130",{"lat":293,"lon":294},38.62727,-90.19789,{"facility":296,"status":8,"city":297,"state":298,"zip":299,"country":116,"geoPoint":300},"Dartmouth Hitchcock Medical Center","Lebanon","New Hampshire","03756",{"lat":301,"lon":302},43.64229,-72.25176,{"facility":304,"status":8,"city":305,"state":306,"zip":307,"country":116,"geoPoint":308},"John Theurer Cancer Center at Hackensack University Medical Center","Hackensack","New Jersey","07601",{"lat":309,"lon":310},40.88593,-74.04347,{"facility":312,"status":8,"city":313,"state":314,"zip":315,"country":116,"geoPoint":316},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14263",{"lat":317,"lon":318},42.88645,-78.87837,{"facility":320,"status":8,"city":314,"state":314,"zip":321,"country":116,"geoPoint":322},"New York Presbyterian - Weill Cornell","10065",{"lat":323,"lon":324},40.71427,-74.00597,{"facility":326,"status":8,"city":327,"state":314,"zip":328,"country":116,"geoPoint":329},"University of Rochester Medical Center","Rochester","14642",{"lat":330,"lon":331},43.15478,-77.61556,{"facility":333,"status":8,"city":334,"state":314,"zip":335,"country":116,"geoPoint":336},"Einstein-Montefiore Medical Center","The Bronx","10467",{"lat":337,"lon":338},40.84985,-73.86641,{"facility":340,"status":8,"city":341,"state":342,"zip":343,"country":116,"geoPoint":344},"Atrium Health","Charlotte","North Carolina","28204",{"lat":345,"lon":346},35.22709,-80.84313,{"facility":348,"status":8,"city":341,"state":342,"zip":343,"country":116,"geoPoint":349},"Novant Health Charlotte",{"lat":345,"lon":346},{"facility":351,"status":8,"city":341,"state":342,"zip":352,"country":116,"geoPoint":353},"Carolina Oncology Specialists","28207",{"lat":345,"lon":346},{"facility":355,"status":8,"city":356,"state":342,"zip":357,"country":116,"geoPoint":358},"Novant Health Winston Salem","Winston-Salem","27106",{"lat":359,"lon":360},36.09986,-80.24422,{"facility":362,"status":8,"city":356,"state":342,"zip":363,"country":116,"geoPoint":364},"Atrium Health Wake Forest Baptist Comprehensive Cancer Center","27157",{"lat":359,"lon":360},{"facility":366,"status":8,"city":367,"state":368,"zip":369,"country":116,"geoPoint":370},"Gabrail Cancer Center","Canton","Ohio","44718",{"lat":371,"lon":372},40.79895,-81.37845,{"facility":374,"status":8,"city":375,"state":368,"zip":376,"country":116,"geoPoint":377},"Miami Valley Hospital South","Centerville","45459",{"lat":378,"lon":379},39.62839,-84.15938,{"facility":381,"status":8,"city":382,"state":368,"zip":383,"country":116,"geoPoint":384},"Oncology Hematology Care","Cincinnati","45226",{"lat":385,"lon":386},39.12711,-84.51439,{"facility":388,"status":8,"city":389,"state":368,"zip":390,"country":116,"geoPoint":391},"University Hospitals Cleveland Medical Center","Cleveland","44106",{"lat":392,"lon":393},41.4995,-81.69541,{"facility":395,"status":8,"city":389,"state":368,"zip":396,"country":116,"geoPoint":397},"Cleveland Clinic","44195",{"lat":392,"lon":393},{"facility":399,"status":8,"city":400,"state":401,"zip":402,"country":116,"geoPoint":403},"Providence Portland Medical Center","Portland","Oregon","97213",{"lat":404,"lon":405},45.52345,-122.67621,{"facility":407,"status":8,"city":400,"state":401,"zip":408,"country":116,"geoPoint":409},"Providence Oncology and Hematology Care Clinic Westside","97225",{"lat":404,"lon":405},{"facility":411,"status":8,"city":412,"state":413,"zip":414,"country":116,"geoPoint":415},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"lat":416,"lon":417},39.95238,-75.16362,{"facility":419,"status":8,"city":412,"state":413,"zip":420,"country":116,"geoPoint":421},"Fox Chase Cancer Center","19111",{"lat":416,"lon":417},{"facility":423,"status":8,"city":424,"state":413,"zip":425,"country":116,"geoPoint":426},"University of Pittsburgh Medical Center","Pittsburgh","15260",{"lat":427,"lon":428},40.44062,-79.99589,{"facility":430,"status":8,"city":431,"state":432,"zip":433,"country":116,"geoPoint":434},"University of Tennessee","Knoxville","Tennessee","37920",{"lat":435,"lon":436},35.96064,-83.92074,{"facility":438,"status":8,"city":439,"state":432,"zip":440,"country":116,"geoPoint":441},"Vanderbilt Ingram Cancer Center","Nashville","37232",{"lat":442,"lon":443},36.16589,-86.78444,{"facility":445,"status":8,"city":446,"state":447,"zip":448,"country":116,"geoPoint":449},"Baylor University Medical Center","Dallas","Texas","75246",{"lat":450,"lon":451},32.78306,-96.80667,{"facility":453,"status":8,"city":454,"state":447,"zip":455,"country":116,"geoPoint":456},"Houston Methodist Cancer Center","Houston","77030",{"lat":457,"lon":458},29.76328,-95.36327,{"facility":460,"status":8,"city":454,"state":447,"zip":455,"country":116,"geoPoint":461},"MD Anderson Cancer Center",{"lat":457,"lon":458},{"facility":463,"status":8,"city":464,"state":447,"zip":465,"country":116,"geoPoint":466},"Texas Oncology - Northeast","Tyler","75702",{"lat":467,"lon":468},32.35126,-95.30106,{"facility":470,"status":8,"city":471,"state":472,"zip":473,"country":116,"geoPoint":474},"Intermountain Healthcare LDS Hospital","Salt Lake City","Utah","84143",{"lat":475,"lon":476},40.76078,-111.89105,{"facility":478,"status":8,"city":479,"state":480,"zip":481,"country":116,"geoPoint":482},"Virginia Commonwealth University - Massey Cancer Center","Richmond","Virginia","23298",{"lat":483,"lon":484},37.55376,-77.46026,{"facility":486,"status":8,"city":487,"state":488,"zip":489,"country":116,"geoPoint":490},"Swedish Cancer Institute","Seattle","Washington","98104",{"lat":491,"lon":492},47.60621,-122.33207,{"facility":494,"status":8,"city":487,"state":488,"zip":495,"country":116,"geoPoint":496},"Fred Hutchinson Cancer Center","98109",{"lat":491,"lon":492},{"facility":498,"status":8,"city":499,"zip":500,"country":501,"geoPoint":502},"Flinders Medical Centre","Bedford Park","5042","Australia",{"lat":503,"lon":504},-35.02204,138.56815,{"facility":506,"status":8,"city":507,"zip":508,"country":501,"geoPoint":509},"Royal Prince Alfred Hospital","Camperdown","2050",{"lat":510,"lon":511},-33.88965,151.17642,{"facility":513,"status":8,"city":514,"zip":515,"country":501,"geoPoint":516},"St Vincents Hospital Melbourne","Fitzroy","3065",{"lat":517,"lon":518},-37.79839,144.97833,{"facility":520,"status":8,"city":521,"zip":522,"country":501,"geoPoint":523},"St George Hospital","Kogarah","2217",{"lat":524,"lon":525},-33.9681,151.13564,{"facility":527,"status":8,"city":528,"zip":529,"country":501,"geoPoint":530},"Peter 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Niguarda","20162",{"lat":1324,"lon":1325},42.78235,12.59836,{"facility":1327,"status":8,"city":1328,"zip":1329,"country":1288,"geoPoint":1330},"Fondazione IRCCS Policlinico San Matteo","Pavia","27100",{"lat":1331,"lon":1332},45.19205,9.15917,{"facility":1334,"status":8,"city":1335,"zip":1336,"country":1288,"geoPoint":1337},"Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia","Perugia","06132",{"lat":1338,"lon":1339},43.1122,12.38878,{"facility":1341,"status":8,"city":1342,"zip":1343,"country":1288,"geoPoint":1344},"AST Pesaro e Urbino Ospedale San Salvatore","Pesaro","61121",{"lat":1345,"lon":1346},43.90921,12.9164,{"facility":1348,"status":8,"city":1349,"zip":1350,"country":1288,"geoPoint":1351},"Ospedale S. Maria Delle Croci","Ravenna","48121",{"lat":1352,"lon":1353},44.41344,12.20121,{"facility":1355,"status":8,"city":1356,"zip":1357,"country":1288,"geoPoint":1358},"Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria","Reggio Calabria","89124",{"lat":1359,"lon":1360},38.11047,15.66129,{"facility":1362,"status":8,"city":1363,"zip":1364,"country":1288,"geoPoint":1365},"IRCCS Istituto Clinico Humanitas","Rozzano","20089",{"lat":1366,"lon":1367},45.38193,9.1559,{"facility":1369,"status":8,"city":1370,"zip":1371,"country":1288,"geoPoint":1372},"Casa Sollievo Della Sofferenza IRCCS","San Giovanni Rotondo","71013",{"lat":1373,"lon":1374},41.70643,15.7277,{"facility":1376,"status":8,"city":1377,"zip":1378,"country":1288,"geoPoint":1379},"Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino","Torino","10126",{"lat":1380,"lon":1381},44.88856,11.99138,{"facility":1383,"status":8,"city":1384,"zip":1385,"country":1386,"geoPoint":1387},"Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital","Bunkyō City","113 8677","Japan",{"lat":1388,"lon":1389},35.5331,139.4217,{"facility":1391,"status":8,"city":1392,"zip":1393,"country":1386,"geoPoint":1394},"Kyushu University Hospital","Fukuoka","812 8582",{"lat":1395,"lon":1396},33.6,130.41667,{"facility":1398,"status":8,"city":1399,"zip":1400,"country":1386,"geoPoint":1401},"Fukushima Medical University Hospital","Fukushima","960 1295",{"lat":1402,"lon":1403},37.75,140.46667,{"facility":1405,"status":8,"city":1406,"zip":1407,"country":1386,"geoPoint":1408},"Gifu Municipal Hospital","Gifu","500-8513",{"lat":1409,"lon":1410},35.42291,136.76039,{"facility":1412,"status":8,"city":1413,"zip":1414,"country":1386,"geoPoint":1415},"Kanazawa University Hospital","Kanazawa","920-8641",{"lat":1416,"lon":1417},36.6,136.61667,{"facility":1419,"status":8,"city":1420,"zip":1421,"country":1386,"geoPoint":1422},"Kobe City Medical Center General Hospital","Kobe","650 0047",{"lat":1423,"lon":1424},34.6913,135.183,{"facility":1426,"status":8,"city":1427,"zip":1428,"country":1386,"geoPoint":1429},"National Hospital Organization Kumamoto Medical Center","Kumamoto","860-0008",{"lat":1430,"lon":1431},32.80589,130.69181,{"facility":1433,"status":8,"city":1434,"zip":1435,"country":1386,"geoPoint":1436},"Gunmaken Saiseikai Maebashi Hospital","Maebashi","371-0821",{"lat":1437,"lon":1438},36.4,139.08333,{"facility":1440,"status":8,"city":1441,"zip":1442,"country":1386,"geoPoint":1443},"Nagoya University Hospital","Nagoya","466 8560",{"lat":1444,"lon":1445},35.18147,136.90641,{"facility":1447,"status":8,"city":1448,"zip":1449,"country":1386,"geoPoint":1450},"Okayama University Hospital","Okayama","700 8558",{"lat":1451,"lon":1452},34.65,133.93333,{"facility":1454,"status":8,"city":1455,"zip":1456,"country":1386,"geoPoint":1457},"Japanese Red Cross Osaka Hospital","Osaka","543 8555",{"lat":1458,"lon":1459},34.69379,135.50107,{"facility":1461,"status":8,"city":1462,"zip":1463,"country":1386,"geoPoint":1464},"Aiiku Hospital","Sapporo","064 0804",{"lat":1465,"lon":1466},43.06667,141.35,{"facility":1468,"status":8,"city":1469,"zip":1470,"country":1386,"geoPoint":1471},"Tohoku University Hospital","Sendai","980 8574",{"lat":1472,"lon":1473},38.26667,140.86667,{"facility":1475,"status":8,"city":1476,"zip":1477,"country":1386,"geoPoint":1478},"Nippon Medical School Hospital","Tokyo","113 8603",{"lat":1479,"lon":1480},35.6895,139.69171,{"facility":1482,"status":8,"city":1483,"zip":1484,"country":1386,"geoPoint":1485},"Yamagata University Hospital","Yamagata","990 2331",{"lat":1486,"lon":1487},38.23333,140.36667,{"facility":1489,"status":8,"city":1490,"zip":1491,"country":1386,"geoPoint":1492},"University of Fukui Hospital","Yoshida","910-1193",{"lat":1493,"lon":1494},30.43252,130.46235,{"facility":1496,"status":8,"city":1497,"zip":1498,"country":1499,"geoPoint":1500},"Centro de Investigacion Clinica Chapultepec","Mexico City","04100","Mexico",{"lat":1501,"lon":1502},19.42847,-99.12766,{"facility":1504,"status":8,"city":1497,"zip":1505,"country":1499,"geoPoint":1506},"Instituto Nacional de Cancerologia","14080",{"lat":1501,"lon":1502},{"facility":1508,"status":8,"city":1497,"zip":1505,"country":1499,"geoPoint":1509},"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran",{"lat":1501,"lon":1502},{"facility":1511,"status":8,"city":1512,"zip":1513,"country":1514,"geoPoint":1515},"Uniwersytecki Szpital Kliniczny w Bialymstoku","Bialystok","15 276","Poland",{"lat":1516,"lon":1517},53.13333,23.16433,{"facility":1519,"status":8,"city":1520,"zip":1521,"country":1514,"geoPoint":1522},"Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy","Bydgoszcz","85-168",{"lat":1523,"lon":1524},53.1235,18.00762,{"facility":1526,"status":8,"city":1527,"zip":1528,"country":1514,"geoPoint":1529},"Uniwersyteckie Centrum Kliniczne","Gdansk","80 214",{"lat":1530,"lon":1531},54.35227,18.64912,{"facility":1533,"status":8,"city":1534,"zip":1535,"country":1514,"geoPoint":1536},"Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach","Kielce","25 734",{"lat":1537,"lon":1538},50.87033,20.62752,{"facility":1540,"status":8,"city":1541,"zip":1542,"country":1514,"geoPoint":1543},"Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi","Lodz","93 513",{"lat":1544,"lon":1545},51.77058,19.47395,{"facility":1547,"status":8,"city":1548,"zip":1549,"country":1514,"geoPoint":1550},"Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu","Wroclaw","50 367",{"lat":1551,"lon":1552},51.10286,17.03006,{"facility":1554,"status":8,"city":1555,"zip":1556,"country":1557,"geoPoint":1558},"Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos","Lisbon","1169 050","Portugal",{"lat":1559,"lon":1560},38.72509,-9.1498,{"facility":1562,"status":8,"city":1555,"zip":1563,"country":1557,"geoPoint":1564},"Uls Santa Maria Hosp. Santa Maria","1649 028",{"lat":1559,"lon":1560},{"facility":1566,"status":8,"city":1567,"zip":1568,"country":1557,"geoPoint":1569},"Uls Santo Antonio - Hosp. Santo Antonio","Porto","4099 001",{"lat":1570,"lon":1571},41.1485,-8.61097,{"facility":1573,"status":8,"city":1567,"zip":1574,"country":1557,"geoPoint":1575},"Instituto Portugues de Oncologia Porto","4200 072",{"lat":1570,"lon":1571},{"facility":1577,"status":8,"city":1567,"zip":1578,"country":1557,"geoPoint":1579},"Uls Sao Joao - Hosp. Sao Joao","4200 319",{"lat":1570,"lon":1571},{"facility":1581,"status":8,"city":1582,"zip":1583,"country":1584,"geoPoint":1585},"Chungnam National University Hospital","Daejeon","35015","South Korea",{"lat":1586,"lon":1587},36.34913,127.38493,{"facility":1589,"status":8,"city":1590,"zip":1591,"country":1584,"geoPoint":1592},"National Cancer Center","Goyang-si","10408",{"lat":1593,"lon":1594},37.65639,126.835,{"facility":1596,"status":8,"city":1597,"zip":1598,"country":1584,"geoPoint":1599},"Seoul National University Bundang Hospital","Gyeonggi-do","13620",{"lat":1600,"lon":1601},37.58944,126.76917,{"facility":1603,"status":8,"city":1604,"zip":1605,"country":1584,"geoPoint":1606},"Seoul National University Hospital","Seoul","03080",{"lat":1607,"lon":1608},37.566,126.9784,{"facility":1610,"status":8,"city":1604,"zip":1611,"country":1584,"geoPoint":1612},"Asan Medical Center","05505",{"lat":1607,"lon":1608},{"facility":1614,"status":8,"city":1604,"zip":1615,"country":1584,"geoPoint":1616},"Samsung Medical Center","06351",{"lat":1607,"lon":1608},{"facility":1618,"status":8,"city":1604,"zip":1619,"country":1584,"geoPoint":1620},"The Catholic University of Korea Seoul St Marys Hospital","137 701",{"lat":1607,"lon":1608},{"facility":1622,"status":8,"city":1623,"zip":1624,"country":1625,"geoPoint":1626},"Hosp Univ A Coruna","A Coruña","15006","Spain",{"lat":1627,"lon":1628},43.37135,-8.396,{"facility":1630,"status":8,"city":1631,"zip":1632,"country":1625,"geoPoint":1633},"Hosp Univ Vall D Hebron","Barcelona","08035",{"lat":1634,"lon":1635},41.38879,2.15899,{"facility":1637,"status":8,"city":1631,"zip":1638,"country":1625,"geoPoint":1639},"Hosp. Clinic de Barcelona","08036",{"lat":1634,"lon":1635},{"facility":1641,"status":8,"city":1631,"zip":1642,"country":1625,"geoPoint":1643},"Hosp. de La Santa Creu I Sant Pau","08041",{"lat":1634,"lon":1635},{"facility":1645,"status":8,"city":1646,"zip":1647,"country":1625,"geoPoint":1648},"Hosp. San Pedro de Alcantara","Cáceres","10003",{"lat":1649,"lon":1650},39.47649,-6.37224,{"facility":1652,"status":8,"city":1653,"zip":1654,"country":1625,"geoPoint":1655},"Hosp. de Jerez de La Frontera","Jerez de la Frontera","11407",{"lat":1656,"lon":1657},36.68645,-6.13606,{"facility":1659,"status":8,"city":1660,"zip":1661,"country":1625,"geoPoint":1662},"Inst. Cat. Doncologia-H Duran I Reynals","L'Hospitalet de Llobregat","08908",{"lat":1663,"lon":1664},41.35967,2.10028,{"facility":1666,"status":8,"city":1667,"zip":1668,"country":1625,"geoPoint":1669},"Clinica Univ. de Navarra Madrid","Madrid","28027",{"lat":1670,"lon":1671},40.4165,-3.70256,{"facility":1673,"status":8,"city":1667,"zip":1674,"country":1625,"geoPoint":1675},"Hosp. Univ. Ramon Y Cajal","28034",{"lat":1670,"lon":1671},{"facility":1677,"status":8,"city":1667,"zip":1678,"country":1625,"geoPoint":1679},"Hosp. Univ. 12 de Octubre","28041",{"lat":1670,"lon":1671},{"facility":1681,"status":8,"city":1682,"zip":1683,"country":1625,"geoPoint":1684},"Clinica Univ. de Navarra","Pamplona","31008",{"lat":1685,"lon":1686},42.81687,-1.64323,{"facility":1688,"status":8,"city":1689,"zip":1690,"country":1625,"geoPoint":1691},"Hosp. Quiron Madrid Pozuelo","Pozuelo de Alarcón","28223",{"lat":1692,"lon":1693},40.43293,-3.81338,{"facility":1695,"status":8,"city":1696,"zip":1697,"country":1625,"geoPoint":1698},"Hosp Clinico Univ de Salamanca","Salamanca","37007",{"lat":1699,"lon":1700},40.96882,-5.66388,{"facility":1702,"status":8,"city":1703,"zip":1704,"country":1625,"geoPoint":1705},"Hosp. Univ. Marques de Valdecilla","Santander","39008",{"lat":1706,"lon":1707},43.46589,-3.80493,{"facility":1709,"status":8,"city":1710,"zip":1711,"country":1625,"geoPoint":1712},"Hosp. Virgen Del Rocio","Seville","41013",{"lat":1713,"lon":1714},37.38283,-5.97317,{"facility":1716,"status":8,"city":1717,"zip":1718,"country":1625,"geoPoint":1719},"Hosp. Univ. I Politecni La Fe","Valencia","46026",{"lat":1720,"lon":1721},39.47391,-0.37966,{"facility":1723,"status":8,"city":1724,"zip":1725,"country":1726,"geoPoint":1727},"Kaohsiung Chang Gung Memorial Hospital","Kaohsiung City","833","Taiwan",{"lat":1728,"lon":1729},22.61626,120.31333,{"facility":1731,"status":8,"city":1732,"zip":1733,"country":1726,"geoPoint":1734},"Chi Mei Medical Center Liouying Branch","Tainan","736",{"lat":1735,"lon":1736},22.99083,120.21333,{"facility":1738,"status":8,"city":1739,"zip":1740,"country":1726,"geoPoint":1741},"National Taiwan University Hospital","Taipei","100",{"lat":1742,"lon":1743},25.05306,121.52639,{"facility":1745,"status":8,"city":1746,"zip":1747,"country":1726,"geoPoint":1748},"Linkou Chang Gung Memorial Hospital","Taoyuan","333",{"lat":1749,"lon":1750},24.99368,121.29696,{"facility":1752,"status":8,"city":1753,"zip":1754,"country":1755,"geoPoint":1756},"Ankara Etlik Sehir Hastanesi","Ankara","06170","Turkey (Türkiye)",{"lat":1757,"lon":1758},39.91987,32.85427,{"facility":1760,"status":8,"city":1753,"zip":1761,"country":1755,"geoPoint":1762},"Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital","06200",{"lat":1757,"lon":1758},{"facility":1764,"status":8,"city":1753,"zip":1765,"country":1755,"geoPoint":1766},"Ankara University School of Medicine Cebeci Hospital","06590",{"lat":1757,"lon":1758},{"facility":1768,"status":8,"city":1769,"zip":1770,"country":1755,"geoPoint":1771},"Memorial Antalya Hospital","Antalya","07025",{"lat":1772,"lon":1773},36.90812,30.69556,{"facility":1775,"status":8,"city":1776,"zip":1777,"country":1755,"geoPoint":1778},"Koc University Medical Faculty","Istanbul","34010",{"lat":1779,"lon":1780},41.01384,28.94966,{"facility":1782,"status":8,"city":1783,"zip":1784,"country":1755,"geoPoint":1785},"VM Medical Park Mersin Hospital","Mersin","33200",{"lat":1786,"lon":1787},36.81196,34.63886,{"facility":1789,"status":8,"city":1790,"zip":1791,"country":1755,"geoPoint":1792},"Sakarya University Training and Research Hospital","Sakarya","54100",{"lat":1793,"lon":1794},39.50333,32.07583,{"facility":1796,"status":8,"city":1797,"zip":1798,"country":1755,"geoPoint":1799},"Ondokuz Mayis University","Samsun","55139",{"lat":1800,"lon":1801},41.27976,36.3361,{"facility":1803,"status":8,"city":1804,"zip":1805,"country":1806,"geoPoint":1807},"Royal Sussex County Hospital","Brighton","BN2 5BE","United Kingdom",{"lat":1808,"lon":1809},50.82838,-0.13947,{"facility":1811,"status":8,"city":1812,"zip":1813,"country":1806,"geoPoint":1814},"Addenbrookes Hospital","Cambridge","CB2 0QQ",{"lat":1815,"lon":1816},52.2,0.11667,{"facility":1818,"status":8,"city":1819,"zip":1820,"country":1806,"geoPoint":1821},"Kent and Canterbury Hospital","Canterbury","CT1 3NG",{"lat":1822,"lon":1823},51.27904,1.07992,{"facility":1825,"status":8,"city":1826,"zip":1827,"country":1806,"geoPoint":1828},"Colchester Hospital University NHS","Colchester","CO4 5JL",{"lat":1829,"lon":1830},51.88921,0.90421,{"facility":1832,"status":8,"city":1833,"zip":1834,"country":1806,"geoPoint":1835},"Western General Hospital","Edinburgh","EH4 2XU",{"lat":1836,"lon":1837},55.95206,-3.19648,{"facility":1839,"status":8,"city":1840,"zip":1841,"country":1806,"geoPoint":1842},"The Clatterbridge Cancer Centre","Liverpool","L7 8YA",{"lat":1843,"lon":1844},53.41058,-2.97794,{"facility":1846,"status":8,"city":730,"zip":1847,"country":1806,"geoPoint":1848},"Guys' and St Thomas' NHS Trust","SE1 9RT",{"lat":1849,"lon":1850},51.50853,-0.12574,{"facility":1852,"status":8,"city":1853,"zip":1854,"country":1806,"geoPoint":1855},"Derriford Hospital","Plymouth","PL6 8DH",{"lat":1856,"lon":1857},50.37153,-4.14305,{"facility":1859,"status":8,"city":1860,"zip":1861,"country":1806,"geoPoint":1862},"Worthing Hospital","Worthing","BN11 2DH",{"lat":1863,"lon":1864},50.81795,-0.37538,[1866],{"name":1867,"role":1868,"phone":1869,"email":1870},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[1872],{"name":1873,"affiliation":13,"role":1874},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":1878,"biomarkers":1880},[1879],"Acute Myeloid Leukemia",[1881,1882],"KMT2A Gene","NPM1 Gene",{"nct_id":4,"found":15,"summary":1884,"prompt_version":1894},{"design":1885,"status":1886,"heading":1887,"summary":1888,"follow_up":1889,"word_count":1890,"commitments":1891,"compensation":1892,"drugs_mentioned":1893},"This study plans to enroll 600 participants. It compares different drug combinations, including bleximenib, Venetoclax, Azacitidine, and a placebo.","completed","A Study of Bleximenib, Venetoclax, and Azacitidine for Newly Diagnosed AML","This study is for people newly diagnosed with acute myeloid leukemia (AML) who have specific gene changes (KMT2Ar or NPM1m) and cannot receive intensive chemotherapy. It is testing a new drug, bleximenib, along with two existing drugs, Venetoclax and Azacitidine. Researchers want to see if this combination works better than Venetoclax and Azacitidine alone, or with a placebo (an inactive substance). The main goals are to see how many participants achieve complete remission (when signs of cancer disappear) and how long participants live. This study plans to enroll 600 participants.","Participants will be followed for up to 4 years and 1 month to assess outcomes like complete remission and overall survival.",90,"Not specified in the trial record.","Not stated in the trial record.",[31,47],"v2"]