[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06652438":3,"trial-entities:NCT06652438":1935,"trial-summary:NCT06652438":1941},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":50,"sex":78,"minimum_age":79,"maximum_age":17,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":111,"locations":114,"central_contacts":1918,"overall_officials":1927,"references":1930,"see_also_links":1931},"NCT06652438","HO177","Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML","Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy","RECRUITING","2032-08-27","2026-07","2026-08-03","2025-05-05","Stichting Hemato-Oncologie voor Volwassenen Nederland","OTHER",true,"Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need. The combination therapy with two medicines, azacitidine and venetoclax, is the usual plan of action. This has brought significant progress in the treatment, but it nevertheless is not curative and the disease does relapse over time.\n\nRevumenib blocks a specific molecule called menin in the cell nucleus. Some types of AML are reliant on menin working properly. These are leukemia cells with a change in the DNA, i.e. a mutation in the NPM1 or KMT2A gene. Revumenib can prevent the production of these types of leukemia cells by disrupting the production of this menin.\n\nThe current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene.\n\nThis is a randomized, double-blind, placebo-controlled clinical study where subjects will be treated until disease progression, or development of side effects or death. From the moment of inclusion of the last patient, there will be a 4-year observational follow-up study in order to register survival duration and follow-up visits.\n\nApproximately 448 previously untreated patients with a mutation in the NPM1 or KMT2A gene and with newly diagnosed AML, who are not eligible for intensive chemotherapy. Patients must be ≥18 years of age.",null,[19],"Acute Myeloid Leukemia, Adult",[21,22,23],"newly AML diagnosed","NPM1","KMT2A","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},448,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Revumenib","day 1- 28 per cycle",[34],{"type":33,"name":38,"description":35,"armGroupLabels":39},"Placebo",[40],"Revumenib-placebo",[42,46],{"measure":43,"description":44,"timeFrame":45},"Overall survival (OS) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy.","To assess if treatment with revumenib, in combination with azacitidine and venetoclax, prolongs overall survival (OS) measured from the date of randomization to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.","58 months after last patient inclusion",{"measure":47,"description":48,"timeFrame":49},"Rate of CR in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","Defined as the proportion of NPM1-mutated AML patients who achieve CR at any time-point during protocol therapy.","58 months after the first randomized NPM1-mutated AML patient",[51,55,58,61,64,67,70,73,76],{"measure":52,"description":53,"timeFrame":54},"Event-free survival (EFS) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy.","Assess if treatment with revumenib, in combination with azacitidine and venetoclax, prolongs event-free survival (EFS); measured from the date of randomization to the date of treatment failure, hematologic relapse from CR\u002FCRh or death from any cause, whichever occurs first. Treatment failure is defined as lack of obtaining either CR or CRh by week 24.","58 months after the first NPM1-mutated AML patient has been randomized",{"measure":56,"description":57,"timeFrame":49},"Rate of CR\u002FCRh in adult patients with newly diagnosed NPM1mutated AML ineligible for intensive chemotherapy,","Defined as the proportion of NPM1-mutated AML patients who achieve CR or CRh at any time-point during protocol therapy.",{"measure":59,"description":60,"timeFrame":49},"Rate of response (CRh and CR\u002FCRi) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","Rate of response (CRh and CR\u002FCRi) is defined as the proportion of patients with response at any time-point during protocol therapy.",{"measure":62,"description":63,"timeFrame":49},"Rates of CRMRD-, CR\u002FCRhMRD-, and CR\u002FCRiMRD- assessed by quantitative PCR of bone marrow in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","defined as the proportion of NPM1-mutated AML patients with CRMRD-, CR\u002FCRhMRD- and CR\u002FCRiMRD- by PCR of bone marrow, respectively, at any time-point during protocol therapy.",{"measure":65,"description":66,"timeFrame":49},"Rates of CRMRD-, CR\u002FCRhMRD-, and CR\u002FCRiMRD- assessed by quantitative PCR of peripheral blood in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","defined as the proportion of NPM1-mutated AML patients with CRMRD-, CR\u002FCRhMRD- and CR\u002FCRiMRD- by PCR of peripheral blood, respectively, at any time-point during protocol therapy.",{"measure":68,"description":69,"timeFrame":49},"Time to achievement of response (CR, CR\u002FCRh and CR\u002FCRi) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","measured as the time from randomization to 1st occurrence of response.",{"measure":71,"description":72,"timeFrame":49},"Duration of response (CR, CR\u002FCRh and CR\u002FCRi; DoR) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","measured from the date of achievement of response until the date of hematologic relapse or death from any cause.",{"measure":74,"description":75,"timeFrame":49},"QoL in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy","Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a 0 to 100 scale. For the Global Health Status\u002FQuality of Life scale and functional scales, higher scores indicate better quality of life\u002Ffunctioning; for symptom scales, higher scores indicate worse symptoms.",{"measure":74,"description":77,"timeFrame":49},"Health-related quality of life was assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system generates a health utility index score based on country-specific value sets. Higher utility values indicate better health status. The EQ Visual Analogue Scale (EQ VAS), if reported, ranges from 0 to 100, where higher scores indicate better perceived health.","ALL","18 Years",false,{"inclusion":82,"exclusion":100,"raw_text":110},[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"≥ 75 years of age: ineligible for intensive chemotherapy per physician's discretion (with an ECOG performance status 0-2) .","18-74 years: patient is not eligible for standard chemotherapy because any of the following co-morbidities:","ECOG performance status 2 or 3 .","Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina.","DLCO ≤ 65% or FEV1 ≤ 65%.","Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C45 ml\u002Fmin calculated by the Cockcroft Gault formula.","Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C 3.0 x upper limit of normal (ULN).","Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor's (co-) Principal Investigator (written approval must be sent to HO177@erasmusmc.nl before study enrolment). 5. Patient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician). 6. Patient must have a white cell blood (WBC) count of \\\u003C 25 x 109\u002FL. Hydroxyurea can be used prior to study enrolment to reduce the WBC count to meet this criterion. 7. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \\>30 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR). 8. Adequate hepatic function as evidenced by:","Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease, or leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).","Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl). 9. Female patient must:","be of nonchildbearing potential: o postmenopausal (defined as at least 1 year without any menses). o documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening).","or, if of childbearing potential (not surgically sterile and not postmenopausal) agree to avoid pregnancy during the study and for 6 months after the final study drug administration.","and have a negative urine or serum pregnancy test at screening.","and, if heterosexually active, agree to consistently apply one highly effective\\* method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration.","Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.","agree not to breastfeed starting at screening and throughout the study period.","agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration. 10. Men must use a latex condom during any sexual contact with women of childbearing potential (WOCBP), even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control. 11. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration. 12. Able to understand and willing to sign an informed consent form (ICF). 13. Institutional Review Board\u002FIndependent Ethics Committee-approved written informed consent as per national regulations must be obtained from the patient prior to any study-related procedures (including consent for withdrawal of prohibited medication, if applicable).",[101,102,103,104,105,106,107,108,109],"New York Heart Association (NYHA) class III or IV congestive heart failure","Myocardial infarction","Unstable angina","Severe cardiac arrhythmias","Congenital long QT syndrome of family member with this condition QTcF \\>450 msec on screening electrogram for males and \\>470msec on screening electrogram for females (mean of triplicate recordings; calculated using Fridericia's correction). 5. Severe obstructive or restrictive ventilation disorder. 6. History of stroke or intracranial hemorrhage within 6 months prior to randomization.","Basal or squamous cell carcinoma of the skin;","Carcinoma in situ of the cervix;","Carcinoma in situ of the breast;","Incidental histologic finding of prostate cancer. 12. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patient, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n1. Patient with newly diagnosed NPM1-mutated AML, consistent with NPM1c, according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts).\n\n   OR Patient with newly diagnosed KMT2A-rearranged AML according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts). KMT2A partial tandem duplications or deletions are NOT eligible.\n\n   Of note: in case both NPM1 and IDH1 are mutated and both EVOLVE-1 (HO173) and EVOLVE-2 (HO177) are open for inclusion at your site, then patients can only be included in the EVOLVE-1 trial (HO173)\n2. Central confirmation of NPM1 mutation or KMT2A rearrangement in one of the dedicated central genetic laboratories.\n3. Age ≥ 18 years, no upper age limit.\n4. Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:\n\n   * ≥ 75 years of age: ineligible for intensive chemotherapy per physician's discretion (with an ECOG performance status 0-2) .\n   * 18-74 years: patient is not eligible for standard chemotherapy because any of the following co-morbidities:\n\n     * ECOG performance status 2 or 3 .\n     * Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina.\n     * DLCO ≤ 65% or FEV1 ≤ 65%.\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C45 ml\u002Fmin calculated by the Cockcroft Gault formula.\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C 3.0 x upper limit of normal (ULN).\n     * Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor's (co-) Principal Investigator (written approval must be sent to HO177@erasmusmc.nl before study enrolment).\n5. Patient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician).\n6. Patient must have a white cell blood (WBC) count of \\\u003C 25 x 109\u002FL. Hydroxyurea can be used prior to study enrolment to reduce the WBC count to meet this criterion.\n7. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \\>30 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR).\n8. Adequate hepatic function as evidenced by:\n\n   * Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease, or leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n9. Female patient must:\n\n   * be of nonchildbearing potential: o postmenopausal (defined as at least 1 year without any menses). o documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening).\n   * or, if of childbearing potential (not surgically sterile and not postmenopausal) agree to avoid pregnancy during the study and for 6 months after the final study drug administration.\n\n     * and have a negative urine or serum pregnancy test at screening.\n     * and, if heterosexually active, agree to consistently apply one highly effective\\* method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration.\n\n       \\*Highly effective forms of birth control include\n\n       \\- Consistent and correct usage of established hormonal contraceptives that inhibit ovulation for at least 1 month prior to taking study drug. (hormonal contraception is only a highly effective method of birth control, if a combined \\[estrogen and progestogen containing\\] hormonal contraception or a progestogen-only hormonal contraception - both associated with inhibition of ovulation - is used.\n\n       \\- Established intrauterine device (IUD) or intrauterine system (IUS)\n\n       \\- Bilateral tubal occlusion\n\n       \\- Vasectomy - a vasectomy is highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n\n       \\- Male is sterile due to a bilateral orchiectomy.\n       * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.\n\n   List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period.\n   * agree not to breastfeed starting at screening and throughout the study period.\n   * agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.\n10. Men must use a latex condom during any sexual contact with women of childbearing potential (WOCBP), even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control.\n11. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.\n12. Able to understand and willing to sign an informed consent form (ICF).\n13. Institutional Review Board\u002FIndependent Ethics Committee-approved written informed consent as per national regulations must be obtained from the patient prior to any study-related procedures (including consent for withdrawal of prohibited medication, if applicable).\n\nExclusion Criteria:\n\nSubject has previously been treated for AML; a treatment period with hydroxyurea to control WBC counts is allowed; prior treatment with a hypomethylating agent for MDS-EB is not allowed; prior treatment with erythropoiesis-stimulating agents or luspatercept for MDS is allowed.\n\n2\\. Acute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations \u002F fusion genes. 3. AML with BCR-ABL1; or myeloid blast crisis of CML. 4. Significant active cardiac disease within 3 months prior to the start of study treatment, including:\n\n* New York Heart Association (NYHA) class III or IV congestive heart failure\n* Myocardial infarction\n* Unstable angina\n* Severe cardiac arrhythmias\n* Congenital long QT syndrome of family member with this condition QTcF \\>450 msec on screening electrogram for males and \\>470msec on screening electrogram for females (mean of triplicate recordings; calculated using Fridericia's correction). 5. Severe obstructive or restrictive ventilation disorder. 6. History of stroke or intracranial hemorrhage within 6 months prior to randomization.\n\n  7\\. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening. 8. Active infection, including hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial; an infection controlled with an approved antibiotic\u002F antiviral\u002F antifungal treatment that is not a strong or moderate CYP3A inducer is allowed. Patients with COVID-19 infection can be enrolled, if the patient has no symptoms and was tested negative twice by PCR test prior to inclusion in the trial. 9. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation. 10. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n\n  11\\. Patient with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C 30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n* Basal or squamous cell carcinoma of the skin;\n* Carcinoma in situ of the cervix;\n* Carcinoma in situ of the breast;\n* Incidental histologic finding of prostate cancer. 12. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patient, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).\n\n  13\\. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n\n  14\\. Contraindication to AZA or VEN (as per Summary of Product Characteristics (SmPC)).\n\n  15\\. Patient weighing \\\u003C40 kg at registration. 16. Participation in other prospective studies with anti-leukemic and\u002For investigational agents.\n\n  17\\. Patient taking Dabigatran unless they can be transferred to other medications within ≥5 half-lives prior to dosing. Patients taking other P-gP transporter-sensitive medications (see Appendix H) should be properly monitored during the study if they cannot be transferred to other medications.\n\n  18\\. Patient taking known strong cytochrome P450 (CYP) 3A4 inducers (see Appendix G), unless they can be transferred to other medications within ≥5 half-lives prior to dosing.\n\n  19\\. The patient is a pregnant or lactating woman, or plans to become pregnant during the study.\n\n  20\\. Patient who has once been screened and randomized into this HO177 trial but was considered ineligible cannot re-enter this trial at a later date.",[112,113],"ADULT","OLDER_ADULT",[115,129,139,150,161,172,183,194,204,215,226,236,247,258,269,280,291,301,310,319,328,337,343,350,356,365,371,381,390,399,408,418,427,436,442,448,457,466,475,484,493,503,512,521,530,540,549,559,568,577,586,596,605,614,623,632,641,650,659,668,677,686,695,704,713,722,731,740,749,758,767,776,786,791,797,806,815,824,833,842,851,860,869,878,890,899,905,914,923,932,941,950,959,968,977,986,995,1004,1013,1022,1031,1040,1049,1059,1068,1074,1080,1086,1095,1104,1114,1123,1132,1141,1150,1159,1168,1177,1186,1192,1201,1210,1220,1230,1239,1248,1254,1263,1272,1281,1290,1295,1304,1313,1322,1331,1340,1349,1358,1367,1376,1385,1394,1403,1412,1422,1431,1434,1443,1452,1461,1470,1480,1489,1495,1501,1507,1513,1519,1528,1537,1546,1555,1564,1573,1583,1592,1601,1610,1620,1629,1638,1647,1656,1665,1675,1684,1693,1702,1711,1720,1729,1738,1747,1756,1765,1774,1783,1792,1801,1810,1816,1822,1831,1837,1846,1855,1864,1873,1882,1891,1900,1909],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":126},"US-Los Angeles CA-UCLA","NOT_YET_RECRUITING","Los Angeles","California","90095","United States",[123],{"name":124,"role":125},"G. Schiller","CONTACT",{"lat":127,"lon":128},34.05223,-118.24368,{"facility":130,"status":117,"city":131,"state":119,"zip":132,"country":121,"contacts":133,"geoPoint":136},"US-San Francisco CA-UCSF","San Francisco","94143",[134],{"name":135,"role":125},"R. Olin",{"lat":137,"lon":138},37.77493,-122.41942,{"facility":140,"status":117,"city":141,"state":142,"zip":143,"country":121,"contacts":144,"geoPoint":147},"US-Jacksonville FL-MAYOFL","Jacksonville","Florida","32224",[145],{"name":146,"role":125},"J. Foran",{"lat":148,"lon":149},30.33218,-81.65565,{"facility":151,"status":8,"city":152,"state":153,"zip":154,"country":121,"contacts":155,"geoPoint":158},"US-Atlanta GA-EMORY","Atlanta","Georgia","30322",[156],{"name":157,"role":125},"William Blum",{"lat":159,"lon":160},33.749,-84.38798,{"facility":162,"status":117,"city":163,"state":164,"zip":165,"country":121,"contacts":166,"geoPoint":169},"US-Kansas City KS-KUMC","Kansas City","Kansas","66160",[167],{"name":168,"role":125},"T Lin",{"lat":170,"lon":171},39.11417,-94.62746,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":121,"contacts":177,"geoPoint":180},"US-Baltimore MD-UMGCCC","Baltimore","Maryland","21201",[178],{"name":179,"role":125},"M. Baer",{"lat":181,"lon":182},39.29038,-76.61219,{"facility":184,"status":117,"city":185,"state":186,"zip":187,"country":121,"contacts":188,"geoPoint":191},"US-Rochester MN-MAYOMN","Rochester","Minnesota","55905",[189],{"name":190,"role":125},"A. Al-Kali",{"lat":192,"lon":193},44.02163,-92.4699,{"facility":195,"status":117,"city":196,"state":196,"zip":197,"country":121,"contacts":198,"geoPoint":201},"US-New York-MSKCC","New York","10065",[199],{"name":200,"role":125},"E. Stein",{"lat":202,"lon":203},40.71427,-74.00597,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":121,"contacts":209,"geoPoint":212},"US-Chapel Hill-UNCNORTHCAROLINA","Chapel Hill","North Carolina","27599",[210],{"name":211,"role":125},"J. Zeidner",{"lat":213,"lon":214},35.9132,-79.05584,{"facility":216,"status":8,"city":217,"state":218,"zip":219,"country":121,"contacts":220,"geoPoint":223},"US-Cincinnati OH-CINCY","Cincinnati","Ohio","45219",[221],{"name":222,"role":125},"E. Curran",{"lat":224,"lon":225},39.12711,-84.51439,{"facility":227,"status":117,"city":228,"state":218,"zip":229,"country":121,"contacts":230,"geoPoint":233},"US-Colombus OH-OSU","Columbus","43210",[231],{"name":232,"role":125},"S. Handa",{"lat":234,"lon":235},39.96118,-82.99879,{"facility":237,"status":117,"city":238,"state":239,"zip":240,"country":121,"contacts":241,"geoPoint":244},"US-Portland OR-OHSU","Portland","Oregon","97239",[242],{"name":243,"role":125},"R. Swords",{"lat":245,"lon":246},45.52345,-122.67621,{"facility":248,"status":117,"city":249,"state":250,"zip":251,"country":121,"contacts":252,"geoPoint":255},"US-Pittsburgh PA-PITT","Pittsburgh","Pennsylvania","15232",[253],{"name":254,"role":125},"A. Im",{"lat":256,"lon":257},40.44062,-79.99589,{"facility":259,"status":117,"city":260,"state":261,"zip":262,"country":121,"contacts":263,"geoPoint":266},"US-Providence RI-BROWN","Providence","Rhode Island","02903",[264],{"name":265,"role":125},"A. 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Errico",{"lat":1853,"lon":1854},52.9536,-1.15047,{"facility":1856,"status":8,"city":1857,"country":1668,"contacts":1858,"geoPoint":1861},"Churchill Hospital, Oxford","Oxford",[1859],{"name":1860,"role":125},"P. Vyas",{"lat":1862,"lon":1863},51.75222,-1.25596,{"facility":1865,"status":8,"city":1866,"country":1668,"contacts":1867,"geoPoint":1870},"Southampton General Hospital","Southampton",[1868],{"name":1869,"role":125},"S. Narayanan",{"lat":1871,"lon":1872},50.90395,-1.40428,{"facility":1874,"status":117,"city":1875,"country":1668,"contacts":1876,"geoPoint":1879},"UK-Stoke on Trent-UHNM","Stoke-on-Trent",[1877],{"name":1878,"role":125},"S. Pillai",{"lat":1880,"lon":1881},53.00415,-2.18538,{"facility":1883,"status":8,"city":1884,"country":1668,"contacts":1885,"geoPoint":1888},"The Royal Marsden NHSFT","Sutton",[1886],{"name":1887,"role":125},"D. Taussig",{"lat":1889,"lon":1890},51.35,-0.2,{"facility":1892,"status":117,"city":1893,"country":1668,"contacts":1894,"geoPoint":1897},"UK-Swindon-GWH","Swindon",[1895],{"name":1896,"role":125},"A. Sternberg",{"lat":1898,"lon":1899},51.55797,-1.78116,{"facility":1901,"status":117,"city":1902,"country":1668,"contacts":1903,"geoPoint":1906},"UK-Cornwall-RCH","Truro",[1904],{"name":1905,"role":125},"R. Witherall",{"lat":1907,"lon":1908},50.26526,-5.05436,{"facility":1910,"status":8,"city":1911,"country":1668,"contacts":1912,"geoPoint":1915},"New cross hospital wolverhampton","Wolverhampton",[1913],{"name":1914,"role":125},"R. Whitmill",{"lat":1916,"lon":1917},52.58547,-2.12296,[1919,1923],{"name":1920,"role":125,"phone":1921,"email":1922},"Gerwin Huls, MD","+31-(0)107041560","HOVON@erasmusmc.nl",{"name":1924,"role":125,"phone":1925,"email":1926},"Paresh Vyas, MD","+44(0)7817248950","paresh.vyas@imm.ox.ac.uk",[1928],{"name":1920,"affiliation":1929,"role":886},"UMCG\u002F HOVON",[],[1932],{"label":1933,"url":1934},"HOVON website","http:\u002F\u002Fhovon.org",{"nct_id":4,"conditions":1936,"biomarkers":1938},[1937],"Acute Myeloid Leukemia",[1939,1940],"KMT2A Gene","NPM1 Gene",{"nct_id":4,"found":15,"summary":1942,"prompt_version":1952},{"design":1943,"status":1944,"heading":1945,"summary":1946,"follow_up":1947,"word_count":1948,"commitments":1949,"compensation":1950,"drugs_mentioned":1951},"This study plans to enroll 448 adult participants. It is an interventional study, meaning participants will receive a specific treatment.","completed","Revumenib for AML with NPM1 or KMT2A Mutations","This study is testing a new treatment for adults with newly diagnosed Acute Myeloid Leukemia (AML) who cannot receive strong chemotherapy. The study is comparing Revumenib along with standard treatments (Azacitidine and Venetoclax) to a placebo (an inactive substance) plus the standard treatments. Revumenib works by blocking a molecule called menin, which is important for the growth of AML cells with specific changes in their DNA (NPM1 or KMT2A mutations). We want to see if Revumenib can help people live longer and achieve complete remission (when signs of cancer disappear). You may be able to join if you have newly diagnosed AML with an NPM1 or KMT2A mutation.","Participants will be followed for overall survival and complete remission for up to 58 months after the last patient is included or the first patient is randomized.",108,"Revumenib or placebo is given daily for 28 days per cycle. The trial record does not specify other procedures or visit schedules.","Not stated in the trial record.",[34,38],"v2"]