[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643635":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":22,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":22,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":22,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)","EXPERIMENTAL","Patients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment.",[13,14,15],"Drug: Azacitidine","Drug: Venetoclax","Drug: Revumenib",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Azacitidine","Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Venetoclax","Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Revumenib","Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.",[9],[32],{"name":33,"affiliation":5,"role":34},"Joshua Zeidner, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":22,"email":40},"Lauren Higgins","CONTACT","919-984-0000","Lauren_Higgins@med.unc.edu",[42],{"facility":43,"status":22,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill","Chapel Hill","North Carolina","27599-7295","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-79.05584,35.9132,{"lat":53,"lon":52},[56,57],{"name":37,"role":38,"phone":39,"phoneExt":22,"email":40},{"name":58,"role":34,"phone":22,"phoneExt":22,"email":22},"Joshua Zeidner",{"type":60,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100643635","phase-2-revumenib-azacitidine-and-venetoclax-in-newly-diagnosed-kmt2a-rearranged-aml-100643635",false,"NCT07605949","Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML","RAVEN","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n* Age 18-65 years at the time of consent.\n* Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics\u002Fkaryotype or FISH\n\nExclusion Criteria:\n\n* Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study)\n* Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry.\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).","ALL","18 Years","65 Years",{"count":72,"type":73},88,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML.\n\nPeople with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects.\n\nThe study has two parts:\n\n1. Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission.\n2. Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs.\n\nPatients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.",[79],"Leukemia Acute Myeloid",[81,82,83,84],"revumenib","azacitidine","venetoclax","allogeneic stem cell transplant","NOT_YET_RECRUITING","2026-06-26",{"date":88,"type":89},"2026-06-30","ACTUAL",{"date":91,"type":73},"2026-07",{"date":93,"type":73},"2028-07",{"name":5,"class":6},1]