[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632236":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":30,"locations":40,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Northside Hospital, Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Axatilimab+Decitabine+Venetoclax","EXPERIMENTAL",null,[13,14,15],"Drug: Decitabine","Drug: Venetoclax","Drug: Axatilimab",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","Decitabine","20mg\u002Fm2\u002Fd x5 days (induction \\& consolidation)",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"Venetoclax","400mg\u002Fd x14 days (induction); 400mg\u002Fd x7 days (consolidation)",[9],{"type":18,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Axatilimab","Dose escalation, given on Days 1 and 15 of each cycle",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Scott R Solomon, MD","CONTACT","404-255-1930","ssolomon@bmtga.com",{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},"Caitlin Guzowski","404-851-8523","caitlin.guzowski@northside.com",[41],{"facility":5,"status":11,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Atlanta","Georgia","30342","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-84.38798,33.749,{"lat":51,"lon":50},[54],{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[58],{"name":59,"class":60},"Incyte Corporation","INDUSTRY","100632236","phase-1-axatilimab-combined-with-decitabinevenetoclax-for-the-treatment-of-tp53-mutated-aml-100632236",false,"NCT07511062","Axatilimab Combined With Decitabine\u002FVenetoclax for the Treatment of TP53-mutated AML","Axatilimab Combined With Decitabine\u002FVenetoclax for the Treatment of TP53-mutated\u002FDeleted AML Patients","Inclusion Criteria:\n\n* MDS\u002FAML or AML with a TP53 mutation or deletion, defined as:\n* greater than or equal to 10% AND (one of the following):\n* presence of a TP53 mutation\n* presence of a TP53 deletion by FISH\n* positive TP53 staining on IHC of diagnostic bone marrow\n* Either untreated or first salvage (primary refractory or first relapse)\n\nExclusion Criteria:\n\n* KPS \\\u003C60\n* active uncontrolled infection\n* history of HIV or active HBV or HBC infection\n* currently active second malignancy\n* calculated CrCl \\\u003C40mL\u002Fmin\n* AST and\u002For ALT and\u002For direct bilirubin \\>3x ULN\n* cardiac ejection fraction \\\u003C40% or history of uncontrolled cardiac arrhythmias\n* history of acute or chronic pancreatitis, history of myositis\n* known leukemia involvement of CNS\n* hematopoietic stem cell transplantation within 3 months of treatment start and\u002For persistent non-hematologic toxicities of Grade 2+ related to the transplant\n* active acute or chronic GVHD requiring immunosuppressive treatment","ALL","18 Years",{"count":71,"type":72},32,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","Axatilimab combined with Decitabine\u002FVenetoclax for the treatment of TP53-mutated\u002Fdeleted AML patients",[78,79],"Acute Myeloid Leukemia","TP53 Gene Mutation","NOT_YET_RECRUITING","2026-03-31",{"date":83,"type":84},"2026-04-06","ACTUAL",{"date":86,"type":72},"2026-08-01",{"date":88,"type":72},"2030-08-01",{"name":5,"class":6},1]