[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647625":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Metronomic decitabine-cedazuridine (DEC-C) plus venetoclax (VEN)","EXPERIMENTAL",null,[13],"Drug: Decitabine-cedazuridine plus venetoclax (DEC-C+VEN)",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm B: Azacitidine (AZA) plus venetoclax (VEN)","ACTIVE_COMPARATOR",[18],"Drug: Azacitidine plus venetoclax (AZA+VEN)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Decitabine-cedazuridine plus venetoclax (DEC-C+VEN)","Decitabine-cedazuridine (DEC-C) dosage per protocol taken by mouth once weekly plus Venetoclax (VEN) 400 milligrams (mg), taken by mouth once weekly",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Azacitidine plus venetoclax (AZA+VEN)","Azacitidine (AZA) 75 milligrams per meters squared (mg\u002Fm2) taken per institutional practice, plus venetoclax (VEN) standard ramp-up",[15],[30],{"name":31,"affiliation":5,"role":32},"Keri Maher, DO","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Massey IIT Research Operations","CONTACT","804-628-6430","masseyepd@vcu.edu",[40],{"facility":5,"status":11,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Richmond","Virginia","23298","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-77.46026,37.55376,{"lat":50,"lon":49},[53,56],{"name":54,"role":36,"phone":37,"phoneExt":11,"email":55},"Acute Leukemia\u002FMyeloid Malignancies CTO Team","masseyhiit@vcu.edu",{"name":31,"role":32,"phone":11,"phoneExt":11,"email":11},{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100647625","phase-2-metronomic-decitabine-cedazuridine-and-venetoclax-in-rr-aml-hr-mds-hrap-mpn-100647625",false,"NCT07710534","Metronomic Decitabine-Cedazuridine and Venetoclax in R\u002FR AML, HR-MDS, HR\u002FAP MPN","Metronomic Decitabine-Cedazuridine and Venetoclax in Relapsed\u002FRefractory Acute Myeloid Leukemia R\u002FR AML), High Risk Myelodysplastic Syndrome (HR-MDS), and High-Risk Myeloproliferative Neoplasms (HR\u002FAP MPN)","Inclusion Criteria:\n\n* Age ≥18 years at time of enrollment\n* Diagnosis of one of the following by World Health Organization (WHO) International Consensus Classification (ICC) criteria as determined by local assessment:\n\n  * Relapsed\u002F refractory acute myeloid leukemia (R\u002FR AML) as defined by ≥5% marrow blasts or unequivocal, measurable extramedullary disease\n  * High Risk Myelodysplastic Syndrome (HR-MDS) (high\u002Fvery high risk MDS by Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)\n  * high-risk accelerated-phase myeloproliferative neoplasm (HR\u002FAP-MPN) defined by ≥10% blasts in blood or bone marrow\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-3\n* White blood cell (WBC) count ≤25 × 109\u002FLiter (L) (cytoreduction with hydroxyurea or steroids is allowed to achieve this)\n* Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (≤5 × ULN if due to leukemic involvement)\n* Total bilirubin ≤2 × ULN (unless the elevation is due to Gilbert's or hemolysis)\n* Creatinine clearance ≥ 30 milliliters \u002F minute (mL\u002Fmin)\n* Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of non-childbearing potential are those who have had a hysterectomy or bilateral oophorectomy, or who have completed menopause (no menses for at least one year and age ≥65 or follicle-stimulating hormone levels in the menopausal range).\n* Subjects and their partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months after the last dose of study treatment. Effective contraception includes methods such as oral contraceptives or double-barrier method.\n\nExclusion Criteria:\n\n* Prior use of hypomethylating agent and venetoclax in combination (Note, use of hypomethylating agent and\u002For venetoclax separately in alternative combinations with other drugs is allowed)\n* Inability to tolerate oral therapies, or medical co-morbidities that significantly impact parenteral absorption\n* Acute promyelocytic leukemia myeloproliferative neoplasm (MPN) with the Philadelphia chromosome translocation (BCR:ABL) translocation\n* Clinically significant cardiovascular disease as defined by unstable angina\n* New York Heart Association class III\u002FIV congestive heart failure\n* Treatment with any investigational drug or therapy within 2 weeks of study treatment or 5 half-lives before the first dose of study treatment, whichever is shorter\n* Known hypersensitivity to azacitidine, venetoclax, decitabine or cedazuridine\n* Cytotoxic chemotherapy or prior azacitidine or decitabine within 2 weeks of first dose of study treatment\n* Concurrent use of AML\u002FMDS\u002FMPN therapies including lenalidomide, erythropoietin, luspatercept, cytotoxic chemotherapies, targeted agents, etc Note: hydroxyurea is allowed in Cycle 1 if necessary for cytoreduction and\u002For cytarabine not exceeding a maximum dose of 1 gram per meter squared (g\u002Fm2) in Cycle 1 is also allowed for cytoreduction\n* Uncontrolled intercurrent illness or infection (those with controlled HIV, hepatitis, or other chronic infections are eligible)\n* Untreated central nervous system disease\n* Pregnancy or breastfeeding\n* Other active malignancy requiring systemic therapy during duration of trial or otherwise would confound endpoints (eg, second malignancy present where survival is expected to be less than 6 months)","ALL","18 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This is a single-center randomized phase 2 open-label clinical trial.",[76,77,78],"Relapsed \u002F Refractory AML","High Risk Myelodysplastic Syndrome","High Risk Myeloproliferative Neoplasms",[76,77,78],"NOT_YET_RECRUITING","2026-07-13",{"date":83,"type":84},"2026-07-17","ACTUAL",{"date":86,"type":70},"2026-09-30",{"date":88,"type":70},"2033-12-31",{"name":5,"class":6},1]