[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-myeloproliferative-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-myeloproliferative-neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-center randomized phase 2 open-label clinical trial.",[26,27,28],"Relapsed \u002F Refractory AML","High Risk Myelodysplastic Syndrome","High Risk Myeloproliferative Neoplasms",[26,27,28],"NOT_YET_RECRUITING","2026-07-13",{"date":33,"type":34},"2026-07-17","ACTUAL",{"date":36,"type":20},"2026-09-30",{"date":38,"type":20},"2033-12-31",{"name":40,"class":41},"Virginia Commonwealth University","OTHER"]