[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659721":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":22,"armGroups":30,"interventions":38,"overallOfficials":48,"centralContacts":53,"locations":62,"responsibleParty":76,"collaborators":22,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":22,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":22,"enrollmentInfo":87,"targetDuration":22,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":100,"whyStopped":22,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Outcome","To evaluate the relapse free survival in patients with AML receiving metronomic maintenance therapy with weekly Decitabine\u002Fcedazuridine plus Venetoclax. RFS is measured from the date of first documented CR\u002FCRi until the date of confirmed relapse or death from any cause, whichever occurs first.","12 months",[14,18],{"measure":15,"description":16,"timeFrame":17},"Secondary Outcome 1","To assess treatment delay defined as postponing treatment for more than 7 days or cancellation of treatment due to adverse effects caused by maintenance chemotherapy.","8 days",{"measure":19,"description":20,"timeFrame":21},"Secondary Outcome 2","To determine the overall survival, defined as the number of days from the start of induction therapy to the date of death. Subjects that have not died will be censored at the last known date to be alive.","24 months",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NA","SINGLE_GROUP","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE","This is an open-label, phase II, safety-primary study evaluating metronomic maintenance with once-weekly Decitabine\u002Fcedazuridine plus once-weekly Ven in patients with AML who are in CR, CRh, CRi,following standard HMAs + Ven induction and are candidates for maintenance.The study uses a single starting regimen (Venetoclax 400 mg weekly) with a pre-specified Venetoclax dose-reduction step in the event of treatment-limiting toxicity (TLT), while maintaining weekly Decitabine\u002Fcedazuridine dosing.",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"Venetoclax Plus HMA: A New Standard of Care for AML","EXPERIMENTAL","Older AML patients have benefited from the advent of venetoclax + HMAs therapy, achieving higher remission rates and longer survival than previously possible. The next challenge is to sustain those remissions with a more acceptable toxicity profile and better quality of life. Building on landmark trials (VIALE-A) and emerging research on lower-dose strategies, we propose a phase 2 study of metronomic weekly Decitabine\u002Fcedazuridine plus venetoclax as maintenance therapy following initial composite CR response. This approach is grounded in strong biological rationale and preliminary clinical evidence suggesting feasibility and potential activity with improved tolerability. By transitioning patients to a maintenance phase of weekly low-dose therapy after maximum of 3 induction cycles of standard IV decitabine + venetoclax (to achieve CRi or better), we aim to evaluate whether remission can be maintained while minimizing toxicity and maximizing QOL.",[36,37],"Drug: Venetoclax, Decitabine\u002FCedaruridine","Drug: decitabine\u002Fcedazuridine",[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":22},"DRUG","Venetoclax, Decitabine\u002FCedaruridine","Patients who consent to the study will receive weekly Decitabine\u002FCedaruridine plus Venetoclax until intolerance or disease progression. Both Decitabine\u002FCedaruridine and Venetoclax are administered orally once on D1, 8, 15, 22 each",[32],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":22},"decitabine\u002Fcedazuridine","Patients who consent to the study will receive weekly decitabine\u002Fcedazuridine plus Venetoclax until intolerance or disease progression. Venetoclax is administered orally once on D1, 8, 15, 22 each 28-day cycle with food and water. Decitabine\u002FCedazuridine is administered orally once on D1, D8, D15 D22 with empty stomach.",[32],[49],{"name":50,"affiliation":51,"role":52},"Xiaoyi Chen, MD, PhD","Rutgers Cancer Institute of New Jersey","PRINCIPAL_INVESTIGATOR",[54,58],{"name":50,"role":55,"phone":56,"phoneExt":22,"email":57},"CONTACT","732-235-2465","xc458@cinj.rutgers.edu",{"name":59,"role":55,"phone":60,"phoneExt":22,"email":61},"Elayne Wesolowsky","732-425-3023","wesoloel@cinj.rutgers.edu",[63],{"facility":64,"status":22,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":22},"Rutgers Cancer Institute","New Brunswick","New Jersey","08902","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-74.45182,40.48622,{"lat":74,"lon":73},{"type":52,"investigatorFullName":50,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Hematologist Oncologist, Rutgers Cancer Institute","100659721","phase-2-phase-ii-de-escalation-study-of-metronomic-decitabinecedazuridine-plus-venetoclax-in-aml-100659721",false,"NCT07867626","Phase II De-Escalation Study of Metronomic Decitabine\u002FCedazuridine Plus Venetoclax in AML","A Phase II De-Escalation Study of Metronomic Decitabine\u002FCedazuridine Plus Venetoclax in Acute Myeloid Leukemia Maintenance.","Inclusion Criteria:\n\n* Newly diagnosed AML (WHO 2022 classification or ICC 2022 classification)\n* Participants must be considered Ineligible for intensive induction defined by the following:\n\n  1. Age 75 years or older, or\n  2. Age 18 to 74 years with at least one of the following comorbidities:\n\n  i) Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina). ii) Severe pulmonary disorder (eg, DLCO ≤65% or FEV1 ≤65%). iii) Creatinine clearance ≥30 mL\u002Fmin to \\\u003C45 mL\u002Fmin iv) Moderate hepatic impairment with total bilirubin \\>1.5 to ≤3.0 × upper limit of normal (ULN).\n* Must have achieved CR,CRh, CRi, following induction with maximum 3 cycles of standard IV HMAs and venetoclax.\n* Able to provide informed consent\n* Prior and concomitant hydroxyurea is permitted\n* ECOG performance status 0 to 3\n\nExclusion Criteria:\n\n* Progression or relapse after induction standard HMAs + Venetoclax therapy\n* Pregnancy or breastfeeding\n* Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy\n* Inability to take oral medication or presence of malabsorption syndrome or any other uncontrolled gastrointestinal condition\n* Candidate for intensive chemotherapy\n* Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy\n* Candidate for stem cell transplant","ALL","18 Years",{"count":88,"type":89},41,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","To evaluate the 12-month relapse free survival with weekly Decitabine\u002Fcedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh)",[95],"Acute Myeloid Leukaemia (AML)",[97,98,99],"acute myeloid leukemia","Venetocalx","Decitabine\u002FCedazuridine","NOT_YET_RECRUITING","2026-10-06",{"date":103,"type":104},"2026-10-09","ACTUAL",{"date":106,"type":89},"2026-09-30",{"date":108,"type":89},"2029-12",{"name":5,"class":6},1]