[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558922":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":56,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":20,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":20,"overallStatus":40,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Institut Paoli-Calmettes","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"VEN-AZA de-escalation","EXPERIMENTAL",[12,13],"Drug: Venetoclax","Drug: Azacitidine",[15,21],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Venetoclax","complete discontinuation of Venetoclax",[9],null,{"type":16,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Azacitidine","complete discontinuation of Azacitidine",[9],[26],{"name":27,"affiliation":5,"role":28},"Sylvain GARCIAZ, MD PhD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Jihane PAKRADOUNI, PharmD,PhD","CONTACT","+33491223778","drci.up@ipc.unicancer.fr",{"name":36,"role":32,"phone":37,"phoneExt":20,"email":34},"Laurie-Anne GOUTY, PhD","33491223778",[39],{"facility":5,"status":40,"city":41,"state":20,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Marseille","13273","France","FR",{"type":46,"coordinates":47},"Point",[48,49],5.38107,43.29695,{"lat":49,"lon":48},[52,54,55],{"name":53,"role":32,"phone":37,"phoneExt":20,"email":34},"Jihane PAKRADOUNI, PharmD, PhD",{"name":36,"role":32,"phone":37,"phoneExt":20,"email":34},{"name":27,"role":28,"phone":20,"phoneExt":20,"email":20},{"type":57,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100558922","phase-2-de-escalation-study-evaluating-venetoclax-and-azacitidine-discontinuation-in-aml-responding-patients-100558922",false,"NCT06557421","De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients","STOP VEN","Inclusion Criteria:\n\n1. Female\u002FMale ≥ 18 years of age;\n2. Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;\n3. VEN-AZA given as first-line treatment;\n4. Duration of VEN-AZA therapy of 12 months (+\u002F- 28 days), regardless of duration of VEN-AZA cycles and the doses;\n5. Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);\n6. Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD \\\u003C0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers \\\u003C0.1% in the blood);\n7. ECOG \\\u003C3;\n8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;\n9. Affiliated to the French Social Security or beneficiary of such a health Insurance;\n10. Signed informed consent.\n\nNon inclusion Criteria:\n\n1. VEN-AZA given as salvage therapy;\n2. Prior allogeneic stem cell transplant;\n3. Discontinuation of treatment because of absence or loss of response;\n4. Patient in emergency situation or unable to give consent;\n5. Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:\n\n* Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.\n* Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.\n\nPatients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.\n\nParticipants will:\n\n* Stop VEN-DASA treatment\n* Be closely monitored by regular evaluation of the disease",[75],"Acute Myeloid Leukemia","2026-03-11",{"date":78,"type":79},"2026-03-13","ACTUAL",{"date":81,"type":79},"2026-02-04",{"date":83,"type":69},"2028-11-01",{"name":5,"class":6},1]