[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558922":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":11,"studyPopulation":11,"armGroups":46,"interventions":53,"overallOfficials":63,"centralContacts":67,"locations":76,"responsibleParty":94,"collaborators":11,"id":96,"slug":11,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":11,"enrollmentInfo":104,"targetDuration":11,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":11,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Institut Paoli-Calmettes","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first.",null,"24 months",[14,16,18,20,22,24,26,28,30,32,34,36,38],{"measure":15,"description":11,"timeFrame":12},"Absolute duration of hematologic response, defined as the time from inclusion to relapse or death.",{"measure":17,"description":11,"timeFrame":12},"Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death.",{"measure":19,"description":11,"timeFrame":12},"Cumulative incidence of relapse, defined as the probability of relapse over time.",{"measure":21,"description":11,"timeFrame":12},"Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death.",{"measure":23,"description":11,"timeFrame":12},"Second complete remission occurence.",{"measure":25,"description":11,"timeFrame":12},"Time to second remission, defined as the time between date of treatment re initiation and complete remission.",{"measure":27,"description":11,"timeFrame":12},"Hospitalization rate associated with VEN-AZA de-escalation.",{"measure":29,"description":11,"timeFrame":12},"Transfusion occurrence associated with VEN-AZA de-escalation.",{"measure":31,"description":11,"timeFrame":12},"Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation.",{"measure":33,"description":11,"timeFrame":12},"Correlation between age and duration of response and survival after VEN-AZA de-escalation.",{"measure":35,"description":11,"timeFrame":12},"Correlation between FAB classification and duration of response and survival after VEN-AZA de-escalation.",{"measure":37,"description":11,"timeFrame":12},"Correlation between cytogenetic and molecular alterations and duration of response and survival after VEN-AZA de-escalation.",{"measure":39,"description":11,"timeFrame":12},"Correlation between number of prior VEN-AZA cycles and duration of response and survival after VEN-AZA de-escalation.",{"allocation":41,"interventionModel":42,"interventionModelDescription":11,"primaryPurpose":43,"observationalModel":11,"timePerspective":11,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":11,"whoMasked":11},"NONE",[47],{"label":48,"type":49,"description":48,"interventionNames":50},"VEN-AZA de-escalation","EXPERIMENTAL",[51,52],"Drug: Venetoclax","Drug: Azacitidine",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":11},"DRUG","Venetoclax","complete discontinuation of Venetoclax",[48],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"Azacitidine","complete discontinuation of Azacitidine",[48],[64],{"name":65,"affiliation":5,"role":66},"Sylvain GARCIAZ, MD PhD","PRINCIPAL_INVESTIGATOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":11,"email":72},"Jihane PAKRADOUNI, PharmD,PhD","CONTACT","+33491223778","drci.up@ipc.unicancer.fr",{"name":74,"role":70,"phone":75,"phoneExt":11,"email":72},"Laurie-Anne GOUTY, PhD","33491223778",[77],{"facility":5,"status":78,"city":79,"state":11,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Marseille","13273","France","FR",{"type":84,"coordinates":85},"Point",[86,87],5.38107,43.29695,{"lat":87,"lon":86},[90,92,93],{"name":91,"role":70,"phone":75,"phoneExt":11,"email":72},"Jihane PAKRADOUNI, PharmD, PhD",{"name":74,"role":70,"phone":75,"phoneExt":11,"email":72},{"name":65,"role":66,"phone":11,"phoneExt":11,"email":11},{"type":95,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":105,"type":106},50,"ESTIMATED","INTERVENTIONAL",[109],"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",[112],"Acute Myeloid Leukemia","2026-03-11",{"date":115,"type":116},"2026-03-13","ACTUAL",{"date":118,"type":116},"2026-02-04",{"date":120,"type":106},"2028-11-01",{"name":5,"class":6},1]