[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520365":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":46,"overallOfficials":33,"centralContacts":52,"locations":61,"responsibleParty":82,"collaborators":33,"id":84,"slug":33,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":33,"enrollmentInfo":93,"targetDuration":33,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":33,"overallStatus":64,"whyStopped":33,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Institut Paoli-Calmettes","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"tumor response","Objective response rate after 2 cycles of 28 days DASATINIB defined as the rate of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) according to ELN 2022 criteria.","2 months",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"response rates","Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.","3 months",{"measure":19,"description":20,"timeFrame":17},"Time to response","Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)",{"measure":22,"description":23,"timeFrame":17},"Duration of relapse-free period","Duration of relapse-free period (time between the response time and the relapse)",{"measure":25,"description":26,"timeFrame":17},"Event-free survival","Event-free survival (EFS, time between start of treatment and relapse, no response or death)",{"measure":28,"description":29,"timeFrame":17},"Overall survival","Overall survival (duration of survival from the start of the treatment)",{"measure":31,"description":32,"timeFrame":17},"Occurrence of Adverse Events","Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":33,"interventionNames":44},"DASATINIB","EXPERIMENTAL",[45],"Drug: Dasatinib",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":33},"DRUG","Dasatinib","Daily orally administration of DASATINIB",[42],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":33,"email":57},"Jihane PAKARANOUNI, PharmD,PhD","CONTACT","+33491223778","drci.up@ipc.unicancer.fr",{"name":59,"role":55,"phone":60,"phoneExt":33,"email":57},"Laurie-Anne GOUTY, PhD","33491223778",[62],{"facility":63,"status":64,"city":65,"state":33,"zip":33,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Institut Paoli Calmettes","RECRUITING","Marseille","France","FR",{"type":69,"coordinates":70},"Point",[71,72],5.38107,43.29695,{"lat":72,"lon":71},[75,78,79],{"name":76,"role":55,"phone":77,"phoneExt":33,"email":57},"Jihane PAKRADOUNI, Dr","0033491223778",{"name":59,"role":55,"phone":60,"phoneExt":33,"email":57},{"name":80,"role":81,"phone":33,"phoneExt":33,"email":33},"Sylvain GARCIAZ, MD PhD","PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100520365",false,"NCT06055621","Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE","Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE","VEN-R DASA","Inclusion Criteria:\n\n* Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)\n* Age ≥ 18 years\n* ECOG ≤3\n* VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration\n* Signed informed consent form\n* Affiliation to a social security system, or beneficiary of such a system\n\nExclusion Criteria:\n\n* Patient eligible to a targeted therapy having a market authorization\n* Central nervous system involvement\n* Heart failure\n* Liver failure\n* Kidney failure\n* Contraindication to DASATINIB\n* Positive for HIV (detectable viral load), Hepatitis B or C\n* Pregnant or breastfeeding woman\n* No efficient contraception for the women of childbearing age\n* Emergency situation person or not able to express his\u002Fher informed consent\n* Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)\n* Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons","ALL","18 Years",{"count":94,"type":95},35,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","The goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy.\n\nParticipants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.",[101],"Acute Myeloid Leukemia","2026-03-11",{"date":104,"type":105},"2026-03-13","ACTUAL",{"date":107,"type":105},"2024-05-22",{"date":109,"type":95},"2027-10-31",{"name":5,"class":6},1]