[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611661":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":52,"studyPopulation":52,"armGroups":55,"interventions":62,"overallOfficials":52,"centralContacts":67,"locations":76,"responsibleParty":150,"collaborators":152,"id":156,"slug":52,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":52,"enrollmentInfo":165,"targetDuration":52,"studyType":168,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":79,"whyStopped":52,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Centre Leon Berard","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":36},[9,13,15,17,19],{"measure":10,"description":11,"timeFrame":12},"Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint","To assess PK exposure parameters : AUC (area under the curve) of venetoclax at steady state","From the first day of venetoclax administration to end of the treatment (days)",{"measure":10,"description":14,"timeFrame":12},"To assess PK exposure parameters : Minimal Concentration (Cmin) of venetoclax at steady state",{"measure":10,"description":16,"timeFrame":12},"To assess PK exposure parameters : Peak Plasma Concentration (Cmax) of venetoclax at steady state",{"measure":10,"description":18,"timeFrame":12},"To assess PK exposure parameters : Equilibrium concentration (Css) of venetoclax at steady state",{"measure":20,"description":21,"timeFrame":22},"Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Clinical Endpoint","Proportion of patients with a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) or partial remission (PR) or no remission","From the first day of venetoclax administration up to day 28 (end of the first venetoclax cure)",[24,28,32],{"measure":25,"description":26,"timeFrame":27},"To assess relationship between different PK markers of venetoclax and its clinical efficacy.","Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and clinical outcome (cytologic response at cycle 6, survival without progression and overall survival).","From the first day of venetoclax administration and through study completion, at least 24 months",{"measure":29,"description":30,"timeFrame":31},"To assess correlation between plasmatic exposition to venetoclax and occurrence of adverse events","Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and occurence of adverse events grade equal or superior to 3 related to venetoclax\u002Fazacitidine and their impact on treatment administration","From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration",{"measure":33,"description":34,"timeFrame":35},"To assess inter-individual and intra-individual variability in plasma exposure to venetoclax.","Coefficient of variation of AUC and Cmin at steady state for venetoclax","From the first day of ventoclax administration and nd through study completion, at least 24 months",[37,41,43,45],{"measure":38,"description":39,"timeFrame":40},"To assess the relationship between plasmatic venetoclax exposition and response to treatment","To assess correlation between minimal concentration of venetoclax and minimal residual disease","From the first day of venetoclax administration to through the study, at least 24 months",{"measure":38,"description":42,"timeFrame":40},"To assess correlation between Peak Plasma Concentration (Cmax) of venetoclax and minimal residual disease",{"measure":38,"description":44,"timeFrame":40},"To assess correlation between Equilibrium concentration of venetoclax (Css) and minimal residual disease",{"measure":46,"description":47,"timeFrame":31},"To assess interaction between azole antifungals and venetoclax","Number of patients treated or not treated by an azole antifungal",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":6,"observationalModel":52,"timePerspective":52,"maskingInfo":53},"NA","SINGLE_GROUP","Clinical-biological cohort",null,{"masking":54,"maskingDescription":52,"whoMasked":52},"NONE",[56],{"label":57,"type":58,"description":59,"interventionNames":60},"Patients with acute myeloid leukaemia receiving venetoclax-azicitine as first line","EXPERIMENTAL","Blood samples",[61],"Other: Pharmacokinetic dosages of venetoclax",[63],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":52},"Pharmacokinetic dosages of venetoclax","Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period",[57],[68,73],{"name":69,"role":70,"phone":71,"phoneExt":52,"email":72},"Michaël Philippe","CONTACT","+33478782666","michael.philippe@lyon.unicancer.fr",{"name":74,"role":70,"phone":52,"phoneExt":52,"email":75},"Amine Belhabri, MD","amine.belhabri@lyon.unicancer.fr",[77,96,111,122,136],{"facility":78,"status":79,"city":80,"state":81,"zip":52,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Centre Hospitalier Pierre Oudot","RECRUITING","Bourgoin","France","FR",{"type":84,"coordinates":85},"Point",[86,87],5.27236,45.59889,{"lat":87,"lon":86},[90,94],{"name":91,"role":70,"phone":92,"phoneExt":52,"email":93},"Clément Rocher, Dr","+33469157329","crocher@ghnd.fr",{"name":91,"role":95,"phone":52,"phoneExt":52,"email":52},"PRINCIPAL_INVESTIGATOR",{"facility":97,"status":79,"city":98,"state":52,"zip":99,"country":81,"countryCode":82,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"CHU de Grenoble","Grenoble","38000",{"type":84,"coordinates":101},[102,103],5.71479,45.17869,{"lat":103,"lon":102},[106],{"name":107,"role":70,"phone":108,"phoneExt":109,"email":110},"Martin CARRÉ, Dr","4 76 76 50 96","+33","mcarre1@chu-grenoble.fr",{"facility":5,"status":79,"city":112,"state":52,"zip":113,"country":81,"countryCode":82,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Lyon","69008",{"type":84,"coordinates":115},[116,117],4.84789,45.74906,{"lat":117,"lon":116},[120],{"name":121,"role":70,"phone":52,"phoneExt":52,"email":75},"Amine BELHABRI",{"facility":123,"status":79,"city":124,"state":52,"zip":125,"country":81,"countryCode":82,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"CHU de Saint-Étienne","Saint-Etienne","42100",{"type":84,"coordinates":127},[128,129],4.39,45.43389,{"lat":129,"lon":128},[132],{"name":133,"role":70,"phone":134,"phoneExt":109,"email":135},"Emmanuelle TAVERNIER, Dr","4 77 82 28 57","Emmanuelle.Tavernier@chu-st-etienne.fr",{"facility":137,"status":79,"city":138,"state":52,"zip":139,"country":81,"countryCode":82,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Hôpitaux Nord-Ouest - Villefranche-sur-Saône","Villefranche-sur-Saône","69400",{"type":84,"coordinates":141},[142,143],4.71961,45.98967,{"lat":143,"lon":142},[146],{"name":147,"role":70,"phone":148,"phoneExt":109,"email":149},"Sylvain LAMURE, Dr","4 74 69 87 46","slamure@hno.fr",{"type":151,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[153],{"name":154,"class":155},"Fédération Leucémie Espoir","UNKNOWN","100611661",false,"NCT07243483","Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia","Prospective, Multicenter, Clinical-biological Cohort Study to Assess Pharmacokinetics and Pharmacodynamics (PK-PD) of Venetoclax (VEN) in Patients With Acute Myeloid Leukemia (AML)","EUREKA-VEN","Inclusion Criteria:\n\n* Male or female patient aged of at least 18 years on day of signing informed consent\n* Patient with histologically-confirmed diagnosis of Acute Myeloblactic Leukaemia according to classification ELN 2022 (European Leukemia Net 2022)\n* Patient who has to initiate treatment venetoclax-azacitidine as first line. Note : triple associations with targeted therapy are not authorized\n* Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.\n* Patient must be affiliated or benificiary of a social security system.\n\nExclusion Criteria:\n\n* Patient with acute promyelocytic leukemia (APL, AML3)\n* Patient with AML eligible to intensive chemotherapy\n* Patient previously treaed with venetoclax and\u002For azacitidine\n* Patient participating to another clinical trial with a medicinal product\n* Any condition that contraindicates blood sampling procedures required by the protocol\n* Any psychological, family, geographical, or social situation that, according to investigator's judgment, could potentially prevent the signing of an informed consent form and\u002For woulld likely interfere compliance with study procedures.\n* Patient under curatorship, guardianship or judicial protection\n* Pregnant or breast-feeding female patient.","ALL","18 Years",{"count":166,"type":167},100,"ESTIMATED","INTERVENTIONAL",[49],"This is a prospective, multicenter, clinical-biological cohort study. Its objective is to assess the pharmacokinetics-pharmacodynamics (PK-PD) of venetoclax (VEN) in patients with Acute Myeloid Leukemia (AML).\n\nThis study involves only minimal risks and constraints related to the collection of biological samples (blood samples for PK testing) and the collection of clinical data. Therapeutic management of patients participating in this study is not changed. A total of 100 patients will be included in the study over a 12-month period. A maximum of 21 additional samples are planned, with a maximum of 12 mL of blood per sampling day (4 mL at each sampling time) for PK dosing of venetoclax.",[172],"Acute Myeloid Leukemia",[174,175,176,177,178],"Pharmacokinetics","Venetoclax","Pharmacodynamics","Cytologic response","Azole antifungal","2026-05-07",{"date":181,"type":182},"2026-05-08","ACTUAL",{"date":184,"type":182},"2026-01-21",{"date":186,"type":167},"2029-01-01",{"name":5,"class":6},5]