[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100381953":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":10,"locations":16,"responsibleParty":106,"collaborators":10,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":10,"enrollmentInfo":118,"targetDuration":10,"studyType":121,"phases":10,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":128,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Venetoclax Participants",null,"Participants treated with Venetoclax in accordance with approved local label. Decision to treat with Venetoclax was made prior to offering participation in this study.",[13],{"name":14,"affiliation":5,"role":15},"ABBVIE INC.","STUDY_DIRECTOR",[17,29,39,49,58,67,76,82,88,97],{"facility":18,"status":10,"city":19,"state":19,"zip":20,"country":21,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":10},"Moscow State budget healthcare \u002FID# 218569","Moscow","125284","Russia","RU",{"type":24,"coordinates":25},"Point",[26,27],37.61781,55.75204,{"lat":27,"lon":26},{"facility":30,"status":10,"city":31,"state":32,"zip":33,"country":21,"countryCode":22,"cosmosGeoPoint":34,"geoPoint":38,"contacts":10},"Saratov State Medical University n.a. V.I. Razumovskiy \u002FID# 226059","Saratov","Saratov Oblast","410012",{"type":24,"coordinates":35},[36,37],45.9901,51.54048,{"lat":37,"lon":36},{"facility":40,"status":10,"city":41,"state":42,"zip":43,"country":21,"countryCode":22,"cosmosGeoPoint":44,"geoPoint":48,"contacts":10},"Hematology department State budgetary health care institution Volgograd region \u002FID# 229813","Volgograd","Volgograd Oblast","400138",{"type":24,"coordinates":45},[46,47],44.4976,48.71378,{"lat":47,"lon":46},{"facility":50,"status":10,"city":51,"state":10,"zip":52,"country":21,"countryCode":22,"cosmosGeoPoint":53,"geoPoint":57,"contacts":10},"Regional Clinical Hospital of Irkutsk \u002FID# 218570","Irkutsk","664049",{"type":24,"coordinates":54},[55,56],104.29076,52.29566,{"lat":56,"lon":55},{"facility":59,"status":10,"city":60,"state":10,"zip":61,"country":21,"countryCode":22,"cosmosGeoPoint":62,"geoPoint":66,"contacts":10},"Clinical Medico-Sanitary Unit #1 \u002FID# 222502","Perm","614077",{"type":24,"coordinates":63},[64,65],56.25017,58.01046,{"lat":65,"lon":64},{"facility":68,"status":10,"city":69,"state":10,"zip":70,"country":21,"countryCode":22,"cosmosGeoPoint":71,"geoPoint":75,"contacts":10},"Russian Research Institute of Hematology and Transfusiology of the FMBA \u002FID# 229812","Saint Petersburg","191024",{"type":24,"coordinates":72},[73,74],30.31413,59.93863,{"lat":74,"lon":73},{"facility":77,"status":10,"city":69,"state":10,"zip":78,"country":21,"countryCode":22,"cosmosGeoPoint":79,"geoPoint":81,"contacts":10},"R.M.Gorbacheva Research Institute of Paediatric Oncology, Haematology and Transp \u002FID# 224831","197101",{"type":24,"coordinates":80},[73,74],{"lat":74,"lon":73},{"facility":83,"status":10,"city":69,"state":10,"zip":84,"country":21,"countryCode":22,"cosmosGeoPoint":85,"geoPoint":87,"contacts":10},"Almazov National Medical Research Centre \u002FID# 218571","197341",{"type":24,"coordinates":86},[73,74],{"lat":74,"lon":73},{"facility":89,"status":10,"city":90,"state":10,"zip":91,"country":21,"countryCode":22,"cosmosGeoPoint":92,"geoPoint":96,"contacts":10},"Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) \u002FID# 224830","Yakutsk","677008",{"type":24,"coordinates":93},[94,95],129.72288,62.03114,{"lat":95,"lon":94},{"facility":98,"status":10,"city":99,"state":10,"zip":100,"country":21,"countryCode":22,"cosmosGeoPoint":101,"geoPoint":105,"contacts":10},"Sakhalin Regional Clinical Hospital \u002FID# 222501","Yuzhno-Sakhalinsk","693004",{"type":24,"coordinates":102},[103,104],142.73559,46.9543,{"lat":104,"lon":103},{"type":107,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100381953","a-study-of-the-effectiveness-of-venetoclax-tablets-in-adult-acute-myeloid-leukemia-participants-ineligible-for-standard-induction-therapy-in-russian-federation-100381953",false,"NCT04253314","A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation","Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Acute Myeloid Leukemia (AML) Patients Ineligible for Standard Induction Therapy in Routine Clinical Practice in Russian Federation (INNOVATE)","INNOVATE","Inclusion Criteria:\n\n* Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label\n* Ineligible for standard induction therapy with cytarabine and anthracycline\n* Eastern Cooperative Oncology Group (ECOG) score \\>2\n* White blood cell counts \\\u003C25 x 109 per liter\n* Started Venetoclax within 4 weeks of enrolling in study\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia\n* Contraindications to Venetoclax as listed on the approved local label in Russian Federation\n* Neuroleukemia - active central nervous system (CNS) involvement\n* Participation in a clinical trial with an investigational drug for AML within 30 days prior to Venetoclax treatment initiation","ALL","18 Years",{"count":119,"type":120},51,"ACTUAL","OBSERVATIONAL","Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for standard induction therapy in Russian Federation.\n\nVenetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation.\n\nParticipants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months.\n\nThere is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.",[124],"Acute Myeloid Leukemia (AML)",[124,126,127],"Venetoclax","Venclexta","COMPLETED","2024-11-06",{"date":131,"type":120},"2024-11-07",{"date":133,"type":120},"2020-03-13",{"date":135,"type":120},"2023-02-16",{"name":5,"class":6},10]