[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556974":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":55,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"St. Petersburg State Pavlov Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sorafenib prophylaxis","EXPERIMENTAL","Sorafenib 200 mg bid for 168 days starting before day+100 after HCT",[13],"Drug: Sorafenib",{"label":15,"type":16,"description":17,"interventionNames":18},"Observation","NO_INTERVENTION","Usual care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Sorafenib","Sorafenib 200 mg bid for 168 days starting in the time fram between engraftment with neutrophils \\> 1.0 x 10\\^9\u002FL, white blood cells\\> 1.5 x 10\\^9\u002FL, platelets\\> 1.5 x 10\\^9\u002FL and day+100 after allogeneic hematopoietic cell trnaplantation",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"IVAN S MOISEEV","CONTACT","+78123386265","moisiv@mail.ru",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Irina V Bykova","+78123386617","bmt-director@1spbgmu.ru",[36],{"facility":37,"status":38,"city":39,"state":18,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RM Gorbacheva Research Institute","RECRUITING","Saint Petersburg","197022","Russia","RU",{"type":44,"coordinates":45},"Point",[46,47],30.31413,59.93863,{"lat":47,"lon":46},[50,53],{"name":51,"role":28,"phone":52,"phoneExt":18,"email":30},"Ivan Moiseev","+79217961951",{"name":54,"role":28,"phone":29,"phoneExt":18,"email":34},"Alexandr Kulagin",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ivan S Moiseev","Vice-director of RM Gorbacheva Research Institute","100556974","phase-2-sorafenib-relapase-prophylaxis-after-hct-with-ptbcy-regimen-100556974",false,"NCT06532084","Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen","Randomized Trial of Sorafenib Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplantation Bendamustine and Cyclophosphamide","SoraGVL","Inclusion Criteria:\n\n* Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.\n* Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:\n\n  * acute myeloid leukemia not in hematological remission prior to transplantation,\n  * ≥ 3 remission of acute myeloid leukemia,\n  * any myeloid malignancy with bi-allelic tp53 mutation,\n  * any myeloid malignancy with complex karyotype,\n  * therapy-related myeloid malignancy not in MRD-negative response\n  * myelodysplastic syndrome with very high IPSS-R risk\n  * any myeloid malignancy with monosomal or t(3;3) karyotype,\n  * any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression\n  * MDS\u002FNPM unclassified not in hematologic remission.\n* Documented hematological remission in the bone marrow at the time of inclusion post-engraftment, measurable residual disease is allowed\n* First 100 days after allogeneic hematopoietic stem cell transplantation\n\nExclusion Criteria:\n\n* successfully treated relapse between transplantation and enrollment\n* use of any other planned method for prophylaxis of relapse besides sorafenib\n* donor lymphocyte infusion prior to randomization\n* Second malignancy not in complete remission within 6 months prior to randomization\n* Moderate or severe cardiac disease: ejection fraction \\\u003C50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion\n* Stroke within 3 months of inclusion, unless related to the underlying malignancy\n* Severe decrease in pulmonary function: FEV1 \\\u003C50% or DLCO\\\u003C50% of predicted or respiratory distress or need for oxygen support;\n* Severe organ dysfunction: AST or ALT \\>10 upper normal limits, bilirubin \\>2 upper normal limits, creatinine \\>2 upper normal limits\n* Creatinine clearance \\\u003C 30 mL\u002Fmin\n* Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\\> 70 mg\u002FL\n* Requirement for vasopressor support at the time of enrollment\n* Requirement for positive-pressure oxygen at the time of enrollment\n* Karnofsky index \\\u003C30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent","ALL","18 Years","75 Years",{"count":71,"type":72},88,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.",[78,79,80,81],"Acute Myeloid Leukemia, in Relapse","Myelodysplastic Syndromes","Chronic Myeloid Leukemia","Myeloproliferative Neoplasm",[83],"post-transplantation cyclophosphamide; post-transplantation bendamustine; acute myeloid leukemia; myelodysplastic syndrome; refractory; sorafenib","2024-07-29",{"date":86,"type":87},"2024-08-01","ACTUAL",{"date":89,"type":87},"2024-05-22",{"date":91,"type":72},"2028-05",{"name":5,"class":6},1]