[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464976":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":40,"overallOfficials":46,"centralContacts":51,"locations":61,"responsibleParty":75,"collaborators":25,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":25,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Belarusian Research Center for Pediatric Oncology, Hematology and Immunology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"Relapse-free survival (RFS)","Time from achievement of CR to the time of relapse or death from any cause.","2 years",{"measure":14,"description":15,"timeFrame":12},"Overall survival (OS)","The proportion of patients with overall survival",[17,21],{"measure":18,"description":19,"timeFrame":20},"Persistence of donor NK cells","Days of persistence of donor NK cells","21 days after the first infusion",{"measure":22,"description":23,"timeFrame":24},"Number of T, B, NK, activated T and NK cells after immunotherapy","Analysis of T, B, NK, activated T and NK cells numbers (cells\u002FmicroL) after NK infusions.","28 days after the first infusion",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Expanded haploidentical NK cell immunotherapy","EXPERIMENTAL","After a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.",[39],"Biological: Expanded haploidentical NK cells",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":25},"BIOLOGICAL","Expanded haploidentical NK cells","Two doses of expanded haploidentical NK cells (30-100 x 10\\^6 cells \u002Fkg).",[35],[47],{"name":48,"affiliation":49,"role":50},"Olga Aleinikova, MD, Prof","Belarussian Research Center for Pediatric Oncology, Hematology and Immunology","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":25,"email":56},"Tatsiana Shman, PhD","CONTACT","+375296341853","shman@oncology.by",{"name":58,"role":54,"phone":59,"phoneExt":25,"email":60},"Mariya Naumovich, MD","+375293563846","mariyanaumovich@gmail.com",[62],{"facility":49,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":25,"geoPoint":25,"contacts":69},"RECRUITING","Minsk","Minsk Oblast","223053","Belarus","BY",[70,73],{"name":71,"role":54,"phone":72,"phoneExt":25,"email":56},"Tatsiana Shman","+37529 6341853",{"name":74,"role":50,"phone":25,"phoneExt":25,"email":25},"Olga Aleinikova",{"type":76,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100464976","phase-1-expanded-haploidentical-natural-killer-cells-as-consolidation-strategy-for-childrenyoung-adults-with-aml-100464976",false,"NCT05334693","Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children\u002FYoung Adults With AML","Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children\u002FYoung Adults With AML","Inclusion Criteria:\n\nPatients:\n\n* primary intermediate risk AML in molecular complete remission;\n* primary high risk AML in molecular complete remission awaiting unrelated HSCT;\n* Karnofsky or Lansky performance scale greater or equal to 70;\n* written informed consent.\n\nDonors:\n\n* haploidentical family donor;\n* donor suitable for cell donation and apheresis according to standard criteria;\n* written informed consent.\n\nExclusion Criteria:\n\nPatients:\n\n* uncontrolled infection;\n* severe hepatic dysfunction: SGOT or SCPT \\>=5x upper limit of normal for age;\n* positive serology for human immunodeficiency virus (HIV).\n\nDonors:\n\n* pregnancy;\n* positive serology for HIV, hepatitis B or C.","ALL","6 Months","21 Years",{"count":88,"type":89},15,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE1","PHASE2","The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children\u002Fyoung adults with intermediate risk AML.",[96],"Acute Myeloid Leukemia",[98,99],"Natural killer cells","Immunotherapy","2024-08-27",{"date":102,"type":103},"2024-08-28","ACTUAL",{"date":105,"type":103},"2021-11-01",{"date":107,"type":89},"2026-06",{"name":5,"class":6},1]