[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464869":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":44,"overallOfficials":57,"centralContacts":61,"locations":71,"responsibleParty":83,"collaborators":28,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":28,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":28,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":74,"whyStopped":28,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Belarusian Research Center for Pediatric Oncology, Hematology and Immunology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","Adverse events will be graded according to the CTCAE v5.0","1 month",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Objective Response Rate (ORR) (CR+CRi+CRm)","The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).","28 days after CAR-T cells infusion",{"measure":19,"description":20,"timeFrame":21},"Overall survival (OS)","The proportion of patients with overall survival","1 year",{"measure":23,"description":24,"timeFrame":21},"Events free survival (EFS)","Time from CAR-T cells infusion to CR failure, relapse, or death.",{"measure":26,"description":27,"timeFrame":21},"Leukemia free survival (LFS)","Time from achievement of CR\u002FCRi\u002FCRm to the time of relapse, death in remission, or last follow-up.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"CD19 CAR-T cells immunotherapy","EXPERIMENTAL","After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells",[42,43],"Biological: CD19 CAR-T-cells","Drug: Tocilizumab",[45,50],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":28},"BIOLOGICAL","CD19 CAR-T-cells","One dose of CD19 CAR-T cells (1\\*10e6 CAR+ T-cells\u002Fkg) by intravenous infusion.",[38],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Tocilizumab","Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg\u002Fkg).",[38],[56],"Actemra",[58],{"name":59,"affiliation":5,"role":60},"Olga Aleinikova, MD, Prof","STUDY_DIRECTOR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":28,"email":66},"Elena Lukoyko, MD","CONTACT","+375291643075","lenalukojko@gmail.com",{"name":68,"role":64,"phone":69,"phoneExt":28,"email":70},"Aleksandr Meleshko, PhD","+375296940023","meleshko@tut.by",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":28,"geoPoint":28,"contacts":80},"Belarussian Research Center for Pediatric Oncology, Hematology and Immunology","RECRUITING","Minsk","Minsk Oblast","223053","Belarus","BY",[81],{"name":63,"role":64,"phone":82,"phoneExt":28,"email":28},"+37529 1643075",{"type":84,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100464869","phase-1-pilot-car-t-cells-therapy-for-childrenyoung-adults-with-cd19-rr-leukemialymphoma-100464869",false,"NCT05333302","Pilot CAR-T Cells Therapy for Children\u002FYoung Adults With CD19+ R\u002FR Leukemia\u002FLymphoma","Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia\u002FLymphoma in Children\u002FYoung Adults","Inclusion Criteria:\n\n* CD19+ relapsed or refractory lymphoblastic leukemia\u002Flymphoma;\n* Karnofsky or Lansky performance scale greater or equal to 70;\n* T-cells count in peripheral blood \\>150 cells\u002FµL;\n* Written informed consent.\n\nExclusion Criteria:\n\n* primary immunodeficiencies or genetic syndromes;\n* neurologic diseases;\n* autoimmune diseases or polyallergie;\n* transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;\n* GvHD grade 2-4;\n* uncontrolled systemic infection;\n* hypoxia (Sp02\\\u003C90%)\n* severe hepatic dysfunction: ALT or AST \\>=3x upper limit of normal for age;\n* renal dysfunction: serum creatinine level \\>=3x upper limit of normal for age;\n* positive serology for human immunodeficiency virus (HIV), active hepatite C or B;\n* pregnancy.","ALL","1 Year","30 Years",{"count":96,"type":97},10,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children\u002Fyoung adults with relapsed or refractory acute lymphoblastic leukemia\u002Flymphoma.",[103,104],"B-cell Acute Lymphoblastic Leukemia","Lymphoblastic B-Cell Lymphoma",[106,107,108],"immunotherapy","CAR-T cells","CD19","2024-08-27",{"date":111,"type":112},"2024-08-28","ACTUAL",{"date":114,"type":112},"2020-10-26",{"date":116,"type":97},"2025-06",{"name":5,"class":6},1]