[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525005":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":39,"overallOfficials":43,"centralContacts":47,"locations":55,"responsibleParty":131,"collaborators":27,"id":133,"slug":27,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":27,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":27,"enrollmentInfo":141,"targetDuration":27,"studyType":144,"phases":27,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":58,"whyStopped":27,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Miltenyi Biomedicine GmbH","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"The incidence of serious and non serious adverse events of special interest","AESIs will be collected","Up to 15 years",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)","Peripheral blood samples may be collected for RCL assessment",{"measure":18,"description":19,"timeFrame":20},"Duration of zamtocabtagene autoleucel persistence","Peripheral blood samples will be collected to test for CAR T cells","Up to 5 years",{"measure":22,"description":23,"timeFrame":12},"Objective response rate","ORR",{"measure":25,"description":26,"timeFrame":12},"Overall Survival","OS",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.","Patients who have received MB-CART2019.1",[34],{"label":35,"type":27,"description":36,"interventionNames":37},"Long-term Follow-Up","No intervention",[38],"Other: Long-term Follow-Up",[40],{"type":41,"name":35,"description":36,"armGroupLabels":42,"otherNames":27},"OTHER",[35],[44],{"name":45,"affiliation":5,"role":46},"Remi Kaleta, MD","STUDY_DIRECTOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":27,"email":52},"Sadie Swift","CONTACT","617-218-0044","clinicaltrials@miltenyi.com",{"name":54,"role":50,"phone":51,"phoneExt":27,"email":52},"Paris Jamiel",[56,74,88,103,117],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Stanford University","RECRUITING","Stanford","California","94305","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-122.16608,37.42411,{"lat":68,"lon":67},[71],{"name":72,"role":50,"phone":27,"phoneExt":27,"email":73},"Christina Tran","ctran13@stanford.edu",{"facility":75,"status":58,"city":76,"state":77,"zip":78,"country":62,"countryCode":63,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Yale University","New Haven","Connecticut","06520",{"type":65,"coordinates":80},[81,82],-72.92816,41.30815,{"lat":82,"lon":81},[85],{"name":86,"role":50,"phone":27,"phoneExt":27,"email":87},"Jialing Zhang","jialing.zhang@yale.edu",{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":62,"countryCode":63,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center","NOT_YET_RECRUITING","Baltimore","Maryland","21201",{"type":65,"coordinates":95},[96,97],-76.61219,39.29038,{"lat":97,"lon":96},[100],{"name":101,"role":50,"phone":27,"phoneExt":27,"email":102},"Nancy Hardy, MD","nhardy1@umm.edu",{"facility":104,"status":58,"city":105,"state":106,"zip":107,"country":62,"countryCode":63,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":65,"coordinates":109},[110,111],-71.05977,42.35843,{"lat":111,"lon":110},[114],{"name":115,"role":50,"phone":27,"phoneExt":27,"email":116},"Christopher Simmons","Christopher_Simmons@DFCI.HARVARD.EDU",{"facility":118,"status":58,"city":119,"state":120,"zip":121,"country":62,"countryCode":63,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":65,"coordinates":123},[124,125],-87.90647,43.0389,{"lat":125,"lon":124},[128],{"name":129,"role":50,"phone":27,"phoneExt":27,"email":130},"Hailey McArthey","hmcarthey@mcw.edu",{"type":132,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100525005",false,"NCT06116110","Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU","A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study","Inclusion Criteria:\n\n* Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study.\n* Provided written informed consent to participate in this study.\n\nExclusion Criteria:\n\n* None","ALL","18 Years",{"count":142,"type":143},150,"ESTIMATED","OBSERVATIONAL","This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.",[147],"Non Hodgkin Lymphoma",[149,150,151,152],"Chimeric antigen receptor","CAR T","CD19","CD20","2024-11-18",{"date":155,"type":156},"2024-11-20","ACTUAL",{"date":158,"type":156},"2024-05-15",{"date":160,"type":143},"2039-12-01",{"name":5,"class":6},5]