[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577128":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":19,"studyPopulation":33,"armGroups":34,"interventions":39,"overallOfficials":45,"centralContacts":49,"locations":57,"responsibleParty":72,"collaborators":19,"id":74,"slug":19,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":19,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":19,"enrollmentInfo":82,"targetDuration":19,"studyType":85,"phases":19,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":60,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of adverse events (AEs) of interest","AEs of interest include:\n\n* Secondary malignancies\n* Cytokine release syndrome (CRS) Grade ≥ 3\n* Neurotoxicity Grade ≥ 3\n* Prolonged cytopenias\n* Pregnancy outcome\n* Tumor lysis syndrome (TLS) Grade ≥ 3\n* Serious infections (ie, those requiring treatment)\n* Organ toxicities Grade ≥ 3\n* Hemophagocytic lymphohistiocytosis (HLH)\u002F macrophage activation syndrome (MAS)-like toxicities\n* Aggravated graft-versus-host disease (GvHD)","Up to 15 years",{"measure":14,"description":15,"timeFrame":12},"Incidence of other adverse events (AEs) of interest","Other clinically important events that have not yet been identified as part of the liso-cel safety profile",[17,20,22,24,26,28],{"measure":18,"description":19,"timeFrame":12},"Overall survival (OS)",null,{"measure":21,"description":19,"timeFrame":12},"Overall response rate (ORR)",{"measure":23,"description":19,"timeFrame":12},"Complete remission rate (CRR)",{"measure":25,"description":19,"timeFrame":12},"Duration of response (DOR)",{"measure":27,"description":19,"timeFrame":12},"Progression-free survival (PFS)",{"measure":29,"description":19,"timeFrame":12},"Time to next treatment (TTNT)",{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":31,"timePerspective":32,"maskingInfo":19},"COHORT","PROSPECTIVE","The study population will include adults with relapsed\u002Frefractory follicular lymphoma that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.",[35],{"label":36,"type":19,"description":19,"interventionNames":37},"Participants receiving lisocabtagene maraleucel treatment",[38],"Biological: Lisocabtagene maraleucel",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":19},"BIOLOGICAL","Lisocabtagene maraleucel","As per product label",[36],[46],{"name":47,"affiliation":47,"role":48},"Bristol-Myers Squibb","STUDY_DIRECTOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":19,"email":54},"BMS Study Connect Contact Center www.BMSStudyConnect.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":56,"role":52,"phone":19,"phoneExt":19,"email":19},"First line of the email MUST contain NCT # and Site #.",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":19},"CIBMTR","RECRUITING","Milwaukee","Wisconsin","53226","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-87.90647,43.0389,{"lat":70,"lon":69},{"type":73,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100577128",false,"NCT06794268","A Study to Patients With Relapsed\u002FRefractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting","Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed\u002FRefractory Follicular Lymphoma in the Postmarketing Setting","Inclusion Criteria:\n\n• Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed\u002Frefractory (R\u002FR) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA\n\nExclusion Criteria:\n\n* Participants known to be participating in investigational studies at the time of liso-cel, infusion\n* Participants treated with liso-cel for the treatment of R\u002FR FL Grade 3b\n* Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product","ALL","18 Years",{"count":83,"type":84},300,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities",[88],"Follicular Lymphoma",[88],"2025-02-21",{"date":92,"type":93},"2025-02-24","ACTUAL",{"date":95,"type":93},"2025-02-04",{"date":97,"type":84},"2044-08-31",{"name":5,"class":6},1]