[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06652633":3,"trial-entities:NCT06652633":164,"trial-summary:NCT06652633":168},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":17,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":65,"locations":68,"central_contacts":152,"overall_officials":158,"references":162,"see_also_links":163},"NCT06652633","LTF-CL-001","Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies","A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies","RECRUITING","2039-07","2026-07","2026-07-13","2024-09-09","Lakefront Biotherapeutics NV","INDUSTRY",true,"This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.\n\nPer Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit\u002Frisk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.",null,[19],"Hematological Malignancies",[21],"CAR T-cell therapy","INTERVENTIONAL","OTHER",[25],"PHASE3",{"count":27,"type":28},546,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"GENETIC","GLPG CAR T-cell therapy","No investigational products will be administered to participants in this study.",[35],"Previously treated participants with GLPG CAR T-cell therapy",[37,40,42,44,46,48],{"measure":38,"timeFrame":39},"Percentage of participants with targeted adverse events (AEs)","From infusion up to 15 years",{"measure":41,"timeFrame":39},"Percentage of participants with detectable CAR transgene levels in peripheral blood",{"measure":43,"timeFrame":39},"Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy",{"measure":45,"timeFrame":39},"Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies",{"measure":47,"timeFrame":39},"Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood",{"measure":49,"timeFrame":39},"Percentage of participants who died with causes",[51,53,55],{"measure":52,"timeFrame":39},"Percentage of participants with disease progression",{"measure":54,"timeFrame":39},"Time to subsequent anticancer therapy",{"measure":56,"timeFrame":39},"Overall survival","ALL","18 Years",false,{"inclusion":61,"exclusion":63,"raw_text":64},[62],"All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.",[],"Inclusion Criteria:\n\n* All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study",[66,67],"ADULT","OLDER_ADULT",[69,78,86,93,100,107,114,122,130,137,144],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Tufts Medical Center","Boston","Massachusetts","02111","United States",{"lat":76,"lon":77},42.35843,-71.05977,{"facility":79,"status":8,"city":80,"zip":81,"country":82,"geoPoint":83},"Antwerp University Hospital","Edegem","2650","Belgium",{"lat":84,"lon":85},51.15662,4.44504,{"facility":87,"status":8,"city":88,"zip":89,"country":82,"geoPoint":90},"Universitair Ziekenhuis Leuven","Leuven","3000",{"lat":91,"lon":92},50.87959,4.70093,{"facility":94,"status":8,"city":95,"zip":96,"country":82,"geoPoint":97},"Centre Hospitalier Universitaire (CHU) De Liège","Liège","4032",{"lat":98,"lon":99},50.63373,5.56749,{"facility":101,"status":8,"city":102,"zip":103,"country":82,"geoPoint":104},"Algemeen Ziekenhuis Delta","Roeselare","8800",{"lat":105,"lon":106},50.94653,3.12269,{"facility":108,"status":8,"city":109,"zip":110,"country":82,"geoPoint":111},"Cliniques Universitaires Saint-Luc","Woluwe-Saint-Lambert","1200",{"lat":112,"lon":113},50.84389,4.42912,{"facility":115,"status":8,"city":116,"zip":117,"country":118,"geoPoint":119},"helsingin yliopistollinen sairaala comprehensive cancer center (HUS)","Helsinki","00290","Finland",{"lat":120,"lon":121},60.16952,24.93545,{"facility":123,"status":8,"city":124,"zip":125,"country":126,"geoPoint":127},"Academisch Medisch Centrum (Amsterdam UMC)","Amsterdam","1105 AZ","Netherlands",{"lat":128,"lon":129},52.37403,4.88969,{"facility":131,"status":8,"city":132,"zip":133,"country":126,"geoPoint":134},"Leids University Medical Center (LUMC)","Leiden","2333 ZA",{"lat":135,"lon":136},52.15833,4.49306,{"facility":138,"status":8,"city":139,"zip":140,"country":126,"geoPoint":141},"Erasmus Medisch Centrum","Rotterdam","3015",{"lat":142,"lon":143},51.9225,4.47917,{"facility":145,"status":8,"city":146,"zip":147,"country":148,"geoPoint":149},"Hospital Clinic De Barcelona","Barcelona","08036","Spain",{"lat":150,"lon":151},41.38879,2.15899,[153],{"name":154,"role":155,"phone":156,"email":157},"Lakefront Biotherapeutics Medical Information","CONTACT","+3215342900","medicalinfo@lakefrontbio.com",[159],{"name":160,"affiliation":13,"role":161},"Lakefront Biotherapeutics Study Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":165,"biomarkers":167},[166],"Hematologic Neoplasm",[],{"nct_id":4,"found":59,"summary":17,"prompt_version":17}]