[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03628612":3,"trial-entities:NCT03628612":134,"trial-summary:NCT03628612":140},{"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":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":43,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":72,"locations":76,"central_contacts":130,"overall_officials":131,"references":132,"see_also_links":133},"NCT03628612","AUTO-LT1","Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells","Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors","ENROLLING_BY_INVITATION","2043-12","2025-08","2025-08-07","2018-08-02","Autolus Limited","INDUSTRY",false,"Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.","The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.",[19,20,21,22,23],"Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy","Multiple Myeloma","DLBCL","ALL, Adult and Pediatric","T Cell Lymphoma",[],"INTERVENTIONAL","OTHER",[28],"PHASE2",{"count":30,"type":31},500,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BIOLOGICAL","AUTO CAR T cell therapy","No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.",[35],[39],{"measure":40,"description":41,"timeFrame":42},"Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy","Monitoring of all SAEs \u002F AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy.\n\nMonitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion.","For up to 15 years",[44,47,50,53,56,59,62],{"measure":45,"description":45,"timeFrame":46},"Overall Survival following first AUTO CAR T cell therapy infusion.","Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15",{"measure":48,"description":49,"timeFrame":46},"Duration of supportive care","B-cell aplasia for patients treated with an AUTO CAR T cell therapy targeting a B-cell malignancy.",{"measure":51,"description":52,"timeFrame":46},"Duration of response","Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression.",{"measure":54,"description":55,"timeFrame":46},"Progression-free survival","Progression free survival following first AUTO CAR T cell therapy infusion.",{"measure":57,"description":58,"timeFrame":42},"Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion","Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion",{"measure":60,"description":61,"timeFrame":46},"Proportion of patients with detectable vector copy number (VCN) in peripheral blood","Blood sample collection for VCN measurement to detect persistence of CAR transgene(s)",{"measure":63,"description":64,"timeFrame":42},"Testing for Insertional mutagenesis in case of a new malignancy","Insertional site analysis of samples to determine insertional mutagenesis as a potential cause \u002F contributor in case of a new malignancy.","ALL","1 Year",null,{"inclusion":69,"exclusion":70,"raw_text":71},[],[],"Inclusion Criteria:\n\n1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.\n2. Patients must have provided informed consent for long-term follow-up study prior to participation.\n3. Patients must be able to comply with the study requirements.\n\nExclusion Criteria:\n\n1. There are no specific exclusion criteria for this study.",[73,74,75],"CHILD","ADULT","OLDER_ADULT",[77,86,94,102,109,115,121,124],{"facility":78,"city":79,"state":80,"zip":81,"country":82,"geoPoint":83},"University of Miami","Miami","Florida","33136","United States",{"lat":84,"lon":85},25.77427,-80.19366,{"facility":87,"city":88,"state":89,"zip":90,"country":82,"geoPoint":91},"Washington University in St. Louis","St Louis","Missouri","63110",{"lat":92,"lon":93},38.62727,-90.19789,{"facility":95,"city":96,"state":97,"zip":98,"country":82,"geoPoint":99},"St David's South Austin Medical Center","Austin","Texas","78704",{"lat":100,"lon":101},30.26715,-97.74306,{"facility":103,"city":104,"country":105,"geoPoint":106},"Queen Elizabeth University Hospital","Glasgow","United Kingdom",{"lat":107,"lon":108},55.86515,-4.25763,{"facility":110,"city":111,"country":105,"geoPoint":112},"University College London Hospitals NHS Foundation Trust","London",{"lat":113,"lon":114},51.50853,-0.12574,{"facility":116,"city":117,"country":105,"geoPoint":118},"Manchester Royal Infirmary Hospital","Manchester",{"lat":119,"lon":120},53.48095,-2.23743,{"facility":122,"city":117,"country":105,"geoPoint":123},"Royal Manchester Children's Hospital",{"lat":119,"lon":120},{"facility":125,"city":126,"country":105,"geoPoint":127},"Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust","Newcastle upon Tyne",{"lat":128,"lon":129},54.97328,-1.61396,[],[],[],[],{"nct_id":4,"conditions":135,"biomarkers":139},[136,137,20,138],"Acute Lymphoblastic Leukemia","Diffuse Large B-Cell Lymphoma","T-Cell Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":15,"summary":67,"prompt_version":67}]