[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06357754":3,"trial-entities:NCT06357754":167,"trial-summary:NCT06357754":171},{"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":15,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":15,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":45,"sex":46,"minimum_age":15,"maximum_age":15,"healthy_volunteers":15,"eligibility_criteria":47,"std_ages":55,"locations":59,"central_contacts":149,"overall_officials":156,"references":159,"see_also_links":160},"NCT06357754","CA082-085","Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy","Protocol for Transgene Assay Service","RECRUITING","2038-10-06","2026-01","2026-01-22","2023-10-06","Bristol-Myers Squibb","INDUSTRY",null,"The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.",[18,19,20],"Non-Hodgkin Lymphoma","Chronic Lymphocytic Leukaemia","Multiple Myeloma",[],"OBSERVATIONAL",[],{"count":25,"type":26},50,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BIOLOGICAL","Idecabtagene vicleucel","As per product label",[33],"Participants treated with idecabtagene vicleucel",{"type":29,"name":35,"description":31,"armGroupLabels":36},"Lisocabtagene maraleucel",[37],"Participants treated with lisocabtagene maraleucel",[39,42],{"measure":40,"timeFrame":41},"Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results","Baseline",{"measure":43,"description":44,"timeFrame":41},"Participant insertion site analysis (ISA) testing results","For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene",[],"ALL",{"inclusion":48,"exclusion":51,"raw_text":54},[49,50],"Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.","Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.",[52,53],"Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.","Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.","Inclusion Criteria:\n\n* Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.\n* Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.\n\nExclusion Criteria:\n\n* Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.\n* Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.",[56,57,58],"CHILD","ADULT","OLDER_ADULT",[60,74,86,97,106,118,130,137],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":71},"Local Institution - 0016","NOT_YET_RECRUITING","Portland","Oregon","97239-3098","United States",[68],{"name":69,"role":70},"Site 0016","CONTACT",{"lat":72,"lon":73},45.52345,-122.67621,{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":66,"contacts":79,"geoPoint":83},"Ut Southwestern","Dallas","Texas","75235",[80],{"name":81,"role":70,"phone":82},"Larry Anderson, Site 0008","214-648-5906",{"lat":84,"lon":85},32.78306,-96.80667,{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":66,"contacts":91,"geoPoint":94},"Huntsman Cancer Institute at the University of Utah","Salt Lake City","Utah","84112",[92],{"name":93,"role":70},"Lauren Lee, Site 0010",{"lat":95,"lon":96},40.76078,-111.89105,{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":66,"geoPoint":103},"Local Institution - 0004","WITHDRAWN","Madison","Wisconsin","53792",{"lat":104,"lon":105},43.07305,-89.40123,{"facility":107,"status":8,"city":108,"zip":109,"country":110,"contacts":111,"geoPoint":115},"Universitaetsklinikum Essen (AoR)","Essen","45147","Germany",[112],{"name":113,"role":70,"phone":114},"Bastian von Tresckow, Site 0001","+491631751277",{"lat":116,"lon":117},51.45657,7.01228,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":123,"contacts":124,"geoPoint":127},"Toyokawa City Hospital","Toyokawa","Aichi-ken","442-8561","Japan",[125],{"name":126,"role":70},"Akimi Kawai, Site 0012",{"lat":128,"lon":129},34.81667,137.4,{"facility":131,"status":99,"city":132,"state":132,"zip":133,"country":123,"geoPoint":134},"Local Institution - 0003","Kumamoto","8608556",{"lat":135,"lon":136},32.80589,130.69181,{"facility":138,"status":8,"city":139,"zip":140,"country":141,"contacts":142,"geoPoint":146},"Kantonsspital Aarau","Aarau","5001","Switzerland",[143],{"name":144,"role":70,"phone":145},"Sabine Veronika Gerull, Site 0002","+41628386505",{"lat":147,"lon":148},47.39254,8.04422,[150,154],{"name":151,"role":70,"phone":152,"email":153},"BMS Study Connect Contact Center www.BMSStudyConnect.com","855-907-3286","Clinical.Trials@bms.com",{"name":155,"role":70},"First line of the email MUST contain NCT # and Site #.",[157],{"name":13,"affiliation":13,"role":158},"STUDY_DIRECTOR",[],[161,164],{"label":162,"url":163},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":165,"url":166},"FDA Safety Alerts and Recalls","https:\u002F\u002Fwww.fda.gov\u002Fsafety\u002Frecalls-market-withdrawals-safety-alerts",{"nct_id":4,"conditions":168,"biomarkers":170},[169,20,18],"Chronic Lymphocytic Leukemia",[],{"nct_id":4,"found":172,"summary":173,"prompt_version":183},true,{"design":174,"status":175,"heading":176,"summary":177,"follow_up":178,"word_count":179,"commitments":180,"compensation":181,"drugs_mentioned":182},"This is an observational study, meaning researchers will collect and analyze information without giving new treatments. It aims to include about 50 participants.","completed","Observational Study of Gene-Modified Cell Therapy and Second Cancers","This study is looking at tumor samples from patients who have received specific gene-modified cell therapies, like idecabtagene vicleucel or lisocabtagene maraleucel, and have since developed a second cancer. The purpose is to check the levels of the gene modification (transgene) in these tumor samples. This helps researchers understand if there's a connection between the cell therapy and the new cancer. You could be eligible if you've had one of these Bristol-Myers Squibb cell therapies and have been diagnosed with a qualifying second cancer, such as Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukaemia, or Multiple Myeloma. The study will measure transgene levels and insertion sites in your tumor samples. The current recruitment status is unclear.","The study measures results at baseline, which means at the beginning of the study. It does not specify ongoing follow-up after this initial measurement.",113,"Not specified in the trial record.","Not stated in the trial record.",[30,35],"v2"]