[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03375619":3,"trial-entities:NCT03375619":91,"trial-summary:NCT03375619":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":27,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":33,"interventions":36,"primary_outcomes":42,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":63,"locations":66,"central_contacts":82,"overall_officials":85,"references":89,"see_also_links":90},"NCT03375619","PRO30317","Long-term Follow-up Study of Patients Receiving CAR-T Cells","RECRUITING","2035-01-01","2025-11","2025-11-10","2017-12-01","Medical College of Wisconsin","OTHER",true,"This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin\u002F Froedtert Hospital. The clinical trials include the following:\n\nPhase 1 Study of CAR-20\u002F19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20\u002F19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)","The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.",[18,19,20,21,22,23,24,25,26],"Chronic Lymphocytic Leukemia","Lymphomas Non-Hodgkin's B-Cell","Lymphoma, Small Lymphocytic","Mantle Cell Lymphoma","Central Nervous System Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","Multiple Myeloma",[28,29],"CAR-T Cell Therapy","chimeric antigen receptor","OBSERVATIONAL",null,[],{"count":34,"type":35},500,"ESTIMATED",[37],{"type":13,"name":38,"description":39,"armGroupLabels":40},"Long-Term Follow-Up of Participants who Received CAR-T cells","No study drug is administered in this study. Participants who received CAR-T cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.",[41],"Participants who received CAR-T cells.",[43,47,50],{"measure":44,"description":45,"timeFrame":46},"Change from baseline in the incidence of a new malignancy at 5 years.","The number of subjects with new malignancy.","Baseline to five years.",{"measure":48,"description":45,"timeFrame":49},"Change from baseline in the incidence of a new malignancy at 10 years.","Baseline to 10 years.",{"measure":51,"description":45,"timeFrame":52},"Change from baseline in the incidence of a new malignancy at 15 years.","Baseline to 15 years.",[],"ALL","18 Years","80 Years",false,{"inclusion":59,"exclusion":61,"raw_text":62},[60],"All participants who enrolled in a CAR-T study at Froedtert Hospital \\& the Medical College of Wisconsin.",[],"Inclusion Criteria:\n\n* All participants who enrolled in a CAR-T study at Froedtert Hospital \\& the Medical College of Wisconsin.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study.",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"status":7,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"Froedtert Hospital & Medical College of Wisconsin","Milwaukee","Wisconsin","53226","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Cancer Center Clinical Trials Office","CONTACT","414-805-8900","cccto@mcw.edu",{"lat":80,"lon":81},43.0389,-87.90647,[83],{"name":84,"role":76,"phone":77,"email":78},"Medical College of Wisconsin Clinical Cancer Center",[86],{"name":87,"affiliation":12,"role":88},"Nirav Shah","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":96},[93,25,22,18,94,24,21,26,95],"B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Small Lymphocytic Lymphoma",[],{"nct_id":4,"found":14,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study following 500 participants who previously received CAR-T cell therapy.","completed","Long-term Follow-up for CAR-T Cell Therapy","This study is observing people who have already received CAR-T cells (a type of cell therapy where your own immune cells are specially trained to fight cancer) in a previous clinical trial at Froedtert Hospital & the Medical College of Wisconsin. The goal is to understand the long-term safety and effectiveness of CAR-T cell treatments for conditions like Chronic Lymphocytic Leukemia and different types of Lymphoma. Researchers will be looking for how often new cancers develop at 5, 10, and 15 years after treatment. You can join if you are between 18 and 80 years old and have participated in a CAR-T study at Froedtert Hospital & the Medical College of Wisconsin. The study is currently unclear on its recruitment status.","Participants will be followed for up to 15 years after their CAR-T cell treatment.",121,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]