[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500757":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":104,"centralContacts":108,"locations":109,"responsibleParty":131,"collaborators":133,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":108,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":108,"enrollmentInfo":146,"targetDuration":108,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":108,"overallStatus":111,"whyStopped":108,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (leukapheresis, external beam radiation, CAR-T)","EXPERIMENTAL","Patients undergo leukapheresis per standard of care, undergo external beam radiation therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo PET\u002FCT throughout the study and may undergo MRI during screening. Patients also undergo blood sample collection throughout the study.",[13,14,15,16,17,18,19],"Procedure: Biospecimen Collection","Biological: Chimeric Antigen Receptor T-Cell Therapy","Procedure: Computed Tomography","Radiation: External Beam Radiation Therapy","Procedure: Leukapheresis","Procedure: Magnetic Resonance Imaging","Procedure: Positron Emission Tomography",[21,30,40,53,71,78,93],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9],[27,28,29],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","Chimeric Antigen Receptor T-Cell Therapy","Receive CAR-T per standard of care",[9],[36,37,38,39],"CAR T Infusion","CAR T Therapy","CAR T-cell Therapy","Chimeric Antigen Receptor T-cell Infusion",{"type":22,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Computed Tomography","Undergo PET\u002FCT",[9],[45,46,47,48,49,50,51,52],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized Tomography","CT","CT Scan","tomography",{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"RADIATION","External Beam Radiation Therapy","Undergo radiation therapy",[9],[59,60,61,62,63,64,65,66,67,68,69,70],"Definitive Radiation Therapy","EBRT","External Beam Radiation","External Beam Radiotherapy","External Beam RT","external radiation","External Radiation Therapy","external-beam radiation","Radiation, External Beam","Teleradiotherapy","Teletherapy","Teletherapy Radiation",{"type":22,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Leukapheresis","Receive leukapheresis",[9],[76,77],"Leukocytopheresis","Therapeutic Leukopheresis",{"type":22,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Magnetic Resonance Imaging","Undergo MRI",[9],[83,84,85,86,87,88,89,90,91,92],"Magnetic Resonance","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging",{"type":22,"name":94,"description":42,"armGroupLabels":95,"otherNames":96},"Positron Emission Tomography",[9],[97,98,99,100,101,102,103],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",[105],{"name":106,"affiliation":5,"role":107},"Savita V Dandapani","PRINCIPAL_INVESTIGATOR",null,[110],{"facility":5,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"RECRUITING","Duarte","California","91010","United States","US",{"type":118,"coordinates":119},"Point",[120,121],-117.97729,34.13945,{"lat":121,"lon":120},[124,130],{"name":125,"role":126,"phone":127,"phoneExt":128,"email":129},"Savita V. Dandapani","CONTACT","626-218-5334","82071","sdandapani@coh.org",{"name":125,"role":107,"phone":108,"phoneExt":108,"email":108},{"type":132,"investigatorFullName":108,"investigatorTitle":108,"investigatorAffiliation":108,"oldNameTitle":108,"oldOrganization":108},"SPONSOR",[134],{"name":135,"class":136},"National Cancer Institute (NCI)","NIH","100500757","early-phase-1-evaluation-of-bridging-radiation-therapy-before-car-t-cell-infusion-for-the-treatment-of-relapsed-or-refractory-large-b-cell-lymphoma-100500757",false,"NCT05800405","Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma","A Feasibility Study of Bridging Radiation to All Sites of FDG-Avid Disease for Commercial CAR T-Cell Infusion in Patients With Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2 or Karnofsky Performance Status (KPS) \\>= 60.\n* Histologically confirmed large B-cell lymphoma.\n* Relapsed\u002Frefractory disease.\n* Planned to undergo commercial CAR T-cell infusion within 3 months of enrollment.\n* 6 or fewer sites (treatable with a maximum of 3 isocenters) of FDG-PET avid disease, treatable with a a maximum of 3 isocenters.\n* Measurable disease e.g., at least 1.5 cm on CT\u002FMRI or by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C grade 1 to prior anti-cancer therapy.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 30 days prior to day 1 of protocol therapy).\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nExclusion Criteria:\n\n* Prior CD19-directed therapy.\n* Radiation therapy within 21 days prior to day 1 of protocol therapy.\n* Central nervous system (CNS) disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Active diarrhea.\n* Clinically significant uncontrolled illness.\n* Active infection requiring antibiotics.\n* Other active malignancy.\n* Females only: Pregnant.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).","ALL","18 Years",{"count":147,"type":148},9,"ESTIMATED","INTERVENTIONAL",[151],"EARLY_PHASE1","This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients have symptomatic or life-threatening disease which often requires bridging therapy. Bridging therapy aims to slow disease progression and control symptoms during this critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve treatment outcomes with minimal toxicity.",[154,155],"Recurrent Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","2026-02-02",{"date":158,"type":159},"2026-02-04","ACTUAL",{"date":161,"type":159},"2023-07-20",{"date":163,"type":148},"2027-01-04",{"name":5,"class":6},1]