[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522616":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":11,"studyPopulation":11,"armGroups":59,"interventions":76,"overallOfficials":102,"centralContacts":106,"locations":114,"responsibleParty":832,"collaborators":11,"id":834,"slug":11,"hasResults":835,"nctId":836,"briefTitle":837,"officialTitle":838,"acronym":839,"eligibilityCriteria":840,"healthyVolunteers":835,"sex":841,"minAge":842,"maxAge":11,"enrollmentInfo":843,"targetDuration":11,"studyType":846,"phases":847,"briefSummary":849,"conditions":850,"keywords":11,"overallStatus":131,"whyStopped":11,"lastUpdateSubmitDate":852,"lastUpdatePostDateStruct":853,"startDateStruct":856,"completionDateStruct":858,"leadSponsor":860,"locationsCount":861},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)",null,"From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)",[14,17,19,22,25,28,30,32,35,37,39,42,44,47,49,51],{"measure":15,"description":11,"timeFrame":16},"Complete response (CR) rate","Up to approximately 24 months",{"measure":18,"description":11,"timeFrame":16},"Objective response rate (ORR)",{"measure":20,"description":11,"timeFrame":21},"Overall survival (OS)","From randomization to death from any cause (up to approximately 24 months)",{"measure":23,"description":11,"timeFrame":24},"Time to deterioration in physical functioning\u002Ffatigue","From randomization to a 10-point decrease in physical functioning\u002F10-point increase in fatigue compared to baseline (up to approximately 24 months)",{"measure":26,"description":11,"timeFrame":27},"Investigator-assessed PFS","From randomization to disease progression or death from any cause (up to approximately 24 months)",{"measure":29,"description":11,"timeFrame":16},"Investigator-assessed CR rate",{"measure":31,"description":11,"timeFrame":16},"Investigator-assessed ORR",{"measure":33,"description":11,"timeFrame":34},"Duration of Complete Response (DOCR)","From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)",{"measure":36,"description":11,"timeFrame":34},"Duration of Response (DOR)",{"measure":38,"description":11,"timeFrame":16},"Proportion of participants reporting each response option for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G) subscale",{"measure":40,"description":11,"timeFrame":41},"Time to deterioration in lymphoma symptoms","From randomization to the first documentation of a 3-point or more decrease in score as assessed by the FACT-Lym lymphoma subscale (LymS) questionnaire (up to approximately 24 months)",{"measure":43,"description":11,"timeFrame":16},"Proportion of participants experiencing a clinically meaningful improvement (3-point or more increase) in lymphoma symptoms as assessed through use of the FACT-Lym LymS",{"measure":45,"description":46,"timeFrame":16},"Change from baseline in physical functioning and fatigue at each cycle as assessed by the European Organization for Research and Treatment (EORTC) core Quality of Life Questionnaire (QLQ-C30)","The EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). 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Cancer Care - Santa Monica","Santa Monica","90404-2023",{"type":124,"coordinates":144},[145,146],-118.49138,34.01949,{"lat":146,"lon":145},{"facility":149,"status":131,"city":150,"state":151,"zip":152,"country":121,"countryCode":122,"cosmosGeoPoint":153,"geoPoint":157,"contacts":11},"Yale Cancer Center","New Haven","Connecticut","06520",{"type":124,"coordinates":154},[155,156],-72.92816,41.30815,{"lat":156,"lon":155},{"facility":159,"status":131,"city":160,"state":161,"zip":162,"country":121,"countryCode":122,"cosmosGeoPoint":163,"geoPoint":167,"contacts":11},"Georgetown University","Washington D.C.","District of Columbia","20007",{"type":124,"coordinates":164},[165,166],-77.03637,38.89511,{"lat":166,"lon":165},{"facility":169,"status":131,"city":170,"state":171,"zip":172,"country":121,"countryCode":122,"cosmosGeoPoint":173,"geoPoint":177,"contacts":11},"University of Miami","Coral Gables","Florida","33146",{"type":124,"coordinates":174},[175,176],-80.26838,25.72149,{"lat":176,"lon":175},{"facility":179,"status":117,"city":180,"state":181,"zip":182,"country":121,"countryCode":122,"cosmosGeoPoint":183,"geoPoint":187,"contacts":11},"Indiana University","Indianapolis","Indiana","46202",{"type":124,"coordinates":184},[185,186],-86.15804,39.76838,{"lat":186,"lon":185},{"facility":189,"status":131,"city":190,"state":191,"zip":192,"country":121,"countryCode":122,"cosmosGeoPoint":193,"geoPoint":197,"contacts":11},"University of Michigan Health System","Ann Arbor","Michigan","48109",{"type":124,"coordinates":194},[195,196],-83.74088,42.27756,{"lat":196,"lon":195},{"facility":199,"status":131,"city":200,"state":201,"zip":202,"country":121,"countryCode":122,"cosmosGeoPoint":203,"geoPoint":207,"contacts":11},"St. Luke's Hospital","Chesterfield","Missouri","63017",{"type":124,"coordinates":204},[205,206],-90.57707,38.66311,{"lat":206,"lon":205},{"facility":209,"status":131,"city":210,"state":211,"zip":212,"country":121,"countryCode":122,"cosmosGeoPoint":213,"geoPoint":217,"contacts":11},"Renown Regional Medical Center","Reno","Nevada","89502",{"type":124,"coordinates":214},[215,216],-119.8138,39.52963,{"lat":216,"lon":215},{"facility":219,"status":131,"city":220,"state":221,"zip":222,"country":121,"countryCode":122,"cosmosGeoPoint":223,"geoPoint":227,"contacts":11},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08901",{"type":124,"coordinates":224},[225,226],-74.45182,40.48622,{"lat":226,"lon":225},{"facility":229,"status":131,"city":230,"state":231,"zip":232,"country":121,"countryCode":122,"cosmosGeoPoint":233,"geoPoint":237,"contacts":11},"Hematology Oncology Associates of Central New York","East Syracuse","New York","13057",{"type":124,"coordinates":234},[235,236],-76.07853,43.06534,{"lat":236,"lon":235},{"facility":239,"status":131,"city":240,"state":231,"zip":241,"country":121,"countryCode":122,"cosmosGeoPoint":242,"geoPoint":246,"contacts":11},"University of Rochester","Rochester","14642",{"type":124,"coordinates":243},[244,245],-77.61556,43.15478,{"lat":245,"lon":244},{"facility":248,"status":117,"city":249,"state":250,"zip":251,"country":121,"countryCode":122,"cosmosGeoPoint":252,"geoPoint":256,"contacts":11},"Medical University of S. 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Camargo","01509-010",{"type":124,"coordinates":389},[376,377],{"lat":377,"lon":376},{"facility":392,"status":131,"city":372,"state":372,"zip":393,"country":343,"countryCode":344,"cosmosGeoPoint":394,"geoPoint":396,"contacts":11},"Instituto D'Or Pesquisa e Ensino","04502-001",{"type":124,"coordinates":395},[376,377],{"lat":377,"lon":376},{"facility":398,"status":131,"city":399,"state":11,"zip":400,"country":343,"countryCode":344,"cosmosGeoPoint":401,"geoPoint":405,"contacts":11},"Americas Medical City","Rio de Janeiro","22775-001",{"type":124,"coordinates":402},[403,404],-43.18223,-22.90642,{"lat":404,"lon":403},{"facility":407,"status":131,"city":372,"state":11,"zip":408,"country":343,"countryCode":344,"cosmosGeoPoint":409,"geoPoint":411,"contacts":11},"Beneficencia Portuguesa de Sao Paulo","01321-00",{"type":124,"coordinates":410},[376,377],{"lat":377,"lon":376},{"facility":413,"status":131,"city":414,"state":415,"zip":416,"country":417,"countryCode":418,"cosmosGeoPoint":419,"geoPoint":423,"contacts":11},"Victoria Hospital - 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Antonio e Biagio e C. Arrigo","Alessandria","Piedmont","15121",{"type":124,"coordinates":632},[633,634],8.61007,44.90924,{"lat":634,"lon":633},{"facility":637,"status":131,"city":638,"state":629,"zip":639,"country":600,"countryCode":601,"cosmosGeoPoint":640,"geoPoint":644,"contacts":11},"A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette","Turin","10126",{"type":124,"coordinates":641},[642,643],7.68682,45.07049,{"lat":643,"lon":642},{"facility":646,"status":131,"city":647,"state":11,"zip":648,"country":649,"countryCode":650,"cosmosGeoPoint":651,"geoPoint":655,"contacts":11},"Auxilio Mutuo Cancer Center","San Juan","00918","Puerto Rico","PR",{"type":124,"coordinates":652},[653,654],-66.10572,18.46633,{"lat":654,"lon":653},{"facility":657,"status":117,"city":658,"state":11,"zip":659,"country":660,"countryCode":11,"cosmosGeoPoint":661,"geoPoint":665,"contacts":11},"Chungnam National University Hospital","Daejeon","35015","South Korea",{"type":124,"coordinates":662},[663,664],127.38493,36.34913,{"lat":664,"lon":663},{"facility":667,"status":464,"city":668,"state":11,"zip":669,"country":660,"countryCode":11,"cosmosGeoPoint":670,"geoPoint":674,"contacts":11},"Severance Hospital, Yonsei University Health System","Seoul","003-722",{"type":124,"coordinates":671},[672,673],126.9784,37.566,{"lat":673,"lon":672},{"facility":676,"status":528,"city":668,"state":11,"zip":677,"country":660,"countryCode":11,"cosmosGeoPoint":678,"geoPoint":680,"contacts":11},"Seoul National University Hospital","03080",{"type":124,"coordinates":679},[672,673],{"lat":673,"lon":672},{"facility":682,"status":464,"city":668,"state":11,"zip":683,"country":660,"countryCode":11,"cosmosGeoPoint":684,"geoPoint":686,"contacts":11},"Asan Medical Center","05505",{"type":124,"coordinates":685},[672,673],{"lat":673,"lon":672},{"facility":688,"status":464,"city":668,"state":11,"zip":689,"country":660,"countryCode":11,"cosmosGeoPoint":690,"geoPoint":692,"contacts":11},"Samsung Medical Center","135-710",{"type":124,"coordinates":691},[672,673],{"lat":673,"lon":672},{"facility":694,"status":131,"city":695,"state":695,"zip":696,"country":697,"countryCode":698,"cosmosGeoPoint":699,"geoPoint":703,"contacts":11},"Hospital Universitario Puerta del Mar","Cadiz","11009","Spain","ES",{"type":124,"coordinates":700},[701,702],-6.2891,36.52672,{"lat":702,"lon":701},{"facility":705,"status":131,"city":706,"state":11,"zip":707,"country":697,"countryCode":698,"cosmosGeoPoint":708,"geoPoint":712,"contacts":11},"Complejo Hospitalario Universitario A Coruña (CHUAC)","A Coruña","15006",{"type":124,"coordinates":709},[710,711],-8.396,43.37135,{"lat":711,"lon":710},{"facility":714,"status":131,"city":715,"state":11,"zip":716,"country":697,"countryCode":698,"cosmosGeoPoint":717,"geoPoint":721,"contacts":11},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"type":124,"coordinates":718},[719,720],2.15899,41.38879,{"lat":720,"lon":719},{"facility":723,"status":131,"city":715,"state":11,"zip":724,"country":697,"countryCode":698,"cosmosGeoPoint":725,"geoPoint":727,"contacts":11},"Hospital Clinic de Barcelona","08036",{"type":124,"coordinates":726},[719,720],{"lat":720,"lon":719},{"facility":729,"status":131,"city":730,"state":11,"zip":731,"country":697,"countryCode":698,"cosmosGeoPoint":732,"geoPoint":736,"contacts":11},"Hospital General Universitario J.M Morales Meseguer","Murcia","30008",{"type":124,"coordinates":733},[734,735],-1.13004,37.98704,{"lat":735,"lon":734},{"facility":738,"status":131,"city":739,"state":11,"zip":740,"country":741,"countryCode":742,"cosmosGeoPoint":743,"geoPoint":747,"contacts":11},"Skånes University Hospital, Skånes Department of Onclology","Lund","221 85","Sweden","SE",{"type":124,"coordinates":744},[745,746],13.19321,55.70584,{"lat":746,"lon":745},{"facility":749,"status":131,"city":750,"state":11,"zip":751,"country":741,"countryCode":742,"cosmosGeoPoint":752,"geoPoint":756,"contacts":11},"Akademiska sjukhuset, Onkologkliniken","Uppsala","751 85",{"type":124,"coordinates":753},[754,755],17.63889,59.85882,{"lat":755,"lon":754},{"facility":758,"status":131,"city":759,"state":11,"zip":760,"country":761,"countryCode":762,"cosmosGeoPoint":763,"geoPoint":767,"contacts":11},"National Taiwan Universtiy Hospital","Taipei","100","Taiwan","TW",{"type":124,"coordinates":764},[765,766],121.52639,25.05306,{"lat":766,"lon":765},{"facility":769,"status":131,"city":770,"state":11,"zip":771,"country":761,"countryCode":762,"cosmosGeoPoint":772,"geoPoint":776,"contacts":11},"Chang Gung Medical Foundation - Linkou","Taoyuan","333",{"type":124,"coordinates":773},[774,775],121.29696,24.99368,{"lat":775,"lon":774},{"facility":778,"status":131,"city":779,"state":11,"zip":780,"country":781,"countryCode":782,"cosmosGeoPoint":783,"geoPoint":787,"contacts":11},"NHS Greater Glasgow and Clyde","Glasgow","G12 0YN","United Kingdom","UK",{"type":124,"coordinates":784},[785,786],-4.25763,55.86515,{"lat":786,"lon":785},{"facility":789,"status":131,"city":790,"state":11,"zip":791,"country":781,"countryCode":782,"cosmosGeoPoint":792,"geoPoint":796,"contacts":11},"Lincolnshire County Hospital","Lincoln","LN2 5QY",{"type":124,"coordinates":793},[794,795],-0.53792,53.22683,{"lat":795,"lon":794},{"facility":798,"status":131,"city":414,"state":11,"zip":799,"country":781,"countryCode":782,"cosmosGeoPoint":800,"geoPoint":804,"contacts":11},"University College London Hospital","NW1 2PG",{"type":124,"coordinates":801},[802,803],-0.12574,51.50853,{"lat":803,"lon":802},{"facility":806,"status":131,"city":807,"state":11,"zip":808,"country":781,"countryCode":782,"cosmosGeoPoint":809,"geoPoint":813,"contacts":11},"Christie Hospital Nhs Trust","Manchester","M2O 4BX",{"type":124,"coordinates":810},[811,812],-2.23743,53.48095,{"lat":812,"lon":811},{"facility":815,"status":131,"city":816,"state":11,"zip":817,"country":781,"countryCode":782,"cosmosGeoPoint":818,"geoPoint":822,"contacts":11},"Oxford Churchill Hospital","Oxford","OX3 7LE",{"type":124,"coordinates":819},[820,821],-1.25596,51.75222,{"lat":821,"lon":820},{"facility":824,"status":131,"city":825,"state":11,"zip":826,"country":781,"countryCode":782,"cosmosGeoPoint":827,"geoPoint":831,"contacts":11},"Derriford Hospital","Plymouth","PL6 8DH",{"type":124,"coordinates":828},[829,830],-4.14305,50.37153,{"lat":830,"lon":829},{"type":833,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100522616",false,"NCT06084936","A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","GLOBRYTE","Inclusion Criteria:\n\n* Life expectancy at least 12 weeks\n* Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry\n* Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease\n* At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option\n* Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment\n* At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Negative HIV test at screening\n* Adequate hematological function\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer\n* Leukemic, non-nodal MCL\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with CAR-T cell therapy\n* Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma\n* Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Significant or extensive cardiovascular disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment\n* Suspected or latent tuberculosis\n* Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Known or suspected chronic active Epstein-Barr viral infection (EBV)\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy (PML)\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Prior solid organ transplantation or allogenic stem cell transplant\n* Eligibility for stem cell transplantation (SCT)\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment\n* Corticosteroid therapy within 2 weeks prior to first dose of study treatment\n* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis\n* Clinically significant history of cirrhotic liver disease","ALL","18 Years",{"count":844,"type":845},182,"ESTIMATED","INTERVENTIONAL",[848],"PHASE3","The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R\u002FR) mantle cell lymphoma (MCL).",[851],"Lymphoma","2026-07-01",{"date":854,"type":855},"2026-07-02","ACTUAL",{"date":857,"type":855},"2023-10-22",{"date":859,"type":845},"2028-03-31",{"name":5,"class":6},77]