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Puerta del Mar","Cadiz","11009","Spain","ES",{"type":73,"coordinates":695},[696,697],-6.2891,36.52672,{"lat":697,"lon":696},{"facility":700,"status":80,"city":701,"state":30,"zip":702,"country":692,"countryCode":693,"cosmosGeoPoint":703,"geoPoint":707,"contacts":30},"Complejo Hospitalario Universitario A Coruña (CHUAC)","A Coruña","15006",{"type":73,"coordinates":704},[705,706],-8.396,43.37135,{"lat":706,"lon":705},{"facility":709,"status":80,"city":710,"state":30,"zip":711,"country":692,"countryCode":693,"cosmosGeoPoint":712,"geoPoint":716,"contacts":30},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"type":73,"coordinates":713},[714,715],2.15899,41.38879,{"lat":715,"lon":714},{"facility":718,"status":80,"city":710,"state":30,"zip":719,"country":692,"countryCode":693,"cosmosGeoPoint":720,"geoPoint":722,"contacts":30},"Hospital Clinic de Barcelona","08036",{"type":73,"coordinates":721},[714,715],{"lat":715,"lon":714},{"facility":724,"status":80,"city":725,"state":30,"zip":726,"country":692,"countryCode":693,"cosmosGeoPoint":727,"geoPoint":731,"contacts":30},"Hospital General Universitario J.M Morales Meseguer","Murcia","30008",{"type":73,"coordinates":728},[729,730],-1.13004,37.98704,{"lat":730,"lon":729},{"facility":733,"status":80,"city":734,"state":30,"zip":735,"country":736,"countryCode":737,"cosmosGeoPoint":738,"geoPoint":742,"contacts":30},"Skånes University Hospital, Skånes Department of Onclology","Lund","221 85","Sweden","SE",{"type":73,"coordinates":739},[740,741],13.19321,55.70584,{"lat":741,"lon":740},{"facility":744,"status":80,"city":745,"state":30,"zip":746,"country":736,"countryCode":737,"cosmosGeoPoint":747,"geoPoint":751,"contacts":30},"Akademiska sjukhuset, Onkologkliniken","Uppsala","751 85",{"type":73,"coordinates":748},[749,750],17.63889,59.85882,{"lat":750,"lon":749},{"facility":753,"status":80,"city":754,"state":30,"zip":755,"country":756,"countryCode":757,"cosmosGeoPoint":758,"geoPoint":762,"contacts":30},"National Taiwan Universtiy Hospital","Taipei","100","Taiwan","TW",{"type":73,"coordinates":759},[760,761],121.52639,25.05306,{"lat":761,"lon":760},{"facility":764,"status":80,"city":765,"state":30,"zip":766,"country":756,"countryCode":757,"cosmosGeoPoint":767,"geoPoint":771,"contacts":30},"Chang Gung Medical Foundation - Linkou","Taoyuan","333",{"type":73,"coordinates":768},[769,770],121.29696,24.99368,{"lat":770,"lon":769},{"facility":773,"status":80,"city":774,"state":30,"zip":775,"country":776,"countryCode":777,"cosmosGeoPoint":778,"geoPoint":782,"contacts":30},"NHS Greater Glasgow and Clyde","Glasgow","G12 0YN","United Kingdom","UK",{"type":73,"coordinates":779},[780,781],-4.25763,55.86515,{"lat":781,"lon":780},{"facility":784,"status":80,"city":785,"state":30,"zip":786,"country":776,"countryCode":777,"cosmosGeoPoint":787,"geoPoint":791,"contacts":30},"Lincolnshire County Hospital","Lincoln","LN2 5QY",{"type":73,"coordinates":788},[789,790],-0.53792,53.22683,{"lat":790,"lon":789},{"facility":793,"status":80,"city":409,"state":30,"zip":794,"country":776,"countryCode":777,"cosmosGeoPoint":795,"geoPoint":799,"contacts":30},"University College London Hospital","NW1 2PG",{"type":73,"coordinates":796},[797,798],-0.12574,51.50853,{"lat":798,"lon":797},{"facility":801,"status":80,"city":802,"state":30,"zip":803,"country":776,"countryCode":777,"cosmosGeoPoint":804,"geoPoint":808,"contacts":30},"Christie Hospital Nhs Trust","Manchester","M2O 4BX",{"type":73,"coordinates":805},[806,807],-2.23743,53.48095,{"lat":807,"lon":806},{"facility":810,"status":80,"city":811,"state":30,"zip":812,"country":776,"countryCode":777,"cosmosGeoPoint":813,"geoPoint":817,"contacts":30},"Oxford Churchill Hospital","Oxford","OX3 7LE",{"type":73,"coordinates":814},[815,816],-1.25596,51.75222,{"lat":816,"lon":815},{"facility":819,"status":80,"city":820,"state":30,"zip":821,"country":776,"countryCode":777,"cosmosGeoPoint":822,"geoPoint":826,"contacts":30},"Derriford Hospital","Plymouth","PL6 8DH",{"type":73,"coordinates":823},[824,825],-4.14305,50.37153,{"lat":825,"lon":824},{"type":828,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100522616","phase-3-a-study-to-evaluate-glofitamab-as-a-single-agent-vs-investigators-choice-in-participants-with-relapsedrefractory-mantle-cell-lymphoma-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":840,"type":841},182,"ESTIMATED","INTERVENTIONAL",[844],"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).",[847],"Lymphoma","2026-08-03",{"date":850,"type":851},"2026-08-05","ACTUAL",{"date":853,"type":851},"2023-10-22",{"date":855,"type":841},"2028-03-31",{"name":5,"class":6},82]