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Barcelona","08036",{"type":73,"coordinates":675},[668,669],{"lat":669,"lon":668},{"facility":678,"status":80,"city":679,"state":30,"zip":680,"country":646,"countryCode":647,"cosmosGeoPoint":681,"geoPoint":685,"contacts":30},"Hospital General Universitario J.M Morales Meseguer","Murcia","30008",{"type":73,"coordinates":682},[683,684],-1.13004,37.98704,{"lat":684,"lon":683},{"facility":687,"status":80,"city":688,"state":30,"zip":689,"country":690,"countryCode":691,"cosmosGeoPoint":692,"geoPoint":696,"contacts":30},"Skånes University Hospital, Skånes Department of Onclology","Lund","221 85","Sweden","SE",{"type":73,"coordinates":693},[694,695],13.19321,55.70584,{"lat":695,"lon":694},{"facility":698,"status":80,"city":699,"state":30,"zip":700,"country":690,"countryCode":691,"cosmosGeoPoint":701,"geoPoint":705,"contacts":30},"Akademiska sjukhuset, Onkologkliniken","Uppsala","751 85",{"type":73,"coordinates":702},[703,704],17.63889,59.85882,{"lat":704,"lon":703},{"facility":707,"status":80,"city":708,"state":30,"zip":709,"country":710,"countryCode":711,"cosmosGeoPoint":712,"geoPoint":716,"contacts":30},"National Taiwan Universtiy Hospital","Taipei","100","Taiwan","TW",{"type":73,"coordinates":713},[714,715],121.52639,25.05306,{"lat":715,"lon":714},{"facility":718,"status":80,"city":719,"state":30,"zip":720,"country":710,"countryCode":711,"cosmosGeoPoint":721,"geoPoint":725,"contacts":30},"Chang Gung Medical Foundation - Linkou","Taoyuan","333",{"type":73,"coordinates":722},[723,724],121.29696,24.99368,{"lat":724,"lon":723},{"facility":727,"status":80,"city":728,"state":30,"zip":729,"country":730,"countryCode":731,"cosmosGeoPoint":732,"geoPoint":736,"contacts":30},"NHS Greater Glasgow and Clyde","Glasgow","G12 0YN","United Kingdom","UK",{"type":73,"coordinates":733},[734,735],-4.25763,55.86515,{"lat":735,"lon":734},{"facility":738,"status":80,"city":739,"state":30,"zip":740,"country":730,"countryCode":731,"cosmosGeoPoint":741,"geoPoint":745,"contacts":30},"Lincolnshire County Hospital","Lincoln","LN2 5QY",{"type":73,"coordinates":742},[743,744],-0.53792,53.22683,{"lat":744,"lon":743},{"facility":747,"status":80,"city":363,"state":30,"zip":748,"country":730,"countryCode":731,"cosmosGeoPoint":749,"geoPoint":753,"contacts":30},"University College London Hospital","NW1 2PG",{"type":73,"coordinates":750},[751,752],-0.12574,51.50853,{"lat":752,"lon":751},{"facility":755,"status":80,"city":756,"state":30,"zip":757,"country":730,"countryCode":731,"cosmosGeoPoint":758,"geoPoint":762,"contacts":30},"Christie Hospital Nhs Trust","Manchester","M2O 4BX",{"type":73,"coordinates":759},[760,761],-2.23743,53.48095,{"lat":761,"lon":760},{"facility":764,"status":80,"city":765,"state":30,"zip":766,"country":730,"countryCode":731,"cosmosGeoPoint":767,"geoPoint":771,"contacts":30},"Oxford Churchill Hospital","Oxford","OX3 7LE",{"type":73,"coordinates":768},[769,770],-1.25596,51.75222,{"lat":770,"lon":769},{"facility":773,"status":80,"city":774,"state":30,"zip":775,"country":730,"countryCode":731,"cosmosGeoPoint":776,"geoPoint":780,"contacts":30},"Derriford Hospital","Plymouth","PL6 8DH",{"type":73,"coordinates":777},[778,779],-4.14305,50.37153,{"lat":779,"lon":778},{"type":782,"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":794,"type":795},182,"ESTIMATED","INTERVENTIONAL",[798],"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).",[801],"Lymphoma","2026-07-01",{"date":804,"type":805},"2026-07-02","ACTUAL",{"date":807,"type":805},"2023-10-22",{"date":809,"type":795},"2028-03-31",{"name":5,"class":6},77]