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Kingdom",{"type":72,"coordinates":721},[722,723],-4.25763,55.86515,{"lat":723,"lon":722},{"facility":726,"status":79,"city":727,"state":30,"zip":728,"country":719,"cosmosGeoPoint":729,"geoPoint":733,"contacts":30},"Lincolnshire County Hospital","Lincoln","LN2 5QY",{"type":72,"coordinates":730},[731,732],-0.53792,53.22683,{"lat":732,"lon":731},{"facility":735,"status":79,"city":360,"state":30,"zip":736,"country":719,"cosmosGeoPoint":737,"geoPoint":741,"contacts":30},"University College London Hospital","NW1 2PG",{"type":72,"coordinates":738},[739,740],-0.12574,51.50853,{"lat":740,"lon":739},{"facility":743,"status":79,"city":744,"state":30,"zip":745,"country":719,"cosmosGeoPoint":746,"geoPoint":750,"contacts":30},"Christie Hospital Nhs Trust","Manchester","M2O 4BX",{"type":72,"coordinates":747},[748,749],-2.23743,53.48095,{"lat":749,"lon":748},{"facility":752,"status":79,"city":753,"state":30,"zip":754,"country":719,"cosmosGeoPoint":755,"geoPoint":759,"contacts":30},"Oxford Churchill Hospital","Oxford","OX3 7LE",{"type":72,"coordinates":756},[757,758],-1.25596,51.75222,{"lat":758,"lon":757},{"facility":761,"status":79,"city":762,"state":30,"zip":763,"country":719,"cosmosGeoPoint":764,"geoPoint":768,"contacts":30},"Derriford Hospital","Plymouth","PL6 8DH",{"type":72,"coordinates":765},[766,767],-4.14305,50.37153,{"lat":767,"lon":766},{"type":770,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"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":781,"type":782},182,"ESTIMATED","INTERVENTIONAL",[785],"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).",[788],"Lymphoma","2026-07-01",{"date":791,"type":792},"2026-07-02","ACTUAL",{"date":794,"type":792},"2023-10-22",{"date":796,"type":782},"2028-03-31",{"name":5,"class":6},77]