[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564047":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":41,"centralContacts":45,"locations":53,"responsibleParty":232,"collaborators":24,"id":234,"slug":24,"hasResults":235,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":24,"eligibilityCriteria":239,"healthyVolunteers":235,"sex":240,"minAge":241,"maxAge":24,"enrollmentInfo":242,"targetDuration":24,"studyType":245,"phases":246,"briefSummary":248,"conditions":249,"keywords":24,"overallStatus":56,"whyStopped":24,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gemcitabine + Glofitamab + Oxaliplatin","EXPERIMENTAL","Participants will receive a single dose of intravenous (IV) obinutuzumab pretreatment 7 days prior to the first dose of glofitamab, followed by up to 8 cycles of glofitamab + gemcitabine + oxaliplatin. This will be followed by up to 4 cycles of glofitamab monotherapy, for a total of up to 12 cycles of glofitamab (cycle length = 21 days).",[13,14,15,16,17],"Drug: Glofitamab","Drug: Tocilizumab","Drug: Obinutuzumab","Drug: Gemcitabine","Drug: Oxaliplatin",[19,25,29,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Glofitamab","Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Tocilizumab","Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)",[9],{"type":20,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"Obinutuzumab","Participants will receive IV obinutuzumab pretreatment",[9],{"type":20,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"Gemcitabine","Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)",[9],{"type":20,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"Oxaliplatin","Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)",[9],[42],{"name":43,"affiliation":5,"role":44},"Clinical Trials","STUDY_DIRECTOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":24,"email":50},"Reference Study ID Number: GO44900 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":52,"role":48,"phone":24,"phoneExt":24,"email":24},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[54,67,76,85,94,104,114,124,134,144,154,164,174,184,194,204,213,222],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":24},"UC San Diego Moores Cancer Center","RECRUITING","La Jolla","California","92093","United States",{"type":62,"coordinates":63},"Point",[64,65],-117.2742,32.84727,{"lat":65,"lon":64},{"facility":68,"status":56,"city":69,"state":58,"zip":70,"country":60,"cosmosGeoPoint":71,"geoPoint":75,"contacts":24},"Saddleback Memorial Medical Center","Laguna Hills","92653",{"type":62,"coordinates":72},[73,74],-117.71283,33.61252,{"lat":74,"lon":73},{"facility":77,"status":56,"city":78,"state":58,"zip":79,"country":60,"cosmosGeoPoint":80,"geoPoint":84,"contacts":24},"Hoag Memorial Hospital","Newport Beach","92658",{"type":62,"coordinates":81},[82,83],-117.92895,33.61891,{"lat":83,"lon":82},{"facility":86,"status":56,"city":87,"state":58,"zip":88,"country":60,"cosmosGeoPoint":89,"geoPoint":93,"contacts":24},"University of California Los Angeles (UCLA) - Cancer Care - Santa Monica","Santa Monica","90404-2023",{"type":62,"coordinates":90},[91,92],-118.49138,34.01949,{"lat":92,"lon":91},{"facility":95,"status":56,"city":96,"state":97,"zip":98,"country":60,"cosmosGeoPoint":99,"geoPoint":103,"contacts":24},"Georgetown University","Washington D.C.","District of Columbia","20007",{"type":62,"coordinates":100},[101,102],-77.03637,38.89511,{"lat":102,"lon":101},{"facility":105,"status":56,"city":106,"state":107,"zip":108,"country":60,"cosmosGeoPoint":109,"geoPoint":113,"contacts":24},"AdventHealth Cancer Institute","Orlando","Florida","32804",{"type":62,"coordinates":110},[111,112],-81.37924,28.53834,{"lat":112,"lon":111},{"facility":115,"status":56,"city":116,"state":117,"zip":118,"country":60,"cosmosGeoPoint":119,"geoPoint":123,"contacts":24},"Winship Cancer Institute of Emory University","Atlanta","Georgia","30329",{"type":62,"coordinates":120},[121,122],-84.38798,33.749,{"lat":122,"lon":121},{"facility":125,"status":56,"city":126,"state":127,"zip":128,"country":60,"cosmosGeoPoint":129,"geoPoint":133,"contacts":24},"University of Illinois Cancer Center","Chicago","Illinois","60612",{"type":62,"coordinates":130},[131,132],-87.65005,41.85003,{"lat":132,"lon":131},{"facility":135,"status":56,"city":136,"state":137,"zip":138,"country":60,"cosmosGeoPoint":139,"geoPoint":143,"contacts":24},"Kansas City VA Medical Center","Kansas City","Kansas","64128",{"type":62,"coordinates":140},[141,142],-94.62746,39.11417,{"lat":142,"lon":141},{"facility":145,"status":56,"city":146,"state":147,"zip":148,"country":60,"cosmosGeoPoint":149,"geoPoint":153,"contacts":24},"Walter Reed National Military Medical Center","Bethesda","Maryland","20814",{"type":62,"coordinates":150},[151,152],-77.10026,38.98067,{"lat":152,"lon":151},{"facility":155,"status":56,"city":156,"state":157,"zip":158,"country":60,"cosmosGeoPoint":159,"geoPoint":163,"contacts":24},"Christus Health - Christus St. Vincent Regional Medical Center","Santa Fe","New Mexico","87505",{"type":62,"coordinates":160},[161,162],-105.9378,35.68698,{"lat":162,"lon":161},{"facility":165,"status":56,"city":166,"state":167,"zip":168,"country":60,"cosmosGeoPoint":169,"geoPoint":173,"contacts":24},"Stony Brook Univ Cancer Ctr","Stony Brook","New York","11794",{"type":62,"coordinates":170},[171,172],-73.14094,40.92565,{"lat":172,"lon":171},{"facility":175,"status":56,"city":176,"state":177,"zip":178,"country":60,"cosmosGeoPoint":179,"geoPoint":183,"contacts":24},"East Carolina University","Greenville","North Carolina","27834",{"type":62,"coordinates":180},[181,182],-77.36635,35.61266,{"lat":182,"lon":181},{"facility":185,"status":56,"city":186,"state":187,"zip":188,"country":60,"cosmosGeoPoint":189,"geoPoint":193,"contacts":24},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"type":62,"coordinates":190},[191,192],-75.16362,39.95238,{"lat":192,"lon":191},{"facility":195,"status":56,"city":196,"state":197,"zip":198,"country":60,"cosmosGeoPoint":199,"geoPoint":203,"contacts":24},"Renovatio Clinical - El Paso","El Paso","Texas","79915",{"type":62,"coordinates":200},[201,202],-106.48693,31.75872,{"lat":202,"lon":201},{"facility":205,"status":56,"city":206,"state":197,"zip":207,"country":60,"cosmosGeoPoint":208,"geoPoint":212,"contacts":24},"Baylor College of Medicine","Houston","77030",{"type":62,"coordinates":209},[210,211],-95.36327,29.76328,{"lat":211,"lon":210},{"facility":214,"status":56,"city":215,"state":197,"zip":216,"country":60,"cosmosGeoPoint":217,"geoPoint":221,"contacts":24},"Renovatio Clinical","The Woodlands","77380",{"type":62,"coordinates":218},[219,220],-95.48938,30.15799,{"lat":220,"lon":219},{"facility":223,"status":56,"city":224,"state":24,"zip":225,"country":226,"cosmosGeoPoint":227,"geoPoint":231,"contacts":24},"Auxilio Mutuo Cancer Center","San Juan","00917","Puerto Rico",{"type":62,"coordinates":228},[229,230],-66.10572,18.46633,{"lat":230,"lon":229},{"type":233,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100564047",false,"NCT06624085","A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed DLBCL, not otherwise specified (NOS)\n* Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \\\u003C 6 months after completion of the last line of therapy) disease\n* At least one prior line of systemic therapy\n* Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)\n* At least one bi-dimensionally measurable (\\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\\> 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Prior enrollment in Study GO41944 (STARGLO; NCT04408638)\n* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation\n* History of transformation of indolent disease to DLBCL\n* High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines\n* Primary mediastinal B-cell lymphoma\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* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with gemcitabine or oxaliplatin\n* Peripheral neuropathy or paresthesia assessed to be Grade \\>\u002F= 2 according to NCI CTCAE v5.0 at enrollment\n* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment\n* Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma\n* Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* History of other primary malignancy, with exceptions defined by the protocol\n* Significant or extensive cardiovascular disease, or significant pulmonary disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment\n* Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment\n* Suspected or latent tuberculosis\n* Positive test results for hepatitis B (HBV) or hepatitis C (HCV)\n* Known or suspected chronic active Epstein-Barr viral infection\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy\n* Prior solid organ transplantation\n* Prior allogenic stem cell transplant\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment\n* Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency\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":243,"type":244},50,"ESTIMATED","INTERVENTIONAL",[247],"PHASE1","The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL).",[250],"Lymphoma","2026-07-01",{"date":253,"type":254},"2026-07-02","ACTUAL",{"date":256,"type":254},"2025-04-28",{"date":258,"type":244},"2030-03-31",{"name":5,"class":6},18]