[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564047":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":41,"centralContacts":45,"locations":53,"responsibleParty":234,"collaborators":24,"id":236,"slug":237,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":24,"eligibilityCriteria":242,"healthyVolunteers":238,"sex":243,"minAge":244,"maxAge":24,"enrollmentInfo":245,"targetDuration":24,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":24,"overallStatus":56,"whyStopped":24,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"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",[54,68,77,86,95,105,115,125,135,145,155,165,175,185,195,205,214,223],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":24},"UC San Diego Moores Cancer Center","RECRUITING","La Jolla","California","92093","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-117.2742,32.84727,{"lat":66,"lon":65},{"facility":69,"status":56,"city":70,"state":58,"zip":71,"country":60,"countryCode":61,"cosmosGeoPoint":72,"geoPoint":76,"contacts":24},"Saddleback Memorial Medical Center","Laguna Hills","92653",{"type":63,"coordinates":73},[74,75],-117.71283,33.61252,{"lat":75,"lon":74},{"facility":78,"status":56,"city":79,"state":58,"zip":80,"country":60,"countryCode":61,"cosmosGeoPoint":81,"geoPoint":85,"contacts":24},"Hoag Memorial Hospital","Newport Beach","92658",{"type":63,"coordinates":82},[83,84],-117.92895,33.61891,{"lat":84,"lon":83},{"facility":87,"status":56,"city":88,"state":58,"zip":89,"country":60,"countryCode":61,"cosmosGeoPoint":90,"geoPoint":94,"contacts":24},"University of California Los Angeles (UCLA) - Cancer Care - Santa Monica","Santa Monica","90404-2023",{"type":63,"coordinates":91},[92,93],-118.49138,34.01949,{"lat":93,"lon":92},{"facility":96,"status":56,"city":97,"state":98,"zip":99,"country":60,"countryCode":61,"cosmosGeoPoint":100,"geoPoint":104,"contacts":24},"Georgetown University","Washington D.C.","District of Columbia","20007",{"type":63,"coordinates":101},[102,103],-77.03637,38.89511,{"lat":103,"lon":102},{"facility":106,"status":56,"city":107,"state":108,"zip":109,"country":60,"countryCode":61,"cosmosGeoPoint":110,"geoPoint":114,"contacts":24},"AdventHealth Cancer Institute","Orlando","Florida","32804",{"type":63,"coordinates":111},[112,113],-81.37924,28.53834,{"lat":113,"lon":112},{"facility":116,"status":56,"city":117,"state":118,"zip":119,"country":60,"countryCode":61,"cosmosGeoPoint":120,"geoPoint":124,"contacts":24},"Winship Cancer Institute of Emory University","Atlanta","Georgia","30329",{"type":63,"coordinates":121},[122,123],-84.38798,33.749,{"lat":123,"lon":122},{"facility":126,"status":56,"city":127,"state":128,"zip":129,"country":60,"countryCode":61,"cosmosGeoPoint":130,"geoPoint":134,"contacts":24},"University of Illinois Cancer Center","Chicago","Illinois","60612",{"type":63,"coordinates":131},[132,133],-87.65005,41.85003,{"lat":133,"lon":132},{"facility":136,"status":56,"city":137,"state":138,"zip":139,"country":60,"countryCode":61,"cosmosGeoPoint":140,"geoPoint":144,"contacts":24},"Kansas City VA Medical Center","Kansas City","Kansas","64128",{"type":63,"coordinates":141},[142,143],-94.62746,39.11417,{"lat":143,"lon":142},{"facility":146,"status":56,"city":147,"state":148,"zip":149,"country":60,"countryCode":61,"cosmosGeoPoint":150,"geoPoint":154,"contacts":24},"Walter Reed National Military Medical Center","Bethesda","Maryland","20814",{"type":63,"coordinates":151},[152,153],-77.10026,38.98067,{"lat":153,"lon":152},{"facility":156,"status":56,"city":157,"state":158,"zip":159,"country":60,"countryCode":61,"cosmosGeoPoint":160,"geoPoint":164,"contacts":24},"Christus Health - Christus St. Vincent Regional Medical Center","Santa Fe","New Mexico","87505",{"type":63,"coordinates":161},[162,163],-105.9378,35.68698,{"lat":163,"lon":162},{"facility":166,"status":56,"city":167,"state":168,"zip":169,"country":60,"countryCode":61,"cosmosGeoPoint":170,"geoPoint":174,"contacts":24},"Stony Brook Univ Cancer Ctr","Stony Brook","New York","11794",{"type":63,"coordinates":171},[172,173],-73.14094,40.92565,{"lat":173,"lon":172},{"facility":176,"status":56,"city":177,"state":178,"zip":179,"country":60,"countryCode":61,"cosmosGeoPoint":180,"geoPoint":184,"contacts":24},"East Carolina University","Greenville","North Carolina","27834",{"type":63,"coordinates":181},[182,183],-77.36635,35.61266,{"lat":183,"lon":182},{"facility":186,"status":56,"city":187,"state":188,"zip":189,"country":60,"countryCode":61,"cosmosGeoPoint":190,"geoPoint":194,"contacts":24},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",{"type":63,"coordinates":191},[192,193],-75.16362,39.95238,{"lat":193,"lon":192},{"facility":196,"status":56,"city":197,"state":198,"zip":199,"country":60,"countryCode":61,"cosmosGeoPoint":200,"geoPoint":204,"contacts":24},"Renovatio Clinical - El Paso","El Paso","Texas","79915",{"type":63,"coordinates":201},[202,203],-106.48693,31.75872,{"lat":203,"lon":202},{"facility":206,"status":56,"city":207,"state":198,"zip":208,"country":60,"countryCode":61,"cosmosGeoPoint":209,"geoPoint":213,"contacts":24},"Baylor College of Medicine","Houston","77030",{"type":63,"coordinates":210},[211,212],-95.36327,29.76328,{"lat":212,"lon":211},{"facility":215,"status":56,"city":216,"state":198,"zip":217,"country":60,"countryCode":61,"cosmosGeoPoint":218,"geoPoint":222,"contacts":24},"Renovatio Clinical","The Woodlands","77380",{"type":63,"coordinates":219},[220,221],-95.48938,30.15799,{"lat":221,"lon":220},{"facility":224,"status":56,"city":225,"state":24,"zip":226,"country":227,"countryCode":228,"cosmosGeoPoint":229,"geoPoint":233,"contacts":24},"Auxilio Mutuo Cancer Center","San Juan","00917","Puerto Rico","PR",{"type":63,"coordinates":230},[231,232],-66.10572,18.46633,{"lat":232,"lon":231},{"type":235,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100564047","phase-1-a-study-evaluating-the-safety-and-efficacy-of-glofitamab--gemcitabine--oxaliplatin-in-us-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-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":246,"type":247},50,"ESTIMATED","INTERVENTIONAL",[250],"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).",[253],"Lymphoma","2026-07-01",{"date":256,"type":257},"2026-07-02","ACTUAL",{"date":259,"type":257},"2025-04-28",{"date":261,"type":247},"2030-03-31",{"name":5,"class":6},18]