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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/R) diffuse large B-cell lymphoma (DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glofitamab | Drug | Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 3 years | |
| Complete response (CR) rate | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Up to 3 years | |
| Duration of response (DOR) | From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 3 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO44900 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Tocilizumab | Drug | Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) |
|
| Obinutuzumab | Drug | Participants will receive IV obinutuzumab pretreatment |
|
| Gemcitabine | Drug | Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days) |
|
| Oxaliplatin | Drug | Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days) |
|
| Duration of CR | From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to 3 years) |
| Progression-free survival (PFS) | From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 3 years) |
| Overall Survival (OS) | From enrollment to date of death from any cause (up to 3 years) |
| Serum concentration of glofitamab | Up to 3 years |
| Incidence of anti-drug antibodies to glofitamab | Baseline up to 3 years |
| Saddleback Memorial Medical Center |
| Recruiting |
| Laguna Hills |
| California |
| 92653 |
| United States |
| Hoag Memorial Hospital | Recruiting | Newport Beach | California | 92658 | United States |
| University of California Los Angeles (UCLA) - Cancer Care - Santa Monica | Recruiting | Santa Monica | California | 90404-2023 | United States |
| Georgetown University | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| AdventHealth Cancer Institute | Recruiting | Orlando | Florida | 32804 | United States |
| Winship Cancer Institute of Emory University | Recruiting | Atlanta | Georgia | 30329 | United States |
| University of Illinois Cancer Center | Recruiting | Chicago | Illinois | 60612 | United States |
| Kansas City VA Medical Center | Recruiting | Kansas City | Kansas | 64128 | United States |
| Walter Reed National Military Medical Center | Recruiting | Bethesda | Maryland | 20814 | United States |
| Christus Health - Christus St. Vincent Regional Medical Center | Recruiting | Santa Fe | New Mexico | 87505 | United States |
| Stony Brook Univ Cancer Ctr | Recruiting | Stony Brook | New York | 11794 | United States |
| East Carolina University | Recruiting | Greenville | North Carolina | 27834 | United States |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Renovatio Clinical - El Paso | Recruiting | El Paso | Texas | 79915 | United States |
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
| Renovatio Clinical | Recruiting | The Woodlands | Texas | 77380 | United States |
| Auxilio Mutuo Cancer Center | Recruiting | San Juan | 00917 | Puerto Rico |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000720108 | glofitamab |
| C502936 | tocilizumab |
| C543332 | obinutuzumab |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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