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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Participants will receive IV obinutuzumab pretreatment
UC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGSaddleback Memorial Medical Center
Incidence of Adverse Events (AEs)
Time frame: Up to 3 years
Complete response (CR) rate
Time frame: Up to 3 years
Objective response rate (ORR)
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 3 years)
Duration of CR
Time frame: 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)
Time frame: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 3 years)
Overall Survival (OS)
Time frame: From enrollment to date of death from any cause (up to 3 years)
Serum concentration of glofitamab
Time frame: Up to 3 years
Incidence of anti-drug antibodies to glofitamab
Time frame: Baseline up to 3 years
Reference Study ID Number: GO44900 https://forpatients.roche.com/
CONTACT
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Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)
Laguna Hills, California, United States
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, United States
RECRUITINGGeorgetown University
Washington D.C., District of Columbia, United States
RECRUITINGAdventHealth Cancer Institute
Orlando, Florida, United States
RECRUITINGWinship Cancer Institute of Emory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Illinois Cancer Center
Chicago, Illinois, United States
RECRUITINGKansas City VA Medical Center
Kansas City, Kansas, United States
RECRUITINGWalter Reed National Military Medical Center
Bethesda, Maryland, United States
RECRUITINGChristus Health - Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States
RECRUITING...and 5 more locations