This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
Participants will receive IV glofitamab for up to 12 cycles.
Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
Overall survival (OS), defined as the time from randomization to date of death from any cause
Time frame: Up to 5 years
Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the Independent Review Committee (IRC)
Time frame: Up to 5 years
PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator
Time frame: Up to 5 years
Complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the IRC
Time frame: Up to 5 years
CR rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the investigator
Time frame: Up to 5 years
Objective response rate (ORR), defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the IRC
Time frame: Up to 5 years
ORR, defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the investigator
Time frame: Up to 5 years
Duration of objective response (DOR), defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first
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Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Community Cancer Institute (CCI)
Fresno, California, United States
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 53 more locations
Time frame: Up to 5 years
Duration of CR, defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first
Time frame: Up to 5 years
Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Time frame: Up to 5 years
Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma subscale (FACT-Lym LymS)
Time frame: Up to 5 years
Percentage of Participants with Adverse Events
Time frame: Up to 5 years
Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events
Time frame: Up to 5 years