The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,130
Participants will receive intravenous (IV) glofitamab
Participants will receive IV polatuzumab vedotin in combination with R-CHP
Participants will receive IV rituximab
Progression-free survival (PFS) as determined by Independent Review Facility (IRF)
Time frame: From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)
PFS as determined by the investigator
Time frame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 65 months)
PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5
Time frame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to 65 months)
Event-free survival efficacy causes (EFSeff)
Time frame: From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months)
Complete response (CR) rate
Time frame: At the end of treatment (up to approximately 65 months)
Objective response rate (ORR)
Time frame: At treatment completion or discontinuation (up to approximately 65 months)
Overall survival (OS)
Time frame: From randomization to death from any cause (up to approximately 65 months)
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 approximately 65 months)
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Participants will receive cyclophosphamide as part of CHP chemotherapy
Participants will receive IV doxorubicin
Participants will receive oral prednisone as part of CHP chemotherapy
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States
Kaiser Permanente - Anaheim (E. La Palma)
Anaheim, California, United States
University of California, San Francisco-Fresno
Clovis, California, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope - Lennar Foundation Cancer Center
Irvine, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente - Roseville
Roseville, California, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, United States
Stanford Univ School of Med
Stanford, California, United States
...and 219 more locations
Duration of complete response (DOCR)
Time frame: From the first occurrence of a documented complete response (CR) to disease progression or death, whichever occurs first (up to approximately 65 months)
Disease-free survival (DFS)
Time frame: From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months)
Serum concentration of glofitamab
Time frame: Up to approximately 65 months
Incidence of anti-drug antibodies (ADAs)
Time frame: Baseline up to approximately 65 months
Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
Time frame: Up to approximately 65 months
Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
Time frame: Up to approximately 65 months
Percentage of Participants with Adverse Events (AEs)
Time frame: From randomization to the end of study (up to approximately 65 months)