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A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-04-28
Completion Date
2030-03-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Glofitamab
Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Obinutuzumab
Participants will receive IV obinutuzumab pretreatment
Gemcitabine
Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
Oxaliplatin
Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)
Locations (16)
UC San Diego Moores Cancer Center
La Jolla, California, United States
Saddleback Memorial Medical Center
Laguna Hills, California, United States
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Kansas City VA Medical Center
Kansas City, Kansas, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Christus Health - Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States
East Carolina University
Greenville, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Renovatio Clinical - El Paso
El Paso, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico