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
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).
Arms & interventions
- DrugGlofitamab
Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
- DrugTocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
- DrugObinutuzumab
Participants will receive IV obinutuzumab pretreatment
- DrugGemcitabine
Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
- DrugOxaliplatin
Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)
Outcome measures
Primary
Incidence of Adverse Events (AEs)
Time frame: Up to 3 years
Complete response (CR) rate
Time frame: Up to 3 years
Secondary
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
Eligibility criteria
Study locations (16)
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, 90404-2023
Georgetown University
Washington D.C., District of Columbia, 20007
AdventHealth Cancer Institute
Orlando, Florida, 32804
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30329
University of Illinois Cancer Center
Chicago, Illinois, 60612
Kansas City VA Medical Center
Kansas City, Kansas, 64128
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Christus Health - Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505
Stony Brook Univ Cancer Ctr
Stony Brook, New York, 11794
East Carolina University
Greenville, North Carolina, 27834
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Renovatio Clinical - El Paso
El Paso, Texas, 79915
Baylor College of Medicine
Houston, Texas, 77030
Renovatio Clinical
The Woodlands, Texas, 77380