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
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed DLBCL, not otherwise specified (NOS) * Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy) disease * At least one prior line of systemic therapy * Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT) * At least one bi-dimensionally measurable (…
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)
Locations (16)
- UC San Diego Moores Cancer CenterLa Jolla, California
- Saddleback Memorial Medical CenterLaguna Hills, California
- University of California Los Angeles (UCLA) - Cancer Care - Santa MonicaSanta Monica, California
- Georgetown UniversityWashington D.C., District of Columbia
- AdventHealth Cancer InstituteOrlando, Florida
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia