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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 (\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\> 1 cm) extranodal lesion, as measured on CT scan
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Locations
United States
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Saddleback Memorial Medical Center
RECRUITING
Laguna Hills
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
RECRUITING
Santa Monica
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
AdventHealth Cancer Institute
RECRUITING
Orlando
Georgia
Winship Cancer Institute of Emory University
RECRUITING
Atlanta
Illinois
University of Illinois Cancer Center
RECRUITING
Chicago
Kansas
Kansas City VA Medical Center
RECRUITING
Kansas City
Maryland
Walter Reed National Military Medical Center
RECRUITING
Bethesda
New Mexico
Christus Health - Christus St. Vincent Regional Medical Center
RECRUITING
Santa Fe
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Texas
Renovatio Clinical - El Paso
RECRUITING
El Paso
Baylor College of Medicine
RECRUITING
Houston
Renovatio Clinical
RECRUITING
The Woodlands
Contact Information
Primary
Reference Study ID Number: GO44900 https://forpatients.roche.com/
Participants will receive a single dose of intravenous (IV) obinutuzumab pretreatment 7 days prior to the first dose of glofitamab, followed by up to 8 cycles of glofitamab + gemcitabine + oxaliplatin. This will be followed by up to 4 cycles of glofitamab monotherapy, for a total of up to 12 cycles of glofitamab (cycle length = 21 days).