Actively Recruiting
A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Led by Hoffmann-La Roche · Updated on 2026-05-04
50
Participants Needed
16
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
- Disease has relapsed (returned after response lasting at least 6 months) or is refractory (did not respond or progressed within 6 months) after last therapy
- At least one prior line of systemic therapy received
- Patients with only one prior therapy must not be candidates for high-dose chemotherapy followed by autologous stem cell transplant
- At least one measurable nodal lesion (> 1.5 cm) or extranodal lesion (> 1 cm) on CT scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
You will not qualify if you...
- Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
- Patients with only one prior therapy who are candidates for stem cell transplantation
- History of transformation from indolent disease to DLBCL
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements or high-grade B-cell lymphoma NOS per 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
- Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known allergy to murine products
- Prior treatment with glofitamab or other bispecific antibodies targeting CD20 and CD3
- Prior treatment with gemcitabine or oxaliplatin
- Peripheral neuropathy or paresthesia grade 2 or higher at enrollment
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressives, or investigational agents for cancer within 2 weeks before first study treatment
- Treatment with monoclonal antibodies for cancer within 4 weeks before first study treatment
- Primary or secondary CNS lymphoma currently or history of CNS lymphoma (unless in complete remission confirmed by MRI or cerebrospinal fluid analysis)
- Current or history of CNS diseases such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- History of other primary malignancy except as defined by protocol
- Significant cardiovascular or pulmonary disease
- Active infection or recent major infection within 4 weeks before study treatment
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months or positive test within 7 days before enrollment
- Suspected or latent tuberculosis
- Positive test for hepatitis B or C
- Known or suspected chronic active Epstein-Barr viral infection
- History of hemophagocytic lymphohistiocytosis (HLH)
- History of progressive multifocal leukoencephalopathy
- Prior solid organ transplant
- Prior allogenic stem cell transplant
- Active autoimmune disease requiring treatment
- Systemic immunosuppressive treatment within 4 weeks before first dose
- Ongoing systemic corticosteroid use increasing risk of adrenal insufficiency
- Recent major surgery within 4 weeks before first treatment except diagnostic surgery
- Clinically significant cirrhotic liver disease
AI-Screening
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Trial Site Locations
Total: 16 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
2
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
Actively Recruiting
3
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Santa Monica, California, United States, 90404-2023
Actively Recruiting
4
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
5
AdventHealth Cancer Institute
Orlando, Florida, United States, 32804
Actively Recruiting
6
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30329
Actively Recruiting
7
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
8
Kansas City VA Medical Center
Kansas City, Kansas, United States, 64128
Actively Recruiting
9
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Actively Recruiting
10
Christus Health - Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
11
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
12
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
13
Renovatio Clinical - El Paso
El Paso, Texas, United States, 79915
Actively Recruiting
14
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
15
Renovatio Clinical
The Woodlands, Texas, United States, 77380
Actively Recruiting
16
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00917
Actively Recruiting
Research Team
R
Reference Study ID Number: GO44900 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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