A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT ID: NCT06624085
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-04-28
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gemcitabine + Glofitamab + Oxaliplatin
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).
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
* History of transformation of indolent disease to DLBCL
* High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
* Primary mediastinal B-cell lymphoma
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
* Prior treatment with gemcitabine or oxaliplatin
* Peripheral neuropathy or paresthesia assessed to be Grade \>/= 2 according to NCI CTCAE v5.0 at enrollment
* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
* Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
* Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible
* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* History of other primary malignancy, with exceptions defined by the protocol
* Significant or extensive cardiovascular disease, or significant pulmonary disease
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
* Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment
* Suspected or latent tuberculosis
* Positive test results for hepatitis B (HBV) or hepatitis C (HCV)
* Known or suspected chronic active Epstein-Barr viral infection
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Known history of progressive multifocal leukoencephalopathy
* Prior solid organ transplantation
* Prior allogenic stem cell transplant
* Active autoimmune disease requiring treatment
* Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment
* Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency
* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
* Clinically significant history of cirrhotic liver disease
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
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
Countries
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Central Contacts
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Reference Study ID Number: GO44900 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728
Email: [email protected]
Other Identifiers
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GO44900
Identifier Type: -
Identifier Source: org_study_id