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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 (> 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

  • Prior enrollment in Study GO41944 (STARGLO; NCT04408638) - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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).
  • Drug: Glofitamab
    Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
  • Drug: Tocilizumab
    Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
  • Drug: Obinutuzumab
    Participants will receive IV obinutuzumab pretreatment
  • Drug: Gemcitabine
    Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
  • Drug: Oxaliplatin
    Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)

Recruiting Locations

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

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

Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00917

More Details

NCT ID
NCT06624085
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GO44900 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center