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NCT06624085PHASE1Recruiting

A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Hoffmann-La Roche

Start Date

4/28/2025

Completion Date

3/31/2030

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Glofitamab

DRUG

Tocilizumab

DRUG

Obinutuzumab

DRUG

Gemcitabine

DRUG

Oxaliplatin

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Conditions

Lymphoma

Locations

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Saddleback Memorial Medical Center

Laguna Hills, California 92653

United States

Hoag Memorial Hospital

Newport Beach, California 92658

United States

University of California Los Angeles (UCLA) - Cancer Care - Santa Monica

Santa Monica, California 90404-2023

United States

Georgetown University

Washington D.C., District of Columbia 20007

United States

AdventHealth Cancer Institute

Orlando, Florida 32804

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia 30329

United States

University of Illinois Cancer Center

Chicago, Illinois 60612

United States

Kansas City VA Medical Center

Kansas City, Kansas 64128

United States

Walter Reed National Military Medical Center

Bethesda, Maryland 20814

United States

Christus Health - Christus St. Vincent Regional Medical Center

Santa Fe, New Mexico 87505

United States

Stony Brook Univ Cancer Ctr

Stony Brook, New York 11794

United States

East Carolina University

Greenville, North Carolina 27834

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Renovatio Clinical - El Paso

El Paso, Texas 79915

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Renovatio Clinical

The Woodlands, Texas 77380

United States

Auxilio Mutuo Cancer Center

San Juan, 00917

Puerto Rico