RecruitingPhase 1NCT06624085

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

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


Sponsor

Hoffmann-La Roche

Enrollment

50 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of glofitamab (a bispecific antibody that helps the immune system attack cancer cells) plus gemcitabine and oxaliplatin (standard chemotherapy) for people in the United States with diffuse large B-cell lymphoma (DLBCL), a type of aggressive blood cancer, that has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with DLBCL (confirmed by pathology) - Your lymphoma has relapsed (came back after 6+ months of remission) or is refractory (did not respond or came back within 6 months) - You have received at least one prior treatment - If you have only had one prior treatment, you are not eligible for or cannot tolerate high-dose chemo plus stem cell transplant - You have at least one measurable tumor **You may NOT be eligible if...** - You have a different type of lymphoma - You have not tried any prior treatments - You are able to undergo stem cell transplant (if this was your first line of treatment) - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlofitamab

Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)

DRUGTocilizumab

Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)

DRUGObinutuzumab

Participants will receive IV obinutuzumab pretreatment

DRUGGemcitabine

Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)

DRUGOxaliplatin

Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)


Locations(16)

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

East Carolina University

Greenville, North Carolina, 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

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT06624085


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