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RECRUITING
NCT06624085
PHASE1

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-28

Completion Date

2030-03-31

Last Updated

2026-04-02

Healthy Volunteers

No

Conditions

Interventions

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)

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