RecruitingPhase 2NCT06806033

A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Sponsor

Hoffmann-La Roche

Enrollment

100 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

B-Cell Non-Hodgkins Lymphoma

Summary

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating an optimized treatment approach for relapsed or treatment-resistant large B-cell lymphoma using a bispecific antibody called glofitamab, which recruits the immune system to attack cancer cells. The study is testing whether a step-up dosing strategy can reduce dangerous immune reactions called cytokine release syndrome. **You may be eligible if...** - You are 18 or older - You have been diagnosed with large B-cell lymphoma (such as DLBCL or high-grade B-cell lymphoma) that has come back or stopped responding to treatment - You have had at least one prior treatment for your lymphoma - Your cancer is measurable on a scan - Your blood counts and kidney function are adequate - You are in good enough health to receive outpatient step-up dosing **You may NOT be eligible if...** - You have previously been enrolled in specific related clinical trials (GO41943, GO41944, GO44900) - You have Waldenstrom's macroglobulinemia or primary mediastinal B-cell lymphoma - You have a history of severe allergic reactions to antibody therapies - You have previously received glofitamab, other bispecific CD20/CD3 antibodies, gemcitabine, or oxaliplatin - You have significant nerve damage (peripheral neuropathy) 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

DRUGObinutuzumab

Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.

DRUGGlofitamab

Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).

DRUGGemcitabine

Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).

DRUGOxaliplatin

Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).

Locations(52)

Alaska Oncology & Hematology, LLC

Anchorage, Alaska, United States

Community Cancer Institute (CCI)

Clovis, California, United States

Providence Medical Foundation

Fullerton, California, United States

Los Angeles Cancer Network

Glendale, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Valkyrie Clinical Trials

Panorama City, California, United States

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

Torrance, California, United States

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

North Florida/ South Georgia VA Medical Center

Gainesville, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

St Luke?s Cancer Institute

Boise, Idaho, United States

Cancer Care Specialists of Central Illinois

Swansea, Illinois, United States

Mission Blood and Cancer - MercyOne Cancer Center

Waukee, Iowa, United States

University of Kentucky - Markey Cancer Center

Lexington, Kentucky, United States

Mary Bird Perkins Cancer Ctr

Baton Rouge, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

Hematology Oncology Associates of Central New York

East Syracuse, New York, United States

Oncology Associates of Oregon, P.C

Eugene, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Tennessee Oncology

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Baylor Scott & White Health

Temple, Texas, United States

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States

Texas Oncology- Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Virginia Oncology Associates - Virginia Beach

Virginia Beach, Virginia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Epworth Hospital

East Melbourne, Victoria, Australia

Arthur J.E. Child Comprehensive Cancer Center

Calgary, Alberta, Canada

CancerCare Manitoba (CCMB)

Winnipeg, Manitoba, Canada

CHU de Grenoble

La Tronche, France

Chu de Montpellier-St Eloi

Montpellier, France

CHU de Bordeaux

Pessac, France

CHU DE RENNES - CHU Pontchaillou

Rennes, France

Chu De Tours

Tours, France

CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie

Berlin, Germany

Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

Berlin, Germany

Universitätsklinikum Köln

Cologne, Germany

Otto von Guericke Uni Magdeburg Uniklinik

Magdeburg, Germany

Istituto Nazionale Tumori Irccs Fondazione g. Pascale

Naples, Campania, Italy

IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

Meldola, Emilia-Romagna, Italy

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

Brescia, Lombardy, Italy

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06806033