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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
Sponsor: Hoffmann-La Roche
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-03-05
Completion Date
2029-03-30
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Obinutuzumab
Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
Glofitamab
Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).
Gemcitabine
Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
Oxaliplatin
Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).
Locations (51)
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
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