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 Diffuse Large B-Cell Lymphoma
Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main goal of this trial is to study the frequency and severity of cytokine release syndrome (CRS) in participants with diffuse large B-cell lymphoma (DLBCL) who are using a combination of glofitamab + gemcitabine + oxaliplatin (Glofit-GemOx) followed by glofitamab-only treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed DLBCL, not otherwise specified (NOS)
• R/R disease, defined as: relapsed = disease that has recurred following a response that lasted \>/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy
• At least one line of prior 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) status of 0, 1, or 2
• Adequate hematologic and renal function
Locations
United States
Alaska
Alaska Oncology & Hematology, LLC
RECRUITING
Anchorage
California
Providence Medical Foundation
RECRUITING
Fullerton
Los Angeles Cancer Network
RECRUITING
Glendale
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Zuckerberg San Francisco General Hospital
RECRUITING
San Francisco
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
RECRUITING
Torrance
Colorado
Rocky Mountain Cancer Centers, LLP
RECRUITING
Aurora
Florida
North Florida/ South Georgia VA Medical Center
RECRUITING
Gainesville
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami
Orlando Health Cancer Institute
RECRUITING
Orlando
Idaho
St Luke?s Cancer Institute
RECRUITING
Boise
Illinois
Cancer Care Specialists of Central Illinois
RECRUITING
Swansea
Kentucky
University of Kentucky - Markey Cancer Center
RECRUITING
Lexington
Louisiana
Mary Bird Perkins Cancer Ctr
RECRUITING
Baton Rouge
Massachusetts
Boston Medical Center
RECRUITING
Boston
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
New York
New York Oncology Hematology, P.C.
RECRUITING
Albany
Hematology Oncology Associates of Central New York
RECRUITING
East Syracuse
Oregon
Oncology Associates of Oregon, P.C
RECRUITING
Eugene
Providence Portland Medical Center
RECRUITING
Portland
Providence St. Vincent Medical Center
RECRUITING
Portland
Tennessee
Tennessee Oncology
RECRUITING
Chattanooga
Tennessee Oncology
RECRUITING
Nashville
Texas
Baylor Scott & White Health
RECRUITING
Temple
Texas Oncology - Gulf Coast
RECRUITING
The Woodlands
Texas Oncology- Northeast Texas
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Gainesville
Virginia Oncology Associates - Virginia Beach
RECRUITING
Virginia Beach
Washington
Northwest Medical Specialties
RECRUITING
Tacoma
Other Locations
Australia
Epworth Hospital
RECRUITING
East Melbourne
Canada
Arthur J.E. Child Comprehensive Cancer Center
RECRUITING
Calgary
CancerCare Manitoba (CCMB)
RECRUITING
Winnipeg
France
CHU de Grenoble
RECRUITING
La Tronche
Chu de Montpellier-St Eloi
RECRUITING
Montpellier
CHU de Bordeaux
RECRUITING
Pessac
CHU DE RENNES - CHU Pontchaillou
RECRUITING
Rennes
Chu De Tours
RECRUITING
Tours
Germany
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
RECRUITING
Berlin
Universitätsklinikum Köln
RECRUITING
Cologne
Otto von Guericke Uni Magdeburg Uniklinik
RECRUITING
Magdeburg
Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
RECRUITING
Brescia
IRCCS Istituto Romagnolo per lo studio dei tumori Dino Amadori
RECRUITING
Meldola
Irccs Istituto Europeo Di Oncologia (IEO)
RECRUITING
Milan
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
RECRUITING
Napoli
Istituto Clinico Humanitas
RECRUITING
Rozzano
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Reference Study ID Number: GO45434 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date:2025-03-05
Estimated Completion Date:2029-03-30
Participants
Target number of participants:100
Treatments
Experimental: R/R DLBCL
Participants with R/R DLBCL will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.