Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-04-27
100
Participants Needed
52
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) with one of the following diagnoses according to World Health Organization, fifth edition: DLBCL Not Otherwise Specified (NOS); High-Grade B-Cell Lymphoma (HGBL), NOS; DLBCL/HGBL with MYC and BCL2 rearrangements
- Relapsed or refractory disease defined as relapsed (recurrence after a response lasting 6 months or more) or refractory (no response or progression within 6 months) after last therapy
- At least one prior line of systemic therapy
- Participants with only one prior therapy must not be candidates for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
- At least one measurable nodal lesion (>1.5 cm) or extranodal lesion (>1 cm) by CT scan
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Ability to receive step-up dose regimen in an outpatient setting as judged by investigator
- Adequate blood and kidney function
You will not qualify if you...
- Prior enrollment in Studies GO41943, GO41944 (STARGLO), or GO44900
- Participants with only one prior therapy who are candidates for stem cell transplant
- Any history of Waldenstrom's macroglobulinemia
- Primary mediastinal B-cell lymphoma
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or related products
- Contraindications to obinutuzumab, gemcitabine, oxaliplatin, or tocilizumab
- Prior treatment with glofitamab or other bispecific antibodies targeting CD20 and CD3
- Prior treatment with gemcitabine or oxaliplatin
- Peripheral neuropathy or paresthesia Grade 2 or higher at enrollment
- Recent cancer treatments within 2 weeks before study treatment
- Recent monoclonal antibody treatments within 4 weeks before study treatment
- Primary or secondary central nervous system lymphoma at recruitment
- Current or history of CNS diseases such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- History of other primary cancers except as allowed by protocol
- Significant cardiovascular or moderate/severe pulmonary disease
- Active infections or major infections within 4 weeks prior to treatment
- Positive for SARS-CoV-2, tuberculosis, hepatitis B or C, or chronic active Epstein-Barr virus infection
- Known or suspected hemophagocytic lymphohistiocytosis or progressive multifocal leukoencephalopathy
- Unresolved adverse events from prior cancer therapies except alopecia or anorexia
- Live attenuated vaccine within 4 weeks before treatment or planned during study
- Prior solid organ or allogeneic stem cell transplant
- Active autoimmune disease needing treatment
- Recent systemic immunosuppressive medication use within 4 weeks before treatment
- Ongoing corticosteroid use increasing risk of steroid-related adrenal insufficiency
- Major surgery within 4 weeks before treatment except diagnostic procedures
- Clinically significant cirrhotic liver disease
- Any other medical condition or lab finding that poses high risk or interferes with study
- Pregnancy, breastfeeding, or planning pregnancy during study or within 18 months after last dose
AI-Screening
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Trial Site Locations
Total: 52 locations
1
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Community Cancer Institute (CCI)
Clovis, California, United States, 93611
Actively Recruiting
3
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
4
Los Angeles Cancer Network
Glendale, California, United States, 91204
Actively Recruiting
5
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
6
Valkyrie Clinical Trials
Panorama City, California, United States, 91402
Actively Recruiting
7
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
8
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, United States, 90502-2006
Actively Recruiting
9
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States, 80012
Actively Recruiting
10
North Florida/ South Georgia VA Medical Center
Gainesville, Florida, United States, 32608
Actively Recruiting
11
Mount Sinai Comprehensive Cancer Center
Miami, Florida, United States, 33140
Actively Recruiting
12
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
13
St Luke?s Cancer Institute
Boise, Idaho, United States, 83712
Actively Recruiting
14
Cancer Care Specialists of Central Illinois
Swansea, Illinois, United States, 62226
Actively Recruiting
15
Mission Blood and Cancer - MercyOne Cancer Center
Waukee, Iowa, United States, 50263
Actively Recruiting
16
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
17
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
18
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
19
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
20
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Actively Recruiting
21
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Actively Recruiting
22
Oncology Associates of Oregon, P.C
Eugene, Oregon, United States, 97401
Actively Recruiting
23
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
24
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
25
Tennessee Oncology
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
26
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
27
Baylor Scott & White Health
Temple, Texas, United States, 76502
Actively Recruiting
28
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
29
Texas Oncology- Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
30
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
31
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, United States, 23456
Actively Recruiting
32
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
33
Epworth Hospital
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
34
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
35
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
36
CHU de Grenoble
La Tronche, France, 38700
Actively Recruiting
37
Chu de Montpellier-St Eloi
Montpellier, France, 34295
Actively Recruiting
38
CHU de Bordeaux
Pessac, France, 33600
Actively Recruiting
39
CHU DE RENNES - CHU Pontchaillou
Rennes, France, 35033
Actively Recruiting
40
Chu De Tours
Tours, France, 37000
Actively Recruiting
41
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
Berlin, Germany, 12200
Actively Recruiting
42
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, Germany, 13353
Actively Recruiting
43
Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
44
Otto von Guericke Uni Magdeburg Uniklinik
Magdeburg, Germany, 39120
Actively Recruiting
45
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Naples, Campania, Italy, 80131
Actively Recruiting
46
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
47
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy, 25123
Actively Recruiting
48
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy, 20141
Actively Recruiting
49
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy, 20089
Actively Recruiting
50
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 463-707
Actively Recruiting
51
Seoul National University Hospital
Seoul, South Korea, 03080
Withdrawn
52
Asan Medical Center
Seoul, South Korea, 05505
Active, Not Recruiting
Research Team
R
Reference Study ID Number: GO45434 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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