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

May 22, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Epworth Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba (CCMB)
  • France
      • La Tronche, France, 38700
        • Recruiting
        • CHU de Grenoble
      • Montpellier, France, 34295
        • Recruiting
        • Chu de Montpellier-St Eloi
      • Pessac, France, 33600
        • Recruiting
        • Chu de Bordeaux
      • Rennes, France, 35033
        • Recruiting
        • CHU DE RENNES - CHU Pontchaillou
      • Tours, France, 37000
        • Recruiting
        • CHU de Tours
  • Germany
      • Berlin, Germany, 12200
        • Active, not recruiting
        • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
      • Berlin, Germany, 13353
        • Active, not recruiting
        • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
      • Cologne, Germany, 50937
        • Recruiting
        • Universitätsklinikum Köln
      • Magdeburg, Germany, 39120
        • Recruiting
        • Otto von Guericke Uni Magdeburg Uniklinik
  • Italy
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Recruiting
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
      • Milan, Lombardy, Italy, 20141
        • Recruiting
        • Irccs Istituto Europeo Di Oncologia (IEO)
      • Rozzano, Lombardy, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
  • South Korea
      • Seongnam-si, South Korea, 463-707
        • Active, not recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Withdrawn
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Active, not recruiting
        • Asan Medical Center
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Oncology & Hematology, LLC
    • California
      • Clovis, California, United States, 93611
        • Recruiting
        • Community Cancer Institute (CCI)
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
      • Glendale, California, United States, 91204
        • Recruiting
        • Los Angeles Cancer Network
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Valkyrie Clinical Trials
      • Panorama City, California, United States, 91402
        • Recruiting
        • Valkyrie Clinical Trials
      • San Francisco, California, United States, 94110
        • Recruiting
        • Zuckerberg San Francisco General Hospital
      • Torrance, California, United States, 90502-2006
        • Recruiting
        • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • North Florida/ South Georgia VA Medical Center
      • Miami, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St Luke?s Cancer Institute
    • Illinois
      • Swansea, Illinois, United States, 62226
        • Recruiting
        • Cancer Care Specialists of Central Illinois
    • Iowa
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • Mission Blood and Cancer - MercyOne Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky - Markey Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Mary Bird Perkins Cancer Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • New York Oncology Hematology, P.C.
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology Oncology Associates of Central New York
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon, P.C
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Tennessee Oncology
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
    • Texas
      • Temple, Texas, United States, 76502
        • Recruiting
        • Baylor Scott & White Health
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology- Northeast Texas
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists, PC
      • Virginia Beach, Virginia, United States, 23456
        • Recruiting
        • Virginia Oncology Associates - Virginia Beach
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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
  • According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting
  • Adequate hematologic and renal function

Exclusion Criteria:

  • Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085)
  • Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation
  • 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 recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
  • Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
  • Prior treatment with gemcitabine or oxaliplatin
  • Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
  • Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
  • Primary or secondary CNS lymphoma at the time of recruitment
  • Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remission is permissible
  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • History of other primary malignancy, with exceptions defined by the protocol
  • Significant or extensive cardiovascular disease
  • Significant pulmonary disease (including moderate or severe obstructive pulmonary disease)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment
  • Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
  • Prior solid organ transplantation or prior allogenic stem cell transplant
  • Active autoimmune disease requiring treatment
  • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
  • Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency
  • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
  • Clinically significant history of cirrhotic liver disease
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R/R Aggressive B-Cell Non-Hodgkin's Lymphoma
Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.
Drug: Obinutuzumab
Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
Drug: 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).
Drug: Gemcitabine
Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
Drug: Oxaliplatin
Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of cytokine release syndrome (CRS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious cytokine release syndrome (CRS) events
Time Frame: Up to approximately 5 years
Up to approximately 5 years
CRS frequency relative to the start of glofitamab infusions
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Complete response (CR) rate as determined by independent review facility (IRF) and the investigator
Time Frame: Up to approximately 5 years
CR rate is defined as the proportion of participants whose best overall response is a CR based on PET/CT according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Up to approximately 5 years
Overall response rate (ORR) as determined by IRF and the investigator
Time Frame: Up to approximately 5 years
ORR is defined as the proportion of participants whose best overall response is a PR or a CR according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Up to approximately 5 years
Duration of response (DOR)
Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
DOR is defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first.
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Duration of complete response (DOCR)
Time Frame: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
DOCR is defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first.
From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Progression-free survival (PFS) as determined by the IRF and the investigator
Time Frame: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
PFS is defined as the time from enrollment to the first occurrence of disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first, as determined by the Independent Review Facility and investigator.
From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Overall survival (OS)
Time Frame: From enrollment to date of death from any cause (Up to approximately 5 years)
OS is defined as the time from enrollment to date of death from any cause.
From enrollment to date of death from any cause (Up to approximately 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Study Director, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 30, 2029

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO45434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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