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Relapsed or Refractory Aggressive B-Cell Non-Hodgkins LymphomaPhase 2NCT06806033

Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL

A Phase 2 study testing Obinutuzumab, Glofitamab and Gemcitabine in people with Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma, run by Hoffmann-La Roche at 53 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) in participants with relapsed or refractory… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Obinutuzumab, Glofitamab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
53 sitesin 7 countries
Study dates
5 Mar 2025to 30 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy >= 12 weeks.
  • For participants in the Glofit-GemOx combination therapy cohort (Cohort A) and the glofitamab monotherapy cohort (Cohort B), participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma (FL); participants with transformed FL must be relapsed or refractory (R/R) to standard therapies of transformed FL) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022). A fresh biopsy at study entry is not mandated. The histology can be confirmed based on fresh biopsy, or pathology report from a previous biopsy or an assessment of archival tumor tissue.
  • Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS).
  • High-Grade B-Cell Lymphoma (HGBL), NOS.
  • DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (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.
Show all 11Show fewer
  • At least one line of prior systemic therapy.
  • Participants who have failed one prior line of therapy (eligible to Cohort A) must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant.
  • 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.

Who cannot join

  • 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. For participants in the monotherapy cohort (Cohort B), participants with contraindication to obinutuzumab or tocilizumab will be excluded.
Show all 30Show fewer
  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.
  • For the Glofit-GemOx combination therapy cohort (Cohort A), prior treatment with gemcitabine or oxaliplatin.
  • For the Glofit-GemOx combination therapy cohort (Cohort A), peripheral neuropathy or paresthesia assessed to be Grade >= 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrolment.
  • 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.

Trial locations and contacts

53 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: GO45434 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

53 sites in 7 countries

United States33 sites, 33 recruiting

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

    Recruiting

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska, 99508

    Recruiting

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012

    Recruiting

  • Mary Bird Perkins Cancer Ctr

    Baton Rouge, Louisiana, 70809

    Recruiting

  • St Luke?s Cancer Institute

    Boise, Idaho, 83712

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Recruiting

  • Tennessee Oncology

    Chattanooga, Tennessee, 37403

    Recruiting

  • Community Cancer Institute (CCI)

    Clovis, California, 93611

    Recruiting

  • Hematology Oncology Associates of Central New York

    East Syracuse, New York, 13057

    Recruiting

  • Oncology Associates of Oregon, P.C

    Eugene, Oregon, 97401

    Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Recruiting

  • North Florida/ South Georgia VA Medical Center

    Gainesville, Florida, 32608

    Recruiting

  • Los Angeles Cancer Network

    Glendale, California, 91204

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Recruiting

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky, 40536

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami, Florida, 33140

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Recruiting

  • Valkyrie Clinical Trials

    Panorama City, California, 91402

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Recruiting

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

    Recruiting

  • Cancer Care Specialists of Central Illinois

    Swansea, Illinois, 62226

    Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

    Recruiting

  • Baylor Scott & White Health

    Temple, Texas, 76502

    Recruiting

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas, 77380

    Recruiting

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

    Torrance, California, 90502-2006

    Recruiting

  • Texas Oncology- Northeast Texas

    Tyler, Texas, 75702

    Recruiting

  • Virginia Oncology Associates - Virginia Beach

    Virginia Beach, Virginia, 23456

    Recruiting

  • Mission Blood and Cancer - MercyOne Cancer Center

    Waukee, Iowa, 50263

    Recruiting

Other trials in United States

France5 sites, 4 recruiting

  • CHU de Grenoble

    La Tronche, 38700

    Recruiting

  • Chu de Montpellier-St Eloi

    Montpellier, 34295

    Recruiting

  • CHU de Bordeaux

    Pessac, 33600

    Recruiting

  • CHU DE RENNES - CHU Pontchaillou

    Rennes, 35033

    Withdrawn

  • Chu De Tours

    Tours, 37000

    Recruiting

Other trials in France

Italy5 sites

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

    Brescia, Lombardy, 25123

    Active, not recruiting

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

    Meldola, Emilia-Romagna, 47014

    Active, not recruiting

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan, Lombardy, 20141

    Active, not recruiting

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale

    Naples, Campania, 80131

    Active, not recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

    Active, not recruiting

Other trials in Italy

Germany4 sites, 2 recruiting

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

    Berlin, 12200

    Withdrawn

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

    Berlin, 13353

    Withdrawn

  • Universitätsklinikum Köln

    Cologne, 50937

    Recruiting

  • Otto von Guericke Uni Magdeburg Uniklinik

    Magdeburg, 39120

    Recruiting

Other trials in Germany

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Withdrawn

  • Asan Medical Center

    Seoul, 05505

    Active, not recruiting

Other trials in South Korea

Canada2 sites, 2 recruiting

  • Arthur J.E. Child Comprehensive Cancer Center

    Calgary, Alberta, T2N 5G2

    Recruiting

  • CancerCare Manitoba (CCMB)

    Winnipeg, Manitoba, R3E 0V9

    Recruiting

Other trials in Canada

Australia1 site, 1 recruiting

  • Epworth Hospital

    East Melbourne, Victoria, 3002

    Recruiting

Other trials in Australia

About this study

Official title: A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab Monotherapy and 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) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) 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.

Being tested
Obinutuzumab, Glofitamab, Gemcitabine, Oxaliplatin
Keywords
Phase 2, Outpatient study, Open-label, Glofitamab, Gemcitabine, Oxaliplatin, Obinutuzumab, GemOx, Glofit-GemOx, Bispecific antibody, Aggressive B-cell Non-Hodgkin's lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), DLBCL NOS (Not Otherwise Specified), High-Grade B-Cell Lymphoma (HGBL), HGBL NOS, Transformed follicular lymphoma, DLBCL/HGBL with MYC and BCL2 rearrangements, Double-hit lymphoma, Relapsed or Refractory (R/R), Non-Hodgkin Lymphoma (NHL)
Medical subject headings
Recurrence, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called RO5072759

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

  • GlofitamabDrug

    Also called RO7082859

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

  • GemcitabineDrug

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

  • OxaliplatinDrug

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

Study groups in NCT06806033
Study groupRoleWhat they receive
Cohort A: Glofit-GemOx Combination therapyExperimentalParticipants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.
Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Gemcitabine; Drug: Oxaliplatin
Cohort B: Glofitamab MonotherapyExperimentalParticipants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab monotherapy.
Receives: Drug: Obinutuzumab; Drug: Glofitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Cytokine Release Syndrome (CRS)

    Measured: Up to approximately 5 years

Secondary outcomes (9)

  1. Incidence of Serious Cytokine Release Syndrome (CRS) Events

    Measured: Up to approximately 5 years

  2. CRS Frequency Relative to the Start of Glofitamab Infusions

    Measured: Up to approximately 5 years

  3. Incidence and Severity of Adverse Events (AEs)

    Measured: Up to approximately 5 years

  4. Complete Response (CR) Rate as Determined by Independent Review Facility (IRF) and the Investigator

    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.

    Measured: Up to approximately 5 years

  5. Overall Response Rate (ORR) as Determined by IRF and the Investigator

    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.

    Measured: Up to approximately 5 years

  6. Duration of Response (DOR)

    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.

    Measured: 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)

  7. Duration of Complete Response (DOCR)

    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.

    Measured: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

  8. Progression-Free Survival (PFS) as Determined by the IRF and the Investigator

    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.

    Measured: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

  9. Overall Survival (OS)

    OS is defined as the time from enrollment to date of death from any cause.

    Measured: From enrollment to date of death from any cause (Up to approximately 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start5 Mar 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06806033
Sponsor's protocol ID
GO45434
Other IDs
2024-516791-15-00
Status last verified
Oct 2026
First submitted
21 Jan 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab, Glofitamab and Gemcitabine in people with Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma, run by Hoffmann-La Roche at 53 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, France, Italy, Germany, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: GO45434 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Cytokine Release Syndrome (CRS) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06806033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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