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Diffuse Large B-cell LymphomaPhase 3NCT04408638

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase 3 study testing Obinutuzumab, Glofitamab and Rituxumab in people with Diffuse Large B-cell Lymphoma, run by Hoffmann-La Roche at 63 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Obinutuzumab, Glofitamab and Rituxumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
63 sitesin 13 countries
Study dates
23 Feb 2021to 31 Mar 2028
Phase
Phase 3
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

  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL), not otherwise specified
  • Relapsed/refractory (R/R) disease, defined as follows: Relapsed = disease that has recurred ≥6 months after completion of the last line of therapy; Refractory = disease that either progressed during the last line of therapy or progressed within 6 months (<6 months) of the last line of prior therapy
  • At least one (≥1) 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, as defined by the study protocol
  • Confirmed availability of tumor tissue, unless unobtainable per investigator assessment. Freshly collected biopsy is preferred. Archival tissue is acceptable
  • At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan
Show all 10Show fewer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Adequate hematologic function (unless attributable to the underlying disease, as established by extensive bone marrow involvement or associated with hypersplenism secondary to the involvement of the spleen by DLBCL per the investigator), as defined by the study protocol
  • Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
  • Adequate renal function, defined as an estimated creatinine clearance ≥30 mL/min

Who cannot join

  • Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation
  • History of transformation of indolent disease to DLBCL
  • High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified, as defined by 2016 WHO guidelines
  • 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, rituximab, gemcitabine or oxaliplatin, or tocilizumab
Show all 29Show fewer
  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
  • Peripheral neuropathy assessed to be Grade >1 according to 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 central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative 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 SARS-CoV-2 infection within 30 days prior to the first study treatment, including asymptomatic SARS-CoV-2 infection
  • Documented SARS-CoV-2 infection within 6 months of first study treatment
  • Suspected or latent tuberculosis
  • Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Known or suspected chronic active Epstein-Barr viral infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Known history of progressive multifocal leukoencephalopathy
  • Adverse events from prior anti-cancer therapy 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
  • Prior allogeneic stem cell transplant
  • Active autoimmune disease requiring treatment
  • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
  • Corticosteroid therapy within 2 weeks prior to first dose of study treatment (exceptions defined by study protocol)
  • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
  • Clinically significant history of cirrhotic liver disease

Trial locations and contacts

63 sites in 13 countries.

63 sites in 13 countries

United States10 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Community Cancer Institute (CCI)

    Fresno, California, 93720

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

China8 sites

  • Peking University Third Hospital

    Beijing, 100083

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Health Monash Medical Centre

    Clayton, Victoria, 3168

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

Other trials in Australia

France6 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Hopital Henri Mondor

    Créteil, 94010

  • Hopital Claude Huriez

    Lille, 59037

  • Chu de Montpellier-St Eloi

    Montpellier, 34295

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Pontchaillou

    Rennes, 35003

Other trials in France

South Korea6 sites

  • Pusan National University Hospital

    Busan, 49241

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli

    Lublin, 20-090

  • Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroc?aw, 50-367

Other trials in Poland

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • Hospital Universitario la Paz

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

United Kingdom5 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OYN

  • St James's Institute of Oncology

    Leeds, LS9 7TF

  • UCLH - Clinical Trials Pharmacy B&D Centre

    London, NW1 2PG

  • Christie Hospital

    Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

Other trials in United Kingdom

Germany3 sites

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

    Giessen, 35392

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

Taiwan3 sites

  • Chang Gung Medical Foundation - Kaohsiung;Oncology

    Kaoisung, 833

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

  • Taichung Veterans General Hospital

    Xitun Dist., 40705

Other trials in Taiwan

Belgium2 sites

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU de Liège (Sart Tilman)

    Liège, 4000

Other trials in Belgium

Denmark2 sites

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

Switzerland2 sites

  • Inselspital Bern, Insel-Gruppe AG

    Bern, 3010

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

Being tested
Obinutuzumab, Glofitamab, Rituxumab, Tocilizumab, Gemcitabine
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • ObinutuzumabDrug

    Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.

  • GlofitamabDrug

    Participants will receive IV glofitamab for up to 12 cycles.

  • RituxumabDrug

    Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.

  • TocilizumabDrug

    Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).

  • GemcitabineDrug

    Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.

  • OxaliplatinDrug

    Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.

Study groups in NCT04408638
Study groupRoleWhat they receive
Glofit-GemOxExperimentalParticipants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles.
Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Tocilizumab; Drug: Gemcitabine; Drug: Oxaliplatin
R-GemOxExperimentalParticipants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.
Receives: Drug: Rituxumab; Drug: Gemcitabine; Drug: Oxaliplatin

What is being measured

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

  1. Overall survival (OS), defined as the time from randomization to date of death from any cause

    Measured: Up to 5 years

Secondary outcomes (12)

  1. Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the Independent Review Committee (IRC)

    Measured: Up to 5 years

  2. PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator

    Measured: Up to 5 years

  3. Complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the IRC

    Measured: Up to 5 years

  4. CR rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the investigator

    Measured: Up to 5 years

  5. Objective response rate (ORR), defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the IRC

    Measured: Up to 5 years

  6. ORR, defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the investigator

    Measured: Up to 5 years

  7. Duration of objective response (DOR), 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: Up to 5 years

  8. Duration of CR, defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first

    Measured: Up to 5 years

  9. Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)

    Measured: Up to 5 years

  10. Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma subscale (FACT-Lym LymS)

    Measured: Up to 5 years

  11. Percentage of Participants with Adverse Events

    Measured: Up to 5 years

  12. Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events

    Measured: Up to 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 posted29 May 2020
  2. Study start23 Feb 2021
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04408638
Sponsor's protocol ID
GO41944
Other IDs
2020-001021-31
Status last verified
Sep 2026
First submitted
26 May 2020
Last updated
2 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

Publications

  • Abramson JS, Townsend W, Fox CP, Ku M, Hertzberg M, Huang HQ, Zhang H, Yoon DH, Kim WS, Abdulhaq H, Herbaux C, Zaucha JM, Zhang QY, Chang H, Liu Y, Cheah CY, Ghesquieres H, Mulvihill E, Kesavan M, Kallemeijn M, Ta R, Choeurng V, Belousov A, Relf J, Bottos A, Lundberg L, Gregory GP. Glofitamab plus gemcitabine and oxaliplatin for relapsed/refractory DLBCL: 3-year follow-up of STARGLO. Blood Adv. 2026 Aug 11;10(15):5367-5377. doi: 10.1182/bloodadvances.2026019764.

    PubMed 42269085

  • Sam J, Leclercq-Cohen G, Gebhardt S, Surowka M, Herter S, Lechner K, Relf J, Briner S, Varol A, Appelt B, Domocos I, Nicolini V, Bez M, Bommer E, Jenni S, Schoenle A, Le Clech M, Colombetti S, Klein C, Umana P, Lundberg P, Korfi K, Bottos A, Bacac M. Preclinical advances in glofitamab combinations: a new frontier for non-Hodgkin lymphoma. Blood. 2025 Oct 9;146(15):1824-1836. doi: 10.1182/blood.2025028863.

    PubMed 40749164

  • Abramson JS, Ku M, Hertzberg M, Huang HQ, Fox CP, Zhang H, Yoon DH, Kim WS, Abdulhaq H, Townsend W, Herbaux C, Zaucha JM, Zhang QY, Chang H, Liu Y, Cheah CY, Ghesquieres H, Simko S, Orellana-Noia V, Ta R, Relf J, Dixon M, Kallemeijn M, Mulvihill E, Huang H, Lundberg L, Gregory GP. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet. 2024 Nov 16;404(10466):1940-1954. doi: 10.1016/S0140-6736(24)01774-4.

    PubMed 39550172

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Obinutuzumab, Glofitamab and Rituxumab in people with Diffuse Large B-cell Lymphoma, run by Hoffmann-La Roche at 63 sites in 13 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 10 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 2 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 63 sites in United States, China, Australia, France, South Korea and 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS), defined as the time from randomization to date of death from any cause (time frame: Up to 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 NCT04408638, which also lists 3 linked publications.

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 2 Oct 2026.

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