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New drug combo aims to outsmart Hard-to-Treat lymphoma

NCT ID NCT04408638

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding the immunotherapy glofitamab to standard chemotherapy (gemcitabine and oxaliplatin) works better than the usual rituximab-chemotherapy combo for people with diffuse large B-cell lymphoma that has come back or not responded to prior treatment. About 270 participants will be randomly assigned to one of the two treatment groups. The main goal is to see if the new combination helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glofitamab (a type of immunotherapy) combined with gemcitabine and oxaliplatin chemotherapy
What this could lead to
If successful, this could offer a new, more effective treatment option for people with hard-to-treat diffuse large B-cell lymphoma.
What could go wrong
This is a phase 3 trial, but results are not yet available. The new combination may not improve survival and could cause serious side effects like cytokine release syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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 * 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 Exclusion Criteria * 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 * 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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200, Denmark

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OYN, United Kingdom

  • CHU Pontchaillou

    Rennes, 35003, France

  • CHU de Liège (Sart Tilman)

    Liège, 4000, Belgium

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

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

    Lublin, 20-090, Poland

  • Chang Gung Medical Foundation - Kaohsiung;Oncology

    Kaoisung, 833, Taiwan

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Chu de Montpellier-St Eloi

    Montpellier, 34295, France

  • Community Cancer Institute (CCI)

    Fresno, California, 93720, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínic i Provincial

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario la Paz

    Madrid, 28046, Spain

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inselspital Bern, Insel-Gruppe AG

    Bern, 3010, Switzerland

  • Institut Bergonie

    Bordeaux, 33076, France

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Monash Health Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

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

    Olsztyn, 10-228, Poland

  • Peking University Third Hospital

    Beijing, 100083, China

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231, United States

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • St James's Institute of Oncology

    Leeds, LS9 7TF, United Kingdom

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060, China

  • Taichung Veterans General Hospital

    Xitun Dist., 40705, Taiwan

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • UCLH - Clinical Trials Pharmacy B&D Centre

    London, NW1 2PG, United Kingdom

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Universitaetsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

    Giessen, 35392, Germany

  • Universitätsspital Zürich

    Zurich, 8091, Switzerland

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

    Wroc?aw, 50-367, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

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

    Wuhan, 430022, China

  • Zhejiang Cancer Hospital

    Zhejiang, 310022, China

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