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
NCT ID: NCT04408638
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
270 participants
INTERVENTIONAL
2021-02-23
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glofit-GemOx
Participants 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.
Obinutuzumab
Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
Glofitamab
Participants will receive IV glofitamab for up to 12 cycles.
Tocilizumab
Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
Gemcitabine
Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Oxaliplatin
Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
R-GemOx
Participants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.
Rituxumab
Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
Gemcitabine
Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Oxaliplatin
Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
Interventions
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Obinutuzumab
Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
Glofitamab
Participants will receive IV glofitamab for up to 12 cycles.
Rituxumab
Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
Tocilizumab
Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
Gemcitabine
Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Oxaliplatin
Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Community Cancer Institute (CCI)
Fresno, California, United States
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health Monash Medical Centre
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHU de Liège (Sart Tilman)
Liège, , Belgium
Peking University Third Hospital
Beijing, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Tianjin Cancer Hospital
Tianjin, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Zhejiang Cancer Hospital
Zhejiang, , China
Henan Cancer Hospital
Zhengzhou, , China
Aarhus Universitetshospital Skejby
Aarhus N, , Denmark
Rigshospitalet
København Ø, , Denmark
Institut Bergonie
Bordeaux, , France
Hopital Henri Mondor
Créteil, , France
Hopital Claude Huriez
Lille, , France
Chu de Montpellier-St Eloi
Montpellier, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Pontchaillou
Rennes, , France
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I
Giessen, , Germany
Universitaetsklinikum Regensburg
Regensburg, , Germany
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli
Lublin, , Poland
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, , Poland
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, , Poland
Pusan National University Hospital
Busan, , South Korea
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clínic i Provincial
Barcelona, , Spain
Hospital Universitario la Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Inselspital Bern, Insel-Gruppe AG
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Chang Gung Medical Foundation - Kaohsiung;Oncology
Kaoisung, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Taichung Veterans General Hospital
Xitun Dist., , Taiwan
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St James's Institute of Oncology
Leeds, , United Kingdom
UCLH - Clinical Trials Pharmacy B&D Centre
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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2020-001021-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO41944
Identifier Type: -
Identifier Source: org_study_id
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