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Study of Glofitamab, Gemcitabine, and Oxaliplatin for Relapsed or Refractory DLBCL

This study is looking at a new treatment combination for people in the U.S. with diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or hasn't responded to previous treatments (refractory). The treatment involves three medicines: glofitamab, gemcitabine, and oxaliplatin. Glofitamab is an immunotherapy, meaning it helps your body's immune system fight cancer. You might also receive tocilizumab if needed for side effects, and obinutuzumab before treatment. The study aims to see how safe this combination is and how many people have a complete response to the treatment. You may be able to join if you have DLBCL that has relapsed or is refractory and you've had at least one prior treatment. The study plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.
What's involved
Participants will receive glofitamab for up to 12 cycles, and gemcitabine and oxaliplatin for up to 8 cycles. Each cycle lasts 21 days.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and complete response rates for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06624085

A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hoffmann-La Roche
~50 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:GlofitamabTocilizumabObinutuzumabGemcitabineOxaliplatin

At a glance

Recruiting sites
11 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (AEs)
Measured over Up to 3 years
+1 more outcome measured

Conditions

Lymphoma

Explore related trials

Diffuse Large B-Cell Lymphoma

NCT06624085

Where you'd take part

This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Cancer Institute

    Orlando, Floridano site contact published

    Recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, Puerto Ricono site contact published

    Recruiting

  • Baylor College of Medicine

    Houston, Texasno site contact published

    Recruiting

  • Hoag Memorial Hospital

    Newport Beach, Californiano site contact published

    Recruiting

  • Kansas City VA Medical Center

    Kansas City, Kansasno site contact published

    Recruiting

  • Renovatio Clinical

    The Woodlands, Texasno site contact published

    Recruiting

  • Saddleback Memorial Medical Center

    Laguna Hills, Californiano site contact published

    Recruiting

  • Stony Brook Univ Cancer Ctr

    Stony Brook, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: GO44900 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728
Email the study team

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Eligibility criteria

Inclusion

Histologically confirmed DLBCL, not otherwise specified (NOS)
Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \< 6 months after completion of the last line of therapy) disease
At least one prior line of 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) Performance Status of 0, 1, or 2

Exclusion

Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
Participant 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 NOS, 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
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 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 or history of CNS lymphoma
Prior CNS involvement that has been definitively treated and confirmed via 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, or significant pulmonary disease
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment
Suspected or latent tuberculosis
Positive test results for hepatitis B (HBV) or hepatitis C (HCV)
Known or suspected chronic active Epstein-Barr viral infection
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Known history of progressive multifocal leukoencephalopathy
Prior solid organ transplantation
Prior allogenic stem cell transplant
Active autoimmune disease requiring treatment
Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment
Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient 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

What this trial measures

  • Incidence of Adverse Events (AEs)Up to 3 years
  • Complete response (CR) rateUp to 3 years