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

  • Cancer
  • Non Hodgkin Lymphoma (NHL)
  • Lymphoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Not yet recruiting

This trial runs in
N/A
Trial Identifier:

NCT06624085 GO44900

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT06624085, GO44900 Trial Identifier
      Glofitamab, Tocilizumab, Obinutuzumab, Gemcitabine, Oxaliplatin Treatments
      Lymphoma Condition
      Official Title

      A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • 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 Criteria
      • 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

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