For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria


  1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL), not otherwise specified
  2. 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
  3. At least one (≥1) line of prior systemic therapy
  4. 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
  5. Confirmed availability of tumor tissue, unless unobtainable per investigator assessment. Freshly collected biopsy is preferred. Archival tissue is acceptable
  6. 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
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  8. 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
  9. Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
  10. Adequate renal function, defined as an estimated creatinine clearance ≥30 mL/min

EXCLUSION CRITERIA

Exclusion Criteria


  1. Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation
  2. History of transformation of indolent disease to DLBCL
  3. 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
  4. Primary mediastinal B-cell lymphoma
  5. 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
  6. Contraindication to obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab
  7. Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
  8. Peripheral neuropathy assessed to be Grade >1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
  9. 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
  10. Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
  11. Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
  12. Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  13. 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
  14. Positive SARS-CoV-2 infection within 30 days prior to the first study treatment, including asymptomatic SARS-CoV-2 infection
  15. Documented SARS-CoV-2 infection within 6 months of first study treatment
  16. Suspected or latent tuberculosis
  17. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  18. Known or suspected chronic active Epstein-Barr viral infection
  19. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  20. Known history of progressive multifocal leukoencephalopathy
  21. Adverse events from prior anti-cancer therapy not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
  22. 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
  23. Prior solid organ transplantation
  24. Prior allogeneic stem cell transplant
  25. Active autoimmune disease requiring treatment
  26. 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
  27. Corticosteroid therapy within 2 weeks prior to first dose of study treatment (exceptions defined by study protocol)
  28. Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
  29. Clinically significant history of cirrhotic liver disease

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Diffuse Large B-cell Lymphoma

Age (in years)

18+

Phase

Phase 3

Participants needed

270

Est. Completion Date

Apr 15, 2025

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT04408638

Study number

GO41944

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