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

NCT06624085 · Hoffmann-La Roche
In plain English

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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
About this study
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).
Eligibility criteria
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
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-28
Estimated completion: 2030-03-31
Last updated: 2026-04-02
Interventions
Drug: GlofitamabDrug: TocilizumabDrug: ObinutuzumabDrug: GemcitabineDrug: Oxaliplatin
Primary outcomes
  • Incidence of Adverse Events (AEs) (Up to 3 years)
  • Complete response (CR) rate (Up to 3 years)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: GO44900 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (16)
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Saddleback Memorial Medical CenterRecruiting
Laguna Hills, California, United States
University of California Los Angeles (UCLA) - Cancer Care - Santa MonicaRecruiting
Santa Monica, California, United States
Georgetown UniversityRecruiting
Washington D.C., District of Columbia, United States
AdventHealth Cancer InstituteRecruiting
Orlando, Florida, United States
Winship Cancer Institute of Emory UniversityRecruiting
Atlanta, Georgia, United States
University of Illinois Cancer CenterRecruiting
Chicago, Illinois, United States
Kansas City VA Medical CenterRecruiting
Kansas City, Kansas, United States
Walter Reed National Military Medical CenterRecruiting
Bethesda, Maryland, United States
Christus Health - Christus St. Vincent Regional Medical CenterRecruiting
Santa Fe, New Mexico, United States
East Carolina UniversityRecruiting
Greenville, North Carolina, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Renovatio Clinical - El PasoRecruiting
El Paso, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
Renovatio ClinicalRecruiting
The Woodlands, Texas, United States
Auxilio Mutuo Cancer CenterRecruiting
San Juan, Puerto Rico
A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma · TrialPath