Overview

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Principal investigator

Eligibility criteria

Inclusion Criteria:
*  Previously untreated participants with CD20-positive LBCL
*  Ability to provide tumor tissue
*  International prognostic index (IPI) score 2-5
*  Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
*  At least one bi-dimensionally measurable lesion, defined as \> 1.5 cm in its longest dimension as measured by CT or MRI
*  Left ventricular ejection fraction (LVEF) \>/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
*  Adequate hematologic function
*  Negative HIV test at screening with exceptions as defined by the protocol
*  Negative SARS-CoV-2 antigen or PCR test

Exclusion Criteria:
*  Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
*  Prior solid organ transplantation
*  Participants receiving systemic immunosuppressive agent such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 4 weeks prior to first dose of study treatment
*  Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
*  History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia)
*  Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type
*  Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
*  Prior treatment with systemic immunotherapeutic agents
*  Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
*  Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
*  Prior radiotherapy to the mediastinal/pericardial region
*  Prior therapy for LBCL, with the exception of corticosteriods
*  Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
*  History of other malignant or non-malignant diseases that could affect compliance with the protocol or interpretation of results
*  Significant or extensive history of cardiovascular disease
*  Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
*  Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
*  Known or suspected chronic active Epstein-Barr viral infection
*  Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
*  Active autoimmune disease requiring treatment
*  Clinically significant liver disease
*  Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover are prohibited
*  Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
*  Suspected active or latent tuberculosis
*  Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1)
*  History of progressive multifocal leukoencephalopathy
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For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Mariel Mimi McKay
Not currently recruiting, contact if interested.