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An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Purpose

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).

Condition

Large B-Cell Lymphoma

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 > 50 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control - History of other malignancy 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 which is not well controlled by therapy - 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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Glofitamab + Pola-R-CHP	Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).	Drug: Glofitamab Participants will receive intravenous (IV) glofitamab Drug: Polatuzumab vedotin Participants will receive IV polatuzumab vedotin in combination with R-CHP Drug: Rituximab Participants will receive IV rituximab Drug: Cyclophosphamide Participants will receive cyclophosphamide as part of CHP chemotherapy Drug: Doxorubicin Participants will receive IV doxorubicin Drug: Prednisone Participants will receive oral prednisone as part of CHP chemotherapy
Active Comparator Pola-R-CHP	Participants will receive Pola-R-CHP.	Drug: Glofitamab Participants will receive intravenous (IV) glofitamab Drug: Polatuzumab vedotin Participants will receive IV polatuzumab vedotin in combination with R-CHP Drug: Rituximab Participants will receive IV rituximab Drug: Cyclophosphamide Participants will receive cyclophosphamide as part of CHP chemotherapy Drug: Doxorubicin Participants will receive IV doxorubicin Drug: Prednisone Participants will receive oral prednisone as part of CHP chemotherapy

Recruiting Locations

Medstar Franklin Square Medical Center
Baltimore, Maryland 21237

More Details

Status: Recruiting
Sponsor: Hoffmann-La Roche

Study Contact

Reference Study ID Number: GO44145 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.