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

Running, not enrolling · Phase 3

Conditions studied: Large B-Cell Lymphoma

In brief

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).

Key facts

Study ID

NCT06047080

Run by

Hoffmann-La Roche

People needed

1130

Starts

2023-09-18

Expected to finish

2030-10-30

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Kaiser Permanente - Anaheim (E. La Palma) — Anaheim, California, United States
• University of California, San Francisco-Fresno — Clovis, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• City of Hope - Lennar Foundation Cancer Center — Irvine, California, United States
• Valkyrie Clinical Trials — Los Angeles, California, United States
• UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente - Roseville — Roseville, California, United States
• Kaiser Permanente - Santa Clara — Santa Clara, California, United States
• Stanford Univ School of Med — Stanford, California, United States
• Kaiser Permanente Medical Ctr — Vallejo, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Rocky Mountain Cancer Center - Denver — Littleton, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Medstar Franklin Square Medical Center — Washington D.C., District of Columbia, United States
• Miami Cancer Institute of Baptist Health, Inc. — Miami, Florida, United States
• Memorial Cancer Institute at Memorial West — Pembroke Pines, Florida, United States
• Hawaii Cancer Care — Honolulu, Hawaii, United States
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Ascension Via Christi Research — Wichita, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Alaska Oncology & Hematology, LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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