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
Glofitamab: Participants will receive intravenous (IV) glofitamab
Polatuzumab vedotin: Participants will receive IV polatuzumab vedotin in combination with R-CHP
Rituximab: Participants will receive IV rituximab
Cyclophosphamide: Participants will receive cyclophosphamide as part of CHP chemotherapy
Doxorubicin: Participants will receive IV doxorubicin
Prednisone: Participants will receive oral prednisone as part of CHP chemotherapy
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
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 \> 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
Primary outcome measure(s)
Progression-free survival (PFS) as determined by Independent Review Facility (IRF) — From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)
Trial sites (229)
Facility
City
Region
Status
Alaska Oncology & Hematology, LLC
Anchorage
Alaska
Kaiser Permanente - Anaheim (E. La Palma)
Anaheim
California
University of California, San Francisco-Fresno
Clovis
California
City of Hope National Medical Center
Duarte
California
City of Hope - Lennar Foundation Cancer Center
Irvine
California
Valkyrie Clinical Trials
Los Angeles
California
UCLA Jonsson Comprehensive Cancer Center
Los Angeles
California
Kaiser Permanente - Roseville
Roseville
California
Kaiser Permanente - Santa Clara
Santa Clara
California
Stanford Univ School of Med
Stanford
California
Kaiser Permanente Medical Ctr
Vallejo
California
University of Colorado Cancer Center
Aurora
Colorado
Rocky Mountain Cancer Center - Denver
Littleton
Colorado
Yale University School Of Medicine
New Haven
Connecticut
Medstar Franklin Square Medical Center
Washington D.C.
District of Columbia
Miami Cancer Institute of Baptist Health, Inc.
Miami
Florida
Memorial Cancer Institute at Memorial West
Pembroke Pines
Florida
Hawaii Cancer Care
Honolulu
Hawaii
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago
Illinois
Illinois Cancer Care
Peoria
Illinois
Springfield Clinic
Springfield
Illinois
University of Iowa
Iowa City
Iowa
Ascension Via Christi Research
Wichita
Kansas
Ochsner Medical Center
New Orleans
Louisiana
Massachusetts General Hospital
Boston
Massachusetts
Dana Farber Cancer Institute
Boston
Massachusetts
Boston Medical Center
Boston
Massachusetts
Henry Ford Health System
Novi
Michigan
M Health Fairview University of Minnesota Medical Center
Minneapolis
Minnesota
St. Luke's Hospital
Chesterfield
Missouri
Washington University School of Medicine
St Louis
Missouri
University of Nebraska Medical Center
Omaha
Nebraska
NYU Langone Hospital?Brooklyn
Brooklyn
New York
NYU Long Island Hospital
Mineola
New York
New York University Medical Center PRIME
New York
New York
Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care
New York
New York
Weill Cornell Medical College-New York Presbyterian Hospital
New York
New York
University of Rochester Medical Center
Rochester
New York
North Shore Hematology Oncology Association PC
Shirley
New York
Montefiore Medical Center
The Bronx
New York
+ 189 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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