Last updated 16 days ago
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
1130 patients around the world
Available in Spain, Argentina
Hoffmann-La Roche
9Research sites
1130Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Large B-cell lymphoma
Lymphoma
Non-Hodgkin lymphoma
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro de Internación e Investigación Clínica FUNDALEU
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Centro Médico Austral OMI - CABA
Hospital Alemán
Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
Hospital General de Mexico Dr. Eduardo Liceaga - Ciudad de México
Recruiting
Instituto Nacional de Cancerología - Ciudad de México
Recruiting
Health Pharma Professional Research
Recruiting
StudyGO44145
SponsorHoffmann-La Roche
Conditions
Large B-cell lymphomaNon-Hodgkin lymphoma
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06047080
