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
Large B-Cell Lymphoma
About this trial
This is an interventional treatment trial for Large B-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Previously untreated participants with CD20-positive LBCL Confirmed availability of 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 Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease History of indolent lymphoma 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; primary effusion DLBCL; and primary cutaneous DLBCL 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 History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents 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 / Locations
- Townsville Hospital; Haematology and OncologyRecruiting
- Barwon HealthRecruiting
- Peter Maccallum Cancer CentreRecruiting
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
- Korea University Anam HospitalRecruiting
- Clinica Universitaria de Navarra; Servicio de HematologiaRecruiting
- Hospital General Universitario Gregorio Marañon; Servicio de HematologíaRecruiting
- Clinica Universidad de Navarra Madrid; Servicio de HematologíaRecruiting
- Hospital Universitario Virgen del Rocio; Servicio de HematologiaRecruiting
- National Taiwan University Hospital; Internal MedicinceRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Glofitamab + Pola-R-CHP
Pola-R-CHP
Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).
Participants will receive Pola-R-CHP.