Resumen

El propósito de este estudio es comparar la eficacia y seguridad de glofitamab en combinación con polatuzumab vedotina más rituximab, ciclofosfamida, doxorrubicina y prednisona (Pola-R-CHP) versus Pola-R-CHP en participantes con linfoma de células B grandes (LCBG) CD20-positivo no tratado previamente.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Glofitamab

Polatuzumab vedotin

Rituximab

Cyclophosphamide

Doxorubicin

Prednisone

Ubicaciones

Instituto Alexander Fleming

FUNDALEU

Hospital Aleman de Buenos Aires

Sanatorio Allende

Patrocinadores