The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
Trial Parameters
Brief Summary
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of Pola-ZR2 (polatuzumab vedotin, zanubrutinib, rituximab and lenalidomide) versus ZR2 (zanubrutinib, rituximab and lenalidomide) in the treatment of old patients with de novo diffuse large B-cell lymphoma
Eligibility Criteria
Inclusion Criteria: Patients must satisfy all of the following criteria to be enrolled in the study: * Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement) * Aged ≥ 80 years old or aged 70-79 with comprehensive geriatric assessment stratified as unfit or frail * International prognostic index score 2 to 5 * At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters) * Able to swallow capsules * Life expectancy of at least 3 months determined by researchers * The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research. * Anti-lymphoma drugs have not been used before (except glucocorticoids) Exclusion Criteria: Presence of any of the following criteria will exclude a patient