Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy

Arms (1)

1. label

   Patients with DLBCL/HGBL and PMBCL

   description

   Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High-Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL) scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug

   interventionNames

   1. Other: Chimeric Antigen Receptor T-cells (CAR-T) therapy

Primary outcomes (19)

1. measure

   Self-assessed neurocognitive performance

   timeFrame

   The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)

   description

   Self-assessed neurocognitive performance will be evaluated through Functional Assessment of Cancer Therapy - Cognitive questionnaire (FACT-Cog Version 3). The FACT-Cog (Version 3) is a self-report questionnaire developed within the measurement system of FACIT.org (Functional Assessment of Chronic Illness Therapy) to assess perceived cognitive functioning in individuals with cancer. The instrument includes 37 items in total, although the most commonly reported total score is based on 33 scored items. Each item is rated on a 5-point Likert scale (0-4) (0 = not at all; 4 = very much / very often, depending on the item). Total score (33-item scoring): Minimum: 0, Maximum: 132. Score interpretation: higher scores indicate better perceived cognitive functioning, lower scores indicate greater perceived cognitive impairment.