About this trial
This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. A longitudinal survey will be carried out by collecting patients' data before starting CAR-T (T0) and after 6 (T1), 12 (T2) and 24 (T3) months after CAR-T infusion.
Eligibility criteria
Qualifiers
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).
Patients undergoing CD19-targeted CAR-T cell salvage therapy for relapsed/refractory disease according to AIFA inclusion criteria.
Age over 18-years-old at the time of lymphoma diagnosis.
Disqualifiers
Patient with histological diagnosis of mantle cell lymphoma (MCL) or acute lymphoblastic leukemia (ALL)
Patients with CNS disease localization.
Patients that received brain/neuroaxis radiotherapy.
Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.
Trial design
Treatments tested in this trial
- Chimeric Antigen Receptor T-cells (CAR-T) therapy
Treatment groups
Sponsors and collaborators
Fondazione Italiana Linfomi - ETS
Lead sponsor
Fondazione Lorenzo Farinelli Onlus
Collaborator