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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS

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

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fondazione Italiana Linfomi - ETS

Lead sponsor

Fondazione Lorenzo Farinelli Onlus

Collaborator