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ClinicalTrials.gov ID

NCT07463781

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Mar 13, 2026Actual

Start Date

May 2026Estimated

Primary Completion Date

May 2029Estimated

Completion Date

May 2029Estimated

Official Title

Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy: a Multicenter Observational Prospective Study

Brief Summary

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.

• Diffuse Large B Cell Lymphoma (DLBCL)
• High Grade B Cell Lymphoma
• Primary Mediastinal B-cell Lymphoma (PMBCL)

• Chimeric Antigen Receptor T-cells (CAR-T) therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

Collaborators

Fondazione Lorenzo Farinelli OnlusUNKNOWN

guido.gini@ospedaliriuniti.marche.it

simona.sica@unicatt.it

claudia.ingrosso@asl.taranto.it