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

Starting soon

Conditions studied: Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL)

In brief

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.

Key facts

Study ID

NCT07463781

Run by

Fondazione Italiana Linfomi - ETS

People needed

100

Starts

2026-05-01

Expected to finish

2029-05-01

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• SCDU Ematologia - AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria — Alessandria, Italy
• Clinica di Ematologia, AOU Ospedali Riuniti — Ancona, Italy
• USD-TMO Adulti - ASST Spedali Civili di Brescia — Brescia, Italy
• Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello — Palermo, Italy
• Ematologia - Grande Ospedale Metropolitano Bianchi Melacrino Morelli — Reggio Calabria, Italy
• Ematologia - Università Cattolica S. Cuore — Roma, Italy
• SC Ematologia - Ospedale "S.G. Moscati" — Taranto, Italy
• SOC Clinica Ematologica - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) — Udine, Italy

Full record on ClinicalTrials.gov

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