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Not yet recruiting NCT07463781

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chimeric Antigen Receptor T-cells (CAR-T) therapy.
Who it may be relevant to
Registry conditions: Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Chimeric Antigen Receptor T-cells (CAR-T) therapy
    Patients will be treated with CAR-T cell product as per routine clinical practice.

Primary outcome measures

  • Self-assessed neurocognitive performance [Time frame: 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)]
  • Neurocognitive performance evaluation: Cognitive Status - Mini-Mental State Examination (MMSE) [Time frame: 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)]
  • Quality of Life (QoL) [Time frame: 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)]
  • Psychological status [Time frame: 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)]
  • Resilience [Time frame: 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)]
  • Adverse events [Time frame: The endpoint wil be evaluated at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Treatment characteristics: Previous Central Nervous System Prophylaxis [Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy)]
  • Overall Survival (OS) [Time frame: The endpoint will be evaluated from the beginning to the end of the study (at least 24 months after CAR-T infusion)]
  • Neurocognitive performance evaluation: Praxic Abilities - Rey-Osterrieth Complex Figure Test (Copy Condition) [Time frame: 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)]
  • Neurocognitive performance evaluation: Verbal Memory - Rey Auditory Verbal Learning Test (Word List 3 Recall) [Time frame: 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 8 centers
  • SCDU Ematologia - AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria — Alessandria
  • Clinica di Ematologia, AOU Ospedali Riuniti — Ancona
  • USD-TMO Adulti - ASST Spedali Civili di Brescia — Brescia
  • Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello — Palermo
  • Ematologia - Grande Ospedale Metropolitano Bianchi Melacrino Morelli — Reggio Calabria
  • Ematologia - Università Cattolica S. Cuore — Roma
  • SC Ematologia - Ospedale "S.G. Moscati" — Taranto
  • SOC Clinica Ematologica - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) — Udine

Identifiers

NCT: NCT07463781 · FIL_NEURO_CAR-T

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗