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New study to track brain health after CAR-T cancer treatment

NCT ID NCT07463781

Knowledge-focused Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 100 adults with certain types of lymphoma who are receiving CAR-T cell therapy. Researchers will test memory, attention, and other thinking skills before treatment and at 6, 12, and 24 months after. The goal is to learn how CAR-T therapy affects brain function over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CAR-T cell therapy
What this could lead to
If successful, this could help doctors better understand and manage memory and thinking problems that may occur after CAR-T therapy.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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) scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma high grade B-cell lymphoma primary mediastinal large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B cell lymphoma (DLBCL) High-grade B-cell lymphoma Primary mediastinal B-cell lymphoma (PMBCL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinica di Ematologia, AOU Ospedali Riuniti

    Ancona, 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

  • SCDU Ematologia - AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria

    Alessandria, Italy

  • SOC Clinica Ematologica - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

    Udine, Italy

  • USD-TMO Adulti - ASST Spedali Civili di Brescia

    Brescia, Italy

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