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Observational Study on Cognitive Effects of CAR T-cell Therapy in Blood Cancers

This study is looking at how CAR T-cell therapy, a treatment where your own immune cells (T-cells) are changed to fight cancer, might affect thinking skills in children and young adults. Researchers want to understand if this treatment impacts memory, processing, and other brain functions. They will follow participants for 12 months after receiving CAR T-cell therapy to see if there are any changes in their working memory. You might be able to join if you are between 5 and 35 years old, have leukemia or lymphoma that has come back or not responded to other treatments, and are scheduled to receive CAR T-cell therapy. The study is trying to enroll 60 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without providing any specific intervention. The study plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after CAR T-cell therapy to evaluate changes in working memory.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05237986

Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

Recruiting
Not specifiedAges 5+Observational
National Cancer Institute (NCI)
~60 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate changes in working memory in children and young adults with relapsed/refractory leukemia or lymphoma at 12 months post CAR T-cell therapy
Measured over 12 months post CAR T-cell therapy

Conditions

Lymphoma
Leukemia

Explore related trials

LeukemiaLymphoma

Where it's being run

3 sites across 3 states
California1
Maryland1
Washington1

Study leadership

  • Pamela L Wolters, Ph.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

NCI Ped LeukemiaLymph Cell Tx Tm
[email protected]
(240) 760-6970
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants with disease
Participants are diagnosed with relapsed/refractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites
For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed.
Age \>= 5 and \<=35 years old
Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study
Participants (\<18 years, or \>=18 years if needed) must have an eligible caregiver to assist with setting up an appropriate test environment for the remote evaluations
Participant must be able to speak and understand English or Spanish
Participants must have access to a computer or tablet with a camera and an internet connection
Participant or parent/guardian must be able to understand and willing to sign a written consent document
Caregivers (informants)
Participants must be able to speak and read in English or Spanish
Participants who are caregivers for participants with disease addressed above
Age \>= 18 years old
Participants must have access to a computer or tablet
Participants (of children \<18 years, or \>18 years if needed) must be willing to help set up an appropriate test environment for the remote evaluations
Participant is able to understand and willing to sign a written consent document

Exclusion

Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)

What this trial measures

  • To evaluate changes in working memory in children and young adults with relapsed/refractory leukemia or lymphoma at 12 months post CAR T-cell therapy12 months post CAR T-cell therapy

    The changes in working memory (as measured by Cogstate One-Back reaction time standardized score) from baseline to 12-month post-infusion will be determined for each participant and the paired difference will be tested for a change from zero using a paired t-test. If the paired difference is not consistent with a normal distribution, then a Wilcoxon signed rank test may be used instead.