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

NCT05237986 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

CAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells. Researchers want to learn more about the effects of potential problems that may be associated with this treatment. We are specifically interested in learning if and how this treatment may affect the brain or your thinking skills.

Objective:

To learn if CAR T-cell therapy can affect how children and adults think, process, and remember things.

Eligibility:

People aged 5-35 who have blood cancer that has not responded to treatment, or the blood cancer has come back after treatment, and who will receive CAR T-cell therapy. Caregivers are also needed. All participants must be able to speak and read in English or Spanish.

Design:

Participants will be screened with a medical history.

Information from participants medical records will be collected.

Participants will take tests at home or at NIH to see how well they think, read, learn, remember, reason, and pay attention. The tests will be both computerized and paper/pencil. They will take less than 1 hour to complete.

Participants and a parent/adult observer will complete a 5-minute Background Information Form and a checklist of nervous system symptoms.

If participants are 5 years or older, they will participate in activities to test their ability to do different thinking tasks, like answer questions, complete puzzle patterns, and remember things.

Participants and their caregivers will complete questions to see if they are having specific symptoms related to receiving CAR T-cells. The questions will assess their well-being and needs. The questions will take less than 1 hour to complete.

Some tests and questions will be repeated at different time points in the study.

Participation will last for up to 3 years.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

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

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2028-09-01
Completion
2028-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05237986 on ClinicalTrials.gov