RecruitingNCT05237986

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

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


Sponsor

National Cancer Institute (NCI)

Enrollment

60 participants

Start Date

Jun 23, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study tracks thinking and memory skills (cognition) in children and young adults with leukemia or lymphoma who receive CAR T-cell therapy — a cutting-edge treatment that reprograms a patient's own immune cells to fight cancer. The goal is to understand whether this treatment affects the brain over time. **You may be eligible if...** - You are between 5 and 35 years old with relapsed or treatment-resistant leukemia or lymphoma - You are scheduled to receive CAR T-cell therapy at one of the participating hospitals - You can speak and understand English or Spanish - You have access to a computer or tablet with a camera and internet - A caregiver (age 18+) is available to support you **You may NOT be eligible if...** - You have a pre-existing global intellectual disability (such as Down syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Children s Hospital of Los Angeles

Los Angeles, California, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Seattle Children s Hospital

Seattle, Washington, United States

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NCT05237986


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