Actively Recruiting

Age: 5Years +
All Genders
Healthy Volunteers
NCT05237986

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-07

60

Participants Needed

3

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 5Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants diagnosed with relapsed or refractory leukemia or lymphoma scheduled to receive CAR T-cell therapy at enrolling sites
  • Data sharing allowed for participants enrolled on a CAR T-cell treatment protocol
  • Age 5 to 35 years old
  • Participant has an eligible caregiver willing to complete assessments
  • Participants under 18 or 18 and older if needed must have a caregiver to help set up testing environment
  • Participant can speak and understand English or Spanish
  • Participant has access to a computer or tablet with camera and internet
  • Participant or parent/guardian can understand and is willing to sign consent
  • Caregivers are 18 years or older, can speak and read English or Spanish
  • Caregivers have access to a computer or tablet
  • Caregivers willing to help set up testing environment if participant is under 18 or 18 and older if needed
  • Caregivers can understand and are willing to sign consent
Not Eligible

You will not qualify if you...

  • Participants with a pre-existing global intellectual disability such as Down Syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Children s Hospital of Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

2

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

3

Seattle Children s Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

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Research Team

N

NCI Pediatric Leukemia, Lymphoma Transpl

CONTACT

P

Pamela L Wolters, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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