Status:

RECRUITING

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Leukemia

Eligibility:

All Genders

5+ years

Brief 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 ...

Detailed Description

Background: * Chimeric antigen receptor (CAR) T-cell immunotherapy has rapidly emerged as a successful and breakthrough treatment in pediatric and adult hematologic malignancies. However, significant...

Eligibility Criteria

Inclusion

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

Exclusion

    Key Trial Info

    Start Date :

    June 23 2025

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 30 2027

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT05237986

    Start Date

    June 23 2025

    End Date

    April 30 2027

    Last Update

    January 9 2026

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Children s Hospital of Los Angeles

    Los Angeles, California, United States, 90027

    2

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892

    3

    Seattle Children s Hospital

    Seattle, Washington, United States, 98105