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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05237986
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Accepted

Study Details

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....

Key Dates

Start date
Jun 23, 2025
Status verified
May 2026
Primary completion
Sep 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Cohort 1
    Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy.
  • Arm: Cohort 2
    Caregivers (informants)

Primary Outcome Measure

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 [ Time Frame: 12 months post CAR T-cell therapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children s Hospital of Los AngelesLos AngelesCalifornia90027
Ashley Whitaker, Ph.D., ABPP-CN
[email protected]
(323) 361-2744
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937
Seattle Children s HospitalSeattleWashington98105
Juliane Gust, M.D., Ph.D.
[email protected]
296-330-7728

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Children s Hospital of Los Angeles· Los Angeles, CANational Institutes of Health Clinical Center· Bethesda, MDSeattle Children s Hospital· Seattle, WA

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