RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-23
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05237986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with disease
  2. * Participants are diagnosed with relapsed/refractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites
  3. * For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed.
  4. * Age \>= 5 and \<=35 years old
  5. * Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study
  6. * 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
  7. * Participant must be able to speak and understand English or Spanish
  8. * Participants must have access to a computer or tablet with a camera and an internet connection
  9. * Participant or parent/guardian must be able to understand and willing to sign a written consent document
  10. * Caregivers (informants)
  11. * Participants must be able to speak and read in English or Spanish
  12. * Participants who are caregivers for participants with disease addressed above
  13. * Age \>= 18 years old
  14. * Participants must have access to a computer or tablet
  15. * 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
  16. * Participant is able to understand and willing to sign a written consent document
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

NCI Pediatric Leukemia, Lymphoma Transpl
CONTACT
(240) 760-6970
ncilltct@mail.nih.gov
Pamela L Wolters, Ph.D.
CONTACT
(240) 760-6035
woltersp@mail.nih.gov

Principal Investigator

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

Study Locations (Sites)

Children s Hospital of Los Angeles
Los Angeles, California, 90027
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Seattle Children s Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-23
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • Cogstate
  • Memory
  • Leukemia
  • Lymphoma
  • Natural History

Additional Relevant MeSH Terms

  • Lymphoma
  • Leukemia