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

NCT05237986 | Recruiting

• 2 other identifiers: 10000631000631-C
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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 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

Lymphoma; Leukemia

Keywords

Cogstate; Memory; Leukemia; Lymphoma; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

  The changes in working memory (as measured by Cogstate One-Back reaction time standardized score) from baseline to 12-month post-infusion will be determined for each participant and the paired difference will be tested for a change from zero using a paired t-test. If the paired difference is not consistent with a normal distribution, then a Wilcoxon signed rank test may be used instead.

  12 months post CAR T-cell therapy

Secondary Outcomes (1)

• To evaluate changes in additional neurocognitive domains in children and young adults with relapsed/refractory leukemia or lymphoma at 12 months post CAR T-cell therapy

  12 months post CAR T-cell therapy

Study Arms (2)

Cohort 1

Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy.

Cohort 2

Caregivers (informants)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy and their caregiver(s).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Children s Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Seattle Children s Hospital

Seattle, Washington, 98105, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Pamela L Wolters, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 14, 2022
• Study Start: June 23, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04-23

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (3)