NCT05237986 · National Cancer Institute (NCI)
Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
What this study 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.
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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....
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Los Angeles, California
- Bethesda, Maryland
- Seattle, Washington
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations