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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Feb 11, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how CAR T-cell therapy, a new treatment for blood cancers like leukemia and lymphoma, may affect thinking and memory in children and young adults between the ages of 5 and 35. CAR T-cell therapy involves changing a patient’s own immune cells to help them fight cancer. Researchers want to find out if this treatment can lead to any changes in how well patients process information, remember things, or pay attention.

To participate, individuals must have blood cancer that hasn’t responded to other treatments or has returned after treatment. They also need to have a caregiver who can help with assessments. Participants will take tests at home or at the National Institutes of Health (NIH) to measure their thinking skills. These tests are simple and will take less than an hour. Participants can expect to be involved in the study for up to three years, with some tests and questions being repeated over time to track any changes. It's important to note that participants must be comfortable speaking and reading in English or Spanish, and have access to a computer or tablet for the tests.

Gender

ALL

Eligibility criteria

• * 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., Downs Syndrome