Effects of CAR T-cell therapy on thinking skills in young patients with blood cancer
Investigation of the Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
This study is trying to see how CAR T-cell therapy affects thinking skills in children and young adults with blood cancer over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | CAR T, Chimeric antigen receptor, immunotherapy |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT05237986 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the cognitive aftereffects of CAR T-cell therapy in children and young adults aged 5-35 with relapsed or refractory leukemia or lymphoma. Researchers will assess how this innovative treatment may impact memory, attention, and other cognitive functions over a 12-month period. Participants will undergo cognitive testing either at home or at designated clinical sites, and their medical histories will be reviewed to gather comprehensive data. The study also involves caregivers who will provide additional insights into the participants' cognitive performance.
Who should consider this trial
Good fit: Ideal candidates include children and young adults aged 5-35 with relapsed or refractory leukemia or lymphoma who are scheduled to receive CAR T-cell therapy.
Not a fit: Patients who do not have blood cancer or are outside the age range of 5-35 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the cognitive effects of CAR T-cell therapy, potentially leading to improved management strategies for patients undergoing this treatment.
How similar studies have performed: While CAR T-cell therapy has shown promise in treating blood cancers, the specific focus on cognitive outcomes in this context is relatively novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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., Down Syndrome)
Where this trial is running
Los Angeles, California and 2 other locations
- Children s Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
- Seattle Children s Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Pamela L Wolters, Ph.D. — National Cancer Institute (NCI)
- Study coordinator: NCI Pediatric Leukemia, Lymphoma Transpl
- Email: ncilltct@mail.nih.gov
- Phone: (240) 760-6970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.