An observational study in Lymphoma and Leukemia, sponsored by National Cancer Institute (NCI). Recruiting at 3 sites in United States. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Cancer Institute (NCI) · Observational
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.
Background:
Objective:
-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
Eligibility:
Design:
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 60 is below the median of 167 across 393 observational studies indexed under Lymphoma.
Browse Lymphoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy and their caregiver(s).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with disease
Caregivers (informants)
EXCLUSION CRITERIA:
-Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy.
Caregivers (informants)
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.
Time frame: 12 months post CAR T-cell therapy
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
The changes in neurocognitive outcomes (reaction time, visual attention, learning and memory, working memory, and executive function) and daily functioning (everyday executive functioning, adaptive behavior, physical and mental health symptoms) 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.
Time frame: 12 months post CAR T-cell therapy
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Started Jun 2025 (actual). Primary completion is estimated for Sep 2028, 38 months after the start.
Of 140 non-industry observational studies under Lymphoma, half reached primary completion within 90 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 269. This study's planned 38 months is below that.
Counting every sponsor, half of 159 studies reached it within 82 months; a quarter within 39 and three quarters within 269.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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