LymphomaNCT05237986
Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
An observational study of Lymphoma and Leukemia, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jun 2025to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy and their caregiver(s).
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- -Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
- Recruiting
Children s Hospital of Los Angeles
Los Angeles, California, 90027
Ashley Whitaker, Ph.D., ABPP-CN, (323) 361-2744, awhitaker@chla.usc.edu
- Recruiting
Seattle Children s Hospital
Seattle, Washington, 98105
Juliane Gust, M.D., Ph.D., 296-330-7728, Juliane.Gust@seattlechildrens.org
About this study
Official title: Investigation of the Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
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.
Read more
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....
Read the detailed description
Background:
- Chimeric antigen receptor (CAR) T-cell immunotherapy has rapidly emerged as a successful and breakthrough treatment in pediatric and adult hematologic malignancies. However, significant toxicities can complicate the therapeutic successes of such therapy, including neurologic toxicity associated with cytokine release syndrome (CRS).
- There is a critical need to characterize the subacute and long-term neurocognitive outcomes of participants undergoing CAR T-cell therapies and to compare the results across trials, some of which are first-in-human studies. It is unknown how acute toxicity affects attention, learning, memory, processing speed, and higher order cognition in participants who are cured of their cancer and survive for many years. Information about subacute and long-term neurocognitive sequelae would help determine whether the acute toxicity of specific CAR T-cell therapies needs to be treated and prevented aggressively or whether it is fully reversible without specific intervention.
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:
- Children and young adults (age >= 5 and <=35 years old) with relapsed/refractory leukemias or lymphomas scheduled to have CAR T-cell therapy and their caregivers (informants).
- Participants who can speak and read in English or Spanish
Design:
- This is a multi-center pilot trial to study the neurocognitive effects of CAR T-cell therapy.
- Eligible participants will be seen in one of the enrolling sites.
- Neurocognitive evaluations will be conducted using a computerized test battery (Cogstate) and other paper/pencil tests that assess cognitive processes known to be most affected in participants treated for leukemia or lymphomas as well as patient-reported and observer-reported outcome measures. Participants with the disease and their informants will be enrolled in this study during the preparation of participants for CAR T-cell therapy and followed for up to 3 years post CAR infusion.
- Keywords
- Cogstate, Memory, Leukemia, Lymphoma, Natural History
- Medical subject headings
- Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy. | |
| Cohort 2 | Caregivers (informants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 12 months post CAR T-cell therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start23 Jun 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Pamela L Wolters, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237986
- Sponsor's protocol ID
- 10000631
- Other IDs
- 000631-C
- Status last verified
- 22 Oct 2026
- First submitted
- 9 Feb 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
- ClinicalTrials.gov ID
- NCT05237986
- Acronym / sponsor ID
- 10000631
- Keywords
- Cogstate, Memory, Leukemia, Lymphoma, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
Background:
- Chimeric antigen receptor (CAR) T-cell immunotherapy has rapidly emerged as a successful and breakthrough treatment in pediatric and adult hematologic malignancies. However, significant toxicities can complicate the therapeutic successes of such therapy, including neurologic toxicity associated with cytokine release syndrome (CRS).
- There is a critical need to characterize the subacute and long-term neurocognitive outcomes of participants undergoing CAR T-cell therapies and to compare the results across trials, some of which are first-in-human studies. It is unknown how acute toxicity affects attention, learning, memory, processing speed, and higher order cognition in participants who are cured of their cancer and survive for many years. Information about subacute and long-term neurocognitive sequelae would help determine whether the acute toxicity of specific CAR T-cell therapies needs to be treated and prevented aggressively or whether it is fully reversible without specific intervention.
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:
- Children and young adults (age >= 5 and <=35 years old) with relapsed/refractory leukemias or lymphomas scheduled to have CAR T-cell therapy and their caregivers (informants).
- Participants who can speak and read in English or Spanish
Design:
- This is a multi-center pilot trial to study the neurocognitive effects of CAR T-cell therapy.
- Eligible participants will be seen in one of the enrolling sites.
- Neurocognitive evaluations will be conducted using a computerized test battery (Cogstate) and other paper/pencil tests that assess cognitive processes known to be most affected in participants treated for leukemia or lymphomas as well as patient-reported and observer-reported outcome measures. Participants with the disease and their informants will be enrolled in this study during the preparation of participants for CAR T-cell therapy and followed for up to 3 years post CAR infusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy. |
| Cohort 2 | – | –Caregivers (informants) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy and their caregiver(s).
Key inclusion criteria (16 listed)
- Participants with disease
- Caregivers (informants)
Key exclusion criteria (1 listed)
- -Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Time frame: 12 months post CAR T-cell therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela L Wolters, Ph.D. principal investigator
National Cancer Institute (NCI)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Leukemia, run by National Cancer Institute (NCI) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NCI Ped LeukemiaLymph Cell Tx Tm ((240) 760-6970, ncilltct@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.