Lymphoma Receiving CAR-T TherapyNCT04107285
Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy
An observational study of Lymphoma Receiving CAR-T Therapy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma Receiving CAR-T Therapy
- What is being tested?
- neurocognitive evaluations, brain MRIs and Blood samples
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
Who may be able to join
- Cohorts A and B
- Patients must be 18 years of age or older
- Patients must have adequate end organ function for CAR T cell therapy
- Eastern Cooperative Group (ECOG) performance status of 0 to 2
- Meet cardiac, pulmonary, hematologic, hepatic, and renal requirements for CART therapy as described in corresponding product package insert
- No evidence of central nervous system disease at study entry
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- Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional.
- o Patients who report that English is not their primary language will be asked the US Census English proficiency question: "How well do you speak English," and the answer "very well" will be required
- Additional Cohort Specific Inclusion Criteria: Cohort A Subjects must meet all of the following criteria to be enrolled in the Lymphoma cohort of this study
- Planned treatment with commercial CD19-specific CAR T cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma.
- Additional Cohort Specific Inclusion Criteria: Cohort B Subjects must meet all of the following criteria to be enrolled in the Multiple Myeloma cohort of this study
- Planned treatment with commercial BCMA CAR T cell therapy ciltacabtagene autoleucel for multiple myeloma
Who cannot join
- All Cohorts
- Signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period.
- Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
- History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report
- A history of epilepsy as per medical records or patient report
- Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report
- Evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
- Contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denise Correa, PhD contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Bianca Santomasso, MD, PhD, 646-888-2092
Dennis Correa, PhD, 212-610-0487
About this study
Official title: A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy
The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.
- Conditions
- Lymphoma Receiving CAR-T Therapy
- Being tested
- neurocognitive evaluations, brain MRIs, Blood samples
- Keywords
- Neurocognitive Evaluations, Neuroimaging Evaluations, 19-268
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurocognitive evaluationsBehavioural
The test battery consists of validated and reliable measures of attention, executive functions and memory.
brain MRIsDiagnostic test
Patients will undergo baseline and follow-up research MRIs in the same scanner at MSKCC (3 Tesla scanner (GE, Discovery 750W, USA) with a GEM HNU 24-channel head coil) (total scan duration=15 minutes).
Blood samplesOther
Research blood samples will be collected pre-CAR T infusion; day of CART infusion (day 0), and post-infusion days 7, 14, 21, 28 (+/- 7 days), at start of neurotoxicity, and at 3-4 months and 6-7 months post-CART.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive evaluation prior to and following CART for relapsed/refractory B cell lymphoma | Not described Receives: Behavioral: neurocognitive evaluations; Diagnostic Test: brain MRIs; Other: Blood samples | |
| Neurocognitive evaluation prior to and following CART with cilta-cel for multiple myeloma | Not described Receives: Behavioral: neurocognitive evaluations; Diagnostic Test: brain MRIs; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in neurocognitive functions
correlations of neurocognitive scores with the FACIT-FS (fatigue) scale score The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (FACITFS V-4 56, is a 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue [66]. The questionnaire asks respondents to indicate the extent to which each item applied to them over "the past 7 days" using a 5-point Likert-type response format ranging from "0 - Not at all" to "4 - Very much". The 13 items produce the Fatigue Subscale (FS) score (range 0 - 52).
Measured: 1 year
changes in functional connectivity
MRIs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start25 Sep 2019
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma Receiving CAR-T TherapyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bianca Santomasso, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107285
- Sponsor's protocol ID
- 19-268
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy
- ClinicalTrials.gov ID
- NCT04107285
- Acronym / sponsor ID
- 19-268
- Conditions
- Lymphoma Receiving CAR-T Therapy
- Keywords
- Neurocognitive Evaluations, Neuroimaging Evaluations, 19-268
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Sep 2019 (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.
The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive evaluation prior to and following CART for relapsed/refractory B cell lymphoma | – | Behavioral: neurocognitive evaluations, Diagnostic Test: brain MRIs, Other: Blood samples |
| Neurocognitive evaluation prior to and following CART with cilta-cel for multiple myeloma | – | Behavioral: neurocognitive evaluations, Diagnostic Test: brain MRIs, Other: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.
Key inclusion criteria (12 listed)
- Cohorts A and B
- Patients must be 18 years of age or older
- Patients must have adequate end organ function for CAR T cell therapy
- No evidence of central nervous system disease at study entry
- Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional.
Key exclusion criteria (8 listed)
- All Cohorts
- Signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period.
- Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
- History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report
- A history of epilepsy as per medical records or patient report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurocognitive evaluationsThe test battery consists of validated and reliable measures of attention, executive functions and memory. | Behavioural | Neurocognitive evaluation prior to and following CART for relapsed/refractory B cell lymphoma, Neurocognitive evaluation prior to and following CART with cilta-cel for multiple myeloma |
| brain MRIsPatients will undergo baseline and follow-up research MRIs in the same scanner at MSKCC (3 Tesla scanner (GE, Discovery 750W, USA) with a GEM HNU 24-channel head coil) (total scan duration=15 minutes). | Diagnostic test | Neurocognitive evaluation prior to and following CART for relapsed/refractory B cell lymphoma, Neurocognitive evaluation prior to and following CART with cilta-cel for multiple myeloma |
| Blood samplesResearch blood samples will be collected pre-CAR T infusion; day of CART infusion (day 0), and post-infusion days 7, 14, 21, 28 (+/- 7 days), at start of neurotoxicity, and at 3-4 months and 6-7 months post-CART. | Other | Neurocognitive evaluation prior to and following CART for relapsed/refractory B cell lymphoma, Neurocognitive evaluation prior to and following CART with cilta-cel for multiple myeloma |
Primary outcome
changes in neurocognitive functions
Time frame: 1 year
correlations of neurocognitive scores with the FACIT-FS (fatigue) scale score The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (FACITFS V-4 56, is a 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue [66]. The questionnaire asks respondents to indicate the extent to which each item applied to them over "the past 7 days" using a 5-point Likert-type response format ranging from "0 - Not at all" to "4 - Very much". The 13 items produce the Fatigue Subscale (FS) score (range 0 - 52).
changes in functional connectivity
Time frame: 1 year
MRIs
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 23 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Denise Correa, PhD contact
Bianca Santomasso, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma Receiving CAR-T Therapy, run by Memorial Sloan Kettering Cancer Center at 1 site 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 12 inclusion and 8 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Bianca Santomasso, MD, PhD (646-888-2092, santomab@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in neurocognitive functions (time frame: 1 year). The study lists 2 primary outcomes in all. 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 23 Oct 2026.